Mallinckrodt plc (in Examinership) Reports Third Quarter 2023 Financial Results
- None.
- None.
Third Quarter Net Sales of
Acthar® Gel (Repository Corticotropin Injection) Delivery Device Supplemental New Drug Application Accepted by
Financial Restructuring Plan Approved by
"Mallinckrodt's results underscore our relentless focus on stabilizing the business. While net loss increased, largely due to reorganization impacts, we achieved year-over-year revenue growth for the second consecutive quarter and year-over-year adjusted EBITDA growth. As a result of our continued commitment to executing on our strategic priorities and solid performance, we now expect to land near the top end of our prior full-year guidance ranges for both net sales and Adjusted EBITDA," said Siggi Olafsson, President and Chief Executive Officer. "Our Specialty Generics business continued to deliver strong growth, reflecting the core strength of our vertically integrated business. With three FDA abbreviated new drug application approvals this quarter, including lisdexamfetamine dimesylate capsules (generic form of Vyvanse®), we are proud of the role Mallinckrodt plays in addressing market supply shortages and delivering high-quality medicines that patients need. In Specialty Brands, we achieved a key regulatory milestone with FDA acceptance of our Acthar® Gel (repository corticotropin injection) delivery device Supplemental New Drug Application (sNDA) submission. Our launch and adoption of Terlivaz® (terlipressin) reflected further positive momentum in the medical community. While we continue to face headwinds from significant competitive pressures, our performance this quarter is another clear indicator of the tangible progress we have made."
Mr. Olafsson continued, "The Chapter 11 proceedings we initiated in August will meaningfully enhance our financial foundation and better position the business for the future, and we are pleased the process is moving on an expedited basis, as anticipated. Our financial restructuring plan was approved by the
Third Quarter 2023 Financial Results
Mallinckrodt's net sales in the third quarter of 2023 were
The Company's Specialty Brands segment reported net sales of
Mallinckrodt's Specialty Generics segment reported net sales of
The Company recorded a net loss for the third quarter of
Mallinckrodt's Adjusted EBITDA in the third quarter was
The Company incurred approximately
Adjusted gross profit as a percentage of sales was
Nine-Month 2023 Results1
Mallinckrodt's net sales were
The Company recorded a net loss of
Mallinckrodt's Adjusted EBITDA was
_________________________________ |
1 As a result of emerging from the prior Chapter 11 cases in June 2022, the Company's nine-month comparison period ended September 30, 2022, includes a predecessor period from January 1, 2022 to June 16, 2022, and a successor period from June 17, 2022 to September 30, 2022. Unless otherwise noted, the nine-month comparisons are the predecessor and successor periods combined. |
Third Quarter 2023 Business Segment Update
Specialty Brands Segment
Acthar Gel net sales declined
Terlivaz's launch continued to exceed initial expectations and track ahead of the product's anticipated launch curve. The Company has gained formulary inclusion for Terlivaz at more than 200 hospitals and is pleased with the utilization seen to date. Mallinckrodt's success with this launch further demonstrates the strength of its engagements with hospitals and the broader medical community.
INOmax® (nitric oxide) gas sales grew outside of the
Therakos® sales grew year over year, driven by strength in the
Specialty Generics Segment
Mallinckrodt's Specialty Generics segment experienced another quarter of strong growth, underscoring the benefits of vertical integration as the high performance of the Company's
The Company received FDA approvals for three products in the Specialty Generics segment during the quarter and successfully launched one, lisdexamfetamine dimesylate capsules. Mallinckrodt expects to launch the other two in the fourth quarter.
Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the third quarter.
Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended September 29, 2023 to be filed with the Securities and Exchange Commission for additional information concerning the Company's Chapter 11 proceedings, liquidity and related risks.
2023 Financial Guidance Update
For the full-year 2023, Mallinckrodt expects to be near the top end of the guidance ranges for both net sales and Adjusted EBITDA, even while assuming approximately
2023 Guidance | |
Net sales | |
Adjusted EBITDA |
The Company does not provide a reconciliation of forward-looking non-GAAP guidance to the comparable GAAP measures as these items are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort.
About Mallinckrodt
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the
NON-GAAP FINANCIAL MEASURES
This press release contains financial measures, including adjusted EBITDA, adjusted gross profit, adjusted SG&A expenses, adjusted R&D expenses, and net sales growth (loss) on a constant-currency basis, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations.
Adjusted EBITDA represents net income or loss prepared in accordance with accounting principles generally accepted in the
Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, adjusted for certain items that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include, as applicable to each measure, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses.
Segment net sales growth (loss) 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 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.
These adjusted measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The Company's definition of these adjusted measures may differ from similarly titled measures used by others.
Because adjusted financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's unaudited condensed consolidated financial statements and publicly filed reports in their entirety. A reconciliation of certain of these historical adjusted financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.
Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the Company's website.
Predecessor and Successor Periods
Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The Successor period runs from June 17, 2022 through September 29, 2023, while the Predecessor period includes June 16, 2022 and prior. As a result of the application of fresh-start accounting, the Company's financial statements for periods prior to June 16, 2022 are not comparable to those for periods subsequent to June 16, 2022. Operating results for the Successor and Predecessor periods are not necessarily indicative of the results to be expected for a full fiscal year.
Mallinckrodt's results of operations as reported in its unaudited condensed consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented here is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
Statements in this document that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments Mallinckrodt believes or anticipates will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the ability of Mallinckrodt and its subsidiaries to obtain approval from the
The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 30, 2022 and Quarterly Reports on Form 10-Q for the quarterly periods ended September 29, 2023, June 30, 2023 and March 31, 2023, and other filings with the SEC, all of which are on file with the SEC and available on Mallinckrodt's website at http://www.sec.gov and http://www.mallinckrodt.com respectively, identify and describe in more detail the risks and uncertainties to which Mallinckrodt's businesses are subject. There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. Given these uncertainties, one should not put undue reliance on any forward-looking statements.
CONTACTS
Investor Relations
Daniel Speciale
Senior Vice President, Finance
314-654-3638
daniel.speciale@mnk.com
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Media
Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2023.
Exhibit 99.1
MALLINCKRODT PLC | |||||
(DEBTOR-IN-POSSESSION) | |||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | |||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
(unaudited, in millions, except per share data) | |||||
Successor | |||||
Three Months | Three Months | ||||
Percent of Net sales | Percent of Net sales | ||||
Net sales | $ 497.0 | 100.0 % | $ 465.4 | 100.0 % | |
Cost of sales | 346.2 | 69.7 | 449.9 | 96.7 | |
Gross profit | 150.8 | 30.3 | 15.5 | 3.3 | |
Selling, general and administrative expenses | 129.2 | 26.0 | 122.3 | 26.3 | |
Research and development expenses | 25.7 | 5.2 | 28.3 | 6.1 | |
Restructuring charges, net | (0.1) | — | 2.2 | 0.5 | |
Non-restructuring impairment charges | 135.9 | 27.3 | — | — | |
Liabilities management and separation costs | 142.1 | 28.6 | 6.9 | 1.5 | |
Operating loss | (282.0) | (56.7) | (144.2) | (31.0) | |
Interest expense | (133.1) | (26.8) | (148.0) | (31.8) | |
Interest income | 3.4 | 0.7 | 1.3 | 0.3 | |
Other income (expense), net | 9.1 | 1.8 | (5.1) | (1.1) | |
Reorganization items, net | (1,311.5) | (263.9) | (14.2) | (3.1) | |
Loss from continuing operations before income taxes | (1,714.1) | (344.9) | (310.2) | (66.7) | |
Income tax expense (benefit) | 10.8 | 2.2 | (24.9) | (5.4) | |
Loss from continuing operations | (1,724.9) | (347.1) | (285.3) | (61.3) | |
Income from discontinued operations, net of income taxes | 0.1 | — | 0.4 | 0.1 | |
Net loss | $ (1,724.8) | (347.0) % | $ (284.9) | (61.2) % | |
Basic and diluted (loss) income per share: | |||||
Loss from continuing operations | $ (128.61) | $ (21.61) | |||
Income from discontinued operations | — | 0.03 | |||
Net loss | $ (128.60) | $ (21.58) | |||
Weighted-average number of shares outstanding | |||||
Basic and diluted | 13.4 | 13.2 |
MALLINCKRODT PLC | |||||||||
(DEBTOR-IN-POSSESSION) | |||||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | |||||||||
CONSOLIDATED ADJUSTED EBITDA | |||||||||
(unaudited, in millions) | |||||||||
Successor | |||||||||
Three Months | Three Months | ||||||||
Gross | SG&A | R&D | Adjusted | Gross | SG&A | R&D | Adjusted | ||
Net loss | $ 150.8 | $ 129.2 | $ 25.7 | $ (1,724.8) | $ 15.5 | $ 122.3 | $ 28.3 | $ (284.9) | |
Adjustments: | |||||||||
Interest expense, net | — | — | — | 129.7 | — | — | — | 146.7 | |
Income tax expense (benefit) | — | — | — | 10.8 | — | — | — | (24.9) | |
Depreciation | 9.3 | (1.6) | (0.5) | 11.4 | 9.2 | (2.1) | (0.6) | 11.9 | |
Amortization | 125.6 | — | — | 125.6 | 136.6 | — | — | 136.6 | |
Restructuring charges, net | — | — | — | (0.1) | — | — | — | 2.2 | |
Non-restructuring impairment charge | — | — | — | 135.9 | — | — | — | — | |
Income from discontinued operations | — | — | — | (0.1) | — | — | — | (0.4) | |
Change in contingent consideration fair value | — | 0.2 | — | (0.2) | — | 0.8 | — | (0.8) | |
Liabilities management and separation | — | — | — | 142.1 | — | — | — | 6.9 | |
Unrealized (gain) loss on equity investment | — | — | — | (7.2) | — | — | — | 5.1 | |
Reorganization items, net | — | — | — | 1,311.5 | — | — | — | 14.2 | |
Share-based compensation | — | (2.3) | (0.1) | 2.4 | — | (0.5) | — | 0.5 | |
Gain on debt extinguishment at par | — | — | — | — | — | — | — | (3.9) | |
Fresh-start impact on debt extinguishment | — | — | — | — | — | — | — | 4.1 | |
Bad debt expense - customer bankruptcy | — | — | — | — | — | (5.8) | — | 5.8 | |
Fresh-start inventory-related expense (2) | 43.6 | — | — | 43.6 | 147.0 | — | — | 147.0 | |
As adjusted: | $ 329.3 | $ 125.5 | $ 25.1 | $ 180.6 | $ 308.3 | $ 114.7 | $ 27.7 | $ 166.1 | |
(1) | Represents costs primarily related to professional fees incurred by the Company (including where the Company is responsible for the fees of third parties) in connection with its evaluation of its financial situation and related discussions with its stakeholders prior to the commencement of the 2023 Chapter 11 Cases, expenses incurred related to the severance of certain former executives of the Predecessor, in addition to professional fees and costs incurred as the Company explores potential sales of non-core assets to enable further deleveraging post-emergence from the 2020 Chapter 11 Cases. As of the 2023 Petition Date, professional fees directly related to the 2023 Chapter 11 proceedings that were previously reflected as liabilities management and separation costs are being classified on a go-forward basis as reorganization items, net. |
(2) | Represents |
MALLINCKRODT PLC | |||
(DEBTOR-IN-POSSESSION) | |||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | |||
SEGMENT OPERATING INCOME | |||
(unaudited, in millions) | |||
Successor | |||
Three Months | Three Months | ||
Specialty Brands (1) | $ 87.6 | $ 43.7 | |
Specialty Generics (2) | 64.0 | (9.0) | |
Segment operating income | 151.6 | 34.7 | |
Unallocated amounts: | |||
Corporate and unallocated expenses (3) | (16.3) | (15.0) | |
Depreciation and amortization | (137.0) | (148.5) | |
Share-based compensation | (2.4) | (0.5) | |
Restructuring charges, net | 0.1 | (2.2) | |
Non-restructuring impairment charge | (135.9) | — | |
Liabilities management and separation costs (4) | (142.1) | (6.9) | |
Bad debt expense - customer bankruptcy | — | (5.8) | |
Operating loss | $ (282.0) | $ (144.2) |
(1) | Includes |
(2) | Includes |
(3) | Includes administration expenses and certain compensation, legal, environmental and other costs not charged to the Company's reportable segments. |
(4) | Represents costs primarily related to professional fees incurred by the Company (including where the Company is responsible for the fees of third parties) in connection with its evaluation of its financial situation and related discussions with its stakeholders prior to the commencement of the 2023 Chapter 11 Cases, expenses incurred related to the severance of certain former executives of the Predecessor, in addition to professional fees and costs incurred as the Company explores potential sales of non-core assets to enable further deleveraging post-emergence from the 2020 Chapter 11 Cases. As of the 2023 Petition Date, professional fees directly related to the 2023 Chapter 11 proceedings that were previously reflected as liabilities management and separation costs are being classified on a go-forward basis as reorganization items, net. |
MALLINCKRODT PLC | |||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH | |||||||||
(unaudited, in millions) | |||||||||
Successor | Non-GAAP Measure | ||||||||
Three Months | Three Months | Percent | Currency | Constant- | |||||
Specialty Brands | $ 286.2 | $ 303.5 | (5.7) % | 0.3 % | (6.0) % | ||||
Specialty Generics | 210.8 | 161.9 | 30.2 | — | 30.2 | ||||
Net sales | $ 497.0 | $ 465.4 | 6.8 % | 0.2 % | 6.6 % |
MALLINCKRODT PLC | |||||||||
SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH | |||||||||
(unaudited, in millions) | |||||||||
Successor | Non-GAAP Measure | ||||||||
Three Months | Three Months | Percent | Currency | Constant- | |||||
Specialty Brands | |||||||||
Acthar Gel | $ 122.1 | $ 125.7 | (2.9) % | — % | (2.9) % | ||||
INOmax | 72.9 | 80.7 | (9.7) | (0.1) | (9.6) | ||||
Therakos | 66.0 | 58.0 | 13.8 | 2.2 | 11.6 | ||||
Amitiza | 18.3 | 37.1 | (50.7) | (0.2) | (50.5) | ||||
Terlivaz | 4.4 | — | — | — | — | ||||
Other | 2.5 | 2.0 | 25.0 | (2.9) | 27.9 | ||||
Specialty Brands Total | 286.2 | 303.5 | (5.7) | 0.3 | (6.0) | ||||
Specialty Generics | |||||||||
Opioids | 65.9 | 46.5 | 41.7 | — | 41.7 | ||||
ADHD | 41.5 | 11.6 | 257.8 | — | 257.8 | ||||
Addiction treatment | 15.1 | 16.6 | (9.0) | (0.2) | (8.8) | ||||
Other | 3.4 | 2.9 | 17.2 | — | 17.2 | ||||
Generics | 125.9 | 77.6 | 62.2 | — | 62.2 | ||||
Controlled substances | 22.0 | 19.7 | 11.7 | — | 11.7 | ||||
APAP | 57.4 | 57.9 | (0.9) | — | (0.9) | ||||
Other | 5.5 | 6.7 | (17.9) | — | (17.9) | ||||
API | 84.9 | 84.3 | 0.7 | — | 0.7 | ||||
Specialty Generics | 210.8 | 161.9 | 30.2 | — | 30.2 | ||||
Net sales | $ 497.0 | $ 465.4 | 6.8 % | 0.2 % | 6.6 % |
MALLINCKRODT PLC | |||||||||
(DEBTOR-IN-POSSESSION) | |||||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | |||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
(unaudited, in millions, except per share data) | |||||||||
Successor | Predecessor | ||||||||
Nine Months | Period from June 17, 2022 through September 30, 2022 | Period from January 1, 2022 through June 16, 2022 | |||||||
Percent of Net sales | Percent of Net sales | Percent of Net sales | |||||||
Net sales | $ 1,396.6 | 100.0 % | $ 550.4 | 100.0 % | $ 874.6 | 100.0 % | |||
Cost of sales | 1,091.1 | 78.1 | 552.1 | 100.3 | 582.0 | 66.5 | |||
Gross profit (loss) | 305.5 | 21.9 | (1.7) | (0.3) | 292.6 | 33.5 | |||
Selling, general and administrative expenses | 369.6 | 26.5 | 143.4 | 26.1 | 266.3 | 30.4 | |||
Research and development expenses | 83.0 | 5.9 | 34.5 | 6.3 | 65.5 | 7.5 | |||
Restructuring charges, net | 0.9 | 0.1 | 3.3 | 0.6 | 9.6 | 1.1 | |||
Non-restructuring impairment charges | 135.9 | 9.7 | — | — | — | — | |||
Liabilities management and separation costs | 157.3 | 11.3 | 16.1 | 2.9 | 9.0 | 1.0 | |||
Operating loss | (441.2) | (31.6) | (199.0) | (36.2) | (57.8) | (6.6) | |||
Interest expense | (457.7) | (32.8) | (169.1) | (30.7) | (108.6) | (12.4) | |||
Interest income | 12.8 | 0.9 | 1.4 | 0.3 | 0.6 | 0.1 | |||
Other (expense) income, net | (6.7) | (0.5) | 0.8 | 0.1 | (14.6) | (1.7) | |||
Reorganization items, net | (1,321.1) | (94.6) | (17.7) | (3.2) | (630.9) | (72.1) | |||
Loss from continuing operations before income taxes | (2,213.9) | (158.5) | (383.6) | (69.7) | (811.3) | (92.8) | |||
Income tax expense (benefit) | 508.1 | 36.4 | (34.6) | (6.3) | (497.3) | (56.9) | |||
Loss from continuing operations | (2,722.0) | (194.9) | (349.0) | (63.4) | (314.0) | (35.9) | |||
Income from discontinued operations, net of income taxes | 0.1 | — | 0.4 | 0.1 | 0.9 | 0.1 | |||
Net loss | $ (2,721.9) | (194.9) % | $ (348.6) | (63.3) % | $ (313.1) | (35.8) % | |||
Basic and diluted (loss) income per share: | |||||||||
Loss from continuing operations | $ (205.37) | $ (26.44) | $ (3.70) | ||||||
Income from discontinued operations | 0.01 | 0.03 | 0.01 | ||||||
Net loss | $ (205.37) | $ (26.41) | $ (3.69) | ||||||
Weighted-average number of shares outstanding: | |||||||||
Basic and diluted | 13.3 | 13.2 | 84.8 |
MALLINCKRODT PLC | ||||||
(DEBTOR-IN-POSSESSION) | ||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | ||||||
CONSOLIDATED ADJUSTED EBITDA | ||||||
(unaudited, in millions) | ||||||
Successor | Non-GAAP | |||||
Nine Months | Nine Months | |||||
Gross | SG&A | R&D | Adjusted | Adjusted | ||
Net loss | $ 305.5 | $ 369.6 | $ 83.0 | $ (2,721.9) | $ (661.7) | |
Adjustments: | ||||||
Interest expense, net | — | — | — | 444.9 | 275.7 | |
Income tax expense (benefit) | — | — | — | 508.1 | (531.9) | |
Depreciation | 27.9 | (5.7) | (1.5) | 35.1 | 54.8 | |
Amortization | 388.1 | — | — | 388.1 | 463.9 | |
Restructuring charges, net | — | — | — | 0.9 | 12.9 | |
Non-restructuring impairment charges | — | — | — | 135.9 | — | |
Income from discontinued operations | — | — | — | (0.1) | (1.3) | |
Change in contingent consideration fair value | — | 7.3 | — | (7.3) | (0.8) | |
Significant legal and environmental charges | — | — | — | — | 11.1 | |
Liabilities management and separation costs (1) | — | — | — | 157.3 | 25.1 | |
Unrealized loss on equity investment | — | — | — | 9.1 | 21.3 | |
Reorganization items, net | — | — | — | 1,321.1 | 648.6 | |
Share-based compensation | — | (7.4) | (0.3) | 7.7 | 2.2 | |
Gain on debt extinguishment at par | — | — | — | — | (3.9) | |
Fresh-start impact on debt extinguishment | — | — | — | — | 4.1 | |
Bad debt expense - customer bankruptcy | — | — | — | — | 5.8 | |
Fresh-start inventory-related expense (2) | 169.2 | — | — | 169.2 | 173.5 | |
As adjusted: | $ 890.7 | $ 363.8 | $ 81.2 | $ 448.1 | $ 499.4 | |
(1) | Represents costs primarily related to professional fees incurred by the Company (including where the Company is responsible for the fees of third parties) in connection with its evaluation of its financial situation and related discussions with its stakeholders prior to the commencement of the 2023 Chapter 11 Cases, expenses incurred related to the Predecessor directors' and officers' insurance policies and severance for the former CEO and certain former executives of the Predecessor, in addition to professional fees and costs incurred as the Company explores potential sales of non-core assets to enable further deleveraging post-emergence from the 2020 Chapter 11 Cases. As of the 2023 Petition Date, professional fees directly related to the 2023 Chapter 11 proceedings that were previously reflected as liabilities management and separation costs are being classified on a go-forward basis as reorganization items, net. |
(2) | Includes |
MALLINCKRODT PLC | ||||||||||||
(DEBTOR-IN-POSSESSION) | ||||||||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | ||||||||||||
CONSOLIDATED ADJUSTED EBITDA | ||||||||||||
(unaudited, in millions) | ||||||||||||
Successor | Predecessor | Non-GAAP | ||||||||||
Period from | Period from | Nine Months | ||||||||||
Gross | SG&A | R&D | Adjusted | Gross | SG&A | R&D | Adjusted | Adjusted | ||||
Net loss | $ (1.7) | $ 143.4 | $ 34.5 | $ (348.6) | $ 292.6 | $ 266.3 | $ 65.5 | $ (313.1) | $ (661.7) | |||
Adjustments: | ||||||||||||
Interest expense, net | — | — | — | 167.7 | — | — | — | 108.0 | 275.7 | |||
Income tax benefit | — | — | — | (34.6) | — | — | — | (497.3) | (531.9) | |||
Depreciation | 11.4 | (2.6) | (0.8) | 14.8 | 32.7 | (5.7) | (1.6) | 40.0 | 54.8 | |||
Amortization | 182.1 | — | — | 182.1 | 280.2 | (1.6) | — | 281.8 | 463.9 | |||
Restructuring charges, net | — | — | — | 3.3 | — | — | — | 9.6 | 12.9 | |||
Income from discontinued | — | — | — | (0.4) | — | — | — | (0.9) | (1.3) | |||
Change in contingent | — | 0.8 | — | (0.8) | — | — | — | — | (0.8) | |||
Significant legal and | — | — | — | — | — | — | — | 11.1 | 11.1 | |||
Liabilities management and | — | — | — | 16.1 | — | — | — | 9.0 | 25.1 | |||
Unrealized (gain) loss on equity | — | — | — | (0.9) | — | — | — | 22.2 | 21.3 | |||
Reorganization items, net | — | — | — | 17.7 | — | — | — | 630.9 | 648.6 | |||
Share-based compensation | — | (0.5) | — | 0.5 | 0.1 | (1.3) | (0.3) | 1.7 | 2.2 | |||
Gain on debt extinguishment at | — | — | — | (3.9) | — | — | — | — | (3.9) | |||
Fresh-start impact on debt | — | — | — | 4.1 | — | — | — | — | 4.1 | |||
Bad debt expense - customer | — | (5.8) | — | 5.8 | — | — | — | — | 5.8 | |||
Fresh-start inventory-related | 173.5 | — | — | 173.5 | — | — | — | — | 173.5 | |||
As adjusted: | $ 365.3 | $ 135.3 | $ 33.7 | $ 196.4 | $ 605.6 | $ 257.7 | $ 63.6 | $ 303.0 | $ 499.4 | |||
(1) | Represents costs primarily related to expenses incurred related to severance for the former Chief Executive Officer and certain former executives of the Predecessor and the Predecessor directors' and officers' insurance policies, in addition to professional fees and costs incurred as we explore potential sales of non-core assets to enable further deleveraging post-emergence from the 2020 Chapter 11 Cases. |
(2) | Includes |
MALLINCKRODT PLC | ||||||
(DEBTOR-IN-POSSESSION) | ||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | ||||||
SEGMENT OPERATING INCOME | ||||||
(unaudited, in millions) | ||||||
Successor | Predecessor | |||||
Nine Months | Period from | Period from | ||||
Specialty Brands (1) | $ 181.6 | $ 48.2 | $ 267.2 | |||
Specialty Generics (2) | 131.9 | (8.7) | 65.3 | |||
Segment operating income | 313.5 | 39.5 | 332.5 | |||
Unallocated amounts: | ||||||
Corporate and unallocated expenses (3) | (29.7) | (15.9) | (48.2) | |||
Depreciation and amortization | (423.2) | (196.9) | (321.8) | |||
Share-based compensation | (7.7) | (0.5) | (1.7) | |||
Restructuring charges, net | (0.9) | (3.3) | (9.6) | |||
Non-restructuring impairment charges | (135.9) | — | — | |||
Liabilities management and separation costs (4) | (157.3) | (16.1) | (9.0) | |||
Bad debt expense - customer bankruptcy | — | (5.8) | — | |||
Operating loss | $ (441.2) | $ (199.0) | $ (57.8) |
(1) | Includes |
(2) | Includes |
(3) | Includes administration expenses and certain compensation, legal, environmental and other costs not charged to our reportable segments. |
(4) | Represents costs primarily related to professional fees incurred by the Company (including where the Company is responsible for the fees of third parties) in connection with its evaluation of its financial situation and related discussions with its stakeholders prior to the commencement of the 2023 Chapter 11 Cases, expenses incurred related to the Predecessor directors' and officers' insurance policies and severance for the former CEO and certain former executives of the Predecessor, in addition to professional fees and costs incurred as the Company explores potential sales of non-core assets to enable further deleveraging post-emergence from the 2020 Chapter 11 Cases. As of the 2023 Petition Date, professional fees directly related to the 2023 Chapter 11 proceedings that were previously reflected as liabilities management and separation costs are being classified on a go-forward basis as reorganization items, net. |
MALLINCKRODT PLC | ||||||
SEGMENT NET SALES | ||||||
(unaudited, in millions) | ||||||
Successor | Predecessor | |||||
Nine Months | Period from | Period from | ||||
Specialty Brands | $ 818.3 | $ 361.7 | $ 587.1 | |||
Specialty Generics | 578.3 | 188.7 | 287.5 | |||
Net sales | $ 1,396.6 | $ 550.4 | $ 874.6 |
MALLINCKRODT PLC | |||||||||
SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH | |||||||||
(unaudited, in millions) | |||||||||
Successor | Non-GAAP | Non-GAAP Measure | |||||||
Nine Months | Nine Months | Percent | Currency | Constant- | |||||
Specialty Brands | $ 818.3 | $ 948.8 | (13.8) % | — % | (13.8) % | ||||
Specialty Generics | 578.3 | 476.2 | 21.4 | — | 21.4 | ||||
Net sales | $ 1,396.6 | $ 1,425.0 | (2.0) % | — % | (2.0) % |
MALLINCKRODT PLC | ||||||
SELECT PRODUCT LINE NET SALES | ||||||
(unaudited, in millions) | ||||||
Successor | Predecessor | |||||
Nine Months | Period from | Period from | ||||
Specialty Brands | ||||||
Acthar Gel | $ 320.9 | $ 153.2 | $ 221.9 | |||
INOmax | 232.5 | 94.2 | 165.8 | |||
Therakos | 187.6 | 68.2 | 109.6 | |||
Amitiza | 61.4 | 42.9 | 81.5 | |||
Terlivaz | 10.0 | — | — | |||
Other | 5.9 | 3.2 | 8.3 | |||
Specialty Brands Total | 818.3 | 361.7 | 587.1 | |||
Specialty Generics | ||||||
Opioids | 200.2 | 55.2 | 88.8 | |||
ADHD | 82.9 | 13.4 | 17.5 | |||
Addiction treatment | 46.8 | 19.1 | 30.0 | |||
Other | 7.6 | 3.0 | 4.9 | |||
Generics | 337.5 | 90.7 | 141.2 | |||
Controlled substances | 61.4 | 21.4 | 37.6 | |||
APAP | 163.6 | 69.2 | 96.5 | |||
Other | 15.8 | 7.4 | 12.2 | |||
API | 240.8 | 98.0 | 146.3 | |||
Specialty Generics | 578.3 | 188.7 | 287.5 | |||
Net sales | $ 1,396.6 | $ 550.4 | $ 874.6 |
MALLINCKRODT PLC | |||||||||
SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH | |||||||||
(unaudited, in millions) | |||||||||
Successor | Non-GAAP | Non-GAAP Measures | |||||||
Nine Months | Nine Months | Percent | Currency | Constant- | |||||
Specialty Brands | |||||||||
Acthar Gel | $ 320.9 | $ 375.1 | (14.4) % | — % | (14.4) % | ||||
INOmax | 232.5 | 260.0 | (10.6) | (0.1) | (10.5) | ||||
Therakos | 187.6 | 177.8 | 5.5 | 0.4 | 5.1 | ||||
Amitiza | 61.4 | 124.4 | (50.6) | (0.1) | (50.5) | ||||
Terlivaz | 10.0 | — | — | — | — | ||||
Other | 5.9 | 11.5 | (48.7) | (1.6) | (47.1) | ||||
Specialty Brands Total | 818.3 | 948.8 | (13.8) | — | (13.8) | ||||
Specialty Generics | |||||||||
Opioids | 200.2 | 144.0 | 39.0 | — | 39.0 | ||||
ADHD | 82.9 | 30.9 | 168.3 | — | 168.3 | ||||
Addiction treatment | 46.8 | 49.1 | (4.7) | (0.4) | (4.3) | ||||
Other | 7.6 | 7.9 | (3.8) | — | (3.8) | ||||
Generics | 337.5 | 231.9 | 45.5 | (0.1) | 45.6 | ||||
Controlled substances | 61.4 | 59.0 | 4.1 | — | 4.1 | ||||
APAP | 163.6 | 165.7 | (1.3) | — | (1.3) | ||||
Other | 15.8 | 19.6 | (19.4) | — | (19.4) | ||||
API | 240.8 | 244.3 | (1.4) | — | (1.4) | ||||
Specialty Generics | 578.3 | 476.2 | 21.4 | — | 21.4 | ||||
Net sales | $ 1,396.6 | $ 1,425.0 | (2.0) % | — % | (2.0) % |
MALLINCKRODT PLC | |||
(DEBTOR-IN-POSSESSION) | |||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
(unaudited, in millions) | |||
Successor | |||
September 29, | December 30, | ||
Assets | |||
Current Assets: | |||
Cash and cash equivalents | $ 389.8 | $ 409.5 | |
Accounts receivable, net | 426.9 | 405.3 | |
Inventories | 834.2 | 947.6 | |
Prepaid expenses and other current assets | 136.6 | 273.4 | |
Total current assets | 1,787.5 | 2,035.8 | |
Property, plant and equipment, net | 459.8 | 457.6 | |
Intangible assets, net | 2,319.8 | 2,843.8 | |
Deferred income taxes | — | 475.5 | |
Other assets | 227.7 | 201.1 | |
Total Assets | $ 4,794.8 | $ 6,013.8 | |
Liabilities and Shareholders' (Deficit) Equity | |||
Current Liabilities: | |||
Current maturities of long-term debt | $ 377.4 | $ 44.1 | |
Accounts payable | 78.2 | 114.0 | |
Accrued payroll and payroll-related costs | 65.1 | 49.5 | |
Accrued interest | 34.6 | 29.0 | |
Acthar Gel-Related Settlement | — | 16.5 | |
Opioid-Related Litigation Settlement liability | — | 200.0 | |
Accrued and other current liabilities | 243.7 | 290.7 | |
Total current liabilities | 799.0 | 743.8 | |
Long-term debt | — | 3,027.7 | |
Acthar Gel-Related Settlement | — | 75.0 | |
Opioid-Related Litigation Settlement liability | — | 379.9 | |
Pension and postretirement benefits | 40.4 | 41.0 | |
Environmental liabilities | 34.8 | 35.8 | |
Other income tax liabilities | 19.2 | 18.2 | |
Other liabilities | 67.4 | 78.7 | |
Liabilities subject to compromise | 4,932.1 | — | |
Total Liabilities | 5,892.9 | 4,400.1 | |
Shareholders' (Deficit) Equity: | |||
Preferred shares | — | — | |
Ordinary shares | 0.1 | 0.1 | |
Ordinary shares held in treasury at cost | (0.1) | — | |
Additional paid-in capital | 2,198.5 | 2,191.0 | |
Accumulated other comprehensive income | 13.5 | 10.8 | |
Retained deficit | (3,310.1) | (588.2) | |
Total Shareholders' (Deficit) Equity | (1,098.1) | 1,613.7 | |
Total Liabilities and Shareholders' (Deficit) Equity | $ 4,794.8 | $ 6,013.8 |
MALLINCKRODT PLC | ||||||
(DEBTOR-IN-POSSESSION) | ||||||
(IN EXAMINATION UNDER PART 10 OF THE IRISH COMPANIES ACT 2014) | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||
(unaudited, in millions) | ||||||
Successor | Predecessor | |||||
Nine Months | Period from | Period from | ||||
Cash Flows From Operating Activities: | ||||||
Net loss | $ (2,721.9) | $ (348.6) | $ (313.1) | |||
Adjustments to reconcile net cash from operating activities: | ||||||
Depreciation and amortization | 423.2 | 196.9 | 321.8 | |||
Share-based compensation | 7.7 | 0.5 | 1.7 | |||
Deferred income taxes | 475.5 | (10.8) | (473.0) | |||
Non-cash impairment charges | 135.9 | — | — | |||
Reorganization items, net | 1,294.1 | — | 425.4 | |||
Non-cash accretion expense | 176.7 | 72.3 | — | |||
Other non-cash items | 11.6 | 5.7 | 35.3 | |||
Changes in assets and liabilities: | ||||||
Accounts receivable, net | (23.8) | 9.2 | 49.8 | |||
Inventories | 99.1 | 150.9 | (33.2) | |||
Accounts payable | (31.2) | (11.6) | (3.6) | |||
Income taxes | 168.7 | (27.8) | (26.9) | |||
Opioid-Related Litigation Settlement liability | (250.0) | — | — | |||
Payments of claims | — | — | (629.0) | |||
Other | (63.3) | (17.4) | 2.5 | |||
Net cash from operating activities | (297.7) | 19.3 | (642.3) | |||
Cash Flows From Investing Activities: | ||||||
Capital expenditures | (41.9) | (15.6) | (33.4) | |||
Proceeds from divestitures, net of cash | — | 65.0 | — | |||
Other | 1.1 | 0.2 | 0.4 | |||
Net cash from investing activities | (40.8) | 49.6 | (33.0) | |||
Cash Flows From Financing Activities: | ||||||
Issuance of external debt | 380.0 | — | 650.0 | |||
Repayment of external debt | (52.0) | (17.3) | (904.6) | |||
Debt financing costs | (2.4) | — | (24.1) | |||
Other | (0.1) | — | — | |||
Net cash from financing activities | 325.5 | (17.3) | (278.7) | |||
Effect of currency rate changes on cash | (1.7) | (3.7) | (3.9) | |||
Net change in cash, cash equivalents and restricted cash | (14.7) | 47.9 | (957.9) | |||
Cash, cash equivalents and restricted cash at beginning of period | 466.7 | 447.3 | 1,405.2 | |||
Cash, cash equivalents and restricted cash at end of period | $ 452.0 | $ 495.2 | $ 447.3 | |||
Cash and cash equivalents at end of period | $ 389.8 | $ 391.2 | $ 297.9 | |||
Restricted cash included in prepaid expenses and other current assets at end | 22.9 | 67.5 | 113.0 | |||
Restricted cash included in other long-term assets at end of period | 39.3 | 36.5 | 36.4 | |||
Cash, cash equivalents and restricted cash at end of period | $ 452.0 | $ 495.2 | $ 447.3 |
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SOURCE Mallinckrodt plc
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