Mallinckrodt plc Reports Earnings and Pipeline Advancements for the Third Quarter 2019 and Raises Adjusted Diluted Earnings Per Share Guidance Range for 2019

- Net sales of $743.7 million with diluted loss per share from continuing operations of $0.01 and adjusted diluted earnings per share (EPS) of $2.07

Published

STAINES-UPON-THAMES, United Kingdom, Nov. 5, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today reported results for the three months ended September 27, 2019. Unless otherwise noted, the quarter comparisons are to the recast prior year comparable three months ended September 28, 2018.

Net sales were $743.7 million in the quarter with diluted loss per share from continuing operations of $0.01 compared with income per share of $1.34. Adjusted diluted EPS were $2.07 versus $2.25, a decrease of 8.0%.

"We continue to be very pleased with the underlying financial strength and cash flow generation capability of our business, resulting in the third consecutive increase to our EPS guidance this year," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "In addition, we are particularly pleased with the ongoing progress of our research and development activities, including successful Phase 3 study results for StrataGraft and terlipressin, data generation for Acthar in rheumatoid arthritis and multiple sclerosis, and our collaboration with Silence Therapeutics in RNAi technology."

Trudeau continued, "We remain focused on strengthening our balance sheet through debt reduction and we also are working to resolve near term uncertainties in our business, particularly opioid litigation and the separation of our Specialty Generics segment."

COMPANY FINANCIAL RESULTSGross profit was $324.3 million with gross profit as a percentage of net sales of 43.6%, compared with 45.8%, driven by increased amortization expense and product mix. Adjusted gross profit was $533.2 million, compared with $583.0 million, with adjusted gross profit as a percentage of net sales of 71.7%, compared with 72.9%, driven primarily by product mix.

Selling, general and administrative (SG&A) expenses were $205.7 million or 27.7% of net sales, as compared to $193.4 million, or 24.2%, driven primarily by legal settlement expenses and separation costs, while partially offset by a reduction in the fair value of contingent consideration due to market conditions. Adjusted SG&A expenses were $182.0 million or 24.5% of net sales, compared with $205.2 million or 25.7%. Adjusted SG&A expenses decreased due to focused efforts of ongoing on SG&A reductions.

Research and development expenses were $103.1 million or 13.9% of net sales, as compared to $86.1 million or 10.8%, due primarily to the $20.0 million up-front payment for our collaboration with Silence Therapeutics in RNAi technology platform for complement-mediated diseases.

Interest expense was $77.6 million as compared to $93.6 million, a reduction of 17.1%, driven by our continued focus on deleveraging.

Income tax benefit was $27.6 million, for an effective tax rate of 96.8%. The adjusted effective tax rate was 18.3%.

Nine-Month Fiscal 2019 ResultsNet sales were $2,357.6 million, compared with $2,380.7 million. The decrease is primarily attributed to Acthar® Gel (repository corticotropin injection), partially offset by strength in the hospital products and AMITIZA® (lubiprostone).

On a GAAP1 basis, net income was $160.6 million compared with $111.4 million. Diluted EPS were $1.91 compared to $1.31.

Adjusted net income was $551.9 million, compared with $511.0 million. Adjusted diluted EPS were $6.55 compared with $6.00.

BUSINESS SEGMENT RESULTS

Specialty Brands SegmentNet sales for the segment in the third quarter 2019 were $580.4 million.

  • Acthar Gel net sales were $229.8 million, a 20.8% decrease, driven primarily by continued reimbursement challenges impacting new and returning patients, and continued payer scrutiny on overall specialty pharmaceutical spending.
  • INOMAX® (nitric oxide) gas, for inhalation, net sales were $136.8 million, up 2.7% driven by more significant utilization in multi-year, unlimited use contracts, while strong customer demand for the product continues.
  • OFIRMEV® (acetaminophen) injection net sales were $86.1 million, a decrease of 1.1%, due to lower demand and typical quarter-to-quarter order variability.
  • Therakos® immunology platform net sales were $60.9 million, an increase of 1.5%, or 3.3% on a constant-currency basis, primarily on growth in the U.S. in Cutaneous T-Cell Lymphoma.
  • AMITZA net sales were $52.6 million, up 9.1% due to continued strong utilization in Japan, partially offset by an increasingly more competitive landscape in the U.S.

Specialty Generics SegmentThe segment reported third quarter net sales in 2019 of $163.3 million, an increase of 2.1%, driven by share recapture across the business, somewhat offset in the quarter by the suspension of the spin-off.

LIQUIDITYCash provided by operating activities in the third quarter was $66.7 million, with free cash flow of $35.6 million, which was impacted by working capital changes from a particular customer in the Specialty Generics segment as well as the $15.4 million payment related to a legacy legal matter settlement. For the year to date, operating cash flow has been $534.1 million and free cash flow $425.4 million.

During the quarter, the company drew the remaining $495.0 million on its revolving credit facility, and used its cash to retire its $200.0 million remaining balance on the accounts receivable securitization program and repurchase $72.9 million face value of debt at a discount.  As of today's earnings announcement, the current cash balance is approximately $600.0 million.

2019 FINANCIAL GUIDANCE UPDATEMallinckrodt is raising guidance for the 2019 fiscal year by increasing the lower end of its adjusted diluted EPS guidance range by $0.10 on the strength of the earnings results today.  The revised 2019 fiscal year adjusted diluted EPS guidance range is $8.50 to $8.70.    

CONFERENCE CALL AND WEBCASTMallinckrodt will hold a conference call on Tuesday, Nov. 5, 2019, beginning at 8:30 a.m. U.S. Eastern Time. This call can be accessed in three ways:

  • 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 6080969.
  • Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Nov. 5, 2019, and ending at 11:59 p.m. Eastern Time on Tuesday, Nov. 19, 2019. Dial-in numbers for U.S.-based participants are (855) 859-2056 or (800) 585-8367. Participants outside the U.S. should use the replay dial-in number of (404) 537-3406. All callers will be required to provide the Conference ID of 6080969.

ABOUT MALLINCKRODTMallinckrodt 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, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics 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 U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

NON-GAAP FINANCIAL MEASURESThis press release contains financial measures, including adjusted net income, adjusted diluted earnings per share, adjusted gross profit, adjusted SG&A, net sales growth on a constant-currency basis, adjusted effective tax rate, net debt and free cash flow, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations.         

Adjusted net income, adjusted gross profit and adjusted SG&A represent amounts prepared in accordance with accounting principles generally accepted in the U.S. (GAAP) and adjusted for certain items that management believes are not reflective of the operational performance of the business. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A and on an after-tax basis for adjusted net income. Adjustments to GAAP amounts include, as applicable to each measure, amortization and non-restructuring impairment charges; restructuring and related charges, net; inventory step-up expenses; discontinued operations; changes in fair value of contingent consideration obligations; acquisition-related expenses; significant legal and environmental charges; losses/gains on repurchase of debt; separation costs; research and development upfront payments; tax effects of aforementioned adjustments, changes in related uncertain tax positions, as well as impacts from certain transactions, such as acquisitions or reorganizations; and other items identified by the company. Adjusted diluted earnings per share represent adjusted net income divided by the number of diluted shares.

The adjusted effective tax rate is calculated as the income tax effects on continuing and discontinued operations plus the income tax impact included in Mallinckrodt's reconciliation of net income, divided by income from continuing and discontinued operations plus the pre-tax, non-income, tax-related adjustments included in its reconciliation of adjusted net income (excluding dilutive share impact). The income tax adjustment included in the reconciliation of adjusted net income primarily represents the tax impact of adjustments between net income and adjusted net income, changes in related uncertain tax positions, as well as tax impacts from certain transactions, such as acquisitions or reorganizations.

Net sales growth on a constant-currency basis measures the change in net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period.

Free cash flow for the third quarter represents net cash provided by operating activities of $66.7 million less capital expenditures of $31.1 million, each as prepared in accordance with GAAP.

Free cash flow for the year to date represents net cash provided by operating activities of $534.1 million less capital expenditures of $108.7 million, each as prepared in accordance with GAAP.

Net debt as of September 27, 2019 represents total debt principal of $5,810.9 million less cash of $498.8 million, each as prepared in accordance with GAAP.

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 these adjusted measures will be used by certain investors to measure Mallinckrodt's operating results. Management believes that presenting these adjusted measures provides useful information about the company's performance across reporting periods on a consistent basis by excluding items that the company does not believe are indicative of its core operating performance.

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 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.

Guidance on the company's 2019 diluted earnings per share and effective tax rate has been provided only on a non-GAAP basis. This is due to the inherent difficulty of forecasting the timing or amount of items that would be included in the most directly comparable forward-looking GAAP financial measures. Because reconciliation is not available without unreasonable effort, it is not included in this release.

Further information regarding non-GAAP financial measures can be found on the Investor Relations page of the company's website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSStatements in this document that are not strictly historical, including statements regarding future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, plans for the Specialty Generics business including the suspension of the previously announced plans to spin off that business, and any other statements regarding events or developments the company 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: general economic conditions and conditions affecting the industries in which Mallinckrodt operates; the commercial success of Mallinckrodt's products; Mallinckrodt's ability to realize anticipated growth, synergies and cost savings from acquisitions; conditions that could necessitate an evaluation of Mallinckrodt's intangible assets for possible impairment; changes in laws and regulations; Mallinckrodt's ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; Mallinckrodt's and Mallinckrodt's licensers' ability to successfully develop or commercialize new products; Mallinckrodt's and Mallinckrodt's licensers' ability to protect intellectual property rights; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; limited clinical trial data for Acthar Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt's ability to navigate price fluctuations; future changes to U.S. and foreign tax laws; Mallinckrodt's ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; the effectiveness of information technology infrastructure; and cybersecurity and data leakage risks; Mallinckrodt's substantial indebtedness and its ability to generate sufficient cash to reduce its indebtedness; any future actions taken with respect to the Specialty Generics business; and Mallinckrodt's ability to complete the exchange offers, the consent solicitations and the transactions contemplated by the exchange agreement, including the expected timing of completion of the exchange offers and receipt of requisite consents in the consent solicitations.

These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 28, 2018 and the "Risk Factors" section of Exhibit 99.2 to Mallinckrodt's Current Report on Form 8-K filed on November 5, 2019. 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.

CONTACTS

Investor Relations Daniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

MediaDaniel YungerKekst CNC212-521-4879mallinckrodt@kekstcnc.com

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. © 2019 08/19.

1 Generally accepted accounting principles in the United States

MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited, in millions, except per share data)
Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales
Net sales $ 743.7 100.0 % $ 799.9 100.0 %
Cost of sales 419.4 56.4 433.5 54.2
Gross profit 324.3 43.6 366.4 45.8
Selling, general and administrative expenses 205.7 27.7 193.4 24.2
Research and development expenses 103.1 13.9 86.1 10.8
Restructuring charges, net 7.2 1.0 14.8 1.9
Non-restructuring impairment charge 2.0 0.3
Loss on divestiture 0.6 0.1
Operating income 8.3 1.1 69.5 8.7
Interest expense (77.6) (10.4) (93.6) (11.7)
Interest income 2.9 0.4 2.0 0.3
Other income, net 37.9 5.1 13.4 1.7
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1)
Income tax benefit (27.6) (3.7) (122.9) (15.4)
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1)
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 %
Basic earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.37
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

 

MALLINCKRODT PLC MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES
(unaudited, in millions, except per share data) (unaudited, in millions except per share data)
Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34
Gross profit 324.3 43.6 366.4 45.8 Adjustments:
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation.
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019.
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34
Gross profit 324.3 43.6 366.4 45.8 Adjustments:
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

 

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) %
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) %
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (1) Includes net sales from an ongoing, post-divestiture supply agreement with the acquirer of the contrast media and delivery systems ("CMDS") business.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) %
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) %
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

 

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) %
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1)
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9)
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4)
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) %
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 %
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24 Acetaminophen (API) (1) 48.5 47.9 1.3 1.3
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14) Other controlled substances (1) 72.9 69.5 4.9 (0.1) 5.0
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24 Other (1) 9.0 13.4 (32.8) (32.8)
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97) Specialty Generics Total $ 163.3 $ 159.9 2.1 % % 2.1 %
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH (1) Prior period amounts have been reclassified to conform to current period presentation.
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) %
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1)
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9)
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4)
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) %
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 %
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24 Acetaminophen (API) (1) 48.5 47.9 1.3 1.3
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14) Other controlled substances (1) 72.9 69.5 4.9 (0.1) 5.0
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24 Other (1) 9.0 13.4 (32.8) (32.8)
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97) Specialty Generics Total $ 163.3 $ 159.9 2.1 % % 2.1 %
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 %
Basic weighted-average shares outstanding 84.0 83.2
Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34
Loss from discontinued operations
Net (loss) income $ (0.01) $ 1.34
Diluted weighted-average shares outstanding 84.0 85.0

 

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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 MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH (1) Prior period amounts have been reclassified to conform to current period presentation. CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions) (unaudited, in millions, except per share data)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended Nine Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands Net sales $ 2,357.6 100.0 % $ 2,380.7 100.0 %
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) % Cost of sales 1,309.3 55.5 1,272.8 53.5
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8 Gross profit 1,048.3 44.5 1,107.9 46.5
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1) Selling, general and administrative expenses 661.8 28.1 594.5 25.0
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3 Research and development expenses 268.0 11.4 260.7 11.0
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1 Restructuring charges, net 11.2 0.5 101.8 4.3
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9) Non-restructuring impairment charges 113.5 4.8 2.0 0.1
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4) Loss on divestiture 0.6
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Operating (loss) income (6.2) (0.3) 148.3 6.2
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01 Interest expense (231.8) (9.8) (280.1) (11.8)
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics Interest income 6.6 0.3 6.6 0.3
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 % Other income, net 128.6 5.5 17.8 0.7
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5 Loss from continuing operations before income taxes (102.8) (4.4) (107.4) (4.5)
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24 Acetaminophen (API) (1) 48.5 47.9 1.3 1.3 Income tax benefit (256.6) (10.9) (203.9) (8.6)
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14) Other controlled substances (1) 72.9 69.5 4.9 (0.1) 5.0 Income from continuing operations 153.8 6.5 96.5 4.1
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24 Other (1) 9.0 13.4 (32.8) (32.8) Income from discontinued operations, net of income taxes 6.8 0.3 14.9 0.6
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97) Specialty Generics Total $ 163.3 $ 159.9 2.1 % % 2.1 % Net income $ 160.6 6.8 % $ 111.4 4.7 %
U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64) Basic earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25 Income from continuing operations $ 1.84 $ 1.15
Loss from discontinued operations Income from discontinued operations 0.08 0.18
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 % Net income $ 1.92 $ 1.32
Basic weighted-average shares outstanding 84.0 83.2 Basic weighted-average shares outstanding 83.8 84.2
Diluted earnings per share: Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34 Income from continuing operations $ 1.83 $ 1.13
Loss from discontinued operations Income from discontinued operations 0.08 0.17
Net (loss) income $ (0.01) $ 1.34 Net income $ 1.91 $ 1.31
Diluted weighted-average shares outstanding 84.0 85.0 Diluted weighted-average shares outstanding 84.2 85.2

 

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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 MALLINCKRODT PLC MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH (1) Prior period amounts have been reclassified to conform to current period presentation. CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions) (unaudited, in millions, except per share data) (unaudited, in millions except per share data)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands Net sales $ 2,357.6 100.0 % $ 2,380.7 100.0 % Grossprofit SG&A Net  income Dilutednetincome per share Grossprofit SG&A Netincome Dilutednet income per share
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) % Cost of sales 1,309.3 55.5 1,272.8 53.5 GAAP $ 1,048.3 $ 661.8 $ 160.6 $ 1.91 $ 1,107.9 $ 594.5 $ 111.4 $ 1.31
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8 Gross profit 1,048.3 44.5 1,107.9 46.5 Adjustments:
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1) Selling, general and administrative expenses 661.8 28.1 594.5 25.0 Intangible asset amortization 645.1 (4.7) 649.8 7.72 541.6 (5.0) 546.5 6.41
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3 Research and development expenses 268.0 11.4 260.7 11.0 Non-restructuring impairment charges (1) 113.5 1.35 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1 Restructuring charges, net 11.2 0.5 101.8 4.3 Restructuring and related charges, net (2) 11.2 0.13 2.9 (1.9) 106.6 1.25
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9) Non-restructuring impairment charges 113.5 4.8 2.0 0.1 Inventory step-up expense 10.0 10.0 0.12 79.5 79.5 0.93
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4) Loss on divestiture 0.6 Income from discontinued operations (6.8) (0.08) (14.9) (0.17)
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Operating (loss) income (6.2) (0.3) 148.3 6.2 Change in contingent consideration fair value 23.5 (23.5) (0.28) 33.3 (33.3) (0.39)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01 Interest expense (231.8) (9.8) (280.1) (11.8) Acquisition-related expenses (3.8) 3.8 0.04
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics Interest income 6.6 0.3 6.6 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 % Other income, net 128.6 5.5 17.8 0.7 Gain on repurchase of debt (98.6) (1.17) (6.5) (0.08)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5 Loss from continuing operations before income taxes (102.8) (4.4) (107.4) (4.5) Write off of unamortized debt discount and fees 9.4 0.11
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24 Acetaminophen (API) (1) 48.5 47.9 1.3 1.3 Income tax benefit (256.6) (10.9) (203.9) (8.6) Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14) Other controlled substances (1) 72.9 69.5 4.9 (0.1) 5.0 Income from continuing operations 153.8 6.5 96.5 4.1 R&D upfront payment (3) 20.0 0.24
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24 Other (1) 9.0 13.4 (32.8) (32.8) Income from discontinued operations, net of income taxes 6.8 0.3 14.9 0.6 Separation costs (50.4) 50.4 0.60
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97) Specialty Generics Total $ 163.3 $ 159.9 2.1 % % 2.1 % Net income $ 160.6 6.8 % $ 111.4 4.7 % Legal entity and intercompany financing reorganization (186.8) (2.22) (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11) U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64) Basic earnings per share: Income taxes (4) (185.5) (2.20) (181.5) (2.13)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25 Income from continuing operations $ 1.84 $ 1.15 As adjusted $ 1,703.4 $ 602.0 $ 551.9 $ 6.55 $ 1,731.9 $ 628.9 $ 511.0 $ 6.00
Loss from discontinued operations Income from discontinued operations 0.08 0.18
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 % Net income $ 1.92 $ 1.32 Percent of net sales 72.3 % 25.5 % 23.4 % 72.7 % 26.4 % 21.5 %
Basic weighted-average shares outstanding 84.0 83.2 Basic weighted-average shares outstanding 83.8 84.2
Diluted earnings per share: Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34 Income from continuing operations $ 1.83 $ 1.13
Loss from discontinued operations Income from discontinued operations 0.08 0.17
Net (loss) income $ (0.01) $ 1.34 Net income $ 1.91 $ 1.31
Diluted weighted-average shares outstanding 84.0 85.0 Diluted weighted-average shares outstanding 84.2 85.2

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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 MALLINCKRODT PLC MALLINCKRODT PLC (1) Represents in-process research and development intangible asset impairment of $113.5 million related to stannsoporfin during the nine months ended September 27, 2019 and impairment of a license associated with a product we elected to discontinue during the three months ended September 28, 2018.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH (1) Prior period amounts have been reclassified to conform to current period presentation. CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation.
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions) (unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents R&D expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019.
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions. (4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands Net sales $ 2,357.6 100.0 % $ 2,380.7 100.0 % Grossprofit SG&A Net  income Dilutednetincome per share Grossprofit SG&A Netincome Dilutednet income per share
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) % Cost of sales 1,309.3 55.5 1,272.8 53.5 GAAP $ 1,048.3 $ 661.8 $ 160.6 $ 1.91 $ 1,107.9 $ 594.5 $ 111.4 $ 1.31
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8 Gross profit 1,048.3 44.5 1,107.9 46.5 Adjustments:
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1) Selling, general and administrative expenses 661.8 28.1 594.5 25.0 Intangible asset amortization 645.1 (4.7) 649.8 7.72 541.6 (5.0) 546.5 6.41
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3 Research and development expenses 268.0 11.4 260.7 11.0 Non-restructuring impairment charges (1) 113.5 1.35 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1 Restructuring charges, net 11.2 0.5 101.8 4.3 Restructuring and related charges, net (2) 11.2 0.13 2.9 (1.9) 106.6 1.25
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9) Non-restructuring impairment charges 113.5 4.8 2.0 0.1 Inventory step-up expense 10.0 10.0 0.12 79.5 79.5 0.93
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4) Loss on divestiture 0.6 Income from discontinued operations (6.8) (0.08) (14.9) (0.17)
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Operating (loss) income (6.2) (0.3) 148.3 6.2 Change in contingent consideration fair value 23.5 (23.5) (0.28) 33.3 (33.3) (0.39)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01 Interest expense (231.8) (9.8) (280.1) (11.8) Acquisition-related expenses (3.8) 3.8 0.04
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics Interest income 6.6 0.3 6.6 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 % Other income, net 128.6 5.5 17.8 0.7 Gain on repurchase of debt (98.6) (1.17) (6.5) (0.08)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5 Loss from continuing operations before income taxes (102.8) (4.4) (107.4) (4.5) Write off of unamortized debt discount and fees 9.4 0.11
Income tax benefit (27.6) (3.7) (122.9) (15.4) Separation costs (19.8) 19.8 0.24 Acetaminophen (API) (1) 48.5 47.9 1.3 1.3 Income tax benefit (256.6) (10.9) (203.9) (8.6) Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14)
(Loss) income from continuing operations (0.9) (0.1) 114.2 14.3 Significant legal and environmental charges (28.2) 28.2 0.33 11.8 (11.8) (0.14) Other controlled substances (1) 72.9 69.5 4.9 (0.1) 5.0 Income from continuing operations 153.8 6.5 96.5 4.1 R&D upfront payment (3) 20.0 0.24
Loss from discontinued operations, net of income taxes (0.2) (0.4) (0.1) R&D upfront payment (3) 20.0 0.24 Other (1) 9.0 13.4 (32.8) (32.8) Income from discontinued operations, net of income taxes 6.8 0.3 14.9 0.6 Separation costs (50.4) 50.4 0.60
Net (loss) income $ (1.1) (0.1) % $ 113.8 14.2 % Legal entity and intercompany financing reorganization 3.0 0.04 (82.3) (0.97) Specialty Generics Total $ 163.3 $ 159.9 2.1 % % 2.1 % Net income $ 160.6 6.8 % $ 111.4 4.7 % Legal entity and intercompany financing reorganization (186.8) (2.22) (82.3) (0.97)
U.S. Tax Reform (9.1) (0.11) U.S. Tax Reform (9.1) (0.11)
Basic earnings per share: Income taxes (4) (69.5) (0.83) (54.0) (0.64) Basic earnings per share: Income taxes (4) (185.5) (2.20) (181.5) (2.13)
(Loss) income from continuing operations $ (0.01) $ 1.37 As adjusted $ 533.2 $ 182.0 $ 174.5 $ 2.07 $ 583.0 $ 205.2 $ 190.9 $ 2.25 Income from continuing operations $ 1.84 $ 1.15 As adjusted $ 1,703.4 $ 602.0 $ 551.9 $ 6.55 $ 1,731.9 $ 628.9 $ 511.0 $ 6.00
Loss from discontinued operations Income from discontinued operations 0.08 0.18
Net (loss) income $ (0.01) $ 1.37 Percent of net sales 71.7 % 24.5 % 23.5 % 72.9 % 25.7 % 23.9 % Net income $ 1.92 $ 1.32 Percent of net sales 72.3 % 25.5 % 23.4 % 72.7 % 26.4 % 21.5 %
Basic weighted-average shares outstanding 84.0 83.2 Basic weighted-average shares outstanding 83.8 84.2
Diluted earnings per share: Diluted earnings per share:
(Loss) income from continuing operations $ (0.01) $ 1.34 Income from continuing operations $ 1.83 $ 1.13
Loss from discontinued operations Income from discontinued operations 0.08 0.17
Net (loss) income $ (0.01) $ 1.34 Net income $ 1.91 $ 1.31
Diluted weighted-average shares outstanding 84.0 85.0 Diluted weighted-average shares outstanding 84.2 85.2

 

MALLINCKRODT PLC MALLINCKRODT PLC (1) In periods where the Company reports a net loss from continuing operations, potential ordinary shares outstanding are excluded from the calculation of diluted earnings per share, prepared in accordance with GAAP, as they would be anti-dilutive. These potentially dilutive shares are included in the calculation of adjusted diluted earnings per share when dilutive. As a result, the adjusted diluted earnings per share utilized a weighted average share count of 84.2 shares for the three months ended September 27, 2019. MALLINCKRODT PLC (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 MALLINCKRODT PLC MALLINCKRODT PLC (1) Represents in-process research and development intangible asset impairment of $113.5 million related to stannsoporfin during the nine months ended September 27, 2019 and impairment of a license associated with a product we elected to discontinue during the three months ended September 28, 2018. MALLINCKRODT PLC
CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH SELECT PRODUCT LINE NET SALES AND CONSTANT-CURRENCY GROWTH (1) Prior period amounts have been reclassified to conform to current period presentation. CONDENSED CONSOLIDATED STATEMENTS OF INCOME NON-GAAP MEASURES (2) Includes pre-tax accelerated depreciation. SEGMENT NET SALES AND CONSTANT-CURRENCY GROWTH
(unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents research and development ("R&D") expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions) (unaudited, in millions) (unaudited, in millions, except per share data) (unaudited, in millions except per share data) (3) Represents R&D expense incurred related to an upfront payment made to Silence in connection with a license and collaboration agreement entered into in July 2019. (unaudited, in millions)
(4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions. (4) Includes tax effects of above adjustments (unless otherwise separately stated), changes in related uncertain tax positions, as well as certain installment sale transactions and other intercompany transactions.
Three Months Ended Three Months Ended Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended Nine Months Ended
September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth September 27, 2019 Percent of Net sales September 28, 2018 Percent of Net sales September 27, 2019 September 28, 2018 September 27, 2019 September 28, 2018 Percent change Currencyimpact Constant-currency growth
Net sales $ 743.7 100.0 % $ 799.9 100.0 % Gross profit SG&A Net (loss) income Dilutednet (loss) income per share(1) Gross profit SG&A Net income Dilutednetincome per share Specialty Brands $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Specialty Brands Net sales $ 2,357.6 100.0 % $ 2,380.7 100.0 % Grossprofit SG&A Net  income Dilutednetincome per share Grossprofit SG&A Netincome Dilutednet income per share Specialty Brands $ 1,812.4 $ 1,844.3 (1.7) % (0.3) % (1.4) %
Cost of sales 419.4 56.4 433.5 54.2 GAAP $ 324.3 $ 205.7 $ (1.1) $ (0.01) $ 366.4 $ 193.4 $ 113.8 $ 1.34 Specialty Generics (1) 163.3 159.9 2.1 % 2.1 Acthar Gel $ 229.8 $ 290.1 (20.8) % % (20.8) % Cost of sales 1,309.3 55.5 1,272.8 53.5 GAAP $ 1,048.3 $ 661.8 $ 160.6 $ 1.91 $ 1,107.9 $ 594.5 $ 111.4 $ 1.31 Specialty Generics (1) 545.2 536.4 1.6 (0.1) 1.7
Gross profit 324.3 43.6 366.4 45.8 Adjustments: Net sales $ 743.7 $ 799.9 (7.0) % (0.2) % (6.8) % Inomax 136.8 133.2 2.7 (0.1) 2.8 Gross profit 1,048.3 44.5 1,107.9 46.5 Adjustments: Net sales $ 2,357.6 $ 2,380.7 (1.0) % (0.2) % (0.8) %
Selling, general and administrative expenses 205.7 27.7 193.4 24.2 Intangible asset amortization 208.9 (1.5) 210.4 2.50 182.7 (1.6) 184.2 2.17 Ofirmev 86.1 87.1 (1.1) (1.1) Selling, general and administrative expenses 661.8 28.1 594.5 25.0 Intangible asset amortization 645.1 (4.7) 649.8 7.72 541.6 (5.0) 546.5 6.41
Research and development expenses 103.1 13.9 86.1 10.8 Non-restructuring impairment charge 2.0 0.02 Therakos 60.9 60.0 1.5 (1.8) 3.3 Research and development expenses 268.0 11.4 260.7 11.0 Non-restructuring impairment charges (1) 113.5 1.35 2.0 0.02
Restructuring charges, net 7.2 1.0 14.8 1.9 Restructuring and related charges, net (2) 7.2 0.09 2.9 (1.9) 19.6 0.23 Amitiza 52.6 48.2 9.1 9.1 Restructuring charges, net 11.2 0.5 101.8 4.3 Restructuring and related charges, net (2) 11.2 0.13 2.9 (1.9) 106.6 1.25
Non-restructuring impairment charge 2.0 0.3 Inventory step-up expense 31.0 31.0 0.36 BioVectra 10.5 13.9 (24.5) (0.6) (23.9) Non-restructuring impairment charges 113.5 4.8 2.0 0.1 Inventory step-up expense 10.0 10.0 0.12 79.5 79.5 0.93
Loss on divestiture 0.6 0.1 Loss from discontinued operations 0.2 0.4 Other 3.7 7.5 (50.7) (1.3) (49.4) Loss on divestiture 0.6 Income from discontinued operations (6.8) (0.08) (14.9) (0.17)
Operating income 8.3 1.1 69.5 8.7 Change in contingent consideration fair value 25.8 (25.8) (0.31) 4.2 (4.2) (0.05) Specialty Brands Total $ 580.4 $ 640.0 (9.3) % (0.2) % (9.1) % Operating (loss) income (6.2) (0.3) 148.3 6.2 Change in contingent consideration fair value 23.5 (23.5) (0.28) 33.3 (33.3) (0.39)
Interest expense (77.6) (10.4) (93.6) (11.7) Acquisition-related expenses (0.7) 0.7 0.01 Interest expense (231.8) (9.8) (280.1) (11.8) Acquisition-related expenses (3.8) 3.8 0.04
Interest income 2.9 0.4 2.0 0.3 Divestiture 0.6 0.01 Specialty Generics Interest income 6.6 0.3 6.6 0.3 Divestiture 0.6 0.01
Other income, net 37.9 5.1 13.4 1.7 Gain on repurchase of debt (18.7) (0.22) Hydrocodone (API) and hydrocodone-containing tablets $ 15.7 $ 15.5 1.3 % % 1.3 % Other income, net 128.6 5.5 17.8 0.7 Gain on repurchase of debt (98.6) (1.17) (6.5) (0.08)
Loss from continuing operations before income taxes (28.5) (3.8) (8.7) (1.1) Write off of unamortized debt discount and fees 0.8 0.01 Oxycodone (API) and oxycodone-containing tablets(1) 17.2 13.6 26.5 26.5 Loss from continuing operations before income taxes (102.8) (4.4) (107.4) (4.5)