Market Overview

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

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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.

Mallinckrodt logo

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 RESULTS
Gross 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 Results
Net 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 Segment
Net 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 Segment
The 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.

LIQUIDITY
Cash 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 UPDATE
Mallinckrodt 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 WEBCAST
Mallinckrodt 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 MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, 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 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 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 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, 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, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com

Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@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)








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