Mallinckrodt plc Reports Third Quarter 2018 Results and Raises Earnings Guidance for 2018

STAINES-UPON-THAMES, United Kingdom, Nov. 6, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today reported results for the three months ended September 28, 2018. Unless otherwise noted, the quarter comparisons are to the prior year comparable three months ended September 29, 2017.

Net sales were $640.0 million in the quarter as compared to $600.6 million, up 6.6%, or 6.7% on a constant-currency basis.

GAAP gross profit was $313.8 million with gross profit as a percentage of net sales of 49.0%, compared with 55.4%, primarily due to recent acquisitions. Adjusted gross profit was $530.4 million, compared with $502.4 million. Adjusted gross profit as a percentage of net sales was 82.9% versus 83.6%.

"Mallinckrodt performed well in the third quarter driven by strong customer demand for our hospital products and effective expense management. This tight expense control also helped us support increased R&D investments in our innovative pipeline. Based on this performance we are raising adjusted diluted earnings per share guidance for the fiscal year," said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt. "We continue to be pleased with the performance trajectory of H.P. Acthar^® Gel and we also look forward to a number of important clinical data and regulatory updates across the portfolio in coming quarters. Finally, we continue to make strong progress against our objective of reducing debt."

GAAP selling, general and administrative (SG&A) expenses were $164.0 million or 25.6% of net sales, as compared to $186.3 million, or 31.0%, while adjusted SG&A expenses were $175.8 million or 27.5% of net sales, compared with $178.3 million or 29.7%. Both measures benefited from the company's focus on SG&A reduction including benefits from restructuring and acquisition synergies.

Research and development expenses were $78.5 million or 12.3% of net sales, as compared to $46.9 million or 7.8%, resulting from increased pipeline investment and in-line portfolio data generation.

Income tax benefit was $125.2 million, for an effective tax rate of 564.0%. The adjusted effective tax rate was 10.0%.

GAAP diluted income per share from continuing operations was $1.21 compared with $0.55. Adjusted diluted earnings per share were $2.10 versus $1.82.

Nine-Month Fiscal 2018 Results
Net sales were $1,844.3 million, up 4.7% compared with $1,760.7 million. The increase is primarily attributed to strength in the hospital products and the addition of AMITIZA^® (lubiprostone).

On a GAAP basis, income from continuing operations was $31.9 million, compared with $26.6 million.  Diluted loss per share from continuing operations was $0.37 compared with loss per share of $0.27.

Adjusted net income was $439.6 million, compared with $418.0 million. Adjusted diluted earnings per share were $5.16 compared with $4.19.

SPECIALTY BRANDS QUARTERLY SEGMENT RESULTS
Net sales for the segment in the third quarter 2018 were $640.0 million.

• H.P. Acthar Gel (repository corticotropin injection) net sales were $290.1 million, a 6.0% decrease over $308.7 million, resulting from the residual impact of previously reported patient withdrawal issues.
• INOMAX^® (nitric oxide) gas, for inhalation, net sales were $133.2 million, up 6.0%, over $125.7 million, due to continued consistent demand.
• OFIRMEV^® (acetaminophen) injection net sales were $87.1 million compared with $75.4 million, an increase of 15.5%, benefiting from continued strong demand.
• Therakos^® immunology platform net sales were $60.0 million compared with $55.3 million, an increase of 8.5%, or 8.6% on a constant-currency basis, on growth, particularly in Europe.
• AMITIZA net sales were $48.2 million.

LIQUIDITY
Mallinckrodt's cash provided by operating activities in the quarter was $219.3 million with free cash flow of $193.1 million. Year-to-date, the company has generated $481.1 million of cash from operating activities with free cash flow of $387.8 million.

During the quarter the company reduced total debt by $170.6 million, primarily comprised of $150.0 million in repayments on its revolving credit facility and a $15.0 million decrease in the receivable securitization. The company ended the quarter with net debt below $6.0 billion.

Mallinckrodt remains focused on debt reduction. Subsequent to the quarter close, the company has further reduced its revolving credit facility to a balance of $220.0 million. The company's current cash balance is in excess of $250 million.

2018 FINANCIAL GUIDANCE UPDATE
Based on its third quarter performance and continued strong execution, the company is raising its adjusted diluted earnings per share guidance for fiscal 2018 to $7.00 to $7.20.

CONFERENCE CALL AND WEBCAST
Mallinckrodt will hold a conference call on Tuesday, Nov. 6, 2018, 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 1560208.
• Through an audio replay: A replay of the call will be available beginning at 11:30 a.m. Eastern Time on Tuesday, Nov. 6, 2018, and ending at 11:59 p.m. Eastern Time on Tuesday, Nov. 20, 2018. 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 1560208.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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. 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 MEASURES
This 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; 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; pension settlement charges; losses/gains on divestiture; tax effects of aforementioned adjustments 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 as well as tax impacts from certain transactions, such as acquisitions or reorganizations.

Net debt for the third quarter represents the total principal debt outstanding of $6,260.1 million less unrestricted cash of $290.7 million, each as prepared in accordance with GAAP.

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 $219.3 million less capital expenditures of $26.2 million, each as prepared in accordance with GAAP.  Free cash flow for the nine-month period represents net cash provided by operating activities of $481.1 million less capital expenditures of $93.3 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 they 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.

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 STATEMENTS
Statements 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 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 goodwill and/or 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 H.P. 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.

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 29, 2017. 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, CPA
Investor Relations and Strategy Officer
314-654-3638
[email protected]

Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
[email protected]

Meredith Fischer
Chief Public Affairs Officer
908-997-9294
[email protected]

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. © 2018 Mallinckrodt.

¹ Generally accepted accounting principles in the United States 

SOURCE Mallinckrodt plc