NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited, dollars in millions, except share data, per share data and where indicated)
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1.
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Background and Basis of Presentation
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Background
Mallinckrodt plc is a global business of multiple wholly owned subsidiaries (collectively, "Mallinckrodt" or "the Company") that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products.
The Company operates in two reportable segments, which are further described below:
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•
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Specialty Brands includes innovative specialty pharmaceutical brands; and
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•
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Specialty Generics includes niche specialty generic drugs and active pharmaceutical ingredients ("API(s)").
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The Company owns or has rights to use the trademarks and trade names that are used in conjunction with the operation of its business. One of the more important trademarks that the Company owns or has rights to use that appears in this Quarterly Report on Form 10-Q is "Mallinckrodt," which is a registered trademark or the subject of pending trademark applications in the United States ("U.S.") and other jurisdictions. Solely for convenience, the Company only uses the ™ or ® symbols the first time any trademark or trade name is mentioned in the following notes. Such references are not intended to indicate in any way that the Company will not assert, to the fullest extent permitted under applicable law, its rights to its trademarks and trade names. Each trademark or trade name of any other company appearing in the following notes is, to the Company's knowledge, owned by such other company.
Basis of Presentation
The unaudited condensed consolidated financial statements have been prepared in U.S. dollars and in accordance with accounting principles generally accepted in the U.S. ("GAAP"). The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amount of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses. Actual results may differ from those estimates. The unaudited condensed consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and entities in which they own or control more than 50.0% of the voting shares, or have the ability to control through similar rights. All intercompany balances and transactions have been eliminated in consolidation and all normal recurring adjustments necessary for a fair presentation have been included in the results reported.
The results of entities disposed of are included in the unaudited condensed consolidated financial statements up to the date of disposal, and where appropriate, these operations have been reported in discontinued operations. Divestitures of product lines and businesses not meeting the criteria for discontinued operations have been reflected in operating income.
The fiscal year end balance sheet data was derived from audited consolidated financial statements, but do not include all of the annual disclosures required by GAAP; accordingly these unaudited condensed consolidated financial statements should be read in conjunction with the Company's audited annual consolidated financial statements included in its Annual Report on Form 10-K for the fiscal year ended December 27, 2019 filed with the U.S. Securities and Exchange Commission ("SEC") on February 26, 2020.
During fiscal 2019, the Company experienced a change in its reportable segments, which primarily served to move the results
related to Amitiza® to the Specialty Brands segment from the Specialty Generics segment. All prior period segment information has been recast to reflect the realignment of the Company's reportable segments on a comparable basis.
Fiscal Year
The Company reports its results based on a "52-53 week" year ending on the last Friday of December. Unless otherwise indicated, the three months ended March 27, 2020 refers to the thirteen week period ended March 27, 2020 and the three months ended March 29, 2019 refers to the thirteen week period ended March 29, 2019.
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2.
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Revenue from Contracts with Customers
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Product Sales Revenue
See Note 13 for presentation of the Company's net sales by product family.
Reserves for variable consideration
The following table reflects activity in the Company's sales reserve accounts:
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Rebates and Chargebacks
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Product Returns
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Other Sales Deductions
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Total
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Balance as of December 28, 2018
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$
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354.3
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$
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34.0
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$
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17.1
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$
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405.4
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Provisions
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602.9
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6.2
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17.7
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626.8
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Payments or credits
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(805.8
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)
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(8.2
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)
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(12.4
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)
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(826.4
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)
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Balance as of March 29, 2019
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$
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151.4
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$
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32.0
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$
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22.4
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$
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205.8
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Balance as of December 27, 2019
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$
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295.8
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$
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28.4
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$
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13.2
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$
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337.4
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Provisions
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457.8
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3.8
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13.7
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475.3
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Payments or credits
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(498.8
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)
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(6.1
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(15.9
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)
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(520.8
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)
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Balance as of March 27, 2020
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$
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254.8
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$
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26.1
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$
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11.0
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$
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291.9
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Product sales transferred to customers at a point in time and over time were as follows:
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Three Months Ended
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March 27,
2020
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March 29,
2019
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Product sales transferred at a point in time
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78.5
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%
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80.7
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%
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Product sales transferred over time
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21.5
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19.3
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Transaction price allocated to the remaining performance obligations
The following table includes estimated revenue from contracts extending greater than one year for certain of the Company's hospital products that are expected to be recognized in the future related to performance obligations that were unsatisfied or partially unsatisfied as of March 27, 2020:
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Remainder of Fiscal 2020
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$
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148.5
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Fiscal 2021
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102.7
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Fiscal 2022
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37.7
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Fiscal 2023
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8.1
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Thereafter
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0.3
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Costs to fulfill a contract
As of March 27, 2020 and December 27, 2019, the total net book value of the devices used in the Company's portfolio of drug-device combination products, which are used in satisfying future performance obligations, were $28.4 million and $26.5 million, respectively, and were classified in property, plant and equipment, net, on the unaudited condensed consolidated balance sheets. The associated depreciation expense recognized during both the three months ended March 27, 2020 and March 29, 2019 was $1.5 million.
Product Royalty Revenues
The Company licenses certain rights to Amitiza to a third party in exchange for royalties on net sales of the product. The Company recognizes such royalty revenue as the related sales occur. The royalty rates consist of several tiers ranging from 18.0% to 26.0% with the royalty rate resetting every year. The associated royalty revenue recognized was as follows:
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Three Months Ended
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March 27,
2020
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March 29,
2019
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Royalty revenue
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$
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15.6
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$
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17.4
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Contract Liabilities
The following table reflects the balance of the Company's contract liabilities at the end of each period:
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March 27,
2020
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December 27,
2019
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Accrued and other current liabilities
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$
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4.7
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$
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5.6
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Other liabilities
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0.6
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0.6
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Contract liabilities
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$
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5.3
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$
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6.2
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Revenue recognized during the three months ended March 27, 2020 and March 29, 2019 from amounts included in contract liabilities at the beginning of the period was $2.3 million and $4.5 million, respectively, inclusive of the Company's wholly owned subsidiary BioVectra Inc. ("BioVectra), prior to the completion of the sale of this business in November 2019.
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3.
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Restructuring and Related Charges
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During fiscal 2018 and 2016, the Company launched restructuring programs designed to improve its cost structure. Charges of $100.0 million to $125.0 million were provided for under each program. Each program generally commenced upon substantial completion of the previous program. In addition to the aforementioned programs, the Company has taken restructuring actions to generate synergies from its acquisitions.
Net restructuring and related charges by segment were as follows:
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Three Months Ended
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March 27,
2020
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March 29,
2019
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Specialty Brands
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$
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—
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$
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0.5
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Specialty Generics
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0.1
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3.5
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Corporate
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(1.9
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0.2
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Restructuring and related charges, net
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(1.8
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4.2
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Less: accelerated depreciation
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—
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—
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Restructuring charges, net
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$
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(1.8
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$
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4.2
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Net restructuring and related charges by program were comprised of the following:
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Three Months Ended
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March 27,
2020
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March 29,
2019
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2018 Program
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$
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0.1
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$
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3.5
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2016 Program
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—
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0.7
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Acquisition Programs
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(1.9
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)
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—
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Total charges expected to be settled in cash
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$
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(1.8
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$
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4.2
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The following table summarizes cash activity for restructuring reserves, substantially all of which related to contract termination costs, employee severance and benefits and exiting of certain facilities:
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2018 Program
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2016 Program
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Acquisition Programs
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Total
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Balance as of December 27, 2019
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$
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2.7
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$
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31.3
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$
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0.2
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$
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34.2
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Charges
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0.1
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—
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—
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0.1
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Changes in estimate
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—
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—
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(1.9
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(1.9
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Cash payments
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(2.5
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)
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(30.5
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)
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(0.2
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)
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(33.2
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)
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Currency translation and other
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—
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—
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1.9
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1.9
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Balance as of March 27, 2020
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$
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0.3
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$
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0.8
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$
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—
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$
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1.1
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As of March 27, 2020, net restructuring and related charges incurred cumulative to date were as follows:
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2018 Program
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2016 Program
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Specialty Brands
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$
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3.0
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$
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68.1
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Specialty Generics
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10.1
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14.6
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Corporate
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2.0
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28.9
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$
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15.1
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$
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111.6
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All of the restructuring reserves were included in accrued and other current liabilities on the Company's unaudited condensed consolidated balance sheets. Amounts paid in the future may differ from the amount currently recorded.
On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. The CARES Act was a response to the market volatility and instability resulting from the coronavirus pandemic. It includes provisions to support individuals and businesses in the form of loans, grants, and tax changes among other types of relief. Estimates of the effects of the changes to the U.S. tax code have been incorporated into the Company’s three months ended March 27, 2020 provision for income taxes, as applicable.
The CARES Act income tax provisions applicable to the Company effective within the three months ended March 27, 2020 include, but are not limited to (1) carrybacks of certain net operating losses (“NOLs”) generated in tax years beginning after December 31, 2017 and before January 1, 2021 to the preceding five taxable years, (2) suspension of the 80.0% taxable income limitation for NOLs generated in tax years beginning after December 31, 2017 and before January 1, 2021, (3) increase in the limitation of the interest expense deduction under Internal Revenue Code §163(j) from 30.0% to 50.0% of adjusted taxable income for any taxable year beginning in 2019 or 2020, (4) expansion of the charitable contribution deduction limit to 25.0% of taxable income versus the previous 10.0% limitation for contributions made during 2020, and (5) acceleration of Alternative Minimum Tax credits being refunded incrementally in tax years 2018, 2019, 2020 and 2021 to recover the entire remaining balance in either the 2018 or 2019 tax year.
Accounting Standards Codification Topic 740, "Income Taxes," requires companies to recognize the effects of tax law changes in the period of enactment, which for the Company is the three months ended March 27, 2020. As a result of the CARES Act, the Company is able to carryback a portion of its estimated prior year U.S. Federal NOLs resulting in an anticipated cash tax refund of $91.5 million. A tax benefit of $11.5 million has been recognized primarily due to a remeasurement of the NOLs to the historical statutory tax rates. The carryback of the U.S. Federal NOLs has an ancillary effect on the Company’s unrecognized tax benefits, as disclosed below. These amounts may change when the Federal income tax return for the tax year ended September 27, 2019 is filed with the Internal Revenue Service ("IRS") no later than in the quarter ending September 25, 2020.
The Company recognized an income tax benefit of $18.9 million on a loss from continuing operations before income taxes of $75.6 million for the three months ended March 27, 2020, and an income tax benefit of $204.7 million on a loss from continuing operations before income taxes of $49.5 million for the three months ended March 29, 2019. This resulted in effective tax rates of 25.0% and 413.5% for the three months ended March 27, 2020 and March 29, 2019, respectively. The income tax benefit for the three months ended March 27, 2020 was comprised of $22.4 million of current tax benefit and $3.5 million of deferred tax expense. The deferred tax expense was predominantly comprised of deferred tax expense as a result of the CARES Act partially offset by deferred tax benefit related to previously acquired intangibles. The income tax benefit for the three months ended March 29, 2019 was comprised of $38.5 million of current tax expense and $243.2 million of deferred tax benefit. The deferred tax benefit was predominantly related to previously acquired intangibles as well as the reorganization of the Company's intercompany financing and associated legal entity ownership which eliminated the interest bearing deferred tax obligation.
The income tax benefit was $18.9 million for the three months ended March 27, 2020, compared with a tax benefit of $204.7 million for the three months ended March 29, 2019. The $185.8 million net decrease in the tax benefit included a decrease of $192.8 million attributed to the tax benefit from the reorganization of the Company's intercompany financing and associated legal entity ownership, a decrease in tax benefit of $6.0 million predominately attributed to changes in the timing, amount and jurisdictional mix of income, and a decrease of $1.4 million attributed to net restructuring, partially offset by an increase of $11.5 million attributed to the CARES Act, an increase of $1.7 million attributed to the gain on debt repurchased, and an increase of $1.2 million attributed to separation costs.
During the three months ended March 27, 2020, and fiscal 2019, the net cash payments for income taxes were $12.7 million and $30.7 million, respectively.
On August 5, 2019, the IRS proposed an adjustment to the taxable income of Mallinckrodt Hospital Products Inc. (“MHP”) (formerly known as Cadence Pharmaceuticals, Inc. ("Cadence")) as a result of its findings in the audit of MHP's tax year ended September 26, 2014. The proposed adjustment to taxable income of $871.0 million, excluding potential associated interest and penalties, is proposed as a multi-year adjustment and may result in a non-cash reduction of the Company's U.S. Federal net operating loss carryforward of $765.1 million. The Company strongly disagrees with the proposed adjustment, continues to engage in resolution discussions with the IRS audit team and intends to contest it through all available administrative and judicial remedies, which may take a number of years to conclude. See Note 11 for further details.
The Company's unrecognized tax benefits, excluding interest, totaled $418.9 million and $398.6 million as of March 27, 2020 and December 27, 2019, respectively. The net increase of $20.3 million primarily resulted from an increase to prior period tax positions of $25.1 million offset by a decrease related to releases due to a lapse of statute of limitations of $4.8 million. If favorably settled, $416.6 million of unrecognized tax benefits as of March 27, 2020 would benefit the effective tax rate, of which up to $20.0 million may be reported in discontinued operations. The total amount of accrued interest and penalties related to these obligations was $34.5 million and $32.9 million as of March 27, 2020 and December 27, 2019, respectively.
It is reasonably possible that within the next twelve months the unrecognized tax benefits could decrease by up to $95.5 million and the amount of related interest and penalties could decrease by up to $22.3 million as a result of payments or releases due to the resolution of various United Kingdom ("U.K.") and non-U.K. examinations, appeals and litigation and the expiration of various statutes of limitation.
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5.
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(Loss) Earnings per Share
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Basic (loss) earnings per share is computed by dividing net (loss) income by the number of weighted-average shares outstanding during the period. Diluted (loss) earnings per share is computed using the weighted-average shares outstanding and, if dilutive, potential ordinary shares outstanding during the period. Potential ordinary shares represent the incremental ordinary shares issuable for restricted share units and share option exercises. The Company calculated the dilutive effect of outstanding restricted share units and share options on (loss) earnings per share by application of the treasury stock method. Dilutive securities, including participating securities, are not included in the computation of loss per share when the Company reports a net loss from continuing operations as the impact would be anti-dilutive.
The weighted-average number of shares outstanding used in the computations of basic and diluted (loss) earnings per share were as follows (in millions):
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|
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Three Months Ended
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|
March 27,
2020
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March 29,
2019
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Basic
|
84.2
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|
|
83.5
|
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Dilutive impact of restricted share units and share options
|
—
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|
1.1
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Diluted
|
84.2
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|
84.6
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The computation of diluted weighted-average shares outstanding for the three months ended March 27, 2020 and March 29, 2019 excluded approximately 5.8 million shares and 3.2 million shares of equity awards, respectively, because the effect would have been anti-dilutive.
Inventories were comprised of the following at the end of each period:
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|
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|
March 27,
2020
|
|
December 27,
2019
|
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Raw materials and supplies
|
$
|
56.5
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|
|
$
|
62.7
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|
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Work in process
|
184.5
|
|
|
166.5
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|
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Finished goods
|
86.1
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|
|
82.9
|
|
|
|
$
|
327.1
|
|
|
$
|
312.1
|
|
|
|
|
|
|
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7.
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Property, Plant and Equipment
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The gross carrying amount and accumulated depreciation of property, plant and equipment were comprised of the following at the end of each period:
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|
|
|
|
|
|
|
|
|
|
|
|
March 27,
2020
|
|
December 27, 2019
|
|
Property, plant and equipment, gross
|
$
|
1,902.7
|
|
|
$
|
1,900.1
|
|
|
Less: accumulated depreciation
|
(1,024.5
|
)
|
|
(1,003.6
|
)
|
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Property, plant and equipment, net
|
$
|
878.2
|
|
|
$
|
896.5
|
|
Depreciation expense was as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
Depreciation expense
|
$
|
25.5
|
|
|
$
|
24.8
|
|
The Company annually tests the indefinite-lived intangible assets for impairment, or whenever events or changes in circumstances indicate that the carrying value may not be recoverable by either a qualitative or income approach. Management relies on a number of qualitative factors when considering a potential impairment such as changes to planned revenue or earnings that could affect significant inputs used to determine the fair value of the indefinite-lived intangible asset.
The gross carrying amount and accumulated amortization of intangible assets were comprised of the following at the end of each period:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 27, 2020
|
|
December 27, 2019
|
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Amortizable:
|
|
|
|
|
|
|
|
|
Completed technology
|
$
|
10,456.9
|
|
|
$
|
4,018.5
|
|
|
$
|
10,456.9
|
|
|
$
|
3,822.8
|
|
|
License agreements
|
120.1
|
|
|
75.1
|
|
|
120.1
|
|
|
74.1
|
|
|
Trademarks
|
77.7
|
|
|
21.0
|
|
|
77.7
|
|
|
20.1
|
|
|
Total
|
$
|
10,654.7
|
|
|
$
|
4,114.6
|
|
|
$
|
10,654.7
|
|
|
$
|
3,917.0
|
|
|
Non-Amortizable:
|
|
|
|
|
|
|
|
|
Trademarks
|
$
|
35.0
|
|
|
|
|
$
|
35.0
|
|
|
|
|
In-process research and development
|
245.3
|
|
|
|
|
245.3
|
|
|
|
|
Total
|
$
|
280.3
|
|
|
|
|
$
|
280.3
|
|
|
|
Intangible asset amortization expense
Intangible asset amortization expense was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
Amortization expense
|
$
|
197.6
|
|
|
$
|
222.8
|
|
The estimated aggregate amortization expense on intangible assets owned by the Company is expected to be as follows:
|
|
|
|
|
|
|
|
Remainder of Fiscal 2020
|
$
|
556.6
|
|
|
Fiscal 2021
|
657.6
|
|
|
Fiscal 2022
|
585.1
|
|
|
Fiscal 2023
|
581.1
|
|
|
Fiscal 2024
|
581.1
|
|
Debt was comprised of the following at the end of each period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 27, 2020
|
|
December 27, 2019
|
|
|
Principal
|
|
Unamortized Discount and Debt Issuance Costs
|
|
Principal
|
|
Unamortized Discount and Debt Issuance Costs
|
|
Current maturities of long-term debt:
|
|
|
|
|
|
|
|
|
4.875% senior notes due April 2020
|
$
|
614.8
|
|
|
$
|
0.1
|
|
|
$
|
614.8
|
|
|
$
|
0.6
|
|
|
Term loan due September 2024
|
15.6
|
|
|
0.1
|
|
|
15.6
|
|
|
0.2
|
|
|
Term loan due February 2025
|
4.1
|
|
|
0.1
|
|
|
4.1
|
|
|
0.1
|
|
|
Total current debt
|
634.5
|
|
|
0.3
|
|
|
634.5
|
|
|
0.9
|
|
|
Long-term debt:
|
|
|
|
|
|
|
|
|
9.50% debentures due May 2022
|
10.4
|
|
|
—
|
|
|
10.4
|
|
|
—
|
|
|
5.75% senior notes due August 2022
|
610.3
|
|
|
3.3
|
|
|
610.3
|
|
|
3.7
|
|
|
8.00% debentures due March 2023
|
4.4
|
|
|
—
|
|
|
4.4
|
|
|
—
|
|
|
4.75% senior notes due April 2023
|
133.7
|
|
|
0.8
|
|
|
133.7
|
|
|
0.8
|
|
|
5.625% senior notes due October 2023
|
514.7
|
|
|
4.1
|
|
|
514.7
|
|
|
4.4
|
|
|
Term loan due September 2024
|
1,501.3
|
|
|
14.7
|
|
|
1,505.2
|
|
|
15.5
|
|
|
Term loan due February 2025
|
398.5
|
|
|
5.8
|
|
|
399.5
|
|
|
6.1
|
|
|
5.50% senior notes due April 2025
|
387.2
|
|
|
3.5
|
|
|
387.2
|
|
|
3.6
|
|
|
10.00% second lien senior notes due April 2025
|
322.9
|
|
|
9.4
|
|
|
322.9
|
|
|
9.9
|
|
|
Revolving credit facility
|
900.0
|
|
|
2.7
|
|
|
900.0
|
|
|
3.1
|
|
|
Total long-term debt
|
4,783.4
|
|
|
44.3
|
|
|
4,788.3
|
|
|
47.1
|
|
|
Total debt
|
$
|
5,417.9
|
|
|
$
|
44.6
|
|
|
$
|
5,422.8
|
|
|
$
|
48.0
|
|
As of March 27, 2020, the applicable interest rate and outstanding borrowings on the Company's variable-rate debt instruments were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Applicable interest rate
|
|
Outstanding borrowings
|
|
Term loan due September 2024
|
4.69
|
%
|
|
$
|
1,516.9
|
|
|
Term loan due February 2025
|
4.70
|
|
|
402.6
|
|
|
Revolving credit facility
|
3.86
|
|
|
900.0
|
|
As of March 27, 2020, the Company was fully drawn on its $900.0 million revolving credit facility.
As of March 27, 2020, the Company continues to be in full compliance with the provisions and covenants associated with its debt agreements. The Company's debt instruments are further described within the notes to the financial statements included within the Company's Annual Report filed on Form 10-K for the fiscal year ended December 27, 2019.
In disposing of assets or businesses, the Company has from time to time provided representations, warranties and indemnities to cover various risks and liabilities, including unknown damage to assets, environmental risks involved in the sale of real estate, liability to investigate and remediate environmental contamination at waste disposal sites and manufacturing facilities, and unidentified tax liabilities related to periods prior to disposition. The Company assesses the probability of potential liabilities related to such representations, warranties and indemnities and adjusts potential liabilities as a result of changes in facts and circumstances. The Company believes, given the information currently available, that the ultimate resolutions will not have a material adverse effect on its financial condition, results of operations and cash flows.
In connection with the sale of the Specialty Chemical business (formerly known as Mallinckrodt Baker) in fiscal 2010, the Company agreed to indemnify the purchaser with respect to various matters, including certain environmental, health, safety, tax and other matters. The indemnification obligations relating to certain environmental, health and safety matters have a term of 17 years from the sale, while some of the other indemnification obligations have an indefinite term. The amount of the liability relating to all of these indemnification obligations included in other liabilities on the Company's unaudited condensed consolidated balance sheets as of March 27, 2020 and December 27, 2019 was $15.7 million and $15.0 million, respectively, of which $12.9 million and $12.3 million, respectively, related to environmental, health and safety matters. The value of the environmental, health and safety indemnity was measured based on the probability-weighted present value of the costs expected to be incurred to address environmental, health and safety claims made under the indemnity. The aggregate fair value of these indemnification obligations did not differ significantly from their aggregate carrying value as of March 27, 2020 and December 27, 2019. As of March 27, 2020, the maximum future payments the Company could be required to make under these indemnification obligations were $70.2 million. The Company was required to pay $30.0 million into an escrow account as collateral to the purchaser, of which $19.0 million and $18.9 million remained in restricted cash, included in other long-term assets on the unaudited condensed consolidated balance sheets as of March 27, 2020 and December 27, 2019, respectively.
The Company has recorded liabilities for known indemnification obligations included as part of environmental liabilities, which are discussed in Note 11.
The Company is also liable for product performance; however, the Company believes, given the information currently available, that the ultimate resolution of any such claims will not have a material adverse effect on its financial condition, results of operations and cash flows.
As of March 27, 2020, the Company had various other letters of credit, guarantees and surety bonds totaling $32.7 million and restricted cash of $22.2 million held in segregated accounts primarily to collateralize surety bonds for the Company's environmental liabilities.
|
|
|
|
|
|
11.
|
Commitments and Contingencies
|
The Company is subject to various legal proceedings and claims, including patent infringement claims, product liability matters, personal injury, environmental matters, employment disputes, contractual disputes and other commercial disputes, including those described below. The Company believes that these legal proceedings and claims likely will be resolved over an extended period of time. Although it is not feasible to predict the outcome of these matters, the Company believes, unless otherwise indicated below, given the information currently available, that their ultimate resolution will not have a material adverse effect on its financial condition, results of operations and cash flows.
Governmental Proceedings
Opioid-Related Matters
Since 2017, multiple U.S. states, counties, a territory, other governmental persons or entities and private plaintiffs have filed lawsuits against certain entities of the Company, as well as various other manufacturers, distributors, pharmacies, pharmacy benefit managers, individual doctors and/or others, asserting claims relating to defendants' alleged sales, marketing, distribution, reimbursement, prescribing, dispensing and/or other practices with respect to prescription opioid medications, including certain of the
Company's products. As of May 6, 2020, the cases the Company is aware of include, but are not limited to, approximately 2,531 cases filed by counties, cities, Native American tribes and/or other government-related persons or entities; approximately 261 cases filed by hospitals, health systems, unions, health and welfare funds or other third-party payers; approximately 116 cases filed by individuals; approximately seven cases filed by schools and school boards; and 17 cases filed by the Attorneys General for New Mexico, Kentucky, Rhode Island, Georgia, Florida, Alaska, New York, Nevada, South Dakota, New Hampshire, Louisiana, Illinois, Mississippi, West Virginia, Puerto Rico, Ohio, and Idaho, with Idaho being the only state Attorney General to file in federal as opposed to state court. As of May 6, 2020, the Mallinckrodt defendants in these cases consist of Mallinckrodt plc and the following subsidiaries of Mallinckrodt plc: Mallinckrodt Enterprises LLC, Mallinckrodt LLC, SpecGx LLC, Mallinckrodt Brand Pharmaceuticals Inc., Mallinckrodt Inc., MNK 2011 Inc., and Mallinckrodt Enterprises Holdings, Inc. On November 22, 2019, the Delaware Attorney General filed a motion in the Superior Court of the State of Delaware to amend its complaint to add certain entities of the Company, which the court granted on December 18, 2019. The Delaware Attorney General has not yet filed its amended complaint. The Hawaii Attorney General filed a complaint against the Company on June 3, 2019. On December 27, 2019, the First Circuit Court entered a written order dismissing the Hawaii Attorney General's claims against all defendants without prejudice, finding that the allegations in the State's complaint failed to give notice of the claims against the defendants. Certain of the lawsuits have been filed as putative class actions.
Most pending federal lawsuits have been coordinated in a federal multi-district litigation (“MDL”) pending in the U.S. District Court for the Northern District of Ohio. The MDL court has issued a series of case management orders permitting motion practice addressing threshold legal issues in certain cases, allowing discovery, setting pre-trial deadlines and setting a trial date on October 21, 2019 for two cases originally filed in the Northern District of Ohio by Summit County and Cuyahoga County against opioid manufacturers, distributors, and pharmacies ("Track 1 Cases"). The counties claimed that opioid manufacturers' marketing activities changed the medical standard of care for treating both chronic and acute pain, which led to increases in the sales of their prescription opioid products. They also alleged that opioid manufacturers' and distributors' failure to maintain effective controls against diversion was a substantial cause of the opioid crisis. On September 30, 2019, the Company announced that Mallinckrodt plc, along with its wholly owned subsidiaries Mallinckrodt LLC and SpecGx LLC, had executed a definitive settlement agreement and release with Cuyahoga and Summit Counties in Ohio. The settlement fully resolves the Track 1 cases against all named Mallinckrodt entities that were scheduled to go to trial in October 2019 in the MDL. Under the agreement, the Company paid $24.0 million in cash on October 1, 2019. In addition, the Company will provide $6.0 million in generic products, including addiction treatment products, and will also provide a $0.5 million payment in two years in recognition of the counties' time and expenses. Further, in the event of a comprehensive resolution of government-related opioid claims, the Company has agreed that the two plaintiff counties will receive the value they would have received under such a resolution, less the payments described above. All named Mallinckrodt entities were dismissed with prejudice from the lawsuit. The value of the settlement should not be extrapolated to any other opioid-related cases or claims. On October 21, 2019, the MDL court issued a Stipulated Dismissal Order dismissing the claims against the remaining manufacturers and distributors pursuant to a settlement agreement, and severing the claims against the remaining pharmacy defendants to be heard in a subsequent trial, currently scheduled for November 9, 2020. Judge Polster issued Suggestions of Remand for City and County of San Francisco, California and City of Chicago, Illinois. Both cases have been remanded, respectively, to the Northern District of California and the Northern District of Illinois. Manufacturer defendants moved to dismiss the City of San Francisco action on April 20, 2020, which the Company joined. Additionally, all manufacturer defendants, including us, were severed from the “Track Two” MDL cases, City of Huntington and Cabell County Commission, West Virginia. Those cases have subsequently been remanded to the Southern District of West Virginia.
Other lawsuits remain pending in various state courts. In some jurisdictions, such as Arizona, California, Connecticut, Illinois, Massachusetts, New York, Pennsylvania, South Carolina, Texas, Utah and West Virginia, certain of the 231 state lawsuits have been consolidated or coordinated for pre-trial proceedings before a single court within their respective state court systems. State cases are generally at the pleading and/or discovery stage. Trials have been set in certain state cases, including in Alaska (January 4, 2021), Arizona (June 1, 2021), Georgia (January 24, 2022), Louisiana (July 19, 2021), New Mexico (September 7, 2021), Rhode Island (January 19, 2021), and West Virginia (March 22, 2021). The Circuit Court for Sullivan County, Tennessee continued the Staubus et al. v. Purdue Pharma, LP et al., No. C-41916 trial originally scheduled to begin on May 18, 2020 until August 17, 2020. During a status conference on February 26, 2020, the District Court for Clark County, Nevada continued the State of Nevada v. McKesson Corp., No. A-19-796755-B trial originally scheduled to begin on January 4, 2021. There is also a trial in Ohio scheduled to begin on August 10, 2020, but the parties have stipulated to moving the trial to March 2021 and are awaiting the court’s ruling. On April 2, 2020, the Texas court entered the parties’ joint motion to reschedule the date that the first of two bellwether trials would be ready for jury trial from January 19, 2021 to April 12, 2021. The Company is named in the alternate bellwether candidate. The date and candidates for the second bellwether trial have not yet been selected. On March 26, 2020, the Supreme Court of Tennessee granted defendants’ application for permission to appeal the judgment of the Tennessee Court of Appeals in Effler et al. v. Purdue Pharma, LP et al., No. 16596, which reversed the Circuit Court for Campbell County’s grant of defendants’ motion to dismiss plaintiffs’ claims under Tennessee’s Drug Dealer Liability Act (DDLA). A successful ruling from the Tennessee Supreme Court in Effler would also require dismissal of the DDLA claim brought by the district attorney general plaintiffs in Staubus et al. v. Purdue Pharma, LP et al., No. C-41916. The Staubus matter is currently set for trial in the Circuit Court for Sullivan County on August 17, 2020.
The lawsuits assert a variety of claims, including, but not limited to, public nuisance, negligence, civil conspiracy, fraud, violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO”) or similar state laws, violations of state Controlled Substances Acts or state False Claims Acts, product liability, consumer fraud, unfair or deceptive trade practices, false advertising, insurance fraud, unjust enrichment, negligence and negligent misrepresentation, and other common law and statutory claims arising from defendants' manufacturing, distribution, marketing and promotion of opioids and seek restitution, damages, injunctive and other relief and attorneys' fees and costs. The claims generally are based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid medications and/or an alleged failure to take adequate steps to prevent diversion.
Litigation Settlement. On February 25, 2020, the Company announced an agreement in principle on the terms of a global settlement that would resolve all opioid-related claims against the Company and its subsidiaries (“Litigation Settlement”). The Litigation Settlement would contemplate the filing of voluntary petitions under Chapter 11 of the U.S. Bankruptcy Code (“Chapter 11”) by certain subsidiaries of Mallinckrodt plc operating the Specialty Generics business (the “Specialty Generics Subsidiaries”) and the establishment of a trust for the benefit of plaintiffs holding opioid-related claims against the Company (the “Opioid Claimant Trust”). Subject to the Settlement Closing (as defined below), the Company would make certain structured payments to the Opioid Claimant Trust. Pursuant to the terms of a channeling injunction and third-party release, which would be subject to court approval, all persons or entities asserting opioid-related claims against the Company would recover solely from the Opioid Claimant Trust on account of such claims. If the Settlement Closing occurs, all other claims against, and equity interests in, the Specialty Generics Subsidiaries would be unimpaired and it is expected that all contracts to which the Specialty Generics Subsidiaries are party would be assumed. The Litigation Settlement would provide for:
|
|
|
|
•
|
the payment of $300.0 million upon Specialty Generics' emergence from the completed Chapter 11 case;
|
|
|
|
|
•
|
the payment to the Opioid Claimant Trust of additional cash totaling $1,300.0 million, consisting of $200.0 million on each of the first and second anniversaries of emergence and $150.0 million on each of the third through eighth anniversaries of emergence; and
|
|
|
|
|
•
|
the issuance of warrants ("Settlement Warrants") upon emergence from the contemplated Chapter 11 process to the Opioid Claimant Trust to purchase ordinary shares of the Company with an eight year term at a strike price of $3.15 per ordinary share that would represent approximately 19.99% of the Company's fully diluted outstanding shares, including after giving effect to the exercise of the warrants, provided that such warrants may not be exercised during any calendar quarter in a quantity that would exceed 5.0% of the number of shares outstanding.
|
The terms of the Litigation Settlement included a number of conditions to its consummation (such consummation, the "Settlement Closing") such as, among other things, bankruptcy court approval of the bankruptcy plan effectuating the Litigation Settlement, the emergence of the Specialty Generics Subsidiaries from bankruptcy and:
|
|
|
|
•
|
the exchange of the 4.875% senior unsecured notes that had a maturity date of April 15, 2020 (the "2020 Notes") and the 5.75% senior unsecured notes due August 2022 (the "2022 Notes") into new secured notes on terms reasonably satisfactory to the Company;
|
|
|
|
|
•
|
the coordination of the action filed by the State of New York against the Company to allow the Specialty Generics Subsidiaries sufficient time to arrange for pre-arranged filings under Chapter 11;
|
|
|
|
|
•
|
the support and participation of a supermajority of all claimants with opioid-related claims, including a future claims representative (if one is deemed necessary by the Company in consultation with an ad hoc committee of certain Supporting Claimants or their representatives (the "AHC")), against the Company on terms satisfactory to the Company;
|
|
|
|
|
•
|
the resolution of U.S. Department of Justice ("DOJ") civil and criminal claims against the Company on reasonable terms;
|
|
|
|
|
•
|
the agreement by and between the Company and the Supporting Claimants to an injunction governing the sale and distribution of opioids by the Specialty Generics Subsidiaries, compliance with which is expected to protect the Company from further opioid-related liability, on terms satisfactory to the Company, with such terms to be binding on the Specialty Generics Subsidiaries and any buyers thereof or successors thereto;
|
|
|
|
|
•
|
the treatment of potential indemnification claims of Covidien plc on terms satisfactory to the Company and the AHC;
|
|
|
|
|
•
|
the disclosure by the Company of a subset of its litigation documents to be made publicly available as part of an industry-wide document disclosure program, subject to scope and protocols to be negotiated by the parties’ informed representatives;
|
|
|
|
|
•
|
the entry of a judgment between the Company and the Centers for Medicare & Medicaid Services ("CMS") and the entry by the Company into any other legal judgments or settlements, each on such terms and at such levels as may be acceptable to the Company, such that the Company is able to make all payments required under the terms of the Litigation Settlement (such condition to the Litigation Settlement, the "Medicaid Lawsuit Condition");
|
|
|
|
|
•
|
the resolution and settlement of certain outstanding intercompany indebtedness between the Specialty Generics Subsidiaries and the Company’s other subsidiaries and the entry into a shared services agreement between the Specialty
|
Generics Subsidiaries and certain other subsidiaries of the Company, as the case may be, in each case on terms reasonably satisfactory to the Company, subject to consent of the AHC;
|
|
|
|
•
|
a rights offering or a shareholder vote to satisfy any applicable legal requirements relating to the issuance of the warrants, in a manner reasonably acceptable to the Company and the AHC; and
|
|
|
|
|
•
|
the satisfaction such other conditions as may be mutually agreed to by the Company and the AHC.
|
As further described below, on March 16, 2020, the Company received an adverse decision from the federal district court for the District of Columbia ("D.C.") with respect to the Medicaid lawsuit, resulting in a failure of the Medicaid Lawsuit Condition. The Company is engaged in constructive dialogue with the plaintiff parties to the Litigation Settlement to address the impact of the court’s decision, but there can be no assurance that such dialogue will result in a modification of or amendment to the Litigation Settlement that will be satisfactory to all parties. In addition, at the time the Company announced the Litigation Settlement, the Company had planned to commence an exchange offer for the 2022 Notes pursuant to a support and exchange agreement, and to refinance the 2020 Notes with the proceeds of new term loans that were then contemplated to be obtained pursuant to a support agreement. Both agreements have since terminated. As further described in Note 14, on April 7, 2020, the Company entered into an exchange agreement with certain noteholders providing for the exchange of such noteholders’ holdings of 2020 Notes for new 10.00% first lien senior secured notes due 2025.
The Litigation Settlement was reached with a court-appointed plaintiffs' executive committee representing the interests of thousands of plaintiffs in the MDL and supported by a broad-based group of 48 state and U.S. Territory Attorneys General, including the New York State Attorney General. In connection with New York State’s support of the Litigation Settlement, on March 9, 2020, the State of New York and Suffolk County, together with Mallinckrodt LLC and SpecGx LLC, jointly filed a motion to sever, or remove, Mallinckrodt LLC and SpecGx LLC from the New York State opioid trial, which, as of March 10, 2020, has been postponed indefinitely due to the coronavirus. Nassau County opposed the motion. The motion to sever Mallinckrodt LLC and SpecGx LLC from the New York State trial is currently pending before the Supreme Court of New York, County of Suffolk.
As a result of the Litigation Settlement, the Company recorded an accrual for this contingency of $1,600.0 million related to the structured cash payments and $43.4 million related to the Settlement Warrants in the unaudited condensed consolidated balance sheet as of December 27, 2019. As of March 27, 2020, the Settlement Warrants were valued at $26.6 million. Refer to Note 12 for further information regarding the valuation of the Settlement Warrants.
Other Opioid-Related Matters. In addition to the lawsuits described above, certain entities of the Company have received subpoenas and civil investigative demands ("CID(s)") for information concerning the sale, marketing and/or distribution of prescription opioid medications and the Company's suspicious order monitoring programs, including from the U.S. DOJ and the Attorneys General for Missouri, New Hampshire, Kentucky, Washington, Alaska, South Carolina, Puerto Rico, New York, West Virginia, Indiana, the Divisions of Consumer Protection and Occupational and Professional Licensing of the Utah Department of Commerce, and the New York State Department of Financial Services. The Company has been contacted by the coalition of State Attorneys General investigating the role manufacturers and distributors may have had in contributing to the increased use of opioids in the U.S. On January 27, 2018, the Company received a grand jury subpoena from the U.S. Attorneys' Office (“USAO”) for the Southern District of Florida for documents related to the distribution, marketing and sale of generic oxymorphone products. On April 17, 2019, the Company received a grand jury subpoena from the USAO for the Eastern District of New York ("EDNY") for documents related to the sales and marketing of controlled substances, the policies and procedures regarding controlled substances, and other related documents. On June 4, 2019, the Company received a rider from the USAO for EDNY requesting additional documents regarding the Company's anti-diversion program. The Company is responding or has responded to these subpoenas, CIDs and any informal requests for documents.
In August 2018, the Company received a letter from the leaders of the Energy and Commerce Committee in the U.S. House of Representatives requesting a range of documents relating to its marketing and distribution of opioids. The Company completed its response to this letter in December 2018. The Company received a follow-up letter in January 2020 and provided the committee a response. The Company is cooperating with the investigation.
The Attorneys General for Kentucky, Alaska, New York, New Hampshire, West Virginia and Puerto Rico have subsequently filed lawsuits against the Company. Similar subpoenas and investigations may be brought by others or the foregoing matters may be expanded or result in litigation. The Company intends to continue to vigorously defend itself in these matters. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with these investigations and/or lawsuits.
On April 21, 2020, New York Governor Andrew Cuomo announced that the New York State Department of Financial Services had filed a Statement of Charges against Mallinckrodt, including allegations that it misrepresented the safety and efficacy of its branded and unbranded opioid products and downplayed the risks of negative outcomes to patients, resulting in claims for payment of medically unnecessary opioid prescriptions to commercial insurance companies. The Statement of Charges claims that Mallinckrodt violated Section 403 of the New York Insurance Law, which prohibits fraudulent insurance acts and includes penalties of up to $5,000 plus the amount of the fraudulent claim for each violation. It further alleges that Mallinckrodt violated Section 408 of the Financial
Services Law, which prohibits intentional fraud or intentional misrepresentation of a material fact with respect to a financial product or service and includes penalties of up to $5,000 per violation. The Department claims that each fraudulent prescription constitutes a separate violation of these laws. A hearing on the Statement of Charges is scheduled for August 24, 2020. The Company intends to continue to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Other Matters
Medicaid Lawsuit. In May 2019, the Company filed a lawsuit under the Administrative Procedure Act ("APA") in U.S. District Court for the District of Columbia ("Court") against the U.S. Department of Health and Human Services ("HHS") and CMS (collectively, the "Agency"). The dispute involves the base date average manufacturer price ("AMP") under the Medicaid Drug Rebate Program for Mallinckrodt's Acthar® Gel. A drug's “base date AMP” is used to calculate the Medicaid rebate amount payable by the drug's manufacturer to state Medicaid agencies when the drug is prescribed to Medicaid beneficiaries. At issue in the lawsuit is whether the U.S. Food and Drug Administration ("FDA")'s 2010 approval of a new drug application for use of Acthar Gel in treating infantile spasms rendered Acthar Gel eligible for a new base date AMP, as indicated by CMS's written communications in 2012. In May 2019, CMS indicated that if the Company failed to revert to use of the original base date AMP in its calculation of Acthar Gel Medicaid rebates, CMS would identify the Company as being out of compliance with its Medicaid Drug Rebate Program reporting requirements, among other potential actions, triggering certain negative consequences. As such, the Company filed a lawsuit alleging (i) that CMS has violated the Medicaid drug rebate statute, (ii) that CMS has violated its own regulations defining “single source drug,” (iii) that CMS has failed to adequately explain its change in position based on two letters that CMS sent Questcor Pharmaceuticals Inc. ("Questcor") in 2012 regarding the base date AMP for Acthar Gel, (iv) that CMS failed to give the Company fair notice of its latest position, and (v) that CMS should be prohibited from applying its new position retroactively. The Court held a hearing regarding this matter in August 2019.
In March 2020, the Company received an adverse decision from the Court, which upheld CMS' decision to reverse its previous determination of the base date AMP used to calculate Acthar Gel rebates. The Company intends to continue to vigorously defend itself in this matter and, on March 16, 2020, filed an Emergency Motion for Reconsideration and Stay of Entry of Judgment Pending Reconsideration Or, Alternatively, Injunction Pending Appeal. In response, the government has agreed that CMS will not require the Company to change the Medicaid rebate calculation for Acthar Gel until June 14, 2020, which will allow the Court time to decide the Company’s motion. Based on current Medicaid patient volume, the Company estimates the annualized prospective change to the Medicaid rebate calculation will reduce Acthar Gel annual net sales by roughly $90.0 million to $100.0 million. In the event the Court denies the motion, the Company intends to immediately appeal the decision to the U.S. Court of Appeals for the D.C. Circuit. The base date AMP would only be adjusted, if required, after conclusion of a stay, an appeal, or a settlement, as necessary. While the Company believes that its lawsuit has strong factual and legal bases, as of March 27, 2020, the potential for retroactive non-recurring charges could be up to approximately $640.0 million ("CMS" Retroactive Rebates"). Given the potential for either retroactive or prospective changes to the base date AMP, or a combination of both, and the Company's considerations of various alternatives to resolve this matter, including but not limited to settlement, the amount of loss cannot be reasonably estimated. As such, the Company has not recognized an accrual for this contingency in its financial results for the three months ended March 27, 2020.
Boston Civil Investigative Demand. In January 2019, the Company received a CID from the USAO for the District of Massachusetts for documents related to the Company's participation in the Medicaid Drug Rebate Program. The Company responded to the government's requests and cooperated with the investigation.
In March 2020, the U.S. District Court for the District of Massachusetts unsealed a qui tam complaint under the federal False Claims Act against the Company in which the DOJ has intervened alleging that the Company had failed to pay rebates for its Acthar Gel product. Other related legal proceedings involving the Company, including the litigation described as the Medicaid Lawsuit, are discussed above. By agreement of the parties, the Company has until July 10, 2020 to respond to the Complaint in Intervention. While the Company disagrees with the government’s characterization of the facts and applicable law and intends to vigorously defend itself in this matter. In the event that the Company does not prevail in its Medicaid Lawsuit the potential for damages in this matter could be up to approximately $1,280.0 million, after subtracting out potential restitution, related to the CMS Retroactive Rebates. Given the early nature of this litigation, the pending underlying dispute over Acthar’s base date AMP, which is driven by a different anchoring statute, and the Company's considerations of various alternatives to resolve this litigation, including but not limited to settlement, the Company does not currently believe a loss related to this matter is probable and the amount of loss cannot be reasonably estimated. As such, the Company has not recognized an accrual for this contingency in its financial results for the three months ended March 27, 2020.
Questcor EDPA Qui Tam Litigation. In September 2012, Questcor received a subpoena from the USAO for the Eastern District of Pennsylvania for information relating to its promotional practices related to Acthar Gel. The investigation eventually expanded to include Questcor's provision of financial and other support to patients, including through charitable foundations and related matters. The Company cooperated with the investigation. In March 2019, the U.S. District Court for the Eastern District of Pennsylvania unsealed two qui tam actions involving the allegations under investigation by the USAO for the Eastern District of Pennsylvania. The
DOJ intervened in both actions, which were later consolidated. In September 2019, the Company executed a settlement agreement with the DOJ for $15.4 million and finalized settlements with the three qui tam plaintiffs. These settlements were paid during the three months ended September 27, 2019 and resolve the portion of the investigation and litigation involving Questcor's promotional practices related to Acthar Gel. In June 2019, the DOJ filed its Complaint in Intervention in the litigation, alleging claims under the federal False Claim Act based on Questcor's relationship with and donations to an independent charitable patient co-pay foundation. The Company disagrees with the DOJ's characterization of the facts and applicable law. In January 2020, the court denied the Company's motion to dismiss the Complaint in Intervention. The Company intends to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Patent Litigation
INOmax® Patent Litigation: Praxair Distribution, Inc. and Praxair, Inc. (collectively “Praxair”). In February 2015, INO Therapeutics LLC and Ikaria, Inc., both subsidiaries of the Company, filed suit in the U.S. District Court for the District of Delaware against Praxair following receipt of a January 2015 notice from Praxair concerning its submission of an abbreviated new drug application ("ANDA") containing a Paragraph IV patent certification with the FDA for a nitric oxide drug product delivery system. In July 2016, the Company filed a second suit against Praxair in the U.S. District Court for the District of Delaware following receipt of a Paragraph IV notice concerning three additional patents recently added to the FDA Orange Book that was submitted by Praxair regarding its ANDA for its nitric oxide drug product delivery system. The infringement claims in the second suit were added to the original suit. In September 2016, the Company filed a third suit against Praxair in the U.S. District Court for the District of Delaware following receipt of a Paragraph IV notice concerning a fourth patent added to the FDA Orange Book that was submitted by Praxair regarding its ANDA for its nitric oxide drug product delivery system.
Trial for the suit filed in February 2015 was held in March 2017 and a decision was rendered September 5, 2017 that ruled five patents invalid and six patents not infringed. The Company appealed the decision to the Court of Appeals for the Federal Circuit. The oral arguments in the appeal occurred on February 6, 2019. Praxair received FDA approval of their ANDA for their Noxivent nitric oxide and clearance of their 510(k) for their NOxBOXi device on October 2, 2018. The appeal decision, issued on August 27, 2019, substantively affirmed the District Court decision with respect to the invalidity of the heart failure (HF) patents and the non-infringement of the delivery system infrared (DSIR) patents. The Company filed a petition for en banc review at the Federal Circuit on September 26, 2019, which the Federal Circuit denied on November 19, 2019. The Company filed a petition for a writ of certiorari with the United States Supreme Court on March 6, 2020 and the petition was denied on April 6, 2020. The adverse final outcome in the appeal of the Praxair litigation decision is expected to result in the broader-scale launch of a competitive nitric oxide product before the expiration of the last of the listed patents on May 3, 2036 (November 3, 2036 including pediatric exclusivity), which could adversely affect the Company's ability to successfully maximize the value of INOmax and have an adverse effect on its financial condition, results of operations and cash flows.
Ofirmev Patent Litigation: Baxter Healthcare Corporation. In March 2020, MHP and Mallinckrodt Hospital Products IP Limited, both subsidiaries of the Company, and New Pharmatop LP, the current owner of the U.S. patents licensed exclusively by the Company, filed suit in the U.S. District Court for the District of Delaware against Baxter Healthcare Corporation (“BHC”) alleging that BHC infringed U.S. Patent No. 6,992,218, U.S. Patent No. 9,399,012, U.S. Patent No. 9,610,265, U.S. Patent No. 9,987,238 and U.S. Patent No. 10,383,834 following receipt of a February 2020 notice from Baxter concerning its submission of an ANDA, containing a Paragraph IV patent certification with the FDA for a competing version of Ofirmev®. The Company intends to vigorously enforce its intellectual property rights relating to Ofirmev. On April 23, 2020, the parties entered into a settlement agreement under which BHC was granted the non-exclusive right to market a competing intravenous acetaminophen product in the U.S. under its ANDA on or after December 6, 2020, or earlier under certain circumstances.
Commercial and Securities Litigation
Health Care Service Corporation Litigation. In February 2020, Health Care Service Corporation (“HCSC”) filed a non-class complaint against the Company in California state court alleging improper pricing and distribution of Acthar Gel, in violation of the New Jersey RICO statute and various states’ antitrust laws. HCSC also brings claims against the Company for conspiracy to violate the New Jersey RICO statute, fraud, unlawful restraint of trade, unfair and deceptive trade practices, insurance fraud, tortious interference with contract and unjust enrichment. The case, which is proceeding as Health Care Service Corp. v. Mallinckrodt ARD LLC, alleges similar facts as those alleged in the Humana matter below. The Company intends to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Local 322. In November 2019, the United Association of Plumbers & Pipefitters Local 322 of Southern New Jersey (“Local 322”) filed a putative class action complaint against the Company and other defendants in New Jersey state court on behalf of New Jersey and third party payers for alleged deceptive marketing and anti-competitive conduct related to the sale and distribution of Acthar Gel.
The complaint asserts claims under the New Jersey Consumer Fraud Act, the New Jersey Antitrust Act, the New Jersey RICO statute, negligent misrepresentation, conspiracy/aiding and abetting and unjust enrichment. The proposed class is defined as “All third-party payors and their beneficiaries (1) who are current citizens and residents of the State of New Jersey, and (2) who, for purposes other than resale, purchased or paid for Acthar Gel from August 27, 2007 through the present.” The Company intends to vigorously defend itself in this action and, in January 2020, after removing the complaint to federal court in New Jersey, moved to dismiss or stay the case. The Company’s motions to dismiss or stay remain pending.
Humana Litigation. In August 2019, Humana Inc. filed a lawsuit against the Company in the U.S. District Court for the Central District of California alleging violations of federal and state antitrust laws; racketeering violations under 18 U.S.C. § 1962(c); conspiracy to violate RICO under 18 U.S.C. § 1962(d); violations of state unfair competition, consumer fraud and deceptive trade practice laws; state insurance fraud; tortious interference with contract; and unjust enrichment related to the pricing of Acthar Gel. Humana alleges that it paid more than $700.0 million for Acthar Gel and seeks undisclosed damages from 2011 through present. The case alleges similar facts as those alleged in the MSP and Rockford matters below, and includes references to allegations at issue in a pending qui tam action against the Company in the U.S. District Court for the Eastern District of Pennsylvania (see Questcor EDPA Qui Tam Litigation above). The case is proceeding as Humana Inc. v. Mallinckrodt ARD LLC. In March 2020, the court granted-in-part and denied-in-part the Company's motion to dismiss Humana's claims. The court dismissed Humana's antitrust and tortious interference claims with leave to amend. The court denied the Company's motion to dismiss Humana's RICO and other fraud-based claims. The Company intends to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Acument Global. In May 2019, Acument Global Technologies, Inc. ("Acument"), filed a non-class complaint against the Company and other defendants in Tennessee state court alleging violations of Tennessee Consumer Protection laws, unjust enrichment, fraud and conspiracy to defraud. The case alleges similar facts as those alleged in the MSP and Rockford matters below, and is captioned Acument Global Technologies, Inc., v. Mallinckrodt ARD Inc., et al. In February 2020, the court granted-in-part and denied-in-part the Company’s motion to dismiss. While the court dismissed Acument’s fraud-based claims and its claim under the Tennessee Consumer Protection Act, the court ruled that the antitrust and unjust enrichment claims may proceed. The Company intends to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Local 542. In May 2018, the International Union of Operating Engineers Local 542 filed a non-class complaint against the Company and other defendants in Pennsylvania state court alleging improper pricing and distribution of Acthar Gel, in violation of Pennsylvania's Unfair Trade Practices and Consumer Protection law, aiding and abetting, unjust enrichment and negligent misrepresentation. The case alleges similar facts as the MSP and Rockford matters below, and is captioned Int'l Union of Operating Engineers Local 542 v. Mallinckrodt ARD Inc., et al. Plaintiff filed an amended complaint in August 2018, the Company's objections to which were denied by the court. Although the court temporarily stayed proceedings in January 2020, the court lifted the stay in February 2020. The Company intends to continue to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Putative Class Action Litigation (MSP). In October 2017, a putative class action lawsuit was filed against the Company and United BioSource Corporation in the U.S. District Court for the Central District of California. Pursuant to a motion filed by the defendants, the case was transferred to the U.S. District Court for the Northern District of Illinois in January 2018, and is currently proceeding as MSP Recovery Claims, Series II, LLC, et al. v. Mallinckrodt ARD, Inc., et al. The Company filed a motion to dismiss in February 2018, which was granted in January 2019 with leave to amend. MSP filed the operative First Amended Class Action Complaint on April 10, 2019, in which it asserts claims under federal and state antitrust laws and state consumer protection laws and names additional defendants. The complaint alleges that the Company unlawfully maintained a monopoly in a purported ACTH product market by acquiring the U.S. rights to Synacthen® Depot ("Synacthen") and reaching anti-competitive agreements with the other defendants by selling Acthar Gel through an exclusive distribution network. The complaint purports to be brought on behalf of all third-party payers, or their assignees, in the U.S. and its territories, who have, as indirect purchasers, in whole or in part, paid for, provided reimbursement for, and/or possess the recovery rights to reimbursement for the indirect purchase of Acthar Gel from August 1, 2007 to present. In March 2020, the court granted the Company’s motion to dismiss with leave to amend. The Company intends to continue to vigorously defend itself in this matter.
Putative Class Action Litigation (Rockford). In April 2017, a putative class action lawsuit was filed against the Company and United BioSource Corporation in the U.S. District Court for the Northern District of Illinois. The case is captioned City of Rockford v. Mallinckrodt ARD, Inc., et al. The complaint was subsequently amended to, among other things, include an additional named plaintiff and additional defendants. As amended, the complaint purports to be brought on behalf of all self-funded entities in the U.S. and its Territories, excluding any Medicare Advantage Organizations, related entities and certain others, that paid for Acthar Gel from August 2007 to the present. Plaintiff alleges violations of federal antitrust and RICO laws, as well as various state law claims in connection with the distribution and sale of Acthar Gel. In January 2018, the Company filed a motion to dismiss the Second Amended Complaint, which was granted in part in January 2019. The court dismissed one of two named plaintiffs and all claims with the exception of Plaintiff's federal and state antitrust claims. The remaining allegation in the case is that the Company engaged in anti-competitive acts to artificially raise and maintain the price of Acthar Gel. To this end, Plaintiff alleges that the Company unlawfully maintained a
monopoly in a purported ACTH product market by acquiring the U.S. rights to Synacthen and conspired with the other named defendants by selling Acthar Gel through an exclusive distributor. The Company intends to vigorously defend itself in this matter. At this stage, the Company is not able to reasonably estimate the expected amount or range of cost or any loss associated with this lawsuit.
Generic Price Fixing Litigation
Generic Pharmaceutical Antitrust MDL. In August 2016, a multidistrict litigation was established in the Eastern District of Pennsylvania relating to allegations of antitrust violations with respect to generic pharmaceutical pricing (the "Generic Pricing MDL"). Plaintiffs in the Generic Pricing MDL, captioned In re: Generic Pharmaceuticals Pricing Antitrust Litigation, allege a conspiracy of price-fixing and customer allocation among generic drug manufacturers beginning in or around July 2009. Since its establishment, the Generic Pricing MDL has expanded to encompass dozens of pharmaceutical companies and more than 100 generic pharmaceutical drugs. The Company was recently named in three cases associated with this litigation. A status conference is scheduled for May 14, 2020.
Environmental Remediation and Litigation Proceedings
The Company is involved in various stages of investigation and cleanup related to environmental remediation matters at a number of sites, including those described below. The ultimate cost of site cleanup and timing of future cash outlays is difficult to predict, given the uncertainties regarding the extent of the required cleanup, the interpretation of applicable laws and regulations and alternative cleanup methods. The Company concluded that, as of March 27, 2020, it was probable that it would incur remediation costs in the range of $38.2 million to $87.0 million. The Company also concluded that, as of March 27, 2020, the best estimate within this range was $61.9 million, of which $1.3 million was included in accrued and other current liabilities and the remainder was included in environmental liabilities on the unaudited condensed consolidated balance sheet as of March 27, 2020. While it is not possible at this time to determine with certainty the ultimate outcome of these matters, the Company believes, given the information currently available, that the final resolution of all known claims, after taking into account amounts already accrued, will not have a material adverse effect on its financial condition, results of operations and cash flows.
Mallinckrodt Veterinary, Inc., Millsboro, Delaware. The Company previously operated a facility in Millsboro, Delaware ("the Millsboro Site") where various animal healthcare products were manufactured. In 2005, the Delaware Department of Natural Resources and Environmental Control found trichloroethylene ("TCE") in the Millsboro public water supply at levels that exceeded the federal drinking water standards. Further investigation to identify the TCE plume in the ground water indicated that the plume has extended to property owned by a third party near the Millsboro Site. The Company, and another former owner, have assumed responsibility for the Millsboro Site cleanup under the Alternative Superfund Program administered by the Environmental Protection Agency ("EPA"). The companies have entered into three Administrative Orders on Consent ("AOC(s)") with the EPA to perform investigations to abate, mitigate or eliminate the release or threat of release of hazardous substances at the Millsboro Site and to conduct an Engineering Evaluation/Cost Analysis ("EE/CA") to characterize the nature and extent of the contamination. In January 2017, the EPA issued its Action Memorandum regarding the EE/CA. In March 2020, the EPA approved the Final Action Report documenting the remedial construction activities completed in accordance with Paragraph 8.12 of AOC 3 for Removal Response Action. The report recommended decommissioning the Directed Groundwater Recirculation system and commencing Long Term Monitoring. Upon receipt of the EPA approved Final Action Report, the Company believes, given the information currently available, that the ultimate resolution of all known claims, after taking into account amounts already accrued, will not have a material adverse effect on its financial condition, results of operations and cash flows.
Products Liability Litigation
Beginning with lawsuits brought in July 1976, the Company is named as a defendant in personal injury lawsuits based on alleged exposure to asbestos-containing materials. A majority of the cases involve product liability claims based principally on allegations of past distribution of products containing asbestos. A limited number of the cases allege premises liability based on claims that individuals were exposed to asbestos while on the Company's property. Each case typically names dozens of corporate defendants in addition to the Company. The complaints generally seek monetary damages for personal injury or bodily injury resulting from alleged exposure to products containing asbestos. The Company's involvement in asbestos cases has been limited because it did not mine or produce asbestos. Furthermore, in the Company's experience, a large percentage of these claims have never been substantiated and have been dismissed by the courts. The Company has not suffered an adverse verdict in a trial court proceeding related to asbestos claims and intends to continue to defend these lawsuits. When appropriate, the Company settles claims; however, amounts paid to settle and defend all asbestos claims have been immaterial. As of March 27, 2020, there were approximately 11,800 asbestos-related cases pending against the Company.
The Company estimates pending asbestos claims, claims that were incurred but not reported and related insurance recoveries, which are recorded on a gross basis in the unaudited condensed consolidated balance sheets. The Company's estimate of its liability for pending and future claims is based on claims experience over the past five years and covers claims either currently filed or expected to be filed over the next seven years. The Company believes that it has adequate amounts recorded related to these matters. While it is not possible at this time to determine with certainty the ultimate outcome of these asbestos-related proceedings, the Company believes, given the information currently available, that the ultimate resolution of all known and anticipated future claims, after taking into account amounts already accrued, along with recoveries from insurance, will not have a material adverse effect on its financial condition, results of operations and cash flows.
Internal Revenue Code Section 453A Interest
As a result of historical internal installment sales, the Company has reported Internal Revenue Code Section 453A interest on its tax returns on the basis of its interpretation of the U.S. Internal Revenue Code and Regulations. Alternative interpretations of these provisions could result in additional interest payable. Due to the inherent uncertainty in these interpretations, the Company has deferred the recognition of the benefit associated with the Company's interpretation and maintains a corresponding liability of $47.4 million as of both March 27, 2020 and December 27, 2019. Favorable resolution of this uncertainty would likely result in a material reversal of this liability and a benefit being recorded to interest expense within the unaudited condensed consolidated statements of operations.
Tax Matters
The Company continues to be subject to examination by the IRS for tax years 2014 to 2018. In August 2019, the IRS proposed an adjustment to the taxable income of MHP as a result of its findings in the audit of MHP's tax year ended September 26, 2014. MHP, formerly known as Cadence, was acquired by the Company as a U.S. subsidiary in March 2014. Following the acquisition of Cadence, the Company transferred certain rights and risks in Ofirmev intellectual property (“Transferred IP”) to a wholly owned non-U.S. subsidiary of the Company. The transfer occurred at a price (“Transfer Price”) determined in conjunction with the Company's external advisors, in accordance with applicable Treasury Regulations and with reference to the $1,329.0 million taxable consideration paid by the Company to the shareholders of Cadence. The IRS asserts the value of the Transferred IP exceeds the value of the acquired Cadence shares and, further, partially disallows the Company's control premium subtraction. The proposed adjustment to taxable income of $871.0 million, excluding potential associated interest and penalties, is proposed as a multi-year adjustment and may result in a non-cash reduction of the Company's U.S. Federal net operating loss carryforward of $765.1 million. The Company strongly disagrees with the proposed increase to the Transfer Price, continues to engage in resolution discussions with the IRS audit team and intends to contest it through all available administrative and judicial remedies, which may take a number of years to conclude. The final outcome cannot be reasonably quantified at this time, however, the proposed adjustment may be material. The Company believes its reserve for income tax contingencies is adequate.
Other Matters
The Company is a defendant in a number of other pending legal proceedings relating to present and former operations, acquisitions and dispositions. The Company does not expect the outcome of these proceedings, either individually or in the aggregate, to have a material adverse effect on its financial condition, results of operations and cash flows.
The Company's legal proceedings and claims are further described within the notes to the financial statements included within the Company's Annual Report filed on Form 10-K for the fiscal year ended December 27, 2019.
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|
|
|
|
|
12.
|
Financial Instruments and Fair Value Measurements
|
Fair value is defined as the exit price that would be received from the sale of an asset or paid to transfer a liability, using assumptions that market participants would use in pricing an asset or liability. The fair value guidance establishes a three-level fair value hierarchy, which maximizes the use of observable inputs and minimizes the use of unobservable inputs used in measuring fair value. The levels within the hierarchy are as follows:
Level 1— observable inputs such as quoted prices in active markets for identical assets or liabilities;
Level 2— significant other observable inputs that are observable either directly or indirectly; and
Level 3— significant unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions.
The following tables provide a summary of the significant assets and liabilities that are measured at fair value on a recurring basis at the end of each period:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 27,
2020
|
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
Debt and equity securities held in rabbi trusts
|
$
|
28.6
|
|
|
$
|
19.3
|
|
|
$
|
9.3
|
|
|
$
|
—
|
|
|
Equity securities
|
29.2
|
|
|
29.2
|
|
|
—
|
|
|
—
|
|
|
|
$
|
57.8
|
|
|
$
|
48.5
|
|
|
$
|
9.3
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Deferred compensation liabilities
|
$
|
27.5
|
|
|
$
|
—
|
|
|
$
|
27.5
|
|
|
$
|
—
|
|
|
Contingent consideration and acquired contingent liabilities
|
68.8
|
|
|
—
|
|
|
—
|
|
|
68.8
|
|
|
Settlement Warrants
|
26.6
|
|
|
—
|
|
|
—
|
|
|
26.6
|
|
|
|
$
|
122.9
|
|
|
$
|
—
|
|
|
$
|
27.5
|
|
|
$
|
95.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 27,
2019
|
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
|
Assets:
|
|
|
|
|
|
|
|
|
Debt and equity securities held in rabbi trusts
|
$
|
30.6
|
|
|
$
|
21.0
|
|
|
$
|
9.6
|
|
|
$
|
—
|
|
|
Equity securities
|
26.2
|
|
|
26.2
|
|
|
—
|
|
|
—
|
|
|
|
$
|
56.8
|
|
|
$
|
47.2
|
|
|
$
|
9.6
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Deferred compensation liabilities
|
$
|
39.2
|
|
|
$
|
—
|
|
|
$
|
39.2
|
|
|
$
|
—
|
|
|
Contingent consideration and acquired contingent liabilities
|
69.3
|
|
|
—
|
|
|
—
|
|
|
69.3
|
|
|
Settlement Warrants
|
43.4
|
|
|
—
|
|
|
—
|
|
|
43.4
|
|
|
|
$
|
151.9
|
|
|
$
|
—
|
|
|
$
|
39.2
|
|
|
$
|
112.7
|
|
Debt and equity securities held in rabbi trusts. Debt securities held in rabbi trusts primarily consist of U.S. government and agency securities and corporate bonds. When quoted prices are available in an active market, the investments are classified as level 1. When quoted market prices for a security are not available in an active market, they are classified as level 2. Equity securities held in rabbi trusts primarily consist of U.S. common stocks, which are valued using quoted market prices reported on nationally recognized securities exchanges.
Equity securities. Equity securities consist of shares in Silence Therapeutics plc, for which quoted prices are available in an active market; therefore, the investment is classified as level 1 and is valued based on quoted market prices reported on an internationally recognized securities exchange.
Deferred compensation liabilities. The Company maintains a non-qualified deferred compensation plan in the U.S., which permits eligible employees of the Company to defer a portion of their compensation. A recordkeeping account is set up for each participant and the participant chooses from a variety of funds for the deemed investment of their accounts. The recordkeeping accounts generally correspond to the funds offered in the Company's U.S. tax-qualified defined contribution retirement plan and the account balance fluctuates with the investment returns on those funds.
Contingent consideration and acquired contingent liabilities. As of March 27, 2020, the Company maintains various contingent consideration and acquired contingent liabilities associated with the acquisitions of Questcor, Stratatech Corporation ("Stratatech"), and Ocera Therapeutics, Inc. ("Ocera").
The contingent liability associated with the acquisition of Questcor pertains to the Company's license agreement with Novartis AG and Novartis Pharma AG (collectively "Novartis") related to Synacthen, otherwise known as the Company's development
product MNK-1411. The fair value of the remaining contingent payments expected to be transferred was measured based on the net present value of a probability-weighted assessment. The Company determined the fair value of the contingent consideration associated with the acquisition of Questcor to be $24.8 million and $24.5 million as of March 27, 2020 and December 27, 2019, respectively.
As part of the acquisition of Stratatech, the Company provided contingent consideration to the prior shareholders of Stratatech, primarily in the form of regulatory filing and approval milestones associated with the deep partial thickness and full thickness indications associated with StrataGraft®. The Company assesses the likelihood and timing of making such payments at each balance sheet date. The fair value of the contingent payments was measured based on the net present value of a probability-weighted assessment. The Company determined the fair value of the contingent consideration associated with the acquisition of Stratatech to be $31.4 million and $29.0 million as of March 27, 2020 and December 27, 2019, respectively.
As part of the acquisition of Ocera, the Company provided contingent consideration to the prior shareholders of Ocera in the form of both patient enrollment clinical study milestones and sales-based milestones associated with MNK-6105 and MNK-6106. The Company determined the fair value of the contingent consideration based on an option pricing model to be $12.6 million and $15.8 million as of March 27, 2020 and December 27, 2019, respectively.
Of the total fair value of the contingent consideration of $68.8 million, $62.1 million was classified as current and $6.7 million was classified as non-current in the unaudited condensed consolidated balance sheet as of March 27, 2020. The following table summarizes the activity for contingent consideration:
|
|
|
|
|
|
|
|
Balance as of December 27, 2019
|
$
|
69.3
|
|
|
Accretion expense
|
0.3
|
|
|
Fair value adjustments
|
(0.8
|
)
|
|
Balance as of March 27, 2020
|
$
|
68.8
|
|
Settlement Warrants. As a result of the Litigation Settlement, the Company is to issue Settlement Warrants upon emergence from the contemplated Chapter 11 process to the Opioid Claimant Trust to purchase ordinary shares of the Company with an eight year term at a strike price of $3.15 per ordinary share that would represent approximately 19.99% of the Company's fully diluted outstanding shares, including after giving effect to the exercise of the warrants, provided that such warrants may not be exercised during any calendar quarter in a quantity that would exceed 5.0% of the number of shares outstanding.
The fair value of the Settlement Warrants has been estimated using the Black-Scholes pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs. The expected volatility assumption is based on the historical and implied volatility of the Company's peer group with similar business models. The expected term assumption is based on the contractual term of the Settlement Warrants, including the maximum exercise restriction of 5.0% per calendar quarter, which resulted in the valuation of four separate tranches. The expected annual dividend per share is based on the Company's current intentions regarding payment of cash dividends. The risk-free interest rate is based on U.S. Treasury zero-coupon issues with a remaining term equal to the expected term assumed. The estimated fair value for the Settlement Warrants will be subject to revaluation at each balance sheet date with any changes in fair value recorded as a non-cash gain or (loss) in the consolidated statements of operations until the Settlement Warrants are issued, at which point they will be recorded as equity or as a liability based upon the facts and circumstances at the time of issuance.
The key assumptions used to estimate the fair value of the Settlement Warrants were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 27, 2020
|
|
December 27, 2019
|
|
Expected share price volatility
|
64.1
|
%
|
|
54.4
|
%
|
|
Weighted-average risk-free rate
|
0.6
|
%
|
|
1.8
|
%
|
|
Expected annual dividend per share
|
—
|
%
|
|
—
|
%
|
|
Weighted-average expected term (in years)
|
7.6
|
|
|
7.6
|
|
|
Share price
|
$
|
2.23
|
|
|
$
|
3.45
|
|
Financial Instruments Not Measured at Fair Value
The following methods and assumptions were used by the Company in estimating fair values for financial instruments not measured at fair value as of March 27, 2020 and December 27, 2019:
|
|
|
|
•
|
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and the majority of other current assets and liabilities approximate fair value because of their short-term nature. The Company classifies cash on hand and deposits in banks, including commercial paper, money market accounts and other investments it may hold from
|
time to time, with an original maturity of three months or less, as cash and cash equivalents (level 1). The fair value of restricted cash was equivalent to its carrying value of $41.2 million and $31.7 million as of March 27, 2020 and December 27, 2019, (level 1), respectively, which was included in other assets on the unaudited condensed consolidated balance sheets.
|
|
|
|
•
|
The Company has received a portion of consideration as part of contingent earn-out payments related to the sale of the Nuclear Imaging business in the form of preferred equity certificates. These securities are classified as held-to-maturity and are carried at amortized cost, which approximates fair value (level 3), of $29.8 million and $18.9 million as of March 27, 2020 and December 27, 2019, respectively. These securities are included in other assets on the unaudited condensed consolidated balance sheets.
|
|
|
|
|
•
|
The Company's life insurance contracts are carried at cash surrender value, which is based on the present value of future cash flows under the terms of the contracts (level 3). Significant assumptions used in determining the cash surrender value include the amount and timing of future cash flows, interest rates and mortality charges. The fair value of these contracts approximates the carrying value of $51.0 million and $51.1 million as of March 27, 2020 and December 27, 2019, respectively. These contracts are included in other assets on the unaudited condensed consolidated balance sheets.
|
|
|
|
|
•
|
The carrying value of the Company's revolving credit facility approximates the fair value due to the short-term nature of this instrument, and is therefore classified as level 1. The Company's 4.875%, 5.75%, 4.75%, 5.625%, 5.50% and 10.00% senior notes are classified as level 1, as quoted prices are available in an active market for these notes. Since the quoted market prices for the Company's term loans and 9.50% and 8.00% debentures are not available in an active market, they are classified as level 2 for purposes of developing an estimate of fair value. The following table presents the carrying values and estimated fair values of the Company's debt as of the end of each period:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 27, 2020
|
|
December 27, 2019
|
|
|
Carrying
Value
|
|
Fair
Value
|
|
Carrying
Value
|
|
Fair
Value
|
|
Level 1:
|
|
|
|
|
|
|
|
|
4.875% senior notes due April 2020
|
$
|
614.8
|
|
|
$
|
408.9
|
|
|
$
|
614.8
|
|
|
$
|
480.0
|
|
|
5.75% senior notes due August 2022
|
610.3
|
|
|
283.3
|
|
|
610.3
|
|
|
251.0
|
|
|
4.75% senior notes due April 2023
|
133.7
|
|
|
28.8
|
|
|
133.7
|
|
|
53.7
|
|
|
5.625% senior notes due October 2023
|
514.7
|
|
|
131.2
|
|
|
514.7
|
|
|
193.2
|
|
|
5.50% senior notes due April 2025
|
387.2
|
|
|
76.1
|
|
|
387.2
|
|
|
135.5
|
|
|
10.00% second lien senior notes due April 2025
|
322.9
|
|
|
221.9
|
|
|
322.9
|
|
|
253.8
|
|
|
Revolving credit facility
|
900.0
|
|
|
900.0
|
|
|
900.0
|
|
|
900.0
|
|
|
Level 2:
|
|
|
|
|
|
|
|
|
9.50% debentures due May 2022
|
10.4
|
|
|
5.2
|
|
|
10.4
|
|
|
5.4
|
|
|
8.00% debentures due March 2023
|
4.4
|
|
|
1.6
|
|
|
4.4
|
|
|
2.0
|
|
|
Term loan due September 2024
|
1,516.9
|
|
|
1,026.3
|
|
|
1,520.8
|
|
|
1,240.0
|
|
|
Term loan due February 2025
|
402.6
|
|
|
270.2
|
|
|
403.6
|
|
|
326.2
|
|
|
Total Debt
|
$
|
5,417.9
|
|
|
$
|
3,353.5
|
|
|
$
|
5,422.8
|
|
|
$
|
3,840.8
|
|
Concentration of Credit and Other Risks
Financial instruments that potentially subject the Company to concentrations of credit risk primarily consist of accounts receivable. The Company generally does not require collateral from customers. A portion of the Company's accounts receivable outside the U.S. includes sales to government-owned or supported healthcare systems in several countries, which are subject to payment delays. Payment is dependent upon the financial stability and creditworthiness of those countries' national economies.
The following table shows net sales attributable to distributors that accounted for 10.0% or more of the Company's total net sales:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
CuraScript, Inc.
|
24.6
|
%
|
|
27.5
|
%
|
The following table shows accounts receivable attributable to distributors that accounted for 10.0% or more of the Company's gross accounts receivable at the end of each period:
|
|
|
|
|
|
|
|
|
|
|
March 27,
2020
|
|
December 27,
2019
|
|
AmerisourceBergen Corporation
|
31.1
|
%
|
|
31.3
|
%
|
|
McKesson Corporation
|
18.5
|
|
|
15.3
|
|
|
CuraScript, Inc.
|
*
|
|
|
12.1
|
|
*Accounts receivable attributable to this distributor were less than 10.0% of total gross accounts receivable during the respective period presented above.
The following table shows net sales attributable to products that accounted for 10.0% or more of the Company's total net sales:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
Acthar Gel
|
25.2
|
%
|
|
28.3
|
%
|
|
INOmax
|
21.3
|
|
|
19.1
|
|
|
Ofirmev
|
11.3
|
|
|
12.1
|
|
The Company operates in two reportable segments, which are further described below:
|
|
|
|
•
|
Specialty Brands includes innovative specialty pharmaceutical brands; and
|
|
|
|
|
•
|
Specialty Generics includes niche specialty generic drugs and APIs.
|
All prior period segment information has been reclassified to reflect the realignment of the Company's reportable segments on a comparable basis, as previously discussed in Note 1.
Selected information by reportable segment was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
Net sales:
|
|
|
|
|
Specialty Brands
|
$
|
490.6
|
|
|
$
|
604.2
|
|
|
Specialty Generics
|
175.2
|
|
|
186.4
|
|
|
Net sales
|
$
|
665.8
|
|
|
$
|
790.6
|
|
|
Operating (loss) income:
|
|
|
|
|
Specialty Brands
|
$
|
212.2
|
|
|
$
|
275.5
|
|
|
Specialty Generics
|
48.3
|
|
|
24.4
|
|
|
Segment operating income
|
260.5
|
|
|
299.9
|
|
|
Unallocated amounts:
|
|
|
|
|
Corporate and unallocated expenses (1)
|
(66.5
|
)
|
|
(45.8
|
)
|
|
Intangible asset amortization
|
(197.6
|
)
|
|
(222.8
|
)
|
|
Restructuring and related charges, net
|
1.8
|
|
|
(4.2
|
)
|
|
Separation costs (2)
|
(21.3
|
)
|
|
(11.7
|
)
|
|
Opioid-related litigation settlement (3)
|
16.8
|
|
|
—
|
|
|
Operating (loss) income
|
$
|
(6.3
|
)
|
|
$
|
15.4
|
|
|
|
|
|
(1)
|
Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the Company's reportable segments.
|
|
|
|
|
(2)
|
These costs, which are included in SG&A expenses, primarily relate to professional fees, incremental costs incurred to build out the corporate infrastructure of the previously planned spin-off of the Company's Specialty Generics segment, costs incurred as the Company works to resolve opioid uncertainties, as well as rebranding initiatives associated with the Specialty Brands ongoing transformation.
|
|
|
|
|
(3)
|
Represents the change in the Settlement Warrants' fair value. Refer to Note 12 for further information regarding the valuations of the Settlement Warrants.
|
Net sales by product family within the Company's reportable segments were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 27,
2020
|
|
March 29,
2019
|
|
Acthar Gel
|
$
|
167.6
|
|
|
$
|
223.9
|
|
|
INOmax
|
141.7
|
|
|
151.1
|
|
|
Ofirmev
|
74.9
|
|
|
95.6
|
|
|
Therakos
|
63.7
|
|
|
61.8
|
|
|
Amitiza (1)
|
41.1
|
|
|
53.0
|
|
|
Other (2)
|
1.6
|
|
|
18.8
|
|
|
Specialty Brands
|
490.6
|
|
|
604.2
|
|
|
|
|
|
|
|
Hydrocodone (API) and hydrocodone-containing tablets
|
26.5
|
|
|
17.4
|
|
|
Oxycodone (API) and oxycodone-containing tablets
|
16.9
|
|
|
16.5
|
|
|
Acetaminophen (API)
|
44.1
|
|
|
46.2
|
|
|
Other controlled substances
|
83.6
|
|
|
94.2
|
|
|
Other
|
4.1
|
|
|
12.1
|
|
|
Specialty Generics
|
175.2
|
|
|
186.4
|
|
|
Net sales
|
$
|
665.8
|
|
|
$
|
790.6
|
|
|
|
|
|
(1)
|
Amitiza consists of both product net sales and royalties. Refer to Note 2 for further details on Amitiza's revenues.
|
|
|
|
|
(2)
|
The three months ended March 29, 2019 includes $12.4 million of net sales related to BioVectra prior to the completion of the sale of this business in November 2019.
|
Commitments and Contingencies
Certain litigation matters occurred during the three months ended March 27, 2020 or prior, but had subsequent updates through the issuance of this report. See further discussion in Note 11.
Financing Activities
2020 Notes
On April 7, 2020, the Company, Mallinckrodt International Finance S.A. and Mallinckrodt CB LLC ("the Issuers") entered into an exchange agreement (the “Exchange Agreement”) with certain third parties (collectively, the “Exchanging Holders”). Pursuant to the Exchange Agreement, the Exchanging Holders agreed to exchange with the Issuers, on April 7, 2020, their holdings of 2020 Notes issued by the Issuers (the “Existing Notes”) (consisting of approximately $495.0 million aggregate principal amount of the Existing Notes) for new 10.00% First Lien Senior Secured Notes due 2025 issued by the Issuers (the “First Lien 2025 Notes”), at a rate of $1,000 of First Lien 2025 Notes for every $1,000 of Existing Notes exchanged (such exchange, the “Exchange”). The Issuers and Exchanging Holders consummated the Exchange on April 7, 2020.
Interest on the First Lien 2025 Notes is payable semi-annually in cash on April 15th and October 15th of each year, commencing on October 15, 2020.
The Issuers may redeem some or all of the First Lien 2025 Notes prior to April 15, 2022 by paying a “make-whole” premium. The Issuers may redeem some or all of the First Lien 2025 Notes on or after April 15, 2022 at specified redemption prices. In addition, prior to April 15, 2022, the Issuers may redeem up to 40% of the aggregate principal amount of the First Lien 2025 Notes with the net proceeds of certain equity offerings. The Issuers may also redeem all, but not less than all, of the First Lien 2025 Notes at any time at a price of 100% of their principal amount, plus accrued and unpaid interest, if any, in the event the Issuers become obligated to pay additional amounts as a result of changes affecting certain withholding tax laws applicable to payments on the First Lien 2025 Notes.
The Issuers are obligated to offer to repurchase (a) all of the First Lien 2025 Notes at a price of 101% of their principal amount plus accrued and unpaid interest, if any, as a result of certain change of control events and (b) First Lien 2025 Notes using asset sale proceeds at a price of 100% of their principal amount plus accrued and unpaid interest, if any, in the event of certain asset sales. These obligations are subject to certain qualifications and exceptions.
The First Lien 2025 Notes are subject to an indenture that contains certain customary covenants and events of default (subject in certain cases to customary grace and cure periods). The occurrence of an event of default under the indenture could result in the acceleration of the First Lien 2025 Notes and could cause a cross-default that could result in the acceleration of other indebtedness of the Company and its subsidiaries.
The First Lien 2025 Notes are jointly and severally guaranteed, subject to certain exceptions, on a secured, unsubordinated basis by the Company and each of its subsidiaries (other than the Issuers) (the “Note Guarantors”) that guarantees the obligations under the Issuers’ existing senior secured credit facilities.
The First Lien 2025 Notes and the guarantees thereof are secured by liens on the same assets of the Issuers and the Note Guarantors that are subject to liens securing the existing senior secured credit facilities, subject to certain exceptions.
On April 15, 2020, the Company paid in full the remaining approximately $119.8 million in principal amount of outstanding 2020 Notes at the maturity thereof with cash on hand.