Announcement • Nov 19

Mallinckrodt plc Presents Data on Terlipressin for Injection in Patients with Hepatorenal Syndrome at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Mallinckrodt plc announced a poster presentation on TERLIVAZ (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in San Diego, CA, from November 15-19, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. HRS involving rapid reduction in kidney function is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population, making it a very rare condition; and rates of hospitalizations are increasing. The poster presentation includes a pooled patient cohort analysis from the CONFIRM, REVERSE, and OT-0401 Phase 3 studies of TERLIVAZ. TERLIVAZ treatment is recommended at a dose of 1 mg every six hours for up to 14 days, which can be escalated on Day 4 to 2 mg every six hours if the patient's serum creatinine (SCr) has decreased from baseline but by less than 30%. In the analysis, most patients who achieved HRS reversal by the end of treatment required continuation of therapy beyond Day 4. The rate of HRS reversal by the end the end of treatment was 33.6% (117/348) in the TERLIVAZ group and 16.8% (42/250) in the placebo group. Most patients who achieved HRS reversal with TERLIVAZ received >12 doses (94.9%, 111/117), and 5.1% (6/117) received 12 doses before discontinuation. There appeared to be significantly more patients who achieved HRS reversal in the TERLIV AZ group who received >12 doses, but not among those who received 12 doses; however, based on the design of the analysis, statistical methodology did not control for confounding variables, thus the p-values are nominal. The limitations of this study include, but are not limited to, small sample sizes, variables in methodology, and possible errors and omissions within the data sets. This study was sponsored by Mallinckrodt Pharmaceuticals. TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

Announcement • Oct 27

Mallinckrodt plc Presents Data on Terlipressin (Terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) At Kidney Week 2024

Mallinckrodt plc announced a poster presentation on TERLIVAZ®? (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function at Kidney Week 2024, the annual meeting of the American Society of Nephrology (ASN) taking place in San Diego from October 23-27, 2024. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. HRS involving rapid reduction in kidney function is estimated to affect more than 42,000 Americans annually, approximately 0.01% of the U.S. population, making it a very rare condition; and rates of hospitalizations are increasing. The poster presentation highlights a pooled analysis of data from the CONFIRM and REVERSE Phase 3 placebo-controlled trials of TERLIVAZ.5 The analysis examined the rates of hepatorenal syndrome-acute kidney injury (HRS-AKI) reversal, renal replacement therapy (RRT), and liver transplant (LT) among a subpopulation of patients listed for LT at baseline who met FDA label guidelines for treatment with TERLIVAZ (SCr. The rate of RRT in the TERLIVAZ and placebo groups was 28% and 46% by Day 30; 32% and 54% by Day 60; and 36% and 54% by Day 90, respectively. The LT rate was similar in the TERLIV AZ and placebo groups at all time points assessed: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% by Day 90, respectively; The limitations of this study include, but are not limited to, small sample sizes, variables in methodology, and possible errors and omissions within the data sets. TERLIVAZ is indicated to improve kidney function in adult patients with hepatorenal syndrome with rapid reduction in kidney function. Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit. IMPORTANT SAFETY information: Warning: SERIOUS OR FATAL RESPIRATORY FAILURE: TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ. Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., Spo2 HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types - a rapidly rapidly rapidly and life-threatening condition that occurs in people with advanced Liver disease.2 HRS is classification into two distinct types - a rapidly rapidly and life-threatening condition.

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CVC Capital Partners Fund IX managed by CVC Capital Partners plc (ENXTAM:CVC) completed the acquisition of Therakos (France) Sas from Mallinckrodt plc.

Mallinckrodt plc Presents Data on Terlipressin for Injection in Patients with Hepatorenal Syndrome at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Mallinckrodt plc Presents Data on Terlipressin (Terlipressin) for Injection in Patients with Hepatorenal Syndrome (HRS) At Kidney Week 2024

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