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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 presented data on TERLIVAZ (terlipressin) for hepatorenal syndrome (HRS) at the 2024 AASLD Annual Meeting. The research analyzed pooled data from three Phase 3 studies, evaluating HRS reversal after 12 doses. Results showed 33.6% reversal rate in the TERLIVAZ group versus 16.8% in placebo. Notably, 94.9% of patients achieving HRS reversal required more than 12 doses. TERLIVAZ is the first FDA-approved treatment for improving kidney function in adults with HRS, a condition affecting approximately 42,000 Americans annually.
Mallinckrodt plc has announced its participation in the upcoming Jefferies London Healthcare Conference. Siggi Olafsson, President and Chief Executive Officer, will deliver a presentation on Tuesday, November 19, 2024, at 9:30 a.m. GMT/4:30 a.m. ET. For those unable to attend in person, a webcast will be available online, with a replay option provided after the event.
Mallinckrodt reported Q3 2024 net sales of $505.5 million, up 1.7% year-over-year. The company raised its full-year Adjusted EBITDA guidance to $590-620 million while reaffirming net sales guidance of $1.9-2.0 billion. Acthar Gel achieved its third consecutive quarter of growth, with sales up 3.5% to $126.4 million, leading to expectations of approximately 10% growth for full-year 2024. The Specialty Generics segment reported 4.1% growth to $219.5 million. The company expects to reduce net debt by more than 60% in Q4 following the sale of Therakos business for $925 million to CVC Capital Partners.
Mallinckrodt announced the presentation of four posters on TERLIVAZ® (terlipressin) at The Liver Meeting 2024. The research focuses on patients with hepatorenal syndrome (HRS) with rapid kidney function reduction, affecting approximately 42,000 Americans annually.
The presentations include pooled data from Phase 3 studies examining: the impact of waiting until Day 4 for assessing HRS reversal, the effect of obesity on HRS reversal, and outcomes in patients treated with standard versus high doses. An additional analysis from the CONFIRM study explores TERLIVAZ's impact on HRS reversal, liver transplant rates, and MELD scores.
TERLIVAZ is the first FDA-approved treatment to improve kidney function in adults with HRS with rapid reduction in kidney function, a rare and life-threatening condition requiring hospitalization.
Mallinckrodt presented real-world data on TERLIVAZ (terlipressin) for hepatorenal syndrome-acute kidney injury (HRS-AKI) at the ACG Annual Meeting. The analysis, based on 125 hospitalized patients, revealed that 74.4% had underlying alcoholic liver disease, with 97.6% being emergent/urgent admissions. The in-hospital mortality rate was 17.6%, and TERLIVAZ was used as first-line treatment in 20.8% of cases. Among patients with available serum creatinine data (n=21), 47.6% achieved HRS reversal. The study highlights treatment challenges in HRS-AKI patients at high risk of death.
Mallinckrodt presented data on TERLIVAZ (terlipressin) for hepatorenal syndrome (HRS) at Kidney Week 2024. The presentation featured a pooled analysis from Phase 3 trials (CONFIRM and REVERSE) examining treatment outcomes in HRS patients. Key findings showed that in patients listed for liver transplant at baseline, TERLIVAZ treatment resulted in 43% HRS-AKI reversal rate compared to 20% in the placebo group. The treatment also reduced the need for renal replacement therapy while maintaining similar liver transplant rates between groups. TERLIVAZ is the first FDA-approved product for improving kidney function in adults with HRS, a condition affecting approximately 42,000 Americans annually.
Mallinckrodt announced it will release its third quarter 2024 financial results on Tuesday, November 5, 2024. The global specialty pharmaceutical company will host an investor conference call at 8:30 a.m. ET on the same day to discuss the results for the period ended September 27, 2024. The company has provided multiple access options for interested parties, including a dial-in registration link, an audio webcast, and access through the corporate website.
Mallinckrodt has announced the nationwide rollout of its FDA-cleared INOmax® EVOLVE™ DS delivery system for INOmax® (nitric oxide) gas inhalation. This next-generation system combines mini-cylinder technology, automation, integration, and interaction into one device. The INOmax EVOLVE DS is designed to meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, enhanced safety features, and a streamlined design.
Key features of the INOmax EVOLVE DS include 1.4-lb mini-cylinders, automated pre-use checkout, electronic blender, and electronic medical record connectivity. The system is intended for use in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. INOmax has been on the market for over 20 years, treating more than 875,000 patients globally.
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.
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