Mr. Thomas Appio reports

BAUSCH HEALTH PROVIDES UPDATE ON RED-C PHASE 3 CLINICAL TRIALS

Bausch Health Companies Inc. has released the results of the global phase 3 RED-C clinical program evaluating amorphous-rifaximin solid soluble dispersion in adults with liver cirrhosis for the primary prevention of hepatic encephalopathy. While safe and well tolerated, both clinical trials did not meet the primary end point.

"We are disappointed in the results as there is currently no approved treatment for these patients. We are currently reviewing the full data set to determine potential new development opportunities," said Thomas J. Appio, chief executive officer, Bausch Health. "We want to thank the patients, families, investigators and research teams whose participation made this important clinical research possible."

Bausch Health remains committed to bringing new treatments to patients across hepatology and other therapeutic areas.

About the RED-C program

The RED-C program consists of two global, randomized, double-blind, placebo-controlled phase 3 trials involving more than 1,000 patients across 398 sites in 17 countries. The clinical trials evaluated rifaximin SSD for the delay of the first episode of hepatic encephalopathy in adults with liver cirrhosis who had no prior HE episodes.

About cirrhosis

Cirrhosis is a major cause of end-stage liver disease in the United States. Based on Oct. 25, 2024, data from the Centers for Disease Control and Prevention, chronic liver disease and cirrhosis rank ninth as a cause of death. In a patient with cirrhosis, progression is characterized by the development of hepatic encephalopathy, jaundice, clinically significant ascites or variceal hemorrhage.

About Bausch Health Companies Inc.

Bausch Health is a global, diversified pharmaceutical company enriching lives through its relentless drive to deliver better health care outcomes. It develops, manufactures and markets a range of products primarily in gastroenterology, hepatology, neuroscience, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health through its controlling interest in Bausch + Lomb Corp. Its ambition is to be a globally integrated health care company, trusted and valued by patients, HCPs, employees and investors.

We seek Safe Harbor.