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Mallinckrodt plc Provides Fiscal Year 2015 Financial Guidance

Company Hosting Investor Briefing and Webcast Today at 9:00 a.m. U.S. EDT

DUBLIN--(BUSINESS WIRE)--Oct. 14, 2014-- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced financial guidance for its fiscal year ending September 25, 2015.

For fiscal 2015, Mallinckrodt’s annual net sales are expected to be in the range of $3.65 billion to $3.75 billion on an operational basis, which excludes the impact of fluctuations in foreign currency exchange rates¹. Net sales for the company’s Specialty Pharmaceutical segment are expected to be in the range of $2.87 billion to $2.92 billion. This forecast includes full fiscal year net sales contributions from H.P. Acthar^® Gel and OFIRMEV^®, two leading branded products in its Specialty Pharmaceuticals segment. Net sales for the company’s Global Medical Imaging segment are expected to be in the range of $760 million to $800 million.

Mallinckrodt expects adjusted diluted earnings per share (EPS)² to be in the range of $6.70 to $7.20 for fiscal 2015. This range reflects a weighted average, diluted share count of approximately 118 million. The non-GAAP effective tax is expected to be between 20% and 23%. Capital expenditures are forecasted to be in the range of $130 million to $150 million.

Mark Trudeau, President and CEO of Mallinckrodt, said, “We are very pleased with the significant progress Mallinckrodt is making toward transforming the company into a leading specialty biopharmaceutical company. In fiscal 2015, we will continue to focus on building our strategic growth platforms in our Specialty Pharmaceutical segment through a balance of organic growth as well as strategic business development and licensing opportunities.”

2015 Mallinckrodt Fiscal Year Guidance (excluding foreign currency impact)
Adjusted diluted EPS				$6.70 to $7.20
Total company net sales				$3.65 billion to $3.75 billion
Specialty Pharmaceuticals net sales				$2.87 billion to $2.92 billion
Global Medical Imaging net sales				$760 million to $ 800 million
Non-GAAP effective tax rate				20% to 23%
Capital Expenditures				$130 million to $150 million

Webcast and Conference Call

The company will hold a briefing for investors, available by conference call and webcast today, October 14, 2014, beginning at 9:00 a.m. U.S. Eastern Daylight Time. The call and webcast can be accessed:

• On Mallinckrodt’s website: http://mallinckrodt.com/investor_relations.aspx
• By telephone: The telephone dial-in number in the U.S. (844) 867-9755. For participants outside the U.S., the dial-in number is (901) 300-3301; all callers should use the access code 95905912.
• Through audio replay: A replay of the presentation will be available by 4:00 p.m. U.S. Eastern Time on October 14, 2014, and ending at 11:59 p.m. U.S. Eastern Time on October 21, 2014. 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 briefing is 95905912.
• The event presentation will be posted on the company’s website immediately prior to the start of the investor briefing.

ABOUT MALLINCKRODT

Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology along with analgesics and central nervous system drugs for prescribing by office- and hospital-based physicians. 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. The company's Specialty Pharmaceuticals segment includes branded and specialty generic drugs and active pharmaceutical ingredients, and the Global Medical Imaging segment include contrast media and nuclear imaging agents. Mallinckrodt has more than 5,500 employees worldwide and a commercial presence in roughly 65 countries. The company's fiscal 2013 revenue totaled $2.2 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

¹ Total company net sales includes net sales to the company’s former parent, which are not included in either reporting segment.

² NON-GAAP FINANCIAL MEASURES

This press release contains financial measures, including adjusted diluted EPS and operational growth, which are considered “non-GAAP” financial measures under applicable U.S. Securities and Exchange Commission rules and regulations.

Adjusted diluted EPS represents diluted EPS prepared in accordance with accounting principles generally accepted in the United States (GAAP), adjusted for amortization; discontinued operations; separation costs; restructuring charges, net; immediately expensed up-front and milestone payments; acquisition-related costs; and non-cash impairment charges.

Operational growth 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. This measure is one of the performance metrics that determines management incentive compensation.

We have provided these non-GAAP financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate our operating performance. In addition, we believe that they will be used by certain investors to measure our operating results. Management believes that presenting these non-GAAP measures provides useful information about our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our 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.

FORWARD-LOOKING STATEMENTS

Statements in this press release that are not strictly historical, including statements regarding, future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting our business 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: general economic conditions and conditions affecting the industries in which we operate; the commercial success of our products, including H.P. Acthar® Gel ("Acthar"); our ability to protect intellectual property rights; our ability to maintain important business relationships; the lack of patent protection for Acthar, and the possible United States Food and Drug Administration ("FDA") approval and market introduction of additional competitive products; our reliance on certain individual products that are material to our financial performance; our ability to continue to generate revenue from sales of our products to treat on-label indications and to develop other therapeutic uses for them; our ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; our ability to obtain and/or timely transport molybdenum-99 to our technetium-99m generator production facilities; customer concentration; cost containment efforts of customers, purchasing groups, third-party payors and governmental organizations; our ability to successfully develop or commercialize new products; competition; our ability to achieve anticipated benefits of price increases; our ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; the reimbursement practices of a small number of large public or private issuers; complex reporting and payment obligations under healthcare rebate programs; changes in laws and regulations; conducting business internationally; foreign exchange rates; material health, safety and environmental liabilities; product liability losses and other litigation liability; information technology infrastructure and restructuring activities. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in (i) our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended September 27, 2013 and our Quarterly Reports on Form 10-Q for the quarterly periods ended December 27, 2013, March 28, 2014 and June 27, 2014; (ii) the SEC filings of Cadence Pharmaceuticals, Inc., which was acquired by Mallinckrodt on March 19, 2014, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2013; and (iii) the SEC filings of Questcor Pharmaceuticals, Inc.’s, which was acquired by Mallinckrodt on August 14, 2014, including its Annual Report on Form 10-K for the year ended December 31, 2013 (and the amendment thereto on Form 10-K/A), its Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2014 and June 30, 2014, and its Current Report on Form 8-K filed with the SEC on July 10, 2014. The forward-looking statements made herein speak only as of the date hereof and neither Mallinckrodt nor any of its affiliates 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.

Source: Mallinckrodt plc

Mallinckrodt plc
Rhonda Sciarra, 314-654-8618
Manager, Communications
rhonda.sciarra@mallinckrodt.com
or
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com
or
John Moten, 314-654-6650
Vice President, Investor Relations
john.moten@mallinckrodt.com