(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
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)) |
(Title of each class) | (Trading Symbol(s)) | (Name of each exchange on which registered) |
Exhibit No. | Exhibit | |
99.1 | ||
104 | Cover Page Interactive Data File (embedded within the inline XBRL document). | |
MALLINCKRODT PLC | ||||
(registrant) | ||||
Date: | February 25, 2020 | By: | /s/ Bryan M. Reasons | |
Bryan M. Reasons | ||||
Executive Vice President and Chief Financial Officer (principal financial officer) |
• | Fourth quarter net sales of $804.9 million and 2019 net sales of $3.163 billion, with strong performance across hospital products and the Specialty Generics segment, offset by declines in Acthar® Gel |
• | Diluted loss per share of $13.76 in the fourth quarter and $11.88 in fiscal 2019; adjusted diluted earnings per share (EPS) of $2.40 in the fourth quarter and $8.88 in fiscal 2019 |
• | Fourth quarter operating cash flow of $208.8 million and free cash flow of $184.5 million; fiscal 2019 operating cash flow of $742.9 million and free cash flow of $609.9 million |
• | Principal debt reduced by $733.9 million in fiscal 2019, with net debt reduced by $1.176 billion, reflecting strong cash-generation, debt repurchased at a discount and the debt exchange offer completed in the fourth quarter |
• | As separately announced today, reached an agreement in principle for a global settlement with a broad-based group of plaintiffs that would resolve all opioid-related claims against the company and its subsidiaries, and taking actions to address near-term maturities to strengthen capital structure |
• | Acthar® Gel net sales were $232.6 million, a 17.8% decrease, primarily driven by continued reimbursement challenges impacting new and returning patients and continued payer scrutiny on overall specialty pharmaceutical spending. |
• | INOMAX® (nitric oxide) gas, for inhalation net sales were $143.8 million, an increase of 3.7%, or 3.8% on a constant-currency basis, driven by strong customer demand for INOmax, partially offset by increased competition in the market. |
• | OFIRMEV® (acetaminophen) injection net sales were $111.8 million, an increase of 28.2%, primarily due to significant quarter-to-quarter order variability that is expected to continue until loss of exclusivity. |
• | Therakos® immunology platform net sales were $63.3 million, an increase of 11.1%, or 11.3% on a constant-currency basis, primarily due to the capture of new patients, and the conversion to the Cellex device. |
• | AMITIZA net sales were $50.9 million, down 21.2% due to lower royalties in the U.S. due to an increasingly competitive landscape. |
• | At the Mallinckrodt website: http://www.mallinckrodt.com/investors. |
• | 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 4168459. |
• | Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Feb. 25, 2020, and ending at 11:30 a.m. Eastern Time on Tuesday, March 10, |
MALLINCKRODT PLC | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
(unaudited, in millions, except per share data) | |||||||||||
Three Months Ended | |||||||||||
December 27, 2019 | Percent of Net sales | December 28, 2018 | Percent of Net sales | ||||||||
Net sales | $ | 804.9 | 100.0 | % | $ | 834.9 | 100.0 | % | |||
Cost of sales | 431.8 | 53.6 | 471.6 | 56.5 | |||||||
Gross profit | 373.1 | 46.4 | 363.3 | 43.5 | |||||||
Selling, general and administrative expenses | 169.2 | 21.0 | 239.6 | 28.7 | |||||||
Research and development expenses | 81.4 | 10.1 | 100.4 | 12.0 | |||||||
Restructuring charges, net | (12.9 | ) | (1.6 | ) | 1.2 | 0.1 | |||||
Non-restructuring impairment charges | 274.5 | 34.1 | 3,891.1 | 466.1 | |||||||
Losses on divestiture | 33.5 | 4.2 | 0.2 | — | |||||||
Opioid-related litigation settlement charge | 1,643.4 | 204.2 | — | — | |||||||
Operating loss | (1,816.0 | ) | (225.6 | ) | (3,869.2 | ) | (463.4 | ) | |||
Interest expense | (77.2 | ) | (9.6 | ) | (90.1 | ) | (10.8 | ) | |||
Interest income | 2.9 | 0.4 | 1.6 | 0.2 | |||||||
Gain on debt extinguishment, net | 377.4 | 46.9 | 5.7 | 0.7 | |||||||
Other income, net | 24.2 | 3.0 | 7.4 | 0.9 | |||||||
Loss from continuing operations before income taxes | (1,488.7 | ) | (185.0 | ) | (3,944.6 | ) | (472.5 | ) | |||
Income tax benefit | (327.7 | ) | (40.7 | ) | (226.2 | ) | (27.1 | ) | |||
Loss from continuing operations | (1,161.0 | ) | (144.2 | ) | (3,718.4 | ) | (445.4 | ) | |||
Income from discontinued operations, net of income taxes | 3.9 | 0.5 | — | — | |||||||
Net loss | $ | (1,157.1 | ) | (143.8 | )% | $ | (3,718.4 | ) | (445.4 | )% | |
Basic (loss) earnings per share: | |||||||||||
Loss from continuing operations | $ | (13.80 | ) | $ | (44.64 | ) | |||||
Income from discontinued operations | 0.05 | — | |||||||||
Net loss | (13.76 | ) | (44.64 | ) | |||||||
Diluted (loss) earnings per share: | |||||||||||
Loss from continuing operations | $ | (13.80 | ) | $ | (44.64 | ) | |||||
Income from discontinued operations | 0.05 | — | |||||||||
Net loss | (13.76 | ) | (44.64 | ) | |||||||
Weighted-average number of shares outstanding: | |||||||||||
Basic | 84.1 | 83.3 | |||||||||
Diluted | 84.1 | 83.3 | |||||||||
MALLINCKRODT PLC | |||||||||||||||||||||||||||
NON-GAAP MEASURES | |||||||||||||||||||||||||||
(unaudited, in millions except per share data) | |||||||||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||||||||
December 27, 2019 | December 28, 2018 | ||||||||||||||||||||||||||
Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share(1) | Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share(1) | ||||||||||||||||||||
GAAP | $ | 373.1 | $ | 169.2 | $ | (1,157.1 | ) | $ | (13.76 | ) | $ | 363.3 | $ | 239.6 | $ | (3,718.4 | ) | $ | (44.64 | ) | |||||||
Adjustments: | |||||||||||||||||||||||||||
Intangible asset amortization | 202.8 | (0.8 | ) | 203.6 | 2.42 | 192.0 | (1.7 | ) | 193.7 | 2.28 | |||||||||||||||||
Restructuring and related charges, net (2) | — | — | (12.9 | ) | (0.15 | ) | — | (0.3 | ) | 1.5 | 0.02 | ||||||||||||||||
Inventory step-up expense | — | — | — | — | 41.3 | — | 41.3 | 0.49 | |||||||||||||||||||
Income from discontinued operations | — | — | (3.9 | ) | (0.05 | ) | — | — | — | — | |||||||||||||||||
Change in contingent consideration fair value | — | 36.7 | (36.7 | ) | (0.44 | ) | — | 16.9 | (16.9 | ) | (0.20 | ) | |||||||||||||||
Acquisition related expenses | — | — | — | — | — | (2.0 | ) | 2.0 | 0.02 | ||||||||||||||||||
Non-restructuring impairment charges (3) | — | — | 274.5 | 3.26 | — | — | 3,891.1 | 45.83 | |||||||||||||||||||
Significant legal and environmental charges (4) | — | — | 1,643.4 | 19.52 | — | (31.5 | ) | 31.5 | 0.37 | ||||||||||||||||||
Divestitures | — | — | 33.5 | 0.40 | — | — | 0.2 | — | |||||||||||||||||||
Separation costs | — | (13.5 | ) | 13.5 | 0.16 | — | (6.0 | ) | 6.0 | 0.07 | |||||||||||||||||
Gains on debt extinguishment, net | — | — | (377.4 | ) | (4.48 | ) | — | — | (6.2 | ) | (0.07 | ) | |||||||||||||||
Unrealized gain on equity investment (5) | — | — | (13.7 | ) | (0.16 | ) | — | — | — | — | |||||||||||||||||
Legal entity and intercompany financing organization | — | — | (26.0 | ) | (0.31 | ) | — | — | (173.7 | ) | (2.05 | ) | |||||||||||||||
U.S. Tax Reform | — | — | — | — | — | — | 0.6 | 0.01 | |||||||||||||||||||
Income taxes (6) | — | — | (338.7 | ) | (4.02 | ) | — | — | (81.6 | ) | (0.96 | ) | |||||||||||||||
Depreciation catch up (7) | — | — | — | — | 11.4 | (2.8 | ) | 13.7 | 0.16 | ||||||||||||||||||
As adjusted | $ | 575.9 | $ | 191.6 | $ | 202.1 | $ | 2.40 | $ | 608.0 | $ | 212.2 | $ | 184.8 | $ | 2.18 | |||||||||||
Percent of net sales | 71.5 | % | 23.8 | % | 25.1 | % | 72.8 | % | 25.4 | % | 22.1 | % | |||||||||||||||
(1) | In periods where losses from continuing operations are incurred, 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 dilutive shares are included in the calculation of adjusted diluted earnings per share if dilutive to adjusted net income. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 and 84.9 shares for the three months ended December 27, 2019 and December 28, 2018, respectively. |
(2) | Includes pre-tax accelerated depreciation. |
(3) | The three months ended December 27, 2019 includes an in-process research and development ("IPR&D") intangible asset impairment of $274.5 million related to VTS-270. The three months ended December 28, 2018 includes the goodwill impairment of $3,672.8 million and an IPR&D intangible asset impairment of $218.3 million related to MNK-1411. |
(4) | Includes the opioid-related litigation settlement charge of $1.643 billion. |
(5) | Represents an unrealized gain related to the company's equity investment in Silence Therapeutics plc ("Silence"). |
(6) | 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. |
(7) | During the three months ended December 28, 2018, "the Specialty Generics Disposal Group" was reclassified to held and used after being classified as held-for-sale since February 2018. In accordance with GAAP, depreciation and amortization are not recorded during the period in which a disposal group is classified as held-for-sale. When the disposal group was reclassified to held and used, it was measured at its carrying amount before it was classified as held-for-sale, adjusted for depreciation and amortization expense that would have been recognized had the disposal group been continuously classified as held and used. The effect of the required adjustment has been reflected in loss from continuing operations during the fourth quarter of 2018, the period in which the held-for-sale criteria was no longer met. |
MALLINCKRODT PLC | ||||||||||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Three Months Ended | ||||||||||||||||
December 27, 2019 | December 28, 2018 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | $ | 611.4 | $ | 652.4 | (6.3 | )% | — | % | (6.3 | )% | ||||||
Specialty Generics(1) | 193.5 | 182.5 | 6.0 | — | 6.0 | |||||||||||
Net sales | $ | 804.9 | $ | 834.9 | (3.6 | ) | — | (3.6 | ) | |||||||
(1) | Includes net sales from the post-divestiture supply agreement with the acquirer of the contrast media and delivery systems ("CMDS") business. |
MALLINCKRODT PLC | ||||||||||||||||
SELECT PRODUCT LINE NET SALES | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Three Months Ended | ||||||||||||||||
December 27, 2019 | December 28, 2018 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | ||||||||||||||||
Acthar Gel | $ | 232.6 | $ | 283.0 | (17.8 | )% | — | % | (17.8 | )% | ||||||
INOmax | 143.8 | 138.7 | 3.7 | (0.1 | ) | 3.8 | ||||||||||
Ofirmev | 111.8 | 87.2 | 28.2 | — | 28.2 | |||||||||||
Therakos | 63.3 | 57.0 | 11.1 | (0.2 | ) | 11.3 | ||||||||||
Amitiza | 50.9 | 64.6 | (21.2 | ) | — | (21.2 | ) | |||||||||
BioVectra (1) | 3.3 | 17.4 | (81.0 | ) | (0.2 | ) | (80.8 | ) | ||||||||
Other | 5.7 | 4.5 | 26.7 | (0.4 | ) | 27.1 | ||||||||||
Specialty Brands Total | $ | 611.4 | $ | 652.4 | (6.3 | )% | — | % | (6.3 | )% | ||||||
Specialty Generics | ||||||||||||||||
Hydrocodone (API) and hydrocodone-containing tablets | $ | 25.1 | $ | 19.6 | 28.1 | % | — | % | 28.1 | % | ||||||
Oxycodone (API) and oxycodone-containing tablets (2) | 21.6 | 22.8 | (5.3 | ) | — | (5.3 | ) | |||||||||
Acetaminophen (API) (2) | 46.8 | 43.7 | 7.1 | — | 7.1 | |||||||||||
Other controlled substances (2) | 86.8 | 85.8 | 1.2 | — | 1.2 | |||||||||||
Other (2) | 13.2 | 10.6 | 24.5 | — | 24.5 | |||||||||||
Specialty Generics Total | $ | 193.5 | $ | 182.5 | 6.0 | % | — | % | 6.0 | % |
(1) | In November 2019, the company completed its sale of the BioVectra business. |
(2) | Prior period amounts have been reclassified to conform to current period presentation. |
MALLINCKRODT PLC | |||||||
SEGMENT OPERATING INCOME | |||||||
(unaudited, in millions) | |||||||
Three Months Ended | |||||||
December 27, 2019 | December 28, 2018 | ||||||
Specialty Brands (1) | $ | 310.3 | $ | 298.7 | |||
Specialty Generics (2) | 28.0 | (5.4 | ) | ||||
Segment operating income | 338.3 | 293.3 | |||||
Unallocated amounts: | |||||||
Corporate and allocated expenses (3) | (32.2 | ) | (70.1 | ) | |||
Intangible asset amortization | (203.6 | ) | (193.7 | ) | |||
Restructuring and related charges, net (4) | 12.9 | (1.6 | ) | ||||
Non-restructuring impairments | (274.5 | ) | (3,891.1 | ) | |||
Separation costs | (13.5 | ) | (6.0 | ) | |||
Opioid-related litigation settlement charge | (1,643.4 | ) | — | ||||
Operating loss | $ | (1,816.0 | ) | $ | (3,869.2 | ) |
(1) | The three months ended December 28, 2018 includes $41.3 million of inventory fair-value step up expense related to Amitiza. |
(2) | During the fourth quarter of 2018, the Specialty Generics Disposal Group was reclassified to held-and-used and measured at its carrying amount before it was classified as held-for-sale, adjusted for depreciation and amortization expense that would have been recognized had the disposal group been continuously classified as held and used. The total depreciation adjustment of $17.7 million was reflected in the Specialty Generics segment operating income during the fourth quarter of 2018, the period in which the held-for-sale criteria were no longer met. |
(3) | Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the company's reportable segments. |
(4) | Includes restructuring-related accelerated depreciation. |
MALLINCKRODT PLC | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
(unaudited, in millions, except per share data) | |||||||||||
Fiscal Year | |||||||||||
2019 | Percent of Net sales | 2018 | Percent of Net sales | ||||||||
Net sales | $ | 3,162.5 | 100.0 | % | $ | 3,215.6 | 100.0 | % | |||
Cost of sales | 1,741.1 | 55.1 | 1,744.4 | 54.2 | |||||||
Gross profit | 1,421.4 | 44.9 | 1,471.2 | 45.8 | |||||||
Selling, general and administrative expenses | 831.0 | 26.3 | 834.1 | 25.9 | |||||||
Research and development expenses | 349.4 | 11.0 | 361.1 | 11.2 | |||||||
Restructuring charges, net | (1.7 | ) | (0.1 | ) | 103.0 | 3.2 | |||||
Non-restructuring impairment charges | 388.0 | 12.3 | 3,893.1 | 121.1 | |||||||
Losses on divestiture | 33.5 | 1.1 | 0.8 | — | |||||||
Opioid-related litigation settlement charge | 1,643.4 | 52.0 | — | — | |||||||
Operating loss | (1,822.2 | ) | (57.6 | ) | (3,720.9 | ) | (115.7 | ) | |||
Interest expense | (309.0 | ) | (9.8 | ) | (370.2 | ) | (11.5 | ) | |||
Interest income | 9.5 | 0.3 | 8.2 | 0.3 | |||||||
Gain on debt extinguishment, net | 466.6 | 14.8 | 8.5 | 0.3 | |||||||
Other income, net | 63.6 | 2.0 | 22.4 | 0.7 | |||||||
Loss from continuing operations before income taxes | (1,591.5 | ) | (50.3 | ) | (4,052.0 | ) | (126.0 | ) | |||
Income tax benefit | (584.3 | ) | (18.5 | ) | (430.1 | ) | (13.4 | ) | |||
Loss from continuing operations | (1,007.2 | ) | (31.8 | ) | (3,621.9 | ) | (112.6 | ) | |||
Income from discontinued operations, net of income taxes | 10.7 | 0.3 | 14.9 | 0.5 | |||||||
Net loss | $ | (996.5 | ) | (31.5 | )% | $ | (3,607.0 | ) | (112.2 | )% | |
Basic (loss) earnings per share: | |||||||||||
Loss from continuing operations | $ | (12.00 | ) | $ | (43.12 | ) | |||||
Income from discontinued operations | 0.13 | 0.18 | |||||||||
Net loss | (11.88 | ) | (42.94 | ) | |||||||
Diluted (loss) earnings per share: | |||||||||||
Loss from continuing operations | $ | (12.00 | ) | $ | (43.12 | ) | |||||
Income from discontinued operations | 0.13 | 0.18 | |||||||||
Net loss | (11.88 | ) | (42.94 | ) | |||||||
Weighted-average number of shares outstanding: | |||||||||||
Basic | 83.9 | 84.0 | |||||||||
Diluted | 83.9 | 84.0 | |||||||||
MALLINCKRODT PLC | |||||||||||||||||||||||||||
NON-GAAP MEASURES | |||||||||||||||||||||||||||
(unaudited, in millions except per share data) | |||||||||||||||||||||||||||
Fiscal Year | |||||||||||||||||||||||||||
2019 | 2018 | ||||||||||||||||||||||||||
Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share(1) | Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share(1) | ||||||||||||||||||||
GAAP | $ | 1,421.4 | $ | 831.0 | $ | (996.5 | ) | $ | (11.88 | ) | $ | 1,471.2 | $ | 834.1 | $ | (3,607.0 | ) | $ | (42.94 | ) | |||||||
Adjustments: | |||||||||||||||||||||||||||
Intangible asset amortization | 847.9 | (5.5 | ) | 853.4 | 10.14 | 733.6 | (6.6 | ) | 740.2 | 8.69 | |||||||||||||||||
Restructuring and related charges, net (2) | — | — | (1.7 | ) | (0.02 | ) | 3.0 | (2.2 | ) | 108.2 | 1.27 | ||||||||||||||||
Inventory step-up expense | 10.0 | — | 10.0 | 0.12 | 120.8 | — | 120.8 | 1.42 | |||||||||||||||||||
Income from discontinued operations | — | — | (10.7 | ) | (0.13 | ) | — | — | (14.9 | ) | (0.17 | ) | |||||||||||||||
Change in contingent consideration fair value | — | 60.2 | (60.2 | ) | (0.71 | ) | — | 50.2 | (50.2 | ) | (0.59 | ) | |||||||||||||||
Acquisition related expenses | — | — | — | — | — | (5.8 | ) | 5.8 | 0.07 | ||||||||||||||||||
Non-restructuring impairment charges (3) | — | — | 388.0 | 4.61 | — | — | 3,893.1 | 45.69 | |||||||||||||||||||
Significant legal and environmental charges (4) | — | (28.2 | ) | 1,671.6 | 19.85 | — | (19.7 | ) | 19.7 | 0.23 | |||||||||||||||||
Divestitures | — | — | 33.5 | 0.40 | — | — | 0.8 | 0.01 | |||||||||||||||||||
R&D upfront payment | — | — | 20.0 | 0.24 | — | — | — | — | |||||||||||||||||||
Separation costs | — | (63.9 | ) | 63.9 | 0.76 | — | (6.0 | ) | 6.0 | 0.07 | |||||||||||||||||
Gains on debt extinguishment, net | — | — | (466.6 | ) | (5.54 | ) | — | — | (12.7 | ) | (0.15 | ) | |||||||||||||||
Unrealized gain on equity investment (5) | — | — | (20.2 | ) | (0.24 | ) | — | — | — | — | |||||||||||||||||
Legal entity and intercompany financing organization | — | — | (212.8 | ) | (2.53 | ) | — | — | (256.0 | ) | (3.00 | ) | |||||||||||||||
U.S. Tax Reform | — | — | — | — | — | — | (8.5 | ) | (0.10 | ) | |||||||||||||||||
Income taxes (6) | — | — | (524.2 | ) | (6.23 | ) | — | — | (263.1 | ) | (3.09 | ) | |||||||||||||||
As adjusted | $ | 2,279.3 | $ | 793.6 | $ | 747.5 | $ | 8.88 | $ | 2,328.6 | $ | 844.0 | $ | 682.2 | $ | 8.01 | |||||||||||
Percent of net sales | 72.1 | % | 25.1 | % | 23.6 | % | 72.4 | % | 26.2 | % | 21.2 | % | |||||||||||||||
(1) | In periods where losses from continuing operations are incurred, 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 dilutive shares are included in the calculation of adjusted diluted earnings per share if dilutive to adjusted net income. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 and 85.2 shares for fiscal 2019 and 2018, respectively. |
(2) | Includes pre-tax accelerated depreciation. |
(3) | Fiscal 2019 includes IPR&D intangible asset impairments of $274.5 and $113.5 million related to VTS-270 and stannsoporfin, respectively. Fiscal 2018 includes the goodwill impairment of $3,672.8 million and an IPR&D intangible asset impairment of $218.3 million related to MNK-1411. |
(4) | Includes the opioid-related litigation settlement charge of $1.643 billion. |
(5) | Represents an unrealized gain related to the company's equity investment in Silence. Fiscal 2019 includes an unrealized gain of $6.5 million and $13.7 million for the three months ended September 27, 2019 and the three months ended December 27, 2019, respectively. |
(6) | 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) | ||||||||||||||||
Fiscal Year | ||||||||||||||||
2019 | 2018 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | $ | 2,423.8 | $ | 2,496.7 | (2.9 | )% | (0.2 | )% | (2.7 | )% | ||||||
Specialty Generics(1) | 738.7 | 718.9 | 2.8 | (0.1 | ) | 2.9 | ||||||||||
Net sales | $ | 3,162.5 | $ | 3,215.6 | (1.7 | ) | (0.2 | ) | (1.5 | ) | ||||||
(1) | Includes net sales from the post-divestiture supply agreement with the acquirer of the CMDS business. |
MALLINCKRODT PLC | ||||||||||||||||
SELECT PRODUCT LINE NET SALES | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Fiscal Year | ||||||||||||||||
2019 | 2018 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | ||||||||||||||||
Acthar Gel | $ | 952.7 | $ | 1,110.1 | (14.2 | )% | — | % | (14.2 | )% | ||||||
INOmax | 571.4 | 542.7 | 5.3 | (0.1 | ) | 5.4 | ||||||||||
Ofirmev | 384.0 | 341.9 | 12.3 | — | 12.3 | |||||||||||
Therakos | 246.9 | 231.2 | 6.8 | (1.5 | ) | 8.3 | ||||||||||
Amitiza | 208.5 | 183.8 | 13.4 | — | 13.4 | |||||||||||
BioVectra (1) | 40.1 | 53.1 | (24.5 | ) | (2.3 | ) | (22.2 | ) | ||||||||
Other | 20.2 | 33.9 | (40.4 | ) | (1.0 | ) | (39.4 | ) | ||||||||
Specialty Brands Total | $ | 2,423.8 | $ | 2,496.7 | (2.9 | )% | (0.2 | )% | (2.7 | )% | ||||||
Specialty Generics | ||||||||||||||||
Hydrocodone (API) and hydrocodone-containing tablets | $ | 76.3 | $ | 65.9 | 15.8 | % | — | % | 15.8 | % | ||||||
Oxycodone (API) and oxycodone-containing tablets (2) | 74.9 | 66.1 | 13.3 | — | 13.3 | |||||||||||
Acetaminophen (API) (2) | 189.9 | 192.7 | (1.5 | ) | — | (1.5 | ) | |||||||||
Other controlled substances (2) | 352.5 | 343.8 | 2.5 | (0.1 | ) | 2.6 | ||||||||||
Other (2) | 45.1 | 50.4 | (10.5 | ) | — | (10.5 | ) | |||||||||
Specialty Generics Total | $ | 738.7 | $ | 718.9 | 2.8 | % | (0.1 | )% | 2.9 | % |
(1) | In November 2019, the company completed its sale of the BioVectra business. |
(2) | Prior period amounts have been reclassified to conform to current period presentation. |
MALLINCKRODT PLC | |||||||
SEGMENT OPERATING INCOME | |||||||
(unaudited, in millions) | |||||||
Fiscal Year | |||||||
2019 | 2018 | ||||||
Specialty Brands (1) | $ | 1,174.5 | $ | 1,093.1 | |||
Specialty Generics | 108.1 | 89.3 | |||||
Segment operating income | 1,282.6 | 1,182.4 | |||||
Unallocated amounts: | |||||||
Corporate and allocated expenses (2) | (137.8 | ) | (155.8 | ) | |||
Intangible asset amortization | (853.4 | ) | (740.2 | ) | |||
Restructuring and related charges, net (3) | 1.7 | (108.2 | ) | ||||
Non-restructuring impairment charges | (388.0 | ) | (3,893.1 | ) | |||
Separation costs | (63.9 | ) | (6.0 | ) | |||
R&D upfront payment (4) | (20.0 | ) | — | ||||
Opioid-related litigation settlement charge | (1,643.4 | ) | — | ||||
Operating loss | $ | (1,822.2 | ) | $ | (3,720.9 | ) |
(1) | Includes $10.0 million and $118.8 million of inventory fair-value step up expense, primarily related to Amitiza during fiscal 2019 and 2018, respectively. |
(2) | Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the company's reportable segments. |
(3) | Includes restructuring-related accelerated depreciation. |
(4) | Represents R&D expense incurred related to an upfront payment made to Silence in connection with the license and collaboration agreement entered into in July 2019. |
MALLINCKRODT PLC | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(unaudited, in millions) | |||||||
December 27, 2019 | December 28, 2018 | ||||||
Assets | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 790.9 | $ | 348.9 | |||
Accounts receivable, net | 577.5 | 623.3 | |||||
Inventories | 312.1 | 322.3 | |||||
Prepaid expenses and other current assets | 150.2 | 132.7 | |||||
Total current assets | 1,830.7 | 1,427.2 | |||||
Property, plant and equipment, net | 896.5 | 982.0 | |||||
Intangible assets, net | 7,018.0 | 8,282.8 | |||||
Other assets | 593.7 | 185.3 | |||||
Total Assets | $ | 10,338.9 | $ | 10,877.3 | |||
Liabilities and Shareholders' Equity | |||||||
Current Liabilities: | |||||||
Current maturities of long-term debt | $ | 633.6 | $ | 22.4 | |||
Accounts payable | 139.8 | 147.5 | |||||
Accrued payroll and payroll-related costs | 105.2 | 124.0 | |||||
Accrued interest | 62.9 | 77.6 | |||||
Accrued and other current liabilities | 485.4 | 572.2 | |||||
Total current liabilities | 1,426.9 | 943.7 | |||||
Long-term debt | 4,741.2 | 6,069.2 | |||||
Opioid-related litigation settlement liability | 1,643.4 | — | |||||
Pension and postretirement benefits | 62.4 | 60.5 | |||||
Environmental liabilities | 60.0 | 59.7 | |||||
Deferred income taxes | 11.0 | 324.3 | |||||
Other income tax liabilities | 227.1 | 228.0 | |||||
Other liabilities | 226.2 | 304.6 | |||||
Total Liabilities | 8,398.2 | 7,990.0 | |||||
Shareholders' Equity: | |||||||
Preferred shares | — | — | |||||
Ordinary shares | 18.7 | 18.5 | |||||
Ordinary shares held in treasury at cost | (1,615.7 | ) | (1,617.4 | ) | |||
Additional paid-in capital | 5,562.5 | 5,528.2 | |||||
Retained deficit | (2,016.9 | ) | (1,017.7 | ) | |||
Accumulated other comprehensive loss | (7.9 | ) | (24.3 | ) | |||
Total Shareholders' Equity | 1,940.7 | 2,887.3 | |||||
Total Liabilities and Shareholders' Equity | $ | 10,338.9 | $ | 10,877.3 |
MALLINCKRODT PLC | |||||||
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF CASH FLOWS | |||||||
(unaudited, in millions) | |||||||
Fiscal Year | |||||||
2019 | 2018 | ||||||
Cash Flows From Operating Activities: | |||||||
Net Loss | $ | (996.5 | ) | $ | (3,607.0 | ) | |
Adjustments to reconcile net cash from operating activities: | |||||||
Depreciation and amortization | 951.1 | 852.1 | |||||
Share-based compensation | 33.8 | 34.6 | |||||
Deferred income taxes | (604.3 | ) | (541.5 | ) | |||
Non-cash impairment charges | 388.0 | 3,893.1 | |||||
Inventory provisions | 18.0 | 37.9 | |||||
Losses on divestiture | 33.5 | 0.8 | |||||
Gain on debt extinguishment, net | (466.6 | ) | (8.5 | ) | |||
Other non-cash items | (65.7 | ) | (42.4 | ) | |||
Changes in assets and liabilities, net of the effects of acquisitions: | |||||||
Accounts receivable, net | 31.6 | (145.8 | ) | ||||
Inventories | (23.1 | ) | 63.1 | ||||
Accounts payable | 6.7 | 24.6 | |||||
Income taxes | (2.1 | ) | 99.0 | ||||
Opioid-related litigation settlement liability | 1,600.0 | — | |||||
Other | (161.5 | ) | 5.5 | ||||
Net cash from operating activities | 742.9 | 665.5 | |||||
Cash Flows From Investing Activities: | |||||||
Capital expenditures | (133.0 | ) | (127.0 | ) | |||
Acquisitions, net of cash | — | (699.9 | ) | ||||
Proceeds from divestiture, net of cash | 95.1 | 313.0 | |||||
Other | 29.6 | 33.6 | |||||
Net cash from investing activities | (8.3 | ) | (480.3 | ) | |||
Cash Flows From Financing Activities: | |||||||
Issuance of external debt | 695.0 | 690.3 | |||||
Repayment of external debt | (945.1 | ) | (1,693.6 | ) | |||
Debt financing costs | (10.1 | ) | (12.1 | ) | |||
Proceeds from exercise of share options | 0.6 | 1.0 | |||||
Repurchase of shares | (2.6 | ) | (57.5 | ) | |||
Other | (17.9 | ) | (23.1 | ) | |||
Net cash from financing activities | (280.1 | ) | (1,095.0 | ) | |||
Effect of currency rate changes on cash | 0.6 | (1.8 | ) | ||||
Net change in cash, cash equivalents and restricted cash | 455.1 | (911.6 | ) | ||||
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 | $ | 822.6 | $ | 367.5 | |||
Cash and cash equivalents at end of period | $ | 790.9 | $ | 348.9 | |||
Restricted cash included in other long-term assets at end of period | 31.7 | 18.6 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 822.6 | $ | 367.5 |