o
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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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 March 31, 2020
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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001-36867 |
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Allergan plc Clonshaugh Business and Technology Park Coolock, Dublin, D17 E400, Ireland (862) 261-7000 |
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Ireland |
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98-1114402 |
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001-36887 |
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Warner Chilcott Limited |
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Bermuda |
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98-0496358 |
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Victoria Place, 5th Floor |
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Hamilton HM 10 |
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Bermuda |
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(441) 295-2244 |
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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 |
AGN |
New York Stock Exchange |
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Floating rate notes due 2020 |
AGN20A |
New York Stock Exchange |
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0.500% notes due 2021 |
AGN21 |
New York Stock Exchange |
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1.500% notes due 2023 |
AGN 23A |
New York Stock Exchange |
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1.250% notes due 2024 |
AGN 24A |
New York Stock Exchange |
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2.625% notes due 2028 |
AGN28 |
New York Stock Exchange |
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2.125% notes due 2029 |
AGN29 |
New York Stock Exchange |
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 |
AGN |
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 |
☒ |
Accelerated filer |
☐ |
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Non-accelerated filer |
☐ |
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 |
☒ |
Smaller reporting company |
☐ |
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Emerging growth company |
☐ |
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: 329,805,791. There is no trading market for securities of Warner Chilcott Limited, all of which are indirectly wholly owned by Allergan plc.
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 |
3 |
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4 |
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5 |
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6 |
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7 |
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Consolidated Balance Sheets of Warner Chilcott Limited as of March 31, 2020 and December 31, 2019 |
8 |
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9 |
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10 |
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11 |
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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 |
54 |
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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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73 |
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Item 1. |
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73 |
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Item 1A. |
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73 |
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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)
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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$ |
3,604.4 |
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$ |
3,597.1 |
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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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623.1 |
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497.8 |
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Research and development |
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430.0 |
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435.0 |
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Selling and marketing |
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972.1 |
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804.0 |
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General and administrative |
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401.3 |
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308.3 |
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Amortization |
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1,416.4 |
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1,399.4 |
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Goodwill impairments |
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913.0 |
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2,467.0 |
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Asset sales and impairments, net |
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148.1 |
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(5.2 |
) |
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Total operating expenses |
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4,904.0 |
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5,906.3 |
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Operating (loss) / income |
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(1,299.6 |
) |
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(2,309.2 |
) |
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Interest income |
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21.2 |
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21.3 |
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Interest (expense) |
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(184.5 |
) |
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(201.8 |
) |
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Other income / (expense), net |
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(24.9 |
) |
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13.8 |
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Total other (expense), net |
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(188.2 |
) |
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(166.7 |
) |
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(Loss) before income taxes and noncontrolling interest |
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(1,487.8 |
) |
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(2,475.9 |
) |
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(Benefit) for income taxes |
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(1,866.8 |
) |
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(68.6 |
) |
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Net income / (loss) |
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379.0 |
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(2,407.3 |
) |
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(Income) attributable to noncontrolling interest |
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(1.0 |
) |
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(0.7 |
) |
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Net Income / (loss) attributable to shareholders |
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$ |
378.0 |
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$ |
(2,408.0 |
) |
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Income / (Loss) per share attributable to shareholders |
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Basic |
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$ |
1.15 |
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$ |
(7.25 |
) |
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Diluted |
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$ |
1.14 |
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$ |
(7.25 |
) |
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Weighted average shares outstanding: |
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Basic |
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329.1 |
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332.0 |
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Diluted |
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331.9 |
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332.0 |
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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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$ |
379.0 |
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$ |
(2,407.3 |
) |
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Other comprehensive (loss) / income |
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Foreign currency translation (losses) |
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(127.2 |
) |
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(127.8 |
) |
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Unrealized (losses), net of tax |
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(1.0 |
) |
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(1.0 |
) |
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Total other comprehensive (loss), net of tax |
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(128.2 |
) |
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(128.8 |
) |
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Comprehensive income / (loss) |
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250.8 |
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(2,536.1 |
) |
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Comprehensive (income) attributable to noncontrolling interest |
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(1.0 |
) |
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(0.7 |
) |
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Comprehensive income / (loss) attributable to ordinary shareholders |
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$ |
249.8 |
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$ |
(2,536.8 |
) |
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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$ |
379.0 |
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$ |
(2,407.3 |
) |
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Reconciliation to net cash provided by operating activities: |
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Depreciation |
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56.8 |
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47.5 |
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Amortization |
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1,416.4 |
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1,399.4 |
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Provision for inventory reserve |
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28.4 |
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18.8 |
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Share-based compensation |
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51.6 |
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52.3 |
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Deferred income tax benefit |
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(1,931.1 |
) |
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(229.7 |
) |
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Goodwill impairments |
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913.0 |
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2,467.0 |
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(Gain) / loss on asset sales and impairments, net |
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148.1 |
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(5.2 |
) |
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Non-cash extinguishment of debt |
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- |
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0.3 |
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Amortization of deferred financing costs |
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4.1 |
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4.6 |
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Non-cash lease expense |
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35.9 |
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30.1 |
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Contingent consideration adjustments, including accretion |
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26.6 |
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18.7 |
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Other, net |
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65.2 |
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(10.3 |
) |
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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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330.2 |
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132.4 |
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Decrease / (increase) in inventories |
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(126.3 |
) |
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(128.3 |
) |
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Decrease / (increase) in prepaid expenses and other current assets |
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(20.1 |
) |
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36.2 |
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Increase / (decrease) in accounts payable and accrued expenses |
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(1,242.9 |
) |
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(199.8 |
) |
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Increase / (decrease) in income and other net taxes payable |
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2.1 |
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60.0 |
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Increase / (decrease) in other assets and liabilities |
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(20.5 |
) |
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(52.7 |
) |
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Net cash provided by operating activities |
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116.5 |
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1,234.0 |
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Cash Flows From Investing Activities: |
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Additions to property, plant and equipment |
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(60.4 |
) |
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(64.8 |
) |
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Additions to product rights and other intangibles |
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(57.6 |
) |
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(7.5 |
) |
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Additions to investments |
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(5.0 |
) |
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(538.2 |
) |
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Proceeds from sale of investments and other assets |
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1,800.0 |
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569.1 |
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Proceeds from sales of property, plant and equipment |
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2.1 |
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17.2 |
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Acquisitions of businesses, net of cash acquired |
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- |
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(80.6 |
) |
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Net cash (used in) / provided by investing activities |
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1,679.1 |
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(104.8 |
) |
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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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(3,031.8 |
) |
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(159.4 |
) |
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Payments of contingent consideration and other financing |
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(2.8 |
) |
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(2.0 |
) |
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Proceeds from stock plans |
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64.4 |
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9.7 |
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Repurchase of ordinary shares |
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(54.7 |
) |
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(829.2 |
) |
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Dividends paid |
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(243.5 |
) |
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(246.1 |
) |
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Net cash (used in) financing activities |
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(3,268.4 |
) |
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(1,227.0 |
) |
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Effect of currency exchange rate changes on cash and cash equivalents |
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(31.0 |
) |
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5.9 |
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Net increase / (decrease) in cash and cash equivalents |
|
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(1,503.8 |
) |
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(91.9 |
) |
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Cash and cash equivalents at beginning of period |
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|
2,503.3 |
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|
880.4 |
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Cash and cash equivalents at end of period |
|
$ |
999.5 |
|
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$ |
788.5 |
|
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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 |
|
$ |
68.7 |
|
|
$ |
105.4 |
|
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Interest |
|
$ |
237.6 |
|
|
$ |
252.0 |
|
|
Schedule of Non-Cash Investing and Financing Activities: |
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|
|
|
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|
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Dividends accrued |
|
$ |
244.5 |
|
|
$ |
1.4 |
|
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 |
|
|
332.6 |
|
|
$ |
- |
|
|
$ |
56,510.0 |
|
|
$ |
7,258.9 |
|
|
$ |
1,345.2 |
|
|
$ |
16.9 |
|
|
$ |
65,131.0 |
|
|
Implementation of new accounting pronouncement |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(22.0 |
) |
|
|
- |
|
|
|
- |
|
|
|
(22.0 |
) |
|
BALANCE, January 1, 2019 |
|
|
332.6 |
|
|
$ |
- |
|
|
$ |
56,510.0 |
|
|
$ |
7,236.9 |
|
|
$ |
1,345.2 |
|
|
$ |
16.9 |
|
|
$ |
65,109.0 |
|
|
Comprehensive (loss): |
|
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|
|
|
|
|
|
|
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|
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|
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|
Net (loss) attributable to shareholders |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,408.0 |
) |
|
|
- |
|
|
|
- |
|
|
|
(2,408.0 |
) |
|
Other comprehensive (loss), net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(128.8 |
) |
|
|
- |
|
|
|
(128.8 |
) |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
52.3 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
52.3 |
|
|
Ordinary shares issued under employee stock plans |
|
|
0.7 |
|
|
|
- |
|
|
|
9.7 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
9.7 |
|
|
Dividends declared |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(246.1 |
) |
|
|
- |
|
|
|
- |
|
|
|
(246.1 |
) |
|
Repurchase of ordinary shares under the share repurchase programs |
|
|
(5.3 |
) |
|
|
- |
|
|
|
(799.7 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(799.7 |
) |
|
Repurchase of ordinary shares |
|
|
(0.2 |
) |
|
|
- |
|
|
|
(29.5 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(29.5 |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.7 |
|
|
|
0.7 |
|
|
BALANCE, March 31, 2019 |
|
|
327.8 |
|
|
$ |
- |
|
|
$ |
55,742.8 |
|
|
$ |
4,582.8 |
|
|
$ |
1,216.4 |
|
|
$ |
17.6 |
|
|
$ |
61,559.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, December 31, 2019 |
|
|
328.6 |
|
|
$ |
- |
|
|
$ |
55,974.9 |
|
|
$ |
991.5 |
|
|
$ |
1,207.2 |
|
|
$ |
22.8 |
|
|
$ |
58,196.4 |
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to shareholders |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
378.0 |
|
|
|
- |
|
|
|
- |
|
|
|
378.0 |
|
|
Other comprehensive income, net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(128.2 |
) |
|
|
- |
|
|
|
(128.2 |
) |
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
51.6 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
51.6 |
|
|
Ordinary shares issued under employee stock plans |
|
|
1.4 |
|
|
|
- |
|
|
|
64.4 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
64.4 |
|
|
Dividends declared |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(487.0 |
) |
|
|
- |
|
|
|
- |
|
|
|
(487.0 |
) |
|
Repurchase of ordinary shares |
|
|
(0.3 |
) |
|
|
- |
|
|
|
(54.7 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(54.7 |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1.0 |
|
|
|
1.0 |
|
|
BALANCE, March 31, 2020 |
|
|
329.7 |
|
|
|
- |
|
|
|
56,036.2 |
|
|
|
882.5 |
|
|
|
1,079.0 |
|
|
|
23.8 |
|
|
|
58,021.5 |
|
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 |
|
$ |
990.5 |
|
|
$ |
2,497.1 |
|
|
Marketable securities |
|
|
1,618.8 |
|
|
|
3,411.6 |
|
|
Accounts receivable, net of allowances for doubtful accounts and credit losses of $144.8 and $110.8 |
|
|
2,800.6 |
|
|
|
3,192.3 |
|
|
Receivables from Parents |
|
|
539.0 |
|
|
|
409.3 |
|
|
Inventories |
|
|
1,199.9 |
|
|
|
1,133.1 |
|
|
Prepaid expenses and other current assets |
|
|
855.3 |
|
|
|
886.4 |
|
|
Total current assets |
|
|
8,004.1 |
|
|
|
11,529.8 |
|
|
Property, plant and equipment, net |
|
|
1,915.4 |
|
|
|
1,926.5 |
|
|
Right of use asset - operating leases |
|
|
481.0 |
|
|
|
490.4 |
|
|
Investments and other assets |
|
|
430.7 |
|
|
|
408.0 |
|
|
Non current assets held for sale |
|
|
31.7 |
|
|
|
31.7 |
|
|
Deferred tax assets |
|
|
597.9 |
|
|
|
576.9 |
|
|
Product rights and other intangibles |
|
|
36,266.2 |
|
|
|
37,890.6 |
|
|
Goodwill |
|
|
41,229.2 |
|
|
|
42,248.3 |
|
|
Total assets |
|
$ |
88,956.2 |
|
|
$ |
95,102.2 |
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
5,044.9 |
|
|
$ |
6,347.0 |
|
|
Payables to Parents |
|
|
2,899.9 |
|
|
|
2,715.5 |
|
|
Income taxes payable |
|
|
73.5 |
|
|
|
65.1 |
|
|
Current portion of long-term debt |
|
|
1,950.7 |
|
|
|
4,532.5 |
|
|
Current portion of lease liability - operating |
|
|
119.8 |
|
|
|
124.4 |
|
|
Total current liabilities |
|
|
10,088.8 |
|
|
|
13,784.5 |
|
|
Long-term debt |
|
|
17,599.0 |
|
|
|
18,116.5 |
|
|
Lease liability - operating |
|
|
438.3 |
|
|
|
446.1 |
|
|
Other long-term liabilities |
|
|
787.9 |
|
|
|
801.4 |
|
|
Other taxes payable |
|
|
1,683.9 |
|
|
|
1,698.6 |
|
|
Deferred tax liabilities |
|
|
2,455.8 |
|
|
|
4,363.2 |
|
|
Total liabilities |
|
|
33,053.7 |
|
|
|
39,210.3 |
|
|
Commitments and contingencies (Refer to Note 15) |
|
|
|
|
|
|
|
|
|
Equity: |
|
|
|
|
|
|
|
|
|
Members' capital |
|
|
63,780.1 |
|
|
|
64,023.6 |
|
|
(Accumulated deficit) |
|
|
(8,980.4 |
) |
|
|
(9,361.7 |
) |
|
Accumulated other comprehensive income |
|
|
1,079.0 |
|
|
|
1,207.2 |
|
|
Total members’ equity |
|
|
55,878.7 |
|
|
|
55,869.1 |
|
|
Noncontrolling interest |
|
|
23.8 |
|
|
|
22.8 |
|
|
Total equity |
|
|
55,902.5 |
|
|
|
55,891.9 |
|
|
Total liabilities and equity |
|
$ |
88,956.2 |
|
|
$ |
95,102.2 |
|
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 |
|
$ |
3,604.4 |
|
|
$ |
3,597.1 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
|
|
623.1 |
|
|
|
497.8 |
|
|
Research and development |
|
|
430.0 |
|
|
|
435.0 |
|
|
Selling and marketing |
|
|
972.1 |
|
|
|
804.0 |
|
|
General and administrative |
|
|
398.0 |
|
|
|
306.1 |
|
|
Amortization |
|
|
1,416.4 |
|
|
|
1,399.4 |
|
|
Goodwill impairments |
|
|
913.0 |
|
|
|
2,467.0 |
|
|
Asset sales and impairments, net |
|
|
148.1 |
|
|
|
(5.2 |
) |
|
Total operating expenses |
|
|
4,900.7 |
|
|
|
5,904.1 |
|
|
Operating (loss) / income |
|
|
(1,296.3 |
) |
|
|
(2,307.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
21.2 |
|
|
|
21.3 |
|
|
Interest (expense) |
|
|
(184.5 |
) |
|
|
(201.8 |
) |
|
Other (expense) income, net |
|
|
(24.9 |
) |
|
|
13.8 |
|
|
Total other (expense), net |
|
|
(188.2 |
) |
|
|
(166.7 |
) |
|
(Loss) / income before income taxes and noncontrolling interest |
|
|
(1,484.5 |
) |
|
|
(2,473.7 |
) |
|
(Benefit) for income taxes |
|
|
(1,866.8 |
) |
|
|
(68.7 |
) |
|
Net income / (loss) |
|
|
382.3 |
|
|
|
(2,405.0 |
) |
|
(Income) attributable to noncontrolling interest |
|
|
(1.0 |
) |
|
|
(0.7 |
) |
|
Net income / (loss) attributable to members |
|
$ |
381.3 |
|
|
$ |
(2,405.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
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) |
|
$ |
382.3 |
|
|
$ |
(2,405.0 |
) |
|
Other comprehensive (loss) / income |
|
|
|
|
|
|
|
|
|
Foreign currency translation (losses) |
|
|
(127.2 |
) |
|
|
(127.8 |
) |
|
Unrealized gains / (losses), net of tax |
|
|
(1.0 |
) |
|
|
(1.0 |
) |
|
Total other comprehensive (loss), net of tax |
|
|
(128.2 |
) |
|
|
(128.8 |
) |
|
Comprehensive income / (loss) |
|
|
254.1 |
|
|
|
(2,533.8 |
) |
|
Comprehensive (income) attributable to noncontrolling interest |
|
|
(1.0 |
) |
|
|
(0.7 |
) |
|
Comprehensive income / (loss) attributable to members |
|
$ |
253.1 |
|
|
$ |
(2,534.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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) |
|
$ |
382.3 |
|
|
$ |
(2,405.0 |
) |
|
Reconciliation to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
56.8 |
|
|
|
47.5 |
|
|
Amortization |
|
|
1,416.4 |
|
|
|
1,399.4 |
|
|
Provision for inventory reserve |
|
|
28.4 |
|
|
|
18.8 |
|
|
Share-based compensation |
|
|
51.6 |
|
|
|
52.3 |
|
|
Deferred income tax benefit |
|
|
(1,931.1 |
) |
|
|
(229.7 |
) |
|
Goodwill impairments |
|
|
913.0 |
|
|
|
2,467.0 |
|
|
(Gain) / loss on asset sales and impairments, net |
|
|
148.1 |
|
|
|
(5.2 |
) |
|
Non-cash extinguishment of debt |
|
|
- |
|
|
|
0.3 |
|
|
Amortization of deferred financing costs |
|
|
4.1 |
|
|
|
4.6 |
|
|
Non-cash lease expense |
|
|
35.9 |
|
|
|
30.1 |
|
|
Contingent consideration adjustments, including accretion |
|
|
26.6 |
|
|
|
18.7 |
|
|
Other, net |
|
|
65.2 |
|
|
|
(10.3 |
) |
|
Changes in assets and liabilities (net of effects of acquisitions): |
|
|
|
|
|
|
|
|
|
Decrease / (increase) in accounts receivable, net |
|
|
330.2 |
|
|
|
132.4 |
|
|
Decrease / (increase) in inventories |
|
|
(126.3 |
) |
|
|
(128.3 |
) |
|
Decrease / (increase) in prepaid expenses and other current assets |
|
|
(20.1 |
) |
|
|
40.4 |
|
|
Increase / (decrease) in accounts payable and accrued expenses |
|
|
(1,000.0 |
) |
|
|
(199.5 |
) |
|
Increase / (decrease) in income and other net taxes payable |
|
|
2.1 |
|
|
|
60.0 |
|
|
Increase / (decrease) in other assets and liabilities, including receivable / payable with Parents |
|
|
(259.8 |
) |
|
|
(79.3 |
) |
|
Net cash provided by operating activities |
|
|
123.4 |
|
|
|
1,214.2 |
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
(60.4 |
) |
|
|
(64.8 |
) |
|
Additions to product rights and other intangibles |
|
|
(57.6 |
) |
|
|
(7.5 |
) |
|
Additions to investments |
|
|
(5.0 |
) |
|
|
(538.2 |
) |
|
Proceeds from sale of investments and other assets |
|
|
1,800.0 |
|
|
|
569.1 |
|
|
Proceeds from sales of property, plant and equipment |
|
|
2.1 |
|
|
|
17.2 |
|
|
Acquisitions of businesses, net of cash acquired |
|
|
- |
|
|
|
(80.6 |
) |
|
Net cash (used in) / provided by investing activities |
|
|
1,679.1 |
|
|
|
(104.8 |
) |
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
|
|
Payments on debt, including finance lease obligations and credit facility |
|
|
(3,031.8 |
) |
|
|
(159.4 |
) |
|
Payments of contingent consideration and other financing |
|
|
(2.8 |
) |
|
|
(2.0 |
) |
|
Dividends to Parents |
|
|
(243.5 |
) |
|
|
(1,045.8 |
) |
|
Net cash (used in) financing activities |
|
|
(3,278.1 |
) |
|
|
(1,207.2 |
) |
|
Effect of currency exchange rate changes on cash and cash equivalents |
|
|
(31.0 |
) |
|
|
5.9 |
|
|
Net increase / (decrease) in cash and cash equivalents |
|
|
(1,506.6 |
) |
|
|
(91.9 |
) |
|
Cash and cash equivalents at beginning of period |
|
|
2,497.1 |
|
|
|
878.6 |
|
|
Cash and cash equivalents at end of period |
|
$ |
990.5 |
|
|
$ |
786.7 |
|
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 |
|
|
100.0 |
|
|
$ |
65,797.9 |
|
|
$ |
(4,219.7 |
) |
|
$ |
1,345.2 |
|
|
$ |
16.9 |
|
|
$ |
62,940.3 |
|
|
Implementation of new accounting pronouncements |
|
|
- |
|
|
|
- |
|
|
|
(22.0 |
) |
|
|
- |
|
|
|
- |
|
|
|
(22.0 |
) |
|
BALANCE, January 1, 2019 |
|
|
100.0 |
|
|
$ |
65,797.9 |
|
|
$ |
(4,241.7 |
) |
|
$ |
1,345.2 |
|
|
$ |
16.9 |
|
|
$ |
62,918.3 |
|
|
Comprehensive (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) attributable to members |
|
|
- |
|
|
|
- |
|
|
|
(2,405.7 |
) |
|
|
- |
|
|
|
- |
|
|
|
(2,405.7 |
) |
|
Other comprehensive (loss), net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(128.8 |
) |
|
|
- |
|
|
|
(128.8 |
) |
|
Dividends to Parents |
|
|
- |
|
|
|
(1,045.8 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,045.8 |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.7 |
|
|
|
0.7 |
|
|
BALANCE, March 31, 2019 |
|
|
100.0 |
|
|
$ |
64,752.1 |
|
|
$ |
(6,647.4 |
) |
|
$ |
1,216.4 |
|
|
$ |
17.6 |
|
|
$ |
59,338.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, December 31, 2019 |
|
|
100.0 |
|
|
$ |
64,023.6 |
|
|
$ |
(9,361.7 |
) |
|
$ |
1,207.2 |
|
|
$ |
22.8 |
|
|
$ |
55,891.9 |
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income attributable to members |
|
|
- |
|
|
|
- |
|
|
|
381.3 |
|
|
|
- |
|
|
|
- |
|
|
|
381.3 |
|
|
Other comprehensive (loss), net of tax |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(128.2 |
) |
|
|
- |
|
|
|
(128.2 |
) |
|
Dividends to Parents |
|
|
- |
|
|
|
(243.5 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(243.5 |
) |
|
Movement in noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1.0 |
|
|
|
1.0 |
|
|
BALANCE, March 31, 2020 |
|
|
100.0 |
|
|
|
63,780.1 |
|
|
|
(8,980.4 |
) |
|
|
1,079.0 |
|
|
|
23.8 |
|
|
|
55,902.5 |
|
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 100 countries. Warner Chilcott Limited is an indirect wholly-owned subsidiary of Allergan plc and has the same principal business activities.
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 $188.24 per Allergan share, or approximately $63.0 billion, based on AbbVie’s then-current stock price at the time the AbbVie Transaction was announced. At the closing of the proposed AbbVie Transaction, Company shareholders will receive 0.8660 shares of AbbVie common stock and $120.30 in cash for each of their existing shares. On October 14, 2019, the Company’s shareholders voted to approve the AbbVie Transaction. The AbbVie Transaction is subject to customary regulatory approvals and other customary closing conditions. On May 5, 2020 the U.S. Federal Trade Commission (“FTC”) accepted a proposed consent order in connection with the AbbVie Transaction. Under the terms of the consent order, the companies have agreed to divest brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle Health Science. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.
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 September 15, 2020 through March 15, 2045 for up to approximately $19.6 billion aggregate principal amount of new notes to be issued by AbbVie and cash. In conjunction with the exchange offer, AbbVie solicited and obtained consents from eligible holders of the Allergan Senior Notes to amend each of the indentures governing the Allergan Senior Notes to eliminate substantially all of the restrictive covenants in such indentures and eliminate any guarantees of the related Allergan Senior Notes. Consummation of the exchange offer is conditioned upon, among other things, the closing of the AbbVie Transaction. The exchange offers are expected to close, and such amendments are expected to become operative, on or about the closing date of the AbbVie Transaction.
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):
|
|
|
As of March 31, 2020 |
|
|
As of December 31, 2019 |
|
||||||||||||||||||
|
|
|
Allergan plc |
|
|
Warner Chilcott Limited |
|
|
Difference |
|
|
Allergan plc |
|
|
Warner Chilcott Limited |
|
|
Difference |
|
||||||
|
Cash and cash equivalents |
|
$ |
999.5 |
|
|
$ |
990.5 |
|
|
$ |
9.0 |
|
|
$ |
2,503.3 |
|
|
$ |
2,497.1 |
|
|
$ |
6.2 |
|
|
Prepaid expenses and other current assets |
|
|
855.3 |
|
|
|
855.3 |
|
|
|
- |
|
|
|
886.4 |
|
|
|
886.4 |
|
|
|
- |
|
|
Accounts payable and accrued liabilities |
|
|
5,289.5 |
|
|
|
5,044.9 |
|
|
|
244.6 |
|
|
|
6,348.7 |
|
|
|
6,347.0 |
|
|
|
1.7 |
|
|
Other taxes payable |
|
|
1,690.4 |
|
|
|
1,683.9 |
|
|
|
6.5 |
|
|
|
1,704.8 |
|
|
|
1,698.6 |
|
|
|
6.2 |
|
|
Total equity |
|
|
58,021.5 |
|
|
|
55,902.5 |
|
|
|
2,119.0 |
|
|
|
58,196.4 |
|
|
|
55,891.9 |
|
|
|
2,304.5 |
|
|
|
|
Three Months Ended March 31, 2020 |
|
|
Three Months Ended March 31, 2019 |
|
||||||||||||||||||
|
|
|
Allergan plc |
|
|
Warner Chilcott Limited |
|
|
Difference |
|
|
Allergan plc |
|
|
Warner Chilcott Limited |
|
|
Difference |
|
||||||
|
General and administrative expenses |
|
$ |
401.3 |
|
|
$ |
398.0 |
|
|
$ |
3.3 |
|
|
$ |
308.3 |
|
|
$ |
306.1 |
|
|
$ |
2.2 |
|
|
Operating income |
|
|
(1,299.6 |
) |
|
|
(1,296.3 |
) |
|
|
(3.3 |
) |
|
|
(2,309.2 |
) |
|
|
(2,307.0 |
) |
|
|
(2.2 |
) |
|
Interest income |
|
|
21.2 |
|
|
|
21.2 |
|
|
|
- |
|
|
|
21.3 |
|
|
|
21.3 |
|
|
|
- |
|
|
(Loss) / income before income taxes and noncontrolling interest |
|
|
(1,487.8 |
) |
|
|
(1,484.5 |
) |
|
|
(3.3 |
) |
|
|
(2,475.9 |
) |
|
|
(2,473.7 |
) |
|
|
(2.2 |
) |
|
(Benefit) for income taxes |
|
|
(1,866.8 |
) |
|
|
(1,866.8 |
) |
|
|
- |
|
|
|
(68.6 |
) |
|
|
(68.7 |
) |
|
|
0.1 |
|
|
Net (loss) / income |
|
|
379.0 |
|
|
|
382.3 |
|
|
|
(3.3 |
) |
|
|
(2,407.3 |
) |
|
|
(2,405.0 |
) |
|
|
(2.3 |
) |
|
Net (loss) / income attributable to ordinary shareholders/members |
|
|
378.0 |
|
|
|
381.3 |
|
|
|
(3.3 |
) |
|
|
(2,408.0 |
) |
|
|
(2,405.7 |
) |
|
|
(2.3 |
) |
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):
|
|
|
Chargebacks |
|
|
Rebates |
|
|
Returns and Other Allowances |
|
|
Cash Discounts |
|
|
Total |
|
|||||
|
Balance at December 31, 2019 |
|
$ |
67.8 |
|
|
$ |
2,103.3 |
|
|
$ |
632.4 |
|
|
$ |
37.0 |
|
|
$ |
2,840.5 |
|
|
Provision related to sales in 2020 |
|
|
279.5 |
|
|
|
1,466.7 |
|
|
|
467.5 |
|
|
|
81.3 |
|
|
|
2,295.0 |
|
|
Credits and payments |
|
|
(285.6 |
) |
|
|
(1,485.3 |
) |
|
|
(431.3 |
) |
|
|
(84.4 |
) |
|
|
(2,286.6 |
) |
|
Balance at March 31, 2020 |
|
$ |
61.7 |
|
|
$ |
2,084.7 |
|
|
$ |
668.6 |
|
|
$ |
33.9 |
|
|
$ |
2,848.9 |
|
|
Contra accounts receivable at March 31, 2020 |
|
$ |
61.7 |
|
|
$ |
72.1 |
|
|
$ |
30.0 |
|
|
$ |
33.9 |
|
|
$ |
197.7 |
|
|
Accounts payable and accrued expenses at March 31, 2020 |
|
$ |
- |
|
|
$ |
2,012.6 |
|
|
$ |
638.6 |
|
|
$ |
- |
|
|
$ |
2,651.2 |
|
The following table summarizes the balance sheet classification of our SRA reserves ($ in millions):
|
|
|
March 31, 2020 |
|
|
December 31, 2019 |
|
||
|
Contra accounts receivable |
|
$ |
197.7 |
|
|
$ |
242.0 |
|
|
Accounts payable and accrued expenses |
|
|
2,651.2 |
|
|
|
2,598.5 |
|
|
Total |
|
$ |
2,848.9 |
|
|
$ |
2,840.5 |
|
16
The SRA provisions recorded to reduce gross product sales to net product sales were as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Gross product sales |
|
$ |
5,752.0 |
|
|
$ |
5,659.9 |
|
|
Provisions to reduce gross product sales to net product sales |
|
|
(2,295.0 |
) |
|
|
(2,139.7 |
) |
|
Net product sales |
|
$ |
3,457.0 |
|
|
$ |
3,520.2 |
|
|
Percentage of SRA provisions to gross sales |
|
|
39.9 |
% |
|
|
37.8 |
% |
Collectability Assessment
At the time of contract inception or customer account set-up, the Company performs a collectability assessment on the creditworthiness of such customer. The Company assesses the probability that the Company will collect the consideration to which it will be entitled in exchange for the goods sold. In evaluating collectability, the Company considers the customer’s ability and intention to pay consideration when it is due. On a recurring basis, the Company estimates the amount of receivables considered uncollectible after sale to the customer to reflect allowances for doubtful accounts. Provision for bad debts, included in general and administrative expenses, were $44.2 million and $3.4 million in the three months ended March 31, 2020 and 2019, respectively. The increase in provisions for bad debts over the prior year period was primarily related to the impact of COVID-19 and the Company’s assessment of customer receivables primarily attributed to the US and International aesthetic business.
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):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Net income / (loss): |
|
|
|
|
|
|
|
|
|
Net income / (loss) attributable to ordinary shareholders |
|
$ |
378.0 |
|
|
$ |
(2,408.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average ordinary shares outstanding |
|
|
329.1 |
|
|
|
332.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Basic EPS: |
|
|
|
|
|
|
|
|
|
Net income / (loss) per share |
|
$ |
1.15 |
|
|
$ |
(7.25 |
) |
|
|
|
|
|
|
|
|
|
|
|
Dividends per ordinary share |
|
$ |
0.74 |
|
|
$ |
0.74 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average ordinary shares outstanding |
|
|
331.9 |
|
|
|
332.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS: |
|
|
|
|
|
|
|
|
|
Net income / (loss) per share |
|
$ |
1.14 |
|
|
$ |
(7.25 |
) |
18
Stock awards to purchase 2.4 million ordinary shares for the three months ended March 31, 2019 were outstanding, but not included in the computation of diluted EPS, because the awards were anti-dilutive. During the three months ended March 31, 2019, the Company repurchased shares under its share repurchase programs. The impact of the 5.3 million shares repurchased in the three months ended March 31, 2019 on basic EPS was 0.7 million shares.
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 |
|
Therapeutic Area |
|
Indication |
|
Expected Launch Year |
|
Phase |
|
Abicipar |
|
Eye Care |
|
Age Related Macular Degeneration |
|
2020 |
|
Review |
|
Atogepant |
|
Central Nervous System |
|
Prophylaxis Migraine |
|
2021 |
|
III |
|
Presbysol |
|
Eye Care |
|
Presbyopia |
|
2022 |
|
III |
|
Cenicriviroc |
|
Gastrointestinal |
|
NASH |
|
2022 |
|
III |
|
Brimonidine DDS |
|
Eye Care |
|
Geographic Atrophy |
|
2024 |
|
II |
|
Relamorelin |
|
Gastrointestinal |
|
Gastroparesis |
|
2024 |
|
III |
|
Botox |
|
Medical Aesthetics |
|
Platysma/Masseter |
|
2025/2024 |
|
II |
|
Abicipar |
|
Eye Care |
|
Diabetic Macular Edema |
|
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):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Debt extinguishment other |
|
|
- |
|
|
|
(0.3 |
) |
|
Other income, net |
|
|
(24.9 |
) |
|
|
14.1 |
|
|
Other income, net |
|
$ |
(24.9 |
) |
|
$ |
13.8 |
|
Other Income, Net
Other income, net includes the mark to market losses of $7.8 million and mark to market gains of $10.4 million on equity securities held by the Company during the three months ended March 31, 2020 and March 31, 2019, respectively.
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:
|
|
• |
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); |
|
|
• |
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. Using the Black-Scholes valuation model, the fair value of options is based on the following assumptions:
|
|
|
2019 Grants |
|
Dividend yield |
|
1.7 - 2.2% |
|
Expected volatility |
|
23.5 - 26.4% |
|
Risk-free interest rate |
|
1.9 - 2.6% |
|
Expected term (years) |
|
7.0 |
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 |
|
$ |
51.6 |
|
|
$ |
52.3 |
|
|
Total share-based compensation expense |
|
$ |
51.6 |
|
|
$ |
52.3 |
|
Unrecognized future share-based compensation expense was $477.0 million as of March 31, 2020. This amount will be recognized as an expense over a remaining weighted average period of 1.8 years. Share-based compensation is being amortized and charged to operations over the same period as the restrictions are eliminated for the participants, which is generally on a straight-line basis.
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 |
|
|
3.1 |
|
|
$ |
159.74 |
|
|
|
1.4 |
|
|
$ |
493.0 |
|
|
Granted |
|
|
1.3 |
|
|
|
193.84 |
|
|
|
|
|
|
|
257.8 |
|
|
Vested |
|
|
(0.8 |
) |
|
|
174.87 |
|
|
|
|
|
|
|
(143.2 |
) |
|
Forfeited |
|
|
- |
|
|
|
164.37 |
|
|
|
|
|
|
|
(4.9 |
) |
|
Restricted shares / units outstanding at March 31, 2020 |
|
|
3.6 |
|
|
$ |
168.76 |
|
|
|
1.9 |
|
|
$ |
602.7 |
|
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 |
|
|
5.5 |
|
|
$ |
127.27 |
|
|
|
3.9 |
|
|
$ |
352.9 |
|
|
Granted |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(0.6 |
) |
|
|
108.13 |
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
- |
|
|
|
229.40 |
|
|
|
|
|
|
|
|
|
|
Outstanding, vested and expected to vest at March 31, 2020 |
|
|
4.9 |
|
|
$ |
128.56 |
|
|
|
3.9 |
|
|
$ |
238.6 |
|
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 three segments.
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):
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):
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® |
|
$ |
608.5 |
|
|
$ |
- |
|
|
$ |
203.7 |
|
|
$ |
812.2 |
|
|
Restasis® |
|
|
278.6 |
|
|
|
- |
|
|
|
11.3 |
|
|
|
289.9 |
|
|
Vraylar® |
|
|
- |
|
|
|
277.3 |
|
|
|
- |
|
|
|
277.3 |
|
|
Juvederm® Collection |
|
|
107.5 |
|
|
|
- |
|
|
|
113.1 |
|
|
|
220.6 |
|
|
Linzess®/Constella® |
|
|
- |
|
|
|
172.2 |
|
|
|
7.1 |
|
|
|
179.3 |
|
|
Lumigan®/Ganfort® |
|
|
63.0 |
|
|
|
- |
|
|
|
80.7 |
|
|
|
143.7 |
|
|
Bystolic® / Byvalson® |
|
|
- |
|
|
|
129.8 |
|
|
|
0.5 |
|
|
|
130.3 |
|
|
Alphagan®/Combigan® |
|
|
81.6 |
|
|
|
- |
|
|
|
36.9 |
|
|
|
118.5 |
|
|
Eye Drops |
|
|
66.5 |
|
|
|
- |
|
|
|
50.9 |
|
|
|
117.4 |
|
|
Lo Loestrin® |
|
|
- |
|
|
|
109.8 |
|
|
|
- |
|
|
|
109.8 |
|
|
Alloderm ® |
|
|
102.1 |
|
|
|
- |
|
|
|
1.7 |
|
|
|
103.8 |
|
|
Ozurdex ® |
|
|
29.9 |
|
|
|
- |
|
|
|
63.8 |
|
|
|
93.7 |
|
|
Viibryd®/Fetzima® |
|
|
- |
|
|
|
89.8 |
|
|
|
3.5 |
|
|
|
93.3 |
|
|
Zenpep® |
|
|
- |
|
|
|
65.6 |
|
|
|
0.4 |
|
|
|
66.0 |
|
|
Armour Thyroid |
|
|
- |
|
|
|
46.3 |
|
|
|
- |
|
|
|
46.3 |
|
|
Breast Implants |
|
|
40.1 |
|
|
|
- |
|
|
|
5.2 |
|
|
|
45.3 |
|
|
Skin Care |
|
|
38.5 |
|
|
|
- |
|
|
|
2.8 |
|
|
|
41.3 |
|
|
Viberzi® |
|
|
- |
|
|
|
37.3 |
|
|
|
0.4 |
|
|
|
37.7 |
|
|
Coolsculpting ® Systems & Add On Applicators |
|
|
36.2 |
|
|
|
- |
|
|
|
1.4 |
|
|
|
37.6 |
|
|
Teflaro® |
|
|
- |
|
|
|
35.0 |
|
|
|
1.5 |
|
|
|
36.5 |
|
|
Coolsculpting ® Consumables |
|
|
22.7 |
|
|
|
- |
|
|
|
8.8 |
|
|
|
31.5 |
|
|
Saphris® |
|
|
- |
|
|
|
31.0 |
|
|
|
- |
|
|
|
31.0 |
|
|
Dalvance® |
|
|
- |
|
|
|
23.0 |
|
|
|
3.1 |
|
|
|
26.1 |
|
|
Liletta® |
|
|
- |
|
|
|
23.1 |
|
|
|
- |
|
|
|
23.1 |
|
|
Carafate ® / Sulcrate ® |
|
|
- |
|
|
|
19.0 |
|
|
|
1.0 |
|
|
|
20.0 |
|
|
Savella® |
|
|
- |
|
|
|
19.3 |
|
|
|
- |
|
|
|
19.3 |
|
|
Namzaric® |
|
|
- |
|
|
|
17.8 |
|
|
|
- |
|
|
|
17.8 |
|
|
Avycaz® |
|
|
- |
|
|
|
11.8 |
|
|
|
- |
|
|
|
11.8 |
|
|
Canasa®/Salofalk® |
|
|
- |
|
|
|
7.2 |
|
|
|
4.0 |
|
|
|
11.2 |
|
|
Ubrelvy® |
|
|
- |
|
|
|
11.1 |
|
|
|
- |
|
|
|
11.1 |
|
|
Asacol®/Delzicol® |
|
|
- |
|
|
|
2.6 |
|
|
|
7.7 |
|
|
|
10.3 |
|
|
Kybella® / Belkyra® |
|
|
5.3 |
|
|
|
- |
|
|
|
0.1 |
|
|
|
5.4 |
|
|
Aczone® |
|
|
3.0 |
|
|
|
- |
|
|
|
- |
|
|
|
3.0 |
|
|
Namenda® |
|
|
- |
|
|
|
2.9 |
|
|
|
- |
|
|
|
2.9 |
|
|
Rapaflo® |
|
|
1.4 |
|
|
|
- |
|
|
|
1.1 |
|
|
|
2.5 |
|
|
Other |
|
|
56.6 |
|
|
|
188.6 |
|
|
|
80.7 |
|
|
|
325.9 |
|
|
Total segment revenues |
|
$ |
1,541.5 |
|
|
$ |
1,320.5 |
|
|
$ |
691.4 |
|
|
$ |
3,553.4 |
|
|
Corporate revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51.0 |
|
|
Total net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,604.4 |
|
25
|
|
|
Three Months Ended March 31, 2019 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Botox® |
|
$ |
627.1 |
|
|
$ |
- |
|
|
$ |
241.3 |
|
|
$ |
868.4 |
|
|
Juvederm® Collection |
|
|
129.7 |
|
|
|
- |
|
|
|
157.8 |
|
|
|
287.5 |
|
|
Restasis® |
|
|
231.7 |
|
|
|
- |
|
|
|
10.4 |
|
|
|
242.1 |
|
|
Linzess®/Constella® |
|
|
- |
|
|
|
161.3 |
|
|
|
5.5 |
|
|
|
166.8 |
|
|
Vraylar® |
|
|
- |
|
|
|
143.7 |
|
|
|
- |
|
|
|
143.7 |
|
|
Lumigan®/Ganfort® |
|
|
57.7 |
|
|
|
- |
|
|
|
85.1 |
|
|
|
142.8 |
|
|
Bystolic® / Byvalson® |
|
|
- |
|
|
|
128.3 |
|
|
|
0.4 |
|
|
|
128.7 |
|
|
Lo Loestrin® |
|
|
- |
|
|
|
125.8 |
|
|
|
- |
|
|
|
125.8 |
|
|
Alphagan®/Combigan® |
|
|
83.0 |
|
|
|
- |
|
|
|
37.6 |
|
|
|
120.6 |
|
|
Eye Drops |
|
|
49.4 |
|
|
|
- |
|
|
|
55.4 |
|
|
|
104.8 |
|
|
Alloderm ® |
|
|
95.0 |
|
|
|
- |
|
|
|
1.6 |
|
|
|
96.6 |
|
|
Ozurdex ® |
|
|
30.3 |
|
|
|
- |
|
|
|
63.1 |
|
|
|
93.4 |
|
|
Viibryd®/Fetzima® |
|
|
- |
|
|
|
85.0 |
|
|
|
2.1 |
|
|
|
87.1 |
|
|
Breast Implants |
|
|
61.2 |
|
|
|
- |
|
|
|
11.2 |
|
|
|
72.4 |
|
|
Coolsculpting ® Consumables |
|
|
47.8 |
|
|
|
- |
|
|
|
17.8 |
|
|
|
65.6 |
|
|
Zenpep® |
|
|
- |
|
|
|
63.0 |
|
|
|
- |
|
|
|
63.0 |
|
|
Carafate ® / Sulcrate ® |
|
|
- |
|
|
|
54.3 |
|
|
|
0.6 |
|
|
|
54.9 |
|
|
Armour Thyroid |
|
|
- |
|
|
|
50.0 |
|
|
|
- |
|
|
|
50.0 |
|
|
Viberzi® |
|
|
- |
|
|
|
37.2 |
|
|
|
0.3 |
|
|
|
37.5 |
|
|
Skin Care |
|
|
34.7 |
|
|
|
- |
|
|
|
2.7 |
|
|
|
37.4 |
|
|
Asacol®/Delzicol® |
|
|
- |
|
|
|
24.7 |
|
|
|
10.3 |
|
|
|
35.0 |
|
|
Teflaro® |
|
|
- |
|
|
|
33.5 |
|
|
|
0.2 |
|
|
|
33.7 |
|
|
Saphris® |
|
|
- |
|
|
|
31.9 |
|
|
|
- |
|
|
|
31.9 |
|
|
Avycaz® |
|
|
- |
|
|
|
29.7 |
|
|
|
- |
|
|
|
29.7 |
|
|
Coolsculpting ® Systems & Add On Applicators |
|
|
15.1 |
|
|
|
- |
|
|
|
10.6 |
|
|
|
25.7 |
|
|
Namzaric® |
|
|
- |
|
|
|
23.4 |
|
|
|
- |
|
|
|
23.4 |
|
|
Savella® |
|
|
- |
|
|
|
20.7 |
|
|
|
- |
|
|
|
20.7 |
|
|
Liletta® |
|
|
- |
|
|
|
14.8 |
|
|
|
- |
|
|
|
14.8 |
|
|
Canasa®/Salofalk® |
|
|
- |
|
|
|
10.2 |
|
|
|
3.6 |
|
|
|
13.8 |
|
|
Rapaflo® |
|
|
11.8 |
|
|
|
- |
|
|
|
0.6 |
|
|
|
12.4 |
|
|
Dalvance® |
|
|
- |
|
|
|
12.0 |
|
|
|
- |
|
|
|
12.0 |
|
|
Namenda® |
|
|
- |
|
|
|
9.5 |
|
|
|
- |
|
|
|
9.5 |
|
|
Kybella® / Belkyra® |
|
|
7.3 |
|
|
|
- |
|
|
|
1.6 |
|
|
|
8.9 |
|
|
Aczone® |
|
|
1.6 |
|
|
|
- |
|
|
|
- |
|
|
|
1.6 |
|
|
Other |
|
|
59.5 |
|
|
|
190.9 |
|
|
|
81.7 |
|
|
|
332.1 |
|
|
Total segment revenues |
|
$ |
1,542.9 |
|
|
$ |
1,249.9 |
|
|
$ |
801.5 |
|
|
$ |
3,594.3 |
|
|
Corporate revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.8 |
|
|
Total net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,597.1 |
|
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 |
|
$ |
484.1 |
|
|
$ |
455.2 |
|
|
Work-in-process |
|
|
234.5 |
|
|
|
246.2 |
|
|
Finished goods |
|
|
621.5 |
|
|
|
581.7 |
|
|
|
|
|
1,340.1 |
|
|
|
1,283.1 |
|
|
Less: inventory reserves |
|
|
140.2 |
|
|
|
150.0 |
|
|
Total Inventories |
|
$ |
1,199.9 |
|
|
$ |
1,133.1 |
|
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 |
|
$ |
2,012.6 |
|
|
$ |
2,001.8 |
|
|
Litigation-related reserves and legal fees |
|
|
352.5 |
|
|
|
1,250.7 |
|
|
Accrued payroll and related benefits |
|
|
528.8 |
|
|
|
830.3 |
|
|
Accrued returns and other allowances |
|
|
638.6 |
|
|
|
596.7 |
|
|
Accrued R&D expenditures |
|
|
160.3 |
|
|
|
184.8 |
|
|
Interest payable |
|
|
136.4 |
|
|
|
189.5 |
|
|
Royalties payable |
|
|
172.4 |
|
|
|
216.9 |
|
|
Accrued pharmaceutical fees |
|
|
143.2 |
|
|
|
125.9 |
|
|
Accrued severance, retention and other shutdown costs |
|
|
14.6 |
|
|
|
12.7 |
|
|
Accrued non-provision taxes |
|
|
68.6 |
|
|
|
64.6 |
|
|
Accrued selling and marketing expenditures |
|
|
78.6 |
|
|
|
61.3 |
|
|
Current portion of contingent consideration obligations |
|
|
14.6 |
|
|
|
12.1 |
|
|
Dividends payable |
|
|
244.5 |
|
|
|
1.1 |
|
|
Other accrued expenses |
|
|
321.8 |
|
|
|
409.9 |
|
|
Total accrued expenses |
|
$ |
4,887.5 |
|
|
$ |
5,958.3 |
|
|
Accounts payable |
|
|
402.0 |
|
|
|
390.4 |
|
|
Total accounts payable and accrued expenses |
|
$ |
5,289.5 |
|
|
$ |
6,348.7 |
|
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 |
|
$ |
20,369.7 |
|
|
$ |
14,723.8 |
|
|
$ |
7,154.8 |
|
|
$ |
42,248.3 |
|
|
Impairments |
|
|
- |
|
|
|
- |
|
|
|
(913.0 |
) |
|
|
(913.0 |
) |
|
Foreign exchange and other adjustments |
|
|
- |
|
|
|
- |
|
|
|
(106.1 |
) |
|
|
(106.1 |
) |
|
Balance as of March 31, 2020 |
|
$ |
20,369.7 |
|
|
$ |
14,723.8 |
|
|
$ |
6,135.7 |
|
|
$ |
41,229.2 |
|
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 $913.0 million within the International Reporting Unit during the three months ended March 31, 2020 primarily related to changes in net assets driven by the reversal of deferred tax liabilities and taking into account changes in cash flow projections resulting from a number of factors, including those stated above.
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 $9,824.8 million and $7,698.8 million, respectively. While management believes the assumptions used are reasonable and commensurate with the views of a market participant, changes in key assumptions for these Reporting Units, including increasing the discount rate, lowering revenue forecasts, lowering the operating margin, R&D pipeline delays, or lowering the long-term growth rate could result in a future impairment. Other market factors and conditions could also result in downward revisions of the Company’s forecasts on future projected cash flows for these reporting units. The duration and impact of the COVID-19 pandemic could affect the forecasted revenues and cash flows of the products and may affect the timing of key clinical trials of the products, which may result in delays. Negative events regarding R&D pipeline assets including, but not limited to, Abicipar, Atogepant and, Ceniciviroc, as well as next generation aesthetic products, could lead to further goodwill impairment charges.
In performing the impairment test, the Company utilized discount rates ranging from 9.5% for the US reporting units and 11.0% for the International reporting unit, which were consistent with the rates utilized in the impairment testing performed in the 2019 annual impairment test. The discount rates included an increase in the alpha risk-related assumptions which reflects the increased level of uncertainty related to forecast estimates in the
28
current COVID-19 environment. The weighted average long-term growth rate utilized in the impairment test was approximately 1.0%. The assumptions used in evaluating goodwill for impairment are significant estimates, are subject to change, are assessed against historical performance by management and could result in additional impairment charges.
As of March 31, 2020 and December 31, 2019, the gross balance of goodwill, prior to the consideration of impairments, was $48,553.3 million and $48,659.4 million, respectively.
Product Rights and Other Intangible Assets
Product rights and other intangible assets consisted of the following ($ 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 |
|
$ |
72,217.5 |
|
|
$ |
7.6 |
|
|
$ |
- |
|
|
$ |
288.0 |
|
|
$ |
(132.0 |
) |
|
$ |
72,381.1 |
|
|
Trade name |
|
|
690.0 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
690.0 |
|
|
Total definite lived intangible assets |
|
$ |
72,907.5 |
|
|
$ |
7.6 |
|
|
$ |
- |
|
|
$ |
288.0 |
|
|
$ |
(132.0 |
) |
|
$ |
73,071.1 |
|
|
Intangibles with indefinite lives: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IPR&D |
|
$ |
4,536.5 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(288.0 |
) |
|
$ |
- |
|
|
$ |
4,248.5 |
|
|
Total indefinite lived intangible assets |
|
$ |
4,536.5 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(288.0 |
) |
|
$ |
- |
|
|
$ |
4,248.5 |
|
|
Total product rights and other intangibles |
|
$ |
77,444.0 |
|
|
$ |
7.6 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(132.0 |
) |
|
$ |
77,319.6 |
|
|
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 |
|
$ |
(39,180.7 |
) |
|
$ |
(1,396.0 |
) |
|
$ |
(148.0 |
) |
|
$ |
- |
|
|
$ |
64.4 |
|
|
$ |
(40,660.3 |
) |
|
Trade name |
|
|
(372.7 |
) |
|
|
(20.4 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(393.1 |
) |
|
Total definite lived intangible assets |
|
$ |
(39,553.4 |
) |
|
$ |
(1,416.4 |
) |
|
$ |
(148.0 |
) |
|
$ |
- |
|
|
$ |
64.4 |
|
|
$ |
(41,053.4 |
) |
|
Total product rights and other intangibles |
|
$ |
(39,553.4 |
) |
|
$ |
(1,416.4 |
) |
|
$ |
(148.0 |
) |
|
$ |
- |
|
|
$ |
64.4 |
|
|
$ |
(41,053.4 |
) |
|
Net Product Rights and Other Intangibles |
|
$ |
37,890.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
36,266.2 |
|
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 $148.0 million in “Asset sales and impairments, net” as a result of a decrease in anticipated future sales forecasts, including the discontinuation of clinical trials for additional indications of the product and the impact of COVID-19.
Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on product rights and other related intangibles as of March 31, 2020 over the remainder of 2020 and each of the next five years is estimated to be as follows ($ in millions):
|
|
|
Amortization Expense |
|
|
|
2020 remaining |
|
$ |
4,157.7 |
|
|
2021 |
|
$ |
4,598.1 |
|
|
2022 |
|
$ |
4,205.2 |
|
|
2023 |
|
$ |
3,749.1 |
|
|
2024 |
|
$ |
2,872.2 |
|
|
2025 |
|
$ |
2,520.8 |
|
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 March 12, 2020 (1) |
|
(3) |
|
March 4, 2015 |
|
Quarterly |
|
|
- |
|
|
|
500.0 |
|
|
|
- |
|
|
|
501.0 |
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
500.0 |
|
|
|
- |
|
|
|
501.0 |
|
|
Fixed Rate Notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$3,500.0 million 3.000% notes due March 12, 2020 |
|
(3) |
|
March 4, 2015 |
|
Semi-annually |
|
|
- |
|
|
|
2,526.0 |
|
|
|
- |
|
|
|
2,529.5 |
|
|
$650.0 million 3.375% notes due September 15, 2020 |
|
(4) |
|
March 17, 2015 |
|
Semi-annually |
|
|
650.0 |
|
|
|
650.0 |
|
|
|
650.2 |
|
|
|
654.7 |
|
|
$750.0 million 4.875% notes due February 15, 2021 |
|
(5) |
|
July 1, 2014 |
|
Semi-annually |
|
|
450.0 |
|
|
|
450.0 |
|
|
|
461.2 |
|
|
|
463.4 |
|
|
$1,200.0 million 5.000% notes due December 15, 2021 |
|
(5) |
|
July 1, 2014 |
|
Semi-annually |
|
|
1,200.0 |
|
|
|
1,200.0 |
|
|
|
1,269.4 |
|
|
|
1,262.9 |
|
|
$3,000.0 million 3.450% notes due March 15, 2022 |
|
(3) |
|
March 4, 2015 |
|
Semi-annually |
|
|
2,878.2 |
|
|
|
2,878.2 |
|
|
|
2,863.8 |
|
|
|
2,945.1 |
|
|
$1,700.0 million 3.250% notes due October 1, 2022 |
|
(4) |
|
October 2, 2012 |
|
Semi-annually |
|
|
1,700.0 |
|
|
|
1,700.0 |
|
|
|
1,689.3 |
|
|
|
1,739.1 |
|
|
$350.0 million 2.800% notes due March 15, 2023 |
|
(4) |
|
March 17, 2015 |
|
Semi-annually |
|
|
350.0 |
|
|
|
350.0 |
|
|
|
347.3 |
|
|
|
352.7 |
|
|
$1,200.0 million 3.850% notes due June 15, 2024 |
|
(3) |
|
June 10, 2014 |
|
Semi-annually |
|
|
1,036.7 |
|
|
|
1,036.7 |
|
|
|
1,081.7 |
|
|
|
1,089.9 |
|
|
$4,000.0 million 3.800% notes due March 15, 2025 |
|
(3) |
|
March 4, 2015 |
|
Semi-annually |
|
|
3,020.7 |
|
|
|
3,020.7 |
|
|
|
3,116.1 |
|
|
|
3,172.4 |
|
|
$2,500.0 million 4.550% notes due March 15, 2035 |
|
(3) |
|
March 4, 2015 |
|
Semi-annually |
|
|
1,789.0 |
|
|
|
1,789.0 |
|
|
|
1,701.1 |
|
|
|
1,953.4 |
|
|
$1,000.0 million 4.625% notes due October 1, 2042 |
|
(4) |
|
October 2, 2012 |
|
Semi-annually |
|
|
456.7 |
|
|
|
456.7 |
|
|
|
540.9 |
|
|
|
482.8 |
|
|
$1,500.0 million 4.850% notes due June 15, 2044 |
|
(3) |
|
June 10, 2014 |
|
Semi-annually |
|
|
1,079.4 |
|
|
|
1,079.4 |
|
|
|
1,003.5 |
|
|
|
1,192.8 |
|
|
$2,500.0 million 4.750% notes due March 15, 2045 |
|
(3) |
|
March 4, 2015 |
|
Semi-annually |
|
|
881.0 |
|
|
|
881.0 |
|
|
|
779.2 |
|
|
|
968.7 |
|
|
|
|
|
|
|
|
|
|
|
15,491.7 |
|
|
|
18,017.7 |
|
|
|
15,503.7 |
|
|
|
18,807.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Euro Denominated Notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
€700.0 million floating rate notes due November 15, 2020 (2) |
|
(3) |
|
November 15, 2018 |
|
Quarterly |
|
|
772.2 |
|
|
|
784.9 |
|
|
|
773.6 |
|
|
|
784.4 |
|
|
€750.0 million 0.500% notes due June 1, 2021 |
|
(3) |
|
May 26, 2017 |
|
Annually |
|
|
827.3 |
|
|
|
841.0 |
|
|
|
826.0 |
|
|
|
846.7 |
|
|
€500.0 million 1.500% notes due November 15, 2023 |
|
(3) |
|
November 15, 2018 |
|
Annually |
|
|
551.6 |
|
|
|
560.7 |
|
|
|
564.3 |
|
|
|
589.8 |
|
|
€700.0 million 1.250% notes due June 1, 2024 |
|
(3) |
|
May 26, 2017 |
|
Annually |
|
|
772.2 |
|
|
|
784.9 |
|
|
|
773.3 |
|
|
|
817.7 |
|
|
€500.0 million 2.625% notes due November 15, 2028 |
|
(3) |
|
November 15, 2018 |
|
Annually |
|
|
551.6 |
|
|
|
560.7 |
|
|
|
569.8 |
|
|
|
648.2 |
|
|
€550.0 million 2.125% notes due June 1, 2029 |
|
(3) |
|
May 26, 2017 |
|
Annually |
|
|
606.7 |
|
|
|
616.7 |
|
|
|
590.9 |
|
|
|
683.9 |
|
|
|
|
|
|
|
|
|
|
|
4,081.6 |
|
|
|
4,148.9 |
|
|
|
4,097.9 |
|
|
|
4,370.7 |
|
|
Total Senior Notes Gross |
|
|
|
|
|
|
|
|
19,573.3 |
|
|
|
22,666.6 |
|
|
|
19,601.6 |
|
|
|
23,679.1 |
|
|
Unamortized premium |
|
|
|
|
|
|
|
|
33.8 |
|
|
|
39.9 |
|
|
|
- |
|
|
|
- |
|
|
Unamortized discount |
|
|
|
|
|
|
|
|
(53.5 |
) |
|
|
(55.4 |
) |
|
|
- |
|
|
|
- |
|
|
Total Senior Notes Net |
|
|
|
|
|
|
|
$ |
19,553.6 |
|
|
$ |
22,651.1 |
|
|
$ |
19,601.6 |
|
|
$ |
23,679.1 |
|
|
Other Indebtedness |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt Issuance Costs |
|
|
|
|
|
|
|
|
(71.4 |
) |
|
|
(74.7 |
) |
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
67.5 |
|
|
|
72.6 |
|
|
|
|
|
|
|
|
|
|
Total Other Borrowings |
|
|
|
|
|
|
|
|
(3.9 |
) |
|
|
(2.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Indebtedness |
|
|
|
|
|
|
|
$ |
19,549.7 |
|
|
$ |
22,649.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Interest on the 2020 floating rate note is three month USD LIBOR plus 1.255% per annum |
|
|||||||||||||||||||||
|
(2) Interest on the 2020 floating rate notes is the three month EURIBOR plus 0.350% per annum |
|
|||||||||||||||||||||
|
(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 $500.0 million floating rate notes due March 12, 2020 and $2,526.0 million of fixed rate notes due March 12, 2020.
Annual Debt Maturities
As of March 31, 2020, annual debt maturities of senior notes gross were as follows ($ in millions):
|
|
|
Total Payments |
|
|
|
2020 remaining |
|
$ |
1,422.2 |
|
|
2021 |
|
|
2,477.3 |
|
|
2022 |
|
|
4,578.2 |
|
|
2023 |
|
|
901.6 |
|
|
2024 |
|
|
1,808.9 |
|
|
2025 |
|
|
3,020.7 |
|
|
2026 and after |
|
|
5,364.4 |
|
|
Total senior notes gross |
|
$ |
19,573.3 |
|
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 |
|
$ |
398.6 |
|
|
$ |
377.3 |
|
|
Long-term pension and post retirement liability |
|
|
153.3 |
|
|
|
144.1 |
|
|
Legacy Allergan deferred executive compensation |
|
|
73.0 |
|
|
|
89.2 |
|
|
Accrued R&D milestone |
|
|
75.0 |
|
|
|
75.0 |
|
|
Deferred revenue |
|
|
22.9 |
|
|
|
26.6 |
|
|
Product warranties |
|
|
29.2 |
|
|
|
29.2 |
|
|
Long-term severance and restructuring liabilities |
|
|
10.7 |
|
|
|
10.8 |
|
|
Other long-term liabilities |
|
|
24.7 |
|
|
|
48.7 |
|
|
Total other long-term liabilities |
|
$ |
787.4 |
|
|
$ |
800.9 |
|
32
NOTE 12 — Income Taxes
The Company’s effective tax rate for the three months ended March 31, 2020 was a benefit of 125.5%, compared to a benefit of 2.8% for the three months ended March 31, 2019. The effective tax rate for the three months ended March 31, 2020 was favorably impacted by a tax benefit of $1.9 billion related to the decrease of certain deferred tax liabilities. The decrease resulted from the intra-entity transfer of intellectual property between entities under common control. As a result of this transfer, a deferred tax asset of $1.2 billion was recognized for the difference between the tax basis in the buyer’s jurisdiction and the net book value of the intellectual property as reported in the consolidated financial statements. However, based on the Company’s evaluation of the realizability of this deferred tax asset, the Company determined that it is not more-likely-than-not that the $1.2 billion deferred tax asset will be realizable as of March 31, 2020 and therefore this amount was offset by a full valuation allowance. The effective tax rate was unfavorably impacted by the goodwill impairment charge of $913.0 million, for which no tax benefit was recorded.
The effective tax rate for the three months ended March 31, 2019 was favorably impacted by a tax benefit of $91.5 million related to excess tax over book basis in a U.S. subsidiary that will reverse in the foreseeable future. The effective tax rate was unfavorably impacted by a goodwill impairment charge of $2,467.0 million, for which no tax benefit was recorded.
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. |
|
2013, 2014, 2015, 2016 and 2017 |
|
Allergan Pharma Inc. & Subsidiaries |
|
2018 |
|
Warner Chilcott Corporation |
|
2010, 2011, 2012 and 2013 |
|
Forest Laboratories, Inc. |
|
2010, 2011, 2012, 2013 and 2014 |
|
Allergan, Inc. |
|
2009, 2010, 2011, 2012, 2013, 2014 and 3/17/2015 |
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 $500.0 million notional floating to fixed interest rate swaps maturing on March 12, 2020 whereby it fixed the interest rates on $500.0 million floating rate notes due March 12, 2020 to an average interest rate of 3.98%. The swaps were being accounted for using hedge accounting treatment. During the quarter ended March 31, 2020, the interest rate swap contracts expired. For the three months ended March 31, 2020, the corresponding realized gain of $0.8 million was recorded in accumulated other comprehensive income / (loss).
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 $4.9 billion as of March 31, 2020 and $5.0 billion as of December 31, 2019. During the three months ended March 31, 2020 and March 31, 2019, the impact of the net investment hedges recorded in other comprehensive loss was a loss of $81.0 million and a gain of $110.8 million, respectively, which offset the currency impact within our net investment in subsidiaries which are impacted by their Euro Denominated Notes.
34
NOTE 14 — Fair Value Measurement
Assets and liabilities that are measured at fair value using Fair Value Leveling or that are disclosed at fair value on a recurring basis as of March 31, 2020 and December 31, 2019 consisted of the following ($ in millions):
|
|
|
Fair Value Measurements as of March 31, 2020 Using: |
|
|||||||||||||
|
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents* |
|
$ |
567.8 |
|
|
$ |
567.8 |
|
|
$ |
- |
|
|
$ |
- |
|
|
Short-term investments |
|
|
1,618.8 |
|
|
|
- |
|
|
|
1,618.8 |
|
|
|
- |
|
|
Deferred executive compensation investments |
|
|
73.0 |
|
|
|
61.0 |
|
|
|
12.0 |
|
|
|
- |
|
|
Contingent income |
|
|
52.6 |
|
|
|
- |
|
|
|
- |
|
|
|
52.6 |
|
|
Investments and other |
|
|
56.8 |
|
|
|
30.6 |
|
|
|
26.2 |
|
|
|
- |
|
|
Total assets |
|
$ |
2,369.0 |
|
|
$ |
659.4 |
|
|
$ |
1,657.0 |
|
|
$ |
52.6 |
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred executive compensation liabilities |
|
$ |
73.0 |
|
|
$ |
61.0 |
|
|
$ |
12.0 |
|
|
$ |
- |
|
|
Contingent consideration obligations |
|
|
413.2 |
|
|
|
- |
|
|
|
- |
|
|
|
413.2 |
|
|
Total liabilities |
|
$ |
486.2 |
|
|
$ |
61.0 |
|
|
$ |
12.0 |
|
|
$ |
413.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* 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 70.0%. Changes in the fair value of the contingent consideration obligations, including accretion, are recorded in our consolidated statements of operations as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||
|
Expense / (Income) |
|
2020 |
|
|
2019 |
|
||
|
Cost of sales |
|
$ |
24.2 |
|
|
$ |
16.2 |
|
|
Research and development |
|
|
2.4 |
|
|
|
2.5 |
|
|
Total |
|
$ |
26.6 |
|
|
$ |
18.7 |
|
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 |
|
$ |
389.4 |
|
|
$ |
- |
|
|
$ |
(2.8 |
) |
|
$ |
26.6 |
|
|
$ |
413.2 |
|
|
|
|
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 |
|
$ |
344.6 |
|
|
$ |
- |
|
|
$ |
(2.1 |
) |
|
$ |
18.7 |
|
|
$ |
361.2 |
|
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 |
|
$ |
264.3 |
|
|
$ |
2.4 |
|
|
$ |
- |
|
|
$ |
266.7 |
|
|
Medicines 360 acquisition |
|
|
79.7 |
|
|
|
19.7 |
|
|
|
(2.0 |
) |
|
|
97.4 |
|
|
AqueSys acquisition |
|
|
5.6 |
|
|
|
- |
|
|
|
- |
|
|
|
5.6 |
|
|
Oculeve acquisition |
|
|
1.7 |
|
|
|
0.1 |
|
|
|
- |
|
|
|
1.8 |
|
|
ForSight acquisition |
|
|
24.4 |
|
|
|
- |
|
|
|
- |
|
|
|
24.4 |
|
|
Forest acquisition |
|
|
12.5 |
|
|
|
4.4 |
|
|
|
(0.8 |
) |
|
|
16.1 |
|
|
Other |
|
|
1.2 |
|
|
|
- |
|
|
|
- |
|
|
|
1.2 |
|
|
Total |
|
$ |
389.4 |
|
|
$ |
26.6 |
|
|
$ |
(2.8 |
) |
|
$ |
413.2 |
|
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 $255.0 million. As of December 31, 2019, the Company’s consolidated balance sheet included accrued loss contingencies of approximately $1,190.0 million.
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 December 17, 2019, and the case was dismissed on January 2, 2020.
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 $157,300,000 under Federal Rule of Civil Procedure 65(c), which Allergan posted. Sandoz appealed the grant of the injunction. On August 29, 2019, the Federal Circuit affirmed the grant of a preliminary injunction against Sandoz. A mandate issued on October 7, 2019. On January 8, 2020, the district court entered a scheduling order. Trial is expected to occur in Q2 2021, on a date to be determined by the court.
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 June 6, 2019, and the case as against Prinston was dismissed. Allergan entered into a settlement agreement with Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals International Limited (f/k/a West-Ward Pharmaceuticals Corp. and West-Ward Pharmaceuticals International Limited, respectively) on February 20, 2020.
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.
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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 January 18, 2018. Plaintiffs entered into a settlement agreement with Aurobindo and the case against Aurobindo was dismissed on May 7, 2018. Plaintiffs entered into a settlement agreement with Mylan and the case against Mylan was dismissed on December 27, 2018. Under the terms of the settlement agreement, Plaintiffs will provide a license to Mylan 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), and its generic version of Linzess® 72 mcg in the United States beginning on August 5, 2030, or earlier in certain circumstances.
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 June 2017, the Company entered into a settlement agreement with KBC. During July 2017, the Court preliminarily enjoined Dima Corp. from, inter alia, promoting or selling within the United States any product bearing the trademark Juvéderm® or any other trademark confusingly similar to it. During January 2018, the Court granted Dermavita’s renewed motion to dismiss the Company’s complaint based on purported lack of personal jurisdiction. During January 2019, the Company subsidiary and Dima Corp. resolved the action and the Court entered a permanent injunction and final judgment in favor of the Company subsidiary and against Dima Corp. for trademark infringement, unfair competition, dilution and false advertising.
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 75,000 Euros in liquidated damages for violation of the preliminary injunction mentioned above. On February 2020, the Paris Court preliminarily enjoined newly-added defendants Lazeo, My Cream Lab, Vital Esthetique and Juvederm Elite Clinics, inter alia, to refrain from promoting or selling in the EU its Juvederm products and to pay provisional damages to the Company.
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 150 trademark opposition and cancellation actions between Allergan and Dermavita have been filed in front of the USPTO, EUIPO and various other national and regional trademark offices around the world. Most of these actions remain pending; however, Allergan has received favorable decisions in more than thirty (30) such actions.
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 $302,500,000. The direct and indirect purchaser settlement agreements remain subject to final court approval.
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 $750,000,000. The agreement, which contains no admission of liability, remains subject to final court approval.
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 $78,800,000 for these settlements. The Company intends to vigorously defend its conduct and the patents or other intellectual property at issue in what remains of this litigation.
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Commercial Litigation
Warner Chilcott Marketing Practices. A 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 two individual opt-out 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 between February 2014 and November 2016 regarding the Company’s internal controls over its financial reporting and that it failed to disclose that its former Actavis generics unit had engaged in illegal, anticompetitive price-fixing with its generic industry peers. These lawsuits have been consolidated in the U.S. District Court for the District of New Jersey. The complaints seek unspecified monetary damages. The Company filed a motion to dismiss the complaint, but the court denied the motion in a ruling on August 6, 2019. The parties are now engaging in discovery in these cases. In addition, class action complaints have been filed premised on the same alleged underlying conduct that is at issue in the securities litigation but that assert claims under the Employee Retirement Income Security Act of 1974 (“ERISA”). These complaints have been consolidated in the district court in New Jersey. The court granted the Company’s motion to dismiss this complaint. The ERISA plaintiffs have appealed this decision to the Third Circuit Court of Appeals.
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 2,000 matters relating to the promotion and sale of prescription opioid pain relievers and additional suits have been filed. The lawsuits allege generally that the manufacturer defendants engaged in a deceptive campaign to promote their products in violation of state laws and seek unspecified monetary damages, penalties and injunctive relief. Plaintiffs in these suits include states, political subdivisions of states (i.e., counties and municipalities), Native American tribes and other private litigants such as insurance plans, hospital systems and consumers who were prescribed opioid products and were subsequently treated for an overdose or addiction. Cases are pending in both federal and state courts. The federal court cases have been consolidated in an MDL in the U.S. District Court for the Northern District of Ohio. The Company recently reached a settlement agreement with the plaintiffs in the first case that is set for trial in the MDL proceeding. To the Company’s knowledge, it was one of the first defendants in the MDL proceeding to reach a settlement with the plaintiffs and that settlement is among the lowest of all the settlements that have been announced to date in that consolidated action. While not directly involved in those discussions, the Company is monitoring them closely and understands that other defendants involved in these lawsuits are engaged in global settlement discussions with plaintiffs in the MDL proceeding, state attorneys general and other plaintiff stakeholders. The Company continues to examine the possibility of broader resolutions in these actions.
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.
44
Product Liability Litigation
Actonel® Litigation. A subsidiary of the Company is a defendant in over 500 filed cases in federal and various state courts, relating to the bisphosphonate prescription drug Actonel®. In addition, there are three cases pending in provincial courts in Canada, two involving single plaintiffs, and a third on behalf of a purported class of injured plaintiffs. The complaints allege, among other things, that Actonel® caused them to suffer osteonecrosis of the jaw (“ONJ”) and/or atypical fractures of the femur. Plaintiffs are seeking unspecified monetary and injunctive relief, as well as attorneys’ fees. The Company subsidiary is being indemnified by Sanofi for certain claims pursuant to an agreement with Sanofi and is being partially indemnified by the Procter & Gamble Company (“P&G”) for ONJ claims that were pending at the time the Company subsidiary acquired P&G’s global pharmaceutical business in 2009. Settlements have been reached that have resolved most of the pending ONJ-related claims. Recently, all pending Actonel cases in New Jersey state court were dismissed without prejudice subject to refilling after the U.S. Supreme Court issues a decision in Merck Sharp & Dohme Corp. v. Albrecht, Doc. No. 17-290. The U.S. Supreme Court issued their decision on May 20, 2019 and remanded the Merck case to the Third Circuit.
Breast Implant Litigation. Certain Company subsidiaries are defendants in approximately 48 cases, including several class actions and individual cases filed on behalf of multiple plaintiffs, alleging that Allergan’s textured breast implants caused women to develop an uncommon cancer known as breast implant associated anaplastic large cell lymphoma (“BIA-ALCL”). Some of the lawsuits include claims that the defendants failed to properly warn against this risk and failed to promptly and properly report the results of the post-marketing studies relating to these products and that plaintiffs suffered injuries as a result. Other lawsuits seek to recover costs related to medical monitoring and damages for fear of developing BIA-ALCL. The federal product liability and “fear of” cases have been consolidated in an MDL in the U.S. District Court for New Jersey. There are several additional cases filed in state courts in the United States and well as provincial courts in Canada. On July 24, 2019, Allergan announced a voluntary worldwide recall of unused BIOCELL textured breast implants and tissue expanders. This announcement may impact the number of lawsuits related to BIA-ALCL filed moving forward.
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 150 actions alleging that Celexa® or Lexapro® caused various birth defects. Several of the cases involve multiple minor-plaintiffs. The majority of these actions have been consolidated in state court in Missouri. The Company has entered into a program to settle a number of the pending claims. None of the actions are set for trial.
RepliForm® Litigation. A Company subsidiary has been named as a defendant in over 300 cases alleging that its biologic mesh product RepliForm® did not perform as intended and caused various injuries. Presently only three cases remain pending. The remainder of these cases have been settled or dismissed.
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 two gastroenterology products; the Saint Regis Mohawk Tribe’s acquisition of six Restasis patents and the granting of exclusive licenses to the Restasis product to the Company; and, the promotion and sale of opioid products. In each case, the Company and its subsidiaries are cooperating fully with the governmental authority’s requests.
45
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.
46
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.
47
Warner Chilcott Limited
Consolidating Balance Sheets
As of March 31, 2020
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
0.1 |
|
|
$ |
7.3 |
|
|
$ |
0.1 |
|
|
$ |
- |
|
|
$ |
983.0 |
|
|
$ |
- |
|
|
$ |
990.5 |
|
|
Marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,618.8 |
|
|
|
- |
|
|
|
1,618.8 |
|
|
Accounts receivable, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,800.6 |
|
|
|
- |
|
|
|
2,800.6 |
|
|
Receivables from Parents |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
539.0 |
|
|
|
- |
|
|
|
539.0 |
|
|
Inventories |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,199.9 |
|
|
|
- |
|
|
|
1,199.9 |
|
|
Intercompany receivables |
|
|
- |
|
|
|
7,241.7 |
|
|
|
71.9 |
|
|
|
49.0 |
|
|
|
15,789.9 |
|
|
|
(23,152.5 |
) |
|
|
- |
|
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
33.3 |
|
|
|
822.0 |
|
|
|
- |
|
|
|
855.3 |
|
|
Total current assets |
|
|
0.1 |
|
|
|
7,249.0 |
|
|
|
72.0 |
|
|
|
82.3 |
|
|
|
23,753.2 |
|
|
|
(23,152.5 |
) |
|
|
8,004.1 |
|
|
Property, plant and equipment, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,915.4 |
|
|
|
- |
|
|
|
1,915.4 |
|
|
Right of use asset - operating leases |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
481.0 |
|
|
|
|
|
|
|
481.0 |
|
|
Investments and other assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
430.7 |
|
|
|
- |
|
|
|
430.7 |
|
|
Investment in subsidiaries |
|
|
55,902.4 |
|
|
|
77,345.8 |
|
|
|
21,149.4 |
|
|
|
84,044.2 |
|
|
|
- |
|
|
|
(238,441.8 |
) |
|
|
- |
|
|
Non current intercompany receivables |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,161.9 |
|
|
|
(1,161.9 |
) |
|
|
- |
|
|
Non current assets held for sale |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
31.7 |
|
|
|
- |
|
|
|
31.7 |
|
|
Deferred tax assets |
|
|
- |
|
|
|
49.6 |
|
|
|
- |
|
|
|
- |
|
|
|
548.3 |
|
|
|
- |
|
|
|
597.9 |
|
|
Product rights and other intangibles |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
36,266.2 |
|
|
|
- |
|
|
|
36,266.2 |
|
|
Goodwill |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
41,229.2 |
|
|
|
- |
|
|
|
41,229.2 |
|
|
Total assets |
|
$ |
55,902.5 |
|
|
$ |
84,644.4 |
|
|
$ |
21,221.4 |
|
|
$ |
84,126.5 |
|
|
$ |
105,817.6 |
|
|
$ |
(262,756.2 |
) |
|
$ |
88,956.2 |
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
- |
|
|
|
0.1 |
|
|
|
80.6 |
|
|
|
119.5 |
|
|
|
4,844.7 |
|
|
|
- |
|
|
|
5,044.9 |
|
|
Intercompany payables |
|
|
- |
|
|
|
4,305.4 |
|
|
|
1,029.4 |
|
|
|
10,455.1 |
|
|
|
7,362.6 |
|
|
|
(23,152.5 |
) |
|
|
- |
|
|
Payables to Parents |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,899.9 |
|
|
|
- |
|
|
|
2,899.9 |
|
|
Income taxes payable |
|
|
- |
|
|
|
- |
|
|
|
2.4 |
|
|
|
- |
|
|
|
71.1 |
|
|
|
- |
|
|
|
73.5 |
|
|
Current portion of long-term debt |
|
|
- |
|
|
|
- |
|
|
|
755.2 |
|
|
|
- |
|
|
|
1,195.5 |
|
|
|
- |
|
|
|
1,950.7 |
|
|
Current portion of lease liability - operating |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
119.8 |
|
|
|
- |
|
|
|
119.8 |
|
|
Total current liabilities |
|
|
- |
|
|
|
4,305.5 |
|
|
|
1,867.6 |
|
|
|
10,574.6 |
|
|
|
16,493.6 |
|
|
|
(23,152.5 |
) |
|
|
10,088.8 |
|
|
Long-term debt |
|
|
- |
|
|
|
- |
|
|
|
13,917.9 |
|
|
|
2,143.9 |
|
|
|
1,537.2 |
|
|
|
- |
|
|
|
17,599.0 |
|
|
Lease liability - operating |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
438.3 |
|
|
|
- |
|
|
|
438.3 |
|
|
Other long-term liabilities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
787.9 |
|
|
|
- |
|
|
|
787.9 |
|
|
Long-term intercompany payables |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,161.9 |
|
|
|
- |
|
|
|
(1,161.9 |
) |
|
|
- |
|
|
Other taxes payable |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,683.9 |
|
|
|
- |
|
|
|
1,683.9 |
|
|
Deferred tax liabilities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,455.8 |
|
|
|
- |
|
|
|
2,455.8 |
|
|
Total liabilities |
|
|
- |
|
|
|
4,305.5 |
|
|
|
15,785.5 |
|
|
|
13,880.4 |
|
|
|
23,396.7 |
|
|
|
(24,314.4 |
) |
|
|
33,053.7 |
|
|
Total equity / (deficit) |
|
|
55,902.5 |
|
|
|
80,338.9 |
|
|
|
5,435.9 |
|
|
|
70,246.1 |
|
|
|
82,420.9 |
|
|
|
(238,441.8 |
) |
|
|
55,902.5 |
|
|
Total liabilities and equity |
|
$ |
55,902.5 |
|
|
$ |
84,644.4 |
|
|
$ |
21,221.4 |
|
|
$ |
84,126.5 |
|
|
$ |
105,817.6 |
|
|
$ |
(262,756.2 |
) |
|
$ |
88,956.2 |
|
48
Warner Chilcott Limited
Consolidating Balance Sheets
As of December 31, 2019
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
0.1 |
|
|
$ |
1.6 |
|
|
$ |
0.1 |
|
|
$ |
- |
|
|
$ |
2,495.3 |
|
|
$ |
- |
|
|
$ |
2,497.1 |
|
|
Marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,411.6 |
|
|
|
- |
|
|
|
3,411.6 |
|
|
Accounts receivable, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,192.3 |
|
|
|
- |
|
|
|
3,192.3 |
|
|
Receivables from Parents |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
409.3 |
|
|
|
- |
|
|
|
409.3 |
|
|
Inventories |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,133.1 |
|
|
|
- |
|
|
|
1,133.1 |
|
|
Intercompany receivables |
|
|
- |
|
|
|
6,508.0 |
|
|
|
154.0 |
|
|
|
40.5 |
|
|
|
14,930.1 |
|
|
|
(21,632.6 |
) |
|
|
- |
|
|
Current assets held for sale |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Prepaid expenses and other current assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
33.3 |
|
|
|
853.1 |
|
|
|
- |
|
|
|
886.4 |
|
|
Total current assets |
|
|
0.1 |
|
|
|
6,509.6 |
|
|
|
154.1 |
|
|
|
73.8 |
|
|
|
26,424.8 |
|
|
|
(21,632.6 |
) |
|
|
11,529.8 |
|
|
Property, plant and equipment, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,926.5 |
|
|
|
- |
|
|
|
1,926.5 |
|
|
Right of use asset - operating leases |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
490.4 |
|
|
|
|
|
|
|
490.4 |
|
|
Investments and other assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
408.0 |
|
|
|
- |
|
|
|
408.0 |
|
|
Investment in subsidiaries |
|
|
55,891.8 |
|
|
|
76,855.8 |
|
|
|
21,016.7 |
|
|
|
83,155.2 |
|
|
|
- |
|
|
|
(236,919.5 |
) |
|
|
- |
|
|
Non current intercompany receivables |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,156.6 |
|
|
|
(1,156.6 |
) |
|
|
- |
|
|
Non current receivables from Parents |
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Non current assets held for sale |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
31.7 |
|
|
|
- |
|
|
|
31.7 |
|
|
Deferred tax assets |
|
|
- |
|
|
|
49.6 |
|
|
|
- |
|
|
|
- |
|
|
|
527.3 |
|
|
|
- |
|
|
|
576.9 |
|
|
Product rights and other intangibles |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
37,890.6 |
|
|
|
- |
|
|
|
37,890.6 |
|
|
Goodwill |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
42,248.3 |
|
|
|
- |
|
|
|
42,248.3 |
|
|
Total assets |
|
$ |
55,891.9 |
|
|
$ |
83,415.0 |
|
|
$ |
21,170.8 |
|
|
$ |
83,229.0 |
|
|
$ |
111,104.2 |
|
|
$ |
(259,708.7 |
) |
|
$ |
95,102.2 |
|
|
LIABILITIES AND EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
- |
|
|
|
0.1 |
|
|
|
155.2 |
|
|
|
97.3 |
|
|
|
6,094.4 |
|
|
|
- |
|
|
|
6,347.0 |
|
|
Intercompany payables |
|
|
- |
|
|
|
3,544.4 |
|
|
|
930.6 |
|
|
|
10,455.1 |
|
|
|
6,702.5 |
|
|
|
(21,632.6 |
) |
|
|
- |
|
|
Payables to Parents |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,715.5 |
|
|
|
- |
|
|
|
2,715.5 |
|
|
Income taxes payable |
|
|
- |
|
|
|
- |
|
|
|
2.4 |
|
|
|
- |
|
|
|
62.7 |
|
|
|
- |
|
|
|
65.1 |
|
|
Current portion of long-term debt and capital leases |
|
|
- |
|
|
|
- |
|
|
|
3,008.2 |
|
|
|
- |
|
|
|
1,524.3 |
|
|
|
- |
|
|
|
4,532.5 |
|
|
Current portion of lease liability - operating |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
124.4 |
|
|
|
- |
|
|
|
124.4 |
|
|
Total current liabilities |
|
|
- |
|
|
|
3,544.5 |
|
|
|
4,096.4 |
|
|
|
10,552.4 |
|
|
|
17,223.8 |
|
|
|
(21,632.6 |
) |
|
|
13,784.5 |
|
|
Long-term debt and capital leases |
|
|
- |
|
|
|
- |
|
|
|
14,742.1 |
|
|
|
2,142.8 |
|
|
|
1,231.6 |
|
|
|
- |
|
|
|
18,116.5 |
|
|
Lease liability - operating |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
446.1 |
|
|
|
- |
|
|
|
446.1 |
|
|
Other long-term liabilities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
801.4 |
|
|
|
- |
|
|
|
801.4 |
|
|
Long-term intercompany payables |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,156.6 |
|
|
|
- |
|
|
|
(1,156.6 |
) |
|
|
- |
|
|
Other taxes payable |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,698.6 |
|
|
|
- |
|
|
|
1,698.6 |
|
|
Deferred tax liabilities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,363.2 |
|
|
|
- |
|
|
|
4,363.2 |
|
|
Total liabilities |
|
|
- |
|
|
|
3,544.5 |
|
|
|
18,838.5 |
|
|
|
13,851.8 |
|
|
|
25,764.7 |
|
|
|
(22,789.2 |
) |
|
|
39,210.3 |
|
|
Total equity / (deficit) |
|
|
55,891.9 |
|
|
|
79,870.5 |
|
|
|
2,332.3 |
|
|
|
69,377.2 |
|
|
|
85,339.5 |
|
|
|
(236,919.5 |
) |
|
|
55,891.9 |
|
|
Total liabilities and equity |
|
$ |
55,891.9 |
|
|
$ |
83,415.0 |
|
|
$ |
21,170.8 |
|
|
$ |
83,229.0 |
|
|
$ |
111,104.2 |
|
|
$ |
(259,708.7 |
) |
|
$ |
95,102.2 |
|
49
Warner Chilcott Limited
Consolidating Statements of Operations
For the Three Months Ended March 31, 2020
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
Net revenues |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3,604.4 |
|
|
$ |
- |
|
|
$ |
3,604.4 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
623.1 |
|
|
|
- |
|
|
|
623.1 |
|
|
Research and development |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
430.0 |
|
|
|
- |
|
|
|
430.0 |
|
|
Selling and marketing |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
972.1 |
|
|
|
- |
|
|
|
972.1 |
|
|
General and administrative |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
398.0 |
|
|
|
- |
|
|
|
398.0 |
|
|
Amortization |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,416.4 |
|
|
|
- |
|
|
|
1,416.4 |
|
|
Goodwill impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
913.0 |
|
|
|
- |
|
|
|
913.0 |
|
|
Asset sales and impairments, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
148.1 |
|
|
|
- |
|
|
|
148.1 |
|
|
Total operating expenses |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,900.7 |
|
|
|
- |
|
|
|
4,900.7 |
|
|
Operating (loss) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,296.3 |
) |
|
|
- |
|
|
|
(1,296.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) / income, net |
|
|
- |
|
|
|
(21.6 |
) |
|
|
(55.6 |
) |
|
|
(20.1 |
) |
|
|
(66.0 |
) |
|
|
- |
|
|
|
(163.3 |
) |
|
Other income, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(24.9 |
) |
|
|
- |
|
|
|
(24.9 |
) |
|
Total other (expense) / income, net |
|
|
- |
|
|
|
(21.6 |
) |
|
|
(55.6 |
) |
|
|
(20.1 |
) |
|
|
(90.9 |
) |
|
|
- |
|
|
|
(188.2 |
) |
|
(Loss) before income taxes and noncontrolling interest |
|
|
- |
|
|
|
(21.6 |
) |
|
|
(55.6 |
) |
|
|
(20.1 |
) |
|
|
(1,387.2 |
) |
|
|
- |
|
|
|
(1,484.5 |
) |
|
Provision / (benefit) for income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,866.8 |
) |
|
|
- |
|
|
|
(1,866.8 |
) |
|
Losses / (earnings) of equity interest subsidiaries |
|
|
(381.3 |
) |
|
|
(392.7 |
) |
|
|
(105.1 |
) |
|
|
(797.8 |
) |
|
|
- |
|
|
|
1,676.9 |
|
|
|
- |
|
|
Net (loss) / income |
|
$ |
381.3 |
|
|
$ |
371.1 |
|
|
$ |
49.5 |
|
|
$ |
777.7 |
|
|
$ |
479.6 |
|
|
$ |
(1,676.9 |
) |
|
$ |
382.3 |
|
|
(Income) attributable to noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1.0 |
) |
|
|
- |
|
|
|
(1.0 |
) |
|
Net (loss) / income attributable to members |
|
$ |
381.3 |
|
|
$ |
371.1 |
|
|
$ |
49.5 |
|
|
$ |
777.7 |
|
|
$ |
478.6 |
|
|
$ |
(1,676.9 |
) |
|
$ |
381.3 |
|
|
Other comprehensive (loss) / income, net of tax |
|
|
(128.2 |
) |
|
|
97.2 |
|
|
|
27.6 |
|
|
|
91.2 |
|
|
|
(128.2 |
) |
|
|
(87.8 |
) |
|
|
(128.2 |
) |
|
Comprehensive (loss) / income attributable to members |
|
$ |
253.1 |
|
|
$ |
468.3 |
|
|
$ |
77.1 |
|
|
$ |
868.9 |
|
|
$ |
350.4 |
|
|
$ |
(1,764.7 |
) |
|
$ |
253.1 |
|
50
Warner Chilcott Limited
Consolidating Statements of Operations
For the Three Months Ended March 31, 2019
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
Net revenues |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3,597.1 |
|
|
$ |
- |
|
|
$ |
3,597.1 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
497.8 |
|
|
|
- |
|
|
$ |
497.8 |
|
|
Research and development |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
435.0 |
|
|
|
- |
|
|
$ |
435.0 |
|
|
Selling and marketing |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
804.0 |
|
|
|
- |
|
|
$ |
804.0 |
|
|
General and administrative |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
306.1 |
|
|
|
- |
|
|
$ |
306.1 |
|
|
Amortization |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,399.4 |
|
|
|
- |
|
|
$ |
1,399.4 |
|
|
Goodwill impairments |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,467.0 |
|
|
|
- |
|
|
$ |
2,467.0 |
|
|
Asset sales and impairments, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5.2 |
) |
|
|
- |
|
|
$ |
(5.2 |
) |
|
Total operating expenses |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,904.1 |
|
|
|
- |
|
|
|
5,904.1 |
|
|
Operating (loss) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,307.0 |
) |
|
|
- |
|
|
|
(2,307.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) / income, net |
|
|
- |
|
|
|
(23.4 |
) |
|
|
(59.6 |
) |
|
|
(19.9 |
) |
|
|
(77.6 |
) |
|
|
- |
|
|
$ |
(180.5 |
) |
|
Other income, net |
|
|
- |
|
|
|
- |
|
|
|
(0.1 |
) |
|
|
- |
|
|
|
13.9 |
|
|
|
- |
|
|
$ |
13.8 |
|
|
Total other (expense) / income, net |
|
|
- |
|
|
|
(23.4 |
) |
|
|
(59.7 |
) |
|
|
(19.9 |
) |
|
|
(63.7 |
) |
|
|
- |
|
|
|
(166.7 |
) |
|
(Loss) before income taxes and noncontrolling interest |
|
|
- |
|
|
|
(23.4 |
) |
|
|
(59.7 |
) |
|
|
(19.9 |
) |
|
|
(2,370.7 |
) |
|
|
- |
|
|
$ |
(2,473.7 |
) |
|
Provision for income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(68.7 |
) |
|
|
- |
|
|
$ |
(68.7 |
) |
|
Losses / (earnings) of equity interest subsidiaries |
|
|
2,405.7 |
|
|
|
2,345.0 |
|
|
|
868.2 |
|
|
|
2,537.2 |
|
|
|
- |
|
|
|
(8,156.1 |
) |
|
$ |
- |
|
|
Net (loss) / income |
|
$ |
(2,405.7 |
) |
|
$ |
(2,368.4 |
) |
|
$ |
(927.9 |
) |
|
$ |
(2,557.1 |
) |
|
$ |
(2,302.0 |
) |
|
$ |
8,156.1 |
|
|
$ |
(2,405.0 |
) |
|
(Income) attributable to noncontrolling interest |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(0.7 |
) |
|
|
- |
|
|
$ |
(0.7 |
) |
|
Net (loss) / income attributable to members |
|
$ |
(2,405.7 |
) |
|
$ |
(2,368.4 |
) |
|
$ |
(927.9 |
) |
|
$ |
(2,557.1 |
) |
|
$ |
(2,302.7 |
) |
|
$ |
8,156.1 |
|
|
$ |
(2,405.7 |
) |
|
Other comprehensive (loss) / income, net of tax |
|
|
(128.8 |
) |
|
|
(140.8 |
) |
|
|
(172.9 |
) |
|
|
(585.0 |
) |
|
|
(128.8 |
) |
|
|
1,027.5 |
|
|
$ |
(128.8 |
) |
|
Comprehensive (loss) / income attributable to members |
|
$ |
(2,534.5 |
) |
|
$ |
(2,509.2 |
) |
|
$ |
(1,100.8 |
) |
|
$ |
(3,142.1 |
) |
|
$ |
(2,431.5 |
) |
|
$ |
9,183.6 |
|
|
$ |
(2,534.5 |
) |
51
Warner Chilcott Limited
Consolidating Statements of Cash Flows
For the Three Months Ended March 31, 2020
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
Cash Flows From Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) / income |
|
$ |
381.3 |
|
|
$ |
371.1 |
|
|
$ |
49.5 |
|
|
$ |
777.7 |
|
|
$ |
479.6 |
|
|
$ |
(1,676.9 |
) |
|
$ |
382.3 |
|
|
Reconciliation to net cash provided by / (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses / (earnings) of equity interest subsidiaries |
|
|
(381.3 |
) |
|
|
(392.7 |
) |
|
|
(105.1 |
) |
|
|
(797.8 |
) |
|
|
- |
|
|
|
1,676.9 |
|
|
|
- |
|
|
Depreciation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
56.8 |
|
|
|
- |
|
|
|
56.8 |
|
|
Amortization |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,416.4 |
|
|
|
- |
|
|
|
1,416.4 |
|
|
Provision for inventory reserve |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
28.4 |
|
|
|
- |
|
|
|
28.4 |
|
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
51.6 |
|
|
|
- |
|
|
|
51.6 |
|
|
Deferred income tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,931.1 |
) |
|
|
- |
|
|
|
(1,931.1 |
) |
|
Goodwill impairments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
913.0 |
|
|
|
|
|
|
|
913.0 |
|
|
Loss on asset sales and impairments, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
148.1 |
|
|
|
- |
|
|
|
148.1 |
|
|
Non-cash extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Amortization of deferred financing costs |
|
|
- |
|
|
|
- |
|
|
|
1.3 |
|
|
|
0.4 |
|
|
|
2.4 |
|
|
|
- |
|
|
|
4.1 |
|
|
Non-cash lease expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
35.9 |
|
|
|
- |
|
|
|
35.9 |
|
|
Contingent consideration adjustments, including accretion |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
26.6 |
|
|
|
- |
|
|
|
26.6 |
|
|
Dividends from subsidiaries |
|
|
243.5 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(243.5 |
) |
|
|
- |
|
|
Other, net |
|
|
- |
|
|
|
- |
|
|
|
(3.7 |
) |
|
|
(0.4 |
) |
|
|
69.3 |
|
|
|
- |
|
|
|
65.2 |
|
|
Changes in assets and liabilities (net of effects of acquisitions) |
|
|
- |
|
|
|
27.3 |
|
|
|
3,084.0 |
|
|
|
20.1 |
|
|
|
(4,205.3 |
) |
|
|
- |
|
|
|
(1,073.9 |
) |
|
Net cash provided by / (used in) operating activities |
|
|
243.5 |
|
|
|
5.7 |
|
|
|
3,026.0 |
|
|
|
- |
|
|
|
(2,908.3 |
) |
|
|
(243.5 |
) |
|
|
123.4 |
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(60.4 |
) |
|
|
- |
|
|
|
(60.4 |
) |
|
Additions to product rights and other intangibles |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(57.6 |
) |
|
|
- |
|
|
|
(57.6 |
) |
|
Additions to investments |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5.0 |
) |
|
|
- |
|
|
|
(5.0 |
) |
|
Proceeds from sale of investments and other assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,800.0 |
|
|
|
- |
|
|
|
1,800.0 |
|
|
Proceeds from sales of property, plant and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2.1 |
|
|
|
- |
|
|
|
2.1 |
|
|
Acquisitions of businesses, net of cash acquired |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net cash provided by / (used in) investing activities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,679.1 |
|
|
|
- |
|
|
|
1,679.1 |
|
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments on debt, including finance lease obligations and credit facility |
|
|
- |
|
|
|
- |
|
|
|
(3,026.0 |
) |
|
|
- |
|
|
|
(5.8 |
) |
|
|
- |
|
|
|
(3,031.8 |
) |
|
Payments of contingent consideration and other financing |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2.8 |
) |
|
|
- |
|
|
|
(2.8 |
) |
|
Dividends to Parents |
|
|
(243.5 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(243.5 |
) |
|
|
243.5 |
|
|
|
(243.5 |
) |
|
Net cash (used in) / provided by financing activities |
|
|
(243.5 |
) |
|
|
- |
|
|
|
(3,026.0 |
) |
|
|
- |
|
|
|
(252.1 |
) |
|
|
243.5 |
|
|
|
(3,278.1 |
) |
|
Effect of currency exchange rate changes on cash and cash equivalents |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(31.0 |
) |
|
|
- |
|
|
|
(31.0 |
) |
|
Net increase / (decrease) in cash and cash equivalents |
|
|
- |
|
|
|
5.7 |
|
|
|
- |
|
|
|
- |
|
|
|
(1,512.3 |
) |
|
|
- |
|
|
|
(1,506.6 |
) |
|
Cash and cash equivalents at beginning of period |
|
|
0.1 |
|
|
|
1.6 |
|
|
|
0.1 |
|
|
|
- |
|
|
|
2,495.3 |
|
|
|
- |
|
|
|
2,497.1 |
|
|
Cash and cash equivalents at end of period |
|
$ |
0.1 |
|
|
$ |
7.3 |
|
|
$ |
0.1 |
|
|
$ |
- |
|
|
$ |
983.0 |
|
|
$ |
- |
|
|
$ |
990.5 |
|
52
Warner Chilcott Limited
Consolidating Statements of Cash Flows
For the Three Months Ended March 31, 2019
(Unaudited; in millions)
|
|
|
Warner Chilcott Limited (Parent Guarantor) |
|
|
Allergan Capital S.a.r.l. (Guarantor) |
|
|
Allergan Funding SCS (Issuer) |
|
|
Allergan Finance, LLC (Issuer and Guarantor) |
|
|
Non- guarantors |
|
|
Eliminations |
|
|
Consolidated Warner Chilcott Limited |
|
|||||||
|
Cash Flows From Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) / income |
|
$ |
(2,405.7 |
) |
|
$ |
(2,368.4 |
) |
|
$ |
(927.9 |
) |
|
$ |
(2,557.1 |
) |
|
$ |
(2,302.0 |
) |
|
$ |
8,156.1 |
|
|
$ |
(2,405.0 |
) |
|
Reconciliation to net cash provided by / (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses / (earnings) of equity interest subsidiaries |
|
|
2,405.7 |
|
|
|
2,345.0 |
|
|
|
868.2 |
|
|
|
2,537.2 |
|
|
|
- |
|
|
|
(8,156.1 |
) |
|
|
- |
|
|
Depreciation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
47.5 |
|
|
|
- |
|
|
|
47.5 |
|
|
Amortization |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,399.4 |
|
|
|
- |
|
|
|
1,399.4 |
|
|
Provision for inventory reserve |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18.8 |
|
|
|
- |
|
|
|
18.8 |
|
|
Share-based compensation |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
52.3 |
|
|
|
- |
|
|
|
52.3 |
|
|
Deferred income tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(229.7 |
) |
|
|
- |
|
|
|
(229.7 |
) |
|
Goodwill impairment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,467.0 |
|
|
|
|
|
|
|
2,467.0 |
|
|
(Gain) on asset sales and impairments, net |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(5.2 |
) |
|
|
- |
|
|
|
(5.2 |
) |
|
Non-cash extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.3 |
|
|
|
- |
|
|
|
0.3 |
|
|
Amortization of deferred financing costs |
|
|
- |
|
|
|
- |
|
|
|
4.1 |
|
|
|
0.4 |
|
|
|
0.1 |
|
|
|
- |
|
|
|
4.6 |
|
|
Non-cash lease expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
30.1 |
|
|
|
- |
|
|
|
30.1 |
|
|
Contingent consideration adjustments, including accretion |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18.7 |
|
|
|
- |
|
|
|
18.7 |
|
|
Dividends from subsidiaries |
|
|
1,045.8 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,045.8 |
) |
|
|
- |
|
|
Other, net |
|
|
- |
|
|
|
- |
|
|
|
(1.3 |
) |
|
|
(0.4 |
) |
|
|
(8.6 |
) |
|
|
- |
|
|
|
(10.3 |
) |
|
Changes in assets and liabilities (net of effects of acquisitions) |
|
|
- |
|
|
|
(207.4 |
) |
|
|
209.4 |
|
|
|
19.9 |
|
|
|
(196.2 |
) |
|
|
- |
|
|
|
(174.3 |
) |
|
Net cash provided by / (used in) operating activities |
|
|
1,045.8 |
|
|
|
(230.8 |
) |
|
|
152.5 |
|
|
- |
|
|
|
1,292.5 |
|
|
|
(1,045.8 |
) |
|
|
1,214.2 |
|
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions to property, plant and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(64.8 |
) |
|
|
- |
|
|
|
(64.8 |
) |
|
Additions to product rights and other intangibles |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(7.5 |
) |
|
|
- |
|
|
|
(7.5 |
) |
|
Additions to investments |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(538.2 |
) |
|
|
- |
|
|
|
(538.2 |
) |
|
Proceeds from sale of investments and other assets |
|
|
- |
|
|
|
289.4 |
|
|
|
- |
|
|
|
- |
|
|
|
279.7 |
|
|
|
- |
|
|
|
569.1 |
|
|
Proceeds from sales of property, plant and equipment |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
17.2 |
|
|
|
- |
|
|
|
17.2 |
|
|
Acquisitions of businesses, net of cash acquired |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(80.6 |
) |
|
|
- |
|
|
|
(80.6 |
) |
|
Net cash provided by investing activities |
|
|
- |
|
|
|
289.4 |
|
|
|
- |
|
|
|
- |
|
|
|
(394.2 |
) |
|
|
- |
|
|
|
(104.8 |
) |
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments on debt, including finance lease obligations and credit facility |
|
|
- |
|
|
|
- |
|
|
|
(152.0 |
) |
|
|
- |
|
|
|
(7.4 |
) |
|
|
- |
|
|
|
(159.4 |
) |
|
Payments of contingent consideration and other financing |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2.0 |
) |
|
|
- |
|
|
|
(2.0 |
) |
|
Dividends to Parents |
|
|
(1,045.8 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,045.8 |
) |
|
|
1,045.8 |
|
|
|
(1,045.8 |
) |
|
Net cash (used in) / provided by financing activities |
|
|
(1,045.8 |
) |
|
|
- |
|
|
|
(152.0 |
) |
|
|
- |
|
|
|
(1,055.2 |
) |
|
|
1,045.8 |
|
|
|
(1,207.2 |
) |
|
Effect of currency exchange rate changes on cash and cash equivalents |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5.9 |
|
|
|
- |
|
|
|
5.9 |
|
|
Net increase / (decrease) in cash and cash equivalents |
|
|
- |
|
|
|
58.6 |
|
|
|
0.5 |
|
|
- |
|
|
|
(151.0 |
) |
|
|
- |
|
|
|
(91.9 |
) |
|
|
Cash and cash equivalents at beginning of period |
|
|
0.1 |
|
|
|
1.8 |
|
|
|
0.8 |
|
|
|
- |
|
|
|
875.9 |
|
|
|
- |
|
|
|
878.6 |
|
|
Cash and cash equivalents at end of period |
|
$ |
0.1 |
|
|
$ |
60.4 |
|
|
$ |
1.3 |
|
|
$ |
- |
|
|
$ |
724.9 |
|
|
$ |
- |
|
|
$ |
786.7 |
|
53
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion of our financial condition and the results of operations should be read in conjunction with the “Consolidated Financial Statements” and notes thereto included elsewhere in this Quarterly Report on Form 10-Q (“Quarterly Report”) and our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019 (the “Annual Report”). This discussion contains forward-looking statements that are subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include, among others, those identified under “Risk Factors” in our Annual Report, and elsewhere in this Quarterly Report.
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. 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.
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 $188.24 per Allergan share, or approximately $63.0 billion, based on AbbVie’s then-current stock price at the time the AbbVie Transaction was announced. At the closing of the proposed AbbVie Transaction, Company shareholders will receive 0.8660 shares of AbbVie common stock and $120.30 in cash for each of their existing shares. On October 14, 2019, the Company’s shareholders voted to approve the AbbVie Transaction. The AbbVie Transaction is subject to customary regulatory approvals and other customary closing conditions. On May 5, 2020 the U.S. Federal Trade Commission (“FTC”) accepted a proposed consent order in connection with the AbbVie Transaction. Under the terms of the consent order, the companies have agreed to divest brazikumab, an investigational IL-23 inhibitor in development for autoimmune diseases, to AstraZeneca and Zenpep, a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, to Nestle Health Science. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.
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 September 15, 2020 through March 15, 2045 for up to approximately $19.6 billion aggregate principal amount of new notes to be issued by AbbVie and cash. In conjunction with the exchange offer, AbbVie solicited and obtained consents from eligible holders of the Allergan Senior Notes to amend each of the indentures governing the Allergan Senior Notes to eliminate substantially all of the restrictive covenants in such indentures and eliminate any guarantees of the related Allergan Senior Notes. Consummation of the exchange offer is conditioned upon, among other things, the closing of the AbbVie Transaction. The exchange offers are expected to close, and such amendments are expected to become operative, on or about the closing date of the AbbVie Transaction.
54
Impact of COVID-19
In the three months ended March 31, 2020, the Company’s net sales were negatively impacted by an estimated 3% compared to the prior year period resulting from the COVID-19 pandemic. The Company’s medical aesthetic portfolio of products has been most significantly impacted by the COVID-19 pandemic as these products are typically administered as elective procedures. These elective procedures have been negatively affected by local and national government restrictions, such as “social distancing, “shelter in place” orders and business closures, that were put in place in the last few weeks of the first quarter in the United States and throughout the first quarter in many international markets as well as by economic conditions. As a consequence, consumer demand has significantly declined and the ability of practitioners to administer these procedures has been restricted. While the Company anticipates the COVID-19 pandemic will have a continued negative effect on the revenues of these products in the near-term, it is difficult to determine the full extent and duration of the impact on the future operating results of the business. For example, the Company has recently observed, particularly in certain Asia Pacific international markets, early signs of some recovery of the global medical aesthetic business and anticipates that the recovery with continue to occur during the second half of 2020. The Company anticipates that the impact of the COVID-19 pandemic on the Company’s therapeutic products will be less significant compared to the Company’s medical aesthetic products. The Company’s therapeutic business may, however, be impacted by changes in commercial and government rebate channels as a result of economic conditions, including increases in unemployment rates.
The Company and our third-party contract manufacturing partners continue to operate our manufacturing facilities at or near normal levels. While we currently do not anticipate any interruptions in our manufacturing process, it is possible that the COVID-19 pandemic may have an impact in the future on our and/or our third-party suppliers’ and contract manufacturing partners' ability to manufacture our products or to have our products reach all markets.
The Company continues to operate clinical trials globally. Due to the COVID-19 pandemic, certain clinical sites have temporarily suspended enrolling new patients. The Company is taking measures to mitigate any potential delays in clinical trials, but it is possible that the timing of these trials and anticipated launch dates of the related projects may be impacted.
The Company has suspended face to face sales meetings and the Company’s sales teams have been working remotely during the COVID-19 pandemic. The Company’s sales teams continue to work with customers to provide sufficient levels of support and detailing. While the global medical aesthetics business has been significantly impacted by the COVID-19 pandemic and the demand for aesthetic products has declined, the Company’s sales teams continues to work with customers to determine customer demand levels and to support these levels when consumer recovery occurs. Additionally, the Company will continue to assess variable sales and marketing expenses, such as direct to consumer advertising, as a result of the COVID-19 pandemic.
The Company continues to monitor the collectability of receivables as a result of our customers’ financial circumstances. The Company’s global medical aesthetics business sells to practitioners who service consumers on a local, regional or national level. As the COVID-19 pandemic impacts their businesses, it may also impact their ability to pay their outstanding invoices. This would have a negative impact on the Company’s account receivable balance, bad debt expenses recognized in general and administrative expenses, and liquidity. During the three months ended March 31, 2020, the Company recorded incremental provisions for bad debts of approximately $30.0 million as we have assessed the impact on the COVID-19 pandemic on our US and international customer bases. The Company will continue to monitor the impact the pandemic has on the Company’s ability to collect customer receivables.
55
Operating Results for the Three Months Ended March 31, 2020 and 2019
Results of operations, including segment net revenues, segment operating expenses and segment contribution consisted of the following for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, 2020 |
|
|||||||||||||
|
|
|
US Specialized Therapeutics |
|
|
US General Medicine |
|
|
International |
|
|
Total |
|
||||
|
Net revenues |
|
$ |
1,541.5 |
|
|
$ |
1,320.5 |
|
|
$ |
691.4 |
|
|
$ |
3,553.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
129.7 |
|
|
|
250.6 |
|
|
|
117.4 |
|
|
|
497.7 |
|
|
Selling and marketing |
|
|
420.4 |
|
|
|
296.4 |
|
|
|
210.7 |
|
|
|
927.5 |
|
|
General and administrative |
|
|
59.0 |
|
|
|
50.2 |
|
|
|
36.3 |
|
|
|
145.5 |
|
|
Segment contribution |
|
$ |
932.4 |
|
|
$ |
723.3 |
|
|
$ |
327.0 |
|
|
$ |
1,982.7 |
|
|
Contribution margin |
|
|
60.5 |
% |
|
|
54.8 |
% |
|
|
47.3 |
% |
|
|
55.8 |
% |
|
Corporate(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
374.8 |
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430.0 |
|
|
Goodwill impairment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
913.0 |
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,416.4 |
|
|
Asset sales and impairments, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
148.1 |
|
|
Operating (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(1,299.6 |
) |
|
Operating margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 $51.0 million. |
|
|||||||||||||||
56
US Specialized Therapeutics Segment
The following table presents top product sales and net contribution for the US Specialized Therapeutics segment for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
Dollars |
|
|
% |
|
||||
|
Total Eye Care |
|
$ |
537.9 |
|
|
$ |
465.1 |
|
|
$ |
72.8 |
|
|
|
15.7 |
% |
|
Restasis® |
|
|
278.6 |
|
|
|
231.7 |
|
|
|
46.9 |
|
|
|
20.2 |
% |
|
Alphagan®/Combigan® |
|
|
81.6 |
|
|
|
83.0 |
|
|
|
(1.4 |
) |
|
|
(1.7 |
)% |
|
Eye Drops |
|
|
66.5 |
|
|
|
49.4 |
|
|
|
17.1 |
|
|
|
34.6 |
% |
|
Lumigan®/Ganfort® |
|
|
63.0 |
|
|
|
57.7 |
|
|
|
5.3 |
|
|
|
9.2 |
% |
|
Ozurdex® |
|
|
29.9 |
|
|
|
30.3 |
|
|
|
(0.4 |
) |
|
|
(1.3 |
)% |
|
Other Eye Care |
|
|
18.3 |
|
|
|
13.0 |
|
|
|
5.3 |
|
|
|
40.8 |
% |
|
Total Medical Aesthetics |
|
|
587.6 |
|
|
|
648.2 |
|
|
|
(60.6 |
) |
|
|
(9.3 |
)% |
|
Facial Aesthetics |
|
|
325.5 |
|
|
|
366.5 |
|
|
|
(41.0 |
) |
|
|
(11.2 |
)% |
|
Botox® Cosmetics |
|
|
212.7 |
|
|
|
229.5 |
|
|
|
(16.8 |
) |
|
|
(7.3 |
)% |
|
Juvederm® Collection |
|
|
107.5 |
|
|
|
129.7 |
|
|
|
(22.2 |
) |
|
|
(17.1 |
)% |
|
Kybella® |
|
|
5.3 |
|
|
|
7.3 |
|
|
|
(2.0 |
) |
|
|
(27.4 |
)% |
|
Plastic Surgery |
|
|
40.1 |
|
|
|
61.2 |
|
|
|
(21.1 |
) |
|
|
(34.5 |
)% |
|
Breast Implants |
|
|
40.1 |
|
|
|
61.2 |
|
|
|
(21.1 |
) |
|
|
(34.5 |
)% |
|
Regenerative Medicine |
|
|
124.6 |
|
|
|
122.9 |
|
|
|
1.7 |
|
|
|
1.4 |
% |
|
Alloderm® |
|
|
102.1 |
|
|
|
95.0 |
|
|
|
7.1 |
|
|
|
7.5 |
% |
|
Other Regenerative Medicine |
|
|
22.5 |
|
|
|
27.9 |
|
|
|
(5.4 |
) |
|
|
(19.4 |
)% |
|
Body Contouring |
|
|
58.9 |
|
|
|
62.9 |
|
|
|
(4.0 |
) |
|
|
(6.4 |
)% |
|
Coolsculpting® Systems & Add On Applicators |
|
|
36.2 |
|
|
|
15.1 |
|
|
|
21.1 |
|
|
n.m. |
|
|
|
Coolsculpting® Consumables |
|
|
22.7 |
|
|
|
47.8 |
|
|
|
(25.1 |
) |
|
|
(52.5 |
)% |
|
Skin Care |
|
|
38.5 |
|
|
|
34.7 |
|
|
|
3.8 |
|
|
|
11.0 |
% |
|
Total Medical Dermatology |
|
|
3.6 |
|
|
|
6.1 |
|
|
|
(2.5 |
) |
|
|
(41.0 |
)% |
|
Aczone® |
|
|
3.0 |
|
|
|
1.6 |
|
|
|
1.4 |
|
|
|
87.5 |
% |
|
Other Medical Dermatology |
|
|
0.6 |
|
|
|
4.5 |
|
|
|
(3.9 |
) |
|
|
(86.7 |
)% |
|
Total Neuroscience and Urology |
|
|
397.2 |
|
|
|
409.4 |
|
|
|
(12.2 |
) |
|
|
(3.0 |
)% |
|
Botox® Therapeutics |
|
|
395.8 |
|
|
|
397.6 |
|
|
|
(1.8 |
) |
|
|
(0.5 |
)% |
|
Rapaflo® |
|
|
1.4 |
|
|
|
11.8 |
|
|
|
(10.4 |
) |
|
|
(88.1 |
)% |
|
Other revenues |
|
|
15.2 |
|
|
|
14.1 |
|
|
|
1.1 |
|
|
|
7.8 |
% |
|
Net revenues |
|
$ |
1,541.5 |
|
|
$ |
1,542.9 |
|
|
$ |
(1.4 |
) |
|
|
(0.1 |
)% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
129.7 |
|
|
|
120.1 |
|
|
|
9.6 |
|
|
|
8.0 |
% |
|
Selling and marketing |
|
|
420.4 |
|
|
|
356.8 |
|
|
|
63.6 |
|
|
|
17.8 |
% |
|
General and administrative |
|
|
59.0 |
|
|
|
54.6 |
|
|
|
4.4 |
|
|
|
8.1 |
% |
|
Segment contribution |
|
$ |
932.4 |
|
|
$ |
1,011.4 |
|
|
$ |
(79.0 |
) |
|
|
(7.8 |
)% |
|
Segment margin |
|
|
60.5 |
% |
|
|
65.6 |
% |
|
|
|
|
|
|
(5.1 |
)% |
|
Segment gross margin(2) |
|
|
91.6 |
% |
|
|
92.2 |
% |
|
|
|
|
|
|
(0.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results. |
|
|||||||||||||||
|
(2) Defined as net revenues less segment related cost of sales as a percentage of net revenues. |
|
|||||||||||||||
57
Net Revenues
Three Months Ended March 31, 2020 and 2019
The decrease in net revenues in the three months ended March 31, 2020 was primarily driven by declines in sales of the Company’s Medical Aesthetic products due to the impact of the COVID-19 pandemic, partially offset by increased sales of certain Eye Care products. The declines in the Facial Aesthetic portfolio, Breast Implants, and Coolsculpting Consumables resulted from a reduction in elective procedures in the US during the latter part of the three months ended March 31, 2020 as a result of local government restrictions, including social distancing, “shelter in place orders” and business closures. Rapaflo® revenues declined primarily due to a loss of exclusivity. The increase in Eye Care was driven by Restasis® and demand growth in Eye Drops during the quarter. The increase in Coolsculpting Systems was driven by the CoolTone launch.
As a result of the COVID-19 pandemic, the Company anticipates a significant decline in the Medical Aesthetics net revenues in the second quarter of 2020. The overall full year reduction in these revenues will be determined by the duration of government restrictions, future economic conditions, and any potential future changes in consumer behavior related to medical aesthetics products, all of which are largely uncertain at this time.
Cost of Sales
Three Months Ended March 31, 2020 and 2019
The increase in cost of sales in the three months ended March 31, 2020 was primarily due to product mix.
Selling and Marketing Expenses
Three Months Ended March 31, 2020 and 2019
The increase in selling and marketing expenses in the three months ended March 31, 2020 was primarily related to increased promotional costs and sales force expansion for Eye Care products for anticipated launches, including Durysta™.
General and Administrative Expenses
Three Months Ended March 31, 2020 and 2019
General and administrative expenses were consistent period over period.
58
US General Medicine Segment
The following table presents top product sales and net contribution for the US General Medicine segment for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
Dollars |
|
|
% |
|
||||
|
Total Central Nervous System (CNS) |
|
$ |
429.9 |
|
|
$ |
293.5 |
|
|
$ |
136.4 |
|
|
|
46.5 |
% |
|
Vraylar® |
|
|
277.3 |
|
|
|
143.7 |
|
|
|
133.6 |
|
|
|
93.0 |
% |
|
Viibryd®/Fetzima® |
|
|
89.8 |
|
|
|
85.0 |
|
|
|
4.8 |
|
|
|
5.6 |
% |
|
Saphris® |
|
|
31.0 |
|
|
|
31.9 |
|
|
|
(0.9 |
) |
|
|
(2.8 |
)% |
|
Namzaric® |
|
|
17.8 |
|
|
|
23.4 |
|
|
|
(5.6 |
) |
|
|
(23.9 |
)% |
|
Ubrelvy® |
|
|
11.1 |
|
|
|
- |
|
|
|
11.1 |
|
|
n.a. |
|
|
|
Namenda®(3) |
|
|
2.9 |
|
|
|
9.5 |
|
|
|
(6.6 |
) |
|
|
(69.5 |
)% |
|
Total Gastrointestinal (GI) |
|
|
309.4 |
|
|
|
358.2 |
|
|
|
(48.8 |
) |
|
|
(13.6 |
)% |
|
Linzess® |
|
|
172.2 |
|
|
|
161.3 |
|
|
|
10.9 |
|
|
|
6.8 |
% |
|
Zenpep® |
|
|
65.6 |
|
|
|
63.0 |
|
|
|
2.6 |
|
|
|
4.1 |
% |
|
Viberzi® |
|
|
37.3 |
|
|
|
37.2 |
|
|
|
0.1 |
|
|
|
0.3 |
% |
|
Carafate®/Sulcrate® |
|
|
19.0 |
|
|
|
54.3 |
|
|
|
(35.3 |
) |
|
|
(65.0 |
)% |
|
Canasa®/Salofalk® |
|
|
7.2 |
|
|
|
10.2 |
|
|
|
(3.0 |
) |
|
|
(29.4 |
)% |
|
Asacol®/Delzicol® |
|
|
2.6 |
|
|
|
24.7 |
|
|
|
(22.1 |
) |
|
|
(89.5 |
)% |
|
Other GI |
|
|
5.5 |
|
|
|
7.5 |
|
|
|
(2.0 |
) |
|
|
(26.7 |
)% |
|
Total Women's Health |
|
|
171.6 |
|
|
|
201.0 |
|
|
|
(29.4 |
) |
|
|
(14.6 |
)% |
|
Lo Loestrin® |
|
|
109.8 |
|
|
|
125.8 |
|
|
|
(16.0 |
) |
|
|
(12.7 |
)% |
|
Liletta® |
|
|
23.1 |
|
|
|
14.8 |
|
|
|
8.3 |
|
|
|
56.1 |
% |
|
Other Women's Health |
|
|
38.7 |
|
|
|
60.4 |
|
|
|
(21.7 |
) |
|
|
(35.9 |
)% |
|
Total Anti-Infectives |
|
|
78.0 |
|
|
|
81.6 |
|
|
|
(3.6 |
) |
|
|
(4.4 |
)% |
|
Teflaro® |
|
|
35.0 |
|
|
|
33.5 |
|
|
|
1.5 |
|
|
|
4.5 |
% |
|
Dalvance® |
|
|
23.0 |
|
|
|
12.0 |
|
|
|
11.0 |
|
|
|
91.7 |
% |
|
Avycaz® |
|
|
11.8 |
|
|
|
29.7 |
|
|
|
(17.9 |
) |
|
|
(60.3 |
)% |
|
Other Anti-Infectives |
|
|
8.2 |
|
|
|
6.4 |
|
|
|
1.8 |
|
|
|
28.1 |
% |
|
Diversified Brands |
|
|
268.7 |
|
|
|
270.9 |
|
|
|
(2.2 |
) |
|
|
(0.8 |
)% |
|
Bystolic®/ Byvalson® |
|
|
129.8 |
|
|
|
128.3 |
|
|
|
1.5 |
|
|
|
1.2 |
% |
|
Armour Thyroid |
|
|
46.3 |
|
|
|
50.0 |
|
|
|
(3.7 |
) |
|
|
(7.4 |
)% |
|
Savella® |
|
|
19.3 |
|
|
|
20.7 |
|
|
|
(1.4 |
) |
|
|
(6.8 |
)% |
|
Other Diversified Brands |
|
|
73.3 |
|
|
|
71.9 |
|
|
|
1.4 |
|
|
|
1.9 |
% |
|
Other revenues |
|
|
62.9 |
|
|
|
44.7 |
|
|
|
18.2 |
|
|
|
40.7 |
% |
|
Net revenues |
|
$ |
1,320.5 |
|
|
$ |
1,249.9 |
|
|
$ |
70.6 |
|
|
|
5.6 |
% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
250.6 |
|
|
|
190.5 |
|
|
|
60.1 |
|
|
|
31.5 |
% |
|
Selling and marketing |
|
|
296.4 |
|
|
|
210.5 |
|
|
|
85.9 |
|
|
|
40.8 |
% |
|
General and administrative |
|
|
50.2 |
|
|
|
43.8 |
|
|
|
6.4 |
|
|
|
14.6 |
% |
|
Segment contribution |
|
$ |
723.3 |
|
|
$ |
805.1 |
|
|
$ |
(81.8 |
) |
|
|
(10.2 |
)% |
|
Segment margin |
|
|
54.8 |
% |
|
|
64.4 |
% |
|
|
|
|
|
|
(9.6 |
)% |
|
Segment gross margin(2) |
|
|
81.0 |
% |
|
|
84.8 |
% |
|
|
|
|
|
|
(3.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results. |
|
|||||||||||||||
|
(2) Defined as net revenues less segment related cost of sales as a percentage of net revenues. |
|
|||||||||||||||
|
(3) Includes Namenda XR® and Namenda® IR. |
|
|||||||||||||||
59
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.
Net Revenues
Three Months Ended March 31, 2020 and 2019
The increase in net revenues in the three months ended March 31, 2020 was primarily due to growth in CNS offset, in part, by a decline in GI and Women’s Health revenues. CNS revenues increased primarily due to strong demand growth for Vraylar® and Viibryd® and the launch of Ubrelvy® during the first quarter of 2020. Women’s Health revenues decreased primarily due to a decrease in the average net selling price for Lo Loestrin® and the impact of products losing exclusivity. GI was negatively affected by the loss of exclusivity for Carafate®/Sulcrate® and the continuing genericization and a temporary supply disruption for Asacol®, offset, in part, by an increase in demand growth for Linzess®.
Cost of Sales
Three Months Ended March 31, 2020 and 2019
The increase in cost of sales in the three months ended March 31, 2020 was primarily due to an increase in net revenues and product mix.
Selling and Marketing Expenses
Three Months Ended March 31, 2020 and 2019
The increase in selling and marketing expenses in the three months ended March 31, 2020 was primarily due to field force investments and increased promotional costs for newly launched, including Ubrelvy™, and promoted products.
General and Administrative Expenses
Three Months Ended March 31, 2020 and 2019
General and administrative expenses were consistent period over period.
60
International Segment
The following table presents top product sales and net contribution for the International segment for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|
Change |
|
||||||||||||||||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Overall Change |
|
|
$ Operational Change (3) |
|
|
$ Currency Change |
|
|
% Overall Change |
|
|
% Operational Change (3) |
|
|
% Currency Change |
|
||||||||
|
Total Eye Care |
|
$ |
282.6 |
|
|
$ |
291.8 |
|
|
$ |
(9.2 |
) |
|
$ |
4.8 |
|
|
$ |
(14.0 |
) |
|
|
(3.2 |
)% |
|
|
1.6 |
% |
|
|
(4.8 |
)% |
|
Lumigan®/Ganfort® |
|
|
80.7 |
|
|
|
85.1 |
|
|
|
(4.4 |
) |
|
|
(0.9 |
) |
|
|
(3.5 |
) |
|
|
(5.2 |
)% |
|
|
(1.1 |
)% |
|
|
(4.1 |
)% |
|
Ozurdex® |
|
|
63.8 |
|
|
|
63.1 |
|
|
|
0.7 |
|
|
|
3.2 |
|
|
|
(2.5 |
) |
|
|
1.1 |
% |
|
|
5.1 |
% |
|
|
(4.0 |
)% |
|
Eye Drops |
|
|
50.9 |
|
|
|
55.4 |
|
|
|
(4.5 |
) |
|
|
(1.6 |
) |
|
|
(2.9 |
) |
|
|
(8.1 |
)% |
|
|
(2.9 |
)% |
|
|
(5.2 |
)% |
|
Alphagan®/Combigan® |
|
|
36.9 |
|
|
|
37.6 |
|
|
|
(0.7 |
) |
|
|
1.2 |
|
|
|
(1.9 |
) |
|
|
(1.9 |
)% |
|
|
3.2 |
% |
|
|
(5.1 |
)% |
|
Restasis® |
|
|
11.3 |
|
|
|
10.4 |
|
|
|
0.9 |
|
|
|
1.5 |
|
|
|
(0.6 |
) |
|
|
8.7 |
% |
|
|
14.4 |
% |
|
|
(5.7 |
)% |
|
Other Eye Care |
|
|
39.0 |
|
|
|
40.2 |
|
|
|
(1.2 |
) |
|
|
1.4 |
|
|
|
(2.6 |
) |
|
|
(3.0 |
)% |
|
|
3.5 |
% |
|
|
(6.5 |
)% |
|
Total Medical Aesthetics |
|
|
249.4 |
|
|
|
352.8 |
|
|
|
(103.4 |
) |
|
|
(96.6 |
) |
|
|
(6.8 |
) |
|
|
(29.3 |
)% |
|
|
(27.4 |
)% |
|
|
(1.9 |
)% |
|
Facial Aesthetics |
|
|
227.6 |
|
|
|
306.8 |
|
|
|
(79.2 |
) |
|
|
(73.4 |
) |
|
|
(5.8 |
) |
|
|
(25.8 |
)% |
|
|
(23.9 |
)% |
|
|
(1.9 |
)% |
|
Botox® Cosmetics |
|
|
114.4 |
|
|
|
147.4 |
|
|
|
(33.0 |
) |
|
|
(30.6 |
) |
|
|
(2.4 |
) |
|
|
(22.4 |
)% |
|
|
(20.8 |
)% |
|
|
(1.6 |
)% |
|
Juvederm® Collection |
|
|
113.1 |
|
|
|
157.8 |
|
|
|
(44.7 |
) |
|
|
(41.3 |
) |
|
|
(3.4 |
) |
|
|
(28.3 |
)% |
|
|
(26.2 |
)% |
|
|
(2.1 |
)% |
|
Belkyra® (Kybella®) |
|
|
0.1 |
|
|
|
1.6 |
|
|
|
(1.5 |
) |
|
|
(1.5 |
) |
|
|
- |
|
|
|
(93.8 |
)% |
|
|
(93.8 |
)% |
|
|
0.0 |
% |
|
Plastic Surgery |
|
|
5.4 |
|
|
|
11.6 |
|
|
|
(6.2 |
) |
|
|
(5.8 |
) |
|
|
(0.4 |
) |
|
|
(53.4 |
)% |
|
|
(50.0 |
)% |
|
|
(3.4 |
)% |
|
Breast Implants |
|
|
5.2 |
|
|
|
11.2 |
|
|
|
(6.0 |
) |
|
|
(5.6 |
) |
|
|
(0.4 |
) |
|
|
(53.6 |
)% |
|
|
(50.0 |
)% |
|
|
(3.6 |
)% |
|
Other Plastic Surgery |
|
|
0.2 |
|
|
|
0.4 |
|
|
|
(0.2 |
) |
|
|
(0.2 |
) |
|
|
- |
|
|
|
(50.0 |
)% |
|
|
(50.0 |
)% |
|
|
0.0 |
% |
|
Regenerative Medicine |
|
|
3.4 |
|
|
|
3.3 |
|
|
|
0.1 |
|
|
|
0.2 |
|
|
|
(0.1 |
) |
|
|
3.0 |
% |
|
|
6.1 |
% |
|
|
(3.1 |
)% |
|
Alloderm® |
|
|
1.7 |
|
|
|
1.6 |
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
- |
|
|
n.m. |
|
|
n.m. |
|
|
n.m. |
|
|||
|
Other Regenerative Medicine |
|
|
1.7 |
|
|
|
1.7 |
|
|
|
- |
|
|
|
0.1 |
|
|
|
(0.1 |
) |
|
|
0.0 |
% |
|
|
5.9 |
% |
|
|
(5.9 |
)% |
|
Body Contouring |
|
|
10.2 |
|
|
|
28.4 |
|
|
|
(18.2 |
) |
|
|
(17.7 |
) |
|
|
(0.5 |
) |
|
|
(64.1 |
)% |
|
|
(62.3 |
)% |
|
|
(1.8 |
)% |
|
Coolsculpting® Consumables |
|
|
8.8 |
|
|
|
17.8 |
|
|
|
(9.0 |
) |
|
|
(8.7 |
) |
|
|
(0.3 |
) |
|
|
(50.6 |
)% |
|
|
(48.9 |
)% |
|
|
(1.7 |
)% |
|
Coolsculpting® Systems & Add On Applicators |
|
|
1.4 |
|
|
|
10.6 |
|
|
|
(9.2 |
) |
|
|
(9.0 |
) |
|
|
(0.2 |
) |
|
|
(86.8 |
)% |
|
|
(84.9 |
)% |
|
|
(1.9 |
)% |
|
Skin Care |
|
|
2.8 |
|
|
|
2.7 |
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
- |
|
|
|
3.7 |
% |
|
|
3.7 |
% |
|
|
0.0 |
% |
|
Botox® Therapeutics and Other |
|
|
140.2 |
|
|
|
138.8 |
|
|
|
1.4 |
|
|
|
6.0 |
|
|
|
(4.6 |
) |
|
|
1.0 |
% |
|
|
4.3 |
% |
|
|
(3.3 |
)% |
|
Botox® Therapeutics |
|
|
89.3 |
|
|
|
93.9 |
|
|
|
(4.6 |
) |
|
|
(1.0 |
) |
|
|
(3.6 |
) |
|
|
(4.9 |
)% |
|
|
(1.1 |
)% |
|
|
(3.8 |
)% |
|
Asacol®/Delzicol® |
|
|
7.7 |
|
|
|
10.3 |
|
|
|
(2.6 |
) |
|
|
(2.5 |
) |
|
|
(0.1 |
) |
|
|
(25.2 |
)% |
|
|
(24.3 |
)% |
|
|
(0.9 |
)% |
|
Constella® |
|
|
7.1 |
|
|
|
5.5 |
|
|
|
1.6 |
|
|
|
1.7 |
|
|
|
(0.1 |
) |
|
|
29.1 |
% |
|
|
30.9 |
% |
|
|
(1.8 |
)% |
|
Other Products |
|
|
36.1 |
|
|
|
29.1 |
|
|
|
7.0 |
|
|
|
7.8 |
|
|
|
(0.8 |
) |
|
|
24.1 |
% |
|
|
26.8 |
% |
|
|
(2.7 |
)% |
|
Other revenues |
|
|
19.2 |
|
|
|
18.1 |
|
|
|
1.1 |
|
|
|
1.1 |
|
|
|
- |
|
|
|
6.1 |
% |
|
|
6.1 |
% |
|
|
0.0 |
% |
|
Net revenues |
|
$ |
691.4 |
|
|
$ |
801.5 |
|
|
$ |
(110.1 |
) |
|
|
(84.7 |
) |
|
$ |
(25.4 |
) |
|
|
(13.7 |
)% |
|
|
(10.6 |
)% |
|
|
(3.1 |
)% |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
117.4 |
|
|
|
109.7 |
|
|
|
7.7 |
|
|
|
12.5 |
|
|
|
(4.8 |
) |
|
|
7.0 |
% |
|
|
11.4 |
% |
|
|
(4.4 |
)% |
|
Selling and marketing |
|
|
210.7 |
|
|
|
237.6 |
|
|
|
(26.9 |
) |
|
|
(19.0 |
) |
|
|
(7.9 |
) |
|
|
(11.3 |
)% |
|
|
(8.0 |
)% |
|
|
(3.3 |
)% |
|
General and administrative |
|
|
36.3 |
|
|
|
25.7 |
|
|
|
10.6 |
|
|
|
13.1 |
|
|
|
(2.5 |
) |
|
|
41.2 |
% |
|
|
51.0 |
% |
|
|
(9.8 |
)% |
|
Segment contribution |
|
$ |
327.0 |
|
|
$ |
428.5 |
|
|
$ |
(101.5 |
) |
|
$ |
(91.3 |
) |
|
$ |
(10.2 |
) |
|
|
(23.7 |
)% |
|
|
(21.3 |
)% |
|
|
(2.4 |
)% |
|
Segment margin |
|
|
47.3 |
% |
|
|
53.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6.2 |
)% |
|
|
|
|
|
|
|
|
|
Segment gross margin(2) |
|
|
83.0 |
% |
|
|
86.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights, as well as indirect cost of sales not attributable to segment results. |
|
|||||||||||||||||||||||||||||||
|
(2) Defined as net revenues less segment related cost of sales as a percentage of net revenues. |
|
|||||||||||||||||||||||||||||||
|
(3) Defined as overall change excluding foreign exchange impact. |
|
|||||||||||||||||||||||||||||||
61
The following table presents our revenue disaggregated by geography for our International segment ($ in millions):
Net Revenues
Three Months Ended March 31, 2020 and 2019
The decrease in net revenues in the three months ended March 31, 2020 was primarily driven by lower sales of the Company’s Medical Aesthetic products due to the impact of the COVID-19 pandemic particularly in the Asia Pacific region where the impact occurred earlier in the quarter than other regions The declines in the Facial Aesthetic portfolio were due to decreased demand as a result of national and local government requirements around social distancing, “shelter in place” orders and business closures.
As a result of the COVID-19 pandemic, the Company anticipates a significant decline in the Medical Aesthetics net revenues to continue in the second quarter of 2020. The overall full year reduction in revenues will be determined by the duration of government restrictions, future economic conditions, and any potential future changes in consumer behavior related to medical aesthetics products, all of which are largely uncertain at this time.
Cost of Sales
Three Months Ended March 31, 2020 and 2019
The increase in cost of sales in the three months ended March 31, 2020 reflects inventory provisions totaling approximately $10.0 million as a result of the COVID-19 pandemic.
Selling and Marketing Expenses
Three Months Ended March 31, 2020 and 2019
The decrease in selling and marketing expenses in the three months ended March 31, 2020 was primarily due to a delay in promotional procedures.
General and Administrative Expenses
Three Months Ended March 31, 2020 and 2019
General and administrative expenses increased $10.6 million in the three months ended March 31, 2020 period over period as a result of an increase in bad debt provisions related to the COVID-19 pandemic.
62
Corporate
Corporate represents the results of corporate initiatives as well as the impact of select revenues and shared costs. The following represents the Corporate amounts for the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, 2020 |
|
|||||||||||||||||||||||||
|
|
|
Integration / Divestiture |
|
|
Non- Acquisition Related Restructuring |
|
|
Fair Value Adjustments |
|
|
Effect of Purchase Accounting |
|
|
Other |
|
|
Revenues and Shared Costs |
|
|
Total |
|
|||||||
|
Net revenues |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
51.0 |
|
|
$ |
51.0 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales(1) |
|
|
2.7 |
|
|
|
- |
|
|
|
24.1 |
|
|
|
0.2 |
|
|
|
- |
|
|
|
98.4 |
|
|
|
125.4 |
|
|
Selling and marketing |
|
|
43.6 |
|
|
|
0.5 |
|
|
|
- |
|
|
|
0.5 |
|
|
|
- |
|
|
|
- |
|
|
|
44.6 |
|
|
General and administrative |
|
|
27.2 |
|
|
|
1.2 |
|
|
|
- |
|
|
|
0.1 |
|
|
|
5.5 |
|
|
|
221.8 |
|
|
|
255.8 |
|
|
Contribution |
|
$ |
(73.5 |
) |
|
$ |
(1.7 |
) |
|
$ |
(24.1 |
) |
|
$ |
(0.8 |
) |
|
$ |
(5.5 |
) |
|
$ |
(269.2 |
) |
|
$ |
(374.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excludes amortization and impairment of acquired intangibles including product rights. |
|
|||||||||||||||||||||||||||
Integration / Divestiture
Three Months Ended March 31, 2020 and 2019
In the three months ended March 31, 2020, AbbVie Transaction-related costs which include legal, consulting and personnel costs were $68.2 million.
Fair Value Adjustments
Fair value adjustments primarily relate to changes in estimated contingent liabilities for future amounts to be paid based on achievement of sales levels for the respective products.
Effect of Purchase Accounting
Three Months Ended March 31, 2020 and 2019
In the three months ended March 31, 2020 and 2019, the Company incurred charges related to the purchase accounting impact on share-based compensation related to the acquisition of Zeltiq Aesthetics, Inc., which increased cost of sales, selling and marketing and general and administrative expenses.
63
Other
Three Months Ended March 31, 2020 and 2019
In the three months ended March 31, 2020 and 2019, general and administrative costs included legal settlement charges of $4.4 million and $10.4 million, respectively.
Revenues and Shared Costs
Shared costs primarily include above site and unallocated costs associated with running our global manufacturing facilities and corporate general and administrative expenses.
In the three months ended March 31, 2020, the Company recorded milestone revenue related to an on-going intellectual property agreement of $50.0 million.
Three Months Ended March 31, 2020 and 2019
In the three months ended March 31, 2020 and 2019, the Company incurred transactional foreign exchange losses of $36.3 million and $6.8 million, respectively.
Research and Development Expenses
R&D expenses consist predominantly of personnel-related costs, active pharmaceutical ingredient costs, contract research, license and milestone fees, biostudy and facilities costs associated with product development.
R&D expenses consisted of the following in the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Ongoing operating expenses |
|
$ |
413.0 |
|
|
$ |
397.9 |
|
|
$ |
15.1 |
|
|
|
3.8 |
% |
|
Milestone expenses and upfront license payments |
|
|
10.8 |
|
|
|
34.1 |
|
|
|
(23.3 |
) |
|
|
(68.3 |
)% |
|
Contingent consideration adjustments, net |
|
|
2.4 |
|
|
|
2.5 |
|
|
|
(0.1 |
) |
|
n.m. |
|
|
|
Acquisition accounting fair market value adjustment to share-based compensation |
|
|
0.1 |
|
|
|
0.4 |
|
|
|
(0.3 |
) |
|
|
(75.0 |
)% |
|
Acquisition, integration, and restructuring charges |
|
|
3.7 |
|
|
|
0.1 |
|
|
|
3.6 |
|
|
n.m. |
|
|
|
Total R&D Expenses |
|
$ |
430.0 |
|
|
$ |
435.0 |
|
|
$ |
(5.0 |
) |
|
|
(1.1 |
)% |
Operating Expenses
Three Months Ended March 31, 2020 and 2019
The increase in ongoing operating expenses in the three months ended March 31, 2020 is mainly due to increased product development spending in early stage development programs and for the Gastrointestinal therapeutic areas offset, in part, by lower spending in the Central Nervous System therapeutic areas.
64
Milestone Expenses and Upfront License Payments
The following represents milestone expenses, asset acquisitions and upfront license payments in the three months ended March 31, 2020 and 2019, respectively ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||
|
|
|
2020 |
|
|
2019 |
|
||
|
Akarna Therapeutics, Ltd. |
|
$ |
- |
|
|
$ |
10.0 |
|
|
Other |
|
|
10.8 |
|
|
|
24.1 |
|
|
Total |
|
$ |
10.8 |
|
|
$ |
34.1 |
|
Amortization
Amortization in the three months ended March 31, 2020 and 2019 was as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Amortization |
|
$ |
1,416.4 |
|
|
$ |
1,399.4 |
|
|
$ |
17.0 |
|
|
|
1.2 |
% |
Three Months Ended March 31, 2020 and 2019
Amortization for the three months ended March 31, 2020 was consistent with the prior year period.
Goodwill, IPR&D and Other Impairments and Asset Sales, Net
Goodwill, IPR&D and other impairments and asset sales, net consisted of the following in the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Goodwill impairments |
|
$ |
913.0 |
|
|
$ |
2,467.0 |
|
|
$ |
(1,554.0 |
) |
|
|
(63.0 |
)% |
|
Asset sales and impairments, net |
|
|
148.1 |
|
|
|
(5.2 |
) |
|
|
153.3 |
|
|
n.a. |
|
|
Refer to “NOTE 9 – Goodwill, Product Rights and Other Intangible Assets” for the description of the goodwill impairments and IPR&D impairments that the Company recorded in the three months ended March 31, 2020 and 2019.
Interest Income
Interest income in the three months ended March 31, 2020 and 2019 was as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Interest income |
|
$ |
21.2 |
|
|
$ |
21.3 |
|
|
$ |
(0.1 |
) |
|
|
(0.5 |
)% |
Interest income represents interest earned on cash and cash equivalents and marketable securities held during the respective periods.
65
Interest Expense
Interest expense consisted of the following in the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Fixed Rate Notes |
|
$ |
161.4 |
|
|
$ |
173.8 |
|
|
$ |
(12.4 |
) |
|
|
(7.1 |
)% |
|
Euro Denominated Notes |
|
|
16.1 |
|
|
|
14.9 |
|
|
|
1.2 |
|
|
|
8.1 |
% |
|
Floating Rate Notes |
|
|
1.9 |
|
|
|
5.0 |
|
|
|
(3.1 |
) |
|
|
(62.0 |
)% |
|
Other |
|
|
5.1 |
|
|
|
8.1 |
|
|
|
(3.0 |
) |
|
|
(37.0 |
)% |
|
Interest expense |
|
$ |
184.5 |
|
|
$ |
201.8 |
|
|
$ |
(17.3 |
) |
|
|
(8.6 |
)% |
Three Months Ended March 31, 2020 and 2019
Interest expense in the three months ended March 31, 2020 decreased versus the three months ended March 31, 2019 due to scheduled maturities and early debt extinguishment of senior secured notes period-over-period.
Other Income, Net
Other income, net consisted of the following in the three months ended March 31, 2020 and 2019 ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|
||||
|
Debt extinguishment other |
|
|
- |
|
|
|
(0.3 |
) |
|
|
0.3 |
|
|
|
(100.0 |
)% |
|
Other income, net |
|
|
(24.9 |
) |
|
|
14.1 |
|
|
|
(39.0 |
) |
|
|
(276.6 |
)% |
|
Other income, net |
|
$ |
(24.9 |
) |
|
$ |
13.8 |
|
|
$ |
(38.7 |
) |
|
|
(280.4 |
)% |
Refer to “NOTE 4 – Other Income / (Expense)” for further details regarding the components of other income, net.
(Benefit) for Income Taxes
(Benefit) for income taxes in the three months ended March 31, 2020 and 2019 was as follows: ($ in millions):
|
|
|
Three Months Ended March 31, |
||||||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|
% Change |
|||
|
(Benefit) for income taxes |
|
$ |
(1,866.8 |
) |
|
$ |
(68.6 |
) |
|
$ |
(1,798.2 |
) |
|
n.m. |
|
Effective tax rate |
|
|
125.5 |
% |
|
|
2.8 |
% |
|
|
|
|
|
|
Three Months Ended March 31, 2020 and 2019
The Company’s effective tax rate for the three months ended March 31, 2020 was a benefit of 125.5%, compared to a benefit of 2.8% for the three months ended March 31, 2019. The effective tax rate for the three months ended March 31, 2020 was favorably impacted by a tax benefit of $1.9 billion related to the decrease of certain deferred tax liabilities. The decrease resulted from the intra-entity transfer of intellectual property between entities under common control. As a result of this transfer, a deferred tax asset of $1.2 billion was recognized for the difference between the tax basis in the buyer’s jurisdiction and the net book value of the intellectual property as reported in the consolidated financial statements. However, based on the Company’s evaluation of the realizability of this deferred tax asset, the Company determined that it is not more-likely-than-not that the $1.2 billion deferred tax asset will be realizable as of March 31, 2020 and therefore this amount was offset by a full valuation allowance. The effective tax rate was unfavorably impacted by the goodwill impairment charge of $913.0 million, for which no tax benefit was recorded.
The effective tax rate for the three months ended March 31, 2019 was favorably impacted by a tax benefit of $91.5 million related to excess tax over book basis in a U.S. subsidiary that will reverse in the foreseeable future. The effective tax rate was unfavorably impacted by a goodwill impairment charge of $2,467.0 million, for which no tax benefit was recorded.
66
The effective tax rate for the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 was primarily impacted by a tax benefit recorded in the first quarter of 2020 for the decrease of certain deferred tax liabilities.
Liquidity and Capital Resources
Working Capital Position
Working capital at March 31, 2020 and December 31, 2019 is summarized as follows ($ in millions):
|
|
March 31, |
|
|
December 31, |
|
|
Increase |
|
|||
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
|||
|
Current Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
999.5 |
|
|
$ |
2,503.3 |
|
|
$ |
(1,503.8 |
) |
|
Marketable securities |
|
1,618.8 |
|
|
|
3,411.6 |
|
|
|
(1,792.8 |
) |
|
Accounts receivable, net |
|
2,800.6 |
|
|
|
3,192.3 |
|
|
|
(391.7 |
) |
|
Inventories |
|
1,199.9 |
|
|
|
1,133.1 |
|
|
|
66.8 |
|
|
Prepaid expenses and other current assets |
|
855.3 |
|
|
|
886.4 |
|
|
|
(31.1 |
) |
|
Total current assets |
|
7,474.1 |
|
|
|
11,126.7 |
|
|
|
(3,652.6 |
) |
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
5,289.5 |
|
|
$ |
6,348.7 |
|
|
$ |
(1,059.2 |
) |
|
Income taxes payable |
|
73.4 |
|
|
|
65.1 |
|
|
|
8.3 |
|
|
Current portion of long-term debt |
|
1,950.7 |
|
|
|
4,532.5 |
|
|
|
(2,581.8 |
) |
|
Current portion of lease liability - operating |
|
119.8 |
|
|
|
124.4 |
|
|
|
(4.6 |
) |
|
Total current liabilities |
|
7,433.4 |
|
|
|
11,070.7 |
|
|
|
(3,637.3 |
) |
|
Working Capital |
$ |
40.7 |
|
|
$ |
56.0 |
|
|
$ |
(15.3 |
) |
|
Current Ratio |
|
1.01 |
|
|
|
1.01 |
|
|
|
|
|
Working capital movements were primarily due to the following:
|
|
• |
The Company generated cash flows from operations of $116.5 million; |
|
|
• |
The Company paid dividends of $243.5 million; and |
|
|
• |
The Company repaid the scheduled maturities of the $3,026.0 million notes during the quarter ending March 31, 2020. |
Cash Flows
The Company’s cash flows are summarized as follows ($ in millions):
|
|
|
Three Months Ended March 31, |
|
|||||||||
|
|
|
2020 |
|
|
2019 |
|
|
$ Change |
|
|||
|
Net cash provided by operating activities |
|
$ |
116.5 |
|
|
$ |
1,234.0 |
|
|
$ |
(1,117.5 |
) |
|
Net cash provided by / (used in) investing activities |
|
$ |
1,679.1 |
|
|
$ |
(104.8 |
) |
|
$ |
1,783.9 |
|
|
Net cash (used in) financing activities |
|
$ |
(3,268.4 |
) |
|
$ |
(1,227.0 |
) |
|
$ |
(2,041.4 |
) |
Cash flows from operations represent net income adjusted for certain non-cash items and changes in assets and liabilities. Cash provided by operating activities decreased in the three months ended March 31, 2020 versus the prior year period as a result of legal settlements payments of approximately $900.0 million, which were accrued as of December 31, 2019 and the impact of COVID-19.
The current balance of cash and marketable securities on hand as of March 31, 2020 was $2,618.3 million. While the ultimate duration and recovery period of the COVID-19 pandemic presents inherent challenges to predict with certainty the overall impact on the Company’s liquidity needs, management expects that available cash balances and the remaining 2020 cash flows from operating activities will provide sufficient resources to fund our operating liquidity needs and expected capital expenditure funding requirements for at least the next twelve months. The Company also has the ability to borrow under its existing $1.5 billion revolving credit facility, which should provide sufficient additional resources to meet any further current liquidity needs. As of March 31, 2020, the Company does not anticipate utilizing the facility to fund liquidity needs.
67
Investing cash flows for the three months ended March 31, 2020 reflect the net cash from investments of $1,800.0 million. Investing cash flows for the three months ended March 31, 2019 reflect the cash used in acquisitions of businesses of $80.6 million.
Financing cash flows consist primarily of borrowings and repayments of debt, repurchases of ordinary shares, dividend payments and proceeds from the exercise of stock options. Cash used in financing activities in the three months ended March 31, 2020 primarily related to the repayment of indebtedness of $3,031.8 million, and the payment of dividends of $243.5 million. Cash used in financing activities in the three months ended March 31, 2019 primarily related to the repayment of indebtedness of $159.4 million, the repurchase of ordinary shares of $829.2 million and the payment of dividends of $246.1 million.
Off-Balance Sheet Arrangements
We do not have any material off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, net revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Available Information
From time to time, we use our website, our Facebook, Instagram, LinkedIn and Twitter accounts and other social media channels as additional means of disclosing public information to investors, the media and others interested in the Company. Additionally, our Chairman, President and Chief Executive Officer, Brent L. Saunders, and our Executive Vice President and Chief Commercial Officer, Bill Meury, may use similar social media channels to disclose public information. It is possible that certain information we post on our website and on social media could be deemed to be material information, and we encourage investors, the media and others interested in the Company to review the business and financial information we post on our website and on the social media channels identified above. The information on our website and those social media channels is not incorporated by reference into this Form 10-Q.
Cautionary note regarding forward-looking statements
Any statements made in this report that are not statements of historical fact or that refer to estimated or anticipated future events are “forward‑looking statements”, as contemplated in the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “plan,” “intend,” “could,” “would,” “should,” “estimate,” “continue,” or “pursue,” or the negative or other variations thereof or comparable terminology, are intended to identify forward‑looking statements. We have based our forward‑looking statements on management’s beliefs and assumptions based on information available to our management at the time these statements are made. Such forward‑looking statements reflect our current perspective of our business, future performance, existing trends and information as of the date of this filing. The statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. We caution the reader that these statements are based on certain assumptions, risks and uncertainties, many of which are beyond our control. We do not undertake any responsibility to release publicly any revisions to these forward-looking statements to take into account events or circumstances that occur after the date of this report.
Actual results may differ materially from our current expectations depending upon a number of factors affecting our business. These factors include, among others:
|
|
• |
global economic and trade conditions; |
|
|
• |
our ability to successfully develop and commercialize new products; |
|
|
• |
uncertainty associated with the continued success of major products; |
|
|
• |
generic product competition with our branded products; |
|
|
• |
expiration of our patents on our branded products and the potential for increased competition from generic manufacturers; |
|
|
• |
the highly competitive nature of the pharmaceutical industry; |
|
|
• |
our ability to protect our technology rights, patents or other intellectual property; |
68
|
|
• |
costs and efforts to defend or enforce technology rights, patents or other intellectual property; |
|
|
• |
our ability to obtain and afford third-party licenses and proprietary technology that we need; |
|
|
• |
our potential infringement of others’ proprietary rights; |
|
|
• |
our dependency on third-party service providers and third-party manufacturers and suppliers that in some cases may be the only source of finished products or raw materials that we need; |
|
|
• |
availability of raw materials and other key ingredients; |
|
|
• |
our vulnerability to and ability to defend against product liability claims and obtain sufficient or any product liability insurance; |
|
|
• |
difficulties or delays in manufacturing; |
|
|
• |
the effect of regulation including our ability to comply with and operate successfully under regulatory regimes that apply to us, including healthcare and privacy regulations; |
|
|
• |
uncertainty and costs of legal actions and government investigations; |
|
|
• |
the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; |
|
|
• |
our ability to successfully navigate consolidation of our distribution network and concentration of our customer base; |
|
|
• |
risks associated with acquisitions, mergers and joint ventures, such as difficulties integrating businesses, uncertainty associated with financial projections, projected synergies, restructuring, increased costs, and adverse tax consequences; |
|
|
• |
the inherent uncertainty associated with financial projections; |
|
|
• |
fluctuations in our operating results and financial conditions; |
|
|
• |
the adverse impact of substantial debt and other financial obligations on the ability to fulfill and/or refinance debt obligations; |
|
|
• |
the effect of goodwill and intangible assets and resulting impairment testing and impairment charges on our financial condition; |
|
|
• |
our ability to obtain additional debt or raise additional equity on terms that are favorable to us; |
|
|
• |
our ability to retain qualified employees and key personnel; |
|
|
• |
risks related to health epidemics and other outbreaks, including the novel coronavirus (COVID-19); |
|
|
• |
risks associated with cyber-security and vulnerability of our information and employee, customer and business information that we store digitally; |
|
|
• |
our ability to manage environmental liabilities; |
|
|
• |
our ability to continue foreign operations in countries and to maintain global operations; |
|
|
• |
uncertainty related to our dividend plan and share repurchase program; |
|
|
• |
risks associated with tax liabilities, or changes in U.S. federal or international tax laws or tax rulings to which we and our affiliates are subject, including changes that impact our effective tax rate and the risk that the Internal Revenue Service disagrees that we are a foreign corporation for U.S. federal tax purposes; |
69
|
|
• |
risks of fluctuations in foreign currency exchange rates; |
|
|
• |
our ability to maintain internal control over financial reporting; |
|
|
• |
the ability of Irish law to protect our shareholders; |
|
|
• |
the impact of Irish laws and regulations on our business, including limitations on capital management; |
|
|
• |
uncertainty on the enforceability of judgements against our officers and directors in an Irish court; |
|
|
• |
risks associated with Irish tax liabilities, which could subject us or our shareholders to Irish stamp duty, dividend withholding tax, income tax and/or capital acquisition tax; and |
|
|
• |
other risks and uncertainties including those discussed in “Risk Factors” in our Annual Report on Form 10-K. |
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
The following discussion provides forward-looking quantitative and qualitative information about our potential exposure to market risk. Market risk represents the potential loss arising from adverse changes in the value of financial instruments. The risk of loss is assessed based on the likelihood of adverse changes in fair values, cash flows or future earnings. We are exposed to market risk for changes in the market values of our investments (Investment Risk), the impact of interest rate changes (Interest Rate Risk) and the impact of foreign currency exchange changes (Foreign Currency Exchange Risk).
We maintain our portfolio of cash equivalents and short-term investments in a variety of securities, including both government and government agency obligations with ratings of A or better and money market funds. Our investments in marketable securities are governed by our investment policy which seeks to preserve the value of our principal, provide liquidity and maximize return on the Company’s investment against minimal interest rate risk. Consequently, our interest rate and principal risk are minimal on our non-equity investment portfolio. The quantitative and qualitative disclosures about market risk are set forth below.
Investment Risk
As of March 31, 2020, our total investments in marketable and equity securities of other companies, including equity method investments, but excluding securities considered cash and cash equivalents, were $1,675.6 million (included in marketable securities and investments and other assets). The fair values of these investments are subject to fluctuations due to volatility of the stock market and changes in general economic conditions.
We regularly review the carrying value of our investments and identify and recognize losses for income statement purposes.
Interest Rate Risk
Our exposure to interest rate risk relates primarily to our non-equity investment portfolio. Our cash is invested in money market securities.
Our permitted investments in marketable securities include highly liquid money market securities classified as available-for-sale securities. No security as of March 31, 2020 has a maturity in excess of one year. These investments include floating rate securities that are exposed to interest rate fluctuations. Because of the short-term nature of these investments, we are subject to minimal interest rate risk and do not believe that an increase in market rates would have a significant negative impact on the value of our portfolio.
Floating Rate Debt
At March 31, 2020, borrowings outstanding under the floating rate notes were $772.2 million. Assuming a one percent increase in the applicable interest rate on the Company’s floating rates notes, annual interest expense would increase by approximately $7.0 million over the next twelve months.
In January 2019, Allergan entered into $500.0 million notional floating to fixed interest rate swaps maturing on March 12, 2020 whereby it fixed the interest rates on $500.0 million floating rate notes due March 12, 2020 to an average interest rate of 3.98%. The swaps were being accounted for using hedge accounting treatment. During the quarter ended March 31, 2020, the interest rate swap
70
contracts expired. For the three months ended March 31, 2020, the corresponding realized gain of $0.8 million was recorded in accumulated other comprehensive income / (loss).
Fixed Rate Debt
The Company has outstanding borrowings under its fixed rate notes. Changes in market interest rates generally affect the fair value of fixed-rate debt, but do not impact earnings or cash flows.
Euro Denominated Debt
The Company has outstanding borrowings under its Euro Denominated Notes. Changes in foreign exchange rates may impact cash flows for principal and interest.
Interest Rate
The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and its overall cost of borrowing. The Company does not use leveraged swaps and does not leverage any of its fixed income investments that would put principal capital at risk.
Foreign Currency Exchange Risk
Overall, we are a net recipient of currencies other than the U.S. dollar and, as such, benefit from a weaker dollar and are 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 our consolidated revenues or operating costs and expenses as expressed in U.S. dollars.
From time to time, we enter into foreign currency forward contracts which change in value as foreign exchange rates change to allow the Company to economically offset the effect of changes in the value of foreign currency assets and liabilities. We have entered into foreign currency forward contracts in amounts between minimum and maximum existing or anticipated foreign exchange exposures.
The Company is subject to transactions which are denominated in currencies other than the functional currency and therefore movements in exchange rates may impact the results of operations. Net foreign currency losses reflected in general and administrative expenses were $36.3 million and $6.8 million for the three months ended March 31, 2020 and 2019, respectively.
The currency for Argentina was deemed hyperinflationary in the third quarter of 2018 and is now being accounted for using the Company’s functional currency. The impact is immaterial to the Company’s operations.
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 $4.9 billion as of March 31, 2020 and $5.0 billion as of December 31, 2019. During the three months ended March 31, 2020 and March 31, 2019, the impact of the net investment hedges recorded in other comprehensive loss was a loss of $81.0 million and a gain of $110.8 million, respectively, which offset the currency impact within our net investment in subsidiaries which are impacted by their Euro Denominated Notes.
Other
We do not believe that inflation has had a significant impact on our revenues or operations, nor do we have any material commodity price risks.
|
ITEM 4. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Allergan plc maintains “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) of the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed in Allergan plc’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such
71
information is accumulated and communicated to Allergan plc’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.
As required by SEC Rule 13a-15(b), Allergan plc carried out an evaluation, under the supervision and with the participation of Allergan plc’s management, including Allergan plc’s Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of Allergan plc’s disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on this evaluation Allergan plc’s Principal Executive Officer and Principal Financial Officer concluded that Allergan plc’s disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2020.
Warner Chilcott Limited maintains “disclosure controls and procedures,” as such term is defined under Rule 13a-15(e) of the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed in the Company’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Warner Chilcott Limited’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.
As required by SEC Rule 13a-15(b), Warner Chilcott Limited carried out an evaluation, under the supervision and with the participation of Warner Chilcott Limited’s management, including Warner Chilcott Limited’s Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of Warner Chilcott Limited’s disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on this evaluation Warner Chilcott Limited’s Principal Executive Officer and Principal Financial Officer concluded that Warner Chilcott Limited’s disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2020.
Changes in Internal Control Over Financial Reporting of Allergan plc and Warner Chilcott Limited
During the quarter ended March 31, 2020, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, Allergan plc and Warner Chilcott Limited’s internal control over financial reporting.
72
PART II. OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS |
For information regarding legal proceedings, refer to “PART I, ITEM 3. LEGAL PROCEEDINGS,” of our Annual Report on Form 10-K for the year ended December 31, 2019 and “Legal Matters” in “NOTE 15 — Commitments and Contingencies” in the accompanying “Notes to the Consolidated Financial Statements” in this Quarterly Report.
|
ITEM 1A. |
RISK FACTORS |
We face risks related to health epidemics and other outbreaks, including the novel coronavirus (COVID-19), which could significantly disrupt our operations and/or business.
Our global operations expose us to risks associated with public health crises, epidemics and pandemics, such as the novel strain of coronavirus (COVID-19) that originated in China and which has since spread across the globe. Our medical aesthetic portfolio of products are particularly 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 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 impact our business.
Parts of our direct and indirect supply chain are also located in areas which have experienced outbreaks of COVID-19 and are accordingly subject to disruption or product contamination. For instance, certain raw materials (including API, other chemicals, packaging components, and electronic components) used in the manufacture of certain of our commercial products including Ubrelvy® and Coolsculpting®, and for certain of our products currently in development, are manufactured in China. Quarantines for COVID-19 could impact personnel at third party manufacturing facilities, or the availability or cost of materials, which would further disrupt our supply chain. In addition, our current and future clinical trials may be affected by the COVID-19 outbreak. Due to the COVID-19 pandemic, certain clinical sites have temporarily suspended enrolling new patients. We are taking measures to mitigate any potential delays in clinical trials, but it is possible that the timing of these trials and anticipated launch dates of the related projects may be impacted. Also, we have suspended face to face sales meetings and the Company’s sales teams have been working remotely during the COVID-19 pandemic. Our sales teams continue to work with customers to provide sufficient levels of support and detailing. Additionally, we will continue to assess variable sales and marketing expenses, such as direct to consumer advertising, as a result of the COVID-19 pandemic
The global outbreak of COVID-19 continues to evolve and the extent to which COVID-19 impacts our results will depend on future developments, which are highly uncertain and cannot be predicted, including the duration of the outbreak, travel restrictions imposed by countries, business closures or business disruption globally, a reduction in time spent out of home, less consumer spending, and the actions taken throughout the world, including in our markets, to contain COVID-19 or treat its impact. As a result, especially in the near term, COVID-19 may have an adverse impact on our operations, supply chains, clinical trials and distribution systems, as well as on our business, financial condition, including goodwill and intangible assets, and results of operations.
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Recent Sale of Unregistered Securities; Uses of Proceeds from Registered Securities
None.
Issuer Purchases of Equity Securities
During the quarter ended March 31, 2020, we repurchased 283,034 of Allergan plc’s Ordinary Shares to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees and directors. On January 29, 2019, the Company announced that its Board of Directors approved a $2.0 billion share repurchase program, all of which remained outstanding as of March 31, 2020.
73
|
Period |
|
Total Number of Shares Purchased |
|
|
Total Number of Shares Purchased to Satisfy Tax Withholdings |
|
|
Average Price Paid per Share |
|
|
Total Number of Shares Purchased as Part of Share Repurchase Program |
|
|
Average Price Paid per Share as Part of Share Repurchase Program |
|
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Share Repurchase Program ($ in millions) |
|
||||||
|
January 1 - 31, 2020 |
|
|
2,687 |
|
|
|
2,687 |
|
|
$ |
190.77 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
2,000.0 |
|
|
February 1 - 28, 2020 |
|
|
2,746 |
|
|
|
2,746 |
|
|
$ |
190.22 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
2,000.0 |
|
|
March 1 - 31, 2020 |
|
|
277,601 |
|
|
|
277,601 |
|
|
$ |
192.22 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
2,000.0 |
|
|
January 1 - March 31, 2020 |
|
|
283,034 |
|
|
|
283,034 |
|
|
$ |
193.41 |
|
|
|
- |
|
|
$ |
- |
|
|
|
|
|
74
|
ITEM 6. |
EXHIBITS |
Reference is hereby made to the Exhibit Index below.
EXHIBIT INDEX
|
Exhibit |
|
Description |
|
|
|
|
|
31.1* |
|
|
|
31.2* |
|
|
|
32.1** |
|
|
|
32.2** |
|
|
|
101.INS |
|
Inline XBRL Instance Document. |
|
101.SCH |
|
Inline XBRL Taxonomy Extension Scheme Document. |
|
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
|
101.DEF |
|
Inline XBRL Taxonomy Extension Label Definition Document. |
|
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
|
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
|
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
|
# |
Indicates a management contract or compensatory plan or arrangement. |
|
* |
Filed herewith. |
|
** |
Furnished herewith and not “filed” for purposes of Section 18 of the Exchange Act. |
75
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on May 7, 2020.
|
|
ALLERGAN PLC WARNER CHILCOTT LIMITED |
||
|
|
|
|
|
|
|
By: |
|
/s/ Matthew M. Walsh |
|
|
Name: |
|
Matthew M. Walsh |
|
|
Title: |
|
Executive Vice President and Chief Financial Officer (Principal Financial Officer) |
|
|
|
|
|
|
|
By: |
|
/s/ James C. D’Arecca |
|
|
Name: |
|
James C. D’Arecca |
|
|
Title: |
|
Chief Accounting Officer (Principal Accounting Officer) |
76
Exhibit 31.1
Certification of Chief Executive Officer
Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
I, Brenton L. Saunders, Chairman, President and Chief Executive Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Allergan plc;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: May 7, 2020 |
|
|
|
|
|
By: |
/s/ BRENTON L. SAUNDERS |
|
|
Brenton L. Saunders |
|
|
Chairman, President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
Certification of Chief Executive Officer
Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
I, Brenton L. Saunders, Chairman, President and Chief Executive Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Warner Chilcott Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: May 7, 2020 |
|
|
|
|
|
By: |
/s/ BRENTON L. SAUNDERS |
|
|
Brenton L. Saunders |
|
|
Chairman, President and Chief Executive Officer |
|
|
(Principal Executive Officer) |
Exhibit 31.2
Certification of Chief Financial Officer
Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
I, Matthew M. Walsh, Executive Vice President and Chief Financial Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Allergan plc;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: May 7, 2020 |
|
|
|
|
|
By: |
/s/ MATTHEW M. WALSH |
|
|
Matthew M. Walsh |
|
|
Executive Vice President and Chief Financial Officer |
|
|
(Principal Financial Officer) |
Certification of Chief Financial Officer
Pursuant to Rule 13a-14(a) Under the Securities Exchange Act of 1934
I, Matthew M. Walsh, Executive Vice President and Chief Financial Officer, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Warner Chilcott Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: May 7, 2020 |
|
|
|
|
|
By: |
/s/ MATTHEW M. WALSH |
|
|
Matthew M. Walsh |
|
|
Executive Vice President and Chief Financial Officer |
|
|
(Principal Financial Officer) |
Exhibit 32.1
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. of Section 1350, as Adopted by
Section 906 of the Sarbanes-Oxley Act of 2002
The undersigned officer of Allergan plc (the “Company”), hereby certifies, to such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Allergan plc.
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Date: May 7, 2020 |
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By: |
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/s/ BRENTON L. SAUNDERS |
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Brenton L. Saunders |
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Chairman, President and Chief Executive Officer |
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(Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. of Section 1350, as Adopted by
Section 906 of the Sarbanes-Oxley Act of 2002
The undersigned officer of Warner Chilcott Limited (the “Company”), hereby certifies, to such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Warner Chilcott Limited.
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Date: May 7, 2020 |
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By: |
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/s/ BRENTON L. SAUNDERS |
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Brenton L. Saunders |
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Chairman, President and Chief Executive Officer |
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(Principal Executive Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Exhibit 32.2
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. of Section 1350, as Adopted by
Section 906 of the Sarbanes-Oxley Act of 2002
The undersigned officer of Allergan plc (the “Company”), hereby certifies, to such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Allergan plc.
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Date: May 7, 2020 |
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By: |
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/s/ MATTHEW M. WALSH |
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Matthew M. Walsh |
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Executive Vice President and Chief Financial Officer |
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(Principal Financial Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. of Section 1350, as Adopted by
Section 906 of the Sarbanes-Oxley Act of 2002
The undersigned officer of Warner Chilcott Limited (the “Company”), hereby certifies, to such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Warner Chilcott Limited.
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Date: May 7, 2020 |
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By: |
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/s/ MATTHEW M. WALSH |
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Matthew M. Walsh |
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Executive Vice President and Chief Financial Officer |
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(Principal Financial Officer) |
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.