Corticotropin

Demonstrated Dose Dependent Effect in EAU Presented in a podium presentation at The Association for Research in Vision and Ophthalmology (ARVO) 2025 annual meeting PRINCETON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced preclinical data on the use of Purified Cortrophin® Gel (repository corticotropin injection USP) (Cortrophin Gel) in an EAU mouse model. “In a preclinical model of autoimmune uveitis, Cortrophin Gel reduced levels of inflammatory molecules without stimulating an adverse immune response,” said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. “The results further support our understanding of Cortrophin Gel’s mechanism of action.” An experimental autoimmune uveitis (EAU) mouse model was used to determine the impact of four doses (4, 40, 160 or 400 U/kg) of repository corticotrophin injection (RCI, an equivalent to Cortrophin Gel in this model). The results showed a significant dose-dependent effect on the suppression of EAU at all doses, with the greatest suppression of EAU at the 400 U/kg dose. RCI also significantly suppressed the production of cytokines implicated in inflammation and immune system activation. Additionally, 400 U/kg Purified Cortrophin Gel treatment suppressed retinal damage caused by EAU, similar to α-MSH treatment, compared to placebo. “The data presentation at ARVO is part of ANI’s broader commitment to clinical research for our products and, specific to Cortrophin Gel, we are committed to building on the scientific evidence and clinical data supporting its mechanism of action and clinical use,” said Nikhil Lalwani, President and Chief Executive Officer at ANI. The data were presented yesterday in a podium presentation by Andrew W. Taylor, PhD at The Association for Research in Vision and Ophthalmology (ARVO) 2025 annual meeting being held May 4-8, 2025 in Salt Lake City, UT. Dr. Taylor is the Sarkis J. Kechejian Professor; Associate Dean of Research; and Professor & Vice-Chair of Research, Department of Ophthalmology at Boston University Chobanian & Avedisian School of Medicine. Presentation Title: The Therapeutic Effects of Purified Cortrophin® Gel on Experimental Autoimmune UveitisSession Title: Innovative Strategies For Modulating Ocular InflammationPresentation #: 896Presentation Time: Sunday, May 4, 2025 from 4:45 PM to 5:00 PMLead Author: Andrew W. Taylor, PhD The abstract and presentation are available online at https://www.arvo.org/annual-meeting/. About Uveitis Uveitis is an inflammatory condition affecting the uvea, the middle layer of the eye. Indication Cortrophin Gel is a prescription medicine that is injected subcutaneously or intramuscularly. It is indicated for: Severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa, such as allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation. Important Safety Information Contraindications Cortrophin Gel is contraindicated for intravenous administration.Cortrophin Gel is contraindicated in patients who have any of the following conditions: scleroderma; osteoporosis; systemic fungal infections; ocular herpes simplex; recent surgery; history of or the presence of a peptic ulcer; congestive heart failure; hypertension; primary adrenocortical insufficiency; adrenocortical hyperfunction; or sensitivity to proteins derived from porcine sources. Warnings and Precautions Infections: Corticotropin therapy may increase susceptibility to infections and may mask the symptoms of infections.Adrenal insufficiency: Prolonged corticotropin therapy can increase the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by gradually reducing the corticotropin dosage. Hormone therapy should be reinstituted if stressful situations arise during discontinuation.Elevated blood pressure, salt and water retention, and hypokalemia: Corticotropin can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium or calcium.Masking symptoms of other diseases: Corticotropin may only suppress signs and symptoms of chronic disease without altering the natural course of disease.Psychiatric reactions: Psychic derangements may appear when corticotropin is used, ranging from euphoria, insomnia, mood swings, personality changes, and depression to psychosis. Existing conditions may be aggravated.Ophthalmic reactions: Prolonged use of corticotropin may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves.Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.Vaccination: Patients should not be vaccinated against smallpox while on corticotropin therapy. Other immunizations should be undertaken with caution due to possible neurologic complications and lack of antibody response.Use in patients with hypothyroidism and cirrhosis: There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis.Use in patients with latent tuberculosis or tuberculin reactivity: Closely observe for reactivation of the disease.Comorbid diseases: Corticotropin should be used with caution in patients with diabetes, abscess, pyogenic infections, diverticulitis, renal insufficiency, and myasthenia gravis.Growth and development: Carefully observe growth and development of infants and children on prolonged corticotropin therapy.Acute gouty arthritis: Treatment of acute gouty arthritis should be limited to a few days. Conventional concomitant therapy should be administered during corticotropin treatment and for several days after it is stopped.Drug interactions: Aspirin should be used cautiously with corticotropin in hypoprothrombinemia.Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Adverse Reactions Adverse reactions for Cortrophin Gel include fluid or sodium retention; muscle weakness; osteoporosis; peptic ulcer with possible perforation and hemorrhage; injection site reactions; impaired wound healing; hypertension; convulsions; headache; development of Cushingoid state; suppression of growth in children; and weight gain. These are not all the adverse reactions reported with Cortrophin Gel. Please see full Prescribing Information. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com. Forward-Looking Statements This press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the recent acquisition of Alimera; the risks that our acquisitions and investments, including the acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

Achieved High End of Full-Year Net Sales Guidance Range and Midpoint of Adjusted EBITDA Guidance Range Grew Full-Year Net Sales by 6.1% to $2.0 Billion, with 14.2% Growth in Acthar® Gel (repository corticotropin injection) and 15.4% Growth in Specialty Generics; Reduced Total Debt by 47% and Net Debt by Approximately 64% Acthar Gel Returned to Growth with Successful Launch of SelfJect™ Device; Uptake of INOmax ® EVOLVE™ DS Delivery System Accelerated in Second Half of the Year Expects 2025 Net Sales of $1.7 Billion to $1.8 Billion and Adjusted EBITDA of $480 Million to $520 Million DUBLIN, March 13, 2025 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the fourth quarter and fiscal year ended December 27, 2024.1 "Our strong performance in 2024 reflects the disciplined execution of our strategy to position Mallinckrodt for long-term success," said Siggi Olafsson, President and Chief Executive Officer. "In Specialty Brands, Acthar Gel returned to growth, marking a key milestone for the brand, with four consecutive quarters of rising net sales. This was driven by prescriber enthusiasm, patient demand and the launch of SelfJect for Acthar Gel, which has exceeded our expectations. We are continuing the commercial rollout of our INOmax EVOLVE DS delivery system to U.S. hospitals nationwide and are pleased with the positive feedback to date. Additionally, we meaningfully grew Terlivaz® (terlipressin) for injection in 2024 and continue to engage with providers about the benefits of early patient identification and treatment." Mr. Olafsson added, "In Specialty Generics, we closed out an exceptional year, with double-digit net sales growth driven by rising demand and our ability to consistently and reliably deliver high-quality products. As we move through 2025 and beyond, we will continue to advance our strategic priorities as we build toward long-term sustainable growth and value creation for all our stakeholders." Fourth Quarter 2024 Financial Results Mallinckrodt's net sales in the fourth quarter of 2024 were $492.1 million, as compared to $469.3 million in the fourth quarter of 2023. This reflects 4.9% growth on a reported basis and 4.8% growth on a constant currency basis. The Company's Specialty Brands segment reported net sales of $265.6 million, as compared to $270.7 million in the fourth quarter of 2023. This 1.9% decrease includes the impact of the Therakos® sale. Excluding Therakos, Specialty Brands net sales grew by 8.9%, driven by growth in Acthar Gel and uptake in SelfJect and Terlivaz. Mallinckrodt's Specialty Generics segment reported net sales of $226.5 million, as compared to $198.6 million in the fourth quarter of 2023. This 14.0% growth was driven by the Company's established track record as a reliable and consistent producer of high-quality products amidst market shortages due to quality and other disruptions, in both the finished dosage products and Controlled Substances active pharmaceutical ingredient (API) businesses, partially offset by a decline in the Acetaminophen (APAP) business as a result of overall softening of the market. The Company's net income for the fourth quarter was $612.8 million, a 41.8% decrease as compared to net income of $1.05 billion in the fourth quarter of 2023. Mallinckrodt's Adjusted EBITDA in the fourth quarter was $124.2 million, essentially flat compared to $123.8 million in the fourth quarter of 2023. This stability was driven by strength in both the Specialty Generics segment and Acthar Gel, largely offset by approximately $9.0 million of transaction-related compensation expenses related to the sale of Therakos, the impact of the Therakos transaction, incremental commercial investments for Acthar Gel and Terlivaz, and the impact of nitric oxide competition in the U.S. Gross profit as a percentage of net sales was 50.2% for the fourth quarter, as compared to 17.2% for the fourth quarter of 2023. Adjusted gross profit as a percentage of net sales was 63.0% for the fourth quarter, as compared to 62.3% for the fourth quarter of 2023. Mallinckrodt's cash balance at the end of the fourth quarter of 2024 was $382.6 million. Total outstanding principal debt was $865.6 million, a reduction of 47% compared to the end of 2023, and outstanding net debt was $492.1 million, a reduction of approximately 64% compared to the end of 2023. Fiscal Year 2024 Results1 Mallinckrodt's net sales were $1.98 billion, an increase of 6.1% compared to $1.87 billion in fiscal 2023. Full-year net sales in the Specialty Brands segment were $1.08 billion in fiscal 2024, essentially flat compared to $1.09 billion in fiscal 2023. Excluding Therakos, Specialty Brands net sales grew 1.4%. Full-year net sales in the Specialty Generics segment were $896.3 million, an increase of 15.4% compared to $776.9 million in fiscal 2023 reflecting the factors discussed above. The Company recorded net income of $477.9 million in fiscal 2024, a substantial improvement as compared to a net loss of $1.67 billion in fiscal 2023. Mallinckrodt's Adjusted EBITDA was $603.7 million in fiscal 2024, an increase of 5.6% compared to $571.9 million in fiscal 2023. Excluding the impact of the Therakos business, Adjusted EBITDA grew by 12.9%. Business Segment Updates & Outlook Specialty Brands Acthar Gel net sales were $138.8 million in the fourth quarter, an increase of 33.0% versus the prior year period, and $485.7 million for the full year, an increase of 14.2%. Growth in the fourth quarter was driven by the successful launch of SelfJect, which accounted for more than 70% of new Acthar Gel prescriptions, as well as prescriber enthusiasm and patient demand. The Company expects Acthar Gel to continue its momentum and grow in the low-single digits in 2025. Terlivaz net sales were $6.1 million in the fourth quarter, up from $5.6 million in the same period last year, and $24.7 million for the full year, up from $15.6 million. The Company continues to engage with healthcare providers to highlight the benefits of early patient identification and treatment initiation. INOmax (nitric oxide) net sales were $60.8 million in the fourth quarter, down 14.0% compared to the prior year period, and full-year net sales were $261.4 million, down 13.8%, primarily due to competitive pressures in the U.S. The Company remains focused on the multi-year rollout of the INOmax EVOLVE DS delivery system and continues to believe this new offering will help stabilize the brand. Specialty Generics Mallinckrodt expects the Specialty Generics segment to deliver flat to low-single digit sales growth in full-year 2025, driven by the Company's strong market position and performance in finished-dosage products, demand for Controlled Substance APIs and the Company's differentiated position as a consistent supplier of high-quality products, moderated by softness in the APAP market, which is expected to continue. 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 fourth quarter. Please see the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the year ended December 27, 2024 filed with the U.S. Securities and Exchange Commission (SEC) for additional information. 2025 Financial Guidance For the full-year fiscal 2025, Mallinckrodt expects: 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. Update on Fourth Quarter and Fiscal Year 2024 Conference Call and Webcast Mallinckrodt will no longer host its previously planned quarterly conference call and webcast this morning. Mallinckrodt has issued a separate press release this morning in conjunction with a proposed transaction with Endo, Inc. which includes the details of a joint conference call and webcast to be held this morning. The Company has posted prepared remarks regarding its fourth quarter and fiscal year 2024 financial results on the Investor Relations section of its website at . 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 . 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; 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; liabilities management and separation costs; losses on debt extinguishment, net; unrealized gain or loss on equity investment; reorganization items, net; share-based compensation; fresh-start inventory related expenses; and other items identified by the Company. Full-year 2024 adjusted EBITDA for Therakos is calculated consistently with the Company Adjusted EBITDA and also includes operating expenses allocated to the Therakos business. 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 $492.1 million as of December 27, 2024, reflects $865.6 million in total debt principal outstanding and $9.1 million in undiscounted finance lease liabilities on a GAAP basis less $382.6 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. Predecessor and Successor Periods Mallinckrodt's financial results presented in this press release include Successor and Predecessor periods. The year ended December 27, 2024 and the period from November 15, 2023 through December 29, 2023 reflect the Successor periods, while the period December 31, 2022 through, and including, November 14, 2023 reflects the Predecessor period. We do not believe that reviewing the results of the Successor period in isolation would be useful in identifying trends in or reaching conclusions regarding our overall operating performance. Management believes that our key performance metrics such as net sales and segment operating income (loss) for the year ended December 27, 2024 (Successor) provide a meaningful comparison and are useful in identifying current business trends when compared to the year ended December 29, 2023 (Successor). The Company reports its results based on a "52-53 week" year ending on the last Friday of December. The year ended December 27, 2024 (Successor) ("fiscal 2024") and the combined periods of December 31, 2022 through November 14, 2023 (Predecessor) and November 15, 2023 through December 29, 2023 (Successor) ("fiscal 2023") consisted of 52 weeks. The three months ended December 27, 2024 and the combined periods of September 30, 2023 through November 14, 2023 and November 15, 2023 through December 29, 2023 ("three months ended December 29, 2023") consisted of 13 weeks. Mallinckrodt's results of operations as reported in its unaudited consolidated financial statements for the Successor and Predecessor periods are in accordance with GAAP. The comparison of the Predecessor and Successor periods for the periods presented here is not in accordance with GAAP. However, the Company believes that the comparison is useful for management and investors to assess Mallinckrodt's ongoing financial and operational performance and trends. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS Statements in this press release that are not strictly historical, including statements regarding future financial condition and operating results, expected product launches, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses, the ongoing strategic review, 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 proposed transaction with Endo; potential changes in Mallinckrodt's business strategy and performance; Mallinckrodt's initiative to explore a variety of potential divestiture, financing and other transactional opportunities; the exercise of contingent value rights by the Opioid Master Disbursement Trust II (the "Trust"); governmental investigations and inquiries, regulatory actions, and lawsuits, in each case related to Mallinckrodt or its officers; Mallinckrodt's contractual and court-ordered compliance obligations that, if violated, could result in penalties; compliance with and restrictions under the global settlement to resolve all opioid-related claims; matters related to Acthar Gel, including the settlement with governmental parties to resolve certain disputes and compliance with and restrictions under the related corporate integrity agreement; the ability to maintain relationships with Mallinckrodt's suppliers, customers, employees and other third parties following the emergence from the 2023 bankruptcy proceedings; 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' or other payers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; 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; any undesirable side effects caused by Mallinckrodt's approved and investigational products, which could limit their commercial profile or result in other negative consequences; Mallinckrodt's and its partners' ability to successfully develop, commercialize or launch new products or expand commercial opportunities of existing products, including Acthar Gel (repository corticotropin injection) SelfJect and the INOmax Evolve DS delivery system; Mallinckrodt's ability to successfully identify or discover additional products or product candidates; Mallinckrodt's ability to navigate price fluctuations and pressures, including the ability to achieve anticipated benefits of price increases of its products; competition; Mallinckrodt's ability to protect intellectual property rights, including in relation to ongoing and future litigation; limited clinical trial data for Acthar Gel; the timing, expense and uncertainty associated with clinical studies and related regulatory processes; product liability losses and other litigation liability; material health, safety and environmental laws and related liabilities; business development activities or other strategic transactions; attraction and retention of key personnel; the effectiveness of information technology infrastructure, including risks of external attacks or failures; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; Mallinckrodt's ability to receive sufficient procurement and production quotas granted by the U.S. Drug Enforcement Administration; complex manufacturing processes; reliance on third-party manufacturers and supply chain providers and related market disruptions; conducting business internationally; Mallinckrodt's significant levels of intangible assets and related impairment testing; natural disasters or other catastrophic events; Mallinckrodt's substantial indebtedness and settlement obligation, its ability to generate sufficient cash to reduce its indebtedness and its potential need and ability to incur further indebtedness; restrictions contained in the agreements governing Mallinckrodt's indebtedness and settlement obligation on Mallinckrodt's operations, future financings and use of proceeds; Mallinckrodt's variable rate indebtedness; Mallinckrodt's tax treatment by the Internal Revenue Service under Section 7874 and Section 382 of the Internal Revenue Code of 1986, as amended; future changes to applicable tax laws or the impact of disputes with governmental tax authorities; the impact of Irish laws; the impact on the holders of Mallinckrodt's ordinary shares if Mallinckrodt were to cease to be a reporting company in the United States; the comparability of Mallinckrodt's post-emergence financial results and the projections filed with the Bankruptcy Court; and the lack of comparability of Mallinckrodt's historical financial statements and information contained in its financial statements after the adoption of fresh-start accounting following emergence from the 2023 bankruptcy proceedings. 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 27, 2024, to be filed with the SEC, and its Quarterly Report on Form 10-Q for the quarterly periods ended March 29, 2024, June 28, 2024, September 27, 2024, and other filings with the SEC, all of which are on file with the SEC and available from the SEC's website () and Mallinckrodt's website (), identify and describe in more detail the risks and uncertainties to which Mallinckrodt's businesses are subject. 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 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. Given these uncertainties, one should not put undue reliance on any forward-looking statements. 1 As a result of emerging from Chapter 11, the year ended December 27, 2024 ("fiscal 2024") and the period November 15, 2023 through December 29, 2023 reflect the Successor periods, while the period December 31, 2022 through, and including, November 14, 2023 reflects the Predecessor period. The combined periods of December 31, 2022 through November 14, 2023 (Predecessor) and November 15, 2023 through December 29, 2023 (Successor) are referred to herein as "fiscal 2023." Please see "Predecessor and Successor Periods" below for further information. CONTACTS Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Media Michael Freitag / Aaron Palash / Aura Reinhard / Catherine Simon Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 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. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED