{"id":846995,"date":"2025-05-06T06:48:53","date_gmt":"2025-05-06T10:48:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/mallinckrodt-plc-reports-first-quarter-2025-financial-results-and-reaffirms-full-year-guidance\/"},"modified":"2025-05-06T06:48:53","modified_gmt":"2025-05-06T10:48:53","slug":"mallinckrodt-plc-reports-first-quarter-2025-financial-results-and-reaffirms-full-year-guidance","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/mallinckrodt-plc-reports-first-quarter-2025-financial-results-and-reaffirms-full-year-guidance\/","title":{"rendered":"Mallinckrodt plc Reports First Quarter 2025 Financial Results and Reaffirms Full-Year Guidance"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Delivers First\u00a0Quarter Net Sales of $419<\/span>.9\u00a0Million, Reflecting a 10%Year-Over-Year Decrease on a Reported Basis; Excluding Impact of Therakos\u00ae<\/sup>\u00a0Divestiture, Net Sales Grew 2.5%<\/i>\n <\/p>\n

\n Reports Net Loss of $27.7 Million<\/span> and Adjusted EBITDA of $102.3 Million<\/span><\/i>\n <\/p>\n

\n Acthar\u00ae<\/sup> Gel (repository corticotropin injection) Net Sales Increased 12.3%, Representing Fifth Consecutive Quarter of Growth<\/i>\n <\/p>\n

\n INOmax\u00ae <\/sup><\/b>EVOLVE\u2122 DS Delivery System Now in More Than 50 Hospitals Nationwide<\/i>\n <\/p>\n

\n Conference Call and Webcast Today at 8:30 a.m. ET<\/span><\/i>\n <\/p>\n

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\n DUBLIN<\/span>
\n <\/span>, May 6, 2025<\/span><\/span> \/PRNewswire\/ — Mallinckrodt<\/span> plc<\/u><\/a> (“Mallinckrodt<\/span>” or the “Company”), a global specialty pharmaceutical company, today reported its financial results for the first quarter ended March\u00a028, 2025.<\/p>\n

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\n
\n \"Mallinckrodt
\n <\/a>\n <\/p>\n<\/p><\/div>\n

“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<\/span>, President and Chief Executive Officer. “In Specialty Brands, we again achieved double-digit sales growth for Acthar\u00a0Gel, driven by increased patient demand from the launch of our SelfJect\u2122 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\u00ae <\/sup>(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.”<\/p>\n

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.”<\/p>\n

\n First<\/b>
\n Quarter 2025 Financial Results<\/b>\n <\/p>\n

\n Mallinckrodt’s<\/span> net sales in the first quarter of 2025 were $419.9 million<\/span>, as compared to $467.8 million<\/span> 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%.<\/p>\n

The Company’s Specialty Brands segment reported net sales of $207.3 million<\/span>, as compared to $257.3 million<\/span> 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.<\/p>\n

\n Mallinckrodt’s<\/span> Specialty Generics segment reported net sales of $212.6 million<\/span>, as compared to $210.5 million<\/span> 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.<\/p>\n

The Company’s net loss for the first quarter of 2025 was $27.7 million<\/span>, an improvement from a net loss of $65.4 million<\/span> in the first quarter of 2024.<\/p>\n

\n Mallinckrodt’s<\/span> Adjusted EBITDA in the first quarter of 2025 was $102.3 million<\/span>, as compared to $144.9 million<\/span> 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.<\/p>\n

Gross profit in the first quarter of 2025 increased $38.9 million<\/span>, or 23.7%, to $202.9 million<\/span>, as compared to $164.0 million<\/span> 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.<\/p>\n

\n Mallinckrodt’s<\/span> cash balance at the end of the first quarter of 2025 was $422.2 million<\/span>. Total outstanding principal debt was $864.6 million<\/span>, a reduction of 47.5% compared to the first quarter of 2024, and outstanding net debt was $451.4 million<\/span>, a reduction of 67.6% compared to the first quarter of 2024.<\/p>\n

\n First<\/b>
\n \u00a0Quarter 2025 Business Segment Updates & Outlook<\/b>\n <\/p>\n

\n
\n Specialty Brands Segment<\/i>
\n <\/b>\n <\/p>\n

\n Acthar Gel <\/b>net sales increased $12.6 million<\/span>, or 12.3%, compared to the first quarter of 2024 to $115.4 million<\/span>, 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.<\/p>\n

\n Terlivaz<\/b>\u00a0net sales increased $1.4 million<\/span>, or 23.3%, compared to the first quarter of 2024 to $7.4 million<\/span>. 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.<\/p>\n

\n INOmax (nitric oxide)<\/b>\u00a0net sales decreased $7.7 million<\/span>, or 11.0%, compared to the first quarter of 2024 to $62.5 million<\/span>. 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<\/span> 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.<\/p>\n

\n
\n Specialty Generics Segment<\/i>
\n <\/b>\n <\/p>\n

\n Specialty Generics<\/b>\u00a0net 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<\/span> continues to expect the Specialty Generics segment to deliver flat to low-single digit sales growth in full-year 2025.<\/p>\n

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.<\/p>\n

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\u00a028, 2025, to be filed with the U.S. Securities and Exchange Commission (SEC) for additional information.<\/p>\n

\n 2025<\/b>
\n Financial Guidance<\/b>\n <\/p>\n

For the full-year fiscal 2025, Mallinckrodt<\/span> reaffirmed its net sales and Adjusted EBITDA guidance:<\/p>\n

\n\n\n\n\n
\n \n <\/td>\n\n

\n
\n 2025<\/b>
\n \u00a0Guidance<\/b>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Total Net Sales<\/span>\n <\/p>\n<\/td>\n

\n

\n \u00a0$1.7 billion to $1.8 billion<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Adjusted EBITDA<\/span>\n <\/p>\n<\/td>\n

\n

\n \u00a0$480 million to $520 million<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

\u00a0<\/p>\n

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.<\/p>\n

\n First Quarter 2025 Conference Call and Webcast<\/b>\n <\/p>\n

\n Mallinckrodt<\/span> will hold a conference call today, May\u00a06, 2025, at 8:30 a.m. Eastern Time<\/span> to discuss its financial results and performance for the first quarter 2025. The live call and subsequent replay can be accessed as follows:<\/p>\n