NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
FOR THE
THREE MONTHS
ENDED
MARCH 31, 2018
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 (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the accompanying
Condensed Consolidated Financial Statements
of Endo 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, 2018
and the results of our operations and our cash flows for the periods presented. Operating results for the
three months ended March 31, 2018
are not necessarily indicative of the results that may be expected for the year ending
December 31, 2018
. The year-end Condensed Consolidated Balance Sheet data as of
December 31, 2017
was derived from audited financial statements.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our Consolidated Financial Statements and accompanying notes included in our Annual Report on Form 10-K for the year ended
December 31, 2017
.
Certain prior period amounts have been reclassified to conform to the current period presentation as a result of our fourth-quarter 2017 adoption of Accounting Standards Update (ASU) No. 2016-18
“Statement of Cash Flows (Topic 230) - Restricted Cash”
(ASU 2016-18). The table below presents the effects of ASU 2016-18 on the Company’s Condensed Consolidated Statement of Cash Flows for the
three months ended March 31, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prior to Adoption
|
|
Impact of Adoption
|
|
Subsequent to Adoption
|
Net cash provided by operating activities
|
$
|
167,763
|
|
|
$
|
—
|
|
|
$
|
167,763
|
|
Net cash used in investing activities
|
(7,121
|
)
|
|
(3,864
|
)
|
|
(10,985
|
)
|
Net cash used in financing activities
|
(53,194
|
)
|
|
—
|
|
|
(53,194
|
)
|
Effect of foreign exchange rate
|
1,444
|
|
|
39
|
|
|
1,483
|
|
Movement in cash held for sale
|
(8,553
|
)
|
|
—
|
|
|
(8,553
|
)
|
Net change (1)
|
$
|
100,339
|
|
|
$
|
(3,825
|
)
|
|
$
|
96,514
|
|
Beginning-of-period balance (2)
|
517,250
|
|
|
287,930
|
|
|
805,180
|
|
End-of-period balance (2)
|
$
|
617,589
|
|
|
$
|
284,105
|
|
|
$
|
901,694
|
|
__________
|
|
(1)
|
This line refers to the “Net increase in cash and cash equivalents” prior to the adoption of ASU 2016-18 and the “Net increase in cash, cash equivalents, restricted cash and restricted cash equivalents” after the adoption.
|
|
|
(2)
|
These lines refer to the beginning or end of period amounts of “Cash and cash equivalents” prior to the adoption of ASU 2016-18 and the beginning or end of period amounts of “Cash, cash equivalents, restricted cash and restricted cash equivalents” after the adoption.
|
Additionally, the information in this Quarterly Report on Form 10-Q has been retrospectively recast to reflect the change in reportable segments referenced in
Note 5. Segment Results
.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Significant Accounting Policies Updated since December 31, 2017
Significant changes to our significant accounting policies since December 31, 2017 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 our Annual Report on Form 10-K for the year ended
December 31, 2017
, filed with the Securities and Exchange Commission on February 27, 2018.
Revenue Recognition
. The Company adopted
Accounting Standards Codification Topic 606, Revenue from Contracts with Customers
(ASC 606) on January 1, 2018 using the modified retrospective method for all revenue-generating contracts, including modifications thereto, that were not completed contracts at the date of adoption. For further discussion of the impact of adoption, refer to the “
Recent Accounting Pronouncements Adopted or Otherwise Effective as of
March 31, 2018
” section below. ASC 606 applies to contracts with commercial substance that establish the payment terms and each party’s rights regarding the goods or services to be transferred, to the extent collection of substantially all of the related consideration is probable. Under ASC 606, we recognize revenue for contracts meeting these criteria when (or as) we satisfy our performance obligations for such contracts by transferring control of the underlying promised goods or services to our customers. The amount of revenue we recognize reflects our estimate of the consideration we expect to be entitled to receive, subject to certain constraints, in exchange for such goods or services. This amount is referred to as the transaction price.
Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship product to a customer pursuant to a purchase order and invoice the customer upon shipment. For contracts such as these, revenue is recognized when our contractual performance obligations have been fulfilled and control has been transferred to the customer pursuant to the contract’s terms, which is generally upon delivery to the customer. The amount of revenue we recognize is equal to the fixed amount of the transaction price, adjusted for our estimates of a number of significant variable components including, but not limited to, estimates for chargebacks, rebates, sales incentives and allowances, distribution service agreement (DSA) and other fees for services, returns and allowances. The Company utilizes the expected value method when estimating the amount of variable consideration to include in the transaction price with respect to each of the foregoing variable components and the most likely amount method when estimating the amount of variable consideration to include in the transaction price with respect to future potential milestone payments that do not qualify for the sales- and usage-based royalty exception. Variable consideration is included in the transaction price only to the extent that it is probable that a significant revenue reversal will not occur when the uncertainty associated with the variable consideration is resolved. Payment terms for these types of contracts generally fall within
30
to
90
days of invoicing. Our most significant components of variable consideration are further described below. Our estimates for these components are based on factors such as historical experience, estimated future trends, estimated customer inventory levels, current contract sales terms with our direct and indirect customers and other competitive factors.
Returns and Allowances.
Consistent with industry practice, we maintain a return policy that allows our customers to return product within a specified period of time both subsequent to and, in certain cases, prior to the product’s expiration date. Our return policy generally allows customers to receive credit for expired products within six months prior to expiration and within one year after expiration. Our provision for returns and allowances consists of our estimates for future product returns, pricing adjustments and delivery errors.
Rebates.
Our provision for rebates, sales incentives and other allowances can generally be categorized into the following four types:
|
|
•
|
governmental rebates, including those for Medicaid, Medicare and TRICARE, among others; and
|
We establish contracts with wholesalers, chain stores and indirect customers that provide for rebates, sales incentives, DSA fees and other allowances. Some customers receive rebates upon attaining established sales volumes. Direct rebates are generally rebates paid to direct purchasing customers based on a percentage applied to a direct customer’s purchases from us, including fees paid to wholesalers under our DSAs, as described above. Indirect rebates are rebates paid to indirect customers which have purchased our products from a wholesaler under a contract with us.
We are subject to rebates on sales made under governmental and managed-care pricing programs based on relevant statutes with respect to governmental pricing programs and contractual sales terms with respect to managed-care providers and group purchasing organizations. For example, we are required to provide a
50%
discount on our brand-name drugs to patients who fall within the Medicare Part D coverage gap, also referred to as the donut hole.
We participate in various federal and state government-managed programs whereby discounts and rebates are provided to participating government entities. For example, Medicaid rebates are amounts owed based upon contractual agreements or legal requirements with public sector (Medicaid) benefit providers after the final dispensing of the product by a pharmacy to a benefit plan participant.
Chargebacks.
We market and sell products to both: (i) direct customers including wholesalers, distributors, warehousing pharmacy chains and other direct purchasing groups and (ii) indirect customers including independent pharmacies, non-warehousing chains, managed-care organizations, group purchasing organizations and government entities. We enter into agreements with certain of our indirect customers to establish contract pricing for certain products. These indirect customers then independently select a wholesaler from which to purchase the products at these contracted prices. Alternatively, we may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, we provide credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler’s invoice price. Such credit is called a chargeback.
New Significant Accounting Policies Added since December 31, 2017
Contract Assets and Contract Liabilities
. Contract assets represent the Company’s right to consideration in exchange for goods or services that the Company has transferred to a customer when that right is conditioned on something other than the passage of time including, for example, the entity’s future performance. The Company records revenue and a corresponding contract asset when it fulfills a contractual performance obligation, but must also fulfill one or more additional performance obligations before being entitled to payment. Once the Company’s right to consideration becomes unconditional, the contract asset amount is reclassified as Accounts receivable.
Contract liabilities represent the Company’s obligation to transfer goods or services to a customer. The Company records a contract liability generally upon receipt of consideration in advance of fulfilling one or more of its contractual performance obligations. Upon completing the corresponding performance obligation, the contract liability amount is reversed and revenue is recognized.
Contract assets and liabilities related to rights and obligations arising from a single contract, or a series of contracts combined and accounted for as a single contract, are generally presented on a net basis. Contract assets and liabilities are further described in
Note 9. Contract Assets and Liabilities
.
Recent Accounting Pronouncements
Recently Issued Accounting Pronouncements Not Yet Adopted as of
March 31, 2018
In February 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-02, “
Leases (Topic 842)
” (ASU 2016-02). ASU 2016-02 establishes the principles to report transparent and economically neutral information about the assets and liabilities that arise from leases. This guidance requires lessees to recognize the lease assets and lease liabilities that arise from leases in the statement of financial position and to disclose qualitative and quantitative information about lease transactions, such as information about variable lease payments and options to renew and terminate leases. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is currently evaluating the impact of ASU 2016-02 on the Company’s consolidated results of operations and financial position.
In February 2018, the FASB issued ASU No. 2018-02 “
Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income
” (ASU 2018-02). ASU 2018-02 allows for a reclassification from accumulated other comprehensive income or loss to retained earnings or accumulated deficit for stranded tax effects resulting from the Tax Cuts and Jobs Act of 2017 (TCJA). ASU 2018-02 also requires certain related disclosures. ASU 2018-02 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2018 and should be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the U.S. federal corporate income tax rate in the TCJA is recognized. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2018-02 on the Company’s consolidated results of operations and financial position.
Recent Accounting Pronouncements Adopted or Otherwise Effective as of
March 31, 2018
In May 2014, the FASB issued ASU No. 2014-09,
“Revenue from Contracts with Customers”
(ASU 2014-09), which was subsequently amended and supplemented by several additional ASUs including:
|
|
•
|
ASU No. 2015-14, “
Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date,”
(issued in August 2015), which deferred the effective date of ASU 2014-09 by one year, such that ASU 2014-09 became effective for Endo for annual and interim reporting periods beginning after December 15, 2017;
|
|
|
•
|
ASU No. 2016-08,
“Revenue from Contracts with Customers (Topic 606): Principal versus Agent Consideration (Reporting Revenue Gross versus Net)”
(issued in March 2016)
,
which clarified the guidance on reporting revenue as a principal versus agent;
|
|
|
•
|
ASU No. 2016-10,
“Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing”
(issued in April 2016)
,
which clarified the guidance on identifying performance obligations and accounting for intellectual property licenses; and
|
|
|
•
|
ASU No. 2016-12,
“Revenue from Contracts with Customers (Topic 606):
Narrow-Scope Improvements and Practical Expedients”
and ASU No. 2016-20,
“Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers,”
(issued in May 2016 and December 2016, respectively), which amended certain narrow aspects of Topic 606.
|
These ASUs have generally been codified in Accounting Standards Codification Topic 606 “
Revenue from Contracts with Customers
”, and are collectively referred to herein as ASC 606. ASC 606 supersedes the revenue recognition requirements in Topic 605
“Revenue Recognition”
(ASC 605), and requires entities to recognize revenue when control of promised goods or services is transferred to customers at an amount that reflects the consideration to which entities expect to be entitled in exchange for those goods or services.
The Company adopted ASC 606 on January 1, 2018 using the modified retrospective method for all revenue-generating contracts, including modifications thereto, that were not completed contracts at the date of adoption. Under the modified retrospective method, results beginning on January 1, 2018 are presented under ASC 606, while the comparative prior period results continue to be presented under ASC 605 based on the accounting standards originally in effect for such periods. As a result of adopting ASC 606, the Company recorded a net decrease of
$3.1 million
to its accumulated deficit at January 1, 2018, representing the cumulative impact of adopting ASC 606.
The current period impact of adoption on our
Condensed Consolidated Statements of Operations
and
Condensed Consolidated Balance Sheets
is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2018
|
Statement of Operations:
|
Amounts reported under ASC 606
|
|
Amounts assuming continued application of ASC 605
|
|
Effect of adoption of ASC 606 (1)
|
Total revenues
|
$
|
700,527
|
|
|
$
|
702,674
|
|
|
$
|
(2,147
|
)
|
Cost of revenues
|
$
|
403,598
|
|
|
$
|
405,326
|
|
|
$
|
(1,728
|
)
|
Loss from continuing operations
|
$
|
(497,738
|
)
|
|
$
|
(497,319
|
)
|
|
$
|
(419
|
)
|
Net loss
|
$
|
(505,489
|
)
|
|
$
|
(505,070
|
)
|
|
$
|
(419
|
)
|
Net loss per share—Basic:
|
|
|
|
|
|
Continuing operations
|
$
|
(2.23
|
)
|
|
$
|
(2.22
|
)
|
|
$
|
—
|
|
Total basic
|
$
|
(2.26
|
)
|
|
$
|
(2.26
|
)
|
|
$
|
—
|
|
Net loss per share—Diluted:
|
|
|
|
|
|
Continuing operations
|
$
|
(2.23
|
)
|
|
$
|
(2.22
|
)
|
|
$
|
—
|
|
Total diluted
|
$
|
(2.26
|
)
|
|
$
|
(2.26
|
)
|
|
$
|
—
|
|
__________
|
|
(1)
|
Amounts may not add due to rounding.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At March 31, 2018
|
Balance Sheet:
|
Amounts reported under ASC 606
|
|
Amounts assuming continued application of ASC 605
|
|
Effect of adoption of ASC 606
|
Assets:
|
|
|
|
|
|
Inventories, net
|
$
|
376,650
|
|
|
$
|
383,603
|
|
|
$
|
(6,953
|
)
|
Prepaid expenses and other current assets
|
$
|
46,734
|
|
|
$
|
38,446
|
|
|
$
|
8,288
|
|
Other assets
|
$
|
51,205
|
|
|
$
|
50,193
|
|
|
$
|
1,012
|
|
Liabilities:
|
|
|
|
|
|
Accounts payable and accrued expenses
|
$
|
953,195
|
|
|
$
|
953,505
|
|
|
$
|
(310
|
)
|
Shareholders' (defici
t) equity:
|
|
|
|
|
|
Accumulated deficit
|
$
|
(8,598,952
|
)
|
|
$
|
(8,601,609
|
)
|
|
$
|
2,657
|
|
In May 2017, the FASB issued ASU No. 2017-09
“Compensation - Stock Compensation”
(ASU 2017-09). ASU 2017-09 provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. It is intended to reduce both (1) diversity in practice and (2) cost and complexity when accounting for changes to the terms or conditions of share-based payment awards. ASU 2017-09 is effective for annual periods, and interim periods within those annual periods, beginning after December 15, 2017. The Company adopted the new standard on January 1, 2018 and the amendments in this update will be applied prospectively to any award modified on or after the adoption date.
NOTE 3. DISCONTINUED OPERATIONS AND DIVESTITURES
Astora
The Company’s Astora business ceased business operations on March 31, 2016. The operating results of Astora 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, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Litigation-related and other contingencies, net
|
$
|
—
|
|
|
$
|
210
|
|
Loss from discontinued operations before income taxes
|
$
|
(7,751
|
)
|
|
$
|
(12,897
|
)
|
Income tax benefit
|
$
|
—
|
|
|
$
|
(4,492
|
)
|
Discontinued operations, net of tax
|
$
|
(7,751
|
)
|
|
$
|
(8,405
|
)
|
The cash flows from discontinued operating activities related to Astora included the impact of net losses of
$7.8 million
and
$8.4 million
for the
three months ended March 31, 2018 and 2017
, respectively, and the impact of cash activity related to vaginal mesh cases, which is further described in
Note 12. Commitments and Contingencies
. There was
no
net cash used in discontinued investing activities related to Astora during the
three months ended March 31, 2018
or
2017
. There was
no
depreciation or amortization during the
three months ended March 31, 2018
or
2017
related to Astora.
Litha
During the fourth quarter of 2016, the Company initiated a process to sell its Litha Healthcare Group Limited and related Sub-Sahara African business assets (Litha) and, on February 27, 2017, the Company entered into a definitive agreement to sell Litha to Acino Pharma AG (Acino). The sale closed on July 3, 2017 and the Company received net cash proceeds of approximately
$94.2 million
, after giving effect to cash and net working capital purchase price adjustments, as well as a short-term receivable of
$4.4 million
, which was subsequently collected in October 2017.
No
additional gain or loss was recognized upon sale. However, in December 2017, Acino became obligated to pay
$10.1 million
of additional consideration to the Company related to the settlement of certain contingencies set forth in the purchase agreement, which was subsequently paid to the Company in January 2018. In December 2017, the Company recorded a short-term receivable and a gain on the sale of Litha for this amount. The gain was recorded in
Other income, net
in the
Condensed Consolidated Statements of Operations
. The purchase agreement contains an additional contingency that could result in a decrease in the purchase price of up to
$26 million
as a result of additional payments to Acino, which would result in a loss on the sale. This contingency is expected to be resolved by June 30, 2018. Litha was part of the Company’s
International Pharmaceuticals
segment. Litha does not meet the requirements for treatment as a discontinued operation.
Somar
On June 30, 2017, the Company entered into a definitive agreement to sell Grupo Farmacéutico Somar, S.A.P.I. de C.V. (Somar) and all of the securities thereof, to AI Global Investments (Netherlands) PCC Limited acting for and on behalf of the Soar Cell (the Purchaser). The sale closed on October 25, 2017 and the Purchaser paid an aggregate purchase price of approximately
$124 million
in cash, after giving effect to estimated cash, debt and net working capital purchase price adjustments. The Company recognized a
$1.3 million
loss upon sale. Somar was part of the Company’s
International Pharmaceuticals
segment. Somar does not meet the requirements for treatment as a discontinued operation.
NOTE 4. RESTRUCTURING
January 2017 Restructuring Initiative
On January 26, 2017, the Company announced a restructuring initiative implemented as part of its ongoing organizational review (the
January 2017 Restructuring Initiative
). This restructuring was intended to further integrate, streamline and optimize the Company’s operations by aligning certain corporate and research and development (R&D) functions with its recently restructured U.S. generics and U.S. branded business units in order to create efficiencies and cost savings. As part of this restructuring, the Company undertook certain cost reduction initiatives, including a reduction of approximately
90
positions of its workforce, primarily related to corporate and branded R&D functions in Malvern, Pennsylvania and Chestnut Ridge, New York, a streamlining of general and administrative expenses, an optimization of commercial spend and a refocusing of research and development efforts.
The Company did not incur any pre-tax charges during the
three months ended March 31, 2018
as a result of the
January 2017 Restructuring Initiative
. During the
three months ended March 31, 2017
, the Company incurred total pre-tax charges of approximately
$15.5 million
related to employee separation and other benefit-related costs. Of the total charges incurred,
$6.9 million
are included in the
U.S. Branded - Specialty & Established Pharmaceuticals
segment,
$5.2 million
are included in Corporate unallocated costs and
$3.4 million
are included in the
U.S. Generic Pharmaceuticals
segment. These charges are included in
Selling, general and administrative
expenses in the
Condensed Consolidated Statements of Operations
. The Company does not expect to incur additional material pre-tax restructuring-related expenses related to this initiative. Substantially all cash payments were made by the end of 2017 and substantially all of the actions associated with this restructuring were completed by the end of April 2017.
2017 U.S. Generic Pharmaceuticals Restructuring Initiative
On July 21, 2017, the Company announced that after completing a comprehensive review of its manufacturing network, the Company would be ceasing operations and closing its manufacturing and distribution facilities in Huntsville, Alabama (the
2017 U.S. Generic Pharmaceuticals Restructuring Initiative
). The closure of the facilities is expected to occur by the end of 2018. Employee separation, retention and certain other employee benefit-related costs are expensed ratably over the requisite service period. Other costs including, but not limited to, contract termination fees and product technology transfer costs, are expensed as incurred.
As a result of the
2017 U.S. 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
U.S. Generic Pharmaceuticals
segment. Accelerated depreciation and employee separation, retention and other benefit-related costs are included in Cost of revenues. 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 expects to incur approximately
$22 million
of additional pre-tax restructuring-related expenses related to this initiative, which primarily relate to accelerated depreciation and employee separation, retention and other benefit-related costs. Substantially all cash payments are expected to be made by the end of the third quarter in 2019.
The liability related to the
2017 U.S. 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, 2018
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Separation and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
Liability balance as of January 1, 2018
|
$
|
22,975
|
|
|
$
|
1,610
|
|
|
$
|
24,585
|
|
Expenses
|
3,812
|
|
|
1,134
|
|
|
4,946
|
|
Cash distributions
|
(8,767
|
)
|
|
(2,744
|
)
|
|
(11,511
|
)
|
Liability balance as of March 31, 2018
|
$
|
18,020
|
|
|
$
|
—
|
|
|
$
|
18,020
|
|
January 2018 Restructuring Initiative
In January 2018, the Company initiated a restructuring initiative that included a reorganization of its
U.S. 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 expects total related pre-tax charges of approximately
$28 million
, including total estimated cash outlays of approximately
$26 million
, substantially all of which will be paid by March 31, 2019. The estimated restructuring charges consist of employee separation, retention and other benefit-related costs of approximately
$24 million
and certain other charges of approximately
$4 million
. Employee separation, retention and certain other employee benefit-related costs are expensed ratably over the requisite service period. Other costs are expensed as incurred.
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
U.S. Generic Pharmaceuticals
segment,
$5.2 million
are included in Corporate unallocated costs,
$3.8 million
are included in the
U.S. Branded - Sterile Injectables
segment,
$3.0 million
are included in the
International Pharmaceuticals
segment and
$0.7 million
are included in the
U.S. Branded - Specialty & Established 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 does not expect to incur additional material pre-tax restructuring-related expenses related to this initiative. Substantially all cash payments are expected to be made by the end of the first quarter in 2019.
The liability related to the
January 2018 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, 2018
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Separation and Other Benefit-Related Costs
|
|
Other Restructuring Costs
|
|
Total
|
Liability balance as of January 1, 2018
|
$
|
—
|
|
|
$
|
650
|
|
|
$
|
650
|
|
Expenses
|
21,897
|
|
|
1,298
|
|
|
23,195
|
|
Cash distributions
|
(4,783
|
)
|
|
(54
|
)
|
|
(4,837
|
)
|
Liability balance as of March 31, 2018
|
$
|
17,114
|
|
|
$
|
1,894
|
|
|
$
|
19,008
|
|
NOTE 5. SEGMENT RESULTS
As of January 1, 2018, we made changes to our reportable segments. Following these changes, the
four
reportable business segments in which we operate are: (1)
U.S. Branded - Specialty & Established Pharmaceuticals
, (2)
U.S. Branded - Sterile Injectables
, (3)
U.S. Generic Pharmaceuticals
and (4)
International Pharmaceuticals
. Previously, we had
three
reportable segments: (1) U.S. Generic Pharmaceuticals, (2) U.S. Branded Pharmaceuticals and (3) International Pharmaceuticals. The updates to our reportable segments were made based on first quarter 2018 changes to the way we manage and evaluate our business.
Our new
U.S. Branded - Sterile Injectables
segment consists of our sterile injectables product portfolio, which was previously part of our former U.S. Generic Pharmaceuticals segment. Our new
U.S. Generic Pharmaceuticals
segment represents the remainder of our former U.S. Generic Pharmaceuticals segment. Additionally, our former U.S. Branded Pharmaceuticals segment has been renamed “
U.S. Branded - Specialty & Established Pharmaceuticals
.”
Our 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, earn-out payments or adjustments, changes in the fair value of contingent consideration and bridge financing costs; cost reduction and integration-related initiatives such as separation benefits, retention payments, other exit costs and certain costs associated with integrating an acquired company’s operations; asset impairment charges; amortization of intangible assets; inventory step-up recorded as part of our acquisitions; certain non-cash interest expense; litigation-related and other contingent matters; gains or losses from early termination of debt; foreign currency gains or losses on intercompany financing arrangements; and certain other items
.
Certain of the corporate expenses incurred by the Company are not attributable to any specific segment. Accordingly, these costs are not allocated to any of the Company’s segments and are included in the results below as “Corporate unallocated 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.
U.S. Branded - Specialty & Established Pharmaceuticals
Our
U.S. Branded - Specialty & Established 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, TESTOPEL
®
, NASCOBAL
®
Nasal Spray, AVEED
®
, PERCOCET
®
, VOLTAREN
®
Gel, LIDODERM
®
, OPANA
®
ER, TESTIM
®
and FORTESTA
®
Gel, among others.
U.S. Branded - Sterile Injectables
Our
U.S. Branded - 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 ephedrine sulfate injection and neostigmine methylsulfate injection, among others.
U.S. Generic Pharmaceuticals
Our
U.S. Generic Pharmaceuticals
segment consists of a differentiated product portfolio including solid oral extended-release, solid oral immediate-release, abuse-deterrent products, 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 (ADHD), pain, women’s health and oncology.
This segment also included: (i) our South African Litha business, which was sold in July 2017
,
and (ii) our Latin American Somar business, which was sold in October 2017.
The following represents selected information for the Company’s reportable segments for the
three months ended March 31, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Net revenues from external customers:
|
|
|
|
U.S. Branded - Specialty & Established Pharmaceuticals
|
$
|
200,235
|
|
|
$
|
250,159
|
|
U.S. Branded - Sterile Injectables
|
215,854
|
|
|
172,168
|
|
U.S. Generic Pharmaceuticals
|
249,240
|
|
|
549,815
|
|
International Pharmaceuticals (1)
|
35,198
|
|
|
65,458
|
|
Total net revenues from external customers
|
$
|
700,527
|
|
|
$
|
1,037,600
|
|
Adjusted income from continuing operations before income tax:
|
|
|
|
U.S. Branded - Specialty & Established Pharmaceuticals
|
$
|
93,814
|
|
|
$
|
129,492
|
|
U.S. Branded - Sterile Injectables
|
169,445
|
|
|
126,467
|
|
U.S. Generic Pharmaceuticals
|
74,280
|
|
|
215,132
|
|
International Pharmaceuticals
|
13,718
|
|
|
14,882
|
|
Total segment adjusted income from continuing operations before income tax
|
$
|
351,257
|
|
|
$
|
485,973
|
|
__________
|
|
(1)
|
Revenues generated by our
International Pharmaceuticals
segment are primarily attributable to external customers located in Canada and, prior to the sale of Litha on July 3, 2017 and Somar on October 25, 2017, South Africa and Latin America.
|
There were
no
material revenues from external customers attributed to an individual country outside of the United States during any of the periods presented. There were
no
material tangible long-lived assets in an individual country other than the United States as of
March 31, 2018
or
December 31, 2017
.
The table below provides reconciliations of our consolidated
Loss from continuing operations before income tax
, which is determined in accordance with U.S. generally accepted accounting principles (U.S. GAAP), to our
total segment adjusted income from continuing operations before income tax
for the
three months ended March 31, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Total consolidated loss from continuing operations before income tax
|
$
|
(482,247
|
)
|
|
$
|
(177,351
|
)
|
Interest expense, net
|
123,990
|
|
|
111,999
|
|
Corporate unallocated costs (1)
|
52,460
|
|
|
47,468
|
|
Amortization of intangible assets
|
157,172
|
|
|
263,134
|
|
Inventory step-up
|
66
|
|
|
115
|
|
Upfront and milestone payments to partners
|
1,332
|
|
|
3,095
|
|
Separation benefits and other cost reduction initiatives (2)
|
48,987
|
|
|
22,670
|
|
Certain litigation-related and other contingencies, net (3)
|
(2,500
|
)
|
|
936
|
|
Asset impairment charges (4)
|
448,416
|
|
|
203,962
|
|
Acquisition-related and integration items (5)
|
6,835
|
|
|
10,880
|
|
Foreign currency impact related to the remeasurement of intercompany debt instruments
|
(2,514
|
)
|
|
(2,694
|
)
|
Other, net
|
(740
|
)
|
|
1,759
|
|
Total segment adjusted income from continuing operations before income tax
|
$
|
351,257
|
|
|
$
|
485,973
|
|
__________
|
|
(1)
|
Amounts include certain corporate overhead costs, such as headcount and facility expenses and certain other income and expenses.
|
|
|
(2)
|
Amounts primarily relate to employee separation costs of
$25.2 million
and
$20.8 million
for the
three months ended March 31, 2018 and 2017
, respectively. Other amounts for the
three months ended March 31, 2018
include accelerated depreciation of
$17.1 million
, charges to increase excess inventory reserves of
$2.4 million
and other charges of
$4.3 million
, each of which related primarily to our restructuring initiatives. During the
three months ended March 31, 2017
there were other restructuring costs of
$1.9 million
. 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 12. Commitments and Contingencies
.
|
|
|
(4)
|
Amounts primarily relate to charges to impair goodwill and intangible assets as further described in
Note 8. Goodwill and Other Intangibles
as well as charges to write down certain property, plant and equipment as further described in
Note 6. Fair Value Measurements
.
|
|
|
(5)
|
During the
three months ended March 31, 2018 and 2017
, there were
charges
due to changes in the fair value of contingent consideration of
$6.8 million
and
$6.2 million
, respectively. Additionally, during the
three months ended March 31, 2017
there were costs directly associated with previous acquisitions of
$4.7 million
.
|
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,
|
|
2018
|
|
2017
|
U.S. Branded - Specialty & Established Pharmaceuticals:
|
|
|
|
Specialty Products:
|
|
|
|
XIAFLEX®
|
$
|
57,141
|
|
|
$
|
49,525
|
|
SUPPRELIN® LA
|
20,577
|
|
|
19,181
|
|
Other Specialty (1)
|
34,197
|
|
|
36,028
|
|
Total Specialty Products
|
$
|
111,915
|
|
|
$
|
104,734
|
|
Established Products:
|
|
|
|
PERCOCET®
|
$
|
31,976
|
|
|
$
|
30,945
|
|
VOLTAREN® Gel
|
11,317
|
|
|
14,274
|
|
OPANA® ER
|
—
|
|
|
35,718
|
|
Other Established (2)
|
45,027
|
|
|
64,488
|
|
Total Established Products
|
$
|
88,320
|
|
|
$
|
145,425
|
|
Total U.S. Branded - Specialty & Established Pharmaceuticals (3)
|
$
|
200,235
|
|
|
$
|
250,159
|
|
U.S. Branded - Sterile Injectables:
|
|
|
|
VASOSTRICT®
|
$
|
113,725
|
|
|
$
|
99,158
|
|
ADRENALIN®
|
29,740
|
|
|
6,097
|
|
Other Sterile Injectables (4)
|
72,389
|
|
|
66,913
|
|
Total U.S. Branded - Sterile Injectables (3)
|
$
|
215,854
|
|
|
$
|
172,168
|
|
Total U.S. Generic Pharmaceuticals (5)
|
$
|
249,240
|
|
|
$
|
549,815
|
|
Total International Pharmaceuticals (6)
|
$
|
35,198
|
|
|
$
|
65,458
|
|
Total Revenues
|
$
|
700,527
|
|
|
$
|
1,037,600
|
|
__________
|
|
(1)
|
Products included within Other Specialty include TESTOPEL
®
, NASCOBAL
®
Nasal Spray and AVEED
®
.
|
|
|
(2)
|
Products included within Other Established include, but are not limited to, LIDODERM
®
, TESTIM
®
and FORTESTA
®
Gel, including the authorized generics.
|
|
|
(3)
|
Individual products presented above represent the top two performing products in each product category and/or any product having revenues in excess of
$25 million
during any quarterly period in
2018
or
2017
.
|
|
|
(4)
|
Products included within Other Sterile Injectables include, but are not limited to, APLISOL
®
, ephedrine sulfate injection and neostigmine methylsulfate injection.
|
|
|
(5)
|
The U.S. 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, 2017, combined sales of ezetimibe tablets and quetiapine ER tablets, for which we lost temporary marketing exclusivity during the second quarter of 2017, made up
19%
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
5%
and
6%
of consolidated total revenues during the three months ended March 31, 2018 and 2017, respectively, 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 also included: (i) our South African business, which was sold in July 2017 and consisted of Litha and certain assets acquired from Aspen Holdings in October 2015 and (ii) our Latin American business consisting of Somar, which was sold in October 2017.
|
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 and time deposits), 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 and time deposits), accounts receivable, accounts payable and accrued expenses approximate their fair values.
At
March 31, 2018
and
December 31, 2017
, the Company had combined restricted cash and cash equivalents of
$339.8 million
and
$324.4 million
, respectively, of which
$335.9 million
and
$320.5 million
, respectively, are classified as current assets and reported in our
Condensed Consolidated Balance Sheets
as Restricted cash and cash equivalents. The remaining amounts, which are classified as non-current assets, are reported in our
Condensed Consolidated Balance Sheets
as Other assets. Approximately
$330.0 million
and
$313.8 million
of our restricted cash and cash equivalents are held in qualified settlement funds (QSFs) for mesh-related matters at
March 31, 2018
and
December 31, 2017
, respectively. See
Note 12. Commitments and Contingencies
for further information relating to the vaginal mesh liability.
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 non-current assets. Equity securities are included in
Marketable securities
in our
Condensed Consolidated Balance Sheets
at
March 31, 2018
and
December 31, 2017
.
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 the inputs may result in a significant adjustment 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, 2018
and
December 31, 2017
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
March 31, 2018
|
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
|
$
|
692,745
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
692,745
|
|
Time deposits
|
—
|
|
|
209,820
|
|
|
—
|
|
|
209,820
|
|
Equity securities
|
3,294
|
|
|
—
|
|
|
—
|
|
|
3,294
|
|
Total
|
$
|
696,039
|
|
|
$
|
209,820
|
|
|
$
|
—
|
|
|
$
|
905,859
|
|
Liabilities:
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
55,537
|
|
|
$
|
55,537
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
113,750
|
|
|
113,750
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
169,287
|
|
|
$
|
169,287
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
December 31, 2017
|
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
|
$
|
439,831
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
439,831
|
|
Time deposits
|
—
|
|
|
303,410
|
|
|
—
|
|
|
303,410
|
|
Equity securities
|
1,456
|
|
|
—
|
|
|
—
|
|
|
1,456
|
|
Total
|
$
|
441,287
|
|
|
$
|
303,410
|
|
|
$
|
—
|
|
|
$
|
744,697
|
|
Liabilities:
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration—short-term
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
70,543
|
|
|
$
|
70,543
|
|
Acquisition-related contingent consideration—long-term
|
—
|
|
|
—
|
|
|
119,899
|
|
|
119,899
|
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
190,442
|
|
|
$
|
190,442
|
|
At
March 31, 2018
and
December 31, 2017
, money market funds include
$58.3 million
and
$35.6 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 12. Commitments and Contingencies
for further discussion of our product liability cases. The differences between the amortized cost and fair value of our money market funds and equity securities were not material, individually or in the aggregate, at
March 31, 2018
or
December 31, 2017
, nor were any of the related gross unrealized gains or losses.
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, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Beginning of period
|
$
|
190,442
|
|
|
$
|
262,113
|
|
Amounts settled
|
(27,767
|
)
|
|
(34,091
|
)
|
Changes in fair value recorded in earnings
|
6,835
|
|
|
6,184
|
|
Effect of currency translation
|
(223
|
)
|
|
185
|
|
End of period
|
$
|
169,287
|
|
|
$
|
234,391
|
|
At
March 31, 2018
, the fair value measurements of the contingent consideration obligations were determined using risk-adjusted discount rates ranging from
10%
to
22%
(weighted average rate of approximately
15%
).
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
, and amounts recorded for the short-term and long-term 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, 2018
by acquisition (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2017
|
|
Fair Value Adjustments and Accretion
|
|
Payments and Other
|
|
Balance as of March 31, 2018
|
Auxilium acquisition
|
$
|
13,061
|
|
|
$
|
58
|
|
|
$
|
(1,844
|
)
|
|
$
|
11,275
|
|
Lehigh Valley Technologies, Inc. acquisitions
|
63,001
|
|
|
(1,576
|
)
|
|
(15,024
|
)
|
|
46,401
|
|
VOLTAREN
®
Gel acquisition
|
98,124
|
|
|
8,147
|
|
|
(10,623
|
)
|
|
95,648
|
|
Other
|
16,256
|
|
|
206
|
|
|
(499
|
)
|
|
15,963
|
|
Total
|
$
|
190,442
|
|
|
$
|
6,835
|
|
|
$
|
(27,990
|
)
|
|
$
|
169,287
|
|
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, 2018
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date using:
|
|
Total Expense for the Three Months Ended March 31, 2018
|
|
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 8)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
178,142
|
|
|
$
|
(54,200
|
)
|
Certain property, plant and equipment (1)
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,216
|
)
|
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
178,142
|
|
|
$
|
(57,416
|
)
|
__________
|
|
(1)
|
Amount includes
$2.6 million
related to the
2017 U.S. Generic Pharmaceuticals Restructuring Initiative
, which is described further in
Note 4. Restructuring
.
|
Additionally, the Company recorded aggregate goodwill impairment charges during the
three months ended March 31, 2018
of
$391.0 million
. Refer to
Note 8. Goodwill and Other Intangibles
for further description, including the valuation methodologies utilized.
NOTE 7. INVENTORIES
Inventories consist of the following at
March 31, 2018
and December 31,
2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
Raw materials (1)
|
$
|
124,420
|
|
|
$
|
124,685
|
|
Work-in-process (1)
|
93,000
|
|
|
109,897
|
|
Finished goods (1)
|
159,230
|
|
|
156,855
|
|
Total
|
$
|
376,650
|
|
|
$
|
391,437
|
|
__________
(1) The components of inventory shown in the table above are net of allowance for obsolescence.
Inventory that is in excess of the amount expected to be sold within one year, which relates primarily to XIAFLEX
®
inventory, is classified as long-term inventory and is not included in the table above. At
March 31, 2018
and
December 31, 2017
,
$18.4 million
and
$17.1 million
, respectively, of long-term inventory was included in Other assets in the
Condensed Consolidated Balance Sheets
. As of
March 31, 2018
and
December 31, 2017
, the Company’s
Condensed Consolidated Balance Sheets
included approximately
$7.9 million
and
$5.9 million
, respectively, of capitalized pre-launch inventories related to generic products that were not yet available to be sold.
NOTE 8. GOODWILL AND OTHER INTANGIBLES
Goodwill
Changes in the carrying amount of our goodwill for the
three months ended March 31, 2018
were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Branded - Specialty & Established Pharmaceuticals
|
|
U.S. Branded - Sterile Injectables
|
|
U.S. Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
Goodwill as of December 31, 2017
|
$
|
828,818
|
|
|
$
|
—
|
|
|
$
|
3,531,301
|
|
|
$
|
89,963
|
|
|
$
|
4,450,082
|
|
Allocation to current segments (1)
|
—
|
|
|
2,731,193
|
|
|
(2,731,193
|
)
|
|
—
|
|
|
—
|
|
Effect of currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,228
|
)
|
|
(2,228
|
)
|
Goodwill impairment charges
|
—
|
|
|
—
|
|
|
(391,000
|
)
|
|
—
|
|
|
(391,000
|
)
|
Goodwill as of March 31, 2018
|
$
|
828,818
|
|
|
$
|
2,731,193
|
|
|
$
|
409,108
|
|
|
$
|
87,735
|
|
|
$
|
4,056,854
|
|
__________
|
|
(1)
|
This allocation relates to the change in segments described in
Note 5. Segment Results
. The amount of goodwill initially attributed to the new
U.S. Branded - Sterile Injectables
and
U.S. Generic Pharmaceuticals
segments was determined using a relative fair value methodology in accordance with U.S. GAAP.
|
The carrying amounts of goodwill at
March 31, 2018
and December 31,
2017
are net of the following accumulated impairments (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Branded - Specialty & Established Pharmaceuticals
|
|
U.S. Branded - Sterile Injectables
|
|
U.S. Generic Pharmaceuticals
|
|
International Pharmaceuticals
|
|
Total
|
Accumulated impairment losses as of December 31, 2017
|
$
|
855,810
|
|
|
$
|
—
|
|
|
$
|
2,342,549
|
|
|
$
|
463,545
|
|
|
$
|
3,661,904
|
|
Accumulated impairment losses as of March 31, 2018
|
$
|
855,810
|
|
|
$
|
—
|
|
|
$
|
2,733,549
|
|
|
$
|
451,858
|
|
|
$
|
4,041,217
|
|
Other Intangible Assets
Changes in the amount of other intangible assets for the
three months ended March 31, 2018
are set forth in the table below (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost basis:
|
Balance as of December 31, 2017
|
|
Acquisitions
|
|
Impairments
|
|
Effect of Currency Translation
|
|
Balance as of March 31, 2018
|
Indefinite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
$
|
347,200
|
|
|
$
|
—
|
|
|
$
|
(40,600
|
)
|
|
$
|
—
|
|
|
$
|
306,600
|
|
Total indefinite-lived intangibles
|
$
|
347,200
|
|
|
$
|
—
|
|
|
$
|
(40,600
|
)
|
|
$
|
—
|
|
|
$
|
306,600
|
|
Finite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
Licenses (weighted average life of 12 years)
|
$
|
457,402
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
457,402
|
|
Tradenames
|
6,409
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,409
|
|
Developed technology (weighted average life of 11 years)
|
6,187,764
|
|
|
—
|
|
|
(13,600
|
)
|
|
(6,737
|
)
|
|
6,167,427
|
|
Total finite-lived intangibles (weighted average life of 11 years)
|
$
|
6,651,575
|
|
|
$
|
—
|
|
|
$
|
(13,600
|
)
|
|
$
|
(6,737
|
)
|
|
$
|
6,631,238
|
|
Total other intangibles
|
$
|
6,998,775
|
|
|
$
|
—
|
|
|
$
|
(54,200
|
)
|
|
$
|
(6,737
|
)
|
|
$
|
6,937,838
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated amortization:
|
Balance as of December 31, 2017
|
|
Amortization
|
|
Impairments
|
|
Effect of Currency Translation
|
|
Balance as of March 31, 2018
|
Finite-lived intangibles:
|
|
|
|
|
|
|
|
|
|
Licenses
|
$
|
(370,221
|
)
|
|
$
|
(7,087
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(377,308
|
)
|
Tradenames
|
(6,409
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,409
|
)
|
Developed technology
|
(2,304,461
|
)
|
|
(150,085
|
)
|
|
—
|
|
|
3,129
|
|
|
(2,451,417
|
)
|
Total other intangibles
|
$
|
(2,681,091
|
)
|
|
$
|
(157,172
|
)
|
|
$
|
—
|
|
|
$
|
3,129
|
|
|
$
|
(2,835,134
|
)
|
Net other intangibles
|
$
|
4,317,684
|
|
|
|
|
|
|
|
|
$
|
4,102,704
|
|
Amortization expense for the
three months ended March 31, 2018 and 2017
totaled
$157.2 million
and
$263.1 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, 2017 is as follows (in thousands):
|
|
|
|
|
2018
|
$
|
596,239
|
|
2019
|
$
|
504,032
|
|
2020
|
$
|
466,965
|
|
2021
|
$
|
448,867
|
|
2022
|
$
|
435,074
|
|
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
.
A summary of significant goodwill and other intangible asset impairment tests and related charges for the
three months ended March 31, 2018 and 2017
is included below.
Our first quarter 2018 change in segments described in
Note 5. Segment Results
resulted in changes to our reporting units for goodwill impairment testing purposes, including the creation of a new
U.S. Branded - 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
U.S. Branded - Sterile Injectables
and
U.S. 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 (determined using a discount rate of
9.5%
) exceeded its carrying amount, resulting in no related goodwill impairment charge.
|
|
|
•
|
The new
U.S. Branded - Sterile Injectables
reporting unit’s estimated fair value (determined using a discount rate of
9.5%
) exceeded its carrying amount, resulting in no related goodwill impairment charge.
|
|
|
•
|
The new
U.S. Generic Pharmaceuticals
reporting unit’s carrying amount exceeded its estimated fair value (determined using a discount rate of
9.5%
), resulting in a pre-tax non-cash goodwill impairment charge of
$391.0 million
.
|
During the three months ended March 31, 2018, the Company identified certain market conditions impacting the recoverability of certain in-process research and development and developed technology intangible assets. Accordingly, we tested these assets for impairment and determined that their carrying amounts were no longer fully recoverable, resulting in pre-tax, non-cash asset impairment charges totaling
$54.2 million
during the first quarter of 2018.
During the three months ended March 31, 2017, the Company identified certain market conditions impacting the recoverability of certain developed technology intangible assets. Accordingly, we tested these assets for impairment and determined that their carrying amounts were no longer fully recoverable, resulting in pre-tax, non-cash asset impairment charges totaling
$72.7 million
during the first quarter of 2017.
Pursuant to an existing agreement with a wholly owned subsidiary of Novartis AG (Novartis), Paladin licensed the Canadian rights to commercialize serelaxin, an investigational drug for the treatment of acute heart failure (AHF). In March 2017, Novartis announced that a Phase 3 study of serelaxin in patients with AHF failed to meet its primary endpoints. As a result, we concluded that the full carrying amount of our serelaxin in-process research and development intangible asset was impaired, resulting in a
$45.5 million
pre-tax non-cash impairment charge for the three months ended March 31, 2017.
In addition and as a result of the serelaxin impairment discussed above, we assessed the recoverability of our Paladin goodwill balance and determined that the estimated fair value of the Paladin reporting unit was below its carrying amount. We recorded a pre-tax, non-cash asset impairment charge of
$82.6 million
during the three months ended March 31, 2017 for the amount by which the carrying amount exceeded the reporting unit’s fair value. We estimated the fair value of the Paladin reporting unit using an income approach that utilized a discounted cash flow model.
NOTE 9. CONTRACT ASSETS AND LIABILITIES
Our revenue consists almost entirely of sales of our pharmaceutical products to customers, whereby we ship product 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, 2018
, the unfulfilled performance obligations for these types of contracts relate to ordered but undelivered product. 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, 2018
|
|
January 1, 2018
|
|
$ Change
|
|
% Change
|
Contract assets, net (1)
|
$
|
9,300
|
|
|
$
|
11,287
|
|
|
$
|
(1,987
|
)
|
|
(18
|
)%
|
Contract liabilities, net (2)
|
$
|
20,483
|
|
|
$
|
20,954
|
|
|
$
|
(471
|
)
|
|
(2
|
)%
|
__________
|
|
(1)
|
At
March 31, 2018
and
January 1, 2018
, approximately
$8.3 million
and
$8.2 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 non-current and are included in Other assets. The
decrease
in contract assets during the
three months
ended
March 31, 2018
was primarily due to a reclassification 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.
|
|
|
(2)
|
At
March 31, 2018
and
January 1, 2018
, approximately
$1.8 million
and
$1.9 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 non-current and are included in Other liabilities. During the
three months
ended
March 31, 2018
, the Company recognized revenue of
$0.5 million
that was included in the contract liability balance at
January 1, 2018
, resulting in a corresponding
decrease
in contract liabilities.
|
During the
three months
ended
March 31, 2018
, we recognized
a reduction in revenue
of
$3.3 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 10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses
include the following at
March 31, 2018
and December 31,
2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
Trade accounts payable
|
$
|
87,235
|
|
|
$
|
85,348
|
|
Returns and allowances
|
293,840
|
|
|
291,034
|
|
Rebates
|
131,623
|
|
|
168,333
|
|
Chargebacks
|
6,245
|
|
|
14,604
|
|
Accrued interest
|
64,785
|
|
|
130,257
|
|
Accrued payroll and related benefits
|
79,956
|
|
|
113,908
|
|
Accrued royalties and other distribution partner payables
|
59,607
|
|
|
63,114
|
|
Acquisition-related contingent consideration—short-term
|
55,537
|
|
|
70,543
|
|
Other
|
174,367
|
|
|
159,684
|
|
Total
|
$
|
953,195
|
|
|
$
|
1,096,825
|
|
NOTE 11. DEBT
The following table presents information about the Company’s total indebtedness at
March 31, 2018
and
December 31, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
|
Effective Interest Rate
|
|
Principal Amount
|
|
Carrying Amount
|
|
Effective Interest Rate
|
|
Principal Amount
|
|
Carrying Amount
|
7.25% Senior Notes due 2022
|
7.91
|
%
|
|
$
|
400,000
|
|
|
$
|
391,454
|
|
|
7.91
|
%
|
|
$
|
400,000
|
|
|
$
|
390,974
|
|
5.75% Senior Notes due 2022
|
6.04
|
%
|
|
700,000
|
|
|
693,248
|
|
|
6.04
|
%
|
|
700,000
|
|
|
692,855
|
|
5.375% Senior Notes due 2023
|
5.62
|
%
|
|
750,000
|
|
|
742,388
|
|
|
5.62
|
%
|
|
750,000
|
|
|
742,048
|
|
6.00% Senior Notes due 2023
|
6.28
|
%
|
|
1,635,000
|
|
|
1,614,269
|
|
|
6.28
|
%
|
|
1,635,000
|
|
|
1,613,446
|
|
5.875% Senior Secured Notes due 2024
|
6.14
|
%
|
|
300,000
|
|
|
295,647
|
|
|
6.14
|
%
|
|
300,000
|
|
|
295,513
|
|
6.00% Senior Notes due 2025
|
6.27
|
%
|
|
1,200,000
|
|
|
1,181,773
|
|
|
6.27
|
%
|
|
1,200,000
|
|
|
1,181,243
|
|
Term Loan B Facility Due 2024
|
5.46
|
%
|
|
3,389,388
|
|
|
3,352,858
|
|
|
5.46
|
%
|
|
3,397,925
|
|
|
3,360,103
|
|
Other debt
|
1.50
|
%
|
|
55
|
|
|
55
|
|
|
1.50
|
%
|
|
55
|
|
|
55
|
|
Total long-term debt, net
|
|
|
$
|
8,374,443
|
|
|
$
|
8,271,692
|
|
|
|
|
$
|
8,382,980
|
|
|
$
|
8,276,237
|
|
Less current portion, net
|
|
|
34,205
|
|
|
34,205
|
|
|
|
|
34,205
|
|
|
34,205
|
|
Total long-term debt, less current portion, net
|
|
|
$
|
8,340,238
|
|
|
$
|
8,237,487
|
|
|
|
|
$
|
8,348,775
|
|
|
$
|
8,242,032
|
|
The senior unsecured notes are unsecured and effectively subordinated in right of priority to our credit agreement (the 2017 Credit Agreement) and our senior secured notes, in each case to the extent of the value of the collateral securing such instruments, which collateral represents substantially all of the assets of the issuers or borrowers and the guarantors party thereto.
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
$7.3 billion
and
$7.5 billion
at
March 31, 2018
and
December 31, 2017
, respectively. Based on this valuation methodology, we determined these debt instruments represent Level 2 measurements within the fair value hierarchy.
Credit Facility
We have
$996.8 million
of remaining credit available through our Revolving Credit Facility as of
March 31, 2018
. As of
March 31, 2018
, we were in compliance with all covenants contained in our credit agreement.
NOTE 12. COMMITMENTS AND CONTINGENCIES
Legal Proceedings and Investigations
We and certain of our subsidiaries are involved in various claims, legal proceedings, internal and governmental investigations (collectively, proceedings) that arise from time to time in the ordinary course of our business, including, among others, those relating to product liability, intellectual property, regulatory compliance, consumer protection 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 current and future financial position, 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 such matters.
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 such 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 resolution of any dispute has been reached and realization of the potential claim for recovery is considered probable. Amounts recovered under our insurance policies will likely be less than the stated coverage limits and may not be adequate to cover damages and/or costs relating to claims. In addition, there is no guarantee that insurers will pay claims or that coverage will otherwise be available.
As of
March 31, 2018
, our reserve for loss contingencies totaled
$1,240.9 million
, of which
$1,032.0 million
relates to our liability accrual for vaginal mesh cases and other mesh-related matters. During the fourth quarter of 2017, the Company recorded a total increase to its legal reserves of approximately
$200 million
related to testosterone-related product liability matters and LIDODERM
®
-related antitrust matters, which reflects the Company’s conclusion that a loss is probable with respect to these matters. The reserve for LIDODERM
®
-related matters includes an estimated loss for, among other matters, settlement of all remaining claims filed against EPI in multidistrict litigation (MDL) No. 2521, which is further discussed below under the heading “
Other Antitrust Matters
.” The testosterone-related reserve includes an estimated loss for, among other matters, all testosterone-related product liability cases filed in MDL No. 2545 and in other courts. These cases are further discussed below under the heading “
Product Liability and Related Matters
.” 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.
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 the U.S. in various state and federal courts (including a federal 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 included in restricted cash and cash equivalents in the
Condensed Consolidated Balance Sheets
.
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.
Although the Company believes it has appropriately estimated the probable total amount of loss associated with all matters as of the date of this report, it is reasonably possible that further claims may be filed or asserted and 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 balance during the
three months ended March 31, 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
Qualified Settlement Funds
|
|
Mesh Liability Accrual
|
Balance as of January 1, 2018
|
$
|
313,814
|
|
|
$
|
1,087,172
|
|
Additional charges
|
—
|
|
|
—
|
|
Cash contributions to Qualified Settlement Funds
|
66,108
|
|
|
—
|
|
Cash distributions to settle disputes from Qualified Settlement Funds
|
(50,636
|
)
|
|
(50,636
|
)
|
Cash distributions to settle disputes
|
—
|
|
|
(4,547
|
)
|
Other
|
734
|
|
|
—
|
|
Balance as of March 31, 2018
|
$
|
330,020
|
|
|
$
|
1,031,989
|
|
As of
March 31, 2018
,
$899.9 million
of the mesh liability accrual amount shown above is classified in the Current portion of the legal settlement accrual in the
Condensed Consolidated Balance Sheets
, with the remainder classified as Long-term legal settlement accrual, less current portion. 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
$3.0 billion
,
$330.0 million
of which remains in the QSFs as of
March 31, 2018
. We expect to fund into the QSFs the remaining payments under all settlement agreements during the remainder of 2018 and 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 a number of state attorneys general into mesh products, including transvaginal surgical mesh products designed to treat POP and SUI. In November 2013, we received a subpoena relating to this investigation from the state of California, and we have subsequently received additional subpoenas from California and other states. We are currently 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 1, 2018
, we were aware of approximately
1,300
testosterone cases (some of which may have been filed on behalf of multiple plaintiffs) pending against one or more of our subsidiaries. Many 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). In addition, there are cases pending against EPI and/or Auxilium in the Philadelphia Court of Common Pleas (PCCP) and in certain other state courts.
In November 2015, the MDL court entered an order granting defendants’ motion to dismiss claims involving certain testosterone products that were approved pursuant to Abbreviated New Drug Applications (ANDAs), including TESTOPEL
®
. Plaintiffs filed a motion for reconsideration and clarification of this order. In March 2016, the MDL court granted plaintiffs’ motion in part and entered an order permitting certain claims to go forward to the extent they are based on allegations of fraudulent off-label marketing.
The first MDL trial against Auxilium involving TESTIM
®
took place in November 2017 and resulted in a defense verdict. The first PCCP trial against Auxilium involving TESTIM
®
was scheduled for January 2018 but resolved prior to trial.
In February 2018, counsel for plaintiffs and counsel for Auxilium and EPI signed a memorandum of understanding regarding a potential settlement, subject to certain contingencies and conditions. The MDL court subsequently entered case management orders directing that proceedings involving these parties be temporarily stayed so that the parties may devote their efforts to finalizing a master settlement agreement. Similarly, in March 2018, orders were entered in the PCCP temporarily staying the testosterone-related product liability proceedings involving these parties. A fourth quarter 2017 increase to the Company’s legal reserves included, among other things, an estimated loss for all testosterone-related product liability claims filed in MDL No. 2545 and in other courts. 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 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 includes 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. After a series of motions to dismiss, plaintiffs filed a third amended complaint in April 2016, asserting civil claims for alleged violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and for negligent misrepresentation based on defendants’ marketing of certain testosterone products. The court denied a motion to dismiss this complaint in August 2016 and the case is currently in discovery. In November 2017, plaintiff filed a motion to certify a nationwide class of third party payers. This lawsuit is not part of the potential settlement described above.
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.
Unapproved Drug Litigation
In September 2013, the State of Louisiana filed a petition for damages against certain of our subsidiaries, including EPI, and more than
50
other pharmaceutical companies in Louisiana state court (19th Judicial District) alleging that the defendants or their subsidiaries marketed products that were not approved by the FDA and seeking damages, fines, penalties, attorneys’ fees and costs under various causes of action. In October 2015, the district court entered judgment for defendants on their exception for no right of action. The State appealed, and in October 2016 the Louisiana First Circuit Court of Appeals reversed the dismissal as to the State’s Medicaid Assistance Program Integrity Law (MAPIL) and Louisiana Unfair Trade Practices Act (LUTPA) claims but affirmed the dismissal as to the State’s other claims. The State’s petition for rehearing was denied in December 2016. Both sides applied to the Louisiana Supreme Court for a writ of certiorari to review the First Circuit’s decision. Those writs were denied in March 2017. In May 2017, defendants filed exceptions for no cause of action in the district court. In August 2017, the court sustained defendants’ exception as to the MAPIL claim but overruled defendants’ exception as to the LUTPA claim. The State then filed a motion seeking reconsideration with respect to the MAPIL claim, and defendants filed a motion for clarification with respect to the court’s ruling on the LUTPA claim. In October 2017, the court denied the State’s motion and entered final judgment against the State with respect to the MAPIL claim. The court also granted defendants’ motion for clarification and dismissed the State’s LUTPA claim insofar as it sought civil penalties for alleged violations occurring before June 2, 2006. In October 2017, defendants applied for a supervisory writ to the Louisiana First Circuit Court of Appeals on the district court’s August 2017 order overruling defendants’ exception on the State’s LUTPA claim. In March 2018, defendants refiled the writ application after the court instructed the defendants to do so.
In March 2017, the State of Mississippi filed a complaint against our subsidiary EPI in Mississippi state court (Hinds County Chancery Court) alleging that EPI marketed products that were not approved by the FDA and seeking damages, penalties, attorneys’ fees, costs and other relief under various causes of action. In April 2017, EPI removed the case to the U.S. District Court for the Southern District of Mississippi. In May 2017, the State moved to remand the case to state court, and that motion was granted in October 2017. In November 2017, EPI filed a motion to dismiss the State’s complaint on various grounds. In January 2018, the State filed a motion for leave to amend its complaint. In February 2018, following an unopposed motion by the State, the court consolidated the State’s case against EPI with
five
substantially similar cases brought by the State against other defendants. The consolidation is solely for purposes of coordinated pretrial proceedings and discovery, not for trial. In March 2018, the court signed an Agreed Order dismissing EPI and granting the State leave to file a first amended complaint. The first amended complaint names our subsidiary Generics International (US), Inc. (Generics) as the defendant. In April 2018, Generics moved to dismiss on various grounds.
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.
Opioid-Related Matters
Since 2014, multiple U.S. states, counties, other governmental persons or entities and private plaintiffs have filed suit against our subsidiaries Endo Health Solutions Inc. (EHSI) and EPI, in some instances the Company and/or our subsidiaries Par Pharmaceutical, Inc. (PPI), Vintage Pharmaceuticals, LLC and/or Generics Bidco I, LLC, and/or 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 1, 2018
, the cases of which we were aware include, but are not limited to, approximately
10
cases filed by states; approximately
780
cases filed by counties, cities, Native American tribes and/or other government-related persons or entities; approximately
50
cases filed by hospitals, health systems, unions, health and welfare funds or other third-party payers; and approximately
20
cases filed by individuals. 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.
Many of these 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 and as a friend of the court. In April 2018, the MDL Court issued a scheduling order permitting motions to dismiss addressing threshold legal issues in certain cases, setting a trial date of March 2019 for
three
cases originally filed in the Northern District of Ohio, and establishing certain other deadlines and procedures.
Other cases remain pending in various state courts. In some jurisdictions, such as Connecticut, Illinois, New York and Pennsylvania, certain state court cases have been transferred to a single court within their respective state court systems for coordinated pretrial proceedings. Some state courts have allowed discovery to begin.
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. Certain of the cases are brought as putative class actions.
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:
In September 2017, the Department of Justice for the State of Oregon and the Office of the Attorney General for the Commonwealth of Massachusetts issued CIDs to EHSI and EPI on behalf of a multistate group which we understand currently includes the District of Columbia and the following additional states: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Nebraska, Nevada, New York, North Carolina, North Dakota, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin and Wyoming. Our subsidiaries are currently cooperating with this investigation. We understand that these CIDs superseded prior subpoenas and/or CIDs issued by certain of the foregoing states.
Other states are conducting their own investigations outside of the multistate group. These states include New Hampshire (subpoenas received by EPI in August 2015 and December 2017); New Jersey (subpoena received by EPI in March 2017); Washington (CID received by the Company, EHSI and EPI in August 2017); Indiana (CID received by EHSI and EPI in November 2017); Montana (CID received by EHSI and EPI in January 2018); Alaska (CID received by EPI in February 2018); and South Carolina (CID received by EHSI and EPI in February 2018). 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. 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.
Generic Drug Pricing Matters
In December 2014, our subsidiary Par Pharmaceuticals 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. The subpoena requested documents and information focused primarily on product and pricing information relating to Par’s authorized generic version of Lanoxin (digoxin) oral tablets and Par’s generic doxycycline products, and on communications with competitors and others regarding those products. Par is cooperating with the investigation.
In December 2015, EPI received interrogatories and a subpoena from the Connecticut Attorney General’s Office requesting documents and information regarding pricing of certain of generic products, including doxycycline hyclate, amitriptyline hydrochloride, doxazosin mesylate, methotrexate sodium and oxybutynin chloride. EPI is cooperating with this 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 April 2017, certain private plaintiff cases alleging price-fixing and other anticompetitive conduct with respect to at least
18
different generic pharmaceutical products 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 cases included in the MDL involve different groups of defendants. Our subsidiary PPI is named as a defendant in proposed class actions relating to
six
of these products: digoxin, doxycycline hyclate, divalproex ER, propranolol, baclofen and amitriptyline hydrochloride. Among the private plaintiff lawsuits now consolidated and/or coordinated in the MDL, the earliest lawsuits naming the Company and/or its subsidiaries were filed in November 2016 and related to digoxin and doxycycline.
The private plaintiffs in the MDL include alleged direct purchasers, end-payers, and indirect purchaser resellers, and they purport to represent not only themselves but also all others similarly situated. At the MDL court’s direction, in August 2017, private plaintiffs filed separate consolidated amended class action complaints as to each product and each type of purchaser (direct purchasers, end-payers and indirect purchaser resellers), except the propranolol direct purchaser plaintiffs are attempting to proceed on a consolidated amended complaint filed in the U.S. District Court for the Southern District of New York prior to MDL transfer (the Southern District of New York had denied a motion to dismiss this complaint). The MDL court has divided the various cases into
three
separate tranches for certain administrative and scheduling purposes, including briefing on motions to dismiss. As to the
six
products in the first tranche (which include digoxin, doxycycline hyclate and divalproex ER), defendants filed motions to dismiss in October 2017; those motions remain pending. Defendants have also asserted that they are entitled to move the MDL court to dismiss the propranolol direct purchaser consolidated amended complaint; the MDL court has taken this issue under advisement. Defendants moved to stay discovery in all cases pending rulings on their motions to dismiss; in February 2018, the court denied that motion with certain exceptions.
In December 2016, the Attorney General for the State of Connecticut, leading a coalition of
20
state attorneys general, filed a complaint in the U.S. District Court for the District of Connecticut alleging price-fixing and other anticompetitive conduct with respect to doxycycline hyclate delayed release and glyburide against certain manufacturers of those products. The Company and its subsidiaries were not named in that complaint, or in an amended complaint filed on behalf of
40
states in March 2017, or in a separate lawsuit filed by
four
more states and the District of Columbia in the same court in July 2017. In August 2017, the state cases were transferred to MDL No. 2724. In October 2017, the state plaintiffs filed a motion for leave to (1) consolidate their
two
cases, (2) add Alaska and the Commonwealth of Puerto Rico as plaintiffs and (3) assert additional claims against existing and new defendants. The proposed amended complaint would add new allegations and claims against
14
new defendants, including our subsidiary Par Pharmaceutical Companies, Inc. (subsequently renamed Endo Generics Holding, Inc. but referred to as Par in this Commitments and Contingencies note), relating to
13
additional products. As to our subsidiary, the proposed amended complaint alleges anticompetitive conduct with respect to doxycycline monohydrate. The proposed amended complaint also alleges that the defendants engaged in an overarching conspiracy to restrain trade across the generic pharmaceutical industry and seeks to hold all defendants, including our subsidiary, jointly and severally liable for harm caused by alleged anticompetitive activity concerning the
15
drugs at issue. The proposed amended complaint seeks declaratory and injunctive relief, disgorgement and other equitable relief, compensatory and treble damages, civil penalties, costs and attorneys’ fees. Defendants have opposed the states’ motion for leave to file their proposed consolidated amended complaint, and the court has not yet ruled on the issue.
In January 2018, The Kroger Co., Albertsons Companies, LLC, and H.E. Butt Grocery Company LP filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania against PPI, as well as numerous other manufacturers of generic pharmaceuticals, alleging anticompetitive conduct relating to
thirty
separate generic pharmaceutical products, including
seven
products allegedly manufactured by PPI: digoxin, doxycycline hyclate, doxycycline monohydrate, divalproex ER, propranolol, baclofen and amitriptyline hydrochloride. The complaint alleges an overarching conspiracy among all named defendants to engage in price-fixing for all
thirty
products, as well as product-specific conspiracies relating to each individual product, in violation of federal antitrust law. The complaint seeks monetary damages, including treble damages, attorneys’ fees and injunctive 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.
Other Pricing Matters
In March 2016, EPI received a CID from the U.S. Attorney’s Office for the Southern District of New York. The CID requested documents and information regarding contracts with pharmacy benefit managers regarding FROVA
®
. 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 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 co-defendants Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. (collectively, Teikoku), and Actavis plc and certain of its subsidiaries (collectively, Actavis), which was subsequently acquired by Teva Pharmaceuticals Industries Ltd and its subsidiaries from Allergan plc. Plaintiffs generally alleged that EPI, Teikoku and Actavis entered into an anticompetitive conspiracy to restrain trade through the settlement of patent infringement litigation concerning U.S. Patent No. 5,827,529 (the ‘529 patent) and other patents. Some complaints also alleged that Teikoku wrongfully listed the ‘529 patent in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as related to LIDODERM
®
,
that EPI and Teikoku commenced sham patent litigation against Actavis and that EPI abused the FDA citizen petition process by filing a citizen petition and amendments solely to interfere with generic companies’ efforts to obtain FDA approval of their versions of LIDODERM
®
. The 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. In June 2017, defendants moved for summary judgment on all claims, and plaintiffs also moved for partial summary judgment on certain elements of their claims. In November 2017, the court granted defendants’ motion in part, ruling in defendants’ favor on the issues of infringement and derivation and also limiting the time period at issue. Defendants’ motions for summary judgment were denied in all other respects. The court also granted plaintiffs’ motions for summary judgment on the issues of agreement and relevant market. EPI settled with certain opt-out plaintiffs in October 2017. EPI reached an agreement in principle with the class plaintiffs in February 2018. In connection with the settlements, several indirect purchasers which previously had opted out were permitted to rejoin the class. The settlement agreements with the direct and indirect purchaser classes, which have received preliminary approval but remain subject to final approval by the court, provide that, subject to certain conditions, EPI will make aggregate payments of approximately
$100 million
, approximately
$90 million
of which are classified in the Current portion of the legal settlement accrual in the Condensed Consolidated Balance Sheets at
March 31, 2018
, with the remainder classified as Long-term legal settlement accrual, less current portion.
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 Inc. (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 discovery. 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 and others alleging violations of antitrust law arising out of Par’s 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 district 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 case against Par with prejudice. In February 2017, the FTC voluntarily dismissed its claims against Par with prejudice. Claims by a putative class of direct purchasers and certain specific alleged direct purchasers or their assignees are still pending. Par has moved for summary judgment on all remaining claims, and the direct purchaser plaintiffs have moved for class certification. The court has not yet ruled on these motions. We will continue 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 assert 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. We intend to vigorously defend these matters and to explore other options as appropriate in our best interests.
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 received similar CIDs from South Carolina’s Office of the Attorney General in February 2016 and from Alaska’s Office of the Attorney General in February 2015. The Alaska CID was also directed to EHSI and included requests for documents and information concerning agreements with Actavis and Impax settling the OPANA
®
ER patent litigation.
In February 2015, Par 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 Par’s settlement of the AndroGel
®
patent litigation as well as documents produced in the aforementioned litigation filed by the FTC.
We are cooperating with each of the foregoing investigations.
A fourth quarter 2017 increase to the Company’s legal reserves includes, among other things, an estimated loss for certain LIDODERM
®
-related claims. 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.
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 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. The time for appeal has not yet run.
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. The case is currently in discovery.
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 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, SEB Investment Management AB was appointed 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
twenty
current and former directors, officers and employees of Endo as defendants. In April 2018, the defendants moved to dismiss the amended complaint.
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 in connection with the allegations of anticompetitive conduct asserted in
In re Generic Pharmaceuticals Pricing Antitrust Litigation
, MDL No. 2724. In January 2018, the Chief Judge of the Eastern District of Pennsylvania designated
Pelletier
as related to
Bier
and reassigned
Pelletier
to the judge overseeing
Bier
. A lead plaintiff has not yet been selected.
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 Par and its affiliate Par Sterile Products, LLC in the U.S. District Court for the District of New Jersey alleging that Par and its affiliate engaged in an anticompetitive scheme to exclude competition from the market for vasopressin solution for intravenous injection in view of Par’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 Par 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 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, Par 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 Par Sterile Products, LLC 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 October 2017, defendants answered the complaint and QuVa asserted counterclaims against PPI and Par Sterile Products, LLC alleging unfair competition under New Jersey common law and seeking declaratory judgment of non-infringement as to
five
U.S. Patents assigned to PPI that are listed in FDA’s Orange Book for VASOSTRICT
®
. The counterclaims seek actual, exemplary, and punitive damages, injunctive relief and other relief. We filed a motion to dismiss the unfair competition counterclaim in November 2017. Briefing on that motion has been completed but no ruling has been issued. Also in November 2017, we filed a motion for preliminary injunction seeking various forms of relief. Briefing on that motion has been completed and a hearing on that motion was held in February 2018. In January 2018, we filed a first amended complaint adding
five
former employees of Par Sterile Products, LLC as defendants and numerous causes of action against some or all of those former employees, 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. 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. These motions are still pending. Full discovery began in May 2018.
In October 2017, Endo Par Innovation Company, LLC (EPIC) and Par Sterile Products, LLC (PSP) filed a complaint in the United States 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 seeks (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 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 will 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.
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 losses that could be incurred.
Paragraph IV Certifications on OPANA
®
ER
In late 2012,
two
patents (U.S. Patent Nos. 8,309,122 and 8,329,216) were issued to EPI covering OPANA
®
ER (oxymorphone hydrochloride extended-release tablets CII). In December 2012, EPI filed a complaint against Actavis in U.S. District Court for the Southern District of New York for patent infringement based on its ANDA for a non-INTAC
®
technology version of OPANA
®
ER. In May 2013 and June 2013, EPI filed similar suits in the U.S. District Court for the Southern District of New York against the following applicants for non-INTAC
®
technology OPANA
®
ER: Roxane Laboratories, Inc. (Roxane) and Ranbaxy Laboratories Limited, which was acquired by Sun Pharmaceutical Industries Ltd. (Ranbaxy). Those suits allege infringement of U.S. Patent Nos. 7,851,482, 8,309,122 and 8,329,216. In July 2013, Actavis and Roxane were granted FDA approval to market all strengths of their respective non-INTAC
®
technology formulations of OPANA
®
ER. In September 2013, Actavis launched its generic version of non-crush-resistant OPANA
®
ER 5, 10, 20, 30 and 40 mg tablets. A trial in this case was held from March 2015 through April 2015 in the U.S. District Court for the Southern District of New York. In August 2015, the District Court ruled that all defendants infringed the claims of U.S. Patent Nos. 8,309,122 and 8,329,216. The District Court also ruled that the defendants failed to show that U.S. Patent Nos. 8,309,122 and 8,329,216 were invalid, enjoined the defendants from launching their generic products until the expiration of those patents and directed Actavis to withdraw its generic product within
60 days
. In October 2015, the District Court tolled the
60
-day period until it decided
two
pending post-trial motions. In April 2016, the District Court issued an order upholding its August 2015 ruling in EPI’s favor and confirming the prior injunction against the manufacture or sale of the generic version of the non-INTAC
®
technology OPANA
®
ER currently offered by Actavis and the additional approved but not yet marketed generic version of the product developed by Roxane. The defendants filed appeals to the Court of Appeals for the Federal Circuit. EPI continued its suit for damages for Actavis’s sales of its infringing generic version of OPANA
®
ER. In August 2017, EPI settled the damages portion of this suit with Actavis. As a result of that settlement, EPI received
$25 million
from Actavis in August 2017. We intend to continue vigorously asserting our intellectual property rights and to oppose any such appeal.
From
September 21, 2012
through
October 30, 2013
, EPI and its partner Grünenthal received Paragraph IV Notices from each of Teva Pharmaceuticals USA, Inc., Amneal Pharmaceuticals, LLC (Amneal), ThoRx Laboratories, Inc. (ThoRx), Actavis, Impax and Ranbaxy (now Sun Pharmaceutical Industries Ltd.), advising of the filing by each such company of an ANDA for a generic version of the formulation of OPANA
®
ER with INTAC
®
technology. These Paragraph IV Notices refer to U.S. Patent Nos. 7,851,482, 8,075,872, 8,114,383, 8,192,722, 8,309,060, 8,309,122 and 8,329,216, which variously cover the formulation of OPANA
®
ER, a highly pure version of the active pharmaceutical ingredient and the release profile of OPANA
®
ER. EPI filed lawsuits against each of these filers in the U.S. District Court for the Southern District of New York. Each lawsuit was filed within the
45
-day deadline to invoke a
30
-month stay of FDA approval pursuant to the Hatch-Waxman legislative scheme. A trial in this case was held from March 2015 through April 2015 in the U.S. District Court for the Southern District of New York against the remaining filers. In August 2015, the District Court issued an Opinion holding that all defendants infringed the claims of U.S. Patent Nos. 8,309,060, 8,309,122 and 8,329,216. The Opinion also held that the defendants had shown that U.S. Patent No. 8,309,060 was invalid, but that the defendants had failed to show that U.S. Patent Nos. 8,309,122 and 8,329,216 were invalid. The District Court also issued an Order enjoining the defendants from launching their generic products until the expiration of U.S. Patent Nos. 8,309,122 and 8,329,216. The defendants filed appeals to the Court of Appeals for the Federal Circuit. An argument was held at the Federal Circuit on this appeal in December 2017. No opinion has yet been issued. We intend to continue to vigorously assert our intellectual property and oppose appeals by the defendants. However, there can be no assurance that we and/or Grünenthal will be successful. If we are unsuccessful and Teva, Amneal, ThoRx, Actavis or Impax is able to obtain FDA approval of its product, generic versions of OPANA
®
ER INTAC
®
technology may be launched prior to the applicable patents’ expirations in 2023. Additionally, we cannot predict or determine the timing or outcome of this defense but will explore all options as appropriate in our best interests.
In August 2014 and October 2014, the U.S. Patent Office issued U.S. Patent Nos. 8,808,737 and 8,871,779 respectively, which cover a method of using OPANA
®
ER and a highly pure version of the active pharmaceutical ingredient of OPANA
®
ER. 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 U.S. Patent No. 8,871,779 was invalid. The District Court issued an Order enjoining the defendants from launching their generic products until the expiration of U.S. Patent No. 8,871,779 in November 2029. A trial for infringement of the ‘799 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 U.S. Patent No. 8,871,779, and that Actavis had failed to show that U.S. Patent No. 8,871,779 was invalid. Teva, Amneal and Actavis have appealed these holdings. We have appealed the holding that the ‘737 patent is invalid.
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 in defense of both the non-INTAC
®
technology formulation OPANA
®
ER and the INTAC
®
technology formulation OPANA
®
ER, 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 13. OTHER COMPREHENSIVE (LOSS) INCOME
The following table presents the tax effects allocated to each component of
Other comprehensive (loss) income
for the
three months ended March 31, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
|
Before-Tax Amount
|
|
Tax (Expense) Benefit
|
|
Net-of-Tax Amount
|
|
Before-Tax Amount
|
|
Tax Benefit (Expense)
|
|
Net-of-Tax Amount
|
Net unrealized loss on securities:
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss arising during the period
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(544
|
)
|
|
$
|
198
|
|
|
$
|
(346
|
)
|
Less: reclassification adjustments for gain realized in net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Net unrealized gains (losses)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(544
|
)
|
|
$
|
198
|
|
|
$
|
(346
|
)
|
Net unrealized (loss) gain on foreign currency:
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation (loss) gain arising during the period
|
(5,797
|
)
|
|
—
|
|
|
(5,797
|
)
|
|
15,134
|
|
|
—
|
|
|
15,134
|
|
Less: reclassification adjustments for loss realized in net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Foreign currency translation (loss) gain
|
$
|
(5,797
|
)
|
|
$
|
—
|
|
|
$
|
(5,797
|
)
|
|
$
|
15,134
|
|
|
$
|
—
|
|
|
$
|
15,134
|
|
Other comprehensive (loss) income
|
$
|
(5,797
|
)
|
|
$
|
—
|
|
|
$
|
(5,797
|
)
|
|
$
|
14,590
|
|
|
$
|
198
|
|
|
$
|
14,788
|
|
Substantially all of the Company’s
Accumulated other comprehensive loss
at
March 31, 2018
and
December 31, 2017
consists of
Foreign currency translation loss
.
NOTE 14. SHAREHOLDERS' (DEFICIT) EQUITY
Changes in Shareholders' (Deficit) Equity
The following table displays a reconciliation of our beginning and ending balances in
shareholders' (deficit) equity
for the
three months ended March 31, 2018
(in thousands):
|
|
|
|
|
|
Total Shareholders' Equity (Deficit)
|
Shareholders' equity at January 1, 2018, prior to the adoption of ASC 606
|
$
|
484,880
|
|
Effect of adopting ASC 606 (1)
|
3,076
|
|
Shareholders' equity at January 1, 2018
|
$
|
487,956
|
|
Net loss
|
(505,489
|
)
|
Other comprehensive loss
|
(5,797
|
)
|
Compensation related to share-based awards
|
17,890
|
|
Tax withholding for restricted shares
|
(1,642
|
)
|
Other
|
(11
|
)
|
Shareholders' deficit at March 31, 2018
|
$
|
(7,093
|
)
|
__________
|
|
(1)
|
Refer to
Note 2. Summary of Significant Accounting Policies
for further description of ASC 606.
|
Share-Based Compensation
The Company recognized share-based compensation expense of
$17.9 million
and
$19.5 million
during the
three months ended March 31, 2018
and
2017
, respectively. As of
March 31, 2018
, the total remaining unrecognized compensation cost related to non-vested share-based compensation awards amounted to
$47.6 million
. This amount excludes
$16.4 million
of additional unrecognized compensation cost related to awards granted on April 2, 2018.
During the third quarter of 2017, the Company issued approximately
1.0 million
stock options and
0.1 million
restricted stock units for which a grant date has not been established as the awards are subject to shareholder approval at the Company’s 2018 Annual General Meeting of Shareholders. If approved, the options will have an exercise price equal to the closing share price on their issuance date in August 2017. Additionally, there are
0.1 million
performance share units outstanding as of
March 31, 2018
, representing target amounts, for which a grant date has not been established.
No
fair value has been ascribed to these awards as no grant date has been established. Accordingly, they are not reflected in the remaining unrecognized compensation cost above or the weighted average remaining requisite service period below.
As of
March 31, 2018
, the weighted average remaining requisite service period of the non-vested stock options was
2.3 years
and for non-vested restricted stock units was
2.0 years
.
NOTE 15. OTHER INCOME, NET
The components of
Other income, net
for the
three months ended March 31, 2018 and 2017
are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Foreign currency gain, net
|
$
|
(2,085
|
)
|
|
$
|
(2,984
|
)
|
Equity loss from investments accounted for under the equity method, net
|
2,626
|
|
|
1,002
|
|
Other miscellaneous, net
|
(3,419
|
)
|
|
(55
|
)
|
Other income, net
|
$
|
(2,878
|
)
|
|
$
|
(2,037
|
)
|
Foreign currency gain, net
results from the remeasurement of the Company’s foreign currency denominated assets and liabilities.
NOTE 16. INCOME TAXES
During the three months ended
March 31, 2018
, the Company recognized
income tax expense
of
$15.5 million
on
$482.2 million
of
loss
from continuing operations before income tax, compared to
$11.9 million
of
income tax benefit
on
$177.4 million
of
loss
from continuing operations before income tax during the comparable 2017 period. The
income tax expense
for the current period is primarily related to the geographic mix of pretax earnings and discrete tax expense incurred in connection with an intercompany asset restructuring. As of
March 31, 2018
, the Company had valuation allowances established against our deferred tax assets in most jurisdictions in which we operate, with the exception of Canada and India. The tax benefit for the comparable 2017 period was primarily related to the geographic mix of pretax earnings and the discrete tax benefit associated with the International Pharmaceuticals Segment intangible asset impairment.
During the year ended December 31, 2017, we recorded a benefit of
$36.2 million
as our estimate of the impact of the TCJA. This benefit, which is primarily related to remeasurement of deferred tax liabilities related to tax deductible goodwill, was recorded in our Consolidated Statements of Operations as Income tax benefit.
We recorded the aforementioned net benefit based on currently available information and interpretations of the TCJA. In accordance with authoritative guidance issued by the SEC, the income tax effect for certain aspects of the TCJA may represent provisional amounts for which our accounting is incomplete but a reasonable estimate could be determined. We consider amounts related to the various transition rules and interpretations of the TCJA to be provisional. Accordingly, we will continue to evaluate the impacts of the TCJA, including administrative and regulatory guidance as it becomes available. The measurement and existence of current and non-current income tax payables and/or the remeasurement of deferred tax assets and liabilities may change upon finalization of our analysis, which is expected to occur no later than one year from December 22, 2017, the date of the TCJA’s enactment. Any adjustment to a provisional amount identified during the one-year measurement period will be recorded as an income tax expense or benefit in the period the adjustment is determined.
During the three months ended
March 31, 2018
, we did not record any adjustments to the provisional amounts recognized in 2017. We will continue to monitor for any significant impact on the Company’s consolidated financial statements with respect to the TCJA as more refined information and further guidance become available.
NOTE 17. NET LOSS PER SHARE
The following is a reconciliation of the numerator and denominator of basic and diluted net
loss per share
for the
three months ended March 31, 2018 and 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018
|
|
2017
|
Numerator:
|
|
|
|
Loss from continuing operations
|
$
|
(497,738
|
)
|
|
$
|
(165,423
|
)
|
Loss from discontinued operations, net of tax
|
(7,751
|
)
|
|
(8,405
|
)
|
Net loss
|
$
|
(505,489
|
)
|
|
$
|
(173,828
|
)
|
Denominator:
|
|
|
|
For basic per share data—weighted average shares
|
223,521
|
|
|
223,014
|
|
Dilutive effect of ordinary share equivalents
|
—
|
|
|
—
|
|
Dilutive effect of various convertible notes and warrants
|
—
|
|
|
—
|
|
For diluted per share data—weighted average shares
|
223,521
|
|
|
223,014
|
|
Basic net
loss per share
data is computed based on the weighted average number of ordinary shares outstanding during the period. Diluted
loss per share
data is computed based on the weighted average number of ordinary shares outstanding and, if there is net income from continuing operations attributable to Endo ordinary shareholders during the period, the dilutive impact of ordinary share equivalents outstanding during the period.
Stock options and awards that have been issued but for which a grant date has not yet been established, such as those discussed in
Note 14. Shareholders' (Deficit) Equity
, are not considered in the calculation of basic of diluted weighted average shares.
All potentially dilutive items were excluded from the diluted share calculation for the
three months ended March 31, 2018 and 2017
because their effect would have been anti-dilutive, as the Company was in a loss position.
NOTE 18. SUBSEQUENT EVENTS
On April 26, 2018, the Company entered into a Membership Interest and Asset Purchase Agreement (the Somerset Purchase Agreement) with Mendham Holdings, LLC (the Seller) and certain other Seller related parties in connection with the acquisition of all of the limited liability company membership interests (the LLC Interests) of Somerset Therapeutics, LLC (Somerset) and certain of Somerset’s assets, including intellectual property, product ANDAs and inventory (the Somerset Assets). Somerset is a specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. market. The Somerset acquisition is contingent upon the closing of the acquisition of the Wintac business (as defined below).
Pursuant to the terms of the Somerset Purchase Agreement, the Company will acquire
100%
of the LLC Interests of Somerset and the Somerset Assets for an aggregate cash purchase price of approximately
$160 million
, subject to customary adjustments for cash, net working capital and indebtedness as described in the Somerset Purchase Agreement. The Somerset Purchase Agreement contains certain customary representations, warranties and covenants and provides for indemnification rights of the parties in respect of inaccuracies or breaches of certain representations, warranties and covenants, subject to the limitations set forth in the Somerset Purchase Agreement.
The Somerset acquisition is expected to close in the second half of 2018, subject to satisfaction of customary closing conditions, including required regulatory approvals and the closing of the acquisition of the Wintac business. In connection with the Somerset acquisition, Endo’s Indian subsidiary has entered into separate agreements to acquire the entire business of Somerset’s Indian-based contract development and manufacturing affiliate, Wintac Limited (Wintac) including certain real property in Bangalore, India and the manufacturing plants thereon and to assume certain debt of Wintac for the expected aggregate amount of the rupee equivalent of approximately
$30 million
, subject to customary adjustments for net working capital.