DUBLIN - Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,4 an acute and life-threatening condition requiring hospitalization.5 TERLIVAZ is not approved in Canada.

Paul J. Thuluvath, MD, will present findings from a pooled analysis of Mallinckrodt's three prospective, randomized, placebo-controlled clinical studies in patients with HRS (OT-0401, REVERSE, and CONFIRM) to examine whether there was any impact of race (White vs. non-White) on treatment response to TERLIVAZ.1 HRS reversal - defined as the proportion of patients achieving a serum creatinine level of 1.5 mg/dL while on treatment including up to 24 hours after the last dose of study drug - was examined by race and assessed for the potential to predict treatment response.1

A post-hoc analysis of the Phase III CONFIRM trial - which evaluated maximum change and time of maximum change in mean arterial pressure, heart rate (HR) and systolic and diastolic blood pressure (SBP and DBP) with TERLIVAZ treatment - will be presented by Jacqueline G. O'Leary, MD.2 The data were analyzed to monitor for significant changes in MAP, SBP and DBP between treatment groups, and to determine the associated level of required cardiac monitoring.2

Additionally, results from a real-world analysis of the impact of hospital size on patient outcomes among those with chronic liver disease (CLD) and acute kidney injury or HRS will be presented by Ronald J. Wong, MD.3 This analysis identified nearly 3 million hospitalized patients with CLD (including cirrhosis) from 2016-2022 using the Premier Healthcare Database inclusive of over 1,041 hospitals/health systems in the U.S., to assess overall outcomes of treatment such as in-hospital mortality and comorbidity for patients in hospitals of varying sizes.3

About Hepatorenal Syndrome (HRS)

Hepatorenal syndrome (HRS) involving rapid reduction in kidney function4 is an acute and life-threatening condition that occurs in people with advanced liver disease.5 HRS is classified into two distinct types - a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.5 HRS involving rapid reduction in kidney function4 is estimated to affect between 30,000 and 40,000 Americans annually.6,7 If left untreated, HRS with rapid reduction in kidney function4 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.8

ABOUT MALLINCKRODT

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including with regard to TERLIVAZ, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the impact of Mallinckrodt's pending Chapter 11 cases; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ and other risks identified and described in more detail in the 'Risk Factors' section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

Contact:

Tel: 954-816-6003

Email: mediainquires@grcomms.com

Daniel J. Speciale

Tel: 314-654-3638

Email: daniel.speciale@mnk.com

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