Mallinckrodt plc Provides Business Update Including Fiscal Year 2016 Financial Guidance Excluding Contrast Media and Delivery Systems (CMDS) and Ex-CMDS Historical Financial Information

CHESTERFIELD, United Kingdom, Oct. 6, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced a business update; its financial guidance for the fiscal year ending September 30, 2016; filed a Current Report on Form 8-K with the U.S. Securities and Exchange Commission (SEC) providing recast historical financial information reflecting the reclassification of its CMDS business to discontinued operations; and announced future investor events. The company will be providing a business update on an investor call at 7:30 a.m. U.S. Eastern Time today; details are provided later in this release.

Fiscal 2016 Mallinckrodt Financial Guidance^1,2

For fiscal 2016, Mallinckrodt's annual net sales are expected to increase at least 10% on an operational basis, which excludes the impact of fluctuations in foreign currency exchange rates. Net sales for the company's Specialty Brands segment are expected to increase at least 30%. The segment forecast includes net sales for H.P. Acthar^® Gel (repository corticotropin injection) and OFIRMEV^® (acetaminophen) injection along with full fiscal year net sales contributions from INOMAX^® (nitric oxide) for inhalation and the Therakos^® immunology platform. Net sales for the company's Specialty Generics segment are expected to decrease 15% to 20%. Net sales for the company's Global Medical Imaging segment (excluding CMDS) are expected to decrease 5% to 10%.  

Mallinckrodt expects adjusted diluted earnings per share (EPS) to be in the range of $7.70 to $8.20 for fiscal 2016. Net interest expense is forecasted to be in the range of $370 million to $385 million. The adjusted effective tax rate is expected to be between 15% and 17%. This range reflects an estimated weighted average diluted share count of 118 million to 121 million.

"We are very pleased with our significant progress in transforming Mallinckrodt into a leading specialty biopharmaceutical company. In fiscal 2016, we will execute against our long-term plan, building our Hospital and Autoimmune and Rare Diseases strategic growth platforms in the Specialty Brands segment through a balance of organic growth and continued pursuit of strategic business development and licensing opportunities," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "Our diverse portfolio, operational excellence and strong cash position enables us to focus on driving durable and sustained growth long term."

Recast Historical Financial Information Excluding CMDS

In a Current Report on Form 8-K filed today with the SEC (available at www.mallinckrodt.com/investors/sec-filings), Mallinckrodt provided recast historical financial information reflecting the reclassification of its CMDS business to discontinued operations. The company's 2015 Annual Report on Form 10-K, when filed in late November, will reflect CMDS as discontinued operations for the full-year period that ended September 25, 2015. The company announced plans to sell its CMDS business to Guerbet in late July 2015, and the transaction is expected to close in the first quarter of fiscal 2016.

Fiscal 2015 Fourth Quarter and Year-End Earnings Call

Mallinckrodt will report fiscal fourth quarter and full-year 2015 earnings results on Monday, November 23, 2015, with a call for investors beginning at 8:30 a.m. U.S. Eastern Time. Access details will be provided at a later date.

Investor Briefing

The company will host an Investor Briefing on Monday, December 7, 2015, from 12:30 p.m. to 6:00 p.m. U.S. Eastern Time. The event will be held in New York City and also made available via webcast. Additional details will be provided at a later date.

Business Update Investor Call Details

The investor call and question and answer session will take place on Tuesday, October 6, 2015, beginning at 7:30 a.m. U.S. Eastern Time. The call can be accessed:

• On Mallinckrodt's website: www.mallinckrodt.com/investors
• By telephone: 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; all callers should use the access code 55504186.
• Through audio replay: A replay of the presentation will be available at 10:30 a.m. U.S. Eastern Time on October 6, 2015, and ending at 11:59 p.m. U.S. Eastern Time on October 20, 2015. The replay dial-in number for U.S. participants is (855) 859-2056. For participants outside the U.S., the replay dial-in number is (404) 537-3406. The replay conference I.D. for the investor call is 55504186. The replay may also be accessed on www.mallinckrodt.com/investors.
• The recast historical financial information is posted in the Investor Relations section of the company's website.

ABOUT MALLINCKRODT

Mallinckrodt is a global specialty biopharmaceutical and imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. To learn more about Mallinckrodt, visit www.mallinckrodt.com. 

Non-GAAP Financial Measures

This press release contains guidance on adjusted diluted earnings per share and adjusted effective tax rate, which are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations.

Adjusted diluted earnings per share represent adjusted net income divided by the number of diluted shares. Adjusted net income represents amounts, prepared in accordance with accounting principles generally accepted in the U.S. (GAAP), adjusted for certain items on an after-tax basis that management believes are not reflective of the operational performance of the business. Adjustments to GAAP amounts include: restructuring and related charges, net; amortization impairment charges; discontinued operations; acquisition-related expenses; significant legal and environmental charges; and other items identified by the company.

The adjusted effective tax rate is calculated as the income tax effects on continuing and discontinued operations plus the income tax impact included in the reconciliation of adjusted net income, divided by income from continuing and discontinued operations plus the pre-tax, non-income, tax-related adjustments included in the reconciliation of adjusted net income (excluding dilutive share impact). The income tax impact item included in the reconciliation of adjusted net income primarily represents the tax impact of adjustments between net income and adjusted net income as well as U.S. tax payments associated with internal installment sale transactions.

The company has provided guidance on these non-GAAP 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 certain investors to measure Mallinckrodt's operating results. Management believes that presenting these non-GAAP 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 non-GAAP measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The company's definition of these non-GAAP measures may differ from similarly titled measures used by others.

Because non-GAAP 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.

Guidance on the company's fiscal year 2016 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.

Cautionary Statements Related to Forward-Looking Statements

Statements in this document that are not strictly historical, including statements regarding the expected timetable for completion of the CMDS divestiture, future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses and any other statements regarding events or developments that we believe or anticipate 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 parties' ability to satisfy the conditions to the divestiture of the CMDS business and complete the divestiture on the anticipated timeline or at all; 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 its recently completed acquisitions; changes in laws and regulations; Mallinckrodt's ability to identify, acquire or close future acquisitions; 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 ability to successfully develop or commercialize new products; Mallinckrodt's 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; limited clinical trial data for H.P. Acthar® Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt's ability to achieve anticipated benefits of price increases; 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; and the effectiveness of information technology infrastructure.

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 September 26, 2014 and Quarterly Reports on Form 10-Q for the quarters ended March 27, 2015 and June 26, 2015. 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
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
[email protected]

Media
Rhonda Sciarra
Communications Manager
314-654-8618
[email protected]

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
[email protected]

¹ Fiscal 2016 revenue guidance is based upon fiscal year 2015, after reclassification of the CMDS business to discontinued operations.
² Fiscal year 2016 reflects the 53-week period ending September 30, 2016.  
³ Fiscal 2016 revenue guidance is based upon fiscal year 2015, after reclassification of the CMDS business to discontinued operations.
⁴ Fiscal year 2016 reflects the 53-week period ending September 30, 2016.  

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SOURCE Mallinckrodt plc

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