NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
FOR THE
THREE AND SIX
MONTHS ENDED
JUNE 30, 2015
NOTE 1. BASIS OF PRESENTATION
The accompanying unaudited
Condensed Consolidated Financial Statements
of
Endo International plc
have been prepared in accordance with United States (U.S.) generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying
Condensed Consolidated Financial Statements
of Endo and its subsidiaries, which are unaudited, include all normal and recurring adjustments necessary to a fair statement of the Company’s financial position as of
June 30, 2015
and the results of our operations and our cash flows for the periods presented. Operating results for the
three and six
months ended
June 30, 2015
are not necessarily indicative of the results that may be expected for the year ending
December 31, 2015
. The year-end
Condensed Consolidated Balance Sheet
data as of
December 31, 2014
was derived from the audited financial statements.
In periods prior to
February 28, 2014
, our
Condensed Consolidated Financial Statements
presented the accounts of Endo Health Solutions Inc., which was incorporated under the laws of the State of Delaware on November 18, 1997, and all of its subsidiaries (EHSI). Endo International plc was incorporated in Ireland on October 31, 2013 as a private limited company and re-registered effective February 18, 2014 as a public limited company. It was established for the purpose of facilitating the business combination between EHSI and Paladin Labs Inc. (Paladin). On
February 28, 2014
, we became the successor registrant of EHSI and Paladin in connection with the consummation of certain transactions further described elsewhere in our
Condensed Consolidated Financial Statements
. In addition, on
February 28, 2014
, the shares of Endo International plc began trading on the NASDAQ under the symbol “ENDP,” the same symbol under which EHSI’s shares previously traded, and on the Toronto Stock Exchange under the symbol “ENL”.
References throughout to “Endo”, the “Company”, “we”, “our” or “us” refer to financial information and transactions of Endo Health Solutions Inc. prior to February 28, 2014 and Endo International plc thereafter.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our Consolidated Financial Statements and accompanying notes included in our Annual Report on Form 10-K for the year ended
December 31, 2014
.
During the three months ended June 30, 2015, the Company recorded a
$2.7 million
correcting adjustment to deferred taxes resulting from the impact of currency translation on a foreign denominated intercompany loan. Based on changes in the underlying exchange rate over the first three months of 2015, the impact to the Company’s
Condensed Consolidated Balance Sheet
as of March 31, 2015 would have been a
$22.2 million
increase to Accumulated other comprehensive loss with an offset to Deferred income taxes. The corresponding impact for the three months ended June 30, 2015 would have been a
$19.5 million
decrease to Accumulated other comprehensive loss with an offset to Deferred income taxes. The net
$2.7 million
adjustment is included in Foreign currency translation gain (loss) in the
Condensed Consolidated Statements of Comprehensive (Loss) Income
for the three and six months ended June 30, 2015. The Company determined that neither the prior period nor the current period corrections are material to the periods presented or the expected 2015 full year results.
NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards update (ASU) No. 2014-09,
“Revenue from Contracts with Customers”
(ASU 2014-09). ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled to receive in exchange for those goods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. On July 9, 2015, the FASB deferred the effective date of the new revenue recognition standard by one year. This ASU, as issued, is effective for annual reporting periods beginning after December 15, 2017 and interim reporting periods within that reporting period. The Company currently plans to adopt this ASU on January 1, 2018. Companies may use either a full retrospective or a modified retrospective approach to adopt this ASU. The Company is currently evaluating the impact of ASU 2014-09 on the Company’s consolidated results of operations and financial position.
In April 2015, the FASB issued ASU 2015-03, “
Simplifying the Presentation of Debt Issuance Costs
” (ASU 2015-03). ASU 2015-03 requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of the related debt liability instead of being presented as an asset. Debt disclosures will include the face amount of the debt liability and the effective interest rate. ASU 2015-03 is effective for fiscal years beginning after December 15,
2015. ASU 2015-03 requires retrospective application. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2015-03 on the Company’s consolidated financial position.
In April 2015, the FASB issued ASU 2015-05, “
Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement
” (ASU 2015-05). ASU 2015-05 provides guidance to customers about whether a cloud computing arrangement includes a software license. If a cloud computing arrangement includes a software license, then the customer should account for the software license element of the arrangement consistent with the acquisition of other software licenses. If a cloud computing arrangement does not include a software license, the customer should account for the arrangement as a service contract. The guidance will not change GAAP for a customer’s accounting for service contracts. In addition, all software licenses within the scope of Subtopic 350-40 will be accounted for consistent with other licenses of intangible assets as a result of the guidance in ASU 2015-05. ASU 2015-05 is effective for annual periods beginning after December 15, 2015 and interim periods in annual periods beginning after December 15, 2016, with early adoption permitted. Companies may use either a full retrospective approach or a prospective approach entered into or materially modified after the effective date to adopt this ASU. The Company is currently evaluating the impact of ASU 2015-05 on the Company’s consolidated results of operations and financial position.
In July 2015, the FASB issued ASU 2015-11, “
Simplifying the Measurement of Inventory”
(ASU 2015-11). ASU 2015-11 states that an entity should measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. For public entities, ASU 2015-11 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments in this update should be applied prospectively and early application is permitted. The Company is currently evaluating the impact of ASU 2015-05 on the Company’s consolidated results of operations and financial position.
NOTE 3. DISCONTINUED OPERATIONS
American Medical Systems
On
February 24, 2015
, the Board of Directors approved a plan to sell the Company’s American Medical Systems Holdings, Inc. (AMS) business, which comprises the entirety of our
Devices
segment. Subsequently, the Company entered into a definitive agreement to sell the Men’s Health and Prostate Health components of the AMS business to Boston Scientific Corporation (Boston Scientific) for up to
$1.65 billion
, with
$1.60 billion
in upfront cash. The Company is also eligible to receive a potential milestone payment of
$50.0 million
in cash conditioned on Boston Scientific achieving certain product revenue milestones in the Men’s Health and Prostate Health components in 2016. In addition, Boston Scientific agreed to pay
$60.0 million
in exchange for
60,000
shares of Series B Non-Voting Preferred Stock issued by American Medical Systems Holdings, Inc. The preferred stock entitles the holder to dividends payable quarterly at an initial annual rate of
7.25%
, which will increase by
0.25%
each year on January 1, from 2018 until the rate equals
11.50%
. While the preferred stock remains outstanding, American Medical Systems Holdings, Inc. will be subject to certain affirmative and negative covenants, including an obligation to maintain assets in excess of the liquidation preference of the preferred stock, and restrictions on the sale of assets and the incurrence of certain indebtedness. The preferred stock matures and becomes mandatorily redeemable in 2035.
The transaction with Boston Scientific closed on
August 3, 2015
. In addition, the Company is currently pursuing a sale of the Women’s Health component of the AMS business.
The majority of the assets and liabilities of the AMS business, previously known as the
Devices
segment, are classified as held for sale in the
Condensed Consolidated Balance Sheets
. Certain of AMS’s assets and liabilities, primarily with respect to its product liability accrual for all known pending and estimated future claims related to vaginal mesh cases, the related Qualified Settlement Funds and certain intangible and fixed assets, are not classified as held for sale based on management’s current expectation that these assets and liabilities will remain with the Company subsequent to sale. Depreciation and amortization expense are not recorded on assets held for sale. The operating results of this business are reported as Discontinued operations, net of tax in the
Condensed Consolidated Statements of Operations
for all periods presented.
In connection with classifying AMS as held-for-sale, the Company was required to compare the estimated fair values of the underlying disposal groups, less the costs to sell, to the respective carrying amounts. As a result of this analysis, the Company recorded a combined asset impairment charge of
$222.8 million
during the three months ended March 31, 2015, which was classified as Discontinued operations, net of tax in the
Condensed Consolidated Statements of Operations
. We estimated the fair value of the Men’s Health and Prostate Health division based on the agreed upon purchase price with Boston Scientific. The fair value of the Women’s Health component was estimated based on expressions of interest from third parties. In addition, as a result of determining that the sale of the AMS disposal groups was probable, the Company re-assessed its permanent reinvestment assertion for certain components of the AMS business and recognized a corresponding tax expense of
$0.5 million
during the three months and a
$159.2 million
tax benefit during six months ended
June 30, 2015
, respectively, which was recorded as
Income tax (benefit) expense
(a component of
(loss) income
from continuing operations) in the
Condensed Consolidated Statements of Operations
. In connection with
the closing of the sale to Boston Scientific, it is expected there will be further tax benefits which will be recorded during the three months ended September 30, 2015.
The following table provides the operating results of the Discontinued operations of AMS, net of tax for the
three and six
months ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Revenue
|
$
|
119,940
|
|
|
$
|
125,836
|
|
|
$
|
238,605
|
|
|
$
|
249,603
|
|
|
Litigation related and other contingencies, net
|
$
|
268,552
|
|
|
$
|
32,000
|
|
|
$
|
273,752
|
|
|
$
|
658,151
|
|
|
Asset impairment charges
|
—
|
|
|
—
|
|
|
222,753
|
|
|
—
|
|
|
Loss from discontinued operations before income taxes
|
(257,642
|
)
|
|
(6,235
|
)
|
|
(487,500
|
)
|
|
(625,655
|
)
|
|
Income tax (benefit) expense
|
(98,010
|
)
|
|
10,786
|
|
|
(101,658
|
)
|
|
(217,338
|
)
|
|
Discontinued operations, net of tax
|
$
|
(159,632
|
)
|
|
$
|
(17,021
|
)
|
|
$
|
(385,842
|
)
|
|
$
|
(408,317
|
)
|
The following table provides the components of Assets and Liabilities held for sale of AMS as of
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
|
Current assets
|
$
|
160,551
|
|
|
$
|
165,075
|
|
|
Property, plant and equipment
|
41,954
|
|
|
41,122
|
|
|
Goodwill
|
636,583
|
|
|
862,960
|
|
|
Other intangibles, net
|
849,475
|
|
|
861,174
|
|
|
Other assets
|
7,496
|
|
|
7,533
|
|
|
Assets held for sale
|
$
|
1,696,059
|
|
|
$
|
1,937,864
|
|
|
Current liabilities
|
$
|
57,617
|
|
|
$
|
53,143
|
|
|
Deferred taxes
|
43,679
|
|
|
46,538
|
|
|
Other liabilities
|
3,698
|
|
|
3,657
|
|
|
Liabilities held for sale
|
$
|
104,994
|
|
|
$
|
103,338
|
|
The following table provides the
Depreciation and amortization
and
Purchases of property, plant and equipment
of AMS for the
six
months ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
Cash flows from discontinued operating activities:
|
|
|
|
|
Net loss
|
$
|
(385,842
|
)
|
|
$
|
(408,317
|
)
|
|
Depreciation and amortization
|
11,555
|
|
|
35,565
|
|
|
Cash flows from discontinued investing activities:
|
|
|
|
|
Purchases of property, plant and equipment
|
$
|
(2,182
|
)
|
|
$
|
(2,460
|
)
|
HealthTronics
On
December 28, 2013
, the EHSI Board approved a plan to sell the HealthTronics business and the Company entered into a definitive agreement to sell the business on
January 9, 2014
to Altaris Capital Partners LLC for an upfront cash payment of
$85.0 million
, subject to cash and other working capital adjustments. During the three months ended March 31, 2015, we received additional cash payments of
$4.7 million
from the purchaser of HealthTronics. In addition, as of
June 30, 2015
, EHSI has rights to additional cash payments of up to
$30.0 million
based on the operating performance of HealthTronics through
December 31, 2015
, for total potential consideration of up to
$119.7 million
. Additional cash payments, if any, will be recorded when earned. The sale was completed on
February 3, 2014
.
In
2014
, the Company recorded a net gain of
$3.6 million
, representing the carrying amount of the assets sold less the amount of the net proceeds, including the
$4.7 million
described above, which the Company became entitled to receive during the fourth quarter of 2014.
Until it was sold on
February 3, 2014
, the assets of this business, previously known as the HealthTronics segment, and related liabilities were classified as held for sale in the
Condensed Consolidated Balance Sheets
. Depreciation and amortization expense were not recorded on assets held for sale. The operating results of this business are reported as Discontinued operations, net of tax, in the
Condensed Consolidated Statements of Operations
for the three and six months ended June 30, 2014.
The following table provides the operating results of Discontinued operations of HealthTronics, net of tax for the
three and six
months ended
June 30, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2014
|
|
2014
|
|
Revenue
|
$
|
—
|
|
|
$
|
14,442
|
|
|
Income from discontinued operations before income taxes
|
$
|
(2,677
|
)
|
|
$
|
1,721
|
|
|
Income tax expense (benefit)
|
491
|
|
|
(530
|
)
|
|
Discontinued operations, net of tax
|
$
|
(3,168
|
)
|
|
$
|
2,251
|
|
There were
no
Assets or Liabilities held for sale relating to HealthTronics included in the
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
.
NOTE 4. RESTRUCTURING
Auxilium Restructuring
In connection with the acquisition of Auxilium on
January 29, 2015
, the Company implemented cost-rationalization and integration initiatives to capture operating synergies and generate cost savings across the Company. These measures included realigning our sales, sales support, and management activities and staffing, which included severance benefits to former Auxilium employees, in addition to the closing of duplicative facilities. The cost reduction initiatives included a reduction in headcount of approximately
40%
of the former Auxilium workforce. For former Auxilium employees that have agreed to continue employment with the Company for a merger transition period, the severance payable upon completion of their retention period is being expensed over their respective retention period.
As a result of the Auxilium restructuring initiative, the Company incurred restructuring expenses of
$4.4 million
and
$45.2 million
during the
three and six
months ended
June 30, 2015
, respectively, consisting of
$4.4 million
and
$30.3 million
of
employee severance, retention and other benefit-related costs
during the
three and six
months ended
June 30, 2015
, respectively. The expenses were also attributable to certain charges related to our Auxilium subsidiary’s former corporate headquarters in Chesterbrook, Pennsylvania, including
$7.0 million
of asset impairment charges on certain related leasehold improvements during the first quarter of
2015
, and
$7.9 million
recorded upon the facility’s cease use date, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income, during the first quarter of
2015
. There were
no
additional asset impairment charges and
no
additional expenses relating to the facility’s cease use date recorded during the
three
months ended
June 30, 2015
. The Company anticipates there will be additional pre-tax restructuring expenses of
$1.1 million
related to
employee severance, retention and other benefit-related costs
and these actions are expected to be completed by
December 31, 2015
, with substantially all cash payments made by the end of 2016. These restructuring costs are allocated to the
U.S. Branded Pharmaceuticals
segment, and are primarily included in
Selling, general and administrative
in the
Condensed Consolidated Statements of Operations
.
A summary of expenses related to the Auxilium restructuring initiatives is included below for the
three and six
months ended
June 30, 2015
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|
|
2015
|
|
2015
|
|
Employee Severance, Retention and Other Benefit-Related Costs
|
$
|
4,365
|
|
|
$
|
30,330
|
|
|
Asset Impairment Charges
|
—
|
|
|
7,000
|
|
|
Other Restructuring Costs
|
—
|
|
|
7,860
|
|
|
Total
|
$
|
4,365
|
|
|
$
|
45,190
|
|
The liability related to the Auxilium restructuring initiative totaled
$24.5 million
at
June 30, 2015
. At
June 30, 2015
, this liability is included in
Accrued expenses
in the
Condensed Consolidated Balance Sheets
. Changes to this accrual during the
six
months ended
June 30, 2015
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Severance, Retention and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
|
Liability balance as of January 1, 2015
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Expenses
|
30,330
|
|
|
7,860
|
|
|
38,190
|
|
|
Cash payments
|
(13,352
|
)
|
|
(348
|
)
|
|
(13,700
|
)
|
|
Liability balance as of June 30, 2015
|
$
|
16,978
|
|
|
$
|
7,512
|
|
|
$
|
24,490
|
|
Other Restructuring Initiatives
The Company and certain of its subsidiaries have recently undertaken certain other restructuring initiatives that were individually not material to the Company’s
Condensed Consolidated Financial Statements
for any of the periods presented. These charges, which primarily related to
employee severance, retention and other benefit-related costs
, are included in the following lines in the
Condensed Consolidated Statements of Operations
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Selling, general and administrative
|
2,305
|
|
|
5,688
|
|
|
11,841
|
|
|
8,121
|
|
|
Discontinued operations, net of tax
|
11,692
|
|
|
85
|
|
|
18,141
|
|
|
2,138
|
|
|
Total Other Restructuring
|
$
|
13,997
|
|
|
$
|
5,773
|
|
|
$
|
29,982
|
|
|
$
|
10,259
|
|
The liability related to these initiatives totaled
$28.8 million
and
$17.0 million
at
June 30, 2015
and
December 31, 2014
, respectively. This liability is included in Accrued expenses in the
Condensed Consolidated Balance Sheets
. The change in the liability relates to recognition of the expenses mentioned in the preceding paragraph, partially offset by cash payments made during
2015
.
NOTE 5. ACQUISITIONS
For each of the acquisitions described below, except for Boca, Paladin and Sumavel
®
DosePro
®
(Sumavel
®
), the estimated fair values of the net assets acquired below are provisional as of
June 30, 2015
and are based on information that is currently available to the Company. Additional information is being gathered to finalize these provisional measurements. Accordingly, the measurement of the assets acquired and liabilities assumed may change upon finalization of the Company’s valuations and completion of the purchase price allocations, all of which are expected to occur no later than one year from the respective acquisition dates. Our measurement period adjustments were complete for Boca, Paladin and Sumavel as of
February 3, 2015
,
February 28, 2015
and
May 19, 2015
, respectively.
Paladin Labs Inc. Acquisition
On
February 28, 2014
(the Paladin Acquisition Date), EHSI acquired all of the shares of Paladin and a subsidiary of ours merged with and into EHSI, with EHSI surviving the merger. As a result of these transactions, the former shareholders of EHSI and Paladin became the shareholders of Endo International plc, a public limited company organized under the laws of Ireland, and both EHSI and Paladin became our indirect wholly-owned subsidiaries.
Under the terms of the transaction, former Paladin shareholders received
1.6331
shares of Endo International plc stock, or
35.5 million
shares, and
C$1.16
in cash, for total consideration of
$2.87 billion
as of February 28, 2014. On the Paladin Acquisition Date, each then current EHSI shareholder received
one
ordinary share of Endo International plc for each share of EHSI common stock owned upon closing. Immediately following the closing of the transaction, former EHSI shareholders owned approximately
79%
of Endo International plc, and former Paladin shareholders owned approximately
21%
.
The acquisition consideration was as follows (in thousands, except for per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
Number of Paladin shares paid through the delivery of Endo International ordinary shares
|
20,765
|
|
|
|
|
Exchange ratio
|
1.6331
|
|
|
|
|
Number of ordinary shares of Endo International—as exchanged*
|
33,912
|
|
|
|
|
Endo International ordinary share price on February 28, 2014
|
$
|
80.00
|
|
|
|
|
Fair value of ordinary shares of Endo International issued to Paladin Shareholders*
|
|
|
$
|
2,712,956
|
|
|
Number of Paladin shares paid in cash
|
20,765
|
|
|
|
|
Per share cash consideration for Paladin shares (1)
|
$
|
1.09
|
|
|
|
|
Cash distribution to Paladin shareholders*
|
|
|
22,647
|
|
|
Fair value of the vested portion of Paladin stock options outstanding—1.3 million at February 28, 2014 (2)
|
|
|
131,323
|
|
|
Total acquisition consideration
|
|
|
$
|
2,866,926
|
|
__________
|
|
|
|
*
|
Amounts do not recalculate due to rounding.
|
|
|
|
|
(1)
|
Represents the cash consideration per the arrangement agreement of
C$1.16
per Paladin share translated into U.S. dollars utilizing an exchange rate of
$0.9402
.
|
|
|
|
|
(2)
|
Represents the fair value of vested Paladin stock option awards attributed to pre-combination services that were outstanding on the Paladin Acquisition Date and settled on a cash-less exercise basis for Endo International plc shares.
|
Paladin is a specialty pharmaceutical company headquartered in Montreal, Canada, focused on acquiring and in-licensing innovative pharmaceutical products for the Canadian and world markets. Paladin’s key products serve growing therapeutic areas including attention deficit hyperactivity disorder (ADHD), pain, and urology. In addition to its Canadian operations, as of the Paladin Acquisition date, Paladin owned a controlling interest in Laboratorios Paladin de Mexico S.A. in Mexico and in publicly traded Litha Healthcare Group Limited (Litha) in South Africa.
The operating results of Paladin are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
and the operating results from the acquisition date of
February 28, 2014
are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of Paladin, effective
February 28, 2014
.
Our measurement period adjustments for Paladin were complete as of
February 28, 2015
. In connection with the finalization of our measurement period adjustments for Paladin, we recorded a decrease to certain deferred tax assets of
$1.4 million
, with a corresponding increase to goodwill. Other than these adjustments, there have been no changes to the fair values of the assets acquired and liabilities assumed at the Paladin Acquisition Date from what was disclosed in
our Annual Report on Form 10-K for the year ended December 31, 2014
, filed with the Securities and Exchange Commission on March 2, 2015. Goodwill arising from the Paladin acquisition has been assigned to multiple reporting units across each of the Company’s reportable segments based on the relative incremental benefit expected to be realized by each impacted reporting unit.
The Company recognized acquisition-related transaction costs associated with the Paladin acquisition during the
six months
ended
June 30, 2014
totaling
$33.4 million
. These costs, which related primarily to bank fees, legal and accounting services, and fees for other professional services, are included in
Acquisition-related and integration items
in the accompanying
Condensed Consolidated Statements of Operations
. There were
no
acquisition-related transaction costs associated with the Paladin acquisition during the six months ended
June 30, 2015
.
The amounts of Paladin Revenue and
Net income attributable to Endo International plc
included in the Company’s
Condensed Consolidated Statements of Operations
from and including
February 28, 2014
to
June 30, 2014
are as follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
Revenue
|
$
|
96,910
|
|
|
Net income attributable to Endo International plc
|
$
|
671
|
|
|
Basic and diluted net income per share
|
$
|
—
|
|
The following supplemental unaudited pro forma information presents the financial results as if the acquisition of Paladin had occurred on
January 1, 2014
for the
six months
ended
June 30, 2014
. This supplemental pro forma information has been prepared for comparative purposes and does not purport to be indicative of what would have occurred had the acquisition been made on
January 1, 2014
, nor are they indicative of any future results.
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2014
|
|
Unaudited pro forma consolidated results (in thousands, except per share data):
|
|
|
Revenue
|
$
|
1,106,690
|
|
|
Net loss attributable to Endo International plc
|
$
|
(426,578
|
)
|
|
Basic and diluted net loss per share
|
$
|
(3.04
|
)
|
These amounts have been calculated after applying the Company’s accounting policies and adjusting the results of Paladin to reflect factually supportable adjustments that give effect to events that are directly attributable to the Paladin acquisition assuming the Paladin acquisition had occurred
January 1, 2014
. These adjustments mainly include adjustments to additional intangible amortization. The adjustments to additional intangible amortization, net of tax, that would have been charged assuming the Company’s estimated fair value of the intangible assets, increased the expense by
$2.8 million
for the
six months
ended
June 30, 2014
.
Acquisition of Remaining Shares of Litha
In February 2015, Paladin acquired substantially all of Litha’s remaining outstanding ordinary share capital that it did not own for consideration of approximately
$40 million
. At
December 31, 2014
, our Paladin subsidiary owned
70.3%
of the issued ordinary share capital of Litha. In connection with this transaction, Paladin had deposited cash into an escrow account, primarily for the purpose of guaranteeing amounts required to be paid to Litha’s security holders in connection with this acquisition. The balance in this account at
December 31, 2014
of approximately
$40 million
was included in Restricted cash and cash equivalents in the
Condensed Consolidated Balance Sheets
and was subsequently paid in February 2015. Refer to
Note 14. Shareholders' Equity
for further information.
Boca Pharmacal LLC Acquisition
On
February 3, 2014
, the Company acquired Boca Pharmacal LLC (Boca) for
$236.6 million
in cash. Boca is a specialty generics company that focuses on niche areas, commercializing and developing products in categories that include controlled substances, semisolids and solutions.
The fair values of the net identifiable assets acquired totaled
$212.3 million
, resulting in goodwill of
$24.3 million
, which was assigned to our
U.S. Generic Pharmaceuticals
segment. The amount of net identifiable assets acquired in connection with the Boca acquisition includes
$140.9 million
of identifiable intangible assets, including
$112.3 million
of developed technology to be amortized over an average life of approximately
11 years
and
$28.6 million
of IPR&D.
The operating results of Boca are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
and the operating results from the acquisition date of
February 3, 2014
are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of Boca, effective
February 3, 2014
. Our measurement period adjustments were complete for Boca as of
February 3, 2015
.
Pro forma results of operations have not been presented because the effect of the Boca acquisition was not material.
Sumavel
®
DosePro
®
On
May 19, 2014
, the Company’s Endo Pharmaceuticals Inc. (EPI) subsidiary acquired the worldwide rights to Sumavel
®
DosePro
®
for subcutaneous use, a needle-free delivery system for sumatriptan, from Zogenix, Inc. The Company is accounting for this transaction as a business combination in accordance with the relevant accounting literature.
EPI acquired the product for consideration of
$93.8 million
, consisting of an upfront payment of
$89.7 million
and contingent cash consideration with an acquisition-date fair value of
$4.1 million
. See
Note 7. Fair Value Measurements
for further discussion of this contingent consideration. In addition, the Company provided Zogenix, Inc. with a
$7.0 million
non-interest bearing loan due 2023 for working capital needs and it assumed an existing third-party royalty obligation on net sales. Sumavel
®
is a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches.
The preliminary fair values of the net identifiable assets acquired totaled
$93.8 million
, resulting in
no
goodwill. The amount of net identifiable assets acquired in connection with the Sumavel
®
acquisition includes
$90.0 million
of identifiable developed technology intangible assets to be amortized over an average life of approximately
13 years
.
The operating results of Sumavel
®
are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
and the operating results from the acquisition date of
May 19, 2014
are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of Sumavel
®
, effective
May 19, 2014
. Our measurement period adjustments were complete for Sumavel as of
May 19, 2015
.
Pro forma results of operations have not been presented because the effect of the Sumavel
®
acquisition was not material.
Grupo Farmacéutico Somar Acquisition
On
July 24, 2014
, the Company, together with its Endo Netherlands B.V. subsidiary (Endo Dutch B.V.), acquired the representative shares of the capital stock of Grupo Farmacéutico Somar, Sociedad Anónima Promotora de Inversión de Capital Variable (Somar), a leading privately-owned specialty pharmaceuticals company based in Mexico City, for
$270.1 million
in cash consideration, subject to a customary post-closing net working capital adjustment.
The preliminary fair values of the net identifiable assets acquired totaled
$184.4 million
, resulting in goodwill of
$85.7 million
, which was assigned to our
International Pharmaceuticals
segment. The amount of net identifiable assets acquired in connection with the Somar acquisition includes
$167.9 million
of identifiable intangible assets, including
$148.3 million
to be amortized over an average life of approximately
12 years
and
$19.6 million
of IPR&D.
The operating results of Somar are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
. There are no results included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of Somar, effective
July 24, 2014
.
Pro forma results of operations have not been presented because the effect of the Somar acquisition was not material.
DAVA Pharmaceuticals, Inc. Acquisition
On
August 6, 2014
(the DAVA Acquisition Date), the Company’s Generics International (US), Inc. subsidiary acquired DAVA Pharmaceuticals, Inc. (DAVA), a privately-held company specializing in marketed, pre-launch and pipeline generic pharmaceuticals based in Fort Lee, New Jersey, for consideration of
$595.3 million
. The consideration consisted of cash consideration of
$590.2 million
, subject to a customary post-closing net working capital adjustment, and contingent cash consideration with an acquisition-date fair value of
$5.1 million
. See
Note 7. Fair Value Measurements
for further discussion of this contingent consideration. DAVA’s strategically-focused generics portfolio includes
thirteen
on-market products in a variety of therapeutic categories.
The operating results of DAVA are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
. There are no results included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of DAVA, effective
August 6, 2014
.
As of
June 30, 2015
, there have been no changes to the preliminary fair values of the assets acquired and liabilities assumed at the DAVA Acquisition Date from what was disclosed in our Annual Report on Form 10-K for the year ended
December 31, 2014
, filed with the Securities and Exchange Commission on
March 2, 2015
.
Pro forma results of operations have not been presented because the effect of the DAVA acquisition was not material.
Natesto™
On
December 9, 2014
, the Company’s EPI subsidiary acquired the rights to Natesto™ (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corporation. EPI will collaborate with Trimel on all regulatory and clinical development activities regarding Natesto™. The Company is accounting for this transaction as a business combination in accordance with the relevant accounting literature. Natesto™ was approved by the U.S. Food and Drug Administration (FDA) in May 2014. On March 16, 2015, Endo announced the commercial availability of Natesto™.
EPI acquired the product for consideration of
$56.7 million
, consisting of an upfront payment of
$25.0 million
, prepaid inventory of
$5.0 million
and contingent cash consideration with an acquisition-date fair value of
$26.7 million
, including the impact of a measurement period adjustment recorded during the first quarter of 2015. See
Note 7. Fair Value Measurements
for further discussion of this contingent consideration.
The preliminary fair values of the net identifiable assets acquired totaled
$56.7 million
, resulting in
no
goodwill. The amount of net identifiable assets acquired in connection with the Natesto™ acquisition includes
$51.7 million
of developed technology to be amortized over
10 years
.
The operating results of Natesto™ are included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2015
. There are no results included in the accompanying
Condensed Consolidated Statements of Operations
for the
three and six
months ended
June 30, 2014
. The
Condensed Consolidated Balance Sheets
as of
June 30, 2015
and
December 31, 2014
reflect the acquisition of Natesto™, effective
December 9, 2014
.
Pro forma results of operations have not been presented because the effect of the Natesto™ acquisition was not material.
Auxilium Pharmaceuticals, Inc.
On
January 29, 2015
(the Auxilium Acquisition Date), the Company’s Endo U.S., Inc. subsidiary acquired all of the outstanding shares of common stock (the Merger Agreement) of Auxilium Pharmaceuticals, Inc. (Auxilium) in a transaction valued at
$2.6 billion
, as enumerated in the table below.
Pursuant to the terms of the Merger Agreement, of the
55.0 million
outstanding Auxilium shares eligible to make an election,
94.9%
elected to receive transaction consideration equal to
0.4880
Endo shares per Auxilium share (the Stock Election Consideration),
0.4%
elected to receive
100%
cash, which equated to
$33.25
of cash per Auxilium share (the Cash Election Consideration) and
4.7%
elected or defaulted to receive a mix of
$16.625
in cash and
0.2440
Endo shares per Auxilium share (the Standard Election Consideration). The result of the elections led to an oversubscription of the Stock Election Consideration and, in accordance with the proration method described in the Merger Agreement and proxy statement/prospectus provided to Auxilium shareholders, each Auxilium share for which an election was made to receive the Stock Election Consideration was instead entitled to receive approximately
0.3448
Endo shares and
$9.75
in cash.
The acquisition consideration was as follows (in thousands, except for per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
Number of Endo ordinary shares issued pursuant to the Merger Agreement
|
18,610
|
|
|
|
|
Endo share price on January 29, 2015
|
$
|
81.64
|
|
|
|
|
Fair value of Endo ordinary shares issued to Auxilium stockholders
|
|
|
$
|
1,519,320
|
|
|
Cash distribution at closing (1)
|
|
|
1,021,864
|
|
|
Settlement of pre-existing relationships
|
|
|
28,400
|
|
|
Total acquisition consideration
|
|
|
$
|
2,569,584
|
|
__________
|
|
|
|
(1)
|
Represents the cash paid directly to shareholders pursuant to the Merger Agreement, the fair value of Auxilium stock awards attributed to pre-combination services that were outstanding on the Auxilium Acquisition Date and settled in connection with the Auxilium acquisition, and amounts paid by Endo on behalf of Auxilium (including transactions costs incurred by Auxilium in connection with the acquisition and amounts paid to settle existing Auxilium indebtedness and related instruments).
|
Auxilium is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specific patients’ needs. Auxilium, with a broad range of first- and second-line products across multiple indications, is an emerging leader in the men’s healthcare sector and has strategically focused its product portfolio and pipeline in orthopedics, dermatology and other therapeutic areas.
The Company believes Auxilium is highly complementary to Endo’s branded pharmaceuticals business. The Company further believes this transaction is well aligned with its growth strategy and the Company sees significant opportunities to leverage
its leading presence in men’s health, as well as the Company’s R&D capabilities and financial resources to accelerate the growth of Auxilium’s XIAFLEX
®
and its other products.
While the Auxilium acquisition was primarily equity based, Endo also made changes to its existing debt structure to complete the transaction, as further described in
Note 11. Debt
.
The operating results from the acquisition date of
January 29, 2015
are included in the accompanying
Condensed Consolidated Statements of Operations
for the three and six months ended
June 30, 2015
. The
Condensed Consolidated Balance Sheet
as of
June 30, 2015
reflects the acquisition of Auxilium, effective
January 29, 2015
.
The following table summarizes the fair values of the assets acquired and liabilities assumed at the Auxilium Acquisition Date (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 29, 2015
(As initially reported)
|
|
Measurement period adjustments
|
|
January 29, 2015
(As adjusted)
|
|
Cash and cash equivalents
|
$
|
115,973
|
|
|
$
|
—
|
|
|
$
|
115,973
|
|
|
Accounts receivable
|
75,849
|
|
|
—
|
|
|
75,849
|
|
|
Inventories
|
341,900
|
|
|
(38,400
|
)
|
|
303,500
|
|
|
Prepaid expenses and other current assets
|
6,687
|
|
|
—
|
|
|
6,687
|
|
|
Property, plant and equipment
|
31,500
|
|
|
—
|
|
|
31,500
|
|
|
Intangible assets
|
2,838,000
|
|
|
7,500
|
|
|
2,845,500
|
|
|
Other assets
|
9,285
|
|
|
(999
|
)
|
|
8,286
|
|
|
Total identifiable assets
|
$
|
3,419,194
|
|
|
$
|
(31,899
|
)
|
|
$
|
3,387,295
|
|
|
Accounts payable and accrued expenses
|
$
|
120,553
|
|
|
$
|
12,391
|
|
|
$
|
132,944
|
|
|
Deferred income taxes
|
164,379
|
|
|
(26,598
|
)
|
|
137,781
|
|
|
Convertible debt, including equity component (1)
|
571,132
|
|
|
—
|
|
|
571,132
|
|
|
Other liabilities
|
171,400
|
|
|
(4,320
|
)
|
|
167,080
|
|
|
Total liabilities assumed
|
$
|
1,027,464
|
|
|
$
|
(18,527
|
)
|
|
$
|
1,008,937
|
|
|
Net identifiable assets acquired
|
$
|
2,391,730
|
|
|
$
|
(13,372
|
)
|
|
$
|
2,378,358
|
|
|
Goodwill
|
177,854
|
|
|
13,372
|
|
|
191,226
|
|
|
Net assets acquired
|
$
|
2,569,584
|
|
|
$
|
—
|
|
|
$
|
2,569,584
|
|
__________
|
|
|
|
(1)
|
As further described in
Note 11. Debt
, this amount consists of
$293.1 million
and
$278.0 million
, representing the debt and equity components of the Auxilium convertible notes, respectively.
|
The estimated fair value of the Auxilium assets acquired and liabilities assumed are provisional as of
June 30, 2015
and are based on information that is currently available to the Company. Additional information is being gathered to finalize these provisional measurements, particularly with respect to property, plant and equipment, intangible assets, inventory, accrued expenses, contingent liabilities, deferred income taxes and income taxes payable. Accordingly, the measurement of the Auxilium assets acquired and liabilities assumed may change significantly upon finalization of the Company’s valuations and completion of the purchase price allocation, both of which are expected to occur no later than one year from the acquisition date.
The valuation of the intangible assets acquired and related amortization periods are as follows:
|
|
|
|
|
|
|
|
|
|
|
Valuation (in millions)
|
|
Amortization period (in years)
|
|
Developed Technology:
|
|
|
|
|
XIAFLEX®
|
$
|
1,501.1
|
|
|
12
|
|
TESTOPEL®
|
584.3
|
|
|
15
|
|
Urology Retail
|
311.0
|
|
|
13
|
|
Other
|
128.7
|
|
|
15
|
|
Total
|
$
|
2,525.1
|
|
|
|
|
In Process Research & Development (IPR&D):
|
|
|
|
|
XIAFLEX®—Cellulite
|
$
|
320.4
|
|
|
n/a
|
|
Total
|
$
|
320.4
|
|
|
n/a
|
|
Total other intangible assets
|
$
|
2,845.5
|
|
|
n/a
|
The preliminary fair values of the developed technology and IPR&D assets were estimated using a discounted present value income approach. Under this method, an intangible asset’s fair value is equal to the present value of the incremental after-tax cash flows (excess earnings) attributable solely to the intangible asset over its remaining useful life. To calculate fair value, the Company used cash flows discounted at rates ranging from
9%
to
11%
, which were considered appropriate given the inherent risks associated with each type of asset. The Company believes that the level and timing of cash flows appropriately reflect market participant assumptions.
The goodwill recognized is attributable primarily to strategic and synergistic opportunities related to existing pharmaceutical businesses, the assembled workforce of Auxilium and other factors. The goodwill is not expected to be deductible for income tax purposes.
Deferred tax assets and liabilities are related primarily to the difference between the book basis and tax basis of identifiable intangible assets and inventory step-up.
The Company recognized acquisition-related transaction costs associated with the Auxilium acquisition during the six months ended
June 30, 2015
totaling
$23.1 million
. These costs, which related primarily to bank fees, legal and accounting services, and fees for other professional services, are included in
Acquisition-related and integration items
in the accompanying
Condensed Consolidated Statements of Operations
.
The amounts of Auxilium Revenue and
Net income attributable to Endo International plc
included in the Company’s
Condensed Consolidated Statements of Operations
from and including
January 29, 2015
to
June 30, 2015
are as follows (in thousands, except per share data):
|
|
|
|
|
|
|
|
Revenue
|
$
|
155,367
|
|
|
Net loss attributable to Endo International plc
|
$
|
(110,838
|
)
|
|
Basic net loss per share
|
$
|
(0.62
|
)
|
|
Diluted net loss per share
|
$
|
(0.61
|
)
|
The following supplemental unaudited pro forma information presents the financial results as if the acquisition of Auxilium had occurred on
January 1, 2014
for the
six months
ended
June 30, 2015
and for the three and six months ended June 30, 2014. This supplemental pro forma information has been prepared for comparative purposes and does not purport to be indicative of what would have occurred had the acquisition been made on
January 1, 2014
, nor are they indicative of any future results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2015
|
|
Three Months Ended June 30, 2014
|
|
Six Months Ended June 30, 2014
|
|
Unaudited pro forma consolidated results (in thousands, except per share data):
|
|
|
|
|
|
|
Revenue
|
$
|
1,472,869
|
|
|
$
|
675,866
|
|
|
$
|
1,235,227
|
|
|
Net loss attributable to Endo International plc
|
$
|
(333,583
|
)
|
|
$
|
(42,256
|
)
|
|
$
|
(562,638
|
)
|
|
Basic net loss per share
|
$
|
(1.88
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(4.01
|
)
|
|
Diluted net loss per share
|
$
|
(1.82
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(4.01
|
)
|
These amounts have been calculated after applying the Company’s accounting policies and adjusting the results of Auxilium to reflect factually supportable adjustments that give effect to events that are directly attributable to the Auxilium acquisition assuming the Auxilium acquisition had occurred
January 1, 2014
. These adjustments mainly include adjustments to interest expense and additional intangible amortization. The adjustments to interest expense, net of tax, related to borrowings to finance the acquisition increased the expense by
$5.5 million
for the
three months
ended
June 30, 2014
, and increased the expense by
$1.1 million
and
$11.4 million
for the
six months
ended
June 30, 2015
and
June 30, 2014
, respectively. In addition, the adjustments include additional intangible amortization, net of tax, that would have been charged assuming the Company’s estimated fair value of the intangible assets, increased the expense by
$21.4 million
for the
three months
ended
June 30, 2014
. An adjustment to the amortization expense for the
six months
ended
June 30, 2015
and
June 30, 2014
increased the expense by
$8.8 million
and
$43.0 million
, respectively.
Authorized Generic of Potassium Chloride Oral Solution
On
March 19, 2015
, our Endo Global Ventures (EGV) subsidiary acquired exclusive license rights to the authorized generic of potassium chloride oral solution from Lehigh Valley Technologies, Inc. (LVT). The Company is accounting for this transaction as a business combination in accordance with the relevant accounting literature.
EGV acquired the product for consideration of
$47.7 million
, consisting of an upfront payment of
$6.0 million
and contingent cash consideration with an acquisition-date fair value of
$41.7 million
. See
Note 7. Fair Value Measurements
for further discussion of this contingent consideration.
The preliminary fair value of the related net identifiable developed technology intangible asset acquired totaled
$47.7 million
, with
no
related goodwill. The intangible asset will be amortized over an average life of approximately
10 years
. However, commensurate with our current expectations with respect to the amount and timing of projected cash flows resulting from this acquisition, we expect to record the majority of the related amortization within the first
18 months
after product launch.
Pro forma results of operations have not been presented because the effect of this acquisition was not material.
The operating results of the acquired authorized generic of potassium chloride oral solution are included in the accompanying Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2015 given the launch of this product in April 2015. There are no results included in the accompanying Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2014. The Condensed Consolidated Balance Sheet as of June 30, 2015 reflects the acquisition of the authorized generic of potassium chloride oral solution, effective March 19, 2015.
Pending Acquisitions
Aspen Holdings
In May 2015, Litha Pharma (Pty) Limited, a subsidiary of the Company, entered into an agreement to acquire a broad portfolio of branded and generic injectable and established products focused on pain, anti-infectives, cardiovascular and other specialty therapeutics areas from a subsidiary of Aspen Holdings, a leading publicly-traded South African company that supplies branded and generic products in more than
150
countries, and from GlaxoSmithKline plc (GSK). The transaction is expected to expand Endo’s presence in South Africa. Under the terms of the agreement, the subsidiary of Aspen Holdings and GSK will receive a one-time payment of approximately
$150 million
subject to usual and customary closing adjustments. The transaction is expected to close in the second half of 2015.
Acquisition of Par Pharmaceutical Holdings, Inc.
In May 2015, the Company entered into a definitive agreement with Par Pharmaceutical Holdings, Inc. (Par) pursuant to which the Company shall acquire privately-held Par from TPG Capital in a transaction initially valued at
$8.05 billion
, including assumption of Par debt. The purchase price consists of
18.0 million
shares (
$1.55 billion
of value based on the 10-day volume weighted average share price of Endo ending on May 15, 2015) of Endo equity and
$6.50 billion
cash consideration to Par shareholders, subject to certain adjustments. The transaction is expected to close in the second half of 2015.
On June 10, 2015, the Company completed the sale of
27,627,628
ordinary shares for aggregate gross proceeds of
$2,300.0 million
in order to finance a portion of the pending Par acquisition. The net proceeds of this share issuance, totaling
$2,235.1 million
are included as a component of
Cash and cash equivalents
at
June 30, 2015
.
In July 2015, Endo Designated Activity Company, formerly known as Endo Limited (
Endo DAC
), Endo Finance LLC and Endo Finco Inc. (collectively, the Issuers) issued $
1.64 billion
in aggregate principal amount of the
2023 Notes
. The Company intends to incur an Incremental Term Loan B Facility in an aggregate principal amount of up to
$2,800 million
in accordance with the
Amended 2014 Credit Facility
prior to or substantially simultaneously with the closing of the Par acquisition. In addition, the Company intends to increase its incremental revolving facility capacity in an aggregate principal amount of up to
$250.0 million
under the
Amended 2014 Credit Facility
prior to or substantially simultaneously with the closing of the Par acquisition.
The
2023 Notes
were issued to, together with the Incremental Term Loan B Facility and cash on hand, (i) fund the purchase price of the Par acquisition, as well as for repayments of indebtedness of Par and certain transaction expenses, (ii) refinance the Company’s existing
2014 Term Loan B Facility
, and (iii) redeem all
$499.9 million
aggregate principal amount outstanding of the
7.00%
Senior Notes due 2019, which redemption occurred in July 2015. The Company intends to use any remaining proceeds for general corporate purposes, including acquisitions and debt repayments.
Par is a specialty pharmaceutical company that develops, manufactures and markets safe, innovative and cost-effective pharmaceuticals that help improve patient quality of life. Par Pharmaceutical offers a line of high-barrier-to-entry generic drugs, while Par Specialty Pharmaceuticals provides niche, innovative brands. Par Sterile Products develops, manufactures and markets both branded and generic aseptic injectable pharmaceuticals. As a result, we believe its business is highly complementary to Endo’s generic pharmaceuticals business. The Company further believes this transaction provides attractive long-term pipeline opportunities and significant financial synergies. The Company has incurred
$9.9 million
and
$10.0 million
of transaction costs during the three and six months ended June 30, 2015, which are included in
Acquisition-related and integration items
in the accompanying
Condensed Consolidated Statements of Operations
.
NOTE 6. SEGMENT RESULTS
On
February 24, 2015
, the Company’s Board of Directors approved a plan to sell its AMS business, which comprises the entirety of our former
Devices
segment. Subsequently, the Company entered into a definitive agreement to sell the Men’s Health and Prostate Health components of the AMS business to Boston Scientific Corporation. On
August 3, 2015
, the Company completed the sale of the Men’s Health and Prostate Health components of its
AMS
business to Boston Scientific Corporation. The assets of this business segment and related liabilities are classified as held for sale in the
Condensed Consolidated Balance Sheets
for all periods presented. Depreciation and amortization expense are not recorded on assets held for sale. The operating results of this business segment are reported as Discontinued operations, net of tax, in the
Condensed Consolidated Statements of Operations
for all periods presented. For additional information, see
Note 3. Discontinued Operations
.
The
three
remaining reportable business segments in which the Company now operates are: (1)
U.S. Branded Pharmaceuticals
, (2)
U.S. Generic Pharmaceuticals
and (3)
International Pharmaceuticals
. These segments reflect the level at which executive management regularly reviews financial information to assess performance and to make decisions about resources to be allocated. Each segment derives revenue from the sales or licensing of its respective products and is discussed in more detail below.
We evaluate segment performance based on each segment’s
adjusted income (loss) from continuing operations before income tax
, which we define as
(loss) income from continuing operations before income tax
before
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 and hedging activities; foreign currency gains or losses on intercompany financing arrangements; and certain other items that the Company believes do not reflect its core operating performance
.
Certain of the corporate general and administrative expenses incurred by the Company are not attributable to any specific segment. Accordingly, these costs are not allocated to any of the Company’s segments and are included in the results below as
“Corporate unallocated”. The Company’s consolidated adjusted income from continuing operations before income tax is equal to the combined results of each of its segment less these unallocated corporate costs.
U.S. Branded Pharmaceuticals
Our
U.S. Branded Pharmaceuticals
segment includes a variety of branded prescription products related to treating and managing pain as well as our urology and men’s health, endocrinology and orthopedic products. The marketed products that are included in this segment include Lidoderm
®
, Opana
®
ER, Voltaren
®
Gel, Percocet
®
, Fortesta
®
Gel, Supprelin
®
LA, XIAFLEX
®
, STENDRA
®
, Aveed
®
and Testim
®
, among others.
U.S. Generic Pharmaceuticals
Our
U.S. Generic Pharmaceuticals
segment consists of products primarily focused in pain management through a differentiated portfolio of controlled substances and liquids that have one or more barriers to market entry, such as complex formulation, regulatory or legal challenges or difficulty in raw material sourcing. The product offerings of this segment include products in the pain management, urology, CNS disorders, immunosuppression, oncology, women’s health and hypertension markets, among others. Additionally, in May 2014, we launched an authorized generic lidocaine patch 5% (referred to as Lidoderm
®
authorized generic).
International Pharmaceuticals
Our
International Pharmaceuticals
segment includes a variety of specialty pharmaceutical products and certain medical devices for the Canadian, Mexican, South African and world markets, which we acquired from Paladin and Somar. Paladin’s key products serve growing therapeutic areas including ADHD, pain, and urology. Somar develops, manufactures, and markets high-quality generic, branded generic and over-the-counter products across key market segments including dermatology and anti-infectives.
The following represents selected information for the Company’s reportable segments for the
three
and
six months
ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Net revenues to external customers:
|
|
|
|
|
|
|
|
|
U.S. Branded Pharmaceuticals
|
$
|
315,913
|
|
|
$
|
248,547
|
|
|
$
|
600,420
|
|
|
$
|
482,712
|
|
|
U.S. Generic Pharmaceuticals
|
338,326
|
|
|
272,213
|
|
|
695,288
|
|
|
484,068
|
|
|
International Pharmaceuticals (1)
|
80,927
|
|
|
72,088
|
|
|
153,586
|
|
|
96,910
|
|
|
Total net revenues to external customers
|
$
|
735,166
|
|
|
$
|
592,848
|
|
|
$
|
1,449,294
|
|
|
$
|
1,063,690
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted income (loss) from continuing operations before income tax:
|
|
|
|
|
|
|
|
|
U.S. Branded Pharmaceuticals
|
$
|
169,575
|
|
|
$
|
130,416
|
|
|
$
|
328,996
|
|
|
$
|
264,833
|
|
|
U.S. Generic Pharmaceuticals
|
146,089
|
|
|
105,234
|
|
|
$
|
329,546
|
|
|
$
|
179,031
|
|
|
International Pharmaceuticals
|
12,797
|
|
|
22,602
|
|
|
$
|
21,091
|
|
|
$
|
31,897
|
|
__________
|
|
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to Canada, Mexico and South Africa.
|
There were no material revenues from external customers attributed to an individual foreign country during the
three
and
six months
ended
June 30, 2015
and
2014
. There were no material tangible long-lived assets attributed to an individual foreign country as of
June 30, 2015
or
December 31, 2014
.
The table below provides reconciliations of our
segment adjusted income from continuing operations before income tax
to our consolidated
(loss) income from continuing operations before income tax
, which is determined in accordance with U.S. GAAP, for the
three and six
months ended
June 30, 2015
and
2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Total segment adjusted income from continuing operations before income tax:
|
$
|
328,461
|
|
|
$
|
258,252
|
|
|
$
|
679,633
|
|
|
$
|
475,761
|
|
|
Corporate unallocated costs
|
(109,154
|
)
|
|
(70,711
|
)
|
|
(212,576
|
)
|
|
(149,608
|
)
|
|
Upfront and milestone payments to partners
|
(2,135
|
)
|
|
(10,350
|
)
|
|
(4,802
|
)
|
|
(21,505
|
)
|
|
Asset impairment charges
|
(70,243
|
)
|
|
—
|
|
|
(77,243
|
)
|
|
—
|
|
|
Acquisition-related and integration items (1)
|
(44,225
|
)
|
|
(19,618
|
)
|
|
(78,865
|
)
|
|
(64,887
|
)
|
|
Separation benefits and other cost reduction initiatives (2)
|
(5,780
|
)
|
|
(11,446
|
)
|
|
(47,587
|
)
|
|
(9,516
|
)
|
|
Excise tax (3)
|
—
|
|
|
4,700
|
|
|
—
|
|
|
(55,300
|
)
|
|
Amortization of intangible assets
|
(116,987
|
)
|
|
(52,761
|
)
|
|
(212,256
|
)
|
|
(92,431
|
)
|
|
Inventory step-up and certain excess manufacturing costs that will be eliminated pursuant to integration plans
|
(48,948
|
)
|
|
(19,144
|
)
|
|
(88,864
|
)
|
|
(22,725
|
)
|
|
Non-cash interest expense related to the 1.75% Convertible Senior Subordinated Notes
|
(253
|
)
|
|
(3,346
|
)
|
|
(1,632
|
)
|
|
(9,315
|
)
|
|
Loss on extinguishment of debt
|
—
|
|
|
(20,089
|
)
|
|
(980
|
)
|
|
(29,685
|
)
|
|
Certain litigation-related charges, net
|
(6,875
|
)
|
|
(3,954
|
)
|
|
(19,875
|
)
|
|
(3,954
|
)
|
|
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
(2,792
|
)
|
|
—
|
|
|
18,298
|
|
|
—
|
|
|
Costs associated with unused financing commitments
|
(2,261
|
)
|
|
—
|
|
|
(14,071
|
)
|
|
—
|
|
|
Acceleration of Auxilium employee equity awards at closing
|
—
|
|
|
—
|
|
|
(37,603
|
)
|
|
—
|
|
|
Charge related to the non-recoverability of certain non-trade receivables
|
—
|
|
|
(10,000
|
)
|
|
—
|
|
|
(10,000
|
)
|
|
Net gain on sale of certain early-stage drug discovery and development assets
|
—
|
|
|
3,850
|
|
|
—
|
|
|
3,850
|
|
|
Other than temporary impairment of equity investment
|
(18,869
|
)
|
|
—
|
|
|
(18,869
|
)
|
|
—
|
|
|
Other, net
|
(3,553
|
)
|
|
—
|
|
|
(2,699
|
)
|
|
—
|
|
|
Total consolidated (loss) income from continuing operations before income tax
|
$
|
(103,614
|
)
|
|
$
|
45,383
|
|
|
$
|
(119,991
|
)
|
|
$
|
10,685
|
|
__________
|
|
|
|
(1)
|
Acquisition-related and integration-items include costs directly associated with the closing of certain acquisitions, changes in the fair value of contingent consideration, costs of integration activities related to both current and prior period acquisitions and excess costs that will be eliminated pursuant to integration plans.
|
|
|
|
|
(2)
|
Separation benefits and other cost reduction initiatives include employee separation costs of
$4.8 million
and
$37.2 million
during the
three
and
six
months ended
June 30, 2015
, respectively, compared to
$4.0 million
and
$6.8 million
during the
three
and
six
months ended
June 30, 2014
, respectively. During the
six
months ended
June 30, 2015
, a
$7.9 million
charge was recorded upon the cease use date of our Auxilium subsidiary’s former corporate headquarters, representing the liability for our remaining obligations under the respective lease agreement, net of estimated sublease income. Amounts in the comparable
2014
period primarily consisted of employee separation costs and changes in estimates related to certain cost reduction initiative accruals. These amounts were primarily recorded as
Selling, general and administrative
expense in our
Condensed Consolidated Statements of Operations
. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
|
|
|
|
(3)
|
This amount represents charges related to the expense for the reimbursement of directors’ and certain employees’ excise tax liabilities pursuant to Section 4985 of the Internal Revenue Code, which we had previously estimated to be
$60.0 million
in the first quarter of 2014.
|
The following represents additional selected financial information for our reportable segments for the
three and six
months ended
June 30, 2015
and
2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Depreciation expense:
|
|
|
|
|
|
|
|
|
U.S. Branded Pharmaceuticals
|
$
|
5,325
|
|
|
$
|
4,374
|
|
|
$
|
10,621
|
|
|
$
|
8,411
|
|
|
U.S. Generic Pharmaceuticals
|
4,744
|
|
|
4,339
|
|
|
9,481
|
|
|
11,908
|
|
|
International Pharmaceuticals
|
918
|
|
|
350
|
|
|
1,579
|
|
|
491
|
|
|
Corporate unallocated
|
1,616
|
|
|
2,119
|
|
|
3,688
|
|
|
4,013
|
|
|
Total depreciation expense
|
$
|
12,603
|
|
|
$
|
11,182
|
|
|
$
|
25,369
|
|
|
$
|
24,823
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Amortization expense:
|
|
|
|
|
|
|
|
|
U.S. Branded Pharmaceuticals
|
$
|
73,957
|
|
|
$
|
17,739
|
|
|
$
|
128,161
|
|
|
$
|
38,462
|
|
|
U.S. Generic Pharmaceuticals
|
25,418
|
|
|
20,156
|
|
|
50,835
|
|
|
38,770
|
|
|
International Pharmaceuticals
|
17,612
|
|
|
11,198
|
|
|
33,260
|
|
|
15,198
|
|
|
Total amortization expense
|
$
|
116,987
|
|
|
$
|
49,093
|
|
|
$
|
212,256
|
|
|
$
|
92,430
|
|
Interest income and expense are considered corporate items and included in Corporate unallocated. Asset information is not reviewed or included within our internal management reporting. Therefore, the Company has not disclosed asset information for each reportable segment.
NOTE 7. FAIR VALUE MEASUREMENTS
Financial Instruments
The financial instruments recorded in our
Condensed Consolidated Balance Sheets
include cash and cash equivalents, restricted cash and cash equivalents, accounts receivable, marketable securities, equity and cost method investments, accounts payable and accrued expenses, acquisition-related contingent consideration and debt obligations. Included in cash and cash equivalents and restricted cash and cash equivalents are money market funds representing a type of mutual fund required by law to invest in low-risk securities (for example, U.S. government bonds, U.S. Treasury Bills and commercial paper). Money market funds are structured to maintain the fund’s net asset value at
$1.00
per unit, which assists in providing adequate liquidity upon demand by the holder. Money market funds pay dividends that generally reflect short-term interest rates. Thus, only the dividend yield fluctuates. Due to their short-term maturity, the carrying amounts of non-restricted and restricted cash and cash equivalents (including money market funds), accounts receivable, accounts payable and accrued expenses approximate their fair values.
Fair value guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
|
|
|
|
•
|
Level 1—Quoted prices in active markets for identical assets or liabilities.
|
|
|
|
|
•
|
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
|
|
•
|
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
Marketable Securities
Equity securities consist of investments in the stock of publicly traded companies, the values of which are based on quoted market prices and thus represent Level 1 measurements within the fair value hierarchy, as defined above. These securities are not held to support current operations and are therefore classified as non-current assets. Equity securities are included in Marketable securities in the
Condensed Consolidated Balance Sheets
at
June 30, 2015
and
December 31, 2014
.
At the time of purchase, we classify our marketable securities as either available-for-sale securities or trading securities, depending on our intent at that time. Available-for-sale and trading securities are carried at fair value with unrealized holding gains and losses recorded within other comprehensive income or net income, respectively. The Company reviews unrealized losses associated with available-for-sale securities to determine the classification as a “temporary” or “other-than-temporary” impairment. A temporary impairment results in an unrealized loss being recorded in other comprehensive income. An impairment that is viewed as
other-than-temporary is recognized in net income. The Company considers various factors in determining the classification, including the length of time and extent to which the fair value has been less than the Company’s cost basis, the financial condition and near-term prospects of the issuer or investee, and the Company’s ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in market value.
Loans Receivable
Our loans receivable at
June 30, 2015
relate primarily to loans totaling
$16.7 million
to our joint venture investment owned through our Litha subsidiary. The joint venture investment is further described below. The majority of this amount is secured by certain of the assets of our joint venture. The fair values of these loans were based on anticipated cash flows, which approximate the carrying amount, and were classified in Level 2 measurements in the fair value hierarchy. These loans are included in Other assets in our
Condensed Consolidated Balance Sheets
.
Equity and Cost Method Investments
As of June 30, 2015, we have various investments that we account for using the equity or cost method of accounting totaling
$23.7 million
, including a joint venture investment owned through our Litha subsidiary. During the three months ended June 30, 2015, the Company recognized an other than temporary impairment of our Litha joint venture investment totaling
$18.9 million
, reflecting the excess carrying value of this investment over its estimated fair value. To estimate the fair value of this joint venture investment we relied primarily on a market approach based on the terms of the recently announced divestiture of that investment. With respect to our other equity or cost method investments, which are included in Other Assets in our Condensed Consolidated Balance Sheets at June 30, 2015 and December 31, 2014, the Company did not recognize any other-than-temporary impairments. We considered various factors, including the operating results of our equity method investments and the lack of an unrealized loss position on our cost method investments.
Acquisition-Related Contingent Consideration
Acquisition-related contingent consideration is measured at fair value on a recurring basis using unobservable inputs; hence these instruments represent Level 3 measurements within the fair value hierarchy. See Recurring Fair Value Measurements below for additional information on the fair value methodology used for the acquisition-related contingent consideration.
Voltaren
®
Gel Royalties due to Novartis
The initial fair value of the Minimum Voltaren
®
Gel royalties due to Novartis were determined using an income approach (present value technique) taking into consideration the level and timing of expected cash flows and an assumed discount rate. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The liability is currently being accreted up to the expected minimum payments, less payments made to date. We believe the carrying amount of this minimum royalty guarantee at
June 30, 2015
and
December 31, 2014
represents a reasonable approximation of the price that would be paid to transfer the liability in an orderly transaction between market participants at the measurement date. Accordingly, the carrying value approximates fair value as of
June 30, 2015
and
December 31, 2014
.
Recurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a recurring basis at
June 30, 2015
and
December 31, 2014
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
June 30, 2015
|
Quoted Prices in
Active Markets
for Identical
Assets (Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
$
|
1,220,671
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,220,671
|
|
|
Equity securities
|
4,916
|
|
|
—
|
|
|
—
|
|
|
4,916
|
|
|
Total
|
$
|
1,225,587
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,225,587
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
41,069
|
|
|
$
|
41,069
|
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
148,013
|
|
|
148,013
|
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
189,082
|
|
|
$
|
189,082
|
|
At
June 30, 2015
, money market funds include
$98.9 million
in Qualified Settlement Funds to be disbursed to mesh-related product liability claimants. See
Note 12. Commitments and Contingencies
for further discussion of our product liability cases.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
December 31, 2014
|
Quoted Prices in
Active Markets
for Identical
Assets (Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
$
|
279,327
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
279,327
|
|
|
Equity securities
|
2,321
|
|
|
—
|
|
|
—
|
|
|
2,321
|
|
|
Total
|
$
|
281,648
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
281,648
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,282
|
|
|
$
|
4,282
|
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
41,723
|
|
|
41,723
|
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46,005
|
|
|
$
|
46,005
|
|
At
December 31, 2014
, money market funds include $
124.4 million
in Qualified Settlement Funds to be disbursed to mesh-related product liability claimants. See
Note 12. Commitments and Contingencies
for further discussion of our product liability cases.
Acquisition-Related Contingent Consideration
On
November 30, 2010
(the Qualitest Pharmaceuticals Acquisition Date), the Company acquired Generics International (US Parent), Inc. (doing business as Qualitest Pharmaceuticals), which was party to an asset purchase agreement with Teva Pharmaceutical Industries Ltd (Teva) (the Teva Agreement). Pursuant to the Teva Agreement, Qualitest Pharmaceuticals purchased certain pipeline generic products from Teva and could be obligated to pay consideration to Teva upon the achievement of certain future regulatory milestones (the Teva Contingent Consideration).
The current range of the undiscounted amounts the Company could be obligated to pay in future periods under the Teva Agreement is between
zero
and
$5.0 million
after giving effect to payments made to date. The Company is accounting for the Teva Contingent Consideration in the same manner as if it had entered into that arrangement with respect to its acquisition of Qualitest Pharmaceuticals. Accordingly, the fair value was estimated based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the contractual obligation to pay the Teva Contingent Consideration was determined to be
$3.8 million
at
June 30, 2015
and
$5.2 million
at
December 31, 2014
. The
decrease
in the balance primarily relates to a first quarter 2015 payment of
$2.5 million
related to the achievement of certain regulatory milestones, partially offset by an increase due to certain market and regulatory considerations impacting the commercial potential of related products.
During the second quarter of 2014, in connection with EPI’s acquisition of Sumavel
®
, we entered into an agreement to make contingent cash consideration payments to the former owner of Sumavel
®
of between
zero
and
$20.0 million
(the Sumavel
®
Contingent Consideration), based on certain factors relating primarily to the financial performance of Sumavel
®
. At the acquisition date, we estimated the fair value of this obligation to be
$4.1 million
based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the contractual obligation to pay the Sumavel
®
Contingent Consideration was determined to be approximately
$4.7 million
at
June 30, 2015
and
$4.7 million
at
December 31, 2014
.
In connection with our acquisition of DAVA, we agreed to make cash consideration payments of up to
$25.0 million
(the DAVA Contingent Consideration) contingent on the achievement of certain sales-based milestones. At the DAVA acquisition date, we estimated the fair value of this obligation to be
$5.1 million
based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the contractual obligation to pay the DAVA Contingent Consideration was determined to be
zero
at
June 30, 2015
and
$5.1 million
at
December 31, 2014
. The
change
in the balance primarily relates to certain market and regulatory considerations impacting the commercial potential of related products.
In connection with the acquisition of Natesto™, we entered into an agreement to make contingent cash consideration payments to the former owners of Natesto™ based on certain potential clinical and commercial milestones of up to
$165.0 million
as well as royalties based on a percentage of potential future sales of Natesto™ (the Natesto™ Contingent Consideration). As of the Natesto acquisition date, Endo estimated the fair value of this obligation to be
$31.0 million
based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the contractual obligation to pay the Natesto™ Contingent Consideration was determined to be
$26.3 million
at
June 30, 2015
and
$31.0 million
at
December 31, 2014
. The
decrease
in the balance primarily relates to a measurement period adjustment of
$4.3 million
.
On January 29, 2015, we acquired Auxilium, which is party to an agreement pursuant to which it could be obligated to make certain contingent cash consideration payments (the Actient Contingent Consideration). These payments relate primarily to potential
sales-based royalties on edex
®
and TESTOPEL
®
, which Auxilium had previously acquired in connection with its 2013 acquisition of Actient Pharmaceuticals, LLC (Actient). As of the Auxilium acquisition date, Endo estimated the fair value of the Actient Contingent Consideration to be
$46.8 million
. The fair value was estimated based on a probability-weighted discounted cash flow model (income approach). The fair value of the Actient Contingent Consideration was determined to be
$36.4 million
at
June 30, 2015
. The change in the balance primarily relates to 2015 payments of
$3.7 million
related to sales-based royalties and a measurement period adjustment.
Auxilium is also party to an agreement with VIVUS, Inc. (VIVUS) to make contingent cash consideration payments consisting of royalties based on a percentage of net sales of STENDRA
®
as well as sales-based milestones of up to approximately
$260 million
(the STENDRA
®
Contingent Consideration). On January 29, 2015, the date Endo acquired Auxilium, Endo estimated the fair value of the STENDRA
®
Contingent Consideration to be
$59.6 million
. The fair value was estimated based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the STENDRA
®
Contingent Consideration was determined to be
$57.4 million
at
June 30, 2015
. The change in the balance primarily relates to a measurement period adjustment.
In connection with the acquisition of the exclusive license rights of potassium chloride oral solution from LVT, we entered into an agreement to make contingent cash consideration payments to LVT based on certain operational and commercial milestones of up to
$4.0 million
, as well as payment to LVT based on a percentage of profits realized on the licensed product, to be determined in accordance with the license agreement with LVT. At the acquisition date, we estimated the fair value of this obligation to be
$41.7 million
based on a probability-weighted discounted cash flow model (income approach). Using this valuation technique, the fair value of the contractual obligation to pay the contingent consideration was determined to be
$42.0 million
at
June 30, 2015
. The
increase
in the balance primarily relates to certain market and regulatory considerations impacting the commercial potential of related products, partially offset by a second quarter 2015 payment of
$2.1 million
related to the achievement of certain commercial milestones and sales-based royalties.
The fair values of contingent consideration amounts above were estimated based on assumptions and projections relevant to revenues and a discounted cash flow model using risk-adjusted discount rates ranging from
4.7%
to
25.0%
. The Company assesses these assumptions on an ongoing basis as additional information impacting the assumptions is obtained.
I
n addition to the material contingent consideration agreements disclosed above, the Company has entered into and may enter into future agreements to make contingent cash consideration payments in connection with other acquisitions.
Amounts recorded for the short-term and long-term portions of acquisition related contingent consideration are included in
Accrued expenses
and Other liabilities, respectively, in the
Condensed Consolidated Balance Sheets
.
Fair Value Measurements Using Significant Unobservable Inputs
The following table presents changes to the Company’s liability for acquisition-related contingent consideration, which is measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the
three and six
months ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Beginning of period
|
$
|
184,261
|
|
|
$
|
4,759
|
|
|
$
|
46,005
|
|
|
$
|
4,747
|
|
|
Amounts acquired
|
18,435
|
|
|
3,700
|
|
|
166,535
|
|
|
3,700
|
|
|
Amounts settled
|
(3,851
|
)
|
|
—
|
|
|
(8,574
|
)
|
|
—
|
|
|
Transfers (in) and/or out of Level 3
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Measurement period adjustments
|
(7,243
|
)
|
|
—
|
|
|
(11,556
|
)
|
|
—
|
|
|
Changes in fair value recorded in earnings
|
(2,520
|
)
|
|
44
|
|
|
(3,328
|
)
|
|
56
|
|
|
End of period
|
$
|
189,082
|
|
|
$
|
8,503
|
|
|
$
|
189,082
|
|
|
$
|
8,503
|
|
Changes in fair value recorded in earnings
related to acquisition-related contingent consideration are included in the
Condensed Consolidated Statements of Operations
as
Acquisition-related and integration items
.
The following is a summary of available-for-sale securities held by the Company at
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
(Losses)
|
|
Fair Value
|
|
June 30, 2015
|
|
|
|
|
|
|
|
|
Money market funds
|
$
|
1,220,671
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,220,671
|
|
|
Total included in cash and cash equivalents
|
$
|
1,121,751
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,121,751
|
|
|
Total included in restricted cash and cash equivalents
|
$
|
98,920
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
98,920
|
|
|
Equity securities
|
$
|
805
|
|
|
$
|
88
|
|
|
$
|
—
|
|
|
$
|
893
|
|
|
Total other short-term available-for-sale securities
|
$
|
805
|
|
|
$
|
88
|
|
|
$
|
—
|
|
|
$
|
893
|
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
2,257
|
|
|
$
|
—
|
|
|
$
|
4,023
|
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
2,257
|
|
|
$
|
—
|
|
|
$
|
4,023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
(Losses)
|
|
Fair Value
|
|
December 31, 2014
|
|
|
|
|
|
|
|
|
Money market funds
|
$
|
279,327
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
279,327
|
|
|
Total included in cash and cash equivalents
|
$
|
154,959
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
154,959
|
|
|
Total included in restricted cash and cash equivalents
|
$
|
124,368
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
124,368
|
|
|
Equity securities
|
$
|
805
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
815
|
|
|
Total other short-term available-for-sale securities
|
$
|
805
|
|
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
815
|
|
|
Equity securities
|
$
|
1,766
|
|
|
$
|
—
|
|
|
$
|
(260
|
)
|
|
$
|
1,506
|
|
|
Long-term available-for-sale securities
|
$
|
1,766
|
|
|
$
|
—
|
|
|
$
|
(260
|
)
|
|
$
|
1,506
|
|
Nonrecurring Fair Value Measurements
The Company’s financial assets measured at fair value on a nonrecurring basis during the six months ended
June 30, 2015
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
Total Income (Expense) for the Year Ended June 30, 2015
|
|
|
Quoted Prices in
Active Markets
for Identical Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
Significant
Unobservable Inputs
(Level 3)
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Auxilium leasehold improvements (Note 4)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,000
|
|
|
Endo equity investment
|
—
|
|
|
—
|
|
|
10,469
|
|
|
18,869
|
|
|
Certain U.S. Generic Pharmaceuticals intangible assets (Note 9)
|
—
|
|
|
—
|
|
|
9,600
|
|
|
70,243
|
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
20,069
|
|
|
$
|
96,112
|
|
There were
no
impairments during the six months ended June 30, 2014.
NOTE 8. INVENTORIES
Inventories consist of the following at
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
|
Raw materials (1)
|
$
|
130,584
|
|
|
$
|
118,432
|
|
|
Work-in-process (1)
|
89,383
|
|
|
43,290
|
|
|
Finished goods (1)
|
405,800
|
|
|
261,599
|
|
|
Total
|
$
|
625,767
|
|
|
$
|
423,321
|
|
(1) The components of inventory shown in the table above are net of allowance for obsolescence.
Inventory that is in excess of the amount expected to be sold within one year, which relates primarily to XIAFLEX
®
inventory acquired in January 2015, is classified as long-term inventory and is not included in the table above. At
June 30, 2015
,
$32.8 million
of long-term inventory was included in Other assets in the
Condensed Consolidated Balance Sheets
.
NOTE 9. GOODWILL AND OTHER INTANGIBLES
Goodwill
Changes in the carrying amount of our goodwill for the
six months
ended
June 30, 2015
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying Amount
|
|
|
U.S. Branded Pharmaceuticals
|
|
U.S. Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total Consolidated
|
|
Balance as of December 31, 2014:
|
|
|
|
|
|
|
|
|
Goodwill
|
$
|
1,131,932
|
|
|
$
|
1,071,637
|
|
|
$
|
696,018
|
|
|
$
|
2,899,587
|
|
|
|
$
|
1,131,932
|
|
|
$
|
1,071,637
|
|
|
$
|
696,018
|
|
|
$
|
2,899,587
|
|
|
Goodwill acquired during the period
|
191,226
|
|
|
—
|
|
|
1,255
|
|
|
192,481
|
|
|
Effect of currency translation
|
—
|
|
|
—
|
|
|
(47,761
|
)
|
|
(47,761
|
)
|
|
Balance as of June 30, 2015:
|
|
|
|
|
|
|
|
|
Goodwill
|
1,323,158
|
|
|
1,071,637
|
|
|
649,512
|
|
|
3,044,307
|
|
|
Accumulated impairment losses
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
$
|
1,323,158
|
|
|
$
|
1,071,637
|
|
|
$
|
649,512
|
|
|
$
|
3,044,307
|
|
Goodwill related to our Devices segment of
$863.0 million
as of December 31, 2014 became part of the disposal group and is part of the Assets held for sale, net of impairment and current period adjustments related to currency translation, as of
June 30, 2015
.
Other Intangible Assets
The following is a summary of other intangibles held by the Company at
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost basis:
|
Balance as of December 31, 2014
|
|
Acquisitions
(1)
|
|
Impairments
(2)
|
|
Other
(3)
|
|
Effect of Currency Translation
|
|
Balance as of June 30, 2015
|
|
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
$
|
184,598
|
|
|
$
|
320,400
|
|
|
$
|
(4,600
|
)
|
|
$
|
(17,000
|
)
|
|
$
|
(5,457
|
)
|
|
$
|
477,941
|
|
|
Total indefinite-lived intangibles
|
$
|
184,598
|
|
|
$
|
320,400
|
|
|
$
|
(4,600
|
)
|
|
$
|
(17,000
|
)
|
|
$
|
(5,457
|
)
|
|
$
|
477,941
|
|
|
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
|
Licenses (weighted average life of 10 years)
|
$
|
664,367
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
664,367
|
|
|
Tradenames (weighted average life of 15 years)
|
21,315
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(82
|
)
|
|
21,233
|
|
|
Developed technology (weighted average life of 13 years)
|
2,243,215
|
|
|
2,595,288
|
|
|
(65,643
|
)
|
|
11,537
|
|
|
(43,742
|
)
|
|
4,740,655
|
|
|
Total definite-lived intangibles (weighted average life of 13 years)
|
$
|
2,928,897
|
|
|
$
|
2,595,288
|
|
|
$
|
(65,643
|
)
|
|
$
|
11,537
|
|
|
$
|
(43,824
|
)
|
|
$
|
5,426,255
|
|
|
Total other intangibles
|
$
|
3,113,495
|
|
|
$
|
2,915,688
|
|
|
$
|
(70,243
|
)
|
|
$
|
(5,463
|
)
|
|
$
|
(49,281
|
)
|
|
$
|
5,904,196
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization:
|
Balance as of December 31, 2014
|
|
Amortization
|
|
Impairments
(2)
|
|
Other
|
|
Effect of Currency Translation
|
|
Balance as of June 30, 2015
|
|
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Total indefinite-lived intangibles
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Definite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
|
|
Licenses
|
$
|
(426,413
|
)
|
|
$
|
(39,432
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(465,845
|
)
|
|
Tradenames
|
(5,462
|
)
|
|
(716
|
)
|
|
—
|
|
|
—
|
|
|
5
|
|
|
(6,173
|
)
|
|
Developed technology
|
(348,427
|
)
|
|
(172,108
|
)
|
|
—
|
|
|
—
|
|
|
2,750
|
|
|
(517,785
|
)
|
|
Total definite-lived intangibles
|
$
|
(780,302
|
)
|
|
$
|
(212,256
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,755
|
|
|
$
|
(989,803
|
)
|
|
Total other intangibles
|
$
|
(780,302
|
)
|
|
$
|
(212,256
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,755
|
|
|
$
|
(989,803
|
)
|
|
Net other intangibles
|
$
|
2,333,193
|
|
|
|
|
|
|
|
|
|
|
$
|
4,914,393
|
|
__________
|
|
|
|
(1)
|
Includes intangible assets acquired primarily in connection with the acquisitions of Auxilium, Lehigh Valley Technologies, Inc. and other acquisitions. See
Note 5. Acquisitions
for further information.
|
(2) Includes the impairment of certain intangible assets of our
U.S. Generic Pharmaceuticals
segment.
|
|
|
|
(3)
|
During the
six months
ended
June 30, 2015
, certain IPR&D assets totaling
$17.0 million
were put into service, partially offset by a reduction of
$5.5 million
relating to measurement period adjustments to certain intangible assets. See
Note 5. Acquisitions
for further information on measurement period adjustments.
|
Amortization expense for the
three and six
months ended
June 30, 2015
totaled
$117.0 million
and
$212.3 million
, respectively. Amortization expense for the
three and six
months ended
June 30, 2014
totaled
$49.1 million
and
$92.4 million
, respectively. Estimated amortization of intangibles for the five fiscal years subsequent to
December 31, 2014
is as follows (in thousands):
|
|
|
|
|
|
|
|
2015
|
$
|
445,765
|
|
|
2016
|
$
|
405,881
|
|
|
2017
|
$
|
395,252
|
|
|
2018
|
$
|
387,139
|
|
|
2019
|
$
|
378,333
|
|
Changes in the gross carrying amount of our other intangibles for the
six months
ended
June 30, 2015
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
Gross
Carrying
Amount
|
|
December 31, 2014
|
$
|
3,113,495
|
|
|
Auxilium acquisition
|
2,845,500
|
|
|
Lehigh Valley Technologies, Inc. acquisition
|
47,700
|
|
|
Other acquisitions
|
22,488
|
|
|
Impairment of certain U.S. Generic Pharmaceuticals intangible assets
|
(70,243
|
)
|
|
Measurement period adjustments relating to acquisitions closed during 2014
|
(5,463
|
)
|
|
Effect of currency translation
|
(49,281
|
)
|
|
June 30, 2015
|
$
|
5,904,196
|
|
Impairments
During the three months ended June 30, 2015, the Company identified certain market and regulatory considerations impacting the commercial potential of certain intangible assets in our U.S. Generic Pharmaceuticals segment. Accordingly, we tested these assets for impairment and determined that the carrying value of certain of these assets was no longer fully recoverable resulting in a pre-tax non-cash asset impairment charge of
$70.2 million
. We determined that an income approach using a discounted cash flow model was an appropriate valuation methodology to utilize in our impairment test.
NOTE 10. LICENSE AND COLLABORATION AGREEMENTS
Our subsidiaries have entered into certain license, collaboration and discovery agreements with third parties for product development. These agreements require our subsidiaries to share in the development costs of such products and grant marketing rights to our subsidiaries for such products.
The Company and its subsidiaries are generally required to make upfront payments as well as other payments upon successful completion of regulatory or sales milestones. In addition, these agreements generally require our subsidiaries to pay royalties on sales of the products arising from these agreements. These agreements generally permit our subsidiaries to terminate the agreement with no significant continuing obligation.
Commercial Products
Novartis AG and Novartis Consumer Health, Inc.
Our subsidiary Endo Pharmaceuticals Inc. (EPI) is party to a License and Supply Agreement (the Voltaren
®
Gel Agreement) with and among Novartis AG and Novartis Consumer Health, Inc. (Novartis) to obtain the exclusive U.S. marketing rights for the prescription medicine Voltaren
®
Gel (Voltaren
®
Gel or the Licensed Product). Voltaren
®
Gel royalties incurred during the
six months
ended
June 30, 2015
and
2014
were
$15.0 million
and
$15.0 million
, respectively, representing minimum royalties pursuant to the Voltaren
®
Gel Agreement.
EPI is required to incur a minimum amount of annual advertising and promotional expenses (A&P Expenditures) on the commercialization of the Licensed Product, which may be reduced under certain circumstances including Novartis’s failure to supply the Licensed Product. During the period beginning on
July 1, 2013
and extending through
June 30, 2014
, EPI agreed to spend
$5.9 million
on A&P Expenditures. During the period beginning on
July 1, 2014
and extending through
June 30, 2015
, EPI agreed to spend
$8.4 million
on A&P Expenditures. In subsequent Agreement Years, the minimum A&P Expenditures set forth in the Voltaren
®
Gel Agreement are determined based on a percentage of net sales of Voltaren
®
Gel, which may be reduced under certain circumstances, including Novartis’s failure to supply Voltaren
®
Gel. Amounts incurred for such A&P Expenditures were
$1.4 million
and
$4.1 million
for the
six months
ended
June 30, 2015
and
2014
, respectively.
BioSpecifics Technologies Corp.
On
January 29, 2015
, we acquired Auxilium, which is party to a development and license agreement, as amended (the BioSpecifics Agreement) with BioSpecifics Technologies Corp. (BioSpecifics). The BioSpecifics Agreement was originally entered into by Auxilium in June 2004 to obtain exclusive worldwide rights to develop, market and sell certain products containing BioSpecifics’ enzyme, which we refer to as XIAFLEX
®
. Auxilium’s licensed rights concern the development and commercialization of products, other than dermal formulations labeled for topical administration, and currently, Auxilium’s licensed rights cover the indications of Dupuytren’s contracture (DC), Peyronie’s Disease (PD), Frozen Shoulder syndrome and cellulite. Auxilium may further
expand the BioSpecifics Agreement, at its option, to cover other indications as they are developed by Auxilium or BioSpecifics.
The BioSpecifics Agreement extends, on a country-by-country and product-by-product basis, for the longer of the patent life, the expiration of any regulatory exclusivity period or
twelve years
. Either party may terminate the BioSpecifics Agreement as a result of the other party’s breach or bankruptcy. Auxilium may terminate the BioSpecifics Agreement with
90
days’ written notice.
Under the BioSpecifics Agreement, the Company is responsible, at its own cost and expense, for developing the formulation and finished dosage form of products and arranging for the clinical supply of products.
Auxilium must pay BioSpecifics on a country-by-country and product-by-product basis a specified percentage within a range of
5%
to
15%
of net sales for products covered by the BioSpecifics Agreement. This royalty applies to net sales by Auxilium or its sublicensees, including Actelion Pharmaceuticals Ltd (Actelion), Asahi Kasei Pharma Corporation (Asahi Kasei) and Swedish Orphan Biovitrum AB (Sobi). Auxilium could also be obligated to pay a percentage of future regulatory or commercial milestone payments received from its sublicensees. In addition, Auxilium must pay BioSpecifics an amount equal to a specified mark-up on the cost of goods related to supply of XIAFLEX
®
(which mark-up is capped at a specified percentage within the range of
5%
to
15%
of the cost of goods of XIAFLEX
®
for the applicable country) for products sold by Auxilium or its sublicensees.
XIAFLEX
®
and XIAPEX
®
Out-license Agreements
Our Auxilium subsidiary is party to certain out-licensing agreements with Actelion, Asahi Kasei and Sobi (the XIAFLEX
®
Sublicensees), pursuant to which the XIAFLEX
®
Sublicensees have marketing, development and/or commercial rights for XIAFLEX
®
and XIAPEX
®
(the European Union trade name for XIAFLEX
®
) in a variety of countries outside of the U.S.
These agreements were entered into from 2011 to 2013 and extend, pursuant to the terms of each respective agreement and subject to each party’s termination rights, as follows:
|
|
|
|
•
|
The agreement with Actelion extends on a product-by-product and country-by-country basis from the date of the agreement until the last to occur of (i) the date on which the product is no longer covered by a valid claim of a patent or patent application controlled by the Company in such country, (ii) the
15
th anniversary of the first commercial sale of the product in such country after receipt of required regulatory approvals, (iii) the achievement of a specified market share of generic versions of the product in such country, or (iv) the loss of certain marketing rights or data exclusivity in such country.
|
|
|
|
|
•
|
The agreement with Asahi Kasei extends on a product-by-product basis from the date of the agreement until the last to occur of (i) the date on which the product is no longer covered by a valid claim of a patent, (ii) the
15
th anniversary of the first commercial sale of the product, or (iii) the entry of a generic to XIAFLEX
®
in the Japanese market.
|
|
|
|
|
•
|
The agreement with Sobi extends on a product-by-product basis from the date of the agreement until its
10
th anniversary. The term will be automatically extended for sequential
two
year periods unless a notice of non-renewal is provided in writing to the other party at least
six
months prior to expiration of the then current term.
|
Under these agreements, the Company is entitled to receive royalties based on net sales of the licensed product by the XIAFLEX
®
Sublicensees. These royalties are tiered as follows:
|
|
|
|
•
|
Actelion—
15%
-
25%
,
20%
-
30%
, and
25%
-
35%
based on net sales of the licensed product;
|
|
|
|
|
•
|
Asahi Kasei—
30%
-
40%
and
35%
-
45%
based on net sales of the licensed product; and
|
|
|
|
|
•
|
Sobi—
45%
-
55%
,
50%
-
60%
and
55%
-
65%
based on net sales of the licensed product, which also include payments for product supply and which percentages will decrease by approximately
10%
upon the occurrence of certain manufacturing milestones or July 1, 2016, whichever is earlier.
|
The applicable royalty percentages increase from tier to tier upon the achievement of a specified threshold of aggregate annual net sales of the licensed product and may decrease if a generic is marketed in the applicable territory. Pursuant to each of these out-licensing agreements, the Company will be responsible for all clinical and commercial drug manufacturing and supply and, in certain cases, for development costs. The Company has determined that these contractual responsibilities, together with the development and commercialization rights provided by the Company, constitute multiple deliverables. In accordance with the accounting guidance on revenue recognition for multiple-element agreements, certain elements of these agreements meet the criteria for separation and are treated as a single unit of accounting, with the corresponding revenue recognized when earned. Deliverables that do not have stand-alone value to the XIAFLEX
®
Sublicensees are being accounted for as one unit of accounting, with the related revenue being recorded on a straight-line basis over the respective performance period.
The Japanese Ministry of Health, Labour and Welfare (MHLW) approved XIAFLEX
®
for manufacturing and marketing in Japan on July 3, 2015 for the indication of Dupuytren's contracture with a palpable cord. A
$20.0 million
milestone payment will be due to Endo from Asahi Kasei upon first commercial sale of XIAFLEX
®
in Japan, which is dependent upon a separate approval by the MHLW of pricing and reimbursement for the product.
Revenue recognized related to these agreements was not material to the
Condensed Consolidated Financial Statements
for any of the periods presented.
VIVUS, Inc.
Our Auxilium subsidiary is party to a license and commercialization agreement (the STENDRA
®
License Agreement) with VIVUS, Inc. (VIVUS). Under the STENDRA
®
License Agreement, Auxilium has the exclusive right to commercialize VIVUS’s pharmaceutical product STENDRA
®
for the treatment of any urological disease or condition in humans, including male erectile dysfunction, in the U.S. and Canada and their respective territories. Subject to each party’s termination rights, the STENDRA
®
License Agreement will remain in effect until the later of, on a country-by-country basis, (i)
10
years from the date STENDRA
®
launches in such country and (ii) the expiration of the last to expire patent covering the product in such country. Upon the expiration of the term of the STENDRA
®
License Agreement, the license grant by VIVUS to Auxilium will become fully paid-up, royalty-free, perpetual and irrevocable.
In connection with the STENDRA
®
License Agreement, Auxilium could become obligated to make certain contingent cash consideration payments to VIVUS consisting of royalties based on a percentage of net sales of STENDRA
®
as well as sales-based milestones of up to approximately
$260 million
. Refer to
Note 7. Fair Value Measurements
for further discussion.
Auxilium makes royalty payments to VIVUS based on tiered percentages of the aggregate annual net sales of STENDRA
®
. The percentage of the Auxilium’s aggregate annual net sales to be paid to VIVUS increases in accordance with the achievement of specified thresholds of aggregate annual net sales of the product. The royalty percentage could range from
5%
-
20%
and could be reduced following the entry of a generic product to the market. Royalties paid to VIVUS were not material to the
Condensed Consolidated Financial Statements
for any of the periods presented.
Products in Development
BioDelivery Sciences International, Inc.
EPI is party to a worldwide license and development agreement (the BioDelivery Agreement) with BioDelivery Sciences International, Inc. (BioDelivery) for the exclusive rights to develop and commercialize Belbuca™ (buprenorphine HCl) Buccal Film. The drug is a transmucosal form of buprenorphine, a partial mu-opiate receptor agonist, which incorporates a bioerodible mucoadhesive (BEMA
®
) technology. The NDA for Belbuca™ was submitted on December 23, 2014 and accepted by the U.S. Food and Drug Administration (FDA) in February 2015.
During each of the
first
,
second
and
fourth
quarters of
2014
,
$10.0 million
of milestones were incurred related to the achievement of certain clinical milestones, resulting in a total of
$30.0 million
recorded as
Research and development
expense during
2014
. If Belbuca™ is approved, EPI will be obligated to pay additional regulatory milestones of
$50.0 million
. In addition, EPI will pay royalties based on net sales of the drug and could be obligated to pay additional commercial milestones of up to
$55.0 million
.
BioSpecifics Technologies Corp.
As disclosed above, our Auxilium subsidiary is party to a development and license agreement, as amended, with BioSpecifics to obtain exclusive worldwide rights to develop, market and sell certain products containing BioSpecifics’ collagenase clostridium histolyticum enzyme (CCH), which we refer to as XIAFLEX
®
. The Company is responsible, at its own cost and expense, for developing the formulation and finished dosage form of products and arranging for the clinical supply of products.
The Company is currently conducting a XIAFLEX
®
Phase II trial for a cellulite indication and in March 2015 completed a XIAFLEX
®
Phase II trial for a Frozen Shoulder syndrome indication. The study for the Frozen Shoulder syndrome indication did not meet its prospective defined primary or secondary efficacy endpoints, primarily as a consequence of an unexpected marked placebo response. The safety profile was as previously seen, with the majority of the adverse events being mild to moderate, transient and related to the local administration of XIAFLEX
®
. The Company is currently conducting additional analyses to determine the path forward for continued progression in this indication.
BioSpecifics is currently conducting a CCH Phase II clinical trial for the treatment of lipomas in humans. The Company has the option to license development and marketing rights to the CCH human lipoma indication based on a full analysis of the data from the Phase II clinical trial, which would transfer responsibility for the future development costs to the Company and trigger an opt-in payment and potential future milestone and royalty payments to BioSpecifics. In 2013, BioSpecifics also concluded a CCH Phase II clinical trial for the treatment of lipomas in canines. The trial did not meet its primary endpoint of a statistically significant post-treatment difference in the mean percent change in lipoma; however, statistical significance was shown in secondary endpoints. The Company is currently managing the development of CCH in canine lipomas.
NOTE 11. DEBT
The following table presents the carrying amounts and estimated fair values of the Company’s total indebtedness at
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
|
|
Carrying
Amount
|
|
Fair Value
|
|
Carrying
Amount
|
|
Fair Value
|
|
1.75% Convertible Senior Subordinated Notes due 2015
|
$
|
—
|
|
|
|
|
$
|
98,818
|
|
|
|
|
Unamortized discount on 1.75% Convertible Senior Subordinated Notes due 2015
|
—
|
|
|
|
|
(1,759
|
)
|
|
|
|
1.75% Convertible Senior Subordinated Notes due 2015, net
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
97,059
|
|
|
$
|
98,317
|
|
|
7.00% Senior Notes due 2019
|
499,875
|
|
|
518,893
|
|
|
499,875
|
|
|
522,813
|
|
|
7.00% Senior Notes due 2020
|
400,000
|
|
|
|
|
400,000
|
|
|
|
|
Unamortized initial purchaser’s discount
|
(2,220
|
)
|
|
|
|
(2,338
|
)
|
|
|
|
7.00% Senior Notes due 2020, net
|
$
|
397,780
|
|
|
421,250
|
|
|
$
|
397,662
|
|
|
422,250
|
|
|
7.25% Senior Notes due 2022
|
400,000
|
|
|
426,500
|
|
|
400,000
|
|
|
429,278
|
|
|
5.75% Senior Notes due 2022
|
700,000
|
|
|
713,125
|
|
|
700,000
|
|
|
707,000
|
|
|
5.375% Senior Notes due 2023
|
750,000
|
|
|
741,094
|
|
|
750,000
|
|
|
735,469
|
|
|
6.00% Senior Notes due 2025
|
1,200,000
|
|
|
1,220,250
|
|
|
—
|
|
|
—
|
|
|
Term Loan A Facility Due 2019
|
1,045,000
|
|
|
|
|
1,069,063
|
|
|
|
|
Unamortized initial purchaser’s discount
|
(2,476
|
)
|
|
|
|
—
|
|
|
|
|
Term Loan A Facility Due 2019, net
|
$
|
1,042,524
|
|
|
1,043,015
|
|
|
$
|
1,069,063
|
|
|
1,062,889
|
|
|
Term Loan B Facility Due 2021
|
419,688
|
|
|
|
|
421,812
|
|
|
|
|
Unamortized initial purchaser’s discount
|
(984
|
)
|
|
|
|
—
|
|
|
|
|
Term Loan B Facility Due 2021, net
|
$
|
418,704
|
|
|
421,261
|
|
|
$
|
421,812
|
|
|
409,685
|
|
|
Other debt
|
20,770
|
|
|
21,046
|
|
|
22,822
|
|
|
22,886
|
|
|
Total long-term debt, net
|
$
|
5,429,653
|
|
|
$
|
5,526,434
|
|
|
$
|
4,358,293
|
|
|
$
|
4,410,587
|
|
|
Less current portion, net
|
68,423
|
|
|
68,423
|
|
|
155,937
|
|
|
154,226
|
|
|
Total long-term debt, less current portion, net
|
$
|
5,361,230
|
|
|
$
|
5,458,011
|
|
|
$
|
4,202,356
|
|
|
$
|
4,256,361
|
|
As of
December 31, 2014
, the fair value of our
1.75%
Convertible Senior Subordinated Notes was based on an income approach, which incorporated certain inputs and assumptions, including scheduled coupon and principal payments, the inherent conversion and put features in the notes and share price volatility assumptions based on historic volatility of the Company’s ordinary shares and other factors. These fair value measurements are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy.
The fair values of the various term loan facilities and senior notes were based on market quotes and transactions proximate to the valuation date. Based on this valuation methodology, we determined these debt instruments represent Level 2 measurements within the fair value hierarchy.
Credit Facility
Upon closing of the Paladin acquisition on February 28, 2014, certain subsidiaries of the Company entered into a credit facility with Deutsche Bank AG New York Branch and Royal Bank of Canada and certain other lenders, which replaced Endo’s prior credit facility. The initial borrowings under this credit facility consisted of a
five
-year senior secured term loan A facility of
$1.1 billion
(the
2014 Term Loan A Facility
), a
seven
-year senior secured term loan B facility of
$425.0 million
(the
2014 Term Loan B Facility
), and a
five
-year revolving credit facility with an initial borrowing capacity of up to
$750.0 million
(the
2014 Revolving Credit Facility
and, together with the
2014 Term Loan A Facility
and the
2014 Term Loan B Facility
, the
2014 Credit Facility
). The
2014 Credit Facility
was issued to refinance certain of our existing indebtedness and for general corporate purposes, including acquisitions.
In April 2015, pursuant to the terms of our credit agreement, we borrowed
$175.0 million
on our
2014 Revolving Credit Facility
, primarily for the purpose of settling our Convertible Notes and for payments relating to our vaginal mesh litigation. On
June 30, 2015
we paid down our
2014 Revolving Credit Facility
in the amount of
$175.0 million
. Subsequent to these transactions, we have
$748.1 million
of remaining credit available through the
2014 Revolving Credit Facility
as of
June 30, 2015
.
In June 2015, we entered into an amendment agreement, pursuant to which we amended the
2014 Credit Facility
(the
Amended 2014 Credit Facility
) to, among other things, (i) permit the proposed acquisition by
Endo DAC
or its affiliates of Par and (ii) permit an incremental revolving facility in an aggregate principal amount of
$250.0 million
,
one
or more incremental term B loan facilities in an aggregate principal amount up to
$5.0 billion
, in each case, in connection with the Par acquisition (the Par Incremental Facilities). In connection with the
Amended 2014 Credit Facility
, Term Loans A and B are recorded net of the unamortized portion of the original purchaser’s discount. This discount is amortized to interest expense over the term of the
Amended 2014 Credit Facility
.
We intend to increase our incremental revolving facility capacity in an aggregate principal amount of up to
$250.0 million
under the
Amended 2014 Credit Facility
. In addition we intend to incur an incremental term loan B facility in an aggregate principal amount of up to
$2,800 million
(the Incremental Term Loan B Facility) in accordance with the
Amended 2014 Credit Facility
prior to or substantially simultaneously with the closing of the Par acquisition. Borrowings under the Incremental Term Loan B Facility prior to or substantially concurrently with the closing of the Par acquisition shall, among other things, refinance in full any amounts outstanding under the
2014 Term Loan B Facility
.
In addition to the Par Incremental Facilities, the
Amended 2014 Credit Facility
also permits up to (i) an aggregate amount of incremental revolving and/or term loan commitments of
$1.0 billion
plus (ii) an unlimited amount of incremental revolving and/or term loan commitments if the Secured Leverage Ratio (as defined in the
Amended 2014 Credit Facility
), at the time of incurrence of such incremental commitments and after giving effect thereto on a pro forma basis, is less than or equal to
3.00 to 1.00
(assuming for purposes of such calculation that any incremental revolving commitments being incurred at the time of such calculation are fully drawn and without netting cash proceeds of any incremental facilities or, in lieu of loans under any incremental facilities, pari passu or junior secured or unsecured notes or junior secured term loans) from one or more of the existing lenders (or their affiliates) or other lenders (with the consent of the administrative agent) and, subject to compliance by the borrowers with the documentation and other requirements under the
Amended 2014 Credit Facility
, without the need for consent from any of the existing lenders under the
Amended 2014 Credit Facility
(other than those existing lenders that have agreed to provide such incremental facilities).
The
Amended 2014 Credit Facility
contains affirmative and negative covenants that the Company believes to be usual and customary for a senior secured credit facility. The negative covenants include, among other things, limitations on capital expenditures, asset sales, mergers and acquisitions, indebtedness, liens, dividends, investments and transactions with the Company’s affiliates. As of
June 30, 2015
, we were in compliance with all such covenants.
6.00% Senior Notes Due 2025
On January 27, 2015,
Endo DAC
, Endo Finance LLC and Endo Finco Inc. (collectively, the Issuers) issued
$1.20 billion
in aggregate principal amount of
6.00%
senior notes due 2025 (the
2025 Notes
). The
2025 Notes
were issued in a private offering for resale to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the
2025 Notes
, we incurred new debt issuance costs of
$24.4 million
, which were deferred and will be amortized over the term of the
2025 Notes
.
The
2025 Notes
are senior unsecured obligations of the Issuers and are guaranteed on a senior unsecured basis by certain of the Company’s subsidiaries. Interest on the
2025 Notes
is payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2015. The
2025 Notes
will mature on February 1, 2025, subject to earlier repurchase or redemption in accordance with the terms of the
2025 Notes
indenture incorporated by reference herein.
The
2025 Notes
were issued to (i) finance its acquisition of Auxilium, (ii) refinance certain indebtedness of Auxilium and (iii) pay related transaction fees and expenses.
On or after February 1, 2020, the Issuers may on any one or more occasions redeem all or a part of the
2025 Notes
, at the redemption prices (expressed as percentages of principal amount) set forth below, plus accrued and unpaid interest and additional interest, if any, if redeemed during the twelve-month period beginning on February 1 of the years indicated below:
|
|
|
|
|
|
|
Payment Dates (between indicated dates)
|
Redemption
Percentage
|
|
From February 1, 2020 to and including January 31, 2021
|
103.000
|
%
|
|
From February 1, 2021 to and including January 31, 2022
|
102.000
|
%
|
|
From February 1, 2022 to and including January 31, 2023
|
101.000
|
%
|
|
From February 1, 2023 and thereafter
|
100.000
|
%
|
In addition, at any time prior to February 1, 2020, the Issuers may on any one or more occasions redeem all or a part of the
2025 Notes
at a specified redemption price set forth in the indenture, plus accrued and unpaid interest and additional interest, if any. In addition, prior to February 1, 2018, the Issuers may redeem up to
35%
of the aggregate principal amount of the
2025 Notes
with the net cash proceeds from specified equity offerings at a redemption price equal to
106.000%
of the aggregate principal amount of the
2025 Notes
redeemed, plus accrued and unpaid interest. If
Endo DAC
experiences certain change of control events, the Issuers must offer to repurchase the
2025 Notes
at
101%
of their principal amount, plus accrued and unpaid interest and additional interest, if any.
The
2025 Notes
indenture contains covenants that, among other things, restrict
Endo DAC’s
ability and the ability of its restricted subsidiaries to incur certain additional indebtedness and issue preferred stock, make restricted payments, sell certain assets, agree to payment restrictions on the ability of restricted subsidiaries to make payments to
Endo DAC
, create certain liens, merge, consolidate or sell substantially all of
Endo DAC’s
assets, or enter into certain transactions with affiliates. These covenants are subject to a number of important exceptions and qualifications, including the fall away or revision of certain of these covenants upon the
2025 Notes
receiving investment grade credit ratings.
Also on January 27, 2015, the Issuers and the guarantors of the
2025 Notes
entered into a registration rights agreement under which they will be required to use their commercially reasonable efforts to (i) file with the SEC by March 31, 2016 an exchange offer registration statement pursuant to which they will offer, in exchange for the
2025 Notes
, new notes having terms substantially identical in all material respects to those of the
2025 Notes
(except the new notes will not contain terms with respect to transfer restrictions) (the A/B Exchange Offer), (ii) complete the A/B Exchange Offer by July 1, 2016 or, under specified circumstances, (iii) file a shelf registration statement with the SEC covering resales of the
2025 Notes
. The Issuers may be required to pay additional interest if they fail to comply with the registration and exchange requirements set forth in the registration rights agreement.
1.75% Convertible Senior Subordinated Notes Due 2015
At
December 31, 2014
, our indebtedness included
1.75%
Convertible Senior Subordinated Notes due
April 15, 2015
(the Convertible Notes). In April 2015, we settled
$98.7 million
aggregate principal amount of the Convertible Notes, which was the remaining outstanding principal balance of the Convertible Notes, for
$316.4 million
, which included the issuance of
2,261,236
ordinary shares.
In connection with the April 2015 Convertible Notes settlement activity, we entered into an agreement with the note hedge counterparty to settle the related call options for the receipt of
2,261,236
of our ordinary shares. These shares were subsequently canceled by the Company. In addition, we entered into an agreement to terminate the related warrants in exchange for our agreement to deliver to the warrant counterparty approximately
1,792,379
ordinary shares, which we delivered in June 2015.
1.50% Convertible Senior Notes Due 2018
On
January 29, 2015
, in connection with the consummation of the Merger Agreement between Endo and Auxilium, Endo entered into an agreement relating to Auxilium’s
$350.0 million
of
1.50%
convertible senior notes due 2018 (the
Auxilium Notes
), pursuant to which the Auxilium Notes are no longer convertible into shares of Auxilium common stock and instead are convertible into cash and ordinary shares of Endo based on the weighted average of the cash and Endo ordinary shares received by Auxilium stockholders that affirmatively made an election in connection with the Merger. As a result of such elections, for each share of Auxilium common stock a holder of Auxilium Notes was previously entitled to receive upon conversion of Notes, such holder instead became entitled to receive
$9.88
in cash and
0.3430
Endo ordinary shares. Pursuant to this agreement, Endo became a co-obligor of Auxilium’s obligations under the Auxilium Notes and expressly agreed to assume, jointly and severally with Auxilium, liability for (a) the due and punctual payment of the principal (and premium, if any) and interest, if any, on all of the Auxilium Notes issued under the corresponding indenture, (b) the due and punctual delivery of Endo ordinary shares and/or cash upon conversion of the Auxilium Notes by note holders and (c) the due and punctual performance and observance of all of the covenants and conditions of the corresponding indenture to be performed by Auxilium.
As further described in
Note 5. Acquisitions
, and as a result of the variability in the number of ordinary shares to be issued, the
Auxilium Notes
were initially recorded at their estimated fair value of
$571.1 million
upon the acquisition of Auxilium. In accordance with accounting guidance for debt with conversion and other options, we separately accounted for the liability and equity components of the
Auxilium Notes
by allocating the proceeds between the liability component and the embedded conversion option, or equity component, due to our ability to settle the
Auxilium Notes
in a combination of cash and ordinary shares, with
$293.1 million
allocated to debt and
$278.0 million
allocated to
Additional paid-in capital
. The fair value of the liability component was determined using a discounted cash flow model with a discount rate consistent that of a similar liability that does not have an associated convertible feature, based on comparable market transactions. Fair value of the equity component was determined using an integrated lattice valuation, which incorporates the conversion option and assumptions related to default.
Subsequent to the closing of the acquisition on
January 29, 2015
, during the first quarter of 2015, holders of the
Auxilium Notes
converted substantially all of the
Auxilium Notes
and received aggregate consideration consisting of
$148.9 million
of cash and
5.2 million
ordinary shares valued at
$408.6 million
. The value of the ordinary shares issued resulted in an increase to
Additional paid-in capital
of
$408.6 million
. In connection with these conversions, we charged
$1.0 million
to expense, representing the differences between the fair value of the repurchased debt components and their carrying amounts. The expense was included in the
Condensed Consolidated Statements of Operations
as a
Loss on extinguishment of debt
. Additionally, we recorded a combined decrease to
Additional paid-in capital
in the amount of
$263.5 million
during the first quarter of 2015, representing the fair value of the equity
component of the repurchased
Auxilium Notes
.
Other than as described above, there have been no material changes to our other indebtedness from what was disclosed in our Annual Report on Form 10-K for the year ended
December 31, 2014
, filed with the Securities and Exchange Commission on
March 2, 2015
. Refer to Note 18. Subsequent Events for further information.
NOTE 12. COMMITMENTS AND CONTINGENCIES
Manufacturing, Supply and Other Service Agreements
Our subsidiaries contract with various third party manufacturers, suppliers and service providers to provide raw materials used in our subsidiaries’ products and semi-finished and finished goods, as well as certain packaging and labeling services. The most significant of these agreements are with Novartis Consumer Health, Inc. and Novartis AG (collectively, Novartis), Teikoku Seiyaku Co., Ltd., Noramco, Inc., Grünenthal GmbH, Sharp Corporation, VIVUS, Inc., Jubilant HollisterStier Laboratories LLC and UPS Supply Chain Solutions, Inc. If, for any reason, we are unable to obtain sufficient quantities of any of the finished goods or raw materials or components required for their products or services needed to conduct their business, it could have a material adverse effect on our business, financial condition, results of operations and cash flows.
In addition to the manufacturing and supply agreements described above, we have agreements with various companies for clinical development services. Although we have no reason to believe that the parties to these agreements will not meet their obligations, failure by any of these third parties to honor their contractual obligations may have a material adverse effect on our business, financial condition, results of operations and cash flows.
Teikoku Seiyaku Co., Ltd.
Under the terms of EPI's agreement (the Teikoku Agreement) with Teikoku Seiyaku Co. Ltd. (Teikoku), during the
six
months ended
June 30, 2015
and
2014
, we recorded
$9.3 million
and
$7.2 million
of royalties to Teikoku, respectively. These amounts were included in our
Condensed Consolidated Statements of Operations
as Cost of revenues. At
June 30, 2015
,
$2.8 million
was recorded as a royalty payable and included in Accounts payable in the accompanying
Condensed Consolidated Balance Sheets
.
The Teikoku Agreement will not expire until
December 31, 2021
, unless terminated in accordance with its terms. After
December 31, 2021
, the Teikoku Agreement shall be automatically renewed on the first day of January each year unless terminated in accordance with its terms. Either party may terminate the Teikoku Agreement, following a
45
-day cure period, in the event that EPI fails to issue firm purchase orders for the annual minimum quantity for each year after 2017. EPI is the exclusive licensee for any authorized generic for Lidoderm
®
until the later of August 15, 2017 or the date of the first commercial sale of the second non-Teikoku generic version of Lidoderm
®
.
Grünenthal GmbH
Pursuant to the terms of EPI’s December 2007 License, Development and Supply Agreement with Grünenthal, EPI made payments to Grünenthal during the
six
months ended
June 30, 2015
and
2014
totaled
$14.5 million
and
$16.1 million
, respectively. These payments are originally recorded in inventory, and upon sale are recorded in
Cost of revenues
in our
Condensed Consolidated Financial Statements
.
UPS Supply Chain Solutions, Inc.
Under the terms of this agreement, EPI utilizes UPS Supply Chain Solutions (UPS) to provide customer service support and warehouse, freight and distribution services for certain of its products in the U.S. The term of the agreement extends through June 30, 2020. The agreement may be terminated by either EPI or UPS (1) without cause upon prior written notice to the other party; (2) with cause in the event of an uncured material breach by the other party; and (3) if the other party becomes insolvent or bankrupt. In the event of termination of services provided under the Warehouse Distribution Services Schedule to the agreement (i) by EPI without cause or (ii) by UPS due to EPI’s breach, failure by EPI to make payments when due, or EPI’s insolvency, EPI would be required to pay UPS certain termination costs. Such termination costs would not be material to the Company’s Consolidated Statements of Operations. On February 21, 2012, EPI amended this agreement to provide for a reduced pricing structure, which included new monthly fees, new variable fees and new termination fees. On August 16, 2013, EPI further amended this agreement to add another mode of transport permissible under the agreement. On June 19, 2015, EPI further amended this agreement to, among other things, extend the terms of certain Service Schedules and replace certain exhibits to the Service Schedules.
VIVUS, Inc.
Our Auxilium subsidiary is party to a commercial supply agreement (the STENDRA
®
Supply Agreement) with VIVUS, Inc. (VIVUS). Under the STENDRA
®
Supply Agreement, VIVUS is the exclusive supplier to Auxilium for STENDRA
®
and manufactures STENDRA
®
, directly or through one or more third party subcontractors. The Company pays to VIVUS its manufacturing cost plus a certain percentage mark up for each unit of STENDRA
®
. For 2015 and each subsequent year during the term, should Auxilium fail to
purchase an agreed minimum amount of the product from VIVUS, it will reimburse VIVUS for the shortfall as it relates to VIVUS’s out-of-pocket costs to acquire certain raw materials needed to manufacture STENDRA
®
.
Subject to each party’s termination rights, the term of the STENDRA
®
Supply Agreement will remain until December 31, 2018. At a time selected by Auxilium, but no later than the third anniversary of the effective date of the STENDRA
®
License Agreement, Auxilium may elect to transfer control of the supply chain for STENDRA
®
to itself or its designee (the Supply Chain Transfer). The STENDRA
®
Supply Agreement will automatically terminate upon the completion of the Supply Chain Transfer.
Amounts purchased under the STENDRA
®
Supply Agreement during the period from
January 29, 2015
to
June 30, 2015
totaled
$11.6 million
. These payments are originally recorded in inventory, and upon sale are recorded in
Cost of revenues
in our
Condensed Consolidated Financial Statements
.
Jubilant HollisterStier Laboratories LLC
On January 29, 2015, we acquired Auxilium, which is party to a supply agreement (the JHS Agreement) with Jubilant HollisterStier Laboratories LLC (JHS). Pursuant to the JHS Agreement, which was initially entered into in June 2008, JHS fills and lyophilizes the XIAFLEX
®
bulk drug substance, which is manufactured by Auxilium, and produces sterile diluent. The initial term of the agreement was
three
years, with automatic renewal provisions thereafter for subsequent
two
-year terms, unless or until either party provides notification prior to expiration of the then current term of the contract. Auxilium is required to purchase a specified percentage of its total forecasted volume of XIAFLEX
®
from JHS each year, unless JHS is unable to supply XIAFLEX
®
within the timeframe established under such forecasts. Auxilium currently is the sole supplier of the active pharmaceutical ingredient for commercial supply of XIAFLEX
®
, but it is currently in the process of qualifying a new secondary manufacturer for XIAFLEX
®
.
Amounts purchased pursuant to the JHS Agreement were not material for any of the periods presented.
Legal Proceedings
We and certain of our subsidiaries are involved in various claims, legal proceedings and governmental investigations that arise from time to time in the ordinary course of our business, including relating to product liability, intellectual property, regulatory compliance and commercial matters. While we cannot predict the outcome of these legal proceedings and we and our subsidiaries intend to defend vigorously our and their position, an adverse outcome in any of these proceedings could have a material adverse effect on our current and future financial position, results of operations and cash flows.
As of
June 30, 2015
, the Company’s reserve for loss contingencies totaled
$1.60 billion
, of which
$1.53 billion
relates to the Company’s product liability accrual for vaginal mesh cases. During 2014, the Company announced that it had reached master settlement agreements with several of the leading plaintiffs’ law firms to resolve claims relating to vaginal mesh products sold by the Company’s AMS subsidiary. The agreements were entered into solely by way of compromise and settlement and are not in any way an admission of liability or fault. Although the Company believes there is a reasonable possibility that a loss in excess of the amount recognized exists, we are unable to estimate the possible loss or range of loss in excess of the amount recognized at this time.
Product Liability
We and certain of our subsidiaries have been named as defendants in numerous lawsuits in various federal and state courts, as well as in Canada and other countries outside the United States, alleging personal injury resulting from the use of certain of our products and the products of our subsidiaries. These matters are described in more detail below.
The Company believes that certain settlements and judgments, as well as legal defense costs, relating to certain product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers. In certain circumstances, insurance carriers reserve their rights with respect to coverage, or contest or deny coverage. The Company and its subsidiaries intend to contest vigorously all such disputes with respect to their insurance coverage and to enforce their rights under the terms of these insurance policies, and accordingly, the Company will record receivables with respect to amounts due under these policies, only when the resolution of any dispute has been reached and realization of the potential claim for recovery is considered probable. Amounts recovered under the Company’s product liability insurance policies will be less than the stated coverage limits and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers will pay claims or that coverage will otherwise be available.
Vaginal Mesh Cases.
On October 20, 2008, the FDA issued a Public Health Notification regarding potential complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The notification provides recommendations and encourages physicians to seek specialized training in mesh procedures, to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications.
In July 2011, the FDA issued an update to the October 2008 Public Health Notification regarding mesh to further advise the public and the medical community of the potential complications associated with transvaginal placement of surgical mesh to treat POP and SUI. In this July 2011 update, the FDA maintained that adverse events are not rare, as previously reported, and questioned the relative effectiveness of transvaginal mesh as a treatment for POP as compared to non-mesh surgical repair. The July 2011 notification
continued to encourage physicians to seek specialized training in mesh procedures, to consider and to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications. The FDA also convened an advisory panel which met on September 8-9, 2011 to further address the safety and effectiveness of transvaginal surgical mesh used to treat POP and SUI. At the conclusion of the meetings, the advisory panel recommended reclassifying transvaginal mesh products used to treat POP to Class III devices (premarket approval) and recommended that manufacturers of these products be required to conduct additional post-market surveillance studies. The advisory panel recommended that transvaginal surgical mesh products used to treat SUI remain as Class II devices. Regarding retropubic and transobturator (TOT) slings, the advisory panel recommended that no additional post-market surveillance studies are necessary. Regarding mini-slings, the advisory panel recommended premarket studies for new devices and additional post-market surveillance studies.
On January 3, 2012, the FDA ordered manufacturers of transvaginal surgical mesh used for POP and of single incision mini-slings for urinary incontinence, such as our subsidiary AMS, to conduct post-market safety studies and to monitor adverse event rates relating to the use of these products. AMS received a total of nineteen class-wide post-market study orders regarding its pelvic floor repair and mini-sling products; however, the FDA agreed to place sixteen of these study orders on hold for a variety of reasons. Three of these post-market study orders remain active and AMS is continuing the process of complying with these orders. In these orders, the FDA also noted that it is still considering the recommendation of the September 9, 2011 advisory committee that urogynecological surgical mesh for transvaginal repair of POP be reclassified from Class II to Class III.
On April 29, 2014, the FDA issued a statement proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse repair from Class II to Class III. Further, the FDA proposed to reclassify urogynecologic surgical mesh instrumentation from Class I to Class II, and to establish special controls for surgical instrumentation for use with urogynecologic surgical mesh. The FDA stated that it was proposing these changes based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices. Although this proposal was subject to a 90-day comment period, to date the FDA has not taken further action regarding these proposals.
Since 2008, AMS, and more recently, in certain cases the Company or certain of its subsidiaries, have been named as defendants in multiple lawsuits in various state courts, a multidistrict litigation (MDL) in the Southern District of West Virginia (MDL No. 2325), as well as in Canada, where various class action and individual complaints are pending, and other countries outside the United States alleging personal injury resulting from the use of transvaginal surgical mesh products designed to treat POP and SUI. Plaintiffs in these suits allege various personal injuries including chronic pain, incontinence and inability to control bowel function and permanent deformities.
As of
June 30, 2015
, AMS and certain plaintiffs’ counsel representing mesh-related product liability claimants have entered into various Master Settlement Agreements (MSAs) regarding settling up to approximately
46,600
filed and unfiled mesh claims handled or controlled by the participating counsel. These MSAs, which were executed at various times from June 14, 2013 through
June 30, 2015
, were entered into solely by way of compromise and settlement and are not in any way an admission of liability or fault by the Company or AMS. All MSAs are subject to a process that includes guidelines and procedures for administering the settlements and the release of funds. In certain cases, the MSAs provide for the creation of Qualified Settlement Funds (QSFs) into which funds may be deposited pursuant to certain schedules set forth in those agreements. All MSAs have participation thresholds requiring participation by the majority of claims represented by each law firm. If certain participation thresholds are not met, then AMS will have the right to terminate the settlement with that law firm. In addition, one agreement gives AMS a unilateral right of approval regarding which claims may be eligible to participate under that settlement. To the extent fewer claims than are authorized under an agreement participate, the total settlement payment under that agreement will be reduced by an agreed-upon amount for each such non-participating claim. Funds deposited in Qualified Settlement Funds are included in Restricted cash and cash equivalents in the
June 30, 2015
Condensed Consolidated Balance Sheets
.
Charges related to vaginal mesh product liability are reported in Discontinued operations, net of tax in our Condensed Consolidated Statements of Operations. Our estimated liability includes a reduction factor applied to the maximum number of potentially eligible claims resulting in a liability that is lower than the maximum payouts under the MSAs. This reduction factor is based on our estimate of likely duplicative claims and claims that will not ultimately obtain recovery under the MSAs or otherwise. The Company is increasing its product liability accrual due primarily to (1) its recently becoming aware of previously unknown U.S. mesh claims, both under and outside the MSAs, and (2) with respect to known claims under the MSAs, a decrease in the applicable reduction factor from approximately
20%
to
18%
. By decreasing the reduction factor from approximately
20%
to
18%
, and thereby increasing the product liability accrual, the Company is reflecting its current estimate that fewer claims will be excluded from the MSAs than previously anticipated. The Company and AMS expect that valid claims under the MSAs will continue to be settled. However, the Company and AMS intend to vigorously contest pending and future claims that are invalid or in excess of the maximum claim amounts under the MSAs. The Company and AMS are also aware of a substantial number of additional claims or potential claims, some of which may be invalid or contested, for which the Company lacks sufficient information to determine whether any potential liability is probable, and such claims have not been included in the Company’s product liability accrual. As of the date of this report, the Company believes that the current product liability accrual includes all known claims for which liability is probable and estimable. However, it is currently not possible to determine the validity or outcome of any additional or potential claims and such
claims may result in additional losses that could have a material adverse effect on the Company’s business, financial condition, results of operations and cash flow. The Company will continue to monitor the situation, including with respect to any additional claims of which the Company may later become aware, and, if appropriate, make further adjustments to the applicable reduction factor and product liability accrual based on new information.
Distribution of funds to any individual claimant is conditioned upon the receipt of documentation substantiating the validity of the claim, a full release and a dismissal of the entire action or claim as to all AMS parties and affiliates. Prior to receiving funds, an individual claimant shall represent and warrant that liens, assignment rights, or other claims that are identified in the claims administration process have been or will be satisfied by the individual claimant. The amount of settlement awards to participating claimants, the claims evaluation process and procedures used in conjunction with award distributions, and the negotiations leading to the settlement shall be kept confidential by all parties and their counsel.
The following table presents the changes in the vaginal mesh Qualified Settlement Funds and product liability balance during the
six months
ended
June 30, 2015
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Qualified Settlement Funds
|
|
Product Liability
|
|
Balance as of December 31, 2014
|
$
|
485,229
|
|
|
$
|
1,655,195
|
|
|
Additional charges
|
—
|
|
|
273,752
|
|
|
Cash distributions to Qualified Settlement Funds
|
377,074
|
|
|
—
|
|
|
Cash distributions to settle disputes from Qualified Settlement Funds
|
(385,087
|
)
|
|
(385,087
|
)
|
|
Cash distributions to settle disputes
|
—
|
|
|
(10,829
|
)
|
|
Balance as of June 30, 2015
|
$
|
477,216
|
|
|
$
|
1,533,031
|
|
As of June 30, 2015, the entire liability is classified as short-term because the combination of amounts that could be released from the Qualified Settlement Funds in the next twelve months plus the contractual maximum payments under the MSAs in the next twelve months is greater than the liability balance.
AMS expects to fund the payments under all settlement agreements by December 31, 2017. As the funds are disbursed out of the Qualified Settlement Funds from time to time, the product liability accrual will be reduced accordingly with a corresponding reduction to Restricted cash and cash equivalents. In addition, the Company may pay cash distributions to settle disputes separate from the Qualified Settlement Funds, which will also decrease the product liability accrual but will not decrease Restricted cash and cash equivalents.
In addition, we have been contacted regarding a civil investigation that has been initiated by a number of state attorneys general into mesh products, including transvaginal surgical mesh products designed to treat POP and SUI. In November 2013, we received a subpoena relating to this investigation from the state of California, and have subsequently received additional subpoenas from other states. We are cooperating fully with this investigation. At this time, we cannot predict or determine the outcome of this investigation or reasonably estimate the amount or range of amounts of fines or penalties, if any, that might result from a settlement or an adverse outcome from this investigation.
MCP Cases.
Qualitest, and in certain cases the Company or certain of its subsidiaries, along with several other pharmaceutical manufacturers, have been named as defendants in numerous lawsuits in various federal and state courts alleging personal injury resulting from the use of the prescription medicine metoclopramide. Plaintiffs in these suits allege various personal injuries including tardive dyskinesia, other movement disorders and death. Qualitest and the Company intend to contest all of these cases vigorously and to explore other options as appropriate in the best interests of the Company and Qualitest.
Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. However, we cannot predict the timing or outcome of any such litigation, or whether any additional litigation will be brought against the Company or its subsidiaries. As of
August 1, 2015
, approximately
645
MCP cases, some of which may have been filed on behalf of multiple plaintiffs, are currently pending against Qualitest and/or the Company or certain of its subsidiaries.
In 2014, the Company and its subsidiaries have reached an agreement with certain plaintiffs’ counsel in an effort to reach resolution of substantially all of these pending MCP cases. The agreement was entered into solely by way of compromise and settlement and is not in any way an admission of liability or fault by the Company or any of its subsidiaries. An essential element of these settlements will be participation by the majority of plaintiffs involved in pending litigation. If certain participation thresholds are not met, the Company will have the right to terminate the agreements.
Distribution of funds to any individual plaintiff will be conditioned upon, among other things a full release and a dismissal with prejudice of the entire action or claim as to the Company and/or each of its subsidiaries. Prior to receiving an award, an individual
claimant shall represent and warrant that liens, assignment rights, or other claims that are identified in the claims administration process have been or will be satisfied by the individual claimant. The amount of settlement awards to participating plaintiffs, claimants, the claims evaluation process and procedures used in conjunction with award distributions, and the negotiations leading to the settlement shall be kept confidential by all parties and their counsel.
Propoxyphene Cases.
Qualitest and, in certain cases, the Company or certain of its subsidiaries, along with several other pharmaceutical manufacturers, have been named as defendants in numerous lawsuits originally filed in various federal and state courts alleging personal injury resulting from the use of prescription pain medicines containing propoxyphene. Plaintiffs in these suits allege various personal injuries including cardiac impairment, damage and death. In August 2011, a multidistrict litigation (MDL) was formed, and certain transferable cases pending in federal court were coordinated in the Eastern District of Kentucky as part of MDL No. 2226. The MDL Judge’s dismissal with prejudice of the claims asserted against generic manufacturers, including Qualitest and the Company, was affirmed by the Sixth Circuit on June 27, 2014, as part of a consolidated appeal. In November 2012, additional cases were filed in various California state courts. While many of these cases were initially remanded to a state court coordinated proceeding in Los Angeles, the Ninth Circuit sitting
en banc
reversed these remands, finding federal subject matter jurisdiction. As a result, these actions were returned to the federal courts to which they were initially removed. Subsequently, many of these actions have been transferred to the Eastern District of Kentucky and assigned to United States District Judge Danny C. Reeves. On November 18, 2014, additional multi-plaintiff cases were filed in state court in Oklahoma. The Oklahoma state court actions were also removed to federal court and are currently pending in the Western District of Oklahoma. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. However, we cannot predict the timing or outcome of any such litigation, or whether any additional litigation will be brought against the Company or its subsidiaries, but Qualitest and the Company intend to contest the litigation vigorously and to explore all options as appropriate in the best interests of Qualitest and the Company. As of
August 1, 2015
, approximately
46
propoxyphene cases, some of which may have been filed on behalf of multiple plaintiffs, are currently pending against Qualitest and/or the Company. The Company and its subsidiaries are unable to predict the outcome of this matter or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss, if any, for this matter.
Testosterone Cases.
EPI, and in certain cases the Company or certain of its subsidiaries, including Auxilium Pharmaceuticals, Inc., along with other pharmaceutical manufacturers, have been named as defendants in lawsuits alleging personal injury resulting from the use of prescription medications containing testosterone, including Fortesta
®
Gel, Delatestryl
®
, Testim
®
, TESTOPEL
®
and Striant
®
. Plaintiffs in these suits allege various personal injuries including pulmonary embolism, stroke, and other vascular and/or cardiac injuries. In June 2014, an MDL was formed to include claims involving all testosterone replacement therapies filed against EPI, Auxilium, and other manufacturers of such products, and certain transferable cases pending in federal court were coordinated in the Northern District of Illinois as part of MDL No. 2545. In addition to the federal cases filed against EPI and Auxilium that have been transferred to the Northern District of Illinois as tag-along actions to MDL No. 2545, litigation has also been filed against EPI in the Court of Common Pleas Philadelphia County and in certain other state courts. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions, and cases brought in federal court will be transferred to the Northern District of Illinois as tag-along actions to MDL No. 2545. However, we cannot predict the timing or outcome of any such litigation, or whether any such additional litigation will be brought against the Company and/or its subsidiaries. The Company and its subsidiaries intend to contest the litigation vigorously and to explore all options as appropriate in the best interests of the Company. As of
August 1, 2015
, approximately
429
cases are currently pending against the Company and/or its subsidiaries; some of which may have been filed on behalf of multiple plaintiffs, and including a class action complaint filed in Canada.
In addition, on November 5, 2014, a civil class action complaint was filed in the Northern District of Illinois against EPI, Auxilium, and various other manufacturers of testosterone products on behalf of a proposed class of health insurance companies and other third party payers that had paid for certain testosterone products, alleging that the marketing efforts of EPI, Auxilium, and other defendant manufacturers with respect to certain testosterone products constituted racketeering activity in violation of 18 U.S.C. §1962(c), and other civil RICO claims. Further, the complaint alleges that EPI, Auxilium, and other defendant manufacturers violated various state consumer protection laws through their marketing of certain testosterone products. On June 10, 2015 plaintiffs in that action filed a Second Amendment Complaint. The Company and/or its subsidiaries are unable to predict the outcome of this matter or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss for this matter, if any.
Department of Health and Human Services Subpoena and Related Matters
As previously reported, in January 2007 and April 2011, the Company received subpoenas issued by the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) and the United States Department of Justice (DOJ), respectively. The subpoenas requested documents relating to Lidoderm
®
(lidocaine patch
5%
), focused primarily on the sale, marketing and promotion of Lidoderm
®
. As previously reported, the Company resolved potential claims of the federal government and numerous states related to potential claims regarding the sale, marketing and promotion of Lidoderm
®
.
As previously reported, EPI is in the process of responding to a Civil Investigative Demand issued by the State of Texas relating to Lidoderm
®
(lidocaine patch 5%), focused primarily on the sale, marketing and promotion of Lidoderm
®
in Texas. EPI and the
Company are cooperating with the State’s investigation. The Company and its subsidiaries are unable to predict the outcome of this matter or the ultimate legal and financial liability and at this time cannot reasonably estimate the possible loss or range of loss for this matter but will explore all options as appropriate in the best interests of EPI and the Company.
Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. However, we cannot predict the timing or outcome of any such litigation, or whether any such litigation will be brought against the Company or its subsidiaries.
Qualitest Pharmaceuticals Civil Investigative Demands
In April 2013, the Company’s subsidiaries, EPI and Qualitest, received Civil Investigative Demands (CIDs) from the U.S. Attorney’s Office for the Southern District of New York. The CIDs request documents and information regarding the manufacture and sale of chewable fluoride tablets and other products sold by Qualitest. EPI and Qualitest are cooperating with the government’s investigation. Discussions between EPI and Qualitest and the U.S. Attorney’s Office for the Southern District of New York have taken place, and the Company believes that a range of loss for this matter is reasonably estimable at this time. The estimated cost of this settlement has been incorporated into our legal loss contingency reserve. However, it is not possible at this time to determine with certainty the ultimate outcome of this matter. It is possible that the outcome of this matter could result in an additional loss that could have a material effect on our business, financial condition, results of operations and cash flows.
Unapproved Drug Litigation
In September 2013, the State of Louisiana filed a Petition for Damages against EPI, Qualitest and Boca and over 50 other pharmaceutical companies alleging the defendants or their subsidiaries marketed products that were not approved by the FDA. See
State of Louisiana v. Abbott Laboratories, Inc., et al
., C624522 (19th Jud. Dist. La.). The State of Louisiana seeks damages, fines, penalties, attorneys’ fees and costs under various causes of action.
EPI, Qualitest and Boca intend to contest the above case vigorously and to explore other options as appropriate in the best interests of the Company, EPI, Qualitest and Boca. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. However, we cannot predict the timing or outcome of any such litigation, or whether any such litigation will be brought against the Company or its subsidiaries. The Company and its subsidiaries are unable to predict the outcome of this matter or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss for this matter, if any.
Opioid-Related Litigations, Subpoenas and Document Requests
In June 2014, Corporation Counsel for the City of Chicago filed suit in Illinois state court against multiple defendants, including the Company’s Endo Health Solutions Inc. (EHSI) and EPI subsidiaries, for alleged violations of city ordinances and other laws relating to defendants’ alleged opioid sales and marketing practices. On June 12, 2014, the case was removed to the United States District Court for the Northern District of Illinois. On October 14, 2014, Plaintiff amended its Complaint to, among other things, add EPI as a defendant. On December 19, 2014, defendants moved to dismiss the Amended Complaint. On May 8, 2015, the Court issued an order granting that motion in part, dismissing the case as to EHS and EPI. That order also granted the City of Chicago leave to amend its complaint.
In May 2014, a lawsuit was filed in California Superior Court (Orange County) in the name of the People of the State of California, acting by and through County Counsel for Santa Clara County and the Orange County District Attorney, against multiple defendants, including the Company’s subsidiary EHSI. The complaint was amended on June 9, 2014, to include allegations against EPI, among other changes. The amended complaint asserts violations of California’s statutory Unfair Competition and False Advertising laws, as well as asserting a claim for public nuisance, based on alleged misrepresentations in connection with sales and marketing of opioids, including Opana
®
. Defendants, including the Company, have filed various motions attacking the pleadings, which are pending and set to be heard by the court in the coming months. Plaintiff seeks declaratory relief, restitution, civil penalties (including treble damages), abatement, an injunction, and attorneys’ fees and costs.
In September 2013, the Company’s subsidiaries, EPI and EHSI received a subpoena from the State of New York Office of Attorney General seeking documents and information regarding the sales and marketing of Opana
®
and in October 2014 received a Subpoena Ad Testificandum seeking testimony regarding the sales and marketing of Opana
®
. In January 2014, the Company’s subsidiaries, EPI and EHSI received a set of informal document requests from the Office of the United States Attorney for the Eastern District of Pennsylvania seeking documents and information regarding the sales and marketing of Opana
®
ER. In September 2014, the Company’s subsidiaries, EPI and EHSI received a Request for Information from the State of Tennessee Office of the Attorney General and Reporter seeking documents and information regarding the sales and marketing of opioids, including Opana
®
ER. In August 2015, the Company’s subsidiaries, EPI and EHSI received a subpoena from the State of New Hampshire Office of the Attorney General seeking documents and information regarding the sales and marketing of opioids, including Opana
®
ER.
The Company is cooperating with the State of New York Office of Attorney General, the Office of the United States Attorney for the Eastern District of Pennsylvania, the State of Tennessee Office of the Attorney General and Reporter, and the State of New Hampshire Office of the Attorney General in their respective investigations. With respect to both the litigations brought on behalf of the City of Chicago and the People of the State of California, the Company and its subsidiaries intend to contest those matters vigorously and to explore all options as appropriate in the best interests of the Company. The Company and its subsidiaries are unable to predict the outcome of these matters or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss, if any, for these matters but will explore all options as appropriate in the best interests of EHSI, EPI and the Company.
Antitrust Litigation and Investigations
Multiple direct and indirect purchasers of Lidoderm
®
have filed a number of cases against EPI and co-defendants Teikoku Seiyaku Co., Ltd., Teikoku Pharma USA, Inc. (collectively, Teikoku) and Actavis plc., f/k/a as Watson Pharmaceuticals, Inc., and a number of its subsidiaries (collectively, Actavis or Watson). Certain of these actions have been asserted on behalf of classes of direct and indirect purchasers, while others are individual cases brought by one or more alleged direct or indirect purchasers. The complaints in these cases generally allege that Endo, Teikoku and Actavis entered into an anticompetitive conspiracy to restrain trade through the settlement of patent infringement litigation concerning U.S. Patent No. 5,827,529 (the ‘529 patent) and other patents. Some of the complaints also allege that Teikoku wrongfully listed the ‘529 patent in the Orange Book as related to Lidoderm
®
,
that Endo and Teikoku commenced sham patent litigation against Actavis and that Endo abused the FDA citizen petition process by filing a citizen petition and amendments solely to interfere with generic companies’ efforts to obtain FDA approval of their versions of Lidoderm
®
. The cases allege violations of Sections 1 and 2 of the Sherman Act (15 U.S.C. §§ 1, 2) and various state antitrust and consumer protection statutes as well as common law remedies in some states. These cases generally seek damages, treble damages, disgorgement of profits, restitution, injunctive relief and attorneys’ fees.
The United States Judicial Panel on Multidistrict Litigation, pursuant to 28 U.S.C. § 1407, issued an order on April 3, 2014, transferring these cases as
In Re Lidoderm Antitrust Litigation
, MDL No. 2521, to the U.S. District Court for the Northern District of California.
Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions, and cases brought in federal court will be transferred to the Northern District of California as tag-along actions to
In Re Lidoderm Antitrust Litigation
.
The cases are in the discovery phase of the litigation in accordance with the pre-trial schedule. Trial is currently scheduled to begin in 2017.
Multiple direct and indirect purchasers of Opana
®
ER have filed cases against EHSI, EPI, Penwest Pharmaceuticals Co., and Impax Laboratories Inc., all of which have been transferred and coordinated for pretrial proceedings in the Norther District of Illinois by the Judicial Panel on Multidistrict Litigation. Some of these cases have been filed on behalf of putative classes of direct and indirect purchasers, while others have been filed on behalf of individual retailers. These cases generally allege that the agreement reached by EPI and Impax to settle patent infringement litigation concerning multiple patents pertaining to Opana
®
ER and EPI’s introduction of the re-formulation of Opana
®
ER violated antitrust laws. The complaints allege violations of Sections 1 and 2 of the Sherman Act (15 U.S.C. §§ 1, 2), various state antitrust and consumer protection statutes, as well as state common law. These cases generally seek damages, treble damages, disgorgement of profits, restitution, injunctive relief and attorneys’ fees. The defendants have filed motions to dismiss these actions and discovery is currently stayed pending the outcome of these motions. We cannot predict whether or not additional cases similar to those described above will be filed by other plaintiffs or the timing or outcome of any such litigation.
The Company and its subsidiaries are unable to predict the outcome of these matters or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss for these matters, if any, but will explore all options as appropriate in the best interests of EPI and the Company.
On February 25, 2014, the Company’s subsidiary, EPI received a Civil Investigative Demand (the February 25 CID) from the U.S. Federal Trade Commission (the FTC). The FTC issued a second Civil Investigative Demand to EPI on March 25, 2014 (the March 25 CID). The February 25 CID requests documents and information concerning EPI’s settlement agreements with Actavis and Impax settling the Opana
®
ER patent litigation, EPI’s Development and Co-Promotion Agreement with Impax,
and its settlement agreement with Actavis settling the Lidoderm
®
patent litigation, as well as information concerning the marketing and sales of Opana
®
ER and Lidoderm
®.
The March 25 CID requests documents and information concerning EPI’s acquisition of U.S. Patent No. 7,852,482 (the ‘482 patent), as well as additional information concerning certain litigation relating to, and the marketing and sales of Opana
®
ER. The FTC also issued subpoenas for investigational hearings (similar to depositions) to Company employees and former Company employees.
On November 3, 2014, EPI received a Civil Investigative Demand from the State of Florida Office of the Attorney General issued pursuant to the Florida Antitrust Act of 1980, Section 542.28 and seeking documents and other information concerning EPI’s
settlement agreement with Actavis settling the Lidoderm
®
patent litigation, as well as information concerning the marketing and sales of Lidoderm
®
.
On February 9, 2015, EPI and EHSI received a Civil Investigative Demand for Production of Documents and Information from the State of Alaska Office of Attorney General issued pursuant to Alaska’s Antitrust and Unfair Trade Practices and Consumer Protection law seeking documents and other information concerning settlement agreements with Actavis and Impax settling the Opana ER patent litigation as well as information concerning EPI’s settlement agreement with Actavis settling the Lidoderm patent litigation, as well as information concerning the marketing and sales of Lidoderm.
EPI is cooperating with the FTC, the State of Florida Office of the Attorney General, and the State of Alaska Office of the Attorney General in their respective investigations. The Company and its subsidiaries are unable to predict the outcome of these investigations or the ultimate legal and financial liability, if any, and at this time cannot reasonably estimate the possible loss or range of loss for these investigations, if any, but will explore all options as appropriate in the best interests of EPI and the Company.
AWP Litigation
On September 18, 2014, the State of Mississippi notified EPI that it intended to assert claims against EPI similar to claims the state brought against it in 2005 and later voluntarily dismissed. In its 2005 lawsuit, the state alleged that EPI reported false pricing information in connection with certain drugs that are reimbursable under Medicaid. Preliminary discussions between EPI and the State of Mississippi have taken place, and the Company believes that a loss is probable and a range of loss for this matter is reasonably estimable at this time. The estimated cost of this settlement has been incorporated into the increase in our legal loss contingency reserve. However, it is not possible at this time to determine with certainty the ultimate outcome of this matter. It is possible that the outcome of this matter could result in an additional loss that could have a material effect on our business, financial condition, results of operations and cash flows. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. However, we cannot predict the timing or outcome of any such litigation, or whether any such litigation will be brought against the Company or its subsidiaries.
Paragraph IV Certifications on Lidoderm
®
As previously reported, the Company’s subsidiary, EPI and the holders of the Lidoderm
®
New Drug Application and relevant patents, Teikoku, received a Paragraph IV Certification Notice under 21 U.S.C. 355(j) (a Paragraph IV Notice) from Watson advising of its filing of an ANDA for a generic version of Lidoderm
®
(lidocaine topical patch
5%
), which resulted in litigation under the Hatch-Waxman Act.
On
May 28, 2012
, EPI entered into a Settlement and License Agreement (the Watson Settlement Agreement) among EPI and Teikoku, on the one hand, and Watson, on the other hand. The Watson Settlement Agreement settled all ongoing patent litigation among the parties relating to Watson’s generic version of Lidoderm
®
. Under the terms of the Watson Settlement Agreement, the parties dismissed their respective claims and counterclaims without prejudice. As part of the settlement, Watson agreed not to challenge the validity or enforceability of EPI’s and Teikoku’s patents relating to Lidoderm
®
with respect to Watson’s generic version of Lidoderm
®
. Watson received FDA approval of its generic version of Lidoderm
®
in August 2012 and began selling its generic version of Lidoderm
®
on
September 16, 2013
(the Start Date) pursuant to a license granted by EPI and Teikoku under the Watson Settlement Agreement. The license to Watson was exclusive as to EPI’s launch of an authorized generic version of Lidoderm
®
until
May 1, 2014
. EPI received an at market royalty equal to
25%
of the gross profit generated on Watson’s sales of its generic version of Lidoderm
®
during its period of exclusivity. During the
three and six
months ended
June 30, 2014
we recorded Watson royalty income of
$13.1 million
and
$51.3 million
, respectively, which is included in
Other revenues
in our
Condensed Consolidated Statements of Operations
. We recorded
no
Watson royalty income during the
three and six
months ended
June 30, 2015
.
On
May 16, 2012
, EPI and Teikoku received a Paragraph IV Notice from Noven Pharmaceuticals, Inc. (Noven) advising of its filing of an ANDA for a generic version of Lidoderm
®
, which resulting in litigation under the Hatch-Waxman Act. On April 15, 2014, EPI entered into a Settlement and License Agreement (the Noven Settlement Agreement) among EPI and Teikoku, on the one hand, and Noven, on the other hand. The Noven Settlement Agreement settled all ongoing patent litigation among the parties relating to Noven’s generic version of Lidoderm
®
. Under the terms of the Noven Settlement Agreement, the parties dismissed their respective claims and counterclaims without prejudice. As part of the settlement, Noven agreed not to challenge the validity or enforceability of EPI’s and Teikoku’s patents relating to Lidoderm
®
with respect to Noven’s generic version of Lidoderm
®
. Under the terms of the Noven Settlement Agreement, should Noven receive FDA approval, Noven may begin selling its generic version of Lidoderm
®
.
On
May 24, 2012
, EPI and Teikoku received a Paragraph IV Notice from TWi Pharmaceuticals, Inc. (TWi) advising of its filing of an ANDA for a generic version of Lidoderm
®
, which resulted in litigation under the Hatch-Waxman Act. On April 18, 2014, EPI entered into a Settlement and License Agreement (the TWi Settlement Agreement) among EPI and Teikoku, on the one hand, and TWi, on the other hand. The TWi Settlement Agreement settled all ongoing patent litigation among the parties relating to TWi’s generic version of Lidoderm
®
. Under the terms of the TWi Settlement Agreement, the parties dismissed their respective claims and counterclaims without prejudice. As part of the settlement, TWi agreed not to challenge the validity or enforceability of EPI’s and
Teikoku’s patents relating to Lidoderm
®
with respect to TWi’s generic version of Lidoderm
®
. Under the terms of the TWi Settlement Agreement, should TWi receive FDA approval, TWi may begin selling its generic version of Lidoderm
®
.
In addition to the above litigation, it is possible that another generic manufacturer may also seek to launch a generic version of Lidoderm
®
.
Paragraph IV Certifications on Opana
®
ER
As previously reported, starting in December 2007 through December 2011, EPI received Paragraph IV Notices from various generic drug manufacturers, including Impax Laboratories, Inc. (Impax), Actavis South Atlantic LLC (Actavis), Sandoz, Inc. (Sandoz), Barr Laboratories, Inc. (Teva), Watson Laboratories, Inc. (Watson), Roxane Laboratories, Inc. (Roxane) and most recently, Ranbaxy Inc. (Ranbaxy) advising of the filing by each such company of an ANDA for a generic version of the non-crush-resistant formulation of Opana
®
ER (oxymorphone hydrochloride extended-release tablets CII). To date, EPI settled all of the Paragraph IV litigation relating to the non-crush-resistant formulation of Opana
®
ER other than those cases discussed in the next paragraph. Under the terms of the settlements, each generic manufacturer agreed not to challenge the validity or enforceability of patents relating to the non-crush-resistant formulation of Opana
®
ER. As a result, Actavis launched its generic version of non-crush-resistant Opana
®
ER 7.5 and 15 mg tablets on
July 15, 2011
, and Impax launched its generic version of non-crush-resistant Opana
®
ER 5, 7.5, 10, 15, 20, 30 and 40 mg tablets on
January 2, 2013
. Pursuant to the terms of the respective settlement agreements, Sandoz, Teva, Watson, Roxane and Actavis were granted licenses to patents listed in the Orange Book at the time each generic filed its ANDA.
In late 2012, two patents (U.S. Patent Nos. 8,309,122 and 8,329,216) were issued to EPI covering Opana
®
ER. On December 11, 2012, EPI filed a complaint against Actavis in U.S. District Court for the Southern District of New York for patent infringement based on its ANDA for a non-crush-resistant generic version of Opana
®
ER. Between May 22 and June 21, 2013, EPI filed similar suits in the U.S. District Court for the Southern District of New York against the following applicants for non-crush-resistant Opana
®
ER: Par Pharmaceuticals, Teva Pharmaceuticals, Mallinckrodt LLC, Sandoz, Roxane and Ranbaxy. Those suits allege infringement of U.S. Patent Nos. 7,851,482, 8,309,122, and 8,329,216. In July 2013, Actavis and Roxane were granted FDA approval to market all strengths of their respective non-crush-resistant formulations of Opana
®
ER. In June 2014, Mallinckrodt LLC was granted FDA approval to market all strengths of their respective non-crush-resistant formulations of Opana
®
ER. On August 1, 2013, EPI dismissed its suit against Teva Pharmaceuticals based on Teva’s demonstration to EPI that Teva does not, at this time, intend to pursue an ANDA for non-crush-resistant Opana
®
ER. On October 18, 2013, EPI dismissed its suit against Sandoz based on its demonstration to EPI that it does not, at this time, intend to pursue an ANDA for non-crush-resistant Opana
®
ER. On December 18, 2013, EPI dismissed its suit against Mallinckrodt LLC based on a settlement allowing Mallinckrodt LLC to launch its non-crush-resistant formulation of Opana ER in October 2017, under certain circumstances. A trial in this case was held from March 23, 2015 through April 24, 2015 in the United States District Court for the Southern District of New York and we are awaiting a decision.
EPI intends to defend vigorously its intellectual property rights and to pursue all available legal and regulatory avenues in defense of the non-crush-resistant formulation Opana
®
ER, including enforcement of the product’s intellectual property rights and approved labeling. However, there can be no assurance that EPI will be successful. If EPI is unsuccessful, competitors that already have obtained, or are able to obtain, FDA approval of their products may be able to launch their generic versions of non-crush-resistant Opana
®
ER prior to the applicable patents’ expirations. Additionally, we cannot predict or determine the timing or outcome of related litigation but will explore all options as appropriate in the best interests of the Company and EPI. In addition to the above litigation, it is possible that another generic manufacturer may also seek to launch a generic version of non-crush-resistant Opana
®
ER and challenge the applicable patents.
From
September 21, 2012
through
October 30, 2013
, EPI and its partner Grünenthal received Paragraph IV Notices from each of Teva Pharmaceuticals USA, Inc. (Teva), Amneal Pharmaceuticals, LLC (Amneal), Sandoz Inc. (Sandoz), ThoRx Laboratories, Inc. (ThoRx), Par Pharmaceuticals (Par), Actavis South Atlantic LLC (Actavis), Impax Pharmaceuticals (Impax) and Ranbaxy Laboratories Limited (Ranbaxy), advising of the filing by each such company of an ANDA for a generic version of the formulation of Opana
®
ER designed to be crush-resistant. These Paragraph IV Notices refer to U.S. Patent Nos. 8,075,872, 8,114,383, 8,192,722, 7,851,482, 8,309,060, 8,309,122 and 8,329,216, which variously cover the formulation of Opana
®
ER, a highly pure version of the active pharmaceutical ingredient and the release profile of Opana
®
ER. EPI filed lawsuits against each of these filers in the U.S. District Court for the Southern District of New York. Each lawsuit was filed within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. On January 30, 2015, EPI informed all defendants that it no longer intends to assert U.S. Patent 7,851,482. EPI intends, and has been advised by Grünenthal that it too intends, to defend vigorously the intellectual property rights covering the formulation of Opana
®
ER designed to be crush-resistant and to pursue all available legal and regulatory avenues in defense of crush-resistant Opana
®
ER, including enforcement of the product’s intellectual property rights and approved labeling. On March 20, 2015, EPI dismissed its suit against Par Pharmaceuticals based on a settlement. The effect of that settlement will vary depending on the outcome of the other lawsuits in this case. On March 23, 2015, EPI dismissed its suit against Sandoz Inc. based on Sandoz’s change of the PIV certification to a PIII certification. A trial in this case was held from March 23, 2015 through April 24, 2015 in the United States District Court for the Southern District of New York against the remaining filers. We are awaiting a decision in that case. However, there can be no assurance that EPI and Grünenthal will be successful. If we are unsuccessful and Teva, Amneal, Sandoz, ThoRx, Par, Actavis or Impax is able to obtain FDA approval of its product, generic versions
of crush-resistant Opana
®
ER may be launched prior to the applicable patents’ expirations in 2023 through 2029. Additionally, we cannot predict or determine the timing or outcome of this defense but will explore all options as appropriate in the best interests of the Company and EPI. In addition to the above litigation, it is possible that another generic manufacturer may also seek to launch a generic version of crush-resistant Opana
®
ER and challenge the applicable patents.
On August 19, 2014 and October 20, 2014, the United States Patent Office issued U.S. Patent Nos. 8,808,737 and 8,871,779 respectively, which cover a method of using Opana
®
ER and a highly pure version of the active pharmaceutical ingredient of Opana
®
ER. On November 7, 2014, EPI filed lawsuits against Teva, ThoRx, Par, Actavis, Impax, Ranbaxy, Roxane, Amneal, and Sandoz in the U.S. District Court for the District of Delaware alleging infringement of these new patents, which expire in 2027 and 2029, respectively.
Paragraph IV Certification on Fortesta
®
Gel
On January 18, 2013, EPI and its licensor Strakan Limited received a notice from Watson advising of the filing by Watson of an ANDA for a generic version of Fortesta
®
(testosterone) Gel. On
February 28, 2013
, EPI filed a lawsuit against Watson in the U.S. District Court for the Eastern District of Texas, Marshall division. Because the suit was filed within the
45
-day period under the Hatch-Waxman Act for filing a patent infringement action, we believe that it triggered an automatic
30
-month stay of approval under the Act. A two-day trial was held February 26 and 27, 2015 and we are awaiting a decision.
EPI intends, and has been advised by Strakan Limited that it too intends, to defend vigorously Fortesta
®
Gel and to pursue all available legal and regulatory avenues in defense of Fortesta
®
Gel, including enforcement of the product’s intellectual property rights and approved labeling. However, there can be no assurance that EPI and Strakan will be successful. If EPI and Strakan are unsuccessful and Watson is able to obtain FDA approval of its product, Watson may be able to launch its generic version of Fortesta
®
Gel prior to the applicable patents’ expirations in 2018. Additionally, we cannot predict or determine the timing or outcome of this litigation but will explore all options as appropriate in the best interests of the Company. In addition to the above litigation, it is possible that another generic manufacturer may also seek to launch a generic version of Fortesta
®
Gel and challenge the applicable patents.
Paragraph IV Certification on Frova
®
As previously reported, in July 2011, EPI and its licensor, Vernalis Development Limited received a notice from Mylan Technologies Inc. (Mylan) advising of the filing by Mylan of an ANDA for a generic version of Frova
®
(frovatriptan succinate) 2.5 mg tablets. Mylan’s notice included a Paragraph IV Notice with respect to U.S. Patent Nos. 5,464,864, 5,561,603, 5,637,611, 5,827,871 and 5,962,501, which cover Frova
®
. These patents are listed in the FDA’s Orange Book and either have expired or will expire by 2015. As a result of this Paragraph IV Notice, on
August 16, 2011
, EPI filed a lawsuit against Mylan in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 5,464,864, 5,637,611 and 5,827,871. Because the suit was filed within the
45
-day period under the Hatch-Waxman Act for filing a patent infringement action, we believe that it triggered an automatic
30
-month stay of approval under the Act. A trial in this case was held starting
November 12, 2013
. On January 28, 2014, the U.S. District Court for the District of Delaware issued a decision upholding the validity and infringement by Mylan of U.S. Patent No. 5,464,864. After the District court decision, Mylan moved to enforce a purported settlement entered into by the parties. A hearing was held in the U.S. District Court for the District of Delaware on March 18, 2014. As a result of that hearing, the court vacated the earlier decision, and held that Mylan and EPI had settled the Frova
®
litigation. The terms of that settlement allow Mylan to sell Mylan’s generic frovatriptan succinate 2.5 mg tablets not earlier than four weeks prior to the expiration of U.S. Patent 5,464,864. EPI has appealed this decision. A hearing on that appeal was held on December 1, 2014. On December 4, 2014 the Federal Circuit affirmed the decision of the Lower Court that EPI and Mylan reached a settlement consistent with the terms outlined above. That settlement agreement was executed on June 15, 2015.
Other Legal Proceedings
In addition to the above proceedings, proceedings similar to those described above may also be brought in the future. Additionally, we and our subsidiaries are involved in, or have been involved in, arbitrations or various other legal proceedings that arise from the normal course of our business. We cannot predict the timing or outcome of these claims and other proceedings. Currently, neither we nor our subsidiaries are involved in any other legal proceedings that we expect to have a material effect on our business, financial condition, results of operations and cash flows.
NOTE 13. OTHER COMPREHENSIVE (LOSS) INCOME
The following table presents the tax effects allocated to each component of Other comprehensive
(loss) income
for the
three
months ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
|
Before-
Tax
Amount
|
|
Tax (Expense) Benefit
|
|
Net-of-Tax
Amount
|
|
Before-Tax
Amount
|
|
Tax (Expense) Benefit
|
|
Net-of-
Tax
Amount
|
|
Net unrealized gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain arising during the period
|
$
|
451
|
|
|
$
|
(250
|
)
|
|
$
|
201
|
|
|
$
|
2,352
|
|
|
$
|
(318
|
)
|
|
$
|
2,034
|
|
|
Less: reclassification adjustments for (gain) loss realized in net (loss) income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Net unrealized gains
|
451
|
|
|
(250
|
)
|
|
201
|
|
|
2,352
|
|
|
(318
|
)
|
|
2,034
|
|
|
Foreign currency translation gain
|
10,516
|
|
|
(2,515
|
)
|
|
8,001
|
|
|
44,404
|
|
|
(11
|
)
|
|
44,393
|
|
|
Other comprehensive income
|
$
|
10,967
|
|
|
$
|
(2,765
|
)
|
|
$
|
8,202
|
|
|
$
|
46,756
|
|
|
$
|
(329
|
)
|
|
$
|
46,427
|
|
The following table presents the tax effects allocated to each component of Other comprehensive
(loss) income
for the
six
months ended
June 30
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
|
Before-
Tax
Amount
|
|
Tax (Expense) Benefit
|
|
Net-of-Tax
Amount
|
|
Before-Tax
Amount
|
|
Tax (Expense) Benefit
|
|
Net-of-
Tax
Amount
|
|
Net unrealized gain on securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain arising during the period
|
$
|
2,649
|
|
|
$
|
(935
|
)
|
|
$
|
1,714
|
|
|
$
|
1,795
|
|
|
$
|
(101
|
)
|
|
$
|
1,694
|
|
|
Less: reclassification adjustments for (gain) loss realized in net (loss) income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Net unrealized gains
|
2,649
|
|
|
(935
|
)
|
|
1,714
|
|
|
1,795
|
|
|
(101
|
)
|
|
1,694
|
|
|
Foreign currency translation (loss) gain
|
(120,863
|
)
|
|
(2,484
|
)
|
|
(123,347
|
)
|
|
49,484
|
|
|
(14
|
)
|
|
49,470
|
|
|
Other comprehensive (loss) income
|
$
|
(118,214
|
)
|
|
$
|
(3,419
|
)
|
|
$
|
(121,633
|
)
|
|
$
|
51,279
|
|
|
$
|
(115
|
)
|
|
$
|
51,164
|
|
The following is a summary of the accumulated balances related to each component of Other comprehensive
(loss) income
, net of taxes, at
June 30, 2015
and
December 31, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2015
|
|
December 31,
2014
|
|
Net unrealized gains (losses)
|
$
|
1,230
|
|
|
$
|
(484
|
)
|
|
Foreign currency translation loss
|
(250,307
|
)
|
|
(123,604
|
)
|
|
Accumulated other comprehensive loss
|
$
|
(249,077
|
)
|
|
$
|
(124,088
|
)
|
NOTE 14. SHAREHOLDERS' EQUITY
Changes in Shareholder’s Equity
The following table displays a reconciliation of our beginning and ending balances in shareholders' equity for the
six
months ended
June 30, 2015
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to:
|
|
|
Endo
International plc
|
|
Noncontrolling
interests
|
|
Total
Shareholders’
Equity
|
|
Shareholders’ equity at January 1, 2015
|
$
|
2,374,757
|
|
|
$
|
33,456
|
|
|
$
|
2,408,213
|
|
|
Net loss
|
(326,137
|
)
|
|
(107
|
)
|
|
(326,244
|
)
|
|
Other comprehensive loss
|
(121,084
|
)
|
|
(549
|
)
|
|
(121,633
|
)
|
|
Compensation related to share-based awards
|
24,753
|
|
|
—
|
|
|
24,753
|
|
|
Tax withholding for restricted shares
|
(12,570
|
)
|
|
—
|
|
|
(12,570
|
)
|
|
Exercise of options
|
23,440
|
|
|
—
|
|
|
23,440
|
|
|
Buy-out of noncontrolling interests, net of contributions
|
(6,876
|
)
|
|
(32,732
|
)
|
|
(39,608
|
)
|
|
Ordinary shares issued in connection with the Auxilium acquisition
|
1,519,320
|
|
|
—
|
|
|
1,519,320
|
|
|
Fair value of equity component of acquired Auxilium Notes
|
278,014
|
|
|
—
|
|
|
278,014
|
|
|
Conversion of Auxilium Notes
|
145,101
|
|
|
—
|
|
|
145,101
|
|
|
Ordinary shares issued
|
2,302,281
|
|
|
—
|
|
|
2,302,281
|
|
|
Equity issuance fees
|
(66,956
|
)
|
|
—
|
|
|
(66,956
|
)
|
|
Other
|
17,827
|
|
|
—
|
|
|
17,827
|
|
|
Shareholders’ equity at June 30, 2015
|
$
|
6,151,870
|
|
|
$
|
68
|
|
|
$
|
6,151,938
|
|
On June 10, 2015, we completed the sale of
27,627,628
ordinary shares, including
3,603,603
ordinary shares sold upon the exercise in full by the underwriters of their option to purchase additional ordinary shares from us, at a price of
$83.25
per share, for aggregate gross proceeds to us of
$2,300.0 million
, before fees, in order to finance a portion of the pending Par acquisition (described in more detail in
Note 5. Acquisitions
). The net proceeds of this share issuance, totaling
$2,235.1 million
are included as a component of
Cash and cash equivalents
at
June 30, 2015
.
During the
six
months ended
June 30, 2015
, the Company completed a buy-out of the noncontrolling interest associated with our Litha subsidiary. The following table reflects the effect on the Company’s equity for the
six
months ended
June 30, 2015
(in thousands):
|
|
|
|
|
|
|
|
Adjustment to Accumulated other comprehensive loss related to the reallocation (from noncontrolling to controlling interests) of foreign currency translation loss attributable to our noncontrolling interest in Litha
|
$
|
(3,904
|
)
|
|
Decrease in noncontrolling interests for buy-out of Litha
|
(32,732
|
)
|
|
Decrease in additional paid-in capital for buy-out of Litha
|
(2,972
|
)
|
|
Total cash consideration paid related to buy-out of Litha
|
$
|
(39,608
|
)
|
The following table displays a reconciliation of our beginning and ending balances in shareholders' equity for the
six
months ended
June 30, 2014
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Attributable to:
|
|
|
Endo
International plc
|
|
Noncontrolling
interests
|
|
Total
Shareholders’
Equity
|
|
Shareholders’ equity at January 1, 2014
|
$
|
526,018
|
|
|
$
|
59,198
|
|
|
$
|
585,216
|
|
|
Net (loss) income
|
(415,752
|
)
|
|
2,860
|
|
|
(412,892
|
)
|
|
Other comprehensive income (loss)
|
53,106
|
|
|
(1,942
|
)
|
|
51,164
|
|
|
Compensation related to share-based awards
|
14,376
|
|
|
—
|
|
|
14,376
|
|
|
Tax withholding for restricted shares
|
(22,803
|
)
|
|
—
|
|
|
(22,803
|
)
|
|
Exercise of options
|
31,616
|
|
|
—
|
|
|
31,616
|
|
|
Distributions to noncontrolling interests
|
—
|
|
|
(6,144
|
)
|
|
(6,144
|
)
|
|
Buy-out of noncontrolling interests, net of contributions
|
—
|
|
|
(82
|
)
|
|
(82
|
)
|
|
Addition of Paladin noncontrolling interests due to acquisition
|
—
|
|
|
40,600
|
|
|
40,600
|
|
|
Removal of HealthTronics, Inc. noncontrolling interests due to disposition
|
—
|
|
|
(57,359
|
)
|
|
(57,359
|
)
|
|
Ordinary shares issued in connection with the Paladin acquisition
|
2,844,279
|
|
|
—
|
|
|
2,844,279
|
|
|
Repurchase of convertible senior subordinated notes due 2015
|
(309,737
|
)
|
|
—
|
|
|
(309,737
|
)
|
|
Settlement of ordinary share warrants
|
(242,192
|
)
|
|
—
|
|
|
(242,192
|
)
|
|
Settlement of the hedge on convertible senior subordinated notes due 2015
|
302,113
|
|
|
—
|
|
|
302,113
|
|
|
Other
|
26,465
|
|
|
—
|
|
|
26,465
|
|
|
Shareholders’ equity at June 30, 2014
|
$
|
2,807,489
|
|
|
$
|
37,131
|
|
|
$
|
2,844,620
|
|
As part of the reorganization upon consummation of the Paladin acquisition, EHSI Common stock and Treasury stock in the amounts of
$1.5 million
and
$763.1 million
, respectively, were retired and reclassified into Additional paid-in capital.
Share-Based Compensation
During the three months ended
June 30, 2015
, the Company’s shareholders approved the 2015 Stock Incentive Plan (the 2015 Plan). Under the 2015 Plan,
10.0 million
ordinary shares, which included the transfer of
5.0 million
shares available to be granted under the 2010 Stock Incentive Plan as of the date the 2015 Plan became effective, have been reserved for the grant of stock options (including incentive stock options), stock appreciation rights, restricted stock awards, performance awards and other share based awards, which may be issued at the discretion of the Company’s board of directors from time to time. Upon the 2015 Plan becoming effective, all other existing stock incentive plans were terminated.
As further discussed in
Note 3. Discontinued Operations
the operating results of the Company's AMS and HealthTronics businesses are reported as Discontinued operations, net of tax in the Condensed Consolidated Statements of Operations for all periods presented. However, as share-based compensation is not material for these businesses, amounts below related to share-based compensation have not been adjusted to exclude the impact of these businesses.
The Company recognized share-based compensation expense of
$10.9 million
and
$62.4 million
during the
three and six
months ended
June 30, 2015
, respectively, compared to
$6.8 million
and
$14.4 million
during the
three and six
months ended
June 30, 2014
, respectively. The share-based compensation expense recognized during the
six
months ended
June 30, 2015
includes a charge related to the acceleration of Auxilium employee equity awards at closing of
$37.6 million
. As of
June 30, 2015
, the total remaining unrecognized compensation cost related to all non-vested share-based compensation awards amounted to
$76.3 million
. As of
June 30, 2015
, the weighted average remaining requisite service period of the non-vested stock options was
2.3
years and
2.0
years for non-vested restricted stock units.
NOTE 15. OTHER EXPENSE (INCOME), NET
The components of
Other expense (income), net
for the
three and six
months ended
June 30
are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Foreign currency (gain) loss, net
|
2,578
|
|
|
3,665
|
|
|
(20,556
|
)
|
|
4,271
|
|
|
Equity loss (earnings) from unconsolidated subsidiaries, net
|
900
|
|
|
(5,233
|
)
|
|
1,751
|
|
|
(7,140
|
)
|
|
Other than temporary impairment of equity investment
|
18,869
|
|
|
—
|
|
|
18,869
|
|
|
—
|
|
|
Costs associated with unused financing commitments
|
2,261
|
|
|
—
|
|
|
14,071
|
|
|
—
|
|
|
Other miscellaneous
|
(115
|
)
|
|
(5,028
|
)
|
|
(1,637
|
)
|
|
(10,135
|
)
|
|
Other expense (income), net
|
$
|
24,493
|
|
|
$
|
(6,596
|
)
|
|
$
|
12,498
|
|
|
$
|
(13,004
|
)
|
NOTE 16. INCOME TAXES
During the
three
months ended
June 30, 2015
, we recognized an income tax
benefit
of
$12.7 million
on
$103.6 million
of
loss from continuing operations before income tax
, compared to
$4.8 million
of tax
expense
on
$45.4 million
of
income from continuing operations before income tax
during the comparable
2014
period. The tax
benefit
for the current period is primarily related to benefits resulting from current period losses from continued operations. Tax
expense
for the comparable
2014
period was primarily related to an unfavorable tax adjustment resulting from the non-deductibility of charges accrued in the prior year period related to the excise tax reimbursement of directors and certain employees excise tax liabilities pursuant to section 4985 of the Internal Revenue Code. This reimbursement was approved by shareholders at a special meeting to vote upon the Paladin transaction.
During the
six
months ended
June 30, 2015
, we recognized an income tax
benefit
of
$179.6 million
on
$120.0 million
of
loss from continuing operations before income tax
, compared to
$17.5 million
of tax
expense
on
$10.7 million
of
income from continuing operations before income tax
during the comparable
2014
period. The tax
benefit
for the current period is primarily related to benefits resulting from the expected realization of deferred tax assets in the foreseeable future related to certain components of our AMS business, which we classified as held-for-sale in the first quarter 2015. Tax
expense
for the comparable
2014
period was primarily related to an unfavorable tax adjustment resulting from the non-deductible excise tax due as a result of the Paladin transaction, which closed in the comparable prior period.
NOTE 17. NET (LOSS) INCOME PER SHARE
The following is a reconciliation of the numerator and denominator of basic and diluted net
(loss) income per share
for the
three and six
months ended
June 30
(in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Numerator:
|
|
|
|
|
|
|
|
|
(Loss) income from continuing operations
|
$
|
(90,894
|
)
|
|
$
|
40,575
|
|
|
$
|
59,598
|
|
|
$
|
(6,826
|
)
|
|
Less: Net loss from continuing operations attributable to noncontrolling interests
|
(107
|
)
|
|
(774
|
)
|
|
(107
|
)
|
|
(674
|
)
|
|
(Loss) income from continuing operations attributable to Endo International plc ordinary shareholders
|
(90,787
|
)
|
|
41,349
|
|
|
59,705
|
|
|
(6,152
|
)
|
|
Loss from discontinued operations attributable to Endo International plc ordinary shareholders, net of tax
|
(159,632
|
)
|
|
(20,189
|
)
|
|
(385,842
|
)
|
|
(409,600
|
)
|
|
Net (loss) income attributable to Endo International plc ordinary shareholders
|
$
|
(250,419
|
)
|
|
$
|
21,160
|
|
|
$
|
(326,137
|
)
|
|
$
|
(415,752
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
|
For basic per share data—weighted average shares
|
185,328
|
|
|
152,368
|
|
|
177,490
|
|
|
140,252
|
|
|
Dilutive effect of ordinary share equivalents
|
—
|
|
|
2,282
|
|
|
2,091
|
|
|
—
|
|
|
Dilutive effect of various convertible notes and warrants
|
—
|
|
|
8,719
|
|
|
3,241
|
|
|
—
|
|
|
For diluted per share data—weighted average shares
|
185,328
|
|
|
163,369
|
|
|
182,822
|
|
|
140,252
|
|
Basic net
(loss) income per share
data is computed based on the weighted average number of ordinary shares outstanding during the period. Diluted
(loss) income per share
data is computed based on the weighted average number of ordinary shares outstanding and, if there is net income from continuing operations attributable to Endo International plc ordinary shareholders during the period,
the dilutive impact of ordinary share equivalents outstanding during the period. Ordinary share equivalents are measured under the treasury stock method.
All stock options and stock awards were excluded from the diluted share calculation for the
three months
ended
June 30, 2015
because their effect would have been anti-dilutive, as the Company was in a loss position. For the
three months
ended
June 30, 2014
, stock options and stock awards of
0.8 million
were excluded from the diluted share calculation because their effect would have been anti-dilutive. For the
six months
ended
June 30, 2015
stock options and stock awards of
1.0 million
were excluded from the diluted share calculation because their effect would have been anti-dilutive. All stock options and stock awards were excluded from the diluted share calculation for the
six months
ended
June 30, 2014
because their effect would have been anti-dilutive, as the Company was in a loss position.
The
1.75%
Convertible Senior Subordinated Notes due
April 15, 2015
were only included in the dilutive net
(loss) income per share
calculations using the treasury stock method during periods in which the average market price of our ordinary shares was above the applicable conversion price of the Convertible Notes, or
$29.20
per share, and the impact would not have been anti-dilutive. In these periods, under the treasury stock method, we calculated the number of shares issuable under the terms of these notes based on the average market price of the shares during the period, and included that number in the total diluted shares outstanding for the period.
We entered into convertible note hedge and warrant agreements, which have subsequently been settled, that, in combination, had the economic effect of reducing the dilutive impact of the Convertible Notes. However, we separately analyzed the impact of the convertible note hedge and the warrant agreements on diluted weighted average shares outstanding. As a result, the purchases of the convertible note hedges were excluded because their impact would have been be anti-dilutive. The treasury stock method was applied when the warrants were in-the-money with the proceeds from the exercise of the warrant used to repurchase shares based on the average share price in the calculation of diluted weighted average shares. Until the warrants were in-the-money, they had no impact to the diluted weighted average share calculation.
The dilutive impact of the
Auxilium Notes
was calculated using the if-converted method, assuming the notes were converted at the time of issuance.
All convertible notes and warrants were excluded from the diluted share calculation for the
three months
ended June 30, 2015 and the six months ended June 30, 2014 because their effect would have been anti-dilutive, as the Company was in a loss position.
NOTE 18. SUBSEQUENT EVENTS
6.00% Senior Notes Due 2023
In July 2015,
Endo DAC
, Endo Finance LLC and Endo Finco Inc. (collectively, the Issuers) issued $
1.64 billion
in aggregate principal amount of
6.00%
senior notes due July 2023 (the
2023 Notes
). The
2023 Notes
were issued in a private offering for resale to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.
The
2023 Notes
are senior unsecured obligations of the Issuers and are guaranteed on a senior unsecured basis by certain of the Company’s subsidiaries. Interest on the
2023 Notes
is payable semiannually in arrears on
January 15
and
July 15
of each year, beginning on
January 15, 2016
. The
2023 Notes
will mature on July
15
, 2023, subject to earlier repurchase or redemption in accordance with the terms of the
2023 Notes
indenture incorporated by reference herein.
The
2023 Notes
were issued to, together with the Incremental Term Loan B Facility and cash on hand, (i) fund the purchase price of the Par acquisition, as well as for repayments of indebtedness of Par and certain transaction expenses, (ii) refinance the Company’s existing
2014 Term Loan B Facility
, and (iii) redeem all
$499.9 million
aggregate principal amount outstanding of the
7.00%
Senior Notes due 2019, which redemption occurred in July 2015. The Company intends to use any remaining proceeds for general corporate purposes, including acquisitions and debt repayments.
On or after July 15, 2018, the Issuers may on any one or more occasions redeem all or a part of the
2023 Notes
, at the redemption prices (expressed as percentages of principal amount) set forth below, plus accrued and unpaid interest, if redeemed during the twelve-month period beginning on July 15 of the years indicated below:
|
|
|
|
|
|
|
Payment Dates (between indicated dates)
|
Redemption
Percentage
|
|
From July 15, 2018 to and including July 14, 2019
|
104.500
|
%
|
|
From July 15, 2019 to and including July 14, 2020
|
103.000
|
%
|
|
From July 15, 2020 to and including July 14, 2021
|
101.500
|
%
|
|
From July 15, 2021 and thereafter
|
100.000
|
%
|
In addition, at any time prior to July 15, 2018, the Issuers may on any one or more occasions redeem all or a part of the
2023 Notes
at a specified redemption price set forth in the indenture, plus accrued and unpaid interest. In addition, prior to July 15, 2018, the Issuers may redeem up to
35%
of the aggregate principal amount of the
2023 Notes
with the net cash proceeds from specified equity offerings at a redemption price equal to
106.000%
of the aggregate principal amount of the
2023 Notes
redeemed, plus accrued and unpaid interest. If
Endo DAC
experiences certain change of control events, the Issuers must offer to repurchase the
2023 Notes
at
101%
of their principal amount, plus accrued and unpaid interest.
The
2023 Notes
indenture contains covenants that, among other things, restrict
Endo DAC’s
ability and the ability of its restricted subsidiaries to incur certain additional indebtedness and issue preferred stock, make restricted payments, sell certain assets, agree to payment restrictions on the ability of restricted subsidiaries to make payments to
Endo DAC
, create certain liens, merge, consolidate or sell substantially all of
Endo DAC’s
assets, or enter into certain transactions with affiliates. These covenants are subject to a number of important exceptions and qualifications, including the fall away or revision of certain of these covenants upon the
2023 Notes
receiving investment grade credit ratings.
In the event that the acquisition of Par is not consummated on or prior to February 12, 2016 or the Company determines to abandon or terminate the acquisition at any time prior thereto, the Issuers will be required to redeem
$1.44 billion
aggregate principal amount of the
2023 Notes
at a special mandatory redemption price equal to
100%
of the issue price of the
2023 Notes
, plus accrued and unpaid interest, if any, to, but not including, the special redemption date.
Redemption of 2019 Senior Notes
In July 2015, the Company’s wholly-owned subsidiaries, Endo Finance LLC and Endo Finco Inc., redeemed all
$481.9 million
aggregate principal amount outstanding of their
7.00%
Senior Notes due 2019 (2019 Endo Finance Notes) and the Company’s wholly-owned subsidiary, EHSI, redeemed all
$18.0 million
aggregate principal amount outstanding of its
7.00%
Senior Notes due 2019 (2019 EHSI Notes). The aggregate redemption price included a redemption fee of
$17.5 million
, or
3.5%
of the aggregate principal amount of the 2019 Endo Finance Notes and the 2019 EHSI Notes, plus accrued and unpaid interest to, but not including, the redemption date.
Disposition of the AMS Men’s Heath Business
On
August 3, 2015
, the Company completed the sale of the Men’s Health and Prostate Health components of its
AMS
business to Boston Scientific Corporation.
