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Mallinckrodt plc (MNK) is a global specialty biopharmaceutical and medical imaging company. Headquartered in Dublin, the company is renowned for developing, manufacturing, marketing, and distributing specialty pharmaceutical products and medical imaging agents. Its diverse portfolio spans therapeutic drugs for autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, ophthalmology, and pulmonology. The company also focuses on immunotherapy, neonatal respiratory critical care therapies, analgesics, and central nervous system drugs.
The company's Specialty Brands segment features a range of branded medicines, while the Specialty Generics segment includes generic drugs and active pharmaceutical ingredients. The Global Medical Imaging segment provides contrast media and nuclear imaging agents. Mallinckrodt's expertise lies in the acquisition and management of highly regulated raw materials, regulatory know-how, and specialized chemistry, formulation, and manufacturing capabilities.
Recent achievements include findings from health economics outcomes research on Acthar® Gel, which were shared at the Academy of Managed Care Pharmacy Nexus 2023. Acthar Gel, approved by the FDA for treating various autoimmune disorders and inflammatory conditions, demonstrated cost-effectiveness for patients with advanced symptomatic sarcoidosis and nephrotic syndrome. Additionally, the company presented new data on TERLIVAZ® at the Society of Critical Care Medicine 2024 Critical Care Congress, showing its efficacy in improving kidney function in adults with hepatorenal syndrome.
Mallinckrodt is committed to continuous innovation, evidenced by the FDA's approval of the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector, designed to provide patients with better control over their medication administration. Financially, Mallinckrodt reported a net sales increase to $467.8 million in Q1 2024, driven by growth in both its Specialty Brands and Specialty Generics segments.
Mallinckrodt plc (NYSE American: MNK) announced its presentation of two scientific abstracts at the 2023 National Kidney Foundation Spring Clinical Meeting (NKF SCM) in Austin, TX. The abstracts focus on the clinical and health economic outcomes of TERLIVAZ (terlipressin) for adult patients with hepatorenal syndrome (HRS), a serious condition causing rapid kidney function reduction. One abstract evaluates treatment costs for HRS patients, while the other analyzes serum creatinine reduction linked to clinical outcomes. TERLIVAZ is the first FDA-approved treatment to improve kidney function in HRS patients, affecting 30,000 to 40,000 Americans annually. Mallinckrodt aims to raise awareness about HRS's clinical and economic challenges during the meeting.
Mallinckrodt plc (NYSE: MNK) announced findings from a retrospective analysis indicating that Acthar Gel significantly reduces corticosteroid use for patients with advanced sarcoidosis compared to other fourth-line treatments. The analysis involved 1,361 patients and was presented at the AMCP 2023 Annual Meeting in San Antonio, Texas, from March 21-24, 2023. Key results revealed that Acthar Gel users exhibited a greater reduction in corticosteroid fills, particularly among those with above-average adherence. The study underscores the importance of treatment adherence for improving patient outcomes in advanced sarcoidosis.
The Buxton Helmsley Group, a New York City-based investment advisor, has issued an open letter to Mallinckrodt's board regarding significant findings from its investigation. BHG alleges severe pre- and post-reorganization violations of accounting standards and securities laws, which have drawn the attention of the U.S. Securities and Exchange Commission. The letter outlines failures to record billions in asset depreciation and impairment expenses, linked to the company's pre-existing asset valuation methods. BHG has also reported its findings to U.S. Senators Elizabeth Warren and Sheldon Whitehouse, among others.
The Buxton Helmsley Group, Inc. has released an open letter addressed to U.S. Senators Elizabeth Warren and Sheldon Whitehouse, highlighting financial misconduct at Mallinckrodt (NYSE: MNK). The investigation uncovered a scheme of concealing asset depreciation and impairment expenses, violating GAAP standards. BHG demands the restatement of historical financial statements and write-downs of asset values based on previous standards. The ongoing concealment of financial data under the current CFO was also pointed out. These revelations raise significant concerns about Mallinckrodt's financial practices and transparency.
Mallinckrodt reported a fourth-quarter net loss of $249.5 million, with net sales declining to $489.3 million, an 18.1% year-over-year decrease. The Specialty Brands segment saw a 19.3% drop in sales, while the Specialty Generics segment decreased by 15.6%. Despite challenges, including competition and a loss of revenue from Amitiza and Acthar Gel, the company enhanced its cash position to $409.5 million. Looking forward to 2023, Mallinckrodt anticipates total net sales between $1.700 billion and $1.820 billion, aiming for adjusted EBITDA of $510 million to $560 million. Key initiatives include the launch of Terlivaz and the appointment of a new Chief Scientific Officer.
Mallinckrodt plc (AMEX:MNK) announced that Siggi Olafsson, President and CEO, will present at Cowen's 43rd Annual Health Care Conference in Boston, MA, on March 7, 2023, at 2:50 p.m. Eastern Time. For those unable to attend in person, a webcast will be available, with a replay accessible after the event. Mallinckrodt, a global specialty pharmaceuticals company, focuses on areas such as autoimmune and rare diseases, including neurology and oncology. More details can be found on their website.
Mallinckrodt plc (NYSE American: MNK) announced it will report its fourth quarter 2022 earnings on February 28, 2023. The reporting period ends on December 30, 2022.
The company also plans a conference call for investors at 8:30 a.m. ET on the same day. This call will allow stakeholders to engage with the company's financial results.
Mallinckrodt specializes in pharmaceutical products, focusing on areas such as autoimmune and rare diseases.
Mallinckrodt plc (NYSE American: MNK) announced findings from a retrospective analysis showing that patients with baseline acute-on-chronic liver failure (ACLF) grade ≤2 treated with TERLIVAZ® plus albumin experienced a higher incidence of hepatorenal syndrome (HRS) reversal compared to those receiving placebo and albumin. The analysis included data from three Phase III studies and highlighted that terlipressin is the only FDA-approved treatment for HRS with rapid kidney function reduction. The data will be presented at SCCM 2023 in San Francisco on January 22, reinforcing the need for early intervention in critically ill patients.
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