NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
FOR THE
THREE MONTHS ENDED MARCH 31, 2019
NOTE 1. BASIS OF PRESENTATION
Endo International plc is an Ireland-domiciled, global specialty pharmaceutical company focused on generic and branded pharmaceuticals. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of generic and branded drugs to meet patients’ needs.
Unless otherwise indicated or required by the context, references throughout to “Endo,” the “Company,” “we,” “our” or “us” refer to financial information and transactions of Endo International plc and its subsidiaries.
The accompanying unaudited
Condensed Consolidated Financial Statements
of Endo International plc and its subsidiaries have been prepared in accordance with United States (U.S.) generally accepted accounting principles (U.S. GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying
Condensed Consolidated Financial Statements
of Endo International plc and its subsidiaries, which are unaudited, include all normal and recurring adjustments necessary for a fair statement of the Company’s financial position as of
March 31, 2019
and the results of our operations and our cash flows for the periods presented. Operating results for the
three months ended March 31, 2019
are not necessarily indicative of the results that may be expected for the year ending
December 31, 2019
. The year-end Condensed Consolidated Balance Sheet data as of
December 31, 2018
was derived from audited financial statements but does not include all disclosures required by U.S. GAAP.
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 the Annual Report.
Certain prior period amounts have been reclassified to conform to the current period presentation.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Significant Accounting Policies Added or Updated since
December 31, 2018
Significant changes to our significant accounting policies since
December 31, 2018
are detailed below. For additional discussion of the Company’s significant accounting policies, see
Note 2. Summary of Significant Accounting Policies
in the
Consolidated Financial Statements
, included in
Part IV, Item 15
of the Annual Report.
Lease Accounting.
The Company adopted
Accounting Standards Codification Topic 842, Leases
(ASC 842) on January 1, 2019. For further discussion of the adoption, refer to the “Recent Accounting Pronouncements Adopted or Otherwise Effective as of March 31, 2019” section below. ASC 842 applies to a number of arrangements to which the Company is party.
Whenever the Company enters into a new arrangement, it must determine, at the inception date, whether the arrangement is or contains a lease. This determination generally depends on whether the arrangement conveys to the Company the right to control the use of an explicitly or implicitly identified asset for a period of time in exchange for consideration. Control of an underlying asset is conveyed to the Company if the Company obtains the rights to direct the use of and to obtain substantially all of the economic benefits from using the underlying asset.
If a lease exists, the Company must then determine the separate lease and nonlease components of the arrangement. Each right to use an underlying asset conveyed by a lease arrangement should generally be considered a separate lease component if it both: (i) can benefit the Company without depending on other resources not readily available to the Company and (ii) does not significantly affect and is not significantly affected by other rights of use conveyed by the lease. Aspects of a lease arrangement that transfer other goods or services to the Company but do not meet the definition of lease components are considered nonlease components. The consideration owed by the Company pursuant to a lease arrangement is generally allocated to each lease and nonlease components for accounting purposes. However, the Company has elected, for all of its leases, to not separate lease and nonlease components. Each lease component is accounted for separately from other lease components, but together with the associated nonlease components.
For each lease, the Company must then determine the lease term, the present value of lease payments and the classification of the lease as either an operating or finance lease.
The lease term is the period of the lease not cancellable by the Company, together with periods covered by: (i) renewal options the Company is reasonably certain to exercise, (ii) termination options the Company is reasonably certain not to exercise and (iii) renewal or termination options that are controlled by the lessor.
The present value of lease payments is calculated based on:
|
|
|
|
•
|
Lease payments—Lease payments include fixed and certain variable payments, less lease incentives, together with amounts probable of being owed by the Company under residual value guarantees and, if reasonably certain of being paid, the cost of certain renewal options and early termination penalties set forth in the lease arrangement. Lease payments exclude consideration that is not related to the transfer of goods and services to the Company.
|
|
|
|
|
•
|
Discount rate—The discount rate must be determined based on information available to the Company upon the commencement of a lease. Lessees are required to use the rate implicit in the lease whenever such rate is readily available; however, as the implicit rate in the Company’s leases is generally not readily determinable, the Company generally uses the hypothetical incremental borrowing rate it would have to pay to borrow an amount equal to the lease payments, on a collateralized basis, over a timeframe similar to the lease term.
|
In making the determination of whether a lease is an operating lease or a finance lease, the Company considers the lease term in relation to the economic life of the leased asset, the present value of lease payments in relation to the fair value of the leased asset and certain other factors, including the lessee's and lessor's rights, obligations and economic incentives over the term of the lease.
Generally, upon the commencement of a lease, the Company will record a lease liability and a right-of-use (ROU) asset. However, the Company has elected, for all underlying assets with initial lease terms of twelve months or less (known as short-term leases), to not recognize a lease liability or ROU asset. Lease liabilities are initially recorded at lease commencement as the present value of future lease payments. ROU assets are initially recorded at lease commencement as the initial amount of the lease liability, together with the following, if applicable: (i) initial direct costs incurred by the lessee and (ii) lease payments made by the lessor, net of lease incentives received, prior to lease commencement.
Over the lease term, the Company generally increases its lease liabilities using the effective interest method and decreases its lease liabilities for lease payments made. The Company generally amortizes its ROU assets over the shorter of the estimated useful life and the lease term and assesses its ROU assets for impairment, similar to other long-lived assets.
For finance leases, amortization expense and interest expense are recognized separately in the Condensed Consolidated Statements of Operations, with amortization expense generally recorded on a straight-line basis and interest expense recorded using the effective interest method. For operating leases, a single lease cost is generally recognized in the Condensed Consolidated Statements of Operations on a straight-line basis over the lease term unless an impairment has been recorded with respect to a leased asset. Lease costs for short-term leases not recognized in the Condensed Consolidated Balance Sheets are recognized in the Condensed Consolidated Statements of Operations on a straight-line basis over the lease term. Variable lease costs not initially included in the lease liability and ROU asset impairment charges are expensed as incurred.
Cloud Computing Arrangements.
The Company may from time to time incur costs in connection with hosting arrangements that are service contracts. Subsequent to the Company’s January 1, 2019 adoption of Accounting Standards Update (ASU) No. 2018-15,
“Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract”
(ASU 2018-15), which is further described below, the Company capitalizes any such implementation costs, expenses them over the terms of the respective hosting arrangements and subjects them to impairment testing consistent with other long-lived assets.
Recent Accounting Pronouncements
Recently Issued Accounting Pronouncements Not Yet Adopted as of
March 31, 2019
In August 2018, the Financial Accounting Standards Board (FASB) issued ASU No. 2018-13,
“Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement”
(ASU 2018-13). ASU 2018-13 modifies the disclosure requirements on fair value measurements in
Accounting Standards Codification Topic 820, Fair Value Measurement
. ASU 2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Certain aspects of ASU 2018-13 require prospective treatment, while others require retrospective treatment. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-13 on the Company’s disclosures.
In November 2018, the FASB issued ASU No. 2018-18,
“Clarifying the Interaction Between Topic 808 and Topic 606”
(ASU 2018-18). The main provisions of ASU 2018-18 include: (i) clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue when the collaborative arrangement participant is a customer in the context of a unit of account and (ii) precluding the presentation of transactions with collaborative arrangement participants that are not directly related to sales to third parties together with revenue. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. ASU 2018-18 should be applied retrospectively to the date of initial application of
Accounting Standards Codification Topic 606, Revenue from Contracts with Customers
(ASC 606), which was January 1, 2018 for the Company. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-18 on the Company’s consolidated results of operations, financial position and disclosures.
Recent Accounting Pronouncements Adopted or Otherwise Effective as of
March 31, 2019
In February 2016, the FASB issued ASU No. 2016-02,
“Leases (Topic 842)”
(ASU 2016-02) to establish a comprehensive new accounting standard for leases. ASU 2016-02, together with a series of subsequently-issued related ASUs, have been codified in ASC 842. ASC 842 supersedes the lease accounting requirements in
Accounting Standards Codification Topic 840, Leases
(ASC 840), and requires lessees to, among other things, recognize on the balance sheet a right-of-use asset and a right-of-use lease liability, representing the present value of future minimum lease payments, for most leases.
The Company adopted ASC 842 using the modified retrospective approach with an effective date of January 1, 2019 for leases that existed on that date. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods.
The Company has elected certain practical expedients permitted under the transition guidance within ASC 842 to leases that commenced before January 1, 2019, including the package of practical expedients, as well as the practical expedient permitting the Company to not assess whether certain land easements contain leases. Due to the Company's election of these practical expedients, the Company has carried forward certain historical conclusions for existing contracts, including conclusions relating to initial direct costs and to the existence and classification of leases.
On January 1, 2019, as a result of adopting ASC 842, the Company recognized new ROU assets, current lease liabilities and noncurrent lease liabilities associated with operating leases of
$59.4 million
,
$11.0 million
and
$57.3 million
, respectively, which were recorded in the
Condensed Consolidated Balance Sheets
as Operating lease assets, Current portion of operating lease liabilities and Operating lease liabilities, less current portion, respectively. The Company also derecognized certain assets and liabilities related to existing build-to-suit lease arrangements for which construction was completed prior to the date of transition and recognized new finance lease ROU assets and lease liabilities related to those lease arrangements. The net effect of the Company’s adoption of ASC 842 resulted in a net increase to Accumulated deficit of
$4.6 million
.
In August 2018, the FASB issued ASU 2018-15. ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (including hosting arrangements where a software license is deemed to exist). ASU 2018-15 also requires the customer to expense any such capitalized implementation costs over the term of the hosting arrangement and to apply the existing impairment guidance for long-lived assets to such capitalized costs. Additionally, ASU 2018-15 sets forth required disclosures and guidance on financial statement classification for expenses, cash flows and balances related to implementation costs within the scope of ASU 2018-15. The Company early adopted this guidance during the first quarter of 2019 on a prospective basis.
NOTE 3. DISCONTINUED OPERATIONS
Astora
The operating results of the Company’s Astora business, which the Board of Directors resolved to wind-down in 2016, are reported as Discontinued operations, net of tax in the
Condensed Consolidated Statements of Operations
for all periods presented.
The following table provides the operating results of Astora Discontinued operations, net of tax, for the
three months ended March 31, 2019 and 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Loss from discontinued operations before income taxes
|
$
|
(5,961
|
)
|
|
$
|
(7,751
|
)
|
|
Income tax benefit
|
$
|
—
|
|
|
$
|
—
|
|
|
Discontinued operations, net of tax
|
$
|
(5,961
|
)
|
|
$
|
(7,751
|
)
|
Loss from discontinued operations before income taxes
includes
Litigation-related and other contingencies, net
, mesh-related legal defense costs and certain other items.
The cash flows from discontinued operating activities related to Astora included the impact of net losses of
$6.0 million
and
$7.8 million
for the
three months ended March 31, 2019 and 2018
, respectively, and the impact of cash activity related to vaginal mesh cases. There were
no
material net cash flows related to Astora discontinued investing activities during the
three months ended March 31, 2019 and 2018
. There was
no
depreciation or amortization during the three months ended
March 31, 2019
or
2018
related to Astora.
NOTE 4. RESTRUCTURING
Set forth below are disclosures relating to restructuring initiatives that resulted in material expenses or cash expenditures during any of the
three months ended March 31, 2019
and
2018
or had material restructuring liabilities at either
March 31, 2019
or
December 31, 2018
. Employee separation, retention and certain other employee benefit-related costs related to our restructurings are expensed ratably over the requisite service period. Other restructuring costs are generally expensed as incurred.
2017 Generic Pharmaceuticals Restructuring Initiative
On July 21, 2017, the Company announced that after completing a comprehensive review of its manufacturing network, it would be ceasing operations and closing its manufacturing and distribution facilities in Huntsville, Alabama (the
2017 Generic Pharmaceuticals Restructuring Initiative
). The closure of the facilities was completed in June 2018 and the facilities were sold in the fourth quarter of 2018 for net cash proceeds of
$23.1 million
, resulting in a net gain on disposal of
$12.5 million
.
As a result of the
2017 Generic Pharmaceuticals Restructuring Initiative
, the Company incurred pre-tax charges of
$27.7 million
during the
three months ended March 31, 2018
. The expenses consisted of charges relating to accelerated depreciation of
$17.1 million
, employee separation, retention and other benefit-related costs of
$3.8 million
, asset impairment charges of
$2.6 million
and certain other charges of
$4.2 million
. These charges are included in the
Generic Pharmaceuticals
segment. Accelerated depreciation and employee separation, retention and other benefit-related costs are primarily included in Cost of revenues in the
Condensed Consolidated Statements of Operations
. Certain other charges are included in both Cost of revenues and
Selling, general and administrative
expenses in the
Condensed Consolidated Statements of Operations
.
The Company did not incur any material pre-tax charges as a result of the
2017 Generic Pharmaceuticals Restructuring Initiative
during the
three months ended March 31, 2019
and does not expect to incur additional material pre-tax restructuring-related expenses related to this initiative.
The liability related to the
2017 Generic Pharmaceuticals Restructuring Initiative
is primarily included in Accounts payable and accrued expenses in the
Condensed Consolidated Balance Sheets
. Changes to this liability during the
three months ended March 31, 2019
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Separation and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
|
Liability balance as of January 1, 2019
|
$
|
4,239
|
|
|
$
|
48
|
|
|
$
|
4,287
|
|
|
Cash distributions
|
(2,827
|
)
|
|
(48
|
)
|
|
(2,875
|
)
|
|
Liability balance as of March 31, 2019
|
$
|
1,412
|
|
|
$
|
—
|
|
|
$
|
1,412
|
|
Substantially all cash payments are expected to be made by the end of the third quarter in 2019.
January 2018 Restructuring Initiative
In January 2018, the Company initiated a restructuring initiative that included a reorganization of its
Generic Pharmaceuticals
segment’s research and development network, a further simplification of the Company’s manufacturing networks and a company-wide unification of certain corporate functions (the
January 2018 Restructuring Initiative
). As a result of the
January 2018 Restructuring Initiative
, the Company incurred pre-tax charges of
$22.9 million
during the
three months ended March 31, 2018
. The expenses primarily consisted of employee separation, retention and other benefit-related costs of
$21.9 million
and certain other charges of
$1.0 million
. Of the total charges incurred,
$10.2 million
are included in the
Generic Pharmaceuticals
segment,
$5.2 million
are included in Corporate unallocated costs,
$3.8 million
are included in the
Sterile Injectables
segment,
$3.0 million
are included in the
International Pharmaceuticals
segment and
$0.7 million
are included in the
Branded Pharmaceuticals
segment. Employee separation, retention and other benefit-related costs are included in Cost of revenues, Selling, general and administrative and Research and development expenses in the
Condensed Consolidated Statements of Operations
. Certain other charges are primarily included in Selling, general and administrative expenses in the
Condensed Consolidated Statements of Operations
.
The Company did not incur any material pre-tax charges as a result of the
January 2018 Restructuring Initiative
during the
three months ended March 31, 2019
and does not expect to incur additional material pre-tax restructuring-related expenses related to this initiative. At December 31, 2018, the remaining liability balance was
$1.1 million
. Substantially all related cash payments were made by the end of the first quarter of 2019.
NOTE 5. SEGMENT RESULTS
During the first quarter of 2019, the Company changed the names of its reportable segments. This change
, which was intended to simplify the segments’ names,
had no impact on the Company’s unaudited
Condensed Consolidated Financial Statements
or segment results for any of the periods presented. The Company’s
four
reportable business segments are set forth below. These segments reflect the level at which the chief operating decision maker 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 from continuing operations before income tax
, which we define as
Loss from continuing operations before income tax
and before
certain upfront and milestone payments to partners; acquisition-related and integration items, including transaction costs and changes in the fair value of contingent consideration; 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; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; litigation-related and other contingent matters; gains or losses from early termination of debt; gains or losses from the sales of businesses and other assets; foreign currency gains or losses on intercompany financing arrangements; and certain other items
.
Certain of the corporate expenses incurred by the Company are not directly 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 costs.” Interest income and expense are also considered corporate items and not allocated to any of the Company’s segments. The Company’s consolidated adjusted income from continuing operations before income tax is equal to the combined results of each of its segments less these unallocated corporate items.
Branded Pharmaceuticals
Our
Branded Pharmaceuticals
segment
includes a variety of branded prescription products to treat and manage conditions in urology, urologic oncology, endocrinology, pain and orthopedics. The products in this segment include XIAFLEX
®
, SUPPRELIN
®
LA, NASCOBAL
®
Nasal Spray, AVEED
®
, PERCOCET
®
, TESTOPEL
®
, LIDODERM
®
, VOLTAREN
®
Gel, EDEX
®
, FORTESTA
®
Gel and TESTIM
®
, among others.
Sterile Injectables
Our
Sterile Injectables
segment
consists primarily of branded sterile injectable products such as VASOSTRICT
®
, ADRENALIN
®
and APLISOL
®
, among others, and certain generic sterile injectable products, including ertapenem for injection, the authorized generic of Merck Sharp & Dohme Corp’s Invanz
®
, and ephedrine sulfate injection, among others.
Generic Pharmaceuticals
Our
Generic Pharmaceuticals
segment
consists of a differentiated product portfolio including solid oral extended-release, solid oral immediate-release, liquids, semi-solids, patches, powders, ophthalmics and sprays and includes products in the pain management, urology, central nervous system disorders, immunosuppression, oncology, women’s health and cardiovascular disease markets, among others.
International Pharmaceuticals
Our
International Pharmaceuticals
segment
includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through our operating company Paladin
Labs Inc. (Paladin).
This segment’s key products serve growing therapeutic areas, including attention deficit hyperactivity disorder, pain, women’s health and oncology.
The following represents selected information for the Company’s reportable segments for the
three months ended March 31, 2019 and 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Net revenues from external customers:
|
|
|
|
|
Branded Pharmaceuticals
|
$
|
203,525
|
|
|
$
|
200,235
|
|
|
Sterile Injectables
|
270,048
|
|
|
215,854
|
|
|
Generic Pharmaceuticals
|
218,526
|
|
|
249,240
|
|
|
International Pharmaceuticals (1)
|
28,312
|
|
|
35,198
|
|
|
Total net revenues from external customers
|
$
|
720,411
|
|
|
$
|
700,527
|
|
|
Adjusted income from continuing operations before income tax:
|
|
|
|
|
Branded Pharmaceuticals
|
$
|
79,008
|
|
|
$
|
93,814
|
|
|
Sterile Injectables
|
196,183
|
|
|
169,445
|
|
|
Generic Pharmaceuticals
|
49,997
|
|
|
74,280
|
|
|
International Pharmaceuticals
|
12,095
|
|
|
13,718
|
|
|
Total segment adjusted income from continuing operations before income tax
|
$
|
337,283
|
|
|
$
|
351,257
|
|
__________
|
|
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to external customers located in Canada.
|
There were
no
material revenues from external customers attributed to an individual country outside of the U.S. during any of the periods presented. There were
no
material tangible long-lived assets in an individual country other than the U.S. as of
March 31, 2019
or
December 31, 2018
.
The table below provides reconciliations of our
Total consolidated loss from continuing operations before income tax
, which is determined in accordance with U.S. GAAP, to our
total segment adjusted income from continuing operations before income tax
for the
three months ended March 31, 2019 and 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Total consolidated loss from continuing operations before income tax
|
$
|
(1,709
|
)
|
|
$
|
(482,247
|
)
|
|
Interest expense, net
|
132,675
|
|
|
123,990
|
|
|
Corporate unallocated costs (1)
|
48,095
|
|
|
52,460
|
|
|
Amortization of intangible assets
|
145,599
|
|
|
157,172
|
|
|
Inventory step-up
|
—
|
|
|
66
|
|
|
Upfront and milestone payments to partners
|
939
|
|
|
1,332
|
|
|
Separation benefits and other cost reduction initiatives (2)
|
2,025
|
|
|
48,987
|
|
|
Certain litigation-related and other contingencies, net (3)
|
6
|
|
|
(2,500
|
)
|
|
Asset impairment charges (4)
|
165,448
|
|
|
448,416
|
|
|
Acquisition-related and integration items (5)
|
(37,501
|
)
|
|
6,835
|
|
|
Gain on extinguishment of debt
|
(119,828
|
)
|
|
—
|
|
|
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
1,534
|
|
|
(2,514
|
)
|
|
Other, net (6)
|
—
|
|
|
(740
|
)
|
|
Total segment adjusted income from continuing operations before income tax
|
$
|
337,283
|
|
|
$
|
351,257
|
|
__________
|
|
|
|
(1)
|
Amounts include certain corporate overhead costs, such as headcount, facility and corporate litigation expenses and certain other income and expenses.
|
|
|
|
|
(2)
|
Amounts for the
three months ended March 31, 2019
primarily relate to employee separation costs of
$1.8 million
and other charges of
$0.2 million
. Amounts for the
three months ended March 31, 2018
primarily relate to employee separation costs of
$25.2 million
, accelerated depreciation of
$17.1 million
, charges to increase excess inventory reserves of
$2.4 million
and other charges of
$4.3 million
. These charges were related primarily to our restructuring initiatives. See
Note 4. Restructuring
for discussion of our material restructuring initiatives.
|
|
|
|
|
(3)
|
Amounts include adjustments for Litigation-related and other contingencies, net as further described in
Note 13. Commitments and Contingencies
.
|
|
|
|
|
(4)
|
Amounts primarily relate to charges to impair goodwill and intangible assets as further described in
Note 9. Goodwill and Other Intangibles
.
|
|
|
|
|
(5)
|
Amounts primarily relate to changes in the fair value of contingent consideration.
|
|
|
|
|
(6)
|
Amounts
primarily relate to gains on sales of businesses and other assets
.
|
Asset information is not reviewed or included within our internal management reporting. Therefore, the Company has not disclosed asset information for each reportable segment.
The Company disaggregates its revenue from contracts with customers into the categories included in the table below (in thousands). The Company believes these categories depict how the nature, timing and uncertainty of revenue and cash flows are affected by economic factors.
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Branded Pharmaceuticals:
|
|
|
|
|
Specialty Products:
|
|
|
|
|
XIAFLEX®
|
$
|
68,507
|
|
|
$
|
57,141
|
|
|
SUPPRELIN® LA
|
22,056
|
|
|
20,577
|
|
|
Other Specialty (1)
|
24,403
|
|
|
19,027
|
|
|
Total Specialty Products
|
$
|
114,966
|
|
|
$
|
96,745
|
|
|
Established Products:
|
|
|
|
|
PERCOCET®
|
$
|
30,760
|
|
|
$
|
31,976
|
|
|
TESTOPEL®
|
15,814
|
|
|
15,170
|
|
|
Other Established (2)
|
41,985
|
|
|
56,344
|
|
|
Total Established Products
|
$
|
88,559
|
|
|
$
|
103,490
|
|
|
Total Branded Pharmaceuticals (3)
|
$
|
203,525
|
|
|
$
|
200,235
|
|
|
Sterile Injectables:
|
|
|
|
|
VASOSTRICT®
|
$
|
139,137
|
|
|
$
|
113,725
|
|
|
ADRENALIN®
|
47,322
|
|
|
29,740
|
|
|
Ertapenem for injection
|
32,219
|
|
|
—
|
|
|
Other Sterile Injectables (4)
|
51,370
|
|
|
72,389
|
|
|
Total Sterile Injectables (3)
|
$
|
270,048
|
|
|
$
|
215,854
|
|
|
Total Generic Pharmaceuticals (5)
|
$
|
218,526
|
|
|
$
|
249,240
|
|
|
Total International Pharmaceuticals (6)
|
$
|
28,312
|
|
|
$
|
35,198
|
|
|
Total revenues, net
|
$
|
720,411
|
|
|
$
|
700,527
|
|
__________
|
|
|
|
(1)
|
Products included within Other Specialty are NASCOBAL
®
Nasal Spray and AVEED
®
. Beginning with our first quarter 2019 reporting, TESTOPEL
®
, which was previously included in Other Specialty, has been reclassified and is now included in the Established Products portfolio for all periods presented.
|
|
|
|
|
(2)
|
Products included within Other Established include, but are not limited to, LIDODERM
®
, VOLTAREN
®
Gel, EDEX
®
, FORTESTA
®
Gel, and TESTIM
®
, including the authorized generics of TESTIM
®
and FORTESTA
®
Gel.
|
|
|
|
|
(3)
|
Individual products presented above represent the top two performing products in each product category for the three months ended March 31, 2019 and/or any product having revenues in excess of
$25 million
during any quarterly period in 2019 or 2018.
|
|
|
|
|
(4)
|
Products included within Other Sterile Injectables include, but are not limited to, APLISOL
®
and ephedrine sulfate injection.
|
|
|
|
|
(5)
|
The
Generic Pharmaceuticals
segment is comprised of a portfolio of products that are generic versions of branded products, are distributed primarily through the same wholesalers, generally have no intellectual property protection and are sold within the U.S. During the
three months ended March 31, 2019
, colchicine tablets, the authorized generic of Takeda Pharmaceuticals U.S.A., Inc.’s Colcrys
®
, which launched in July 2018, made up
6%
of consolidated total revenue. No other individual product within this segment has exceeded
5%
of consolidated total revenues for the periods presented.
|
|
|
|
|
(6)
|
The
International Pharmaceuticals
segment, which accounted for
4%
and
5%
of consolidated total revenues during the
three months ended March 31, 2019 and 2018
, respectively, includes a variety of specialty pharmaceutical products sold outside the U.S., primarily in Canada through our operating company Paladin.
|
NOTE 6. FAIR VALUE MEASUREMENTS
Financial Instruments
The financial instruments recorded in our
Condensed Consolidated Balance Sheets
include cash and cash equivalents (including money market funds), 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 pay dividends that generally reflect short-term interest rates. 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.
The following table presents current and noncurrent restricted cash and cash equivalent balances at
March 31, 2019
and
December 31, 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Restricted cash and cash equivalents—current portion (1)
|
$
|
332,547
|
|
|
$
|
305,368
|
|
|
Restricted cash and cash equivalents—noncurrent portion (2)
|
22,357
|
|
|
22,356
|
|
|
Restricted cash and cash equivalents—total (3)
|
$
|
354,904
|
|
|
$
|
327,724
|
|
__________
|
|
|
|
(1)
|
These amounts are reported in our
Condensed Consolidated Balance Sheets
as Restricted cash and cash equivalents.
|
|
|
|
|
(2)
|
These amounts are reported in our
Condensed Consolidated Balance Sheets
as Other assets.
|
|
|
|
|
(3)
|
Approximately
$327.4 million
and
$299.7 million
of our restricted cash and cash equivalents are held in qualified settlement funds (QSFs) for mesh-related matters at
March 31, 2019
and
December 31, 2018
, respectively. The remaining amount of restricted cash and cash equivalents at
March 31, 2019
primarily relates to other litigation-related matters. See
Note 13. Commitments and Contingencies
for further information.
|
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 above-defined fair value hierarchy. These securities are not held to support current operations and are therefore classified as noncurrent assets. Equity securities are included in
Marketable securities
in our
Condensed Consolidated Balance Sheets
at
March 31, 2019
and
December 31, 2018
.
Acquisition-Related Contingent Consideration
The fair value of contingent consideration liabilities is determined using unobservable inputs; hence these instruments represent Level 3 measurements within the above-defined fair value hierarchy. These inputs include the estimated amount and timing of projected cash flows, the probability of success (achievement of the contingent event) and the risk-adjusted discount rate used to present value the probability-weighted cash flows. Subsequent to the acquisition date, at each reporting period, the contingent consideration liability is remeasured at current fair value with changes recorded in earnings. Changes in any of these estimated inputs used as of the date of this report could have resulted in significant adjustments to fair value. See
Recurring Fair Value Measurements
below for additional information on acquisition-related contingent consideration.
Recurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a recurring basis at
March 31, 2019
and
December 31, 2018
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at March 31, 2019 using:
|
|
|
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
|
$
|
641,012
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
641,012
|
|
|
Equity securities
|
969
|
|
|
—
|
|
|
—
|
|
|
969
|
|
|
Total
|
$
|
641,981
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
641,981
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—current
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
28,305
|
|
|
$
|
28,305
|
|
|
Acquisition-related contingent consideration—noncurrent
|
—
|
|
|
—
|
|
|
39,537
|
|
|
39,537
|
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
67,842
|
|
|
$
|
67,842
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at December 31, 2018 using:
|
|
|
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
|
$
|
137,215
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
137,215
|
|
|
Equity securities
|
738
|
|
|
—
|
|
|
—
|
|
|
738
|
|
|
Total
|
$
|
137,953
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
137,953
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—current
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
36,514
|
|
|
$
|
36,514
|
|
|
Acquisition-related contingent consideration—noncurrent
|
—
|
|
|
—
|
|
|
80,189
|
|
|
80,189
|
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
116,703
|
|
|
$
|
116,703
|
|
At
March 31, 2019
and
December 31, 2018
, money market funds include
$69.1 million
and
$86.9 million
, respectively, in QSFs to be disbursed to mesh-related or other product liability claimants. Amounts in QSFs are considered restricted cash equivalents. See
Note 13. Commitments and Contingencies
for further discussion of our product liability cases. At
March 31, 2019
and
December 31, 2018
, the differences between the amortized cost and the fair value of our money market funds and equity securities, as well as the related gross unrealized gains or losses, were not material, individually or in the aggregate.
Fair Value Measurements Using Significant Unobservable Inputs
The following table presents changes to the Company’s liability for acquisition-related contingent consideration, which was measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the
three months ended March 31, 2019
and
2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Beginning of period
|
$
|
116,703
|
|
|
$
|
190,442
|
|
|
Amounts settled
|
(11,591
|
)
|
|
(27,767
|
)
|
|
Changes in fair value recorded in earnings
|
(37,501
|
)
|
|
6,835
|
|
|
Effect of currency translation
|
231
|
|
|
(223
|
)
|
|
End of period
|
$
|
67,842
|
|
|
$
|
169,287
|
|
At
March 31, 2019
, the fair value measurements of the contingent consideration obligations were determined using risk-adjusted discount rates ranging from approximately
9.5%
to
15.0%
(weighted average rate of approximately
11.7%
).
Changes in fair value recorded in earnings
related to acquisition-related contingent consideration are included in our
Condensed Consolidated Statements of Operations
as
Acquisition-related and integration items
. Amounts recorded for the current and noncurrent portions of acquisition-related contingent consideration are included in
Accounts payable and accrued expenses
and Other liabilities, respectively, in our
Condensed Consolidated Balance Sheets
.
The following table presents changes to the Company’s liability for acquisition-related contingent consideration during the
three months ended March 31, 2019
by acquisition (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2018
|
|
Changes in Fair Value Recorded in Earnings
|
|
Amounts Settled and Other
|
|
Balance as of March 31, 2019
|
|
Auxilium acquisition
|
$
|
14,157
|
|
|
$
|
388
|
|
|
$
|
—
|
|
|
$
|
14,545
|
|
|
Lehigh Valley Technologies, Inc. acquisitions
|
34,700
|
|
|
(400
|
)
|
|
(5,000
|
)
|
|
29,300
|
|
|
VOLTAREN® Gel acquisition (1)
|
56,240
|
|
|
(37,784
|
)
|
|
(6,260
|
)
|
|
12,196
|
|
|
Other
|
11,606
|
|
|
295
|
|
|
(100
|
)
|
|
11,801
|
|
|
Total
|
$
|
116,703
|
|
|
$
|
(37,501
|
)
|
|
$
|
(11,360
|
)
|
|
$
|
67,842
|
|
__________
|
|
|
|
(1)
|
The change in fair value recorded in earnings includes the impact of certain competitive events occurring during the
three months ended March 31, 2019
.
|
Nonrecurring Fair Value Measurements
The Company’s financial assets and liabilities measured at fair value on a nonrecurring basis during the
three months ended March 31, 2019
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements during the Three Months Ended March 31, 2019 (1) using:
|
|
Total Expense for the Three Months Ended March 31, 2019
|
|
|
Quoted Prices in Active Markets for Identical Assets (Level 1)
|
|
Significant Other Observable Inputs (Level 2)
|
|
Significant Unobservable Inputs (Level 3)
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Intangible assets, excluding goodwill (Note 9)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
41,839
|
|
|
$
|
(78,700
|
)
|
|
Certain property, plant and equipment
|
—
|
|
|
—
|
|
|
—
|
|
|
(748
|
)
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
41,839
|
|
|
$
|
(79,448
|
)
|
__________
|
|
|
|
(1)
|
The fair value amounts are presented as of the date of the fair value measurement as these assets are not measured at fair value on a recurring basis. Such measurements generally occur in connection with our quarter-end financial reporting close procedures.
|
Additionally, the Company recorded aggregate pre-tax non-cash goodwill impairment charges during the
three months ended March 31, 2019
of
$86.0 million
. Refer to
Note 9. Goodwill and Other Intangibles
for further description, including the valuation methodologies utilized.
NOTE 7. INVENTORIES
Inventories consist of the following at
March 31, 2019
and December 31,
2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Raw materials (1)
|
$
|
127,622
|
|
|
$
|
122,825
|
|
|
Work-in-process (1)
|
84,801
|
|
|
70,458
|
|
|
Finished goods (1)
|
118,968
|
|
|
128,896
|
|
|
Total
|
$
|
331,391
|
|
|
$
|
322,179
|
|
__________
(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 is classified as noncurrent inventory and is not included in the table above. At
March 31, 2019
and
December 31, 2018
,
$9.9 million
and
$8.1 million
, respectively, of noncurrent inventory was included in Other assets in the
Condensed Consolidated Balance Sheets
. As of
March 31, 2019
and
December 31, 2018
, the Company’s
Condensed Consolidated Balance Sheets
included approximately
$10.5 million
and
$12.5 million
, respectively, of capitalized pre-launch inventories related to generic and sterile injectable products that were not yet available to be sold.
NOTE 8. LEASES
We have entered into contracts with third parties to lease a variety of assets, including certain real estate, machinery, equipment, automobiles and other assets.
Our leases frequently allow for lease payments that could vary based on factors such as inflation or the degree of utilization of the underlying asset and the incurrence of contractual charges such as those for common area maintenance or utilities.
Renewal and/or early termination options are common in our lease arrangements, particularly with respect to our real estate leases. Our ROU assets and lease liabilities generally exclude periods covered by renewal options and include periods covered by early termination options (based on our conclusion that it is not reasonably certain that we will exercise such options).
Our most significant lease is for our U.S. headquarters in Malvern, Pennsylvania. The initial term of the lease is through
2024
and includes three renewal options, each for an additional
60
-month period. These renewal options are not considered reasonably certain of exercise and are therefore excluded from the ROU asset and lease liability.
We are party to certain sublease arrangements, primarily related to our real estate leases, where we act as the lessee and intermediate lessor. For example, we sublease portions of our Malvern, Pennsylvania facility to multiple tenants through sublease arrangements ending in
2024
, with certain limited renewal and early termination options.
The following table presents information about the Company's ROU assets and lease liabilities at
March 31, 2019
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets Line Items
|
|
March 31, 2019
|
|
ROU assets:
|
|
|
|
|
Operating lease ROU assets
|
Operating lease assets
|
|
$
|
57,771
|
|
|
Finance lease ROU assets
|
Property, plant and equipment, net
|
|
57,935
|
|
|
Total ROU assets
|
|
$
|
115,706
|
|
|
Operating lease liabilities:
|
|
|
|
|
Current operating lease liabilities
|
Current portion of operating lease liabilities
|
|
$
|
12,051
|
|
|
Noncurrent operating lease liabilities
|
Operating lease liabilities, less current portion
|
|
54,258
|
|
|
Total operating lease liabilities
|
|
$
|
66,309
|
|
|
Finance lease liabilities:
|
|
|
|
|
Current finance lease liabilities
|
Accounts payable and accrued expenses
|
|
$
|
5,105
|
|
|
Noncurrent finance lease liabilities
|
Other liabilities
|
|
33,979
|
|
|
Total finance lease liabilities
|
|
$
|
39,084
|
|
The following table presents information about lease costs and expenses and sublease income for the
three months ended March 31, 2019
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations Line Items
|
|
Three Months Ended March 31, 2019
|
|
Operating lease cost
|
Various (1)
|
|
$
|
3,499
|
|
|
Finance lease cost:
|
|
|
|
|
Amortization of ROU assets
|
Various (1)
|
|
$
|
2,296
|
|
|
Interest on lease liabilities
|
Interest expense, net
|
|
$
|
500
|
|
|
Other lease costs and income:
|
|
|
|
|
Variable lease costs (2)
|
Various (1)
|
|
$
|
2,089
|
|
|
Sublease income
|
Various (1)
|
|
$
|
(964
|
)
|
__________
|
|
|
|
(1)
|
Amounts are included in Cost of revenues, Selling, general and administrative and/or Research and development based on the function that the underlying leased asset supports. Of these amounts, a total of
$2.7 million
was
Cost of revenues
,
$4.1 million
was
Selling, general and administrative
and
$0.1 million
was
Research and development
.
|
|
|
|
|
(2)
|
Amounts represent variable lease costs incurred that were not included in the initial measurement of the lease liability, such as common area maintenance and utilities costs associated with leased real estate and certain costs associated with our automobile leases.
|
The following table, determined in accordance with ASC 842, provides the undiscounted amount of future cash flows included in our lease liabilities at
March 31, 2019
for each of the five years subsequent to
December 31, 2018
and thereafter, as well as a reconciliation of such undiscounted cash flows to our lease liabilities at
March 31, 2019
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Leases
|
|
Finance Leases
|
|
2019, excluding amounts already paid
|
$
|
11,135
|
|
|
$
|
5,240
|
|
|
2020
|
13,667
|
|
|
7,329
|
|
|
2021
|
13,021
|
|
|
7,476
|
|
|
2022
|
12,309
|
|
|
7,626
|
|
|
2023
|
9,890
|
|
|
7,780
|
|
|
Thereafter
|
20,622
|
|
|
10,521
|
|
|
Total future lease payments
|
$
|
80,644
|
|
|
$
|
45,972
|
|
|
Less: amount representing interest
|
14,335
|
|
|
6,888
|
|
|
Present value of future lease payments (lease liability)
|
$
|
66,309
|
|
|
$
|
39,084
|
|
The Company’s future minimum lease commitments as of
December 31, 2018
under ASC 840, as reported in the Annual Report, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital Leases (1)
|
|
Operating Leases
|
|
2019
|
$
|
6,884
|
|
|
$
|
15,800
|
|
|
2020
|
6,819
|
|
|
14,519
|
|
|
2021
|
6,921
|
|
|
12,883
|
|
|
2022
|
7,072
|
|
|
12,454
|
|
|
2023
|
7,225
|
|
|
9,945
|
|
|
Thereafter
|
9,127
|
|
|
20,573
|
|
|
Total minimum lease payments
|
$
|
44,048
|
|
|
$
|
86,174
|
|
|
Less: Amount representing interest
|
4,084
|
|
|
|
|
Total present value of minimum payments
|
$
|
39,964
|
|
|
|
|
Less: Current portion of such obligations
|
5,845
|
|
|
|
|
Long-term capital lease obligations
|
$
|
34,119
|
|
|
|
__________
|
|
|
|
(1)
|
The Malvern, Pennsylvania headquarters lease arrangement is included under Capital Leases.
|
The following table provides the weighted average remaining lease term and weighted average discount rates for our leases as of
March 31, 2019
:
|
|
|
|
|
|
|
|
March 31, 2019
|
|
Weighted average remaining lease term (years), weighted based on lease liability balances:
|
|
|
Operating leases
|
6.5 years
|
|
|
Finance leases
|
6.2 years
|
|
|
Weighted average discount rate (percentages), weighted based on the remaining balance of lease payments:
|
|
|
Operating leases
|
5.8
|
%
|
|
Finance leases
|
5.1
|
%
|
The following table provides certain cash flow and supplemental noncash information related to our lease liabilities for the
three months ended March 31, 2019
(in thousands):
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2019
|
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
Operating cash payments for operating leases
|
$
|
3,692
|
|
|
Operating cash payments for finance leases
|
$
|
473
|
|
|
Financing cash payments for finance leases
|
$
|
1,174
|
|
|
Lease liabilities arising from obtaining right-of-use assets:
|
|
|
Operating leases
|
$
|
—
|
|
|
Finance leases
|
$
|
—
|
|
NOTE 9. GOODWILL AND OTHER INTANGIBLES
Goodwill
Changes in the carrying amount of our goodwill for the
three months ended March 31, 2019
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Branded Pharmaceuticals
|
|
Sterile Injectables
|
|
Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
|
Goodwill as of December 31, 2018
|
$
|
828,818
|
|
|
$
|
2,731,193
|
|
|
$
|
151,108
|
|
|
$
|
53,517
|
|
|
$
|
3,764,636
|
|
|
Effect of currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
1,165
|
|
|
1,165
|
|
|
Goodwill impairment charges
|
—
|
|
|
—
|
|
|
(86,000
|
)
|
|
—
|
|
|
(86,000
|
)
|
|
Goodwill as of March 31, 2019
|
$
|
828,818
|
|
|
$
|
2,731,193
|
|
|
$
|
65,108
|
|
|
$
|
54,682
|
|
|
$
|
3,679,801
|
|
The carrying amounts of goodwill at
March 31, 2019
and December 31,
2018
are net of the following accumulated impairments (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Branded Pharmaceuticals
|
|
Sterile Injectables
|
|
Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
|
Accumulated impairment losses as of December 31, 2018
|
$
|
855,810
|
|
|
$
|
—
|
|
|
$
|
2,991,549
|
|
|
$
|
456,408
|
|
|
$
|
4,303,767
|
|
|
Accumulated impairment losses as of March 31, 2019
|
$
|
855,810
|
|
|
$
|
—
|
|
|
$
|
3,077,549
|
|
|
$
|
466,317
|
|
|
$
|
4,399,676
|
|
Other Intangible Assets
Changes in the amount of other intangible assets for the
three months ended March 31, 2019
are set forth in the table below (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost basis:
|
Balance as of December 31, 2018
|
|
Acquisitions
|
|
Impairments
|
|
Effect of Currency Translation
|
|
Balance as of March 31, 2019
|
|
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
$
|
93,900
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
93,900
|
|
|
Total indefinite-lived intangibles
|
$
|
93,900
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
93,900
|
|
|
Finite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
Licenses (weighted average life of 14 years)
|
$
|
457,402
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
457,402
|
|
|
Tradenames
|
6,409
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,409
|
|
|
Developed technology (weighted average life of 11 years)
|
6,182,015
|
|
|
—
|
|
|
(78,700
|
)
|
|
5,356
|
|
|
6,108,671
|
|
|
Total finite-lived intangibles (weighted average life of 11 years)
|
$
|
6,645,826
|
|
|
$
|
—
|
|
|
$
|
(78,700
|
)
|
|
$
|
5,356
|
|
|
$
|
6,572,482
|
|
|
Total other intangibles
|
$
|
6,739,726
|
|
|
$
|
—
|
|
|
$
|
(78,700
|
)
|
|
$
|
5,356
|
|
|
$
|
6,666,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization:
|
Balance as of December 31, 2018
|
|
Amortization
|
|
Impairments
|
|
Effect of Currency Translation
|
|
Balance as of March 31, 2019
|
|
Finite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
|
Licenses
|
$
|
(398,182
|
)
|
|
$
|
(4,869
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(403,051
|
)
|
|
Tradenames
|
(6,409
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,409
|
)
|
|
Developed technology
|
(2,877,829
|
)
|
|
(140,730
|
)
|
|
—
|
|
|
(2,769
|
)
|
|
(3,021,328
|
)
|
|
Total other intangibles
|
$
|
(3,282,420
|
)
|
|
$
|
(145,599
|
)
|
|
$
|
—
|
|
|
$
|
(2,769
|
)
|
|
$
|
(3,430,788
|
)
|
|
Net other intangibles
|
$
|
3,457,306
|
|
|
|
|
|
|
|
|
$
|
3,235,594
|
|
Amortization expense for the
three months ended March 31, 2019 and 2018
totaled
$145.6 million
and
$157.2 million
, respectively. Amortization expense is included in Cost of revenues in the
Condensed Consolidated Statements of Operations
. Estimated amortization of intangibles for the five fiscal years subsequent to
December 31, 2018
is as follows (in thousands):
|
|
|
|
|
|
|
|
2019
|
$
|
545,757
|
|
|
2020
|
$
|
461,267
|
|
|
2021
|
$
|
419,045
|
|
|
2022
|
$
|
403,142
|
|
|
2023
|
$
|
372,939
|
|
Impairments
Endo tests goodwill and indefinite-lived intangible assets for impairment annually, or more frequently whenever events or changes in circumstances indicate that the asset might be impaired. Our annual assessment is performed as of October 1st.
As part of our goodwill and intangible asset impairment assessments, we estimate the fair values of our reporting units and our intangible assets using an income approach that utilizes a discounted cash flow model or, where appropriate, a market approach. The discounted cash flow models are dependent upon our estimates of future cash flows and other factors. These estimates of future cash flows involve assumptions concerning (i) future operating performance, including future sales, long-term growth rates, operating margins, tax rates, variations in the amount and timing of cash flows and the probability of achieving the estimated cash flows and (ii) future economic conditions. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The discount rates applied to the estimated cash flows are based on the overall risk associated with the particular assets and other market factors. We believe the discount rates and other inputs and assumptions are consistent with those that a market participant would use. Any impairment charges resulting from annual or interim goodwill and intangible asset impairment assessments are recorded to
Asset impairment charges
in our
Condensed Consolidated Statements of Operations
.
During the
three months ended March 31, 2019 and 2018
, the Company incurred the following goodwill and other intangible asset impairment charges (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2019
|
|
2018
|
|
Goodwill impairment charges
|
$
|
86,000
|
|
|
$
|
391,000
|
|
|
Other intangible asset impairment charges
|
$
|
78,700
|
|
|
$
|
54,200
|
|
A summary of significant goodwill and other intangible asset impairment tests and related charges is included below. Pre-tax non-cash intangible asset impairment charges related primarily to certain in-process research and development and/or developed technology intangible assets that were tested for impairment following changes in market conditions and certain other factors impacting recoverability.
As a result of certain competitive events that occurred during the first quarter of 2019, we tested the goodwill of our
Generic Pharmaceuticals
reporting unit for impairment as of March 31, 2019. The fair value of the reporting unit was estimated using an income approach that utilized a discounted cash flow model. The discount rate utilized in this test was
10.5%
. This goodwill impairment test resulted in a pre-tax non-cash goodwill impairment charge of
$86.0 million
during the three months ended March 31, 2019, representing the excess of this reporting unit’s carrying amount over its estimated fair value. The
Generic Pharmaceuticals
impairment can be primarily attributed to the impact of the competitive events referenced above and an increase in the discount rate used in the determination of fair value.
During the first quarter of 2018, a change in segments resulted in changes to our reporting units for goodwill impairment testing purposes, including the creation of a new
Sterile Injectables
reporting unit, which was previously part of our Generics reporting unit. As a result of these changes, under U.S. GAAP, we tested the goodwill of the former Generics reporting unit immediately before the segment realignment and the goodwill of both the new
Sterile Injectables
and
Generic Pharmaceuticals
reporting units immediately after the segment realignment. These goodwill tests were performed using an income approach that utilizes a discounted cash flow model. The results of these goodwill impairment tests were as follows:
|
|
|
|
•
|
The former Generics reporting unit’s estimated fair value exceeded its carrying amount, resulting in
no
related goodwill impairment charge.
|
|
|
|
|
•
|
The new
Sterile Injectables
reporting unit’s estimated fair value exceeded its carrying amount, resulting in
no
related goodwill impairment charge.
|
|
|
|
|
•
|
The new
Generic Pharmaceuticals
reporting unit’s carrying amount exceeded its estimated fair value, resulting in a pre-tax non-cash goodwill impairment charge of
$391.0 million
.
|
NOTE 10. CONTRACT ASSETS AND LIABILITIES
Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship products to a customer pursuant to a purchase order. Revenue contracts such as these do not generally give rise to contract assets or contract liabilities because: (i) the underlying contracts generally have only a single performance obligation and (ii) we do not generally receive consideration until the performance obligation is fully satisfied. At
March 31, 2019
, the unfulfilled performance obligations for these types of contracts relate to ordered but undelivered products. We generally expect to fulfill the performance obligations and recognize revenue within
one
week of entering into the underlying contract. Based on the short-term initial contract duration, additional disclosure about the remaining performance obligations is not required.
Certain of our other revenue-generating contracts, including license and collaboration agreements, may result in contract assets and/or contract liabilities. For example, we may recognize contract liabilities upon receipt of certain upfront and milestone payments from customers when there are remaining performance obligations.
The following table shows the opening and closing balances of contract assets and contract liabilities from contracts with customers (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
$ Change
|
|
% Change
|
|
Contract assets, net (1)
|
$
|
9,406
|
|
|
$
|
12,065
|
|
|
$
|
(2,659
|
)
|
|
(22
|
)%
|
|
Contract liabilities, net (2)
|
$
|
22,756
|
|
|
$
|
19,217
|
|
|
$
|
3,539
|
|
|
18
|
%
|
__________
|
|
|
|
(1)
|
At
March 31, 2019
and
December 31, 2018
, approximately
$9.4 million
and
$9.3 million
, respectively, of these contract asset amounts are classified as current assets and are included in Prepaid expenses and other current assets in the Company’s
Condensed Consolidated Balance Sheets
. The remaining amounts are classified as noncurrent and are included in Other assets. The net
decrease
in contract assets during the
three months ended March 31, 2019
was primarily due to reclassifications to accounts receivable following the resolution of certain conditions other than the passage of time affecting the Company’s rights to consideration for the sale of certain goods, partially offset by certain sales activity during the period.
|
|
|
|
|
(2)
|
At
March 31, 2019
and
December 31, 2018
, approximately
$2.8 million
and
$1.7 million
, respectively, of these contract liability amounts are classified as current liabilities and are included in Accounts payable and accrued expenses in the Company’s
Condensed Consolidated Balance Sheets
. The remaining amounts are classified as noncurrent and are included in Other liabilities. During the
three months ended March 31, 2019
, the Company entered into new contracts resulting in an
increase
to contract liabilities of approximately
$4.0 million
. This increase was partially offset by approximately
$0.5 million
in revenue recognized during the period.
|
During the
three months
ended
March 31, 2019
, we recognized
revenue
of
$10.1 million
relating to performance obligations satisfied, or partially satisfied, in prior periods. Such revenue generally relates to changes in estimates with respect to our variable consideration.
NOTE 11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses
include the following at
March 31, 2019
and December 31,
2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Trade accounts payable
|
$
|
97,592
|
|
|
$
|
96,024
|
|
|
Returns and allowances
|
223,156
|
|
|
236,946
|
|
|
Rebates
|
118,658
|
|
|
144,860
|
|
|
Chargebacks
|
2,481
|
|
|
2,971
|
|
|
Accrued interest
|
45,351
|
|
|
130,182
|
|
|
Accrued payroll and related benefits
|
45,037
|
|
|
89,895
|
|
|
Accrued royalties and other distribution partner payables
|
103,649
|
|
|
122,028
|
|
|
Acquisition-related contingent consideration—current
|
28,305
|
|
|
36,514
|
|
|
Other
|
176,601
|
|
|
149,780
|
|
|
Total
|
$
|
840,830
|
|
|
$
|
1,009,200
|
|
NOTE 12. DEBT
The following table presents information about the Company’s total indebtedness at
March 31, 2019
and
December 31, 2018
(dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
|
Effective Interest Rate
|
|
Principal Amount
|
|
Carrying Amount
|
|
Effective Interest Rate
|
|
Principal Amount
|
|
Carrying Amount
|
|
7.25% Senior Notes due 2022
|
7.25
|
%
|
|
$
|
10,084
|
|
|
$
|
10,083
|
|
|
7.91
|
%
|
|
$
|
400,000
|
|
|
$
|
392,947
|
|
|
5.75% Senior Notes due 2022
|
5.75
|
%
|
|
182,479
|
|
|
182,462
|
|
|
6.04
|
%
|
|
700,000
|
|
|
694,464
|
|
|
5.375% Senior Notes due 2023
|
5.61
|
%
|
|
210,440
|
|
|
208,733
|
|
|
5.62
|
%
|
|
750,000
|
|
|
743,438
|
|
|
6.00% Senior Notes due 2023
|
6.28
|
%
|
|
1,439,840
|
|
|
1,424,854
|
|
|
6.28
|
%
|
|
1,635,000
|
|
|
1,616,817
|
|
|
5.875% Senior Secured Notes due 2024
|
6.14
|
%
|
|
300,000
|
|
|
296,205
|
|
|
6.14
|
%
|
|
300,000
|
|
|
296,062
|
|
|
6.00% Senior Notes due 2025
|
6.27
|
%
|
|
1,200,000
|
|
|
1,183,979
|
|
|
6.27
|
%
|
|
1,200,000
|
|
|
1,183,415
|
|
|
7.50% Senior Secured Notes due 2027
|
7.71
|
%
|
|
1,500,000
|
|
|
1,480,876
|
|
|
|
|
|
—
|
|
|
—
|
|
|
Term Loan B Facility Due 2024
|
6.96
|
%
|
|
3,355,238
|
|
|
3,324,085
|
|
|
7.02
|
%
|
|
3,363,775
|
|
|
3,331,276
|
|
|
Total long-term debt, net
|
|
|
$
|
8,198,081
|
|
|
$
|
8,111,277
|
|
|
|
|
$
|
8,348,775
|
|
|
$
|
8,258,419
|
|
|
Less current portion, net
|
|
|
35,940
|
|
|
35,940
|
|
|
|
|
34,150
|
|
|
34,150
|
|
|
Total long-term debt, less current portion, net
|
|
|
$
|
8,162,141
|
|
|
$
|
8,075,337
|
|
|
|
|
$
|
8,314,625
|
|
|
$
|
8,224,269
|
|
The Company and its subsidiaries, with certain customary exceptions, guarantee or serve as issuers or borrowers of the debt instruments representing substantially all of the Company’s indebtedness at
March 31, 2019
.
The obligations under (i) the senior secured notes and (ii) the
Credit Agreement
(as defined below) and related loan documents are secured on a
pari passu
basis by a perfected first priority (subject to certain permitted liens) lien on the collateral securing such instruments, which collateral represents substantially all of the assets of the issuers or borrowers and the guarantors party thereto (subject to customary exceptions). Our senior unsecured notes are unsecured and effectively subordinated in right of priority to our credit agreement and our senior secured notes, in each case to the extent of the value of the collateral securing such instruments.
The aggregate estimated fair value of the Company’s long-term debt, which was estimated using inputs based on quoted market prices for the same or similar debt issuances, was
$7.5 billion
and
$7.2 billion
at
March 31, 2019
and
December 31, 2018
, respectively. Based on this valuation methodology, we determined these debt instruments represent Level 2 measurements within the fair value hierarchy.
Senior Notes and Senior Secured Notes
At
March 31, 2019
and
December 31, 2018
, we were in compliance with all covenants contained in the indentures governing our various senior notes and senior secured notes.
Credit Facilities
The credit facilities consist of a
$1,000.0 million
revolving credit facility (the
Revolving Credit Facility
) and a senior secured term loan facility (the
Term Loan Facility
and, together with the
Revolving Credit Facility
, the
Credit Facilities
). As of
March 31, 2019
, we had
$996.8 million
of remaining credit available through the
Revolving Credit Facility
. At
March 31, 2019
and
December 31, 2018
, we were in compliance with all covenants contained in the
Credit Agreement
(as defined below).
March 2019 Refinancing
In March 2019, the Company executed several transactions (the
March 2019 Refinancing Transactions
), which included:
|
|
|
|
•
|
the entry into an amendment (the
Revolving Credit Facility Amendment
) to the Company’s existing credit agreement, which was originally dated April 27, 2017 (the
Credit Agreement
);
|
|
|
|
|
•
|
the issuance of
$1,500.0 million
of
7.50% Senior Secured Notes due 2027
(the
2027 Notes
);
|
|
|
|
|
•
|
the repurchase of
$1,642.2 million
aggregate principal amount of certain of the Company’s senior unsecured notes for
$1,500.0 million
in cash, excluding accrued interest (the
Notes Repurchases
); and
|
|
|
|
|
•
|
the solicitation of consents from the holders of the existing
7.25%
Senior Notes due 2022 and
5.75%
Senior Notes due 2022 (together, the Consent Notes) to certain amendments to the indentures governing such notes, which eliminated substantially all of the restrictive covenants, certain events of default and other provisions contained in each such indenture.
|
The
Revolving Credit Facility Amendment
amended the
Credit Agreement
to, among other things, (i) extend the maturity of the commitments under the
Revolving Credit Facility
from April
2022
to March
2024
(with the exception of
$76.0 million
of commitments that were not extended), (ii) provide greater covenant flexibility by increasing the maximum Secured Net Leverage Ratio described in the Financial Covenant (as defined in the
Credit Agreement
) from
3.50
:1.00 to
4.50
:1.00 and (iii) limit the scenarios under which such Financial Covenant will be tested.
The
2027 Notes
were issued by Par Pharmaceutical, Inc. (PPI), a wholly-owned indirect subsidiary of the Company, in a private offering to “qualified institutional buyers” (as defined in Rule 144A under the Securities Act) and outside the U.S. to non-U.S. persons in compliance with Regulation S under the Securities Act. The
2027 Notes
are guaranteed on a senior secured basis by the Company and its subsidiaries that also guarantee the
Credit Agreement
(collectively, the
Guarantors
). The
2027 Notes
are senior secured obligations of PPI and the
Guarantors
and are secured by the same collateral that secures the
Credit Agreement
and the Company’s existing senior secured notes. Interest on the
2027 Notes
is payable semiannually in arrears on April 1 and October 1 of each year, beginning on October 1, 2019.
The
2027 Notes
will mature on April 1, 2027; however, the indenture governing these notes allows for redemption prior to maturity, in whole or in part, subject to certain restrictions and limitations described therein, in the following ways:
|
|
|
|
•
|
Before April 1, 2022, the
2027 Notes
may be redeemed, in whole or in part, by paying the sum of: (i)
100%
of the principal amount being redeemed, (ii) an applicable make-whole premium as described in the indenture and (iii) accrued and unpaid interest, if any, to, but not including, the date of redemption.
|
|
|
|
|
•
|
On or after April 1, 2022, the
2027 Notes
may be redeemed, in whole or in part, at redemption prices set forth in the indenture, plus accrued and unpaid interest, if any, to, but not including, the date of redemption. The redemption prices for the
2027 Notes
vary over time pursuant to a step-down schedule set forth in the indenture, beginning at
105.625%
of the principal amount redeemed and decreasing to
100%
by April 1, 2025.
|
|
|
|
|
•
|
Before April 1, 2022, the
2027 Notes
may be redeemed, in part (up to
35%
of the principal amount outstanding) with the net cash proceeds from specified equity offerings at
107.500%
of the principal amount redeemed, plus accrued and unpaid interest, if any, to, but not including, the date of redemption.
|
The
2027 Notes
indenture contains covenants that, among other things, restrict the Company’s ability and the ability of its Restricted Subsidiaries (as defined in the indenture) to incur certain additional indebtedness and issue preferred stock; make certain dividends, distributions, investments and other restricted payments; sell certain assets; enter into sale and leaseback transactions; agree to certain restrictions on the ability of restricted subsidiaries to make certain payments to the Company or any of its restricted subsidiaries; create certain liens; merge, consolidate or sell all or substantially all of the Company’s assets; enter into certain transactions with affiliates or designate subsidiaries as unrestricted subsidiaries. These covenants are subject to a number of exceptions and qualifications, including the fall away or revision of certain of these covenants and release of collateral upon the
2027 Notes
receiving investment grade credit ratings.
The Company used the net proceeds of the
2027 Notes
and cash on hand primarily to fund the
Notes Repurchases
and to pay certain premiums, fees and expenses related thereto. The
Notes Repurchases
were completed by Endo Finance LLC (Endo Finance), a wholly-owned subsidiary of the Company, pursuant to a tender offer to repurchase portions of the Company’s outstanding
7.25% Senior Notes due 2022
,
5.75% Senior Notes due 2022
,
5.375% Senior Notes due 2023
and
6.00% Senior Notes due 2023
. In connection with the
Notes Repurchases
, Endo Finance repurchased
$1,642.2 million
of senior unsecured note indebtedness, representing the aggregate principal amount repurchased, for
$1,500.0 million
in cash (including certain cash premiums related thereto). The
$1,642.2 million
aggregate repurchase amount consisted of (i)
$389.9 million
aggregate principal amount of the
7.25% Senior Notes due 2022
, (ii)
$517.5 million
aggregate principal amount of the
5.75% Senior Notes due 2022
, (iii)
$539.6 million
aggregate principal amount of the
5.375% Senior Notes due 2023
and (iv)
$195.2 million
aggregate principal amount of the
6.00% Senior Notes due 2023
. The aggregate carrying amount of notes repurchased was
$1,624.0 million
. In conjunction with the
Notes Repurchases
, Endo Finance also solicited consents from holders of the Consent Notes to certain proposed amendments to the applicable indentures under which each series of Consent Notes were issued, which would eliminate substantially all restrictive covenants, certain events of default and certain other provisions contained in each such indenture.
The proposed amendments were effected pursuant to a supplemental indenture to each such indenture executed by Endo Finance and the guarantors of the Consent Notes, which became operative upon the repurchase of at least the requisite consent amount of the applicable series of Consent Notes tendered.
The difference between the cash paid and the carrying amount of notes repurchased in the
Notes Repurchases
resulted in a
$124.0 million
gain recorded as
Gain on extinguishment of debt
in the
Condensed Consolidated Statements of Operations
. In connection with the
March 2019 Refinancing Transactions
, we also incurred costs and fees totaling
$26.2 million
, of which
$4.2 million
related to the
Notes Repurchases
,
$19.1 million
related to the
2027 Notes
issuance and
$2.9 million
related to the
Revolving Credit Facility Amendment
. The costs incurred in connection with the
Notes Repurchases
were charged to expense in the first quarter of 2019 and recorded as an offset to the
Gain on extinguishment of debt
. The costs incurred in connection with the
2027 Notes
issuance and the
Revolving Credit Facility Amendment
, together with previously deferred debt issuance costs associated with the
Revolving Credit Facility
, have been deferred and will be amortized as interest expense over the terms of the respective instruments.
Maturities
The following table presents the maturities on our long-term debt for each of the five fiscal years subsequent to
December 31, 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Maturities (1)
|
|
2019 (2)
|
|
$
|
34,150
|
|
|
2020
|
|
$
|
34,150
|
|
|
2021
|
|
$
|
34,150
|
|
|
2022 (2)
|
|
$
|
226,713
|
|
|
2023
|
|
$
|
1,684,430
|
|
__________
|
|
|
|
(1)
|
Certain amounts borrowed pursuant to the
Credit Facilities
will immediately mature if certain of our senior notes are not refinanced or repaid in full prior to the date that is
91
days prior to the respective stated maturity dates thereof. Accordingly, we may seek to repay or refinance certain senior notes prior to their stated maturity dates. The amounts in this maturities table do not reflect any such early repayment or refinancing; rather, they reflect stated maturity dates.
|
|
|
|
|
(2)
|
In April 2019, the Company redeemed
$1.8 million
of senior notes, which had a stated maturity date in 2022. The amounts in this table do not reflect this early redemption; rather, they reflect stated maturity dates.
|
NOTE 13. COMMITMENTS AND CONTINGENCIES
Legal Proceedings and Investigations
We and certain of our subsidiaries are involved in various claims, legal proceedings and internal and governmental investigations (collectively, proceedings) that arise from time to time, including, among others, those relating to product liability, intellectual property, regulatory compliance, consumer protection, tax and commercial matters. While we cannot predict the outcome of these proceedings and we intend to vigorously prosecute or defend our position as appropriate, there can be no assurance that we will be successful or obtain any requested relief, and an adverse outcome in any of these proceedings could have a
material adverse effect on our business, financial condition, results of operations and cash flows
. Matters that are not being disclosed herein are, in the opinion of our management, immaterial both individually and in the aggregate with respect to our financial position, results of operations and cash flows. If and when such matters, in the opinion of our management, become material, either individually or in the aggregate, we will disclose them.
We believe that certain settlements and judgments, as well as legal defense costs, relating to certain product liability or other matters are or may be covered in whole or in part under our insurance policies with a number of insurance carriers. In certain circumstances, insurance carriers reserve their rights to contest or deny coverage. We intend to contest vigorously any and all disputes with our insurance carriers and to enforce our rights under the terms of our insurance policies. Accordingly, we will record receivables with respect to amounts due under these policies only when the realization of the potential claim for recovery is considered probable. Amounts recovered under our insurance policies could be materially less than the stated coverage limits and may not be adequate to cover damages, other relief and/or costs relating to claims. In addition, there is no guarantee that insurers will pay claims or that coverage will otherwise be available.
As of
March 31, 2019
, our accrual for loss contingencies totaled
$861.3 million
, the most significant components of which relate to product liability and related matters associated with vaginal mesh and testosterone. Although we believe 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. While the timing of the resolution of certain of the matters accrued for as loss contingencies remains uncertain and could extend beyond 12 months, as of
March 31, 2019
, the entire liability accrual amount is classified in the
Current portion of legal settlement accrual
in the
Condensed Consolidated Balance Sheets
.
Product Liability and Related Matters
We and certain of our subsidiaries have been named as defendants in numerous lawsuits in various U.S. federal and state courts, as well as in Canada and other countries, alleging personal injury resulting from the use of certain products of our subsidiaries. These and other related matters are described below in more detail.
Vaginal Mesh.
Since 2008, we and certain of our subsidiaries, including American Medical Systems Holdings, Inc. (subsequently converted to Astora Women’s Health Holding LLC and merged into Astora Women’s Health LLC and referred to herein as AMS) and/or Astora, have been named as defendants in multiple lawsuits in various state and federal courts in the U.S. (including a federal multidistrict litigation (MDL) pending in the U.S. District Court for the Southern District of West Virginia (MDL No. 2325)), and in Canada and other countries, alleging personal injury resulting from the use of transvaginal surgical mesh products designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In January 2018, a representative proceeding (class action) was filed in the Federal Court of Australia against American Medical Systems, LLC. In the various class action and individual complaints, plaintiffs claim a variety of personal injuries, including chronic pain, incontinence, inability to control bowel function and permanent deformities, and seek compensatory and punitive damages, where available.
We and certain plaintiffs’ counsel representing mesh-related product liability claimants have entered into various Master Settlement Agreements (MSAs) and other agreements to resolve up to approximately
71,000
filed and unfiled mesh claims handled or controlled by the participating counsel. These MSAs and other agreements were entered into at various times between June 2013 and the present, were solely by way of compromise and settlement and were not in any way an admission of liability or fault by us or any of our subsidiaries.
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 QSFs into which funds may be deposited pursuant to certain schedules set forth in those agreements. All MSAs have participation requirements regarding the claims represented by each law firm party to the MSA. In addition,
one
agreement gives us 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 QSFs are considered restricted cash and/or restricted cash equivalents.
Distribution of funds to any individual claimant is conditioned upon the receipt of documentation substantiating the validity of the claim, a full release and dismissal of the entire action or claim as to all AMS parties and affiliates. Prior to receiving funds, an individual claimant is required to represent and warrant that liens, assignment rights or other claims identified in the claims administration process have been or will be satisfied by the individual claimant. Confidentiality provisions apply to 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 settlements.
In June 2017, the MDL court entered a case management order which, among other things, requires plaintiffs in newly-filed MDL cases to provide expert disclosures on specific causation within one hundred twenty (
120
) days of filing a claim (the Order). Under the Order, a plaintiff's failure to meet the foregoing deadline may be grounds for the entry of judgment against such plaintiff. In July 2017, a similar order was entered in Minnesota state court. In June 2018, at the request of the MDL court, the Judicial Panel on Multidistrict Litigation entered a minute order suspending the transfer of cases into the MDL. Subsequently, the MDL court issued a pretrial order discontinuing the direct filing of claims in MDL No. 2325. The MDL court also issued similar orders in other MDLs involving claims against other mesh manufacturers.
Although the Company believes it has appropriately estimated the probable total amount of loss associated with all mesh-related matters as of the date of this report, fact and expert discovery is ongoing in certain cases that have not settled, and it is reasonably possible that further claims may be filed or asserted and that adjustments to our liability accrual may be required. This could have a
material adverse effect on our business, financial condition, results of operations and cash flows
.
The following table presents the changes in the QSFs and mesh liability accrual balances during the
three months ended March 31, 2019
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Qualified Settlement Funds
|
|
Mesh Liability Accrual
|
|
Balance as of January 1, 2019
|
$
|
299,733
|
|
|
$
|
748,606
|
|
|
Additional charges
|
—
|
|
|
—
|
|
|
Cash contributions to Qualified Settlement Funds
|
81,582
|
|
|
—
|
|
|
Cash distributions to settle disputes from Qualified Settlement Funds
|
(54,984
|
)
|
|
(54,984
|
)
|
|
Cash distributions to settle disputes
|
—
|
|
|
(10,239
|
)
|
|
Other (1)
|
1,057
|
|
|
1,057
|
|
|
Balance as of March 31, 2019
|
$
|
327,388
|
|
|
$
|
684,440
|
|
__________
|
|
|
|
(1)
|
Amounts deposited in the QSFs may earn interest, which is generally used to pay administrative costs of the fund and is reflected in the table above as an increase to the QSF and Mesh Liability Accrual balances. Any interest remaining after all claims have been paid will generally be distributed to the claimants who participated in that settlement.
|
Charges related to vaginal mesh liability and associated legal fees and other expenses for all periods presented are reported in Discontinued operations, net of tax in our
Condensed Consolidated Statements of Operations
.
To date, the Company has made total mesh liability payments of approximately
$3.4 billion
,
$327.4 million
of which remains in the QSFs as of
March 31, 2019
. We currently expect to fund into the QSFs the remaining payments under all settlement agreements during 2019. As the funds are disbursed out of the QSFs from time to time, the liability accrual will be reduced accordingly with a corresponding reduction to restricted cash and cash equivalents. In addition, we may pay cash distributions to settle disputes separate from the QSFs, which will also decrease the liability accrual and decrease cash and cash equivalents.
We were contacted in October 2012 regarding a civil investigation initiated by various 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 we have subsequently received additional subpoenas from California and other states. We are cooperating with these investigations.
We will continue to vigorously defend any unresolved claims and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred.
Testosterone.
Various manufacturers of prescription medications containing testosterone, including our subsidiaries Endo Pharmaceuticals Inc. (EPI) and Auxilium Pharmaceuticals, Inc. (subsequently converted to Auxilium Pharmaceuticals, LLC and hereinafter referred to as Auxilium), have been named as defendants in multiple lawsuits alleging personal injury resulting from the use of such medications, including FORTESTA
®
Gel, DELATESTRYL
®
, TESTIM
®
, TESTOPEL
®
, AVEED
®
and STRIANT
®
. Plaintiffs in these suits generally allege various personal injuries, including pulmonary embolism, stroke or other vascular and/or cardiac injuries, and seek compensatory and/or punitive damages, where available.
As of
May 2, 2019
, we were aware of approximately
935
testosterone cases (some of which may have been filed on behalf of multiple plaintiffs) pending against one or more of our subsidiaries in federal or state court. Most of these cases have been coordinated in a federal MDL pending in the U.S. District Court for the Northern District of Illinois (
MDL No. 2545
). An MDL trial against Auxilium involving TESTIM
®
took place in November 2017 and resulted in a defense verdict. A trial against Auxilium involving TESTIM
®
was scheduled for January 2018 in the Philadelphia Court of Common Pleas but resolved prior to trial.
In June 2018, counsel for plaintiffs, on the one hand, and Auxilium and EPI, on the other, executed an MSA allowing for the resolution of all known testosterone replacement therapy product liability claims against our subsidiaries. The MSA was solely by way of compromise and settlement and was not in any way an admission of fault by us or any of our subsidiaries.
The MSA is subject to a process that includes guidelines and procedures for administering the settlement and the release of funds. Among other things, the MSA provides for the creation of a QSF into which the settlement funds will be deposited, establishes participation requirements and allows for a reduction of the total settlement payment in the event the participation threshold is not met. Distribution of funds to any individual claimant is conditioned upon the receipt of documentation substantiating product use and injury as determined by a third-party special master, the dismissal of any lawsuit and the release of the claim as to us and all affiliates. Prior to receiving funds, an individual claimant must represent and warrant that liens, assignment rights or other claims identified in the claims administration process have been or will be satisfied by the individual claimant. Confidentiality provisions apply to the settlement funds, amounts allocated to individual claimants and other terms of the agreement.
Although the Company believes it has appropriately estimated the probable total amount of loss associated with testosterone-related product liability matters as of the date of this report, it is reasonably possible that further claims may be filed or asserted and that adjustments to our liability accrual may be required. This could have a
material adverse effect on our business, financial condition, results of operations and cash flows
.
The MDL also included a lawsuit filed in November 2014 in the U.S. District for 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 claim to have paid for certain testosterone products. This lawsuit is not part of the settlement described above. After a series of motions to dismiss, plaintiff filed a third amended complaint in April 2016, asserting civil claims for alleged violations of the Racketeer Influenced and Corrupt Organizations Act and negligent misrepresentation based on defendants’ marketing of certain testosterone products. The court denied a motion to dismiss this complaint in August 2016. In July 2018, the court denied plaintiff’s motion for class certification. In February 2019, the court granted defendants’ motion for summary judgment. Plaintiffs have appealed to the U.S. Court of Appeals for the Seventh Circuit.
We will continue to vigorously defend any unresolved claims and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred.
Opioid-Related Matters
Since 2014, multiple U.S. states, counties, other governmental persons or entities and private plaintiffs have filed suit against us and/or certain of our subsidiaries, including Endo Health Solutions Inc. (EHSI), EPI, PPI, Par Pharmaceutical Companies, Inc. (PPCI), Vintage Pharmaceuticals, LLC, Generics Bidco I, LLC and DAVA Pharmaceuticals, LLC, as well as various other manufacturers, distributors and/or others, asserting claims relating to defendants’ alleged sales, marketing and/or distribution practices with respect to prescription opioid medications, including certain of our products. As of
May 2, 2019
, the cases of which we were aware include, but are not limited to, approximately
13
cases filed by or on behalf of states; approximately
1,925
cases filed by counties, cities, Native American tribes and/or other government-related persons or entities; approximately
136
cases filed by hospitals, health systems, unions, health and welfare funds or other third-party payers and approximately
59
cases filed by individuals. Certain of the cases have been filed as putative class actions. In addition to the litigation in the U.S., in August 2018, an action against Paladin Labs Inc., EPI, the Company and various other manufacturers and distributors was commenced in British Columbia on behalf of all federal, provincial and territorial governments and agencies in Canada that paid healthcare, pharmaceutical and treatment costs related to opioids.
Many of the U.S. cases have been coordinated in a federal MDL pending in the U.S. District Court for the Northern District of Ohio (MDL No. 2804). In March 2018, the U.S. Department of Justice (DOJ) filed a statement of interest in the case, and in April 2018 it filed a motion to participate in settlement discussions as a friend of the court, which the MDL court granted. The MDL court has issued a series of case management orders permitting motions to dismiss addressing threshold legal issues in certain cases (and has issued orders granting in part and denying in part some of those motions), setting a trial date in October 2019 for the claims of
two
Ohio counties, allowing certain discovery and establishing certain other deadlines and procedures, among other things.
Other cases remain pending in various state courts. In some jurisdictions, such as Connecticut, Illinois, New York, Pennsylvania, South Carolina and Texas, certain state court cases have been transferred to a single court within their respective state court systems for coordinated pretrial proceedings. The state cases are generally at the pleading and/or discovery stage with certain of these cases scheduled for trial beginning in 2020.
The complaints in the cases assert a variety of claims including, but not limited to, claims for alleged violations of public nuisance, consumer protection, unfair trade practices, racketeering, Medicaid fraud and/or drug dealer liability statutes and/or common law claims for public nuisance, fraud/misrepresentation, strict liability, negligence and/or unjust enrichment. The claims are generally based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid medications and/or an alleged failure to take adequate steps to prevent abuse and diversion. Plaintiffs generally seek declaratory and/or injunctive relief; compensatory, punitive and/or treble damages; restitution, disgorgement, civil penalties, abatement, attorneys’ fees, costs and/or other relief.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Such matters could have a
material adverse effect on our business, financial condition, results of operations and cash flows
.
In addition to the lawsuits described above, the Company and/or its subsidiaries have received certain subpoenas, civil investigative demands (CIDs) and informal requests for information concerning the sale, marketing and/or distribution of prescription opioid medications, including the following:
Various state attorneys general have served subpoenas and/or CIDs on EHSI and/or EPI. We are cooperating with these investigations.
In January 2018, our subsidiary EPI received a federal grand jury subpoena from the U.S. District Court for the Southern District of Florida in connection with an investigation being conducted by the U.S. Attorney’s Office for the Southern District of Florida in conjunction with the U.S. Food and Drug Administration (FDA). The subpoena seeks information related to OPANA
®
ER and other oxymorphone products. EPI is cooperating with the investigation.
Similar investigations may be brought by others or the foregoing matters may be expanded or result in litigation. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred. Such matters could have a
material adverse effect on our business, financial condition, results of operations and cash flows
.
Generic Drug Pricing Matters
In December 2014, we received a grand jury subpoena from the Antitrust Division of the DOJ issued by the U.S. District Court for the Eastern District of Pennsylvania addressed to Par Pharmaceuticals. The subpoena requested documents and information focused primarily on product and pricing information relating to the authorized generic version of Lanoxin (digoxin) oral tablets and generic doxycycline products, and on communications with competitors and others regarding those products. We are cooperating with the investigation.
In May 2018, we and our subsidiary PPCI each received a CID from the DOJ in relation to a False Claims Act investigation concerning whether generic pharmaceutical manufacturers engaged in price-fixing and market allocation agreements, paid illegal remuneration and caused the submission of false claims. We are cooperating with the investigation.
Similar investigations may be brought by others or the foregoing matters may be expanded or result in litigation. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred.
Since March 2016, various private plaintiffs and state attorneys general have filed cases against our subsidiary PPI and/or, in some instances, the Company, Generics Bidco I, LLC, DAVA Pharmaceuticals, LLC and/or PPCI, as well as other pharmaceutical manufacturers and, in some instances, other corporate and/or individual defendants, alleging price-fixing and other anticompetitive conduct with respect to generic pharmaceutical products. These cases, which include proposed class actions filed on behalf of direct purchasers, end-payers and indirect purchaser resellers, as well as non-class action suits, have been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Eastern District of Pennsylvania under the caption
In re Generic Pharmaceuticals Pricing Antitrust Litigation
(MDL No. 2724).
The various complaints and amended complaints generally assert claims under federal and/or state antitrust law, state consumer protection statutes and/or state common law, and seek damages, treble damages, civil penalties, disgorgement, declaratory and injunctive relief, costs and attorneys’ fees. Some claims are based on alleged product-specific conspiracies. With respect to our subsidiaries, the allegations in the various complaints focus on amitriptyline, baclofen, digoxin, divalproex ER, doxycycline hyclate, doxycycline monohydrate, nystatin, propranolol and/or zoledronic acid. Other claims allege broader, multiple-product conspiracies involving various combinations of these and/or other products. Under these overarching conspiracy theories, plaintiffs seek to hold all alleged participants in a particular conspiracy jointly and severally liable for all harms caused by the alleged conspiracy, not just harms related to the products manufactured and/or sold by a particular defendant.
In October 2018, the MDL court denied defendants’ motions to dismiss federal antitrust claims relating to digoxin, divalproex ER and doxycycline hyclate, among other products. In February 2019, the MDL court dismissed certain state law claims relating to these same products, but allowed other state law claims relating to those products to proceed. In February 2019, the defendants moved to dismiss plaintiffs’ overarching conspiracy claims; that motion remains pending. The MDL court has also allowed certain discovery.
In May 2019, our subsidiary PPCI received written notice from certain state attorneys general that they intend to assert federal and/or state antitrust and/or consumer protection law claims with respect to additional generic pharmaceutical products. We do not know when or against whom such claims will be filed or the substance of such claims.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred.
Other Antitrust Matters
Beginning in November 2013, multiple direct and indirect purchasers of LIDODERM
®
filed a number of cases against our subsidiary EPI and other pharmaceutical companies generally alleging that they had entered into an anticompetitive agreement to restrain trade through the settlement of patent infringement litigation concerning U.S. Patent No. 5,827,529 (the ‘529 patent) and other patents. The complaints asserted claims under Sections 1 and 2 of the Sherman Act (15 U.S.C. §§ 1, 2), and/or various state antitrust and consumer protection statutes, as well as common law claims, and generally sought damages, treble damages, disgorgement of profits, restitution, injunctive relief and attorneys’ fees. The cases were consolidated and/or coordinated in April 2014 in a federal MDL in the U.S. District Court for the Northern District of California (MDL
No. 2521
). The MDL court certified classes of direct and indirect purchasers in February 2017. EPI settled with certain opt-out retailer plaintiffs in October 2017. In September 2018, the court approved EPI’s settlement with the class plaintiffs and entered judgment dismissing the class cases with prejudice. In connection with the settlements, several indirect purchasers which previously had opted out were permitted to rejoin the class. The class settlement agreements provide for aggregate payments of approximately
$100 million
. As of
May 2, 2019
, EPI had paid approximately
$90 million
of this total, including approximately
$60 million
in 2018 and
$30 million
in the first quarter of 2019. The remaining
$10 million
is included in our accrual for loss contingencies.
Beginning in June 2014, multiple direct and indirect purchasers of OPANA
®
ER filed cases against our subsidiaries EHSI and EPI and other pharmaceutical companies, including Impax Laboratories, LLC (formerly Impax Laboratories, Inc. and referred to herein as Impax) and Penwest Pharmaceuticals Co., which our subsidiary EPI had acquired. Some cases were filed on behalf of putative classes of direct and indirect purchasers, while others were filed on behalf of individual retailers or health care benefit plans. All cases have been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Northern District of Illinois (MDL No. 2580). Plaintiffs generally allege that an agreement reached by EPI and Impax to settle patent infringement litigation concerning multiple patents pertaining to OPANA
®
ER and EPI’s introduction of reformulated OPANA
®
ER violated antitrust laws. The complaints assert claims under Sections 1 and 2 of the Sherman Act, various state antitrust and consumer protection statutes and/or state common law. Plaintiffs generally seek damages, treble damages, disgorgement of profits, restitution, injunctive relief and attorneys’ fees. In February 2016, the MDL court issued orders (i) denying defendants’ motion to dismiss the claims of the direct purchasers, (ii) denying in part and granting in part defendants’ motion to dismiss the claims of the indirect purchasers, but giving them permission to file amended complaints and (iii) granting defendants’ motion to dismiss the complaints filed by certain retailers, but giving them permission to file amended complaints. In response to the MDL court’s orders, the indirect purchasers filed an amended complaint to which the defendants filed a renewed motion to dismiss certain claims, and certain retailers also filed amended complaints. The court has dismissed the indirect purchaser unjust enrichment claims arising under the laws of the states of California, Rhode Island and Illinois. The cases are currently in expert discovery. In March 2019, direct and indirect purchaser plaintiffs filed motions for class certification. We will continue to vigorously defend these matters and to explore other options as appropriate in our best interests.
Beginning in February 2009, the FTC and certain private plaintiffs, including distributors and retailers, filed suit against our subsidiary Par Pharmaceutical Companies, Inc. (since June 2016, Endo Generics Holdings, Inc., and referred to in this Commitments and Contingencies note as EGHI) and other pharmaceutical companies alleging violations of antitrust law arising out of their settlement of certain patent litigation concerning the generic version of AndroGel
®
. Generally, the complaints seek damages, treble damages, equitable relief and attorneys’ fees and costs. The cases have been consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Northern District of Georgia (MDL No. 2084). In September 2012, the MDL court granted summary judgment to defendants on plaintiffs’ claims of sham litigation. In May 2016, plaintiffs representing a putative class of indirect purchasers voluntarily dismissed their claims with prejudice. In February 2017, the FTC voluntarily dismissed its claims against EGHI with prejudice. Claims by certain alleged direct purchasers or their assignees are still pending against EGHI and other defendants. In June 2018, the MDL court granted in part and denied in part various summary judgment and evidentiary motions filed by defendants. In particular, the court rejected
two
of direct purchasers’
three
causation theories, rejected damages claims related to AndroGel
®
1.62% and granted in part a motion seeking to exclude part of plaintiffs’ proposed manufacturing expert’s opinions. The motions were denied in all other respects, and the court denied a motion for reconsideration, or in the alternative leave to file an interlocutory appeal, in October 2018. In July 2018, the district court denied certain plaintiffs’ motion for certification of a direct purchaser class. The MDL court has scheduled trial for February 2020. We will continue to vigorously defend these matters and to explore other options as appropriate in our best interests.
Beginning in May 2018, multiple alleged direct and indirect purchasers filed complaints in the U.S. District Court for the Southern District of New York against PPI, EPI and/or us, as well as others, alleging a conspiracy to delay generic competition and monopolize the market for Exforge
®
(amlodipine/valsartan) and its generic equivalents. Some cases were filed on behalf of putative classes of direct and indirect purchasers; others are non-class action suits. The plaintiffs generally assert claims under Sections 1 and 2 of the Sherman Act, various state antitrust and consumer protection statutes and state common law and seek damages, treble damages, equitable relief and attorneys’ fees and costs. In September 2018, the putative class plaintiffs stipulated to the dismissal without prejudice of their claims against EPI and us, and the retailer plaintiffs later did the same. PPI filed a partial motion to dismiss certain claims in September 2018. We intend to vigorously defend these matters and to explore other options as appropriate in our best interests.
Beginning in February 2018, several alleged indirect purchasers filed proposed class actions against our subsidiary PPI and others alleging a conspiracy to delay generic competition and monopolize the market for Zetia
®
(ezetimibe) and its generic equivalents. The complaints generally asserted claims under Sections 1 and 2 of the Sherman Act, various state antitrust and consumer protection statutes and state common law and seek injunctive relief, damages, treble damages, attorneys’ fees and costs. In June 2018, these and other cases, including proposed direct purchaser class actions in which PPI was not named as a defendant, were consolidated and/or coordinated for pretrial proceedings in a federal MDL pending in the U.S. District Court for the Eastern District of Virginia (MDL No. 2836). In May 2019, the direct purchaser plaintiffs filed a motion seeking leave of court to file an amended consolidated class complaint adding PPI as a defendant in the direct purchaser actions.
In November 2014, EPI received a CID from Florida’s Office of the Attorney General seeking documents and other information concerning EPI’s agreement with Actavis settling the LIDODERM
®
patent litigation, as well as information concerning marketing and sales of LIDODERM
®
. EPI and/or EHSI later received similar CIDs from other states. A CID from Alaska’s Office of the Attorney General in February 2015 included requests for documents and information concerning agreements with Actavis and Impax settling the OPANA
®
ER patent litigation. We are cooperating with these investigations.
In February 2015, EGHI and affiliates received a CID from the Office of the Attorney General for the state of Alaska seeking production of certain documents and information regarding EGHI’s settlement of the AndroGel
®
patent litigation as well as documents produced in the aforementioned litigation filed by the FTC. We are cooperating with this investigation.
Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred.
Securities Litigation
In May 2016, a putative class action entitled
Craig Friedman v. Endo International plc, Rajiv Kanishka Liyanaarchchie de Silva and Suketu P. Upadhyay
was filed in the U.S. District Court for the Southern District of New York by an individual shareholder on behalf of himself and all similarly situated shareholders. In August 2016, the court appointed Steamfitters’ Industry Pension Fund and Steamfitters’ Industry Security Benefit Fund as lead plaintiffs in the action. In October 2016, plaintiffs filed a second amended complaint that, among other things, added Paul Campanelli as a defendant, and we filed a motion to dismiss. In response, and without resolving the motion, the court permitted lead plaintiffs to file a third amended complaint. The amended complaint alleged violations of Sections 10(b) and 20(a) of the Exchange Act based on the Company’s revision of its 2016 earnings guidance and certain disclosures about its generics business, the integration of Par Pharmaceutical Holdings, Inc. and its subsidiaries, certain other alleged business issues and the receipt of a CID from the U.S. Attorney’s Office for the Southern District of New York regarding contracts with pharmacy benefit managers concerning FROVA
®
. Lead plaintiffs sought class certification, damages in an unspecified amount and attorneys’ fees and costs. We filed a motion to dismiss the third amended complaint in December 2016. In January 2018, the court granted our motion and dismissed the case with prejudice. In February 2018, lead plaintiffs filed a motion for relief from the judgment and leave to file a fourth amended complaint; the court denied this motion in April 2018. Lead plaintiffs appealed to the U.S. Court of Appeals for the Second Circuit. In April 2019, the Court of Appeals affirmed the District Court’s decision in full.
In February 2017, a putative class action entitled
Public Employees’ Retirement System of Mississippi v. Endo International plc
was filed in the Court of Common Pleas of Chester County, Pennsylvania by an institutional purchaser of shares in our June 2, 2015 public offering, on behalf of itself and all similarly situated purchasers. The lawsuit alleges violations of Sections 11, 12(a)(2) and 15 of the Securities Act of 1933 against Endo, certain of its current and former directors and officers, and the underwriters who participated in the offering, based on certain disclosures about Endo’s generics business. In March 2017, defendants removed the case to the U.S. District Court for the Eastern District of Pennsylvania. In August 2017, the court remanded the case back to the Chester County Court of Common Pleas. In October 2017, plaintiff filed an amended complaint. In December 2017, defendants filed preliminary objections to the amended complaint. The court denied those preliminary objections in April 2018. Plaintiff filed its motion for class certification in July 2018. In April 2019, the parties informed the court that they had reached a settlement in principle. The settlement in principle would provide the investor class
$50 million
in exchange for a release of their claims; the settlement is subject to court approval. As a result, during the first quarter of 2019, the Company recorded an increase of approximately
$50 million
to its accrual for loss contingencies. As the Company’s insurers have agreed to fund the foregoing settlement, the Company also recorded a corresponding insurance receivable of approximately
$50 million
during the first quarter of 2019, which is included in
Prepaid expenses and other current assets
in the
Condensed Consolidated Balance Sheets
.
In April 2017, a putative class action entitled
Phaedra A. Makris v. Endo International plc, Rajiv Kanishka Liyanaarchchie de Silva and Suketu P. Upadhyay
was
filed in the Superior Court of Justice in Ontario, Canada by an individual shareholder on behalf of herself and similarly-situated Canadian-based investors who purchased Endo’s securities between January 11 and May 5, 2016. The statement of claim generally seeks class certification, declaratory relief, damages, interest and costs based on alleged violations of the Ontario Securities Act. The statement of claim alleges negligent misrepresentations concerning the Company’s revenues, profit margins and earnings per share; its receipt of a subpoena from the state of Connecticut regarding doxycycline hyclate, amitriptyline hydrochloride, doxazosin mesylate, methotrexate sodium and oxybutynin chloride; and the erosion of the Company’s U.S. generic pharmaceuticals business. In January 2019, plaintiff amended her statement of claim to add a claim on behalf of herself and similarly-situated Canadian investors who purchased Endo’s securities between January 11, 2016 and June 8, 2017. This new claim is based on the Company’s decision to remove reformulated OPANA
®
ER from the market.
In August 2017, a putative class action entitled
Bier v. Endo International plc, et al.
was filed in the U.S. District Court for the Eastern District of Pennsylvania by an individual shareholder on behalf of himself and all similarly situated shareholders. The original complaint alleged violations of Section 10(b) and 20(a) of the Exchange Act against Endo and
four
current and former directors and officers, based on the Company’s decision to remove reformulated OPANA
®
ER from the market. In December 2017, the court appointed SEB Investment Management AB lead plaintiff in the action. In February 2018, the lead plaintiff filed an amended complaint, which added claims alleging violations of Sections 11 and 15 of the Securities Act in connection with the June 2015 offering. The amended complaint named the Company, EHSI and
20
current and former directors, officers and employees of Endo as defendants. In April 2018, the defendants moved to dismiss the amended complaint. In December 2018, the court dismissed the plaintiff’s claims against
four
individual defendants, but otherwise denied the motion to dismiss. The case is currently in discovery.
In November 2017, a putative class action entitled
Pelletier v. Endo International plc, Rajiv Kanishka Liyanaarchchie De Silva, Suketu P. Upadhyay and Paul V. Campanelli
was filed in the U.S. District Court for the Eastern District of Pennsylvania by an individual shareholder on behalf of himself and all similarly situated shareholders. The lawsuit alleges violations of Section 10(b) and 20(a) of the Exchange Act relating to the pricing of various generic pharmaceutical products. In June 2018, the court appointed Park Employees’ Annuity and Benefit Fund of Chicago lead plaintiff in the action. In August 2018, the lead plaintiff filed an amended complaint. In September 2018, the defendants moved to dismiss the amended complaint. That motion remains pending.
We will continue to vigorously defend the foregoing matters and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred.
VASOSTRICT
®
Related Matters
In July 2016, Fresenius Kabi USA, LLC (Fresenius) filed a complaint against PPCI and its affiliate Par Sterile Products, LLC (PSP) in the U.S. District Court for the District of New Jersey alleging that Par Pharmaceutical Companies, Inc. and its affiliate engaged in an anticompetitive scheme to exclude competition for PPCI’s VASOSTRICT
®
(vasopressin) product. The complaint alleges violations of Sections 1 and 2 of the Sherman Antitrust Act, as well as state antitrust and common law, based on assertions that PPCI and its affiliate entered into exclusive supply agreements with one or more active pharmaceutical ingredient (API) manufacturers and that, as a result, Fresenius has been unable to obtain vasopressin API in order to file an Abbreviated New Drug Application (ANDA) to obtain FDA approval for its own vasopressin product. Fresenius seeks actual, treble and punitive damages, attorneys’ fees and costs and injunctive relief. In September 2016, PPCI and its affiliate filed a motion to dismiss, which the district court denied in February 2017. The case is currently in discovery.
In August 2017, our subsidiaries PPI and PSP filed a complaint for actual, exemplary and punitive damages, injunctive relief and other relief against QuVa Pharma, Inc. (QuVa), Stuart Hinchen, Peter Jenkins and Mike Rutkowski in the U.S. District Court for the District of New Jersey. The complaint alleges misappropriation in violation of the federal Defend Trade Secrets Act, New Jersey’s Trade Secrets Act and New Jersey common law, as well as unfair competition, breach of contract, breach of fiduciary duty, breach of the duty of loyalty, tortious interference with contractual relations and breach of the duty of confidence in connection with VASOSTRICT
®
, a vasopressin-based cardiopulmonary drug. In November 2017, we filed a motion for preliminary injunction seeking various forms of relief. In January 2018, we filed a first amended complaint adding
four
former employees and
one
former consultant of PSP as defendants and numerous causes of action against some or all of those individuals, including misappropriation under the federal Defend Trade Secrets Act, New Jersey’s Trade Secrets Act and New Jersey common law, as well as breach of contract, breach of the duty of loyalty and breach of the duty of confidence. In March 2018, the court granted in part our motion for preliminary injunction and enjoined QuVa from marketing and releasing its planned vasopressin product through the conclusion of trial. We subsequently deposited a bond to the court’s interest-bearing account to secure the preliminary injunction. Defendants filed a motion asking the court to reconsider the bond amount, which the court denied. Also in March 2018, QuVa and
seven
of the individual defendants filed a motion to dismiss the New Jersey common law claims,
four
of the individual defendants filed a motion to dismiss for lack of personal jurisdiction and
one
of the individuals filed a motion to dismiss the breach of contract claim. In April 2018, another individual defendant filed a motion to dismiss asserting numerous arguments, including lack of personal jurisdiction, improper venue and choice of law. Discovery began in May 2018. Also in May 2018, defendants filed a notice of appeal to the Third Circuit Court of Appeal indicating intent to appeal the court’s preliminary injunction. The parties completed appellate briefing in January 2019. Also in January 2019, the court denied all
four
of defendants’ pending motions to dismiss. In February 2019, the defendants filed their answers and affirmative defenses, and certain defendants also filed counterclaims for defamation, tortious interference with contract, tortious interference with prospective business relations and witness interference. The counterclaims seek actual, exemplary and punitive damages and other relief. In March 2019, we filed a motion to dismiss all of the defendants’ counterclaims. This motion is still pending. In April 2019, the Third Circuit Court of Appeals affirmed the court’s preliminary injunction but remanded for additional fact-finding concerning the duration of the preliminary injunction and, if needed, consideration of the additional trade secrets raised in our motion for preliminary injunction but not addressed by the preliminary injunction order.
In October 2017, Endo Par Innovation Company, LLC (EPIC) and PSP filed a complaint in the U.S. District Court for the District of Columbia challenging the legality of the FDA’s
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
(January 2017) with respect to the listing of vasopressin in Category 1 of the
Interim Policy
. The complaint contends that the
Interim Policy
is unlawful because it is inconsistent with the Federal Food, Drug, and Cosmetic Act, including, but not limited to, Section 503B of that Act. The complaint sought (i) a declaration that FDA’s
Interim Policy
and its listing of vasopressin in Category 1 of the
Interim Policy
are unlawful and (ii) an order enjoining and vacating the
Interim Policy
and the FDA’s listing of vasopressin in Category 1 of the
Interim Policy
. In January 2018, EPIC and PSP agreed to a temporary
60
-day stay of the litigation in light of the FDA’s announcement that forthcoming guidance would address the concerns set forth in the Company’s complaint. In March 2018, the FDA released new draft guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Shortly thereafter, the parties agreed to extend the temporary stay for an additional
180
days. In August 2018, before the
180
-day stay period expired, Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC announced they had commenced bulk compounding of vasopressin, and moved to intervene in EPIC and PSP’s case against the FDA. Later that month, EPIC and PSP invoked their ability to terminate the stay and filed a Motion for Preliminary Injunction. Before responding to the Motion for Preliminary Injunction, the FDA issued a notice containing a proposed finding that there is no clinical need to bulk compound vasopressin under Section 503B in August 2018. In September 2018, the FDA advised EPIC and PSP that it would agree to use its best efforts to finalize the vasopressin clinical need rulemaking by December 31, 2018, if the case were again stayed. EPIC and PSP agreed to the requested stay. In December 2018, the appropriations act that had been funding the DOJ and components of the FDA expired, resulting in a lapse of appropriations; therefore, the FDA moved the court for a further stay of the case until appropriations were restored. The court granted the motion in January 2019, ordering the FDA to file a notification with the court within
three
business days of DOJ operations resuming. After government appropriations were restored, the FDA advised that it would use its best efforts to finalize the vasopressin clinical need determination by March 15, 2019. The FDA finalized the vasopressin clinical need determination on March 4, 2019, finding that because of VASOSTRICT
®
’s availability, there is no clinical need for outsourcing facilities to compound drugs using bulk vasopressin. That same day, Athenex, Inc., Athenex Pharma Solutions, LLC, and Athenex Pharmaceutical Division, LLC filed a complaint in the U.S. District Court for the District of Columbia, challenging the FDA’s clinical need determination for vasopressin. EPIC and PSP intervened as defendants in the action. The parties and the court agreed to an expedited summary judgment briefing, and a hearing on cross-motions for summary judgment was held in April 2019. EPIC and PSP expect a ruling by early summer. EPIC and PSP’s suit against the FDA remains stayed until that ruling issues.
In August 2018, Athenex filed a declaratory judgment action in the U.S. District Court for the Western District of New York, a case styled
Athenex v. Par
, alleging non-infringement and/or invalidity of the patents the Company has listed in the Orange Book in view of VASOSTRICT
®
. The Company moved to dismiss Athenex’s case on multiple grounds in October 2018, which motion was opposed by Athenex in December 2018. The Company responded to this opposition in December 2018. This motion has not yet been decided.
In April 2018, PSP and PPI received a notice letter from Eagle Pharmaceuticals, Inc. (Eagle) advising of the filing by such company of an ANDA for a generic version of VASOSTRICT
®
(vasopressin IV solution (infusion)) 20 units/ml. In May 2018, PSP and PPI received a second notice letter from Eagle advising of the same filing, but adding an additional patent. The Paragraph IV notices refer to U.S. Patent Nos. 9,375,478; 9,687,526; 9,744,209; 9,744,239; 9,750,785; and 9,937,223, which variously cover either vasopressin-containing pharmaceutical compositions or methods of using a vasopressin-containing dosage form to increase blood pressure in humans. In May 2018, PPI, PSP and EPIC filed a lawsuit against Eagle in the U.S. District Court for the District of Delaware within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. In August 2018, Eagle filed an answer and a counterclaim for non-infringement and invalidity of asserted patents. A claim construction hearing is scheduled for May 2019, with a bench trial scheduled for May 2020.
In September 2018, PSP and PPI received a notice letter from Sandoz Inc. (Sandoz) advising of the filing by such company of an ANDA for a generic version of VASOSTRICT
®
(vasopressin IV solution (infusion)) 200 units/10 ml. In October 2018, PPI, PSP and EPIC filed a lawsuit against Sandoz in the U.S. District Court for the District of New Jersey within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. In October 2018, PSP and PPI received an additional notice letter from Sandoz advising of the filing by such company of an ANDA for a generic version of the 20 units/1 ml presentation for VASOSTRICT
®
. In November 2018, the complaint was amended to add a claim for the additional notice letter, within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. The Company continues to vigorously defend its intellectual property.
In November 2018, PSP and PPI received a notice letter from Amphastar Pharmaceuticals, Inc. (Amphastar) advising of the filing by such company of an ANDA for a generic version of VASOSTRICT
®
(vasopressin IV solution (infusion)) 20 units/1 ml. In December 2018, PPI, PSP and EPIC filed a lawsuit against Amphastar in the U.S. District Court for the District of Delaware within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. The Company continues to vigorously defend its intellectual property.
In March 2019, PSP and PPI received a notice letter from Amneal Pharmaceuticals LLC (Amneal) advising of the filing by such company of an ANDA for a generic version of VASOSTRICT
®
(vasopressin IV solution (infusion)) 20 units/1 ml and 200 units/10 ml. In April 2019, PPI, PSP and EPIC filed a lawsuit against Amneal in the U.S. District Court for the District of Delaware within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. The Company continues to vigorously defend its intellectual property.
The Company’s accrual for loss contingencies includes, among other things, an estimated accrual for certain VASOSTRICT
®
-related matters. We will continue to vigorously defend or prosecute the foregoing matters as appropriate, to protect our intellectual property rights, to pursue all available legal and regulatory avenues and to explore other options as appropriate in our best interests. Similar matters may be brought by others or the foregoing matters may be expanded. We are unable to predict the outcome of these matters or to estimate the possible range of any additional losses that could be incurred.
Paragraph IV Certifications on OPANA
®
ER
In August 2014 and October 2014, the U.S. Patent Office issued U.S. Patent Nos. 8,808,737 (the ‘737 patent) and 8,871,779 (the ‘779 patent) respectively, which cover a method of using OPANA
®
ER and a highly pure version of the API of OPANA
®
ER. In November 2014, EPI filed lawsuits against Teva, ThoRx, Actavis, Impax, Ranbaxy, Roxane, Amneal and Sandoz Inc. based on their ANDAs filed against both the INTAC
®
technology and non-INTAC
®
technology versions of OPANA
®
ER. Those lawsuits were filed in the U.S. District Court for the District of Delaware alleging infringement of these new patents, which expire in 2027 and 2029, respectively. On November 17, 2015, the District Court held the ‘737 patent invalid for claiming unpatentable subject matter. That patent has been dismissed from all suits and the suits administratively closed as to that patent, subject to appeal at the end of the case on the ‘779 patent. In July 2016, a
three
-day trial was held in the U.S. District Court for the District of Delaware against Teva and Amneal for infringement of the ‘779 patent. In October 2016, the District Court issued an opinion holding that the defendants infringed the claims of U.S. Patent No. 8,871,779. The opinion also held that the defendants had failed to show that the ‘779 patent was invalid. The District Court issued an order enjoining the defendants from launching their generic products until the expiration of the ‘779 patent in November 2029. A trial for infringement of the ‘779 patent by Actavis was held in February 2017 in the same court (U.S. District Court for the District of Delaware) in front of the same judge. In August 2017, the District Court issued an opinion holding that Actavis infringed the claims of the ‘779 patent and that Actavis had failed to show that the ‘779 patent was invalid. Teva, Amneal and Actavis have appealed these holdings. We have appealed the holding that the ‘737 patent is invalid. A hearing on those appeals took place in December 2018. We are awaiting decisions on the Teva, Amneal and Actavis appeals. On Endo’s appeal, the court ruled in Endo’s favor in April 2019, holding that the ‘737 patent is not invalid for claiming a natural law. Once the remaining appeals are decided, this case will be referred back to the District Court.
We will continue to vigorously defend or prosecute the foregoing matter as appropriate, to protect our intellectual property rights, to pursue all available legal and regulatory avenues and to explore other options as appropriate in our best interests in defense of our intellectual property, including enforcement of the product’s intellectual property rights and approved labeling. We are unable to predict the outcome of these matters or to estimate the possible range of any losses that could be incurred.
Other Proceedings and Investigations
Proceedings similar to those described above may also be brought in the future. Additionally, we are involved in, or have been involved in, arbitrations or various other proceedings that arise from the normal course of our business. We cannot predict the timing or outcome of these other proceedings. Currently, neither we nor our subsidiaries are involved in any other proceedings that we expect to have a material effect on our business, financial condition, results of operations and cash flows.
NOTE 14. OTHER COMPREHENSIVE INCOME (LOSS)
There were
no
tax effects allocated to any component of
Other comprehensive income (loss)
for the
three months ended March 31, 2019 and 2018
. Substantially all of the Company’s