o
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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Commission File Number
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Exact name of registrant as specified in its charter, principal office and address and telephone number
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State of incorporation or organization
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I.R.S. Employer Identification No.
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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AGN |
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Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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Allergan plc Ordinary Shares, $0.0001 par value |
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New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:
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Allergan plc |
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YES ☒ |
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NO ☐ |
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Warner Chilcott Limited |
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YES ☒ |
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NO ☐ |
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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Allergan plc |
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YES ☒ |
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NO ☐ |
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Warner Chilcott Limited |
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YES ☒ |
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NO ☐ |
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Allergan plc |
Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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Warner Chilcott Limited |
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
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Allergan plc |
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YES |
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NO ☒ |
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Warner Chilcott Limited |
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YES |
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NO ☒ |
Number of shares of Allergan plc’s Ordinary Shares outstanding on May 1, 2020:
This Quarterly Report on Form 10-Q is a combined report being filed separately by two different registrants: Allergan plc and Warner Chilcott Limited. Warner Chilcott Limited is an indirect wholly-owned subsidiary of Allergan plc. The information in this Quarterly Report on Form 10-Q is equally applicable to Allergan plc and Warner Chilcott Limited, except where otherwise indicated. Warner Chilcott Limited meets the conditions set forth in General Instruction H(1)(a) and (b) of Form 10-Q and, to the extent applicable, is therefore filing this form with a reduced disclosure format.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2020
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PAGE |
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Item 1. |
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3 |
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Consolidated Balance Sheets of Allergan plc as of March 31, 2020 and December 31, 2019 |
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4 |
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6 |
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Consolidated Balance Sheets of Warner Chilcott Limited as of March 31, 2020 and December 31, 2019 |
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12 |
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13 |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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70 |
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Item 4. |
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71 |
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Item 1. |
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Item 1A. |
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Item 2. |
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74 |
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Item 6. |
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75 |
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76 |
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2
PART I. FINANCIAL INFORMATION
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ITEM 1. |
CONSOLIDATED FINANCIAL STATEMENTS |
ALLERGAN PLC
CONSOLIDATED BALANCE SHEETS
(Unaudited; in millions, except par value)
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March 31, |
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December 31, |
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2020 |
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2019 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Accounts receivable, net of allowances for doubtful accounts and credit losses of $ |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property, plant and equipment, net |
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Right of use asset - operating leases |
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Investments and other assets |
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Non current assets held for sale |
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Deferred tax assets |
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Product rights and other intangibles |
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Goodwill |
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Total assets |
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$ |
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$ |
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LIABILITIES AND EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Income taxes payable |
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Current portion of long-term debt |
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Current portion of lease liability - operating |
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Total current liabilities |
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Long-term debt |
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Lease liability - operating |
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Other long-term liabilities |
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Other taxes payable |
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Deferred tax liabilities |
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Total liabilities |
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Commitments and contingencies (Refer to Note 15) |
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Equity: |
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Ordinary shares; $ authorized, outstanding, respectively |
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$ |
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$ |
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Additional paid-in capital |
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Retained earnings |
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Accumulated other comprehensive income |
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Total shareholders’ equity |
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Noncontrolling interest |
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Total equity |
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Total liabilities and equity |
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$ |
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$ |
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See accompanying Notes to the Consolidated Financial Statements.
3
ALLERGAN PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in millions, except per share amounts)
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Three Months Ended March 31, |
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2020 |
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2019 |
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Net revenues |
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$ |
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$ |
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Operating expenses: |
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Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
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Research and development |
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Selling and marketing |
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General and administrative |
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Amortization |
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Goodwill impairments |
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Asset sales and impairments, net |
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Total operating expenses |
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Operating (loss) / income |
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Interest income |
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Interest (expense) |
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Other income / (expense), net |
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Total other (expense), net |
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(Loss) before income taxes and noncontrolling interest |
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(Benefit) for income taxes |
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Net income / (loss) |
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(Income) attributable to noncontrolling interest |
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Net Income / (loss) attributable to shareholders |
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$ |
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$ |
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Income / (Loss) per share attributable to shareholders |
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Basic |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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See accompanying Notes to the Consolidated Financial Statements.
4
ALLERGAN PLC
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME / (LOSS)
(Unaudited; in millions)
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Three Months Ended March 31, |
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2020 |
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2019 |
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Net income / (loss) |
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$ |
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$ |
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Other comprehensive (loss) / income |
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Foreign currency translation (losses) |
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Unrealized (losses), net of tax |
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Total other comprehensive (loss), net of tax |
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Comprehensive income / (loss) |
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( |
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Comprehensive (income) attributable to noncontrolling interest |
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Comprehensive income / (loss) attributable to ordinary shareholders |
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$ |
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$ |
( |
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See accompanying Notes to the Consolidated Financial Statements.
5
ALLERGAN PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in millions)
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Three Months Ended March 31, |
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2020 |
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2019 |
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Cash Flows From Operating Activities: |
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Net income / (loss) |
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$ |
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$ |
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Reconciliation to net cash provided by operating activities: |
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Depreciation |
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Amortization |
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Provision for inventory reserve |
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Share-based compensation |
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Deferred income tax benefit |
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Goodwill impairments |
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(Gain) / loss on asset sales and impairments, net |
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Non-cash extinguishment of debt |
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- |
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Amortization of deferred financing costs |
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Non-cash lease expense |
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Contingent consideration adjustments, including accretion |
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Other, net |
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Changes in assets and liabilities (net of effects of acquisitions): |
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Decrease / (increase) in accounts receivable, net |
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Decrease / (increase) in inventories |
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Decrease / (increase) in prepaid expenses and other current assets |
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Increase / (decrease) in accounts payable and accrued expenses |
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Increase / (decrease) in income and other net taxes payable |
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Increase / (decrease) in other assets and liabilities |
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Net cash provided by operating activities |
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Cash Flows From Investing Activities: |
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Additions to property, plant and equipment |
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Additions to product rights and other intangibles |
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Additions to investments |
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Proceeds from sale of investments and other assets |
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Proceeds from sales of property, plant and equipment |
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Acquisitions of businesses, net of cash acquired |
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- |
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Net cash (used in) / provided by investing activities |
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Cash Flows From Financing Activities: |
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Payments on debt, including finance lease obligations and credit facility |
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Payments of contingent consideration and other financing |
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Proceeds from stock plans |
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Repurchase of ordinary shares |
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( |
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Dividends paid |
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( |
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Net cash (used in) financing activities |
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Effect of currency exchange rate changes on cash and cash equivalents |
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Net increase / (decrease) in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Supplemental Disclosures of Cash Flow Information |
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Cash paid during the year for: |
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Income taxes other, net of refunds |
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$ |
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$ |
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Interest |
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$ |
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$ |
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Schedule of Non-Cash Investing and Financing Activities: |
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Dividends accrued |
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$ |
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$ |
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See accompanying Notes to the Consolidated Financial Statements.
6
ALLERGAN PLC
CONSOLIDATED STATEMENTS OF EQUITY
(Unaudited; in millions)
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Accumulated |
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Additional |
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Other |
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Ordinary Shares |
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Paid-in- |
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Retained |
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Comprehensive |
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Noncontrolling |
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Shares |
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Amount |
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Capital |
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Earnings |
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Income / (Loss) |
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Interest |
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Total |
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BALANCE, December 31, 2018 |
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$ |
- |
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$ |
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$ |
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$ |
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$ |
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$ |
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Implementation of new accounting pronouncement |
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- |
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- |
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- |
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( |
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- |
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- |
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( |
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BALANCE, January 1, 2019 |
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$ |
- |
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$ |
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$ |
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$ |
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$ |
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$ |
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Comprehensive (loss): |
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Net (loss) attributable to shareholders |
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- |
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- |
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- |
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( |
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- |
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- |
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( |
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Other comprehensive (loss), net of tax |
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- |
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- |
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- |
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- |
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( |
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- |
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( |
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Share-based compensation |
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- |
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- |
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- |
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- |
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- |
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Ordinary shares issued under employee stock plans |
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- |
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- |
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- |
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|
- |
|
|
|
|
|
|
Dividends declared |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Repurchase of ordinary shares under the share repurchase programs |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Repurchase of ordinary shares |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
BALANCE, March 31, 2019 |
|
|
|
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, December 31, 2019 |
|
|
|
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to shareholders |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Other comprehensive income, net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Ordinary shares issued under employee stock plans |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Dividends declared |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Repurchase of ordinary shares |
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
BALANCE, March 31, 2020 |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to the Consolidated Financial Statements.
7
WARNER CHILCOTT LIMITED
CONSOLIDATED BALANCE SHEETS
(Unaudited; in millions)
|
|
|
March 31, |
|
|
December 31, |
|
||
|
|
|
2020 |
|
|
2019 |
|
||
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
|
$ |
|
|
|
Marketable securities |
|
|
|
|
|
|
|
|
|
Accounts receivable, net of allowances for doubtful accounts and credit losses of $ |
|
|
|
|
|
|
|
|
|
Receivables from Parents |
|
|
|
|
|
|
|
|
|
Inventories |
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
|
|
|
|
|
|
|
Right of use asset - operating leases |
|
|
|
|
|
|
|
|
|
Investments and other assets |
|
|
|
|
|
|
|
|
|
Non current assets held for sale |
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
|
|
|
|
|
|
|
|
Product rights and other intangibles |
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
|
|
|
$ |
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
|
|
|
$ |
|
|
|
Payables to Parents |
|
|
|
|
|
|
|
|
|
Income taxes payable |
|
|
|
|
|
|
|
|
|
Current portion of long-term debt |
|
|
|
|
|
|
|
|
|
Current portion of lease liability - operating |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
|
|
|
|
|
|
|
Lease liability - operating |
|
|
|
|
|
|
|
|
|
Other long-term liabilities |
|
|
|
|
|
|
|
|
|
Other taxes payable |
|
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Refer to Note 15) |
|
|
|
|
|
|
|
|
|
Equity: |
|
|
|
|
|
|
|
|
|
Members' capital |
|
|
|
|
|
|
|
|
|
(Accumulated deficit) |
|
|
( |
) |
|
|
( |
) |
|
Accumulated other comprehensive income |
|
|
|
|
|
|
|
|
|
Total members’ equity |
|
|
|
|
|
|
|
|
|
Noncontrolling interest |
|
|
|
|
|
|
|
|
|
Total equity |
|
|
|
|
|
|
|
|
|
Total liabilities and equity |
|
$ |
|
|
|
$ |
|
|
See accompanying Notes to the Consolidated Financial Statements.
8
WARNER CHILCOTT LIMITED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in millions)
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Net revenues |
|
$ |
|
|
|
$ |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
Amortization |
|
|
|
|
|
|
|
|
|
Goodwill impairments |
|
|
|
|
|
|
|
|
|
Asset sales and impairments, net |
|
|
|
|
|
|
( |
) |
|
Total operating expenses |
|
|
|
|
|
|
|
|
|
Operating (loss) / income |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
|
|
|
Interest (expense) |
|
|
( |
) |
|
|
( |
) |
|
Other (expense) income, net |
|
|
( |
) |
|
|
|
|
|
Total other (expense), net |
|
|
( |
) |
|
|
( |
) |
|
(Loss) / income before income taxes and noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
(Benefit) for income taxes |
|
|
( |
) |
|
|
( |
) |
|
Net income / (loss) |
|
|
|
|
|
|
( |
) |
|
(Income) attributable to noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
Net income / (loss) attributable to members |
|
$ |
|
|
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
See accompanying Notes to the Consolidated Financial Statements.
9
WARNER CHILCOTT LIMITED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME / (LOSS)
(Unaudited; in millions)
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Net income / (loss) |
|
$ |
|
|
|
$ |
( |
) |
|
Other comprehensive (loss) / income |
|
|
|
|
|
|
|
|
|
Foreign currency translation (losses) |
|
|
( |
) |
|
|
( |
) |
|
Unrealized gains / (losses), net of tax |
|
|
( |
) |
|
|
( |
) |
|
Total other comprehensive (loss), net of tax |
|
|
( |
) |
|
|
( |
) |
|
Comprehensive income / (loss) |
|
|
|
|
|
|
( |
) |
|
Comprehensive (income) attributable to noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
Comprehensive income / (loss) attributable to members |
|
$ |
|
|
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to the Consolidated Financial Statements.
10
WARNER CHILCOTT LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in millions)
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Cash Flows From Operating Activities: |
|
|
|
|
|
|
|
|
|
Net income / (loss) |
|
$ |
|
|
|
$ |
( |
) |
|
Reconciliation to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
|
|
|
|
|
|
|
Amortization |
|
|
|
|
|
|
|
|
|
Provision for inventory reserve |
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
|
( |
) |
|
|
( |
) |
|
Goodwill impairments |
|
|
|
|
|
|
|
|
|
(Gain) / loss on asset sales and impairments, net |
|
|
|
|
|
|
( |
) |
|
Non-cash extinguishment of debt |
|
|
- |
|
|
|
|
|
|
Amortization of deferred financing costs |
|
|
|
|
|
|
|
|
|
Non-cash lease expense |
|
|
|
|
|
|
|
|
|
Contingent consideration adjustments, including accretion |
|
|
|
|
|
|
|
|
|
Other, net |
|
|
|
|
|
|
( |
) |
|
Changes in assets and liabilities (net of effects of acquisitions): |
|
|
|
|
|
|
|
|
|
Decrease / (increase) in accounts receivable, net |
|
|
|
|
|
|
|
|
|
Decrease / (increase) in inventories |
|
|
( |
) |
|
|
( |
) |
|
Decrease / (increase) in prepaid expenses and other current assets |
|
|
( |
) |
|
|
|
|
|
Increase / (decrease) in accounts payable and accrued expenses |
|
|
( |
) |
|
|
( |
) |
|
Increase / (decrease) in income and other net taxes payable |
|
|
|
|
|
|
|
|
|
Increase / (decrease) in other assets and liabilities, including receivable / payable with Parents |
|
|
( |
) |
|
|
( |
) |
|
Net cash provided by operating activities |
|
|
|
|
|
|
|
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
( |
) |
|
|
( |
) |
|
Additions to product rights and other intangibles |
|
|
( |
) |
|
|
( |
) |
|
Additions to investments |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from sale of investments and other assets |
|
|
|
|
|
|
|
|
|
Proceeds from sales of property, plant and equipment |
|
|
|
|
|
|
|
|
|
Acquisitions of businesses, net of cash acquired |
|
|
- |
|
|
|
( |
) |
|
Net cash (used in) / provided by investing activities |
|
|
|
|
|
|
( |
) |
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
|
|
Payments on debt, including finance lease obligations and credit facility |
|
|
( |
) |
|
|
( |
) |
|
Payments of contingent consideration and other financing |
|
|
( |
) |
|
|
( |
) |
|
Dividends to Parents |
|
|
( |
) |
|
|
( |
) |
|
Net cash (used in) financing activities |
|
|
( |
) |
|
|
( |
) |
|
Effect of currency exchange rate changes on cash and cash equivalents |
|
|
( |
) |
|
|
|
|
|
Net increase / (decrease) in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
|
Cash and cash equivalents at beginning of period |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
|
|
|
$ |
|
|
See accompanying Notes to the Consolidated Financial Statements.
11
WARNER CHILCOTT LIMITED
CONSOLIDATED STATEMENTS OF EQUITY
(Unaudited; in millions, except share data)
|
|
|
Members' Capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
Shares |
|
|
Amount |
|
|
(Accumulated Deficit) |
|
|
Accumulated Other Comprehensive Income / (Loss) |
|
|
Noncontrolling Interest |
|
|
Total |
|
||||||
|
BALANCE, December 31, 2018 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Implementation of new accounting pronouncements |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
BALANCE, January 1, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Comprehensive (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) attributable to members |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Other comprehensive (loss), net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Dividends to Parents |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
BALANCE, March 31, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, December 31, 2019 |
|
|
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to members |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Other comprehensive (loss), net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Dividends to Parents |
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
BALANCE, March 31, 2020 |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying Notes to the Consolidated Financial Statements.
12
ALLERGAN PLC AND WARNER CHILCOTT LIMITED
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 — General
Allergan plc is a global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As a part of its approach to deliver innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry. The Company has operations in more than
Merger Agreement with AbbVie Inc.
On June 25, 2019, the Company announced that it entered into a transaction agreement (the “AbbVie Agreement”) under which AbbVie Inc. (“AbbVie”), a global, research-driven biopharmaceutical company, would acquire Allergan plc in a stock and cash transaction (the “AbbVie Transaction”), valued at $
On May 6, 2020, the Irish High Court (the “Court”) approved the AbbVie Transaction at a sanction hearing in relation to the scheme of arrangement (the “Scheme”) (and to confirm the associated capital reduction) under the AbbVie Transaction.
Completion of the AbbVie Transaction remains subject to the delivery to, and registration by, the Registrar of Companies in Ireland of copies of (i) the order of the Court sanctioning the Scheme and confirming the associated reduction of capital; and (ii) the minute required by Section 86 of the Act in respect of the reduction of capital, each of which is expected to occur on May 8, 2020.
Additionally, on October 25, 2019, in connection with the AbbVie Transaction, AbbVie commenced offers to exchange all Allergan Senior Notes issued by Allergan and maturing from
13
The accompanying consolidated financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2019 (“Annual Report”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted from the accompanying consolidated financial statements. The accompanying year end consolidated balance sheet was derived from the audited financial statements included in the Annual Report. The accompanying interim financial statements are unaudited and reflect all adjustments which are in the opinion of management necessary for a fair statement of the Company’s consolidated financial position, results of operations, comprehensive (loss) / income and cash flows for the periods presented. All such adjustments are of a normal, recurring nature. All intercompany transactions and balances have been eliminated in consolidation. The Company’s results of operations, comprehensive (loss) / income and cash flows for the interim periods are not necessarily indicative of the results of operations, comprehensive (loss) / income and cash flows that it may achieve in future periods.
References throughout to “we,” “our,” “us,” the “Company” or “Allergan” refer to financial information and transactions of Allergan plc. References to “Warner Chilcott Limited” refer to Warner Chilcott Limited, the Company’s indirect wholly-owned subsidiary, and, unless the context otherwise requires, its subsidiaries.
NOTE 2 — Reconciliation of Warner Chilcott Limited results to Allergan plc results
Warner Chilcott Limited is an indirect wholly-owned subsidiary of Allergan plc, the ultimate parent of the group (together with other direct or indirect parents of Warner Chilcott Limited, the “Parents”). The results of Warner Chilcott Limited are consolidated into the results of Allergan plc. Due to the de minimis activity between Warner Chilcott Limited and the Parents (including Allergan plc), content throughout this filing relates to both Allergan plc and Warner Chilcott Limited. Warner Chilcott Limited disclosures relate only to itself and not to any other company. Except where otherwise indicated, and excluding certain insignificant cash and non-cash transactions at the Allergan plc level, these notes relate to the consolidated financial statements for both separate registrants, Allergan plc and Warner Chilcott Limited. In addition to certain inter-company payable and receivable amounts between the entities, the following is a reconciliation of the financial position and results of operations of Warner Chilcott Limited to Allergan plc ($ in millions):
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As of March 31, 2020 |
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As of December 31, 2019 |
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Allergan plc |
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Warner Chilcott Limited |
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Difference |
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Allergan plc |
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Warner Chilcott Limited |
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Difference |
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||||||
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Cash and cash equivalents |
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$ |
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$ |
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$ |
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|
|
$ |
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|
$ |
|
|
|
$ |
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|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
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- |
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Accounts payable and accrued liabilities |
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Other taxes payable |
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Total equity |
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Three Months Ended March 31, 2020 |
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Three Months Ended March 31, 2019 |
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Allergan plc |
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Warner Chilcott Limited |
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Difference |
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Allergan plc |
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Warner Chilcott Limited |
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Difference |
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||||||
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General and administrative expenses |
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$ |
|
|
|
$ |
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|
$ |
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|
|
$ |
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|
$ |
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$ |
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|
Operating income |
|
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( |
) |
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( |
) |
|
|
( |
) |
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( |
) |
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( |
) |
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( |
) |
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Interest income |
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|
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- |
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- |
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(Loss) / income before income taxes and noncontrolling interest |
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( |
) |
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( |
) |
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|
( |
) |
|
|
( |
) |
|
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( |
) |
|
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( |
) |
|
(Benefit) for income taxes |
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( |
) |
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( |
) |
|
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- |
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|
|
( |
) |
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( |
) |
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Net (loss) / income |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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Net (loss) / income attributable to ordinary shareholders/members |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
14
The differences between general and administrative expenses in the three months ended March 31, 2020 and 2019 were due to corporate related expenses incurred at Allergan plc. The difference in accounts payable and accrued liabilities as of March 31, 2020 was due to accrued dividends. The differences in total equity were due to historical differences in the results of operations of the companies and differences in equity awards and dividends.
NOTE 3 — Summary of Significant Accounting Policies
The following are interim updates to certain of the policies described in “Note 4” of the notes to the Company’s audited consolidated financial statements for the year ended December 31, 2019 included in the Annual Report.
Implementation of new guidance
In June 2016 the FASB issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The FASB subsequently issued amendments to ASU 2016-13, which have the same effective date and transition date of January 1, 2020. This standard requires entities to estimate an expected lifetime credit loss on financial assets ranging from short-term trade accounts receivable to long-term financings and report credit losses using an expected losses model rather than the incurred losses model that was previously used, and establishes additional disclosures related to credit risks. This standard limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which amortized cost exceeds fair value and requires the reversal of previously recognized credit losses if fair value increases.
This standard became effective for us on January 1, 2020, and based on the composition of our trade receivables, investment portfolio and other financial assets, current and forecasted economic conditions and historical credit loss activity, the adoption of this standard did not have a material impact on our consolidated financial statements and related disclosures.
Risk and Uncertainties
We are subject to risks and uncertainties as a result of the COVID-19 pandemic. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including sales, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain. The Company continues to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets.
The Company's medical aesthetic portfolio of products are susceptible to local and national government restrictions, such as social distancing, “shelter in place” orders and business closures, due to the economic and logistical impacts these measures have on consumer demand as well as the practitioners’ ability to administer such procedures. The inability to perform such procedures may cause customer liquidity issues resulting in the inability of our customers to pay receivables. While the Company has recently observed, particularly in certain Asia Pacific international markets, early signs of some recovery of the global medial aesthetic business and anticipates that the recovery will continue to occur during the second half of 2020, the extent and duration of these logistical impediments and any reduced demand and the corresponding decreased sales is uncertain. Capital markets and economies worldwide have also been negatively impacted by the COVID-19 pandemic, and it is possible that this can lead to a local and/or global economic recession. Such economic disruption could adversely effect on our business.
The severity of the impact of the COVID-19 pandemic on the Company's business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company's customers, all of which are uncertain. The Company's future results of operations and liquidity could be adversely impacted by reductions in sales, delays in payments of outstanding invoices beyond normal payment terms, supply chain disruptions and uncertain demand, a delay in the timing and completion of key clinical trials, and any impact on the Company’s access to the capital markets. As of the date of issuance of these condensed consolidated financial statements, the extent to which the COVID-19 pandemic may materially impact the Company's financial condition, liquidity, or results of operations is uncertain. Furthermore, the estimation
15
process required to prepare the Company’s consolidated financial statements requires assumptions to be made about future events and conditions and the impact of COVID-19 on our financial results, and while we believe such assumptions are reasonable, they are inherently subjective and uncertain. The Company’s actual results could differ materially from those estimates.
Revenue Recognition
General
ASU No. 2014-09, “Revenue from Contracts with Customers” (“Topic 606”) provides that revenues are recognized when control of the promised goods under a contract is transferred to a customer, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods as specified in the underlying terms with the customer. The Company warrants products against defects and for specific quality standards, permitting the return of products under certain circumstances. Product sales are recorded net of all sales-related deductions including, but not limited to: chargebacks, trade discounts, commercial and government rebates, customer loyalty programs, fee-for-service arrangements with certain distributors, returns, and other allowances which we refer to in the aggregate as sales returns and allowances (“SRA”).
The Company’s performance obligations are primarily achieved when control of the products is transferred to the customer. Transfer of control is based on contractual performance obligations, but typically occurs upon receipt of the goods by the customer as that is when the customer has obtained control of significantly all of the economic benefits. During the three months ended March 31, 2020, the impact of COVID-19 on the Company’s SRA was not material. The Company will continue to evaluate the potential impacts of COVID-19 on the commercial and government segments, including the impact unemployment and other factors may have on commercial and government utilization rates in future periods.
Refer to “NOTE 6 – Reportable Segments” for our revenues disaggregated by product and segment and our revenues disaggregated by geography for our international segment. We believe this level of disaggregation best depicts how the nature, amount, timing and uncertainty of our revenue and cash flows are affected by economic factors.
The following table summarizes the activity from operations in the Company’s major categories of SRA ($ in millions):
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Chargebacks |
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Rebates |
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Returns and Other Allowances |
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Cash Discounts |
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Total |
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|||||
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Balance at December 31, 2019 |
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$ |
|
|
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$ |
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$ |
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$ |
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$ |
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Provision related to sales in 2020 |
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Credits and payments |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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Balance at March 31, 2020 |
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$ |
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$ |
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|
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$ |
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|
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$ |
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$ |
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Contra accounts receivable at March 31, 2020 |
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$ |
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|
|
$ |
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|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Accounts payable and accrued expenses at March 31, 2020 |
|
$ |
|
|
|
$ |
|
|
|
$ |
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|
|
$ |
|
|
|
$ |
|
|
The following table summarizes the balance sheet classification of our SRA reserves ($ in millions):
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March 31, 2020 |
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December 31, 2019 |
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||
|
Contra accounts receivable |
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$ |
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$ |
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|
Accounts payable and accrued expenses |
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|
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Total |
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$ |
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|
$ |
|
|
16
The SRA provisions recorded to reduce gross product sales to net product sales were as follows ($ in millions):
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Three Months Ended March 31, |
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|||||
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2020 |
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2019 |
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||
|
Gross product sales |
|
$ |
|
|
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$ |
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|
|
Provisions to reduce gross product sales to net product sales |
|
|
( |
) |
|
|
( |
) |
|
Net product sales |
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$ |
|
|
|
$ |
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|
Percentage of SRA provisions to gross sales |
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|
% |
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% |
Collectability Assessment
Goodwill and Intangible Assets with Indefinite Lives
General
The Company tests goodwill and intangible assets with indefinite lives for impairment annually in the second quarter. Additionally, the Company may perform interim tests if an event occurs or circumstances change that could potentially reduce the fair value of a reporting unit or an indefinite lived intangible asset below its carrying amount. The carrying value of each reporting unit is determined by assigning the assets and liabilities, including the existing goodwill and intangible assets, to those reporting units.
The Company tests goodwill for impairment by either performing a qualitative evaluation or a quantitative test. The qualitative evaluation is an assessment of factors, including Reporting Unit specific operating results as well as industry, market and general economic conditions, to determine whether it is more likely than not that the fair values of a Reporting Unit is less than its carrying amount, including goodwill. The Company may elect to bypass this qualitative assessment for some or all of its Reporting Units and perform a quantitative test as of the measurement date of the test.
Goodwill is considered impaired if the carrying amount of the net assets exceeds the fair value of the reporting unit. Impairment, if any, would be recorded in operating income / (loss) and this could result in a material impact to net income / (loss) and income / (loss) per share.
Prior to Allergan’s 2018 annual impairment test, the Company adopted the new guidance under Accounting Standard Update No. 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Accounting for Goodwill Impairment which eliminated step 2 of the goodwill impairment test, which required a hypothetical purchase price allocation to measure goodwill impairment loss. A goodwill impairment loss under the new guidance is instead measured using a single step test based on the amount by which a reporting unit’s carrying amount exceeds its fair value, not to exceed the carrying amount of goodwill.
17
Acquired in-process research and development (“IPR&D”) intangible assets represent the value assigned to research and development (“R&D”) projects acquired in a business combination that, as of the date acquired, represent the right to develop, use, sell and/or offer for sale a product or other intellectual property that has not been completed or approved. The IPR&D intangible assets are subject to impairment testing until completion or abandonment of each project. Upon abandonment, the assets are impaired if there is no future alternative use or ability to sell the asset. Impairment testing requires management to develop significant estimates and assumptions involving the determination of the fair value of the IPR&D asset, including estimated revenues, the probability of success of the project, determination of the appropriate discount rate, assessment of the asset’s life, potential regulatory risks, and net revenue growth curve assumptions. The major risks and uncertainties associated with the timely and successful completion of IPR&D projects include legal risk, market risk and regulatory risk. Changes in our assumptions could result in future impairment charges. No assurances can be given that the underlying assumptions used to prepare the discounted cash flow analysis will not change or the timely completion of each project and commercial success will occur. For these and other reasons, actual results may vary significantly from estimated results.
Upon successful completion of each project and approval of a product, we will make a separate determination of the useful life of the intangible asset, transfer the amount to currently marketed products (“CMP”) and amortization expense will be recorded over the estimated useful life.
Refer to “NOTE 9 –Goodwill, Product Rights, and Other Intangible Assets” for further discussion on the Company’s goodwill and intangible assets balances and impairments.
Earnings Per Share (“EPS”)
The Company computes EPS in accordance with Accounting Standards Codification (“ASC”) Topic 260, “Earnings Per Share” (“ASC 260”) and related guidance, which requires two calculations of EPS to be disclosed: basic and diluted. Basic EPS is computed by dividing net income / (loss) by the weighted average ordinary shares outstanding during a period. Diluted EPS is based on the treasury stock method and includes the effect from potential issuance of ordinary shares, such as shares issuable pursuant to the exercise of stock options and restricted stock units. Ordinary share equivalents have been excluded where their inclusion would be anti-dilutive.
A reconciliation of the numerators and denominators of basic and diluted EPS follows ($ in millions, except per share amounts):
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Three Months Ended March 31, |
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2020 |
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2019 |
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Net income / (loss): |
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Net income / (loss) attributable to ordinary shareholders |
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$ |
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$ |
( |
) |
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Basic weighted average ordinary shares outstanding |
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Basic EPS: |
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Net income / (loss) per share |
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$ |
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$ |
( |
) |
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Dividends per ordinary share |
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$ |
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$ |
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Diluted weighted average ordinary shares outstanding |
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Diluted EPS: |
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Net income / (loss) per share |
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$ |
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|
$ |
( |
) |
18
Stock awards to purchase
Research and Development Activities
Research and development (“R&D”) activities are expensed as incurred and consist of self-funded R&D costs, the costs associated with work performed under collaborative R&D agreements, regulatory fees, and acquisition and license related milestone payments, if any.
As of March 31, 2020, we are developing a number of products, some of which utilize novel drug delivery systems, through a combination of internal and collaborative programs, and we additionally have products in development as part of our life-cycle management strategy for our existing product portfolio. These development projects include but are not limited to the following:
|
Product |
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Therapeutic Area |
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Indication |
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Expected Launch Year |
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Phase |
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Abicipar |
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Eye Care |
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Age Related Macular Degeneration |
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2020 |
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Review |
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Atogepant |
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Central Nervous System |
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Prophylaxis Migraine |
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2021 |
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III |
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Presbysol |
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Eye Care |
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Presbyopia |
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2022 |
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III |
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Cenicriviroc |
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Gastrointestinal |
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NASH |
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2022 |
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III |
|
Brimonidine DDS |
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Eye Care |
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Geographic Atrophy |
|
2024 |
|
II |
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Relamorelin |
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Gastrointestinal |
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Gastroparesis |
|
2024 |
|
III |
|
Botox |
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Medical Aesthetics |
|
Platysma/Masseter |
|
2025/2024 |
|
II |
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Abicipar |
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Eye Care |
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Diabetic Macular Edema |
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2025 |
|
II |
On March 5, 2020, the Company received FDA approval for Durysta™ (bimatoprost SR), a single intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
As of March 31, 2020, the Company has not experienced a material delay in clinical trials for its R&D projects due to COVID-19 although there could be delays in the future depending on the duration and impact of COVID-19. In addition to the projects listed in the table above, the Company continues to develop brazikumab, a gastrointestinal development project for indications of Crohn’s disease and ulcerative colitis. On January 27, 2020, in connection with the AbbVie Transaction, Allergan announced that it entered into definitive agreements to divest the global development and commercial rights of brazikumab. This agreement was made in conjunction with the regulatory approval process for the AbbVie Transaction. The closing of the divestiture of brazikumab is contingent upon the closing of the AbbVie Transaction and the satisfaction of other customary closing conditions.
Recent Accounting Pronouncements
In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) that provides elective optional expedients and exceptions to existing accounting requirements for entities that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform if certain criteria are met. The ASU is effective as of March 12, 2020 through December 31, 2022. The expedients and exceptions provided by this ASU do not apply to contract modifications made and hedging relationships entered into or evaluated after December 31, 2022, except for hedging relationships existing as of December 31, 2022, that an entity has elected certain optional expedients for and that are retained through the end of the hedging relationship. As of March 31, 2020, this ASU does not have a material impact on our financial position and results of operations.
19
NOTE 4 – Other Income / (Expense)
Other income, net consisted of the following ($ in millions):
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Three Months Ended March 31, |
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|||||
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2020 |
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2019 |
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|
Debt extinguishment other |
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- |
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|
|
( |
) |
|
Other income, net |
|
|
( |
) |
|
|
|
|
|
Other income, net |
|
$ |
( |
) |
|
$ |
|
|
Other Income, Net
Other income, net includes the mark to market losses of $
NOTE 5 — Share-Based Compensation
The Company recognizes compensation expense for all share-based compensation awards made to employees and directors based on the fair value of the awards on the date of grant.
The Company grants awards with the following features:
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• |
Time-based restricted stock and restricted stock unit awards (including, in certain foreign jurisdictions, cash-settled restricted stock unit awards, which are recorded as a liability); |
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• |
Performance-based restricted stock unit awards measured against performance-based targets defined by the Company, including, but not limited to, total shareholder return metrics and R&D milestones, as defined by the Company; and |
|
|
• |
Non-qualified options to purchase outstanding shares. |
The Company recognizes share-based compensation expense for granted awards over the applicable vesting period.
Fair Value Assumptions
All restricted stock and restricted stock units (whether time-based or performance-based) are granted and expensed using the fair value per share on the applicable grant date, over the applicable vesting period. Non-qualified options to purchase ordinary shares are granted to employees at exercise prices per share equal to the closing market price per share on the date of grant. The fair value of non-qualified options is determined on the applicable grant dates using the Black-Scholes method of valuation and that amount is recognized as an expense over the vesting period.
|
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|
2019 Grants |
|
Dividend yield |
|
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|
Expected volatility |
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|
Risk-free interest rate |
|
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Expected term (years) |
|
|
20
Share-Based Compensation Expense
Share-based compensation expense recognized in the Company’s results of operations for the three months ended March 31, 2020 and 2019 was as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Equity-based compensation awards |
|
$ |
|
|
|
$ |
|
|
|
Total share-based compensation expense |
|
$ |
|
|
|
$ |
|
|
Unrecognized future share-based compensation expense was $
Share Activity
The following is a summary of equity award activity for unvested restricted stock and stock units in the period from December 31, 2019 through March 31, 2020 (in millions, except per share data):
|
|
|
Shares |
|
|
Weighted Average Grant Date Fair Value |
|
|
Weighted Average Remaining Contractual Term (Years) |
|
|
Aggregate Grant Date Fair Value |
|
||||
|
Restricted shares / units outstanding at December 31, 2019 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
Granted |
|
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Vested |
|
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( |
) |
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|
|
( |
) |
|
Forfeited |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
Restricted shares / units outstanding at March 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
The following is a summary of equity award activity for non-qualified options to purchase ordinary shares in the period from December 31, 2019 through March 31, 2020 (in millions, except per share data):
|
|
|
Options |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Term (Years) |
|
|
Aggregate Intrinsic Value |
|
||||
|
Outstanding, vested and expected to vest at December 31, 2019 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
Granted |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, vested and expected to vest at March 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
21
NOTE 6 — Reportable Segments
The Company’s businesses are organized into the following segments: US Specialized Therapeutics, US General Medicine and International. In addition, certain revenues and shared costs, and the results of corporate initiatives, are managed outside of the
The operating segments are organized as follows:
|
|
• |
The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the U.S., including Medical Aesthetics, Eye Care and Neuroscience and Urology therapeutic products. |
|
|
• |
The US General Medicine segment includes sales and expenses relating to branded products within the U.S. that do not fall into the US Specialized Therapeutics business units, including Central Nervous System, Gastrointestinal, Women’s Health, Anti-Infectives and Diversified Brands. |
|
|
• |
The International segment includes sales and expenses relating to products sold outside the U.S. |
The Company evaluates segment performance based on segment contribution. Segment contribution for our segments represents net revenues less cost of sales (defined below), selling and marketing expenses, and select general and administrative expenses. The Company does not evaluate the following items at the segment level:
|
|
• |
Revenues and operating expenses within cost of sales, selling and marketing expenses, and general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives primarily include integration, restructuring, divestitures, acquisitions, certain milestones and other shared costs. |
|
|
• |
General and administrative expenses that result from shared infrastructure, including certain expenses located within the United States. |
|
|
• |
Other select revenues and operating expenses including R&D expenses, amortization, IPR&D impairments, goodwill impairments and asset sales and impairments, net as not all such information has been accounted for at the segment level, or such information has not been used by all segments. |
|
|
• |
Total assets including capital expenditures. |
The Company defines segment net revenues as product sales and other revenue derived from our products or licensing agreements.
Cost of sales within segment contribution includes standard production and packaging costs for the products we manufacture, third party acquisition costs for products manufactured by others, profit-sharing or royalty payments for products sold pursuant to licensing agreements and finished goods inventory reserve charges. Cost of sales within segment contribution excludes non-standard production costs, such as non-finished goods inventory obsolescence charges, manufacturing variances and excess capacity utilization charges, where applicable. Cost of sales does not include amortization or impairment costs for acquired product rights or other acquired intangibles.
Selling and marketing expenses consist mainly of personnel-related costs, product promotion costs, distribution costs, professional service costs, insurance, depreciation and travel costs.
General and administrative expenses consist mainly of personnel-related costs, facilities costs, transaction costs, insurance, depreciation, litigation costs and professional services costs which are general in nature and attributable to the segment.
22
Segment net revenues, segment operating expenses and segment contribution information consisted of the following for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, 2020 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Net revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Contribution margin |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Corporate(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill impairment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset sales and impairments, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results. |
|
|||||||||||||||
|
(2) Corporate includes net revenues of $ |
|
|||||||||||||||
|
|
|
Three Months Ended March 31, 2019 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Net revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment contribution |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Contribution margin |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
|
|
% |
|
Corporate(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill impairment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset sales and impairments, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
Operating (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
( |
) |
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results. |
|
|||||||||||||||
|
(2) Corporate includes net revenues of $ |
|
|||||||||||||||
23
The following table presents our net revenue disaggregated by geography for our international segment for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Europe |
|
$ |
|
|
|
$ |
|
|
|
Asia Pacific, Middle East and Africa |
|
|
|
|
|
|
|
|
|
Latin America and Canada |
|
|
|
|
|
|
|
|
|
Other* |
|
|
|
|
|
|
|
|
|
Total International |
|
$ |
|
|
|
$ |
|
|
|
* |
|
|||||||
24
The following tables present global net revenues for the top products greater than 10% of total revenues of the Company as well as a reconciliation of segment revenues to total net revenues for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, 2020 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Botox® |
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
|
|
|
Restasis® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Vraylar® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Juvederm® Collection |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Linzess®/Constella® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lumigan®/Ganfort® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Bystolic® / Byvalson® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alphagan®/Combigan® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Eye Drops |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Lo Loestrin® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Alloderm ® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Ozurdex ® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Viibryd®/Fetzima® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zenpep® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Armour Thyroid |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Breast Implants |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Skin Care |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Viberzi® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coolsculpting ® Systems & Add On Applicators |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Teflaro® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coolsculpting ® Consumables |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Saphris® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Dalvance® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liletta® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Carafate ® / Sulcrate ® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Savella® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Namzaric® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Avycaz® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Canasa®/Salofalk® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ubrelvy® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Asacol®/Delzicol® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kybella® / Belkyra® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Aczone® |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Namenda® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Rapaflo® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total segment revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Corporate revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
25
|
|
|
Three Months Ended March 31, 2019 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Botox® |
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
$ |
|
|
|
Juvederm® Collection |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Restasis® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Linzess®/Constella® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vraylar® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Lumigan®/Ganfort® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Bystolic® / Byvalson® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lo Loestrin® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Alphagan®/Combigan® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Eye Drops |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Alloderm ® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Ozurdex ® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Viibryd®/Fetzima® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast Implants |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Coolsculpting ® Consumables |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Zenpep® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Carafate ® / Sulcrate ® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Armour Thyroid |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Viberzi® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin Care |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Asacol®/Delzicol® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Teflaro® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Saphris® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Avycaz® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Coolsculpting ® Systems & Add On Applicators |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Namzaric® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Savella® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Liletta® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Canasa®/Salofalk® |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rapaflo® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Dalvance® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Namenda® |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Kybella® / Belkyra® |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Aczone® |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total segment revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Corporate revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
As previously described, the closing of the divestiture of Zenpep® is contingent upon the closing of the AbbVie Transaction and the satisfaction of other customary closing conditions.
26
NOTE 7 — Inventories
Inventories consist of finished goods held for sale and distribution, raw materials and work-in-process. Inventories are stated at the lower of cost (first-in, first-out method) or net realizable value. The Company writes down inventories to net realizable value based on forecasted demand, market conditions or other factors, which may differ from actual results.
Inventories consisted of the following ($ in millions):
|
|
|
March 31, |
|
|
December 31, |
|
||
|
|
|
2020 |
|
|
2019 |
|
||
|
Raw materials |
|
$ |
|
|
|
$ |
|
|
|
Work-in-process |
|
|
|
|
|
|
|
|
|
Finished goods |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: inventory reserves |
|
|
|
|
|
|
|
|
|
Total Inventories |
|
$ |
|
|
|
$ |
|
|
NOTE 8 — Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following ($ in millions):
|
|
|
March 31, |
|
|
December 31, |
|
||
|
|
|
2020 |
|
|
2019 |
|
||
|
Accrued expenses: |
|
|
|
|
|
|
|
|
|
Accrued third-party rebates |
|
$ |
|
|
|
$ |
|
|
|
Litigation-related reserves and legal fees |
|
|
|
|
|
|
|
|
|
Accrued payroll and related benefits |
|
|
|
|
|
|
|
|
|
Accrued returns and other allowances |
|
|
|
|
|
|
|
|
|
Accrued R&D expenditures |
|
|
|
|
|
|
|
|
|
Interest payable |
|
|
|
|
|
|
|
|
|
Royalties payable |
|
|
|
|
|
|
|
|
|
Accrued pharmaceutical fees |
|
|
|
|
|
|
|
|
|
Accrued severance, retention and other shutdown costs |
|
|
|
|
|
|
|
|
|
Accrued non-provision taxes |
|
|
|
|
|
|
|
|
|
Accrued selling and marketing expenditures |
|
|
|
|
|
|
|
|
|
Current portion of contingent consideration obligations |
|
|
|
|
|
|
|
|
|
Dividends payable |
|
|
|
|
|
|
|
|
|
Other accrued expenses |
|
|
|
|
|
|
|
|
|
Total accrued expenses |
|
$ |
|
|
|
$ |
|
|
|
Accounts payable |
|
|
|
|
|
|
|
|
|
Total accounts payable and accrued expenses |
|
$ |
|
|
|
$ |
|
|
27
NOTE 9 — Goodwill, Product Rights and Other Intangible Assets
Goodwill
Goodwill for the Company’s reporting segments consisted of the following ($ in millions):
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Balance as of December 31, 2019 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Impairments |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Foreign exchange and other adjustments |
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Balance as of March 31, 2020 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
During the first quarter of 2020, the headroom in the Company’s US Medical Aesthetics and International Reporting Units was significantly decreased due the reversal of deferred tax liabilities as a result of certain intra-entity intellectual property transfers. At the same time, the Company’s net sales for the three months ended March 31, 2020 were negatively impacted compared to the prior year period resulting from the COVID-19 pandemic. The Company anticipates that the COVID-19 pandemic will also have a negative impact on its expected forecasted revenues, particularly the Company’s global medical aesthetic products within the US Medical Aesthetics and the International Reporting Units. These products are typically administered via elective procedures which are susceptible to local and national government restrictions, such as social distancing, “shelter in place” orders and business shutdowns. Moreover, these measures may have economic, as well as logistical, impacts on consumer demand. While the Company has recently observed, particularly in certain Asia Pacific international markets, early signs of some recovery of the global medial aesthetic business and anticipates that the recovery will continue to occur during the second half of 2020, the extent and duration of these logistical impediments and any reduced demand and the corresponding decreased sales is uncertain. Expected future cash flows of the Company’s Eye Care Reporting Unit were also negatively affected by reductions in office and hospital procedures as a result of COVID-19 as well as an anticipated decline in expected forecasted sales of recently launched products.
Consequently, the Company assessed the impact of the above factors on the future cash flows of each of the applicable reporting units, determined that these constituted triggering events in the International, US Medical Aesthetic, and US Eye Care Reporting Units, and evaluated these reporting units for goodwill impairment.
The Company developed multiple forecasted future cash flow scenarios for the reporting units with varied recovery timing and sales impact assumptions. These scenarios included assumptions of recovery for the global medical aesthetics business during the second half of 2020, as well as longer recovery periods. As a result of the impairment test, the Company recorded a goodwill impairment of $
As of March 31, 2020, the fair value of the Company’s US Eye Care Reporting Unit and the fair value of the US Medical Aesthetic Reporting Unit exceeded the respective book values (“headroom”) by less than five percent. The Company’s US Eye Care Reporting Unit and US Medical Aesthetics Reporting Unit, which are components of the US Specialized Therapeutics Segment, have an allocated goodwill balance of $
In performing the impairment test, the Company utilized discount rates ranging from
28
current COVID-19 environment. The weighted average long-term growth rate utilized in the impairment test was approximately
As of March 31, 2020 and December 31, 2019, the gross balance of goodwill, prior to the consideration of impairments, was $
Product Rights and Other Intangible Assets
Product rights and other intangible assets consisted of the following ($ in millions):
|
Cost Basis |
|
Balance as of December 31, 2019 |
|
|
Additions |
|
|
Impairments |
|
|
IPR&D to CMP Transfers |
|
|
Foreign Currency Translation / Other |
|
|
Balance as of March 31, 2020 |
|
||||||
|
Intangibles with definite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights and other intangibles |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Trade name |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total definite lived intangible assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Intangibles with indefinite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IPR&D |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
Total indefinite lived intangible assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
Total product rights and other intangibles |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
Accumulated Amortization |
|
Balance as of December 31, 2019 |
|
|
Amortization |
|
|
Impairments |
|
|
IPR&D to CMP Transfers |
|
|
Foreign Currency Translation / Other |
|
|
Balance as of March 31, 2020 |
|
||||||
|
Intangibles with definite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights and other intangibles |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
Trade name |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
Total definite lived intangible assets |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
Total product rights and other intangibles |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
Net Product Rights and Other Intangibles |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
Three Months Ended March 31, 2020
During the three months ended March 31, 20120, the Company received FDA approval for Durysta™ (bimatoprost SR) for a single intracameral administration. As a result, the Company reclassified the intangible asset from IPR&D to CMP and will amortize the asset over its remaining useful life.
29
During the three months ended March 31, 2020, the Company impaired the intangible assets associated with Kybella® by $
Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on product rights and other related intangibles as of March 31, 2020 over the remainder of 2020 and each of the next five years is estimated to be as follows ($ in millions):
|
|
|
Amortization Expense |
|
|
|
2020 remaining |
|
$ |
|
|
|
2021 |
|
$ |
|
|
|
2022 |
|
$ |
|
|
|
2023 |
|
$ |
|
|
|
2024 |
|
$ |
|
|
|
2025 |
|
$ |
|
|
The above amortization expense is an estimate. Actual amounts may change from such estimated amounts due to fluctuations in foreign currency exchange rates, additional intangible asset acquisitions, finalization of preliminary fair value estimates, potential impairments, accelerated amortization or other events. Additional amortization may occur as products are approved. In addition, the Company has certain currently marketed products for which operating contribution performance has been below that which was originally assumed in the products’ initial valuations, and certain IPR&D projects which are subject to delays in timing or other events which may negatively impact the asset’s value. The Company, on a quarterly basis, monitors the related intangible assets for these products for potential impairments. It is reasonably possible that impairments may occur in future periods, which may have a material adverse effect on the Company’s results of operations and financial position.
30
NOTE 10 — Long-Term Debt
Debt consisted of the following ($ in millions):
|
|
|
|
|
|
|
|
|
Balance As of |
|
|
Fair Market Value As of |
|
||||||||||
|
|
|
Guarantor |
|
Issuance Date / Acquisition Date |
|
Interest Payments |
|
March 31, 2020 |
|
|
December 31, 2019 |
|
|
March 31, 2020 |
|
|
December 31, 2019 |
|
||||
|
Senior Notes: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Floating Rate Notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$500.0 million floating rate notes due |
|
(3) |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Fixed Rate Notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$3,500.0 million |
|
(3) |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
$650.0 million |
|
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$750.0 million |
|
(5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1,200.0 million |
|
(5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$3,000.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1,700.0 million |
|
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$350.0 million |
|
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1,200.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$4,000.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2,500.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1,000.0 million |
|
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$1,500.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2,500.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Euro Denominated Notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€700.0 million floating rate notes due |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€750.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€500.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€700.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€500.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€550.0 million |
|
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Senior Notes Gross |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized premium |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
Unamortized discount |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
Total Senior Notes Net |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Other Indebtedness |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Issuance Costs |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Borrowings |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Indebtedness |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
|||||||||||||||||||||
|
(2) |
|
|||||||||||||||||||||
|
(3) Guaranteed by Warner Chilcott Limited, Allergan Capital S.a.r.l. and Allergan Finance, LLC |
|
|||||||||||||||||||||
|
(4) Guaranteed by Allergan plc and Warner Chilcott Limited |
|
|||||||||||||||||||||
|
(5) Guaranteed by Allergan plc |
|
|||||||||||||||||||||
Fair market value in the table above is determined in accordance with Fair Value Leveling (defined below) under Level 2 based upon quoted prices for similar items in active markets.
Companies are required to use a fair value hierarchy as defined in ASC Topic 820 “Fair Value Measurement,” (“ASC 820”) which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value (“Fair Value Leveling”). There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:
Level 1 — Quoted prices (unadjusted) in active markets for identical assets or liabilities.
31
Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, 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. The Level 3 assets are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as instruments for which the determination of fair value requires significant judgment or estimation.
Fair value is the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants.
During the three months ended March 31, 2020 the Company repaid the scheduled maturities of the $
Annual Debt Maturities
As of March 31, 2020, annual debt maturities of senior notes gross were as follows ($ in millions):
|
|
|
Total Payments |
|
|
|
2020 remaining |
|
$ |
|
|
|
2021 |
|
|
|
|
|
2022 |
|
|
|
|
|
2023 |
|
|
|
|
|
2024 |
|
|
|
|
|
2025 |
|
|
|
|
|
2026 and after |
|
|
|
|
|
Total senior notes gross |
|
$ |
|
|
Amounts represent total anticipated cash payments assuming scheduled repayments.
NOTE 11 — Other Long-Term Liabilities
Other long-term liabilities consisted of the following ($ in millions):
|
|
|
March 31, |
|
|
December 31, |
|
||
|
|
|
2020 |
|
|
2019 |
|
||
|
Acquisition related contingent consideration liabilities |
|
$ |
|
|
|
$ |
|
|
|
Long-term pension and post retirement liability |
|
|
|
|
|
|
|
|
|
Legacy Allergan deferred executive compensation |
|
|
|
|
|
|
|
|
|
Accrued R&D milestone |
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
|
|
|
|
Product warranties |
|
|
|
|
|
|
|
|
|
Long-term severance and restructuring liabilities |
|
|
|
|
|
|
|
|
|
Other long-term liabilities |
|
|
|
|
|
|
|
|
|
Total other long-term liabilities |
|
$ |
|
|
|
$ |
|
|
32
NOTE 12 — Income Taxes
The Company’s effective tax rate for the three months ended March 31, 2020 was a benefit of
The effective tax rate for the three months ended March 31, 2019 was favorably impacted by a tax benefit of $
The Company evaluates the realizability of its deferred tax assets by assessing its valuation allowance and by adjusting the amount of such allowance, if necessary. The factors used to assess the likelihood of realization include the Company’s forecast of future taxable income and available tax planning strategies that could be implemented to realize the net deferred tax assets. Failure to achieve forecasted taxable income in applicable tax jurisdictions could affect the ultimate realization of deferred tax assets and could significantly impact the Company’s effective tax rate on future earnings.
Tax Audits
The Company conducts business globally and, as a result, files U.S. federal, state and foreign tax returns. The Company strives to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While the Company has accrued for amounts it believes are in accordance with the accounting standard, the final outcome with a tax authority may result in a tax liability that is different than that reflected in the consolidated financial statements. Furthermore, the Company may decide to challenge any assessments, if made, and may exercise its right to appeal. The uncertain tax positions are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations with tax authorities, identification of new issues and issuance of new legislation, regulations or case law.
The Company has several concurrent audits open and pending with the IRS as set forth below:
|
IRS Audits |
|
Taxable Years |
|
Allergan W.C. Holding Inc. f/k/a Actavis W.C. Holding Inc. |
|
|
|
Allergan Pharma Inc. & Subsidiaries |
|
|
|
Warner Chilcott Corporation |
|
|
|
Forest Laboratories, Inc. |
|
|
|
Allergan, Inc. |
|
33
NOTE 13 — Derivative Instruments and Hedging Activities
The Company’s revenue, earnings, cash flows and fair value of its assets and liabilities can be impacted by fluctuations in foreign exchange and interest rates, as applicable. The Company manages the impact of foreign exchange risk and interest rate movements through operational means and through the use of various financial instruments, including derivative instruments such as foreign currency derivatives.
Internationally, the Company is a net recipient of currencies other than the U.S. dollar and, as such, benefits from a weaker dollar and is adversely affected by a stronger dollar relative to major currencies worldwide. Accordingly, changes in exchange rates, and in particular a strengthening of the U.S. dollar may negatively affect the Company’s consolidated revenues and favorably impact operating expenses in U.S. dollars.
Derivatives Designated as Hedging Instruments
Cash Flow Hedge
In January 2019, Allergan entered into $
Net Investment Hedge
In the normal course of business, we manage certain foreign exchange risks through a variety of strategies, including hedging. Our hedging strategies include the use of derivatives, as well as net investment hedges. For net investment hedges, the effective portion of the gains and losses on the instruments arising from the effects of foreign exchange are recorded in the currency translation adjustment component of accumulated other comprehensive income / (loss), consistent with the underlying hedged item. Hedging transactions are limited to an underlying exposure. As a result, any change in the value of our hedging instruments would be substantially offset by an opposite change in the value of the underlying hedged items. The Company does not use derivative instruments for trading or speculative purposes.
The Company is exposed to foreign exchange risk in its international operations from foreign currency purchases, net investments in foreign subsidiaries, and foreign currency assets and liabilities created in the normal course of business, including its Euro Denominated Notes. In the three months ended March 31, 2020, we used effective net investment hedges to partially offset the effects of foreign currency on our investments in certain of our foreign subsidiaries. The total notional amount of our instruments designated as net investment hedges was $
34
NOTE 14 — Fair Value Measurement
Assets and liabilities that are measured at fair value using Fair Value Leveling or that are disclosed at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 consisted of the following ($ in millions):
|
|
|
Fair Value Measurements as of March 31, 2020 Using: |
|
|||||||||||||
|
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents* |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
Short-term investments |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
Deferred executive compensation investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Contingent income |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Investments and other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Total assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred executive compensation liabilities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
Contingent consideration obligations |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Total liabilities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Marketable securities with less than |
|
|||||||||||||||
|
|
|
Fair Value Measurements as of December 31, 2019 Using: |
|
|||||||||||||
|
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents* |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
Short-term investments |
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
Deferred executive compensation investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Contingent income |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Investments and other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Total assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred executive compensation liabilities |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
Contingent consideration obligations |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Total liabilities |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Marketable securities with less than 90 days remaining until maturity at the time of acquisition are classified as cash equivalents. |
|
|||||||||||||||
Marketable securities and investments consist of money market securities, U.S. treasury and agency securities. Unrealized gains or losses on marketable securities are recorded in interest income, while unrealized gains or losses on marketable debt securities are recorded in accumulated other comprehensive income. Investments and other include equity and debt securities of publicly traded companies for which market prices are readily available. Unrealized gains or losses on long-term equity investments are recorded in other income / (expense), net. The Company’s marketable securities and other long-term investments are recorded at fair value based on quoted market prices using the specific identification method. These investments are classified as either current or non-current, as appropriate, in the Company’s consolidated balance sheets. The Company may sell certain of its marketable securities prior to their stated maturities for strategic reasons including, but not limited to, anticipation of credit deterioration and maturity management.
35
Contingent Consideration Obligations
The fair value measurement of the contingent consideration obligations is determined using Level 3 inputs and is based on a probability-weighted income approach. The measurement is based upon unobservable inputs supported by little or no market activity, and is based on our own assumptions. These assumptions include revenue estimates, post-tax gross profit levels and a probability assessment with respect to the likelihood of achieving contingent obligations including contingent payments such as milestone obligations, royalty obligations and contract earn-out criteria, where applicable. The weighted average probability assessment utilized in the continent consideration obligations fair value measurement was approximately
|
|
|
Three Months Ended March 31, |
|
|||||
|
Expense / (Income) |
|
2020 |
|
|
2019 |
|
||
|
Cost of sales |
|
$ |
|
|
|
$ |
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
The table below provides a summary of the changes in fair value, including net transfers in and/or out, of all financial assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Balance as of December 31, 2019 |
|
|
Net transfers in to (out of) Level 3 |
|
|
Purchases, settlements, and other net |
|
|
Net accretion and fair value adjustments |
|
|
Balance as of March 31, 2020 |
|
|||||
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration obligations |
|
$ |
|
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
|
|
|
Balance as of December 31, 2018 |
|
|
Net transfers in to (out of) Level 3 |
|
|
Purchases, settlements, and other net |
|
|
Net accretion and fair value adjustments |
|
|
Balance as of March 31, 2019 |
|
|||||
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration obligations |
|
$ |
|
|
|
$ |
- |
|
|
$ |
( |
) |
|
$ |
|
|
|
$ |
|
|
During the three months ended March 31, 2020, the activity in contingent consideration obligations by acquisition consisted of the following ($ in millions):
|
Business Acquisition |
|
Balance as of December 31, 2019 |
|
|
Fair Value Adjustments and Accretion |
|
|
Payments and Other |
|
|
Balance as of March 31, 2020 |
|
||||
|
Tobira acquisition |
|
$ |
|
|
|
$ |
|
|
|
$ |
- |
|
|
$ |
|
|
|
Medicines 360 acquisition |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
AqueSys acquisition |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Oculeve acquisition |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
ForSight acquisition |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Forest acquisition |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
Other |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Contingent Income
36
The fair value measurement of the contingent income is determined using Level 3 inputs and is based on a probability-weighted income approach. The measurement is based upon unobservable inputs supported by little or no market activity, and is based on our own assumptions. There were no material changes noted in the fair value of the contingent income for the three months ended March 31, 2020.
NOTE 15 — Commitments & Contingencies
The Company and its affiliates are involved in various disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings, and litigation matters that arise from time to time in the ordinary course of business. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable.
The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that is accrued. As of March 31, 2020, the Company’s consolidated balance sheet includes accrued loss contingencies of approximately $
The Company’s legal proceedings range from cases brought by a single plaintiff to mass tort actions and class actions with thousands of putative class members. These legal proceedings, as well as other matters, involve various aspects of our business and a variety of claims (including, but not limited to, qui tam actions, antitrust, product liability, breach of contract, securities, patent infringement and trade practices), some of which present novel factual allegations and/or unique legal theories. In addition, a number of the matters pending against us are at very early stages of the legal process (which in complex proceedings of the sort faced by us often extend for several years). As a result, some matters have not yet progressed sufficiently through discovery and/or development of important factual information and legal issues to enable us to estimate a range of possible loss. In those proceedings in which plaintiffs do request publicly quantified amounts of relief, the Company does not believe that the quantified amounts are meaningful because they are merely stated jurisdictional limits, exaggerated and/or unsupported by the evidence or applicable burdens of proof.
In matters involving the assertion or defense of the Company’s intellectual property, the Company believes it has meritorious claims and intends to vigorously assert or defend the patents or other intellectual property at issue in such litigation. Similarly, in matters where the Company is a defendant, the Company believes it has meritorious defenses and intends to defend itself vigorously. However, the Company can offer no assurances that it will be successful in a litigation or, in the case of patent enforcement matters, that a generic version of the product at issue will not be launched or enjoined. Failing to prevail in a litigation could adversely affect the Company and could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.
Intellectual Property Litigation
Patent Enforcement Matters
Bystolic®. On July 2, 2019, subsidiaries of the Company brought an action for infringement of U.S. Patent No. 6,545,040 in the United States District Court for the District of Delaware against Ajanta Pharma Ltd. and Ajanta Pharma USA Inc. (collectively, “Ajanta”) in connection with an abbreviated new drug application filed with the FDA by Ajanta seeking approval to market a generic version of Bystolic® and challenging said patent. The Company entered into a settlement agreement with Ajanta on
Combigan®. On October 30, 2017, subsidiaries of the Company filed an action for infringement of U.S. Patent Number 9,770,453 (the “‘453 Patent”) against Sandoz, Inc. and Alcon Laboratories, Inc. (“Sandoz”) in the U.S. District Court for the District of New Jersey, in connection with the abbreviated new drug applications respectively filed with the FDA by Sandoz and Alcon, seeking approval to market a generic version of Combigan®. On March 6, 2018, U.S. Patent Nos. 9,907,801 (the “‘801 Patent”) and 9,907,802 (the “‘802 Patent”) were added to the case. The ‘453, ‘801 and ‘802 Patents are listed in the Orange Book for Combigan® and expire on April 19, 2022. On July 13, 2018, the district court adopted Allergan’s proposed claim construction and granted Allergan’s motion for
37
preliminary injunction against Sandoz. On August 1, 2018, the district court entered an order setting a preliminary injunction bond in the amount of $
Fetzima®. In October and November 2017, subsidiaries of the Company and Pierre Fabre Medicament S.A.S. brought actions for infringement of U.S. Patent Nos. RE43,879 (the “‘879 Patent”); 8,481,598 (the “‘598 Patent”); and 8,865,937 (the “‘937 Patent”) against MSN Laboratories Private Limited and MSN Pharmaceuticals Inc. (collectively, “MSN”), Prinston Pharmaceutical Inc. and Solco Healthcare U.S., LLC (collectively, “Prinston”), Torrent Pharmaceuticals Limited and Torrent Pharma Inc. (collectively, “Torrent”), West-Ward Pharmaceuticals International Limited and West-Ward Pharmaceuticals Corp. (collectively, “West-Ward”), Zydus Pharmaceuticals (USA) Inc. (“Zydus”), Aurobindo Pharma USA, Inc. and Aurobindo Pharma Limited (collectively, “Aurobindo”), and Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals Private Limited (collectively, “Amneal”), in connection with abbreviated new drug applications, respectively filed with the FDA by MSN, Prinston, Torrent, West-Ward, Zydus, Aurobindo, and Amneal, each seeking approval to market generic versions of Fetzima® and challenging said patents. The ‘879 Patent expires in June 2023 (not including a pending application for patent term extension (“PTE”)), the ‘598 patent expires in March 2031, and the ‘937 Patent expires in May 2032. Fact discovery is completed. Trial is expected to begin in August 2020, subject to the Court’s availability. Allergan entered into a settlement agreement with Amneal on December 18, 2018, and the case as against Amneal was dismissed. Allergan entered into a settlement agreement with Prinston on
In April 2019, subsidiaries of the Company and Pierre Fabre Medicament S.A.S. brought an action for infringement of the ‘879, ‘598 and ‘937 Patents against Micro Labs Ltd. and Micro Labs USA, Inc. (“Micro”) in connection with Micro’s abbreviated new drug application seeking approval to market a generic version of Fetzima® and challenging said patents. Allergan entered into a settlement agreement with Micro Labs on October 22, 2019 and the case was dismissed.
In December 2019, subsidiaries of the Company and Pierre Fabre Medicament S.A.S. brought an action for infringement of the ‘879, ‘598 and ‘937 Patents against Torrent in connection with the same numbered Torrent abbreviated new drug application that was at issue in the action filed by Plaintiffs in 2017. Fact discovery is scheduled to close in November 2020. No trial date has been set.
Juvéderm®. On February 26, 2019, subsidiaries of the Company filed an amended complaint for infringement of U.S. Patent Nos. 8,450,475 (the “‘475 Patent”), 8,357,795 (the “‘795 Patent”), 8,822,676 (the “‘676 Patent”), 9,089,519 (the “‘519 Patent”), 9,238,013 (the “‘013 Patent”) and 9,358,322 (the “‘322 Patent”) in the U.S. District Court for the District of Delaware against Prollenium US Inc. and Prollenium Medical Technologies, Inc. (collectively, “Prollenium”). The amended complaint seeks, among other things, a judgment that Defendants have infringed these patents by making, selling, offering to sell, and importing Prollenium’s Revanesse® Versa+TM products within and into the United States. Plaintiffs seek injunctive relief and damages for Defendants’ infringement. Trial is scheduled for June 14, 2021. On April 13, 2020, Prollenium filed a motion to stay the action pending resolution of Inter Partes Review (“IPR”) petitions that were filed by Prollenium with respect to the asserted patents and instituted by the USPTO in March and April 2020.
On January 23, 2020, subsidiaries of the Company filed a complaint for infringement of U.S. Patent Nos. 10,391,202 (the “‘202 Patent”), and 10,485,896 (the “‘896 Patent”) in the U.S. District Court for the District of Delaware against Prollenium. The complaint seeks, among other things, a judgment that Defendants have infringed these patents by making, selling, offering to sell, and importing Prollenium’s Revanesse® Versa+TM products within and into the United States. Plaintiffs seek injunctive relief and damages for Defendants’ infringement. On April 13, 2020, Prollenium filed a motion to stay the action pending resolution of Inter Partes Review (“IPR”) petitions that were filed by Prollenium with respect to patents asserted in the earlier-filed action and instituted by the USPTO in March and April 2020.
38
Juvéderm® IPR. In August, September and October 2019, Prollenium US Inc. (“Prollenium”) submitted Inter Partes Review (“IPR”) petitions to the USPTO regarding U.S. Patent Nos. 8,450,475 (the “‘475 Patent), 9,238,013 (the “‘013 patent”), 9,358,322 (the “‘322 patent”), 8,822,676 (the “‘676 patent”), 8,357,795 (the “‘795 patent”) and 9,089,519 (the “‘519 patent”). Prollenium’s IPR petitions seek review of all claims of the ‘013, ‘322, 676, and ‘519 patents, claims 1-9, 18, and 27-37 of the ‘475 patent, and claims 1-11, 22, 26-39, and 40-41 of the ‘795 patent. Patent owner’s preliminary responses for these petitions are due on December 19, 2019, or later. The Company filed patent owner's preliminary responses in December 2019 and January 2020 for petitions related to the ‘475, ‘013, ‘322, ‘676, ‘795, and ‘519 patents. On January 17, 2020, Prollenium filed a consolidated reply to the patent owner's preliminary responses with respect to the ‘475, ‘013, ‘322, ‘676, and ‘795 patents, and on January 24, 2020, the Company filed a consolidated sur-reply. In March and April 2020, the USPTO issued decisions granting institution of the IPRs filed by Prollenium. Oral argument, if requested, is scheduled in January 2021.
Latisse® IV. In December 2016, Sandoz announced the U.S. market launch of its generic copy of Latisse®. In July 2017, subsidiaries of the Company and Duke University (collectively, “Plaintiffs”) filed a complaint for infringement of U.S. Patent Number 9,579,270 (“‘270 Patent”) against Defendants Sandoz Inc. (“Sandoz”) and Alcon Laboratories, Inc. (“Alcon”) in the U.S. District Court for the Eastern District of Texas (EDTX). The ‘270 patent expires in January 2021. In their complaint, Plaintiffs seek, among other things, a judgment that Defendants have infringed the ‘270 patent by making, selling, and offering to sell, and/or importing, their generic copy of Latisse® within the United States. Plaintiffs seek injunctive relief and damages for Defendants’ infringement. On April 3, 2018, the EDTX court issued an order, among other things, severing Plaintiff’s claims against Defendants and transferring Plaintiff’s claims against Alcon to the District Court of Delaware and Plaintiff’s claims against Sandoz to the District of Colorado. On October 5, 2018, the Delaware District Court entered an order dismissing the Delaware action against Alcon. On September 18, 2019, the District of Colorado denied Sandoz’s motion for summary judgment. Discovery is closed in the District of Colorado case and a trial date has not yet been set.
Linzess®. Beginning in November 2016 subsidiaries of the Company and Ironwood Pharmaceuticals, Inc. (collectively, “Plaintiffs”), brought multiple actions for infringement of some or all of U.S. Patent Nos. 7,304,036 (the “‘036 Patent”); 7,371,727 (the “‘727 Patent”); 7,704,947 (the “‘947 Patent”); 7,745,409 (the “‘409 Patent”); 8,080,526 (the “‘526 Patent”); 8,110,553 (the “‘553 Patent”); 8,748,573 (the “‘573 Patent”); 8,802,628 (the “‘628 Patent”); and 8,933,030 (the “‘030 Patent”) against Teva Pharmaceuticals USA, Inc. (“Teva”), Aurobindo Pharma Ltd. (“Aurobindo”), Mylan Pharmaceuticals Inc. (“Mylan”), Sandoz Inc. (“Sandoz”) and Sun Pharma Global FZE (“Sun”) in the U.S. District Court for the District of Delaware in connection with abbreviated new drug applications respectively filed with the FDA by Teva, Aurobindo, Mylan, Sandoz and Sun, each seeking approval to market generic versions of Linzess® 145 mcg and 290 mcg capsules and challenging some or all of said patents (“November 2016 Action”). The ‘727, ‘947, ‘409, ‘526 and ‘553 Patents expire in January 2024; the ‘036 Patent expires in August 2026; and the ‘573, ‘628 and ‘030 Patents expire in 2031. In the November 2016 Action, expert discovery has been completed. On May 31, 2019, due to a scheduling conflict, the bench trial set for June 2019 was postponed to January 7, 2020.
On October 20, 2017, November 30, 2017 and January 20, 2018, Plaintiffs brought actions for infringement of U.S. Patent No. 9,708,371 (the “‘371 Patent”) in the U.S. District Court for the District of Delaware against Teva, Mylan and Sandoz, respectively. The ‘371 Patent expires in 2033. The ‘371 patent actions have been consolidated with the November 2016 Action.
On February 2, 2018 and March 29, 2018, Plaintiffs brought actions for infringement of some or all of the ‘036, ‘727, ‘947, ‘409, ‘526, ‘553, ‘030 and ‘371 Patents against Teva and Mylan in the U.S. District Court for the District of Delaware in connection with abbreviated new drug applications respectively filed with the FDA by Teva and Mylan, each seeking approval to market generic versions generic versions of Linzess® 72 mcg capsules (“72 mcg ANDA”) before the expiration said patents. The district court consolidated the 72 mcg ANDA actions with the November 2016 Action.
In May and August 2018, the district court granted joint stipulations and orders to dismiss without prejudice all claims, counterclaims, and defenses in the November 2016 Action with respect to the ‘371 Patent and the ‘030 Patent, respectively, as between Plaintiffs, Teva, Mylan and Sandoz.
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On September 4, 2018, Plaintiffs filed an amended complaint as to Mylan to assert the ‘628 patent against Mylan’s 72 mcg ANDA product.
Plaintiffs entered into a settlement agreement with Sun and certain Sun affiliates and the case against Sun was dismissed on
Plaintiffs entered into a settlement agreement with Sandoz on January 3, 2020, and the cases against Sandoz were dismissed on January 7, 2020. Under the terms of the settlement agreement, Plaintiffs will provide a license to Sandoz to market its generic versions of Linzess® 145 mcg and 290 mcg in the United States beginning on February 5, 2030 (subject to FDA approval), or earlier in certain circumstances.
On January 17, 2020, upon the parties' request, the district court dismissed without prejudice the litigations relating only to Teva's 72 mcg version of Linzess®. Plaintiffs had asserted patents against Teva's 72 mcg ANDA, the last of which expires in 2026, subject to possible pediatric extension. Prior to the dismissal, Teva had stipulated to infringement of certain claims of those patents. On January 21, 2020, Plaintiffs entered into a settlement agreement with Teva and the remaining case against Teva was dismissed. Under the terms of the settlement agreement, Plaintiffs will provide a license to Teva to market its generic versions of Linzess® 145 mcg and 290 mcg in the United States beginning on March 31, 2029 (subject to FDA approval), or earlier in certain circumstances. This settlement does not grant any license to Teva with regard to its 72 mcg generic version of Linzess®.
Saphris®. Between September 2014 and May 2015, subsidiaries of the Company brought actions for infringement of some or all of U.S. Patent Nos. 5,763,476 (the “‘476 patent”), 7,741,358 (the “‘358 patent”) and 8,022,228 (the “‘228 patent”) against Sigmapharm Laboratories, LLC (“Sigmapharm”), Hikma Pharmaceuticals, LLC (“Hikma”), Breckenridge Pharmaceutical, Inc. (“Breckenridge”), Alembic Pharmaceuticals, Ltd. (“Alembic”) and Amneal Pharmaceuticals, LLC (“Amneal”), and related subsidiaries and affiliates thereof in the U.S. District Court for the District of Delaware in connection with an abbreviated new drug applications respectively filed with FDA by Sigmapharm, Hikma, Breckenridge, Alembic and Amneal, each seeking approval to market a generic versions of Saphris® and challenging each of said patents. Including a 6-month pediatric extension of regulatory exclusivity, the ‘476 patent expires in December 2020, and the ‘358 and ‘228 patents expire in October 2026. In 2016, the parties agreed to dismiss all claims related to the ‘358 and ‘228 patents, leaving only the ‘476 patent at issue. On October 13, 2016, the court stayed trial as to Sigmapharm and extended the 30-month stay as to Sigmapharm. On June 30, 2017, the district court issued an opinion and order finding all asserted claims of the ‘476 patent valid, that claims 1, 2, 5 and 6 were infringed by Alembic, Amneal, Breckenridge and Hikma, and that claims 4, 9 and 10 were not infringed by Alembic and Breckenridge. On July 11, 2017, the district court entered a final judgment that ordered, among other things, that Alembic’s, Amneal’s, Breckenridge’s and Hikma’s respective ANDAs not be granted final approval by FDA earlier than the date of expiration of the ‘476 patent inclusive of any applicable adjustments, extensions or exclusivities.
On March 14, 2019, the Federal Circuit vacated the district court’s July 2017 judgment that claims 1 and 4 are not invalid and remanded for the district court to consider a fact question and its impact on the obviousness analysis. On April 15, 2019, Plaintiffs filed a combined petition for panel rehearing and rehearing en banc with respect to this issue, which was denied on May 15, 2019. In its March 14, 2019 order, the Federal Circuit also vacated the judgment of non-infringement of claims 4, 9 and 10 as to Alembic and Breckenridge and remanded for the district court to consider their infringement under a revised claim construction. In a joint stipulation entered by the district court on November 5, 2019, Alembic stipulated that its ANDA infringed claims 4, 9 and 10 of the '476 patent. On December 17, 2019, the district court entered a schedule for briefing on the remanded issues. Oral argument is currently scheduled for June 9, 2020.
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A separate bench trial concerning Sigmapharm’s infringement of claim 1 of the ‘476 patent began on June 20, 2018, and on November 16, 2018, the court held that Sigmapharm’s proposed ANDA product would infringe claim 1 of the ‘476 patent On November 26, 2018, Sigmapharm sought relief from the November 16, 2018 decision. On November 30, 2018, the Company moved for entry of final judgment. On August 6, 2019, the district court denied Sigmapharm’s motion to reconsider its November 2018 Order, and denied without prejudice the Company’s motion for entry of final judgment. On August 22, 2019, the district court entered Plaintiffs and Sigmapharm’s stipulated final judgment finding that Sigmapharm infringed claims 1, 2, 5, and 6 of the ‘476 patent and ordering, among other things, that Sigmapharm’s ANDA be converted to tentative approval and not be granted final approval by FDA earlier than the date of expiration of the ‘476 patent inclusive of any applicable adjustments, extensions or exclusivities.
Viberzi®. On September 6, 2019, subsidiaries of the Company and Janssen Pharmaceutica NV brought an action for infringement of U.S. Patent Nos. 7,741,356 ("the '356 patent"), 7,786,158 ("the '158 patent"), 8,344,011 ("the '011 patent"), 8,609,709 ("the '709 patent"), 8,772,325 ("the '325 patent"), 9,205,076 ("the '076 patent"), 9,700,542 ("the '542 patent"), and 10,213,415 ("the '415 patent") in the United States District Court for the District of Delaware against Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. (collectively, “Aurobindo”) in connection with an abbreviated new drug application filed with the FDA by Aurobindo seeking approval to market a generic version of Viberzi® and challenging said patents. Trial has been scheduled for May 2, 2022.
On September 13, 2019, subsidiaries of the Company brought an action for infringement of United States Patent Nos. 8,691,860 ("the '860 patent"), 9,115,091 ("the '091 patent"), 9,364,489 ("the '489 patent"), 9,675,587 ("the '587 patent"), 9,789,125 ("the '125 patent"), and 10,188,632 ("the '632 patent") in the United States District Court for the District of Delaware against Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc. (collectively, “Aurobindo”), Alkem Laboratories Limited (“Alkem”), Hetero Labs Limited and Hetero USA Inc. (collectively, “Hetero”), MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, “MSN”), Sun Pharmaceutical Industries Limited (“Sun”), and Zydus Pharmaceuticals (USA) Inc. (“Zydus”) in connection with abbreviated new drug applications, respectively filed with the FDA by Aurobindo, Alkem, Hetero, MSN, Sun and Zydus, each seeking approval to market generic versions of Viberzi® and challenging said patents. Trial has been scheduled for May 2, 2022.
Vraylar®. On December 20, 2019, subsidiaries of the Company and Gedeon Richter Plc. brought an action for infringement of U.S. Patent Nos. 7,737,142 ("the '142 patent"), and 7,943,621 ("the '621 patent") in the United States District Court for the District of Delaware against Sun Pharmaceutical Industries Limited and Sun Pharma Global FZE (collectively, "Sun"), Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. (collectively, "Aurobindo"), and Zydus Pharmaceuticals (USA), Inc. and Cadila Healthcare Limited (collectively, "Zydus") in connection with abbreviated new drug applications, respectively filed with the FDA by Sun, Aurobindo, and Zydus, seeking approval to market generic versions of Vraylar® and challenging said patents. No trial date or case schedule has been set.
Trade Secret Matters
Botulinum Neurotoxin ITC Investigation. On January 30, 2019, subsidiaries of the Company and Medytox Inc. (collectively, “Complainants”) filed a complaint with the United States International Trade Commission (“ITC”) against Daewoong Pharmaceuticals Co., Ltd., Daewoong Co., Ltd., and Evolus Inc. (collectively, “Respondents”) requesting the ITC commence an investigation with respect to the Respondents’ importation into the United States of Respondents’ botulinum neurotoxin products, including DWP-450 (also known as JeuveauTM), which Complainants assert were developed, made and/or imported using Medytox’s trade secrets. Complainants seek, among other things, a permanent exclusionary order and cease and desist orders covering Respondents’ botulinum neurotoxin products, including DWP-450/JeuveauTM. On February 28, 2019, the ITC instituted an investigation into Respondents’ botulinum neurotoxin products, including DWP-450/JeuveauTM. Fact and expert discovery is closed and a hearing was held in early February 2020. Post-hearing briefing was completed on February 28, 2020. The target date for completion of the investigation is October 6, 2020.
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Trademark Enforcement Matters
Juvéderm®. On April 5, 2017, a subsidiary of the Company brought an action for unfair competition, false advertising, dilution, conspiracy and infringement of Allergan’s Juvéderm ® trademarks in the U.S. District Court for the Central District of California against Dermavita Limited Partnership (“Dermavita”), Dima Corp. S.A. (“Dima Corp.”) and KBC Media Relations LLC (“KBC”). Dima Corp. had previously announced its acquisition of a license from Dermavita to develop and market in the U.S. cosmetic products under the Juvederm trademark. During
Subsidiaries of the Company requested a preliminary injunction against Dermavita, Dima Corp, Aesthetic Services & Development, Jacqueline Sillam and Dimitri Sillam in the High Court of Paris, France. During June 2017, the Paris Court preliminarily enjoined the above-listed defendants, inter alia, to refrain from promoting or selling in France its Juvederm products, to transfer various domain names and to pay provisional damages to Allergan, on the basis that such use would infringe Allergan’s EU and French Juvéderm® trademarks and would amount to unfair competition. This injunction has become final. During July 2018, the Paris Court ordered Dermavita, Dima Corp, Aesthetic Services & Development to pay more than
A subsidiary of the Company has also filed against Dermavita, Dima Corp. and others a full action of trademark infringement in the Paris court. Dermavita has submitted two requests that the full action be stayed pending the outcome of the Nanterre action and the EUIPO trademark proceedings, both mentioned below. The Paris court rejected both of Dermavita’s stay requests. Furthermore, Dermavita filed an action against subsidiaries of the Company in the Nanterre, France court alleging that the subsidiaries have not used its Juvéderm trademark and requesting the court to revoke the Company’s trademark based on its purported lack of use or purportedly invalid license and assignment agreements. On February 21, 2019, the Nanterre Court ruled in the Company’s favor, holding that the license and assignment agreements were valid and that Allergan has used its trademark in commerce. Dermavita has appealed this decision.
Dermavita has filed another action against subsidiaries of the Company in the Paris court requesting the court to declare that a trademark license agreement and trademark assignment agreement between subsidiaries of the Company are invalid and/or fraudulent. The case is still ongoing.
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On January 22, 2019, subsidiaries of the Company brought a related action for infringement of the Company’s Juvéderm® trademarks against Aesthetic Services and Development Limited, Juvederm Elite Clinics SARL and Jamal Hamadi in the (UK) High Court of Justice. The case is still ongoing.
Furthermore, more than
Antitrust Litigation
Loestrin® 24 Litigation. Putative classes of direct and indirect purchasers as well as opt-out direct purchasers have filed complaints that have been consolidated in the U.S. District Court for the District of Rhode Island. The lawsuits allege that subsidiaries of the Company engaged in anticompetitive conduct, including when settling patent lawsuits related to Loestrin® 24 Fe, in violation of federal and state antitrust and consumer protection laws. The complaints each seek declaratory and injunctive relief and compensatory damages in the billions of dollars which, if plaintiffs are successful, are subject to trebling under the antitrust laws. The court granted the direct purchaser plaintiffs’ class certification motion but had not decided the indirect purchaser plaintiffs’ class motion. Summary judgement motions were fully briefed, and oral arguments were held in September 2019. Trial in this action was scheduled to begin in January 2020. The parties reached agreements with each group of plaintiffs that, taken together, will resolve this litigation in its entirety. Based on the settlements with the plaintiffs, the Company booked an accrual of $
Namenda® Litigation. In 2014, the State of New York filed a lawsuit in the U.S. District Court for the Southern District of New York alleging that Forest was acting to prevent or delay generic competition to Namenda® in violation of federal and New York antitrust laws and committed other fraudulent acts in connection with its commercial plans for Namenda® XR. The district court granted the state’s motion for a preliminary injunction which was later affirmed by the Court of Appeals for the Second Circuit. The parties in that case then reached a settlement to resolve the dispute. Following the conclusion of the New York Attorney General Matter, putative class actions were filed on behalf of direct and indirect purchasers in the same federal court. The class action complaints make claims similar to those asserted by the New York Attorney General and also include claims that Namenda® patent litigation settlements between a Company subsidiary and generic companies also violated the antitrust laws. The court had denied defendants’ motion for summary judgment in the direct purchaser action, certified the direct purchaser class of plaintiffs and set a trial date for October 28, 2019. Prior to the start of the trial, the parties in the direct purchaser class action reached an agreement in principle to settle that litigation for $
Restasis® Competitor Litigation. Shire, which offers the dry-eye disease drug Xiidra®, sued subsidiaries of the Company in U.S. District Court for the District of New Jersey alleging that defendants unlawfully harmed competition by foreclosing Xiidra® from sales to Medicare Part D plans (and the members of such plans) through the use of discounts (a) contingent on Restasis® receiving preferential formulary treatment; and/or (b) across a bundle of Allergan’s products, including Restasis®. The complaint seeks injunctive relief and damages under federal and state law. The court issued a decision on March 22, 2019 granting the defendants’ motion to dismiss the complaint. On April 25, 2019, Shire filed an amended complaint. Defendants have moved to dismiss the amended complaint. At the request of the parties, the court entered an Order on June 28, 2019, staying the action through December 27, 2019. The stay was extended through February 18, 2020 during which time the parties reached an agreement in principal to settle this litigation
Restasis® Class Action Litigation. Several class actions were filed on behalf of putative classes of direct and indirect purchasers of Restasis® alleging that subsidiaries of the company harmed competition by engaging in conduct to delay the market entry of generic versions of Restasis® in violation of the federal antitrust laws as well as state antitrust and consumer-protection laws and unjust enrichment. The cases have been consolidated in the U.S. District Court for the District of New Jersey. All plaintiffs seek compensatory damages in the billions of dollars which, if plaintiffs are successful are subject to trebling under the antitrust laws, as well as declaratory relief, and injunctive relief. The parties are currently engaged in discovery. Trial in this action is scheduled to begin in April 2020. Recently, the Company reached agreements to settle the claims asserted by all direct purchaser plaintiffs and the Company has taken a reserve of $
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Commercial Litigation
Warner Chilcott Marketing Practices. putative nationwide class of private payer entities, or their assignees, that paid Medicare benefits on behalf of their beneficiaries filed a complaint against certain subsidiaries of the Company in the U.S. District Court for the District of Massachusetts. The Complaint asserts claims under the federal RICO statute, state consumer protection statutes, common law fraud, and unjust enrichment with respect to the sale and marketing of certain products. The court recently granted Defendants’ motion to dismiss the Amended Complaint. Following the dismissal of the action in federal court, plaintiffs recently filed a nearly identical complaint in state court in New Jersey. On March 27, 2020, the state court granted the Defendants’ motion to dismiss.
Generic Drug Pricing Securities and ERISA Litigation. Putative classes of shareholders and
Prescription Opioid Drug Abuse Litigation. The Company has been named as a defendant, along with several other manufacturers and distributors of opioid products, in over
Breast Implant Securities Class Action. In December 2018, two plaintiffs filed class action lawsuits against the Company and certain of its current and former officers alleging that defendants made materially false and misleading statements regarding the Company’s textured breast implants and their association with an uncommon cancer known as breast implant associated anaplastic large cell lymphoma. These lawsuits have been consolidated in the U.S. District Court for the Southern District of New York. The complaints seek unspecified monetary damages. The Company filed a motion to dismiss the amended complaint, which the court granted in part and denied in part in a ruling on September 20, 2019. The Company filed its answer on October 18, 2019 and the parties are now engaging in discovery.
Oculeve Shareholder Dispute. On February 26, 2019, Fortis Advisors LLC, as a representative of the former stockholders of Oculeve, Inc., filed a lawsuit against a subsidiary of the Company in state court in Delaware. The lawsuit centers on a claim that the Company breached the terms of a July 2015 merger agreement. The court recently denied the Company subsidiary’s motion to dismiss the complaint.
AbbVie Transaction Shareholder Action. On June 25, 2019, the Company and AbbVie Inc. announced that the companies had entered into a definitive transaction agreement whereby AbbVie will acquire the Company in a cash and stock transaction. On September 20, 2019, a putative class action lawsuit was filed against the Company by one of its shareholders alleging that the Company and its Board of Directors violated the Securities laws by omitting or misrepresenting material information in the proxy statement the Company filed on September 16, 2019 seeking shareholder approval of the transaction with AbbVie. In addition to the complaint in this action, the Company received a shareholder demand letter from a shareholder following the issuance of the preliminary proxy statement filed with the Securities and Exchange Commission on August 12, 2019. The lawsuit and demand letters were voluntarily dismissed and withdrawn.
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Product Liability Litigation
Actonel® Litigation. A subsidiary of the Company is a defendant in over
Breast Implant Litigation. Certain Company subsidiaries are defendants in approximately
Benicar® Litigation. A subsidiary of the Company has been named in a number of lawsuits involving allegations that Benicar® caused certain gastrointestinal injuries. Under a co-promotion agreement, Daiichi Sankyo is defending the Company subsidiary in these lawsuits and has announced that it has agreed to enter into a program to settle all of the pending cases on behalf of all defendants, including the Company subsidiary.
Celexa®/Lexapro® Litigation. Certain Company subsidiaries are defendants in over
RepliForm® Litigation. A Company subsidiary has been named as a defendant in over
Testosterone Litigation. A number of product liability suits were filed against certain Company subsidiaries as well as other manufacturers and distributors of testosterone products, for personal injuries including but not limited to cardiovascular events allegedly arising out of the use of Androderm®. The cases have been consolidated in an MDL in the U.S. District Court for Northern District of Illinois. In mid-2018, the parties reached an agreement to settle all of the pending cases.
Government Investigations, Government Litigation and Qui Tam Litigation
The Company and its subsidiaries are involved in various disputes, governmental and/or regulatory inspections, inquires, investigations and proceedings that could result in litigation, and other litigation matters that arise from time to time.
Company subsidiaries have received subpoenas and/or Civil Investigative Demands (“CID”) from the United States Department of Justice, the United States Health and Human Services, Office of Inspector General, United States Congressional Committees as well as various state regulatory and enforcement authorities. Each of the subpoenas and CIDs seek documents and information relating to discrete topics, including but not limited to: the calculation and reporting by certain Company subsidiaries of their Average Manufacturer Prices, Average Wholesale Prices and Best Prices for several of their products; sales and marketing practices of Botox to urology practices; the promotion and sale of
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Certain states have initiated lawsuits and qui tam lawsuits have been filed by private parties, also known as relators, on behalf of the federal or state governments. Certain Company subsidiaries have been named as defendants in lawsuits that allege generally that state Medicaid agencies were overcharged for their share of Medicaid drug reimbursement costs due to inflated Average Wholesale Prices (“AWP”) reported by the Company subsidiaries. AWP lawsuits are currently pending in Illinois, Utah and Wisconsin.
Namenda XR®/Namzaric® Qui Tam. A relator filed a qui tam lawsuit on behalf of the United States government and several individual states against the Company and certain of its subsidiaries along with Adamas Pharma LLC and Adamas Pharmaceuticals, Inc. (collectively, “Adamas”). The lawsuit, filed in the U.S. District Court for the Northern District of California, was unsealed on February 6, 2019. The federal and state governments have declined to intervene in this action. The complaint alleges generally that the Adamas and Allergan defendants each engaged in conduct that delayed generic versions of Namenda XR® and/or Namzaric® from entering the market and that such conduct resulted in the submission of false claims to the government. The Company Defendants and Adamas have moved to dismiss the complaint. Oral argument on the motions to dismiss was held in December 2019.
Medical Aesthetics Qui Tam. A subsidiary of the Company was served with a qui tam lawsuit that was filed in the U.S. District Court for the Central District of California on behalf of the United States and several individual states. The federal and state governments have declined to intervene in this action. The complaint alleges that certain promotional programs and sampling practices of the Company’s Medical Aesthetics business result in price reporting violations and violate anti-kickback statutes. The court recently denied the Company subsidiary’s motion to dismiss this complaint.
Lumigan® Qui Tam. A relator filed a qui tam lawsuit on behalf of the United States government and several individual states against a subsidiary of the Company in the U.S. District Court for the Southern District of New York, which was unsealed on October 1, 2019. The federal and state governments have declined to intervene in this action. The complaint alleges generally that Allergan failed to disclose certain side effects of Lumigan® which resulted in the submission of false claims for reimbursement to the government. The Company has not yet been served with the complaint.
Pricing Qui Tam. A relator filed a qui tam lawsuit on behalf of the United States government and several individual states against certain subsidiaries of the Company in the U.S. District Court for the District of Maryland, which was unsealed on September 17, 2019. The federal and state governments have declined to intervene in this action. The complaint alleges generally that the Company misreported its Best Price and Average Manufacturer Price for a number of products, thereby causing overpayment by the government. Defendants have moved to dismiss relator’s complaint.
Matters Relating to the Company’s Divested Generics Business
The following matters relate to the former generics business of the Company or the transaction pursuant to which that business was sold to Teva, effective August 2, 2016. Teva has agreed to indemnify and defend the Company against all matters asserted in litigation against the Company arising out of the former generics business, including litigations and investigations relating to generic opioid products including, without limitation, the actions described below.
Hydrocortisone Investigation. In 2016, the Company received notice from the UK Competition and Markets Authority (“CMA”) that it would be included within the scope of the CMA’s formal investigation under Section 25 of the Competition Act of 1998 (“CA98”) into suspected abuse of dominance by a former generics business subsidiary of the Company in relation to the supply of 10mg and 20mg hydrocortisone tablets. The CMA is investigating: (i) alleged excessive and unfair prices with respect to hydrocortisone tablets and (ii) whether the former generics business subsidiary entered into anti-competitive agreements with a potential competitor for this product. The CMA has issued statements of objection with respect to both parts of its investigation. The Company intends to cooperate fully with the investigation.
Teva Shareholder Derivative Litigation. In 2017, the Company was named as defendant in a proposed Teva shareholder derivative litigation filed in the Economic Division of the Tel Aviv District Court in Israel. The lawsuit contains allegations that the Company aided and abetted Teva’s board of directors’ violations of Israeli securities laws. Recently, the plaintiffs have sought to assert additional claims against the Company. To date, the court has not determined whether it will allow plaintiffs to proceed with this action.
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NOTE 16 — Warner Chilcott Limited (“WCL”) Guarantor and Non-Guarantor Condensed Consolidating Financial Information
The following financial information is presented to segregate the financial results of WCL, Allergan Funding SCS, and Allergan Finance, LLC (the issuers of the long-term notes), the guarantor subsidiaries for the long-term notes and the non-guarantor subsidiaries. The guarantors jointly and severally, and fully and unconditionally, guarantee the Company’s obligation under the long-term notes.
The information includes elimination entries necessary to consolidate the guarantor and the non-guarantor subsidiaries. Investments in subsidiaries are accounted for using the equity method of accounting. The principal elimination entries eliminate investments in subsidiaries, equity and intercompany balances and transactions.
WCL, Allergan Capital S.à.r.l. and Allergan Finance, LLC are guarantors of the long-term notes.
WCL has revised its consolidating balance sheets as previously presented in Footnote 27 of the December 31, 2019 Annual Report on Form 10-K and its consolidating financial statements as previously presented in Footnote 21 of the March 31, 2019 Quarterly Report on Form 10-Q due to a change in the Company’s legal entity structure and other reclassifications that occurred during the three months ended March 31, 2020. As a result, prior period information has been recast to conform to the current period presentation.
The following financial information presents the consolidating balance sheets as of March 31, 2020 and December 31, 2019, the related statements of operations for the three months ended March 31, 2020 and 2019 and the statements of cash flows for the three months ended March 31, 2020 and 2019.
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Warner Chilcott Limited
Consolidating Balance Sheets
As of March 31, 2020
(Unaudited; in millions)
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Warner Chilcott Limited (Parent Guarantor) |
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Allergan Capital S.a.r.l. (Guarantor) |
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|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Inventories |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Intercompany receivables |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Total current assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
Property, plant and equipment, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Right of use asset - operating leases |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments and other assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Investment in subsidiaries |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
Non current intercompany receivables |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
Non current assets held for sale |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Deferred tax assets |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Product rights and other intangibles |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Goodwill |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Total assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Intercompany payables |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
- |
|
|
Payables to Parents |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Income taxes payable |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Current portion of long-term debt |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Current portion of lease liability - operating |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
Total current liabilities |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||