Ireland
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001-35803
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98-1088325
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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(Title of each class)
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(Trading Symbol(s))
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(Name of each exchange on which registered)
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Ordinary shares, par value $0.20 per share
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MNK
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New York Stock Exchange
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Mark Casey, EVP and Chief Legal Officer
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$900,000
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Bryan Reasons, EVP and Chief Financial Officer
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$825,000
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Steven Romano, M.D., EVP and Chief Scientific Officer
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$930,000
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Exhibit No.
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Exhibit
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10.1
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99.1
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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MALLINCKRODT PLC
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(registrant)
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Date:
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November 5, 2019
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By:
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/s/ Bryan M. Reasons
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Bryan M. Reasons
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Executive Vice President and Chief Financial Officer
(principal financial officer)
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•
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Net sales of $743.7 million with diluted loss per share from continuing operations of $0.01 and adjusted diluted earnings per share (EPS) of $2.07
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•
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Operating cash flows of $66.7 million in the third quarter and $534.1 million for the year-to-date
|
•
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Reported positive topline Phase 3 results for both terlipressin and StrataGraft® regenerative tissue
|
•
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Raised 2019 fiscal year adjusted diluted EPS guidance range to $8.50 to $8.70 (previously $8.40 to $8.70)
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•
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Company remains focused on achieving a global resolution of all opioid lawsuits
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•
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Acthar Gel net sales were $229.8 million, a 20.8% decrease, driven primarily by continued reimbursement challenges impacting new and returning patients, and continued payer scrutiny on overall specialty pharmaceutical spending.
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•
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INOMAX® (nitric oxide) gas, for inhalation, net sales were $136.8 million, up 2.7% driven by more significant utilization in multi-year, unlimited use contracts, while strong customer demand for the product continues.
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•
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OFIRMEV® (acetaminophen) injection net sales were $86.1 million, a decrease of 1.1%, due to lower demand and typical quarter-to-quarter order variability.
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•
|
Therakos® immunology platform net sales were $60.9 million, an increase of 1.5%, or 3.3% on a constant-currency basis, primarily on growth in the U.S. in Cutaneous T-Cell Lymphoma.
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•
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AMITZA net sales were $52.6 million, up 9.1% due to continued strong utilization in Japan, partially offset by an increasingly more competitive landscape in the U.S.
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•
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At the Mallinckrodt website: http://www.mallinckrodt.com/investors.
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•
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By telephone: For both listen-only participants and those who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is (877) 359-9508. For participants outside the U.S., the dial-in number is (224) 357-2393. Callers will need to provide the Conference ID of 6080969.
|
•
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Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Nov. 5, 2019, and ending at 11:59 p.m. Eastern Time on Tuesday, Nov. 19, 2019. Dial-in numbers for U.S.-based participants are (855) 859-2056 or (800) 585-8367. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 6080969.
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MALLINCKRODT PLC
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|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
|||||||||||
(unaudited, in millions, except per share data)
|
|||||||||||
|
|
|
|
|
|
||||||
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Three Months Ended
|
||||||||||
|
September 27,
2019 |
Percent of
Net sales
|
|
September 28,
2018 |
Percent of
Net sales
|
||||||
Net sales
|
$
|
743.7
|
|
100.0
|
%
|
|
$
|
799.9
|
|
100.0
|
%
|
Cost of sales
|
419.4
|
|
56.4
|
|
|
433.5
|
|
54.2
|
|
||
Gross profit
|
324.3
|
|
43.6
|
|
|
366.4
|
|
45.8
|
|
||
Selling, general and administrative expenses
|
205.7
|
|
27.7
|
|
|
193.4
|
|
24.2
|
|
||
Research and development expenses
|
103.1
|
|
13.9
|
|
|
86.1
|
|
10.8
|
|
||
Restructuring charges, net
|
7.2
|
|
1.0
|
|
|
14.8
|
|
1.9
|
|
||
Non-restructuring impairment charge
|
—
|
|
—
|
|
|
2.0
|
|
0.3
|
|
||
Loss on divestiture
|
—
|
|
—
|
|
|
0.6
|
|
0.1
|
|
||
Operating income
|
8.3
|
|
1.1
|
|
|
69.5
|
|
8.7
|
|
||
Interest expense
|
(77.6
|
)
|
(10.4
|
)
|
|
(93.6
|
)
|
(11.7
|
)
|
||
Interest income
|
2.9
|
|
0.4
|
|
|
2.0
|
|
0.3
|
|
||
Other income, net
|
37.9
|
|
5.1
|
|
|
13.4
|
|
1.7
|
|
||
Loss from continuing operations before income taxes
|
(28.5
|
)
|
(3.8
|
)
|
|
(8.7
|
)
|
(1.1
|
)
|
||
Income tax benefit
|
(27.6
|
)
|
(3.7
|
)
|
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(122.9
|
)
|
(15.4
|
)
|
||
(Loss) income from continuing operations
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(0.9
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)
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(0.1
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)
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114.2
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|
14.3
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|
||
Loss from discontinued operations, net of income taxes
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(0.2
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)
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—
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(0.4
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)
|
(0.1
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)
|
||
Net (loss) income
|
$
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(1.1
|
)
|
(0.1
|
)%
|
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$
|
113.8
|
|
14.2
|
%
|
|
|
|
|
|
|
||||||
Basic earnings per share:
|
|
|
|
|
|
||||||
(Loss) income from continuing operations
|
$
|
(0.01
|
)
|
|
|
$
|
1.37
|
|
|
||
Loss from discontinued operations
|
—
|
|
|
|
—
|
|
|
||||
Net (loss) income
|
$
|
(0.01
|
)
|
|
|
$
|
1.37
|
|
|
||
|
|
|
|
|
|
||||||
Basic weighted-average shares outstanding
|
84.0
|
|
|
|
83.2
|
|
|
||||
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|
||||||
Diluted earnings per share:
|
|
|
|
|
|
||||||
(Loss) income from continuing operations
|
$
|
(0.01
|
)
|
|
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$
|
1.34
|
|
|
||
Loss from discontinued operations
|
—
|
|
|
|
—
|
|
|
||||
Net (loss) income
|
$
|
(0.01
|
)
|
|
|
$
|
1.34
|
|
|
||
|
|
|
|
|
|
||||||
Diluted weighted-average shares outstanding
|
84.0
|
|
|
|
85.0
|
|
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MALLINCKRODT PLC
|
|||||||||||||||||||||||||||
NON-GAAP MEASURES
|
|||||||||||||||||||||||||||
(unaudited, in millions except per share data)
|
|||||||||||||||||||||||||||
|
|
|
|
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|
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|
|
|
||||||||||||||||
|
Three Months Ended
|
||||||||||||||||||||||||||
|
September 27, 2019
|
|
September 28, 2018
|
||||||||||||||||||||||||
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Gross profit
|
SG&A
|
Net (loss) income
|
|
Diluted
net (loss) income
per share (1)
|
|
Gross profit
|
SG&A
|
Net income
|
|
Diluted
net income per share |
||||||||||||||||
GAAP
|
$
|
324.3
|
|
$
|
205.7
|
|
$
|
(1.1
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
366.4
|
|
$
|
193.4
|
|
$
|
113.8
|
|
|
$
|
1.34
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Intangible asset amortization
|
208.9
|
|
(1.5
|
)
|
210.4
|
|
|
2.50
|
|
|
182.7
|
|
(1.6
|
)
|
184.2
|
|
|
2.17
|
|
||||||||
Non-restructuring impairment charge
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
—
|
|
2.0
|
|
|
0.02
|
|
||||||||
Restructuring and related charges, net (2)
|
—
|
|
—
|
|
7.2
|
|
|
0.09
|
|
|
2.9
|
|
(1.9
|
)
|
19.6
|
|
|
0.23
|
|
||||||||
Inventory step-up expense
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
31.0
|
|
—
|
|
31.0
|
|
|
0.36
|
|
||||||||
Loss from discontinued operations
|
—
|
|
—
|
|
0.2
|
|
|
—
|
|
|
—
|
|
—
|
|
0.4
|
|
|
—
|
|
||||||||
Change in contingent consideration fair value
|
—
|
|
25.8
|
|
(25.8
|
)
|
|
(0.31
|
)
|
|
—
|
|
4.2
|
|
(4.2
|
)
|
|
(0.05
|
)
|
||||||||
Acquisition-related expenses
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
(0.7
|
)
|
0.7
|
|
|
0.01
|
|
||||||||
Divestiture
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
—
|
|
0.6
|
|
|
0.01
|
|
||||||||
Gain on repurchase of debt
|
—
|
|
—
|
|
(18.7
|
)
|
|
(0.22
|
)
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Write off of unamortized debt discount and fees
|
—
|
|
—
|
|
0.8
|
|
|
0.01
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Separation costs
|
—
|
|
(19.8
|
)
|
19.8
|
|
|
0.24
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Significant legal and environmental charges
|
—
|
|
(28.2
|
)
|
28.2
|
|
|
0.33
|
|
|
—
|
|
11.8
|
|
(11.8
|
)
|
|
(0.14
|
)
|
||||||||
R&D upfront payment (3)
|
—
|
|
—
|
|
20.0
|
|
|
0.24
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Legal entity and intercompany financing reorganization
|
—
|
|
—
|
|
3.0
|
|
|
0.04
|
|
|
—
|
|
—
|
|
(82.3
|
)
|
|
(0.97
|
)
|
||||||||
U.S. Tax Reform
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
—
|
|
(9.1
|
)
|
|
(0.11
|
)
|
||||||||
Income taxes (4)
|
—
|
|
—
|
|
(69.5
|
)
|
|
(0.83
|
)
|
|
—
|
|
—
|
|
(54.0
|
)
|
|
(0.64
|
)
|
||||||||
As adjusted
|
$
|
533.2
|
|
$
|
182.0
|
|
$
|
174.5
|
|
|
$
|
2.07
|
|
|
$
|
583.0
|
|
$
|
205.2
|
|
$
|
190.9
|
|
|
$
|
2.25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Percent of net sales
|
71.7
|
%
|
24.5
|
%
|
23.5
|
%
|
|
|
|
72.9
|
%
|
25.7
|
%
|
23.9
|
%
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019.
|
(2)
|
Includes pre-tax accelerated depreciation.
|
(3)
|
Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019.
|
(4)
|
Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
|
MALLINCKRODT PLC
|
||||||||||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
|
||||||||||||||||
(unaudited, in millions)
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Three Months Ended
|
|
|
|
|
|
|
|||||||||
|
September 27,
2019 |
|
September 28,
2018 |
|
Percent
change
|
|
Currency impact
|
|
Constant-currency growth
|
|||||||
Specialty Brands
|
$
|
580.4
|
|
|
$
|
640.0
|
|
|
(9.3
|
)%
|
|
(0.2
|
)%
|
|
(9.1
|
)%
|
Specialty Generics (1)
|
163.3
|
|
|
159.9
|
|
|
2.1
|
%
|
|
—
|
|
|
2.1
|
|
||
Net sales
|
$
|
743.7
|
|
|
$
|
799.9
|
|
|
(7.0
|
)%
|
|
(0.2
|
)%
|
|
(6.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Includes net sales from an ongoing, post-divestiture supply agreement with the acquirer of the contrast media and delivery systems ("CMDS") business.
|
MALLINCKRODT PLC
|
||||||||||||||||
SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH
|
||||||||||||||||
(unaudited, in millions)
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Three Months Ended
|
|
|
|
|
|
|
|||||||||
|
September 27,
2019 |
|
September 28,
2018 |
|
Percent
change
|
|
Currency impact
|
|
Constant-currency growth
|
|||||||
Specialty Brands
|
|
|
|
|
|
|
|
|
|
|||||||
Acthar Gel
|
$
|
229.8
|
|
|
$
|
290.1
|
|
|
(20.8
|
)%
|
|
—
|
%
|
|
(20.8
|
)%
|
Inomax
|
136.8
|
|
|
133.2
|
|
|
2.7
|
|
|
(0.1
|
)
|
|
2.8
|
|
||
Ofirmev
|
86.1
|
|
|
87.1
|
|
|
(1.1
|
)
|
|
—
|
|
|
(1.1
|
)
|
||
Therakos
|
60.9
|
|
|
60.0
|
|
|
1.5
|
|
|
(1.8
|
)
|
|
3.3
|
|
||
Amitiza
|
52.6
|
|
|
48.2
|
|
|
9.1
|
|
|
—
|
|
|
9.1
|
|
||
BioVectra
|
10.5
|
|
|
13.9
|
|
|
(24.5
|
)
|
|
(0.6
|
)
|
|
(23.9
|
)
|
||
Other
|
3.7
|
|
|
7.5
|
|
|
(50.7
|
)
|
|
(1.3
|
)
|
|
(49.4
|
)
|
||
Specialty Brands Total
|
$
|
580.4
|
|
|
$
|
640.0
|
|
|
(9.3
|
)%
|
|
(0.2
|
)%
|
|
(9.1
|
)%
|
|
|
|
|
|
|
|
|
|
|
|||||||
Specialty Generics
|
|
|
|
|
|
|
|
|
|
|||||||
Hydrocodone (API) and hydrocodone-containing tablets
|
$
|
15.7
|
|
|
$
|
15.5
|
|
|
1.3
|
%
|
|
—
|
%
|
|
1.3
|
%
|
Oxycodone (API) and oxycodone-containing tablets(1)
|
17.2
|
|
|
13.6
|
|
|
26.5
|
|
|
—
|
|
|
26.5
|
|
||
Acetaminophen (API) (1)
|
48.5
|
|
|
47.9
|
|
|
1.3
|
|
|
—
|
|
|
1.3
|
|
||
Other controlled substances (1)
|
72.9
|
|
|
69.5
|
|
|
4.9
|
|
|
(0.1
|
)
|
|
5.0
|
|
||
Other (1)
|
9.0
|
|
|
13.4
|
|
|
(32.8
|
)
|
|
—
|
|
|
(32.8
|
)
|
||
Specialty Generics Total
|
$
|
163.3
|
|
|
$
|
159.9
|
|
|
2.1
|
%
|
|
—
|
%
|
|
2.1
|
%
|
(1)
|
Prior period amounts have been reclassified to conform to current period presentation.
|
MALLINCKRODT PLC
|
|||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
|||||||||||
(unaudited, in millions, except per share data)
|
|||||||||||
|
|
|
|
|
|
||||||
|
Nine Months Ended
|
||||||||||
|
September 27,
2019 |
Percent of
Net sales
|
|
September 28,
2018 |
Percent of
Net sales
|
||||||
Net sales
|
$
|
2,357.6
|
|
100.0
|
%
|
|
$
|
2,380.7
|
|
100.0
|
%
|
Cost of sales
|
1,309.3
|
|
55.5
|
|
|
1,272.8
|
|
53.5
|
|
||
Gross profit
|
1,048.3
|
|
44.5
|
|
|
1,107.9
|
|
46.5
|
|
||
Selling, general and administrative expenses
|
661.8
|
|
28.1
|
|
|
594.5
|
|
25.0
|
|
||
Research and development expenses
|
268.0
|
|
11.4
|
|
|
260.7
|
|
11.0
|
|
||
Restructuring charges, net
|
11.2
|
|
0.5
|
|
|
101.8
|
|
4.3
|
|
||
Non-restructuring impairment charges
|
113.5
|
|
4.8
|
|
|
2.0
|
|
0.1
|
|
||
Loss on divestiture
|
—
|
|
—
|
|
|
0.6
|
|
—
|
|
||
Operating (loss) income
|
(6.2
|
)
|
(0.3
|
)
|
|
148.3
|
|
6.2
|
|
||
Interest expense
|
(231.8
|
)
|
(9.8
|
)
|
|
(280.1
|
)
|
(11.8
|
)
|
||
Interest income
|
6.6
|
|
0.3
|
|
|
6.6
|
|
0.3
|
|
||
Other income, net
|
128.6
|
|
5.5
|
|
|
17.8
|
|
0.7
|
|
||
Loss from continuing operations before income taxes
|
(102.8
|
)
|
(4.4
|
)
|
|
(107.4
|
)
|
(4.5
|
)
|
||
Income tax benefit
|
(256.6
|
)
|
(10.9
|
)
|
|
(203.9
|
)
|
(8.6
|
)
|
||
Income from continuing operations
|
153.8
|
|
6.5
|
|
|
96.5
|
|
4.1
|
|
||
Income from discontinued operations, net of income taxes
|
6.8
|
|
0.3
|
|
|
14.9
|
|
0.6
|
|
||
Net income
|
$
|
160.6
|
|
6.8
|
%
|
|
$
|
111.4
|
|
4.7
|
%
|
|
|
|
|
|
|
||||||
Basic earnings per share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
1.84
|
|
|
|
$
|
1.15
|
|
|
||
Income from discontinued operations
|
0.08
|
|
|
|
0.18
|
|
|
||||
Net income
|
$
|
1.92
|
|
|
|
$
|
1.32
|
|
|
||
|
|
|
|
|
|
||||||
Basic weighted-average shares outstanding
|
83.8
|
|
|
|
84.2
|
|
|
||||
|
|
|
|
|
|
||||||
Diluted earnings per share:
|
|
|
|
|
|
||||||
Income from continuing operations
|
$
|
1.83
|
|
|
|
$
|
1.13
|
|
|
||
Income from discontinued operations
|
0.08
|
|
|
|
0.17
|
|
|
||||
Net income
|
$
|
1.91
|
|
|
|
$
|
1.31
|
|
|
||
|
|
|
|
|
|
||||||
Diluted weighted-average shares outstanding
|
84.2
|
|
|
|
85.2
|
|
|
MALLINCKRODT PLC
|
|||||||||||||||||||||||||||
NON-GAAP MEASURES
|
|||||||||||||||||||||||||||
(unaudited, in millions except per share data)
|
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
Nine Months Ended
|
||||||||||||||||||||||||||
|
September 27, 2019
|
|
September 28, 2018
|
||||||||||||||||||||||||
|
Gross profit
|
SG&A
|
Net income
|
|
Diluted
net income
per share
|
|
Gross profit
|
SG&A
|
Net income
|
|
Diluted
net income per share |
||||||||||||||||
GAAP
|
$
|
1,048.3
|
|
$
|
661.8
|
|
$
|
160.6
|
|
|
$
|
1.91
|
|
|
$
|
1,107.9
|
|
$
|
594.5
|
|
$
|
111.4
|
|
|
$
|
1.31
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Intangible asset amortization
|
645.1
|
|
(4.7
|
)
|
649.8
|
|
|
7.72
|
|
|
541.6
|
|
(5.0
|
)
|
546.5
|
|
|
6.41
|
|
||||||||
Non-restructuring impairment charges (1)
|
—
|
|
—
|
|
113.5
|
|
|
1.35
|
|
|
—
|
|
—
|
|
2.0
|
|
|
0.02
|
|
||||||||
Restructuring and related charges, net (2)
|
—
|
|
—
|
|
11.2
|
|
|
0.13
|
|
|
2.9
|
|
(1.9
|
)
|
106.6
|
|
|
1.25
|
|
||||||||
Inventory step-up expense
|
10.0
|
|
—
|
|
10.0
|
|
|
0.12
|
|
|
79.5
|
|
—
|
|
79.5
|
|
|
0.93
|
|
||||||||
Income from discontinued operations
|
—
|
|
—
|
|
(6.8
|
)
|
|
(0.08
|
)
|
|
—
|
|
—
|
|
(14.9
|
)
|
|
(0.17
|
)
|
||||||||
Change in contingent consideration fair value
|
—
|
|
23.5
|
|
(23.5
|
)
|
|
(0.28
|
)
|
|
—
|
|
33.3
|
|
(33.3
|
)
|
|
(0.39
|
)
|
||||||||
Acquisition-related expenses
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
(3.8
|
)
|
3.8
|
|
|
0.04
|
|
||||||||
Divestiture
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
—
|
|
0.6
|
|
|
0.01
|
|
||||||||
Gain on repurchase of debt
|
—
|
|
—
|
|
(98.6
|
)
|
|
(1.17
|
)
|
|
—
|
|
—
|
|
(6.5
|
)
|
|
(0.08
|
)
|
||||||||
Write off of unamortized debt discount and fees
|
—
|
|
—
|
|
9.4
|
|
|
0.11
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Significant legal and environmental charges
|
—
|
|
(28.2
|
)
|
28.2
|
|
|
0.33
|
|
|
—
|
|
11.8
|
|
(11.8
|
)
|
|
(0.14
|
)
|
||||||||
R&D upfront payment (3)
|
—
|
|
—
|
|
20.0
|
|
|
0.24
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Separation costs
|
—
|
|
(50.4
|
)
|
50.4
|
|
|
0.60
|
|
|
—
|
|
—
|
|
—
|
|
|
—
|
|
||||||||
Legal entity and intercompany financing reorganization
|
—
|
|
—
|
|
(186.8
|
)
|
|
(2.22
|
)
|
|
—
|
|
—
|
|
(82.3
|
)
|
|
(0.97
|
)
|
||||||||
U.S. Tax Reform
|
—
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
—
|
|
(9.1
|
)
|
|
(0.11
|
)
|
||||||||
Income taxes (4)
|
—
|
|
—
|
|
(185.5
|
)
|
|
(2.20
|
)
|
|
—
|
|
—
|
|
(181.5
|
)
|
|
(2.13
|
)
|
||||||||
As adjusted
|
$
|
1,703.4
|
|
$
|
602.0
|
|
$
|
551.9
|
|
|
$
|
6.55
|
|
|
$
|
1,731.9
|
|
$
|
628.9
|
|
$
|
511.0
|
|
|
$
|
6.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Percent of net sales
|
72.3
|
%
|
25.5
|
%
|
23.4
|
%
|
|
|
|
72.7
|
%
|
26.4
|
%
|
21.5
|
%
|
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Represents in-process research and development intangible asset impairment of $113.5 million related to stannsoporfin during the nine months ended September 27, 2019 and impairment of a license associated with a product we elected to discontinue during the three months ended September 28, 2018.
|
(2)
|
Includes pre-tax accelerated depreciation.
|
(3)
|
Represents R&D expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019.
|
(4)
|
Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
|
MALLINCKRODT PLC
|
||||||||||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
|
||||||||||||||||
(unaudited, in millions)
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Nine Months Ended
|
|
|
|
|
|
|
|||||||||
|
September 27,
2019 |
|
September 28,
2018 |
|
Percent
change
|
|
Currency impact
|
|
Constant-currency growth
|
|||||||
Specialty Brands
|
$
|
1,812.4
|
|
|
$
|
1,844.3
|
|
|
(1.7
|
)%
|
|
(0.3
|
)%
|
|
(1.4
|
)%
|
Specialty Generics (1)
|
545.2
|
|
|
536.4
|
|
|
1.6
|
|
|
(0.1
|
)
|
|
1.7
|
|
||
Net sales
|
$
|
2,357.6
|
|
|
$
|
2,380.7
|
|
|
(1.0
|
)%
|
|
(0.2
|
)%
|
|
(0.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Includes net sales from an ongoing, post-divestiture supply agreement with the acquirer of the CMDS business.
|
MALLINCKRODT PLC
|
||||||||||||||||
SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH
|
||||||||||||||||
(unaudited, in millions)
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
Nine Months Ended
|
|
|
|
|
|
|
|||||||||
|
September 27,
2019 |
|
September 28,
2018 |
|
Percent
change
|
|
Currency impact
|
|
Constant-currency growth
|
|||||||
Specialty Brands
|
|
|
|
|
|
|
|
|
|
|||||||
Acthar Gel
|
$
|
720.1
|
|
|
$
|
827.1
|
|
|
(12.9
|
)%
|
|
—
|
%
|
|
(12.9
|
)%
|
Inomax
|
427.6
|
|
|
404.0
|
|
|
5.8
|
|
|
(0.1
|
)
|
|
5.9
|
|
||
Ofirmev
|
272.2
|
|
|
254.7
|
|
|
6.9
|
|
|
—
|
|
|
6.9
|
|
||
Therakos
|
183.6
|
|
|
174.2
|
|
|
5.4
|
|
|
(1.9
|
)
|
|
7.3
|
|
||
Amitiza
|
157.6
|
|
|
119.2
|
|
|
32.2
|
|
|
—
|
|
|
32.2
|
|
||
BioVectra
|
36.8
|
|
|
35.7
|
|
|
3.1
|
|
|
(3.3
|
)
|
|
6.4
|
|
||
Other
|
14.5
|
|
|
29.4
|
|
|
(50.7
|
)
|
|
(1.0
|
)
|
|
(49.7
|
)
|
||
Specialty Brands Total
|
$
|
1,812.4
|
|
|
$
|
1,844.3
|
|
|
(1.7
|
)%
|
|
(0.3
|
)%
|
|
(1.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|||||||
Specialty Generics
|
|
|
|
|
|
|
|
|
|
|||||||
Hydrocodone (API) and hydrocodone-containing tablets
|
$
|
51.2
|
|
|
$
|
46.3
|
|
|
10.6
|
%
|
|
—
|
%
|
|
10.6
|
%
|
Oxycodone (API) and oxycodone-containing tablets(1)
|
53.3
|
|
|
43.3
|
|
|
23.1
|
|
|
—
|
|
|
23.1
|
|
||
Acetaminophen (API) (1)
|
143.1
|
|
|
149.0
|
|
|
(4.0
|
)
|
|
—
|
|
|
(4.0
|
)
|
||
Other controlled substances (1)
|
265.7
|
|
|
258.0
|
|
|
3.0
|
|
|
(0.2
|
)
|
|
3.2
|
|
||
Other (1)
|
31.9
|
|
|
39.8
|
|
|
(19.8
|
)
|
|
—
|
|
|
(19.8
|
)
|
||
Specialty Generics Total
|
$
|
545.2
|
|
|
$
|
536.4
|
|
|
1.6
|
%
|
|
(0.1
|
)%
|
|
1.7
|
%
|
(1)
|
Prior period amounts have been reclassified to conform to current period presentation.
|
MALLINCKRODT PLC
|
|||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|||||||
(unaudited, in millions)
|
|||||||
|
|
|
|
||||
|
September 27,
2019 |
|
December 28,
2018 |
||||
Assets
|
|
|
|
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
498.8
|
|
|
$
|
348.9
|
|
Accounts receivable, net
|
538.8
|
|
|
623.3
|
|
||
Inventories
|
325.5
|
|
|
322.3
|
|
||
Prepaid expenses and other current assets
|
122.2
|
|
|
132.7
|
|
||
Assets held for sale
|
175.9
|
|
|
—
|
|
||
Total current assets
|
1,661.2
|
|
|
1,427.2
|
|
||
Property, plant and equipment, net
|
894.7
|
|
|
982.0
|
|
||
Intangible assets, net
|
7,496.1
|
|
|
8,282.8
|
|
||
Other assets
|
304.1
|
|
|
185.3
|
|
||
Total Assets
|
$
|
10,356.1
|
|
|
$
|
10,877.3
|
|
|
|
|
|
||||
Liabilities and Shareholders' Equity
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Current maturities of long-term debt
|
$
|
716.1
|
|
|
$
|
22.4
|
|
Accounts payable
|
100.9
|
|
|
147.5
|
|
||
Accrued payroll and payroll-related costs
|
83.7
|
|
|
124.0
|
|
||
Accrued interest
|
90.9
|
|
|
77.6
|
|
||
Accrued and other current liabilities
|
506.5
|
|
|
572.2
|
|
||
Liabilities held for sale
|
55.8
|
|
|
—
|
|
||
Total current liabilities
|
1,553.9
|
|
|
943.7
|
|
||
Long-term debt
|
5,048.7
|
|
|
6,069.2
|
|
||
Pension and postretirement benefits
|
58.6
|
|
|
60.5
|
|
||
Environmental liabilities
|
60.3
|
|
|
59.7
|
|
||
Deferred income taxes
|
22.0
|
|
|
324.3
|
|
||
Other income tax liabilities
|
253.5
|
|
|
228.0
|
|
||
Other liabilities
|
278.7
|
|
|
304.6
|
|
||
Total Liabilities
|
7,275.7
|
|
|
7,990.0
|
|
||
Shareholders' Equity:
|
|
|
|
||||
Preferred shares
|
—
|
|
|
—
|
|
||
Ordinary shares
|
18.7
|
|
|
18.5
|
|
||
Ordinary shares held in treasury at cost
|
(1,615.6
|
)
|
|
(1,617.4
|
)
|
||
Additional paid-in capital
|
5,559.2
|
|
|
5,528.2
|
|
||
Retained deficit
|
(859.8
|
)
|
|
(1,017.7
|
)
|
||
Accumulated other comprehensive loss
|
(22.1
|
)
|
|
(24.3
|
)
|
||
Total Shareholders' Equity
|
3,080.4
|
|
|
2,887.3
|
|
||
Total Liabilities and Shareholders' Equity
|
$
|
10,356.1
|
|
|
$
|
10,877.3
|
|
MALLINCKRODT PLC
|
|||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|||||||
(unaudited, in millions)
|
|||||||
|
|
|
|
||||
|
Nine Months Ended
|
||||||
|
September 27,
2019 |
|
September 28,
2018 |
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net income
|
$
|
160.6
|
|
|
$
|
111.4
|
|
Adjustments to reconcile net cash from operating activities:
|
|
|
|
||||
Depreciation and amortization
|
723.5
|
|
|
597.0
|
|
||
Share-based compensation
|
30.6
|
|
|
27.9
|
|
||
Deferred income taxes
|
(301.9
|
)
|
|
(232.7
|
)
|
||
Non-cash impairment charges
|
113.5
|
|
|
2.0
|
|
||
Loss on divestiture
|
—
|
|
|
0.6
|
|
||
Gain on repurchase of debt
|
(98.6
|
)
|
|
(6.5
|
)
|
||
Other non-cash items
|
(31.7
|
)
|
|
2.8
|
|
||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
||||
Accounts receivable, net
|
68.7
|
|
|
(59.0
|
)
|
||
Inventories
|
(32.0
|
)
|
|
43.1
|
|
||
Accounts payable
|
(27.8
|
)
|
|
(0.1
|
)
|
||
Income taxes
|
17.2
|
|
|
16.7
|
|
||
Other
|
(88.0
|
)
|
|
(22.1
|
)
|
||
Net cash from operating activities
|
534.1
|
|
|
481.1
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Capital expenditures
|
(108.7
|
)
|
|
(93.3
|
)
|
||
Acquisitions, net of cash
|
—
|
|
|
(699.9
|
)
|
||
Proceeds from divestiture, net of cash
|
—
|
|
|
313.2
|
|
||
Other
|
13.7
|
|
|
28.8
|
|
||
Net cash from investing activities
|
(95.0
|
)
|
|
(451.2
|
)
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Issuance of external debt
|
695.0
|
|
|
657.2
|
|
||
Repayment of external debt
|
(940.1
|
)
|
|
(1,563.4
|
)
|
||
Debt financing costs
|
—
|
|
|
(12.0
|
)
|
||
Proceeds from exercise of share options
|
0.5
|
|
|
1.0
|
|
||
Repurchase of shares
|
(2.5
|
)
|
|
(57.4
|
)
|
||
Other
|
(18.1
|
)
|
|
(24.3
|
)
|
||
Net cash from financing activities
|
(265.2
|
)
|
|
(998.9
|
)
|
||
Effect of currency rate changes on cash
|
0.5
|
|
|
(0.9
|
)
|
||
Net change in cash, cash equivalents and restricted cash, including cash classified within assets held for sale
|
174.4
|
|
|
(969.9
|
)
|
||
Less: Net change in cash classified within assets held for sale
|
(15.1
|
)
|
|
—
|
|
||
Net change in cash, cash equivalents and restricted cash
|
159.3
|
|
|
(969.9
|
)
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
367.5
|
|
|
1,279.1
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
526.8
|
|
|
$
|
309.2
|
|
|
|
|
|
||||
Cash and cash equivalents at end of period
|
$
|
498.8
|
|
|
$
|
290.7
|
|
Restricted cash included in other assets at end of period
|
28.0
|
|
|
18.5
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
526.8
|
|
|
$
|
309.2
|
|