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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 announced the publication of findings from nine human factors studies on the Acthar Gel Single-Dose Pre-filled SelfJect Injector. The studies, published in Expert Opinion on Drug Delivery, assessed the design and user interface of SelfJect. Key findings include:
- 91% of participants successfully administered their first injection
- 98% cumulative success after the second trial
- Use errors were rare (6.9% in simulated-use and 1.6% in knowledge-based testing)
- SelfJect received the Arthritis Foundation's Ease of Use certification
The FDA approved SelfJect in February 2024 for treating several autoimmune disorders and inflammatory conditions. It's available in 40 USP units/0.5 mL and 80 USP units/1.0 mL injectors for adults 18 and older.
Mallinckrodt plc reported strong Q2 2024 financial results, raising its full-year guidance. Key highlights include:
- Q2 net sales of $514.3 million, up 8.3% year-over-year
- Net loss of $43.3 million, a 94.2% improvement from Q2 2023
- Adjusted EBITDA of $174.0 million, up 20.8% year-over-year
- Raised full-year net sales guidance to $1.9-$2.0 billion
- Raised full-year Adjusted EBITDA guidance to $585-$615 million
The company launched Acthar Gel Single-Dose Pre-filled SelfJect Injector and agreed to sell its Therakos business for $925 million, with proceeds to reduce net debt by over 50%. Specialty Generics segment reported 23% net sales growth, while Specialty Brands segment saw a slight decline due to competition in INOmax sales.
Mallinckrodt plc announced the availability of Acthar Gel Single-Dose Pre-filled SelfJect Injector in the U.S., offering a new administration option for patients with chronic and acute inflammatory and autoimmune conditions. Key points:
- SelfJect is the first and only ACTH product available in a self-injection device
- FDA approved the supplemental New Drug Application in February 2024
- Available in 40 USP units/0.5 mL and 80 USP units/1.0 mL versions
- Designed for subcutaneous administration by adults 18 years or older
- Simplifies injection process with fewer materials and steps
- Includes safety features like a hidden needle to prevent needlesticks
- Acthar Gel is accessible to over 220 million individuals covered by insurance
- Prescribed by over 9,200 healthcare professionals and used by more than 43,500 patients (2013-2021)
Mallinckrodt plc has agreed to sell its Therakos business to CVC Capital Partners for $925 million. This strategic move aims to optimize Mallinckrodt's capital structure and focus on core areas of expertise. The company plans to use the net proceeds to reduce its net debt by more than 50%. Therakos, a fully integrated extracorporeal photopheresis (ECP) delivery system, is approved for use in multiple countries to treat immune-related diseases.
CVC, with its expertise in healthcare, intends to invest in Therakos' research, development, and geographic expansion. The transaction is expected to close in Q4 2024, subject to regulatory approvals. Key Therakos employees will transition with the business to ensure continuity in product support and stakeholder relations.
Mallinckrodt plc, a global specialty pharmaceutical company, has announced it will report its second quarter 2024 earnings results on Tuesday, August 6, 2024. The results will cover the period ended June 28, 2024. A conference call for investors is scheduled for 8:30 a.m. ET on the same day. Interested parties can access the call through various means, including:
- Live Call Participant Registration (with dial-in)
- Audio Only Webcast Link (live and replay)
- Mallinckrodt's investor relations website
This announcement provides investors and analysts an opportunity to prepare for the upcoming financial disclosure and engage with the company's management team regarding its performance and outlook.
Mallinckrodt announced data on TERLIVAZ® (terlipressin) at the 2024 European Association for the Study of the Liver (EASL) Congress. Three posters were presented, focusing on outcomes in patients with hepatorenal syndrome (HRS) and rapid kidney function decline.
Key findings include potential benefits of early diagnosis and treatment with TERLIVAZ, resulting in 3,040 more HRS reversals, 960 fewer needing renal replacement therapy, and significant healthcare cost savings. Data also showed improved survival rates in patients with lower baseline mean arterial pressure and better renal function among those with alcohol-associated hepatitis and acute-on-chronic liver failure grades 0–2.
However, the FDA has not evaluated the safety and efficacy of TERLIVAZ within these subgroups. Limitations include small sample sizes and potential methodological errors. TERLIVAZ remains the only FDA-approved treatment for adults with HRS with rapid kidney function decline, but it poses serious respiratory risks, particularly in specific patient groups.
Mallinckrodt presented data on TERLIVAZ® (terlipressin) for treating hepatorenal syndrome (HRS) at the 2024 Digestive Disease Week in Washington, DC. The presentations included a post-hoc analysis from the Phase III CONFIRM trial and a pooled analysis of three Phase III studies. The results indicate that TERLIVAZ is effective in improving kidney function in patients with HRS-AKI, even with dose interruptions, and is particularly beneficial for patients with baseline serum creatinine (SCr) levels below 5 mg/dL. TERLIVAZ is the first FDA-approved treatment for HRS with rapid kidney function decline, impacting over 42,000 Americans annually. The safety profile includes risks of serious respiratory failure and ischemic events, and the treatment is not recommended for certain high-risk patients.
Mallinckrodt plc reported first quarter 2024 financial results with net sales of $467.8 million, showing 10.2% year-over-year growth. The company achieved a net loss of $65.4 million, reflecting a 73.8% improvement, and delivered adjusted EBITDA of $144.9 million, up by 17.3% year-over-year. Mallinckrodt also initiated the rollout of INOmax EVOLVE DS Delivery System and anticipates the launch of Acthar Gel SelfJect Injector in the third quarter of 2024.
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