SAN DIEGO - Mallinckrodt (OTC:MNKKQ) plc, a global specialty pharmaceutical company, has presented new research on TERLIVAZ® (terlipressin) at The Liver Meeting hosted by the American Association for the Study of Liver Diseases (AASLD). The study focused on the timing of assessing treatment outcomes in adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function.
TERLIVAZ is the only FDA-approved medication designed to improve kidney function in adults with this form of HRS, a rare and acute condition that leads to hospitalization and affects an estimated 42,000 Americans each year. The poster presented pooled analysis from three Phase 3 studies, which suggested that most patients who achieved HRS reversal by the end of treatment had received more than 12 doses of TERLIVAZ. These findings highlight the importance of continuing therapy beyond the initial 12 doses, typically administered by Day 4, before evaluating patient response.
The analysis reported a 33.6% rate of HRS reversal in patients treated with TERLIVAZ, compared to 16.8% in the placebo group. Notably, the majority of patients who responded to TERLIVAZ had received more than 12 doses. However, the study's design did not control for confounding variables, and the results are considered nominal.
Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer at Mallinckrodt, expressed satisfaction with the research, emphasizing the need for full treatment duration before assessing patient response. The study's limitations include small sample sizes and potential data set errors.
TERLIVAZ's safety profile includes a boxed warning for serious or fatal respiratory failure, particularly in patients with volume overload or acute-on-chronic liver failure (ACLF) Grade 3. It is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms and in those with ongoing coronary, peripheral, or mesenteric ischemia.
The research is based on a press release statement from Mallinckrodt, which also cautions about forward-looking statements regarding TERLIVAZ's potential impact on health and treatment outcomes. These statements are subject to various factors that could cause actual results to differ materially from those anticipated.
InvestingPro Insights
Mallinckrodt's recent presentation of new research on TERLIVAZ® at The Liver Meeting underscores the company's commitment to advancing treatments for rare conditions like hepatorenal syndrome. This focus on specialized pharmaceuticals is reflected in the company's financial metrics and market performance.
According to InvestingPro data, Mallinckrodt's revenue for the last twelve months as of Q3 2024 stands at $2,124.9 million. While this represents a slight decline of 1.31% year-over-year, the company's EBITDA growth of 7.27% over the same period suggests improved operational efficiency. This growth in EBITDA, despite a revenue dip, may indicate that Mallinckrodt is effectively managing costs while investing in key products like TERLIVAZ.
The company's price-to-earnings (P/E) ratio of 15.9 and price-to-book (P/B) ratio of 1.51 suggest that the stock is reasonably valued compared to its earnings and book value. Moreover, Mallinckrodt's one-year price total return of 32.29% indicates strong market confidence in the company's prospects, possibly influenced by developments in its specialty pharmaceutical portfolio.
InvestingPro Tips highlight additional strengths:
1. Mallinckrodt has a high return on invested capital, suggesting efficient use of its investments to generate profits.
2. The company's earnings per share (EPS) growth has outperformed the industry average over the past year, which aligns with the positive reception of its research and development efforts.
These insights are part of 14 additional tips available on InvestingPro, offering a more comprehensive analysis of Mallinckrodt's financial health and market position.
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