Mallinckrodt plc Reports Third Quarter 2022 Financial Results and Reaffirms Guidance

Launched Terlivaz^® Following U.S. Food and Drug Administration (FDA) Approval in September; Submitted U.S. FDA Premarket Notification Application for Next-Generation Delivery System of INOmax^®

Strengthened Organization with Appointment of New Executives and Directors; Ordinary Shares Commenced Trading on NYSE American in October

Conference Call and Webcast Today at 8:30 a.m. ET

DUBLIN, Nov. 8, 2022 /PRNewswire/ -- Mallinckrodt plc (NYSE:MNK) ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported results for the third quarter ended September 30, 2022.¹

"We are pleased to reaffirm our 2022 guidance following solid performance in the third quarter," said Siggi Olafsson, President and Chief Executive Officer. "We made important progress executing on our strategic initiatives, including advancing Mallinckrodt's branded pipeline, improving our balance sheet and strengthening the organization with key leadership appointments at the executive and board levels, adding deep commercial and human resources expertise. More recently, we received approval and commenced trading on NYSE American, providing enhanced liquidity and access for our shareholders."

Mr. Olafsson continued, "We are also excited to report that we recently launched Terlivaz (terlipressin) for injection, which in September became the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome. Looking ahead, I am confident we are well-positioned to continue advancing our strategic initiatives and create long-term value for shareholders while improving outcomes for patients with severe and critical conditions."

Third Quarter 2022 Financial Results¹

Mallinckrodt's net sales in the third quarter 2022 were $465.4 million, as compared to $507.2 million in the third quarter 2021. This reflects a decrease of 8.2% on a reported basis and 7.5% on a constant currency basis.

The Company's Specialty Brands segment reported net sales of $303.5 million, as compared to $359.7 million. This reflects a decrease of 15.6% on a reported basis and 14.7% on a constant currency basis, primarily due to the impact of competition; utilization of certain products due to the continued impact of the pandemic; and continued scrutiny on overall specialty pharmaceutical spending.

Mallinckrodt's Specialty Generics segment reported net sales of $161.9 million, as compared to $147.5 million. This reflects an increase of 9.8% on a reported basis and 9.9% on a constant currency basis, primarily due to growth in acetaminophen (APAP) and attention-deficit hyperactivity disorder (ADHD) products.

The Company recorded a net loss for the third quarter of $284.9 million, as compared to a net loss of $263.7 million. Diluted loss per share was $21.58 with adjusted diluted earnings per share of $5.25 for the third quarter.

Mallinckrodt's Adjusted EBITDA in the third quarter was $166.1 million, as compared to $185.7 million. This reflects a decrease of 10.6%, primarily due to lower net sales; investments associated with the launches of StrataGraft^® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat) and Terlivaz; and the impact from foreign currency, partially offset by other reductions in selling, general and administrative (SG&A) expenses and research and development (R&D) expenses as a result of the Company's initiatives to improve its overall cost structure.

Mallinckrodt's cash balance at the end of the third quarter was $391.2 million, and the Company continues to maintain an undrawn $200 million accounts receivable financing facility, ending the quarter with approximately $590 million in liquidity. Total principal debt outstanding at the end of the third quarter was $3.584 billion, with net debt of $3.193 billion, which reflects certain repurchases of second lien notes due 2025 and 2029 at a discount.

Pipeline Highlights

Mallinckrodt received U.S. Food and Drug Administration (FDA) approval of Terlivaz (terlipressin) for injection in September, ahead of its December 2022 PDUFA date. This enabled the Company to subsequently launch Terlivaz ahead of schedule, and product is now shipping across the United States.

In addition, the Company made progress during the third quarter toward its planned 2023 launch of its next-generation delivery system of INOmax (nitric oxide) gas, for inhalation. In September, Mallinckrodt submitted a 510(k) premarket notification application to the FDA. Consistent with its review process, the FDA asked Mallinckrodt to provide summary tables of certain submitted data, which the Company anticipates submitting later this month.

2022 Financial Guidance

For the full-year 2022, Mallinckrodt reaffirmed the following guidance:

Conference Call and Webcast

Mallinckrodt will hold a conference call today, November 8, 2022, at 8:30 a.m. Eastern Time to discuss the results of its financial performance for the third quarter 2022. The live call and subsequent replay can be accessed as follows:

• Live Call Participant Registration (including dial-in): https://register.vevent.com/register/BIf21622d19b2541d683e118c8be5a33c2
• Directly via the webcast link (live and replay): https://edge.media-server.com/mmc/p/mqe6ixxi
• At the Company's website: https://ir.mallinckrodt.com/

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, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes 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 EBITDA, adjusted net income, adjusted diluted earnings per share, adjusted gross profit, adjusted SG&A, net sales growth on a constant-currency basis, and net debt, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations.

Adjusted EBITDA represents net income or loss 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. Adjustments to GAAP amounts include, as applicable to each measure, interest expense, net; income taxes; depreciation; amortization; restructuring charges, net; non-restructuring impairment charges; inventory step-up expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; separation costs; gains on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start related expenses; and other items identified by the Company.

Adjusted net income, adjusted gross profit and adjusted SG&A represent amounts prepared in accordance with GAAP, 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 expense; discontinued operations; changes in fair value of contingent consideration obligations; significant legal and environmental charges; divestitures; separation costs; gains on debt extinguishment, net; acquisition and fresh-start related expenses; unrealized gain or loss on equity investments; reorganization items, net; tax effects of the aforementioned adjustments, changes in uncertain tax positions, as well as tax impacts from certain transactions, such as acquisitions or legal entity or asset reorganizations; and other items identified by the company. Adjusted diluted earnings per share represent adjusted net income divided by the number of diluted shares.

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

Net debt as of September 30, 2022 represents the total principal debt outstanding of $3.584 billion, less cash of $391.2 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 unaudited condensed 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.

Predecessor and Successor Periods

Mallinckrodt's financial results for the year-to-date period ending September 30, 2022 include Successor and Predecessor periods. The Successor period runs from June 17, 2022 through September 30, 2022, while the Predecessor period includes January 1, 2022 through, and including, June 16, 2022. As a result of the application of fresh-start accounting, the Company's financial statements for periods prior to June 16, 2022 are not comparable to those for periods subsequent to June 16, 2022. Operating results for the Successor and Predecessor periods are not necessarily indicative of the results to be expected for a full fiscal year.

Mallinckrodt's results of operations as reported in its unaudited condensed consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The presentation of the combined financial information of the Predecessor and Successor periods for the nine months ended September 30, 2022 is not in accordance with GAAP. However, the Company believes that for purposes of discussion and analysis, the combined financial information is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. Accordingly, in addition to presenting results of operations as reported in unaudited condensed consolidated financial statements in accordance with GAAP, certain tables and discussion included within this release also present the combined results for nine months ended September 30, 2022.

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, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, and any other statements regarding events or developments Mallinckrodt 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: the comparability of Mallinckrodt's post-emergence financial results to its historical results and the projections filed with the bankruptcy court, changes in Mallinckrodt's business strategy that may be implemented by its board of directors, the listing of Mallinckrodt's ordinary shares on NYSE American LLC, the emergence of an active trading market for Mallinckrodt's ordinary shares and fluctuations in market price and trading volume, Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended, Mallinckrodt repurchases of debt securities, the effects of the Chapter 11 cases on the liquidity, results of operations and businesses of Mallinckrodt and its subsidiaries; governmental investigations and inquiries, regulatory actions and lawsuits brought against Mallinckrodt by government agencies and private parties with respect to its historical commercialization of opioids, including the agreement set forth in the Chapter 11 plan regarding a global settlement to resolve all opioid-related claims; the settlement set forth in the Chapter 11 plan with governmental parties to resolve certain disputes relating to Acthar Gel; the ability to maintain relationships with Mallinckrodt's suppliers, customers, employees and other third parties as a result of, and following, the Chapter 11 cases; the possibility that Mallinckrodt may be unable to achieve its business and strategic goals even now that the Chapter 11 plan is successfully consummated; the non-dischargeability of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt's business plan and continuing as a going concern; Mallinckrodt's post-bankruptcy capital structure; scrutiny from governments, legislative bodies and enforcement agencies related to sales, marketing and pricing practices; 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; the impact of the outbreak of the COVID-19 coronavirus; the reimbursement practices of governmental health administration authorities, private health coverage insurers and other third-party payers; complex reporting and payment obligations under the Medicare and Medicaid rebate programs and other governmental purchasing and rebate programs; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; changes in or failure to comply with relevant laws and regulations; Mallinckrodt's and its partners' ability to successfully develop or commercialize new products or expand commercial opportunities; Mallinckrodt's ability to navigate price fluctuations; competition; Mallinckrodt's and its partners' ability to protect intellectual property rights; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental liabilities; potential indemnification liabilities to Covidien pursuant to the separation and distribution agreement; business development activities; retention of key personnel; the effectiveness of information technology infrastructure including cybersecurity and data leakage risks; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; conducting business internationally; Mallinckrodt's ability to achieve expected benefits from restructuring activities; Mallinckrodt's significant levels of intangible assets and related impairment testing; labor and employment laws and regulations; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; Mallinckrodt's ability to generate sufficient cash to service indebtedness even now that the prepetition indebtedness has been restructured; restrictions on Mallinckrodt's operations contained in the agreements governing Mallinckrodt's indebtedness; Mallinckrodt's variable rate indebtedness; future changes to U.S. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

The "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Reports on Form 10-Q for the quarterly periods ended September 30, 2022, July 1, 2022 and April 1, 2022, and other filings with the SEC, all of which are on file with the SEC and available on Mallinckrodt's website at http://www.sec.gov and http://www.mallinckrodt.com respectively, identify and describe in more detail the risks and uncertainties to which Mallinckrodt's businesses are subject. 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 Speciale

Global Corporate Controller and Chief Investor Relations Officer

314-654-3638

[email protected]

Derek Belz

Vice President, Investor Relations

314-654-3950

[email protected]

Media

Michael Freitag / Aaron Palash / Aura Reinhard

Joele Frank, Wilkinson Brimmer Katcher

212-355-4449

Exhibit 99.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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SOURCE Mallinckrodt plc