mnk-20211102
0001567892false00015678922021-11-022021-11-02


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): November 2, 2021
 
Mallinckrodt plc
(Exact name of registrant as specified in its charter)
Ireland001-3580398-1088325
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
 Identification No.)

College Business & Technology Park, Cruiserath,
Blanchardstown, Dublin 15, Ireland
(Address of principal executive offices) (Zip Code)
 
Registrant's telephone number, including area code:  +353 1 696 0000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company  
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  





Item 2.02    Results of Operations and Financial Condition.
On November 2, 2021, Mallinckrodt plc (the "Company" or "Mallinckrodt") provided its financial results for the three and nine months ended September 24, 2021 in the attached Exhibit 99.1.
The information in this Current Report on Form 8-K, including Exhibit 99.1, should be read in conjunction with the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 24, 2021.
The information contained in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as otherwise expressly set forth by specific reference in such a filing.
NON-GAAP FINANCIAL MEASURES
Exhibit 99.1 contains financial measures, including adjusted EBITDA and net sales growth on a constant-currency basis, which are considered "non-GAAP" financial measures under applicable U.S. Securities and Exchange Commission rules and regulations.
Adjusted EBITDA represents amounts prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) and adjusts for certain items that management believes are not reflective of the operational performance of the business. Consolidated adjusted EBITDA represents net loss, adjusted for interest expense, net, taxes, depreciation and amortization and certain items that management believes are not reflective of the operational performance of the business and additional adjustments. These adjustments include, but are not limited to, restructuring charges, net; non-restructuring impairment charges; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; separation costs; unrealized gain on equity investment; reorganization items, net; share-based compensation and other items identified by the Company.
Segment net sales growth on a constant-currency basis measures the change in segment net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period.
The Company has provided these adjusted financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate the company's operating performance. In addition, the Company believes that they will be used by certain investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the Company's performance across reporting periods on a consistent basis by excluding items that the Company does not believe are indicative of its core operating performance. Reconciliations of these financial measures to the most directly comparable GAAP financial measures are included in Exhibit 99.1.
These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP.

Item 9.01    Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Exhibit
99.1
104Cover Page Interactive Data File (embedded within the inline XBRL document).




SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MALLINCKRODT PLC
(registrant)
Date:November 2, 2021By: /s/ Bryan M. Reasons
Bryan M. Reasons
Executive Vice President and Chief Financial Officer
(principal financial officer)



Document

Exhibit 99.1

MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in millions, except per share data)
Three Months Ended
September 24,
2021
Percent of
Net sales
September 25,
2020
Percent of
Net sales
Net sales
$507.2 100.0 %$698.3 100.0 %
Cost of sales319.2 62.9 403.0 57.7 
Gross profit188.0 37.1 295.3 42.3 
Selling, general and administrative expenses127.3 25.1 220.8 31.6 
Research and development expenses47.3 9.3 65.5 9.4 
Restructuring charges, net11.0 2.2 3.2 0.5 
Gains on divestiture— — (9.7)(1.4)
Opioid-related litigation settlement loss (gain)125.0 24.6 (25.8)(3.7)
Medicaid lawsuit— — (0.2)— 
Operating (loss) income(122.6)(24.2)41.5 5.9 
Interest expense(48.7)(9.6)(62.2)(8.9)
Interest income— — 0.9 0.1 
Other expense, net(3.5)(0.7)— — 
Reorganization items, net(126.2)(24.9)— — 
Loss from continuing operations before income taxes(301.0)(59.3)(19.8)(2.8)
Income tax benefit(32.0)(6.3)(211.6)(30.3)
(Loss) income from continuing operations(269.0)(53.0)191.8 27.5 
Income (loss) from discontinued operations, net of income taxes5.3 1.0 (0.2)— 
Net (loss) income$(263.7)(52.0)%$191.6 27.4 %
Basic (loss) income per share:
(Loss) income from continuing operations$(3.18)$2.27 
Income (loss) from discontinued operations0.06 — 
Net (loss) income$(3.11)$2.26 
Diluted (loss) income per share:
(Loss) income from continuing operations$(3.18)$2.27 
Income (loss) from discontinued operations0.06 — 
Net (loss) income$(3.11)$2.26 
Weighted-average number of shares outstanding
Basic84.784.6
Diluted84.784.6




1


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
CONSOLIDATED ADJUSTED EBITDA
(unaudited, in millions)
Three Months Ended
September 24, 2021September 25, 2020
Gross ProfitSG&AR&DAdjusted EBITDAGross ProfitSG&AR&DAdjusted EBITDA
Net loss$188.0 $127.3 $47.3 $(263.7)$295.3 $220.8 $65.5 $191.6 
Adjustments:
Interest expense, net— — — 48.7 — — — 61.3 
Income taxes— — — (32.0)— — — (211.6)
Depreciation (1)
17.3 (4.3)(1.6)23.2 18.3 (5.5)(1.7)25.5 
Amortization144.5 (0.8)— 145.3 209.7 (0.9)— 210.6 
Restructuring charges, net— — — 11.0 — — — 3.2 
(Income) loss from discontinued operations— — — (5.3)— — — 0.2 
Change in contingent consideration fair value— 2.1 — (2.1)— (8.1)— 8.1 
Significant legal and environmental charges— — — 125.0 0.7 (13.4)— (11.9)
Gains on divestiture— — — — — — — (9.7)
Separation costs— (0.1)— 0.1 — (33.0)— 33.0 
Unrealized loss on equity investment— — — 6.9 — — — 0.8 
Reorganization items, net— — — 126.2 — — — — 
Share-based compensation 0.1 (1.9)(0.4)2.4 0.2 (3.4)(0.7)4.3 
As adjusted:$349.9 $122.3 $45.3 $185.7 $524.2 $156.5 $63.1 $305.4 
(1)Includes $0.7 millions of accelerated depreciation in selling general and administrative ("SG&A") related to restructuring charges incurred during the three months ended September 24, 2021.



2


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SEGMENT OPERATING INCOME
(unaudited, in millions)
Three Months Ended
September 24,
2021
September 25,
2020
Specialty Brands$189.9 $291.8 
Specialty Generics15.2 43.1 
Segment operating income205.1 334.9 
Unallocated amounts:
Corporate and unallocated expenses (1)
(20.8)(42.1)
Depreciation and amortization(168.4)(236.1)
Share-based compensation(2.4)(4.3)
Restructuring charges, net(11.0)(3.2)
Separation costs(0.1)(33.0)
Opioid-related litigation settlement (loss) gain(125.0)25.8 
Medicaid lawsuit— (0.5)
Operating (loss) income$(122.6)$41.5 
(1)Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the Company's reportable segments.
3


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions)
Three Months Ended
September 24,
2021
September 25,
2020
Percent
change
Currency impactConstant-currency growth
Specialty Brands$359.7 $539.6 (33.3)%0.1 %(33.4)%
Specialty Generics147.5 159.4 (7.5)0.1 (7.6)
Segment net sales507.2 699.0 (27.4)0.1 (27.5)
Medicaid lawsuit— (0.7)***
Net sales$507.2 $698.3 (27.4)%0.1 %(27.5)%
*Not meaningful


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions)
Three Months Ended
September 24,
2021
September 25,
2020
Percent
change
Currency impactConstant-currency growth
Specialty Brands
Acthar Gel $143.4 $195.3 (26.6)%— %(26.6)%
INOmax98.4 141.9 (30.7)— (30.7)
Ofirmev4.7 88.7 (94.7)— (94.7)
Therakos62.5 62.6 (0.2)0.7 (0.9)
Amitiza49.6 47.7 4.0 — 4.0 
Other1.1 3.4 (67.6)— (67.6)
Specialty Brands Total359.7 539.6 (33.3)0.1 (33.4)
Specialty Generics
Hydrocodone (API) and hydrocodone-containing tablets16.9 20.0 (15.5)— (15.5)
Oxycodone (API) and oxycodone-containing tablets15.2 16.1 (5.6)— (5.6)
Acetaminophen (API)49.6 54.9 (9.7)— (9.7)
Other controlled substances60.8 62.4 (2.6)0.3 (2.9)
Other5.0 6.0 (16.7)— (16.7)
Specialty Generics Total147.5 159.4 (7.5)0.1 (7.6)
Segment net sales507.2 699.0 (27.4)0.1 (27.5)
Medicaid lawsuit— (0.7)***
Net sales$507.2 $698.3 (27.4)%0.1 %(27.5)%
*Not meaningful



4


MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in millions, except per share data)
Nine Months Ended
September 24,
2021
Percent of
Net sales
September 25,
2020
Percent of
Net sales
Net sales (includes refined estimate of the retrospective one-time charge of $535.1 million related to the Medicaid lawsuit for the nine months ended September 25, 2020)
$1,611.6 100.0 %$1,530.6 100.0 %
Cost of sales958.4 59.5 1,171.7 76.6 
Gross profit653.2 40.5 358.9 23.4 
Selling, general and administrative expenses408.3 25.3 683.2 44.6 
Research and development expenses166.3 10.3 225.8 14.8 
Restructuring charges, net17.5 1.1 15.8 1.0 
Non-restructuring impairment charges64.5 4.0 63.5 4.1 
Losses (gains) on divestiture0.8 — (10.1)(0.7)
Opioid-related litigation settlement loss (gain)125.0 7.8 (34.1)(2.2)
Medicaid lawsuit— — 105.1 6.9 
Operating loss(129.2)(8.0)(690.3)(45.1)
Interest expense(160.7)(10.0)(200.9)(13.1)
Interest income1.9 0.1 5.4 0.4 
Other income, net15.9 1.0 1.1 0.1 
Reorganization items, net(329.2)(20.4)— — 
Loss from continuing operations before income taxes
(601.3)(37.3)(884.7)(57.8)
Income tax benefit(81.9)(5.1)(69.2)(4.5)
Loss from continuing operations(519.4)(32.2)(815.5)(53.3)
Income from discontinued operations, net of income taxes
6.0 0.4 23.8 1.6 
Net loss$(513.4)(31.9)%$(791.7)(51.7)%
Basic loss per share:
Loss from continuing operations$(6.13)$(9.66)
Income from discontinued operations0.07 0.28 
Net loss$(6.06)$(9.38)
Diluted loss per share:
Loss from continuing operations$(6.13)$(9.66)
Income from discontinued operations0.07 0.28 
Net loss$(6.06)$(9.38)
Weighted-average number of shares outstanding:
Basic84.784.4
Diluted84.784.4
5


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
CONSOLIDATED ADJUSTED EBITDA
(unaudited, in millions)
Nine Months Ended
September 24, 2021September 25, 2020
Gross ProfitSG&AR&DAdjusted EBITDAGross ProfitSG&AR&DAdjusted EBITDA
Net loss$653.2 $408.3 $166.3 $(513.4)$358.9 $683.2 $225.8 $(791.7)
Adjustments:
Interest expense, net— — — 158.8 — — — 195.5 
Income tax benefit— — — (81.9)— — — (69.2)
Depreciation (1)
52.2 (13.4)(4.7)70.3 54.2 (16.3)(5.2)75.7 
Amortization433.3 (2.5)— 435.8 597.2 (2.6)— 599.8 
Restructuring charges, net— — — 17.5 — — — 15.8 
Non-restructuring impairment charges— — — 64.5 — — — 63.5 
Income from discontinued operations— — — (6.0)— — — (23.8)
Change in contingent consideration fair value— 7.6 — (7.6)— (2.4)— 2.4 
Significant legal and environmental charges— — — 125.0 535.1 (53.1)— 659.2 
Losses (gains) on divestiture— — — 0.8 — — — (10.1)
Separation costs— (1.0)— 1.0 — (75.0)— 75.0 
Unrealized gain on equity investment— — — (4.8)— — — (2.2)
R&D upfront payment— — — — — — (5.0)5.0 
Reorganization items, net— — — 329.2 — — — — 
Share-based compensation 0.4 (6.6)(1.4)8.4 0.8 (14.0)(2.8)17.6 
As adjusted:$1,139.1 $392.4 $160.2 $597.6 $1,546.2 $519.8 $212.8 $812.5 
(1)Includes $2.0 million of accelerated depreciation in SG&A related to restructuring charges incurred during the nine months ended September 24, 2021.

6


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SEGMENT OPERATING INCOME
(unaudited, in millions)
Nine Months Ended
September 24,
2021
September 25,
2020
Specialty Brands$588.6 $765.0 
Specialty Generics73.8 155.5 
Segment operating income662.4 920.5 
Unallocated amounts:
Corporate and unallocated expenses (1)
(69.1)(152.3)
Depreciation and amortization(506.1)(675.5)
Share-based compensation(8.4)(17.6)
Restructuring charges, net(17.5)(15.8)
Non-restructuring impairment charges(64.5)(63.5)
Separation costs(1.0)(75.0)
R&D upfront payment— (5.0)
Opioid-related litigation settlement (loss) gain(125.0)34.1 
Medicaid lawsuit— (640.2)
Operating loss$(129.2)$(690.3)
(1)Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the Company's reportable segments.


7



MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions)
Nine Months Ended
September 24,
2021
September 25,
2020
Percent
change
Currency impactConstant-currency growth
Specialty Brands$1,149.6 $1,553.0 (26.0)%0.3 %(26.3)%
Specialty Generics462.0 512.7 (9.9)0.1 (10.0)
Segment net sales1,611.6 2,065.7 (22.0)0.2 (22.2)
Medicaid lawsuit— (535.1)***
Net sales$1,611.6 $1,530.6 5.3 %0.2 %5.1 %
*Not meaningful

MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
SELECT PRODUCT LINE NET SALES
(unaudited, in millions)
Nine Months Ended
September 24,
2021
September 25,
2020
Percent
change
Currency impactConstant-currency growth
Specialty Brands
Acthar$423.9 $576.6 (26.5)%— %(26.5)%
Inomax338.3 438.5 (22.9)0.1 (23.0)
Ofirmev24.0 216.0 (88.9)— (88.9)
Therakos197.8 174.1 13.6 2.1 11.5 
Amitiza155.8 138.2 12.7 — 12.7 
Other9.8 9.6 2.1 — 2.1 
Specialty Brands Total1,149.6 1,553.0 (26.0)0.3 (26.3)
Specialty Generics
Hydrocodone (API) and hydrocodone-containing tablets60.7 71.9 (15.6)— (15.6)
Oxycodone (API) and oxycodone-containing tablets49.5 48.0 3.1 — 3.1 
Acetaminophen (API)146.8 154.5 (5.0)— (5.0)
Other controlled substances187.9 223.8 (16.0)0.3 (16.3)
Other17.1 14.5 17.9 — 17.9 
Specialty Generics Total462.0 512.7 (9.9)0.1 (10.0)
Segment net sales1,611.6 2,065.7 (22.0)0.2 (22.2)
Medicaid lawsuit— (535.1)***
Net sales$1,611.6 $1,530.6 5.3 %0.2 %5.1 %
*Not meaningful



8


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in millions)
September 24,
2021
December 25,
2020
Assets
Current Assets:
Cash and cash equivalents$1,322.6 $1,070.6 
Accounts receivable, net431.7 538.8 
Inventories367.6 344.9 
Prepaid expenses and other current assets203.7 350.0 
Total current assets2,325.6 2,304.3 
Property, plant and equipment, net767.7 833.1 
Intangible assets, net5,684.1 6,184.5 
Other assets380.6 393.5 
Total Assets$9,158.0 $9,715.4 
Liabilities and Shareholders' Equity
Current Liabilities:
Current maturities of long-term debt$1,388.1 $3,587.9 
Accounts payable122.2 93.3 
Accrued payroll and payroll-related costs62.7 79.4 
Accrued interest25.7 26.9 
Accrued and other current liabilities387.1 331.2 
Total current liabilities1,985.8 4,118.7 
Pension and postretirement benefits32.6 34.6 
Environmental liabilities60.3 59.8 
Deferred income taxes61.5 80.6 
Other income tax liabilities82.9 100.1 
Other liabilities86.0 109.8 
Liabilities subject to compromise6,335.5 4,192.6 
Total Liabilities8,644.6 8,696.2 
Shareholders' Equity:
Preferred shares— — 
Ordinary shares
18.9 18.8 
Ordinary shares held in treasury at cost(1,616.1)(1,616.1)
Additional paid-in capital5,596.0 5,587.6 
Retained deficit(3,474.9)(2,961.5)
Accumulated other comprehensive loss(10.5)(9.6)
Total Shareholders' Equity513.4 1,019.2 
Total Liabilities and Shareholders' Equity$9,158.0 $9,715.4 


9


MALLINCKRODT PLC
(DEBTOR-IN-POSSESSION)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited, in millions)
Nine Months Ended
September 24,
2021
September 25,
2020
Cash Flows From Operating Activities:
Net loss$(513.4)$(791.7)
Adjustments to reconcile net cash from operating activities:
Depreciation and amortization506.1 675.5 
Share-based compensation8.4 17.6 
Deferred income taxes(19.1)304.0 
Non-cash impairment charges64.5 63.5 
Losses (gains) on divestiture0.8 (10.1)
Reorganization items, net22.5 — 
Other non-cash items(6.0)(21.6)
Changes in assets and liabilities:
Accounts receivable, net105.7 61.1 
Inventories(30.9)(43.9)
Accounts payable14.7 (52.4)
Income taxes92.5 (431.2)
Opioid-related litigation settlement liability125.0 — 
Medicaid lawsuit(4.8)640.2 
Other40.4 (116.3)
Net cash from operating activities406.4 294.7 
Cash Flows From Investing Activities:
Capital expenditures(39.2)(42.4)
Proceeds from divestitures, net of cash15.7 (0.7)
Other1.4 6.7 
Net cash from investing activities(22.1)(36.4)
Cash Flows From Financing Activities:
Repayment of external debt(128.2)(134.6)
Debt financing costs— (9.3)
Repurchase of shares— (0.4)
Other— (36.3)
Net cash from financing activities(128.2)(180.6)
Effect of currency rate changes on cash(0.9)0.2 
Net change in cash, cash equivalents and restricted cash255.2 77.9 
Cash, cash equivalents and restricted cash at beginning of period1,127.0 822.6 
Cash, cash equivalents and restricted cash at end of period$1,382.2 $900.5 
Cash and cash equivalents at end of period$1,322.6 $844.2 
Restricted cash included in prepaid expenses and other assets at end of period23.3 20.2 
Restricted cash included in other long-term assets at end of period36.3 36.1 
Cash, cash equivalents and restricted cash at end of period$1,382.2 $900.5 
10