Mallinckrodt plc Reports First Quarter 2025 Financial Results and Reaffirms Full-Year Guidance
Mallinckrodt plc Reports First Quarter 2025 Financial Results and Reaffirms Full-Year Guidance |
| [06-May-2025] |
Delivers First Quarter Net Sales of $419.9 Million, Reflecting a 10%Year-Over-Year Decrease on a Reported Basis; Excluding Impact of Therakos® Divestiture, Net Sales Grew 2.5% Reports Net Loss of $27.7 Million and Adjusted EBITDA of $102.3 Million Acthar® Gel (repository corticotropin injection) Net Sales Increased 12.3%, Representing Fifth Consecutive Quarter of Growth INOmax® EVOLVE™ DS Delivery System Now in More Than 50 Hospitals Nationwide Conference Call and Webcast Today at 8:30 a.m. ET DUBLIN, May 6, 2025 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the first quarter ended March 28, 2025.
"Our first quarter results demonstrate the positive momentum we are building across the Company and reinforce our optimism for the significant strategic benefits of our planned combination with Endo, Inc.," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, we again achieved double-digit sales growth for Acthar Gel, driven by increased patient demand from the launch of our SelfJect™ device and ongoing commercial investment. We are continuing our multi-year rollout of the INOmax EVOLVE DS delivery system, which is now in more than 50 hospitals across the U.S., and making good progress in our efforts to expand adoption of Terlivaz® (terlipressin) through healthcare provider outreach and engagement. Specialty Generics remains a consistent growth driver for our business, and we continue to see the benefits of our stable supply chain and reputation for quality and reliability in our strong overall performance. In light of our results, we are pleased to reaffirm our full-year guidance today, a sign of our confidence in the business." Mr. Olafsson added, "Our team has made excellent progress toward completing our merger with Endo to create a global, scaled, diversified pharmaceuticals leader, which we expect to occur in the second half of this year. I am confident that as one company, we will deliver even greater value to our shareholders and customers for the ultimate benefit of the patients we serve." First Quarter 2025 Financial Results Mallinckrodt's net sales in the first quarter of 2025 were $419.9 million, as compared to $467.8 million in the first quarter of 2024. This reflects a 10.2% decrease on a reported and constant currency basis. Excluding the impact of the Therakos divestiture, total net sales grew by 2.5%. The Company's Specialty Brands segment reported net sales of $207.3 million, as compared to $257.3 million in the first quarter of 2024. This 19.4% decrease includes the impact of the Therakos divestiture. Excluding Therakos, Specialty Brands net sales grew by 4.1%, driven primarily by growth in Acthar Gel and the uptake in SelfJect. Mallinckrodt's Specialty Generics segment reported net sales of $212.6 million, as compared to $210.5 million in the first quarter of 2024. This 1.0% growth was driven by continued strong attention deficit hyperactivity disorder (ADHD) product sales, offset by a decline in the active pharmaceutical ingredient (API) business, particularly Acetaminophen (APAP) products, driven primarily by global competition. The Company's net loss for the first quarter of 2025 was $27.7 million, an improvement from a net loss of $65.4 million in the first quarter of 2024. Mallinckrodt's Adjusted EBITDA in the first quarter of 2025 was $102.3 million, as compared to $144.9 million in the first quarter of 2024, driven by strength in both the Specialty Generics segment and Acthar Gel, largely offset by the impact of the Therakos divestiture, incremental commercial investments for Acthar Gel and the impact of nitric oxide competition in the U.S. Gross profit in the first quarter of 2025 increased $38.9 million, or 23.7%, to $202.9 million, as compared to $164.0 million in the first quarter of 2024. Gross profit margin was 48.3% in the first quarter of 2025, as compared with 35.1% in the first quarter of 2024. Mallinckrodt's cash balance at the end of the first quarter of 2025 was $422.2 million. Total outstanding principal debt was $864.6 million, a reduction of 47.5% compared to the first quarter of 2024, and outstanding net debt was $451.4 million, a reduction of 67.6% compared to the first quarter of 2024. First Quarter 2025 Business Segment Updates & Outlook Specialty Brands Segment Acthar Gel net sales increased $12.6 million, or 12.3%, compared to the first quarter of 2024 to $115.4 million, driven by growth in the overall market and the successful launch of SelfJect. SelfJect continues to receive positive physician and patient feedback and now accounts for more than 70% of new Acthar Gel prescriptions, reflecting momentum with both new and returning healthcare providers. In light of strong performance in the first quarter, which represented the fifth consecutive quarter of year-over-year growth for the brand, the Company now expects Acthar Gel to grow in the high-single digits in 2025. Terlivaz net sales increased $1.4 million, or 23.3%, compared to the first quarter of 2024 to $7.4 million. The Company remains focused on highlighting the potential benefits of treatment with Terlivaz with healthcare providers, emphasizing the importance of early patient identification and treatment initiation. INOmax (nitric oxide) net sales decreased $7.7 million, or 11.0%, compared to the first quarter of 2024 to $62.5 million. Despite continued competitive pressures in the U.S., the Company delivered net sales growth outside of the U.S., including 12.0% sales growth in Japan compared to the first quarter of 2024. The Company also continues to make progress on its rollout of the INOmax EVOLVE DS delivery system, with more than 400 systems placed in over 50 hospitals as of the end of March, and expects the rollout to continue through the end of 2026. Specialty Generics Segment Specialty Generics net sales growth was primarily driven by strong performance in the finished-dosage ADHD products business, offset primarily by global competitive pressures facing the API business, particularly APAP products. Mallinckrodt continues to expect the Specialty Generics segment to deliver flat to low-single digit sales growth in full-year 2025. Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the first quarter. Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended March 28, 2025, to be filed with the U.S. Securities and Exchange Commission (SEC) for additional information. 2025 Financial Guidance For the full-year fiscal 2025, Mallinckrodt reaffirmed its net sales and Adjusted EBITDA guidance:
The Company does not provide comparable GAAP measures for its forward-looking non-GAAP guidance or a reconciliation of such measures because the reconciling items described in the definition of Adjusted EBITDA provided below are inherently uncertain and difficult to estimate and cannot be predicted without unreasonable effort. The variability of such items may have a significant impact on our future GAAP results. First Quarter 2025 Conference Call and Webcast Mallinckrodt will hold a conference call today, May 6, 2025, at 8:30 a.m. Eastern Time to discuss its financial results and performance for the first quarter 2025. The live call and subsequent replay can be accessed as follows:
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, and ophthalmology; neonatal respiratory critical care therapies; 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 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 gross profit, adjusted selling, general, and administrative ("SG&A") expenses, adjusted research and development ("R&D") expenses, net sales growth (loss) 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 from intangible assets and right-of use asset resulting from finance leases; combination, integration, and other related expenses; restructuring charges, net; liabilities management and separation costs; divestitures; reorganization items, net; discontinued operations; changes in fair value of contingent consideration obligations; changes in derivative assets and liabilities fair value; unrealized gain or loss on equity investment; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. Adjusted gross profit, adjusted SG&A expenses and adjusted R&D expenses represent amounts prepared in accordance with GAAP, 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, the aforementioned items in the Adjusted EBITDA paragraph. The adjustments for these items are on a pre-tax basis for adjusted gross profit and adjusted SG&A expenses. Segment net sales growth (loss) 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 of $451.4 million as of March 28, 2025, reflects $864.6 million in total debt outstanding and $9.0 million in undiscounted finance lease liabilities on a GAAP basis less $422.2 million in cash and cash equivalents (unrestricted cash) on a GAAP basis. 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 and liquidity. In addition, the Company believes that they will be used by 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. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information About the Combination and Where to Find It In connection with the proposed transaction, Mallinckrodt has filed with the SEC a registration statement on Form S-4 that includes a preliminary joint proxy statement of Mallinckrodt and Endo and that also constitutes a preliminary prospectus of Mallinckrodt ordinary shares. Each of Mallinckrodt and Endo may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the joint proxy statement/prospectus or registration statement or any other document that Mallinckrodt or Endo may file with the SEC. The definitive joint proxy statement/prospectus (if and when available) will be mailed to shareholders of Mallinckrodt and Endo. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, JOINT PROXY STATEMENT/PROSPECTUS, AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and joint proxy statement/prospectus (if and when available) and other documents containing important information about Mallinckrodt, Endo, and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Mallinckrodt will be available free of charge on Mallinckrodt's website at https://ir.mallinckrodt.com. Copies of the documents filed with the SEC by Endo will be available free of charge on Endo's website at https://investor.endo.com. Participants in the Solicitation of Proxies Mallinckrodt, Endo, and certain of their respective directors, executive officers, and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of Mallinckrodt, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in (i) Mallinckrodt's proxy statement for its 2025 Annual Meeting of Shareholders, which was filed with the SEC on April 3, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/0001567892/000110465925031453/tm252514-2_def14a.htm), including under the headings "Our Director Nominees", "Corporate Governance", "Board of Directors and Board Committees," "Compensation of Non-Employee Directors," "Compensation of Executive Officers," "Security Ownership and Reporting," "Equity Compensation Plan Information" and "Proposals 1(A) Through 1(E): Election of Directors", (ii) Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended December 27, 2024, which was filed with the SEC on March 13, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/1567892/000156789225000010/mnk-20241227.htm), including under the headings "Item 10. Directors, Executive Officers and Corporate Governance", "Item 11. Executive Compensation", "Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters", "Item 13. Certain Relationships and Related Transactions and Director Independence", and (iii) to the extent holdings of Mallinckrodt's securities by its directors or executive officers have changed since the amounts set forth in Mallinckrodt's proxy statement for its 2025 Annual Meeting of Shareholders, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001567892&type=&dateb=&owner=only&count=40&search_text=). Information about the directors and executive officers of Endo, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in (i) the registration statement on Form S-4, (ii) Endo's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 13, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/2008861/000200886125000007/ndoi-20241231.htm), including under the headings "Item 10. Directors, Executive Officers and Corporate Governance", "Item 11. Executive Compensation", "Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters", "Item 13. Certain Relationships and Related Transactions and Director Independence", and (iii) to the extent holdings of Endo's securities by its directors or executive officers have changed since the amounts set forth in the registration statement on Form S-4, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0002008861&type=&dateb=&owner=only&count=40&search_text=). Other information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the preliminary joint proxy statement/prospectus and will be contained in other relevant materials to be filed with the SEC regarding the proposed transaction when such materials become available. Investors should read these materials carefully before making any voting or investment decisions. You may obtain free copies of these documents from Mallinckrodt or Endo using the sources indicated above. Information Regarding Forward Looking Statements Statements in this communication that are not strictly historical 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 registration statement on Form S-4 filed with the SEC describes additional risks in connection with the proposed transaction. While the list of factors presented here is, and the list of factors presented in the registration statement on Form S-4 are, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. For additional information about other factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Mallinckrodt's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC, which are available from the SEC's website (www.sec.gov) and Mallinckrodt's website (www.mallinckrodt.com) and Endo's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and other filings with the SEC, which are available from the SEC's website (www.sec.gov) and Endo's website (www.endo.com). There may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt and Endo do 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements. CONTACTS Investor Relations Media 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. © 2025.
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Company Codes: NYSE:MNK, AMEX:MNK | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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