Ireland | 001-35803 | 98-1088325 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Exhibit No. | Exhibit | |
99.1 | ||
MALLINCKRODT PUBLIC LIMITED COMPANY | ||||
(registrant) | ||||
Date: | February 26, 2019 | By: | /s/ George A. Kegler | |
George A. Kegler | ||||
Executive Vice President and Chief Financial Officer, Interim |
• | Fourth quarter net sales of $834.9 million, a 5.4% increase; 2018 net sales of $3.2 billion comparable to prior year |
• | Fourth quarter operating cash flow of $184.4 million, free cash flow of $150.7 million; annual operating cash flow of $665.5 million, free cash flow of $538.5 million |
• | Total debt reduced by $384.0 million in the fourth quarter and subsequent to quarter close |
• | GAAP1 diluted loss per share of $44.64 in the fourth quarter and $42.94 in fiscal 2018, primarily due to a non-cash goodwill impairment and driven by continued disparity between Mallinckrodt's expected performance and share price |
• | Strong operating results, with adjusted diluted earnings per share of $2.18 in the fourth quarter, an increase of 8.5%, and $8.01 for 2018, an increase of 6.9% |
• | Company provides guidance for 2019, including net sales and adjusted diluted EPS: |
Metric (excluding foreign currency impact) | 2019 Guidance |
Total net sales for Specialty Brands segment | Increase 1% to 4% |
Total net sales for Specialty Generics and Amitiza segment | Increase 1% to 4% |
Adjusted diluted EPS (total company) | $8.10 to $8.40 |
2019 Strategic Priorities |
Maximize value of the diversified, inline portfolio |
Advance further data generation and the pipeline |
Complete separation of Specialty Generics and Amitiza |
Execute disciplined capital allocation, with net debt reduction primary focus |
• | H.P. Acthar® Gel (repository corticotropin injection) net sales were $283.0 million, a 4.1% decrease from $295.2 million, as the brand continues to recover from patient withdrawal issues from 2017 while navigating growing payer scrutiny on overall specialty pharmaceutical spending. |
• | INOMAX® (nitric oxide) gas, for inhalation, generated net sales of $138.7 million, up 10.4%, or 10.5% on a constant-currency basis, over $125.6 million, due to continued consistent demand. |
• | OFIRMEV® (acetaminophen) injection net sales were $87.2 million compared with $78.0 million, an increase of 11.8%, benefiting from continued strong commercial execution and demand. |
• | Therakos® immunology platform net sales were $57.0 million compared with $57.2 million, a decrease of 0.3%, or an increase of 0.6% on a constant-currency basis; the results in the quarter were impacted by significant device sales in the prior year period due to the U.S. market conversion to the CELLEX® device. |
Metric (excluding foreign currency impact) | 2019 Guidance |
Total net sales for Specialty Brands segment | Increase 1% to 4% |
Total net sales for Specialty Generics and Amitiza segment | Increase 1% to 4% |
Net interest expense | $320 million to $350 million |
Adjusted effective tax rate | 14% to 16% |
Adjusted diluted EPS | $8.10 to $8.40 |
• | 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 5938419. |
• | Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Feb. 26, 2019, and ending at 11:59 p.m. Eastern Time on Tuesday, Mar. 12, 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 5938419. |
MALLINCKRODT PLC | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||||||
(unaudited, in millions, except per share data) | |||||||||||
Three Months Ended | |||||||||||
December 28, 2018 | Percent of Net sales | December 29, 2017 | Percent of Net sales | ||||||||
Net sales | $ | 834.9 | 100.0 | % | $ | 792.3 | 100.0 | % | |||
Cost of sales | 471.6 | 56.5 | 371.3 | 46.9 | |||||||
Gross profit | 363.3 | 43.5 | 421.0 | 53.1 | |||||||
Selling, general and administrative expenses | 239.6 | 28.7 | 174.6 | 22.0 | |||||||
Research and development expenses | 100.4 | 12.0 | 86.4 | 10.9 | |||||||
Restructuring charges, net | 1.2 | 0.1 | (0.9 | ) | (0.1 | ) | |||||
Non-restructuring impairment charges | 3,891.1 | 466.1 | 63.7 | 8.0 | |||||||
Losses (gains) on divestiture and license | 0.2 | — | (0.3 | ) | — | ||||||
Operating (loss) income | (3,869.2 | ) | (463.4 | ) | 97.5 | 12.3 | |||||
Interest expense | (90.1 | ) | (10.8 | ) | (90.1 | ) | (11.4 | ) | |||
Interest income | 1.6 | 0.2 | 1.8 | 0.2 | |||||||
Other income (expense), net | 13.1 | 1.6 | (0.6 | ) | (0.1 | ) | |||||
(Loss) income from continuing operations before income taxes | (3,944.6 | ) | (472.5 | ) | 8.6 | 1.1 | |||||
Income tax benefit | (226.2 | ) | (27.1 | ) | (1,598.8 | ) | (201.8 | ) | |||
(Loss) income from continuing operations | (3,718.4 | ) | (445.4 | ) | 1,607.4 | 202.9 | |||||
Income from discontinued operations, net of income taxes | — | — | 1.3 | 0.2 | |||||||
Net (loss) income | $ | (3,718.4 | ) | (445.4 | )% | $ | 1,608.7 | 203.0 | % | ||
Basic earnings per share: | |||||||||||
(Loss) income from continuing operations | $ | (44.64 | ) | $ | 17.43 | ||||||
Income from discontinued operations | — | 0.01 | |||||||||
Net (loss) income | (44.64 | ) | 17.45 | ||||||||
Diluted earnings per share: | |||||||||||
(Loss) income from continuing operations | $ | (44.64 | ) | $ | 17.40 | ||||||
Income from discontinued operations | — | 0.01 | |||||||||
Net (loss) income | (44.64 | ) | 17.41 | ||||||||
Weighted-average number of shares outstanding: | |||||||||||
Basic | 83.3 | 92.2 | |||||||||
Diluted | 83.3 | 92.4 | |||||||||
MALLINCKRODT PLC | |||||||||||||||||||||||||||
NON-GAAP MEASURES | |||||||||||||||||||||||||||
(unaudited, in millions except per share data) | |||||||||||||||||||||||||||
Three Months Ended | |||||||||||||||||||||||||||
December 28, 2018 | December 29, 2017 | ||||||||||||||||||||||||||
Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share(7) | Gross profit | SG&A | Net income | Diluted net income per share | ||||||||||||||||||||
GAAP | $ | 363.3 | $ | 239.6 | $ | (3,718.4 | ) | $ | (44.64 | ) | $ | 421.0 | $ | 174.6 | $ | 1,608.7 | $ | 17.41 | |||||||||
Adjustments: | |||||||||||||||||||||||||||
Intangible asset amortization | 192.0 | (1.7 | ) | 193.7 | 2.28 | 169.8 | (1.7 | ) | 171.5 | 1.86 | |||||||||||||||||
Restructuring and related charges, net (1) | — | (0.3 | ) | 1.5 | 0.02 | 0.5 | (1.1 | ) | 0.7 | 0.01 | |||||||||||||||||
Inventory step-up expense | 41.3 | — | 41.3 | 0.49 | 1.5 | — | 1.5 | 0.02 | |||||||||||||||||||
Income from discontinued operations | — | — | — | — | — | — | (1.3 | ) | (0.01 | ) | |||||||||||||||||
Change in contingent consideration fair value | — | 16.9 | (16.9 | ) | (0.20 | ) | — | 45.5 | (45.5 | ) | (0.49 | ) | |||||||||||||||
Acquisition related expenses | — | (2.0 | ) | 2.0 | 0.02 | — | (5.1 | ) | 5.1 | 0.06 | |||||||||||||||||
Non-restructuring impairment charges (2) | — | — | 3,891.1 | 45.83 | — | — | 63.7 | 0.69 | |||||||||||||||||||
Significant legal and environmental charges | — | (31.5 | ) | 31.5 | 0.37 | — | — | — | — | ||||||||||||||||||
Divestitures | — | — | 0.2 | — | — | — | — | — | |||||||||||||||||||
Separation costs | — | (6.0 | ) | 6.0 | 0.07 | ||||||||||||||||||||||
Gain on repurchase of debt | — | — | (6.2 | ) | (0.07 | ) | — | — | — | — | |||||||||||||||||
Reorganization of legal entity ownership (3) | — | — | (173.7 | ) | (2.05 | ) | — | — | (1,082.0 | ) | (11.71 | ) | |||||||||||||||
U.S. Tax Reform (4) | — | — | 0.6 | 0.01 | — | — | (457.4 | ) | (4.95 | ) | |||||||||||||||||
Income taxes (5) | — | — | (81.6 | ) | (0.96 | ) | — | — | (78.8 | ) | (0.85 | ) | |||||||||||||||
Depreciation catch up (6) | 11.4 | (2.8 | ) | 13.7 | 0.16 | — | — | — | — | ||||||||||||||||||
As adjusted | $ | 608.0 | $ | 212.2 | $ | 184.8 | $ | 2.18 | $ | 592.8 | $ | 212.2 | $ | 186.2 | $ | 2.01 | |||||||||||
Percent of net sales | 72.8 | % | 25.4 | % | 22.1 | % | 74.8 | % | 26.8 | % | 23.5 | % | |||||||||||||||
(1) | Includes pre-tax accelerated depreciation. |
(2) | Includes goodwill impairment of $3,672.8 million and an IPR&D intangible asset impairment of $218.3 million related to MNK-1411. |
(3) | Represents the incremental tax effect associated with the intercompany financing and associated legal entity ownership reorganization commenced during the three months ended September 28, 2018 and the legal entity reorganization commenced during the three months ended September 29, 2017. Of the total adjustment during the three months ended December 29, 2017, $8.9 million represents a one-time charge to interest expense related to the reduction in the Company's interest-bearing deferred tax liabilities. |
(4) | Represents the incremental tax expense associated with the impact of the U.S. tax reform bill being signed into law. Of the total adjustment during the three months ended December 29, 2017, $0.5 million represents a one-time reduction to interest expense related to the reduction in the Company's interest-bearing deferred tax liabilities. |
(5) | Includes tax effects of above adjustments (unless otherwise separately stated), as well as certain installment sale transactions and other intercompany transactions. |
(6) | 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 accounting principles generally accepted in the U.S. ("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 income from continuing operations during the fourth quarter of 2018, the period in which the held-for-sale criteria was no longer met. |
(7) | 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 84.9 shares. |
MALLINCKRODT PLC | ||||||||||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Three Months Ended | ||||||||||||||||
December 28, 2018 | December 29, 2017 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | $ | 586.5 | $ | 591.7 | (0.9 | )% | (0.2 | )% | (0.7 | )% | ||||||
Specialty Generics and Amitiza (1) | 248.4 | 200.6 | 23.8 | (0.1 | ) | 23.9 | ||||||||||
Net sales | $ | 834.9 | $ | 792.3 | 5.4 | (0.2 | ) | 5.6 | ||||||||
(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 | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Three Months Ended | ||||||||||||||||
December 28, 2018 | December 29, 2017 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | ||||||||||||||||
H.P. Acthar Gel | $ | 283.0 | $ | 295.2 | (4.1 | )% | — | % | (4.1 | )% | ||||||
Inomax | 138.7 | 125.6 | 10.4 | % | (0.1 | ) | 10.5 | % | ||||||||
Ofirmev | 87.2 | 78.0 | 11.8 | % | — | 11.8 | % | |||||||||
Therakos | 57.0 | 57.2 | (0.3 | )% | (0.9 | ) | 0.6 | % | ||||||||
BioVectra | 17.4 | 18.3 | (4.9 | )% | (4.1 | ) | (0.8 | )% | ||||||||
Other | 3.2 | 17.4 | (81.6 | )% | (0.3 | ) | (81.3 | )% | ||||||||
Specialty Brands Total | $ | 586.5 | $ | 591.7 | (0.9 | )% | (0.2 | )% | (0.7 | )% | ||||||
Specialty Generics and Amitiza | ||||||||||||||||
Hydrocodone (API) and hydrocodone-containing tablets | $ | 19.6 | $ | 22.0 | (10.9 | )% | — | % | (10.9 | )% | ||||||
Oxycodone (API) and oxycodone-containing tablets (1) | 22.8 | 20.4 | 11.8 | — | 11.8 | |||||||||||
Acetaminophen (API) (1) | 43.7 | 42.7 | 2.3 | — | 2.3 | |||||||||||
Amitiza | 64.6 | — | — | — | — | |||||||||||
Other controlled substances (1) | 85.8 | 94.3 | (9.0 | ) | (0.2 | ) | (8.8 | ) | ||||||||
Other (1) | 11.9 | 21.2 | (43.9 | ) | — | (43.9 | ) | |||||||||
Specialty Generics and Amitiza Total | $ | 248.4 | $ | 200.6 | 23.8 | % | (0.1 | )% | 23.9 | % |
(1) | Prior period amounts have been reclassified to conform to current period presentation. |
MALLINCKRODT PLC | |||
SEGMENT DATA | |||
Three Months Ended December 28, 2018 | |||
(unaudited, in millions) | |||
Net sales: | |||
Specialty Brands | $ | 586.5 | |
Specialty Generics and Amitiza | 248.4 | ||
Net sales | $ | 834.9 | |
Operating income (loss): | |||
Specialty Brands | $ | 290.2 | |
Specialty Generics and Amitiza (1) | 3.1 | ||
Segment operating income | 293.3 | ||
Unallocated amounts: | |||
Corporate and allocated expenses (2) | (70.1 | ) | |
Intangible asset amortization | (193.7 | ) | |
Restructuring and related charges, net (3) | (1.6 | ) | |
Non-restructuring impairments | (3,891.1 | ) | |
Separation costs (4) | (6.0 | ) | |
Operating loss | $ | (3,869.2 | ) |
(1) | 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 and Amitiza segment operating income during the fourth quarter of 2018, the period in which the held-for-sale criteria were no longer met. Additionally includes $41.3 million of inventory fair-value step up expense, primarily related to Amitiza. |
(2) | Includes administration expenses and certain compensation, environmental and other costs not charged to the Company's operating segments. |
(3) | Includes restructuring-related accelerated depreciation. |
(4) | Represents costs incurred related to the separation of the Company’s Specialty Generics and Amitiza segment, which are included in selling, general and administrative expenses. |
MALLINCKRODT PLC | |||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||||||
(unaudited, in millions, except per share data) | |||||||||||
Fiscal Year Ended | |||||||||||
December 28, 2018 | Percent of Net sales | December 29, 2017 | Percent of Net sales | ||||||||
Net sales | $ | 3,215.6 | 100.0 | % | $ | 3,221.6 | 100.0 | % | |||
Cost of sales | 1,744.4 | 54.2 | 1,564.1 | 48.6 | |||||||
Gross profit | 1,471.2 | 45.8 | 1,657.5 | 51.4 | |||||||
Selling, general and administrative expenses | 834.1 | 25.9 | 849.7 | 26.4 | |||||||
Research and development expenses | 361.1 | 11.2 | 276.9 | 8.6 | |||||||
Restructuring charges, net | 103.0 | 3.2 | 31.2 | 1.0 | |||||||
Non-restructuring impairment charges | 3,893.1 | 121.1 | 63.7 | 2.0 | |||||||
Losses (gains) on divestiture | 0.8 | — | (56.9 | ) | (1.8 | ) | |||||
Operating (loss) income | (3,720.9 | ) | (115.7 | ) | 492.9 | 15.3 | |||||
Interest expense | (370.2 | ) | (11.5 | ) | (369.1 | ) | (11.5 | ) | |||
Interest income | 8.2 | 0.3 | 4.6 | 0.1 | |||||||
Other income (expense), net | 30.9 | 1.0 | (66.8 | ) | (2.1 | ) | |||||
(Loss) income from continuing operations before income taxes | (4,052.0 | ) | (126.0 | ) | 61.6 | 1.9 | |||||
Income tax benefit | (430.1 | ) | (13.4 | ) | (1,709.6 | ) | (53.1 | ) | |||
(Loss) income from continuing operations | (3,621.9 | ) | (112.6 | ) | 1,771.2 | 55.0 | |||||
Income from discontinued operations, net of income taxes | 14.9 | 0.5 | 363.2 | 11.3 | |||||||
Net (loss) income | $ | (3,607.0 | ) | (112.2 | )% | $ | 2,134.4 | 66.3 | % | ||
Basic earnings per share: | |||||||||||
(Loss) income from continuing operations | $ | (43.12 | ) | $ | 18.13 | ||||||
Income from discontinued operations | 0.18 | 3.72 | |||||||||
Net (loss) income | (42.94 | ) | 21.85 | ||||||||
Diluted earnings per share: | |||||||||||
(Loss) income from continuing operations | $ | (43.12 | ) | $ | 18.09 | ||||||
Income from discontinued operations | 0.18 | 3.71 | |||||||||
Net (loss) income | (42.94 | ) | 21.80 | ||||||||
Weighted-average number of shares outstanding: | |||||||||||
Basic | 84.0 | 97.7 | |||||||||
Diluted | 84.0 | 97.9 | |||||||||
MALLINCKRODT PLC | |||||||||||||||||||||||||||
NON-GAAP MEASURES | |||||||||||||||||||||||||||
(unaudited, in millions except per share data) | |||||||||||||||||||||||||||
Fiscal Year Ended | |||||||||||||||||||||||||||
December 28, 2018 | December 29, 2017 | ||||||||||||||||||||||||||
Gross profit | SG&A | Net (loss) income | Diluted net (loss) income per share (6) | Gross profit | SG&A | Net income | Diluted net income per share | ||||||||||||||||||||
GAAP | $ | 1,471.2 | $ | 834.1 | $ | (3,607.0 | ) | $ | (42.94 | ) | $ | 1,657.5 | $ | 849.7 | $ | 2,134.4 | $ | 21.80 | |||||||||
Adjustments: | |||||||||||||||||||||||||||
Intangible asset amortization | 733.6 | (6.6 | ) | 740.2 | 8.69 | 685.8 | (8.7 | ) | 694.5 | 7.09 | |||||||||||||||||
Restructuring and related charges, net (1) | 3.0 | (2.2 | ) | 108.2 | 1.27 | 2.1 | (3.2 | ) | 36.4 | 0.37 | |||||||||||||||||
Inventory step-up expense | 120.8 | — | 120.8 | 1.42 | 10.1 | — | 10.1 | 0.10 | |||||||||||||||||||
Income from discontinued operations | — | — | (14.9 | ) | (0.17 | ) | — | — | (363.2 | ) | (3.71 | ) | |||||||||||||||
Change in contingent consideration fair value | — | 50.2 | (50.2 | ) | (0.59 | ) | — | 41.4 | (41.4 | ) | (0.42 | ) | |||||||||||||||
Acquisition related expenses | — | (5.8 | ) | 5.8 | 0.07 | — | (7.4 | ) | 7.4 | 0.08 | |||||||||||||||||
Non-restructuring impairment charges (2) | — | — | 3,893.1 | 45.69 | — | — | 63.7 | 0.65 | |||||||||||||||||||
Significant legal and environmental charges | — | (19.7 | ) | 19.7 | 0.23 | — | — | — | — | ||||||||||||||||||
Debt refinancing | — | — | — | — | — | — | 10.0 | 0.10 | |||||||||||||||||||
Pension settlement charges | — | — | — | — | — | — | 69.2 | 0.71 | |||||||||||||||||||
Divestitures | — | — | 0.8 | 0.01 | — | — | (56.6 | ) | (0.58 | ) | |||||||||||||||||
Separation costs | — | (6.0 | ) | 6.0 | 0.07 | — | — | — | — | ||||||||||||||||||
Gain on repurchase of debt | — | — | (12.7 | ) | (0.15 | ) | — | — | — | — | |||||||||||||||||
Reorganization of legal entity ownership (3) | — | — | (256.0 | ) | (3.00 | ) | — | — | (1,045.9 | ) | (10.68 | ) | |||||||||||||||
U.S. Tax Reform (4) | — | — | (8.5 | ) | (0.10 | ) | — | — | (457.4 | ) | (4.67 | ) | |||||||||||||||
Income taxes (5) | — | — | (263.1 | ) | (3.09 | ) | — | — | (327.8 | ) | (3.35 | ) | |||||||||||||||
As adjusted | $ | 2,328.6 | $ | 844.0 | $ | 682.2 | $ | 8.01 | $ | 2,355.5 | $ | 871.8 | $ | 733.4 | $ | 7.49 | |||||||||||
Percent of net sales | 72.4 | % | 26.2 | % | 21.2 | % | 73.1 | % | 27.1 | % | 22.8 | % | |||||||||||||||
(1) | Includes pre-tax accelerated depreciation. |
(2) | Includes goodwill impairment of $3,672.8 million and an IPR&D intangible asset impairment of $218.3 million related to MNK-1411. |
(3) | Represents the incremental tax effect associated with the intercompany financing and associated legal entity ownership reorganization commenced during the three months ended September 28, 2018 and the legal entity reorganization commenced during the three months ended September 29, 2017. Of the total adjustment during the fiscal year ended December 29, 2017, $8.9 million represents a one-time charge to interest expense related to the reduction in the Company's interest-bearing deferred tax liabilities. |
(4) | Represents the incremental tax expense associated with the impact of the U.S. tax reform bill being signed into law. Of the total adjustment during the fiscal year ended December 29, 2017, $0.5 million represents a one-time reduction to interest expense related to the reduction in the Company's interest-bearing deferred tax liabilities. |
(5) | Includes tax effects of above adjustments (unless otherwise separately stated), as well as certain installment sale transactions and other intercompany transactions. |
(6) | 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 85.2 shares. |
MALLINCKRODT PLC | ||||||||||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Fiscal Year Ended | ||||||||||||||||
December 28, 2018 | December 29, 2017 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | $ | 2,306.2 | $ | 2,352.0 | (1.9 | )% | 0.1 | % | (2.0 | )% | ||||||
Specialty Generics and Amitiza | 909.4 | 869.6 | 4.6 | — | 4.6 | |||||||||||
Net sales | $ | 3,215.6 | $ | 3,221.6 | (0.2 | ) | 0.1 | (0.3 | ) | |||||||
(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 | ||||||||||||||||
(unaudited, in millions) | ||||||||||||||||
Fiscal Year Ended | ||||||||||||||||
December 28, 2018 | December 29, 2017 | Percent change | Currency impact | Constant-currency growth | ||||||||||||
Specialty Brands | ||||||||||||||||
H.P. Acthar Gel | $ | 1,110.1 | $ | 1,195.1 | (7.1 | )% | — | % | (7.1 | )% | ||||||
Inomax | 542.7 | 505.2 | 7.4 | — | 7.4 | |||||||||||
Ofirmev | 341.9 | 302.5 | 13.0 | — | 13.0 | |||||||||||
Therakos | 231.2 | 214.9 | 7.6 | 1.3 | 6.3 | |||||||||||
BioVectra | 53.1 | 54.7 | (2.9 | ) | (1.1 | ) | (1.8 | ) | ||||||||
Other | 27.2 | 79.6 | (65.8 | ) | 0.4 | (66.2 | ) | |||||||||
Specialty Brands Total | $ | 2,306.2 | $ | 2,352.0 | (1.9 | )% | 0.1 | % | (2.0 | )% | ||||||
Specialty Generics and Amitiza | ||||||||||||||||
Hydrocodone (API) and hydrocodone-containing tablets | $ | 65.9 | $ | 85.3 | (22.7 | )% | — | % | (22.7 | )% | ||||||
Oxycodone (API) and oxycodone-containing tablets (1) | 66.1 | 88.0 | (24.9 | ) | — | (24.9 | ) | |||||||||
Acetaminophen (API) (1) | 192.7 | 185.5 | 3.9 | — | 3.9 | |||||||||||
Amitiza | 183.8 | — | — | — | — | |||||||||||
Other controlled substances (1) | 343.8 | 412.0 | (16.6 | ) | — | (16.6 | ) | |||||||||
Other (1) | 57.1 | 98.8 | (42.2 | ) | — | (42.2 | ) | |||||||||
Specialty Generics and Amitiza Total | $ | 909.4 | $ | 869.6 | 4.6 | % | — | % | 4.6 | % |
(1) | Prior period amounts have been reclassified to conform to current period presentation. |
MALLINCKRODT PLC | |||
SEGMENT DATA | |||
Fiscal Year Ended December 28, 2018 | |||
(unaudited, in millions) | |||
Net sales: | |||
Specialty Brands | $ | 2,306.2 | |
Specialty Generics and Amitiza | 909.4 | ||
Net sales | $ | 3,215.6 | |
Operating income (loss): | |||
Specialty Brands | $ | 1,077.4 | |
Specialty Generics and Amitiza (1) | 105.0 | ||
Segment operating income | 1,182.4 | ||
Unallocated amounts: | |||
Corporate and allocated expenses (2) | (155.8 | ) | |
Intangible asset amortization | (740.2 | ) | |
Restructuring and related charges, net (3) | (108.2 | ) | |
Non-restructuring impairments | (3,893.1 | ) | |
Separation costs (4) | (6.0 | ) | |
Operating loss | $ | (3,720.9 | ) |
(1) | Includes $118.8 million of inventory fair-value step up expense, primarily related to Amitiza. |
(2) | Includes administration expenses and certain compensation, environmental and other costs not charged to the Company's operating segments. |
(3) | Includes restructuring-related accelerated depreciation. |
(4) | Represents costs incurred related to the separation of the Company’s Specialty Generics and Amitiza segment, which are included in selling, general and administrative expenses. |
MALLINCKRODT PLC | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(unaudited, in millions) | |||||||
December 28, 2018 | December 29, 2017 | ||||||
Assets | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 348.9 | $ | 1,260.9 | |||
Accounts receivable, net | 623.3 | 445.8 | |||||
Inventories | 322.3 | 340.4 | |||||
Prepaid expenses and other current assets | 132.7 | 84.1 | |||||
Notes receivable | — | 154.0 | |||||
Total current assets | 1,427.2 | 2,285.2 | |||||
Property, plant and equipment, net | 982.0 | 966.8 | |||||
Goodwill | — | 3,482.7 | |||||
Intangible assets, net | 8,282.8 | 8,375.0 | |||||
Other assets | 185.3 | 171.2 | |||||
Total Assets | $ | 10,877.3 | $ | 15,280.9 | |||
Liabilities and Shareholders' Equity | |||||||
Current Liabilities: | |||||||
Current maturities of long-term debt | $ | 22.4 | $ | 313.7 | |||
Accounts payable | 147.5 | 113.3 | |||||
Accrued payroll and payroll-related costs | 124.0 | 98.5 | |||||
Accrued interest | 77.6 | 57.0 | |||||
Income taxes payable | 25.0 | 15.8 | |||||
Accrued and other current liabilities | 547.2 | 452.1 | |||||
Total current liabilities | 943.7 | 1,050.4 | |||||
Long-term debt | 6,069.2 | 6,420.9 | |||||
Pension and postretirement benefits | 60.5 | 67.1 | |||||
Environmental liabilities | 59.7 | 73.2 | |||||
Deferred income taxes | 324.3 | 689.0 | |||||
Other income tax liabilities | 228.0 | 94.1 | |||||
Other liabilities | 304.6 | 364.2 | |||||
Total Liabilities | 7,990.0 | 8,758.9 | |||||
Shareholders' Equity: | |||||||
Preferred shares | — | — | |||||
Ordinary shares | 18.5 | 18.4 | |||||
Ordinary shares held in treasury at cost | (1,617.4 | ) | (1,564.7 | ) | |||
Additional paid-in capital | 5,528.2 | 5,492.6 | |||||
Retained (deficit) earnings | (1,017.7 | ) | 2,588.6 | ||||
Accumulated other comprehensive loss | (24.3 | ) | (12.9 | ) | |||
Total Shareholders' Equity | 2,887.3 | 6,522.0 | |||||
Total Liabilities and Shareholders' Equity | $ | 10,877.3 | $ | 15,280.9 |
MALLINCKRODT PLC | |||||||
CONDENSED CONSOLIDATED AND COMBINED STATEMENTS OF CASH FLOWS | |||||||
(unaudited, in millions) | |||||||
Fiscal Year Ended | |||||||
December 28, 2018 | December 29, 2017 | ||||||
Cash Flows From Operating Activities: | |||||||
Net (loss) income | $ | (3,607.0 | ) | $ | 2,134.4 | ||
Adjustments to reconcile net cash from operating activities: | |||||||
Depreciation and amortization | 852.1 | 808.3 | |||||
Share-based compensation | 34.6 | 59.2 | |||||
Deferred income taxes | (541.5 | ) | (1,744.1 | ) | |||
Non-cash impairment charges | 3,893.1 | 63.7 | |||||
Inventory provisions | 37.9 | 34.1 | |||||
Loss (gain) on divestiture | 0.8 | (418.1 | ) | ||||
Other non-cash items | (50.9 | ) | (21.4 | ) | |||
Changes in assets and liabilities, net of the effects of acquisitions: | |||||||
Accounts receivable, net | (145.8 | ) | (16.2 | ) | |||
Inventories | 63.1 | (23.6 | ) | ||||
Accounts payable | 24.6 | (25.8 | ) | ||||
Income taxes | 99.0 | (34.2 | ) | ||||
Other | 5.5 | (89.0 | ) | ||||
Net cash from operating activities | 665.5 | 727.3 | |||||
Cash Flows From Investing Activities: | |||||||
Capital expenditures | (127.0 | ) | (186.1 | ) | |||
Acquisitions, net of cash acquired | (699.9 | ) | (76.3 | ) | |||
Proceeds from divestiture, net of cash | 313.0 | 576.9 | |||||
Other | 33.6 | 3.9 | |||||
Net cash from investing activities | (480.3 | ) | 318.4 | ||||
Cash Flows From Financing Activities: | |||||||
Issuance of external debt | 690.3 | 1,465.0 | |||||
Repayment of external debt and capital lease obligation | (1,693.6 | ) | (917.2 | ) | |||
Debt financing costs | (12.1 | ) | (12.7 | ) | |||
Proceeds from exercise of share options | 1.0 | 4.1 | |||||
Repurchase of shares | (57.5 | ) | (651.7 | ) | |||
Other | (23.1 | ) | (17.7 | ) | |||
Net cash from financing activities | (1,095.0 | ) | (130.2 | ) | |||
Effect of currency rate changes on cash | (1.8 | ) | 2.5 | ||||
Net change in cash, cash equivalents and restricted cash | (911.6 | ) | 918.0 | ||||
Cash, cash equivalents and restricted cash at beginning of period | 1,279.1 | 361.1 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 367.5 | $ | 1,279.1 | |||
Cash and cash equivalents at end of period | $ | 348.9 | $ | 1,260.9 | |||
Restricted cash included in prepaid expenses and other assets at end of period | — | — | |||||
Restricted cash included in other long-term assets at end of period | 18.6 | 18.2 | |||||
Cash, cash equivalents and restricted cash at end of period | $ | 367.5 | $ | 1,279.1 |