Ms. Amy Cairns reports

BAUSCH HEALTH, CANADA INC. AND THE PAN-CANADIAN PHARMACEUTICAL ALLIANCE SIGN LETTER OF INTENT FOR PUBLIC DRUG PLAN COVERAGE OF (PR)OKEDI (RISPERIDONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION) FOR THE TREATMENT OF SCHIZOPHRENIA

Bausch Health Canada Inc., part of Bausch Health Companies Inc., has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), resulting in a letter of intent (LOI) for PrOKEDI (risperidone extended-release injectable suspension) 75 milligrams and 100 mg, a long-acting injectable antipsychotic agent for the treatment of schizophrenia in adults.

The issuance of this LOI marks a key milestone toward securing public coverage and enabling patient access to PrOKEDI across Canada. Bausch Health remains committed to working closely with federal, provincial and territorial public drug plans, to finalize product listing agreements, and support timely and equitable access for Canadians living with schizophrenia.

PrOKEDI is designed to provide rapid attainment of clinically relevant risperidone plasma concentrations, followed by sustained release over the four-week dosing interval, without the need for oral supplementation or a loading dose.

"We are very pleased to have reached agreement with the pan-Canadian Pharmaceutical Alliance on terms that will help expand access to PrOKEDI for people living with schizophrenia through public drug plans," said Amy Cairns, general manager, Bausch Health Canada. "This milestone brings us closer to supporting patients, their families and caregivers with new treatment options, and we look forward to quickly finalizing agreements so Canadians can benefit as soon as possible."

"We welcome the letter of intent between Bausch Health Canada Inc. and pCPA, which will advance access to PrOKEDI and providing people living with schizophrenia with an important new treatment option," said Dr. Howard Margolese, MD, CM, MSc, FRCPC, president of Early Psychosis Intervention Canada.

"It is very encouraging to see progress toward improved access to medications for Canadians living with schizophrenia," said Dave Gallson, National Executive Director of Mood Disorders Society of Canada. "Schizophrenia is a life-changing illness that can profoundly affect daily functioning, independence and quality of life, making timely access to additional treatment options critical to helping people living with schizophrenia lead more stable, fulfilling lives."

About schizophrenia

Schizophrenia is a chronic and severe psychiatric disorder that typically emerges in late adolescence or early adulthood and affects about 1 per cent of the population. The illness is characterized by episodes of psychosis and loss of contact with reality, as well as emotional and cognitive symptoms. It affects how a person thinks, feels, behaves and relates to others, often impairing functioning, relationships, employment and quality of life.

Relapses are common throughout the illness, with over 80 per cent of patients experiencing relapse within five years of a first episode of schizophrenia. Relapse is associated with progressive brain loss, worsening symptoms, hospitalization, functional decline and increasing treatment resistance, highlighting the importance of early intervention, sustained symptom control and continuity of care. Although there is no cure for schizophrenia, the illness can be effectively managed through a combination of antipsychotic medication, psychosocial support and community-based care, enabling many people to achieve stability, recovery and meaningful participation in daily life.

Long-acting injectable antipsychotics may play an important role in supporting treatment continuity and reducing the risk of relapses in patients living with schizophrenia.

OKEDI clinical data and safety information

The pivotal PRISMA-3 randomized, double-blind, placebo-controlled study in adults with acute exacerbation of schizophrenia (N equals 438) demonstrated that once-monthly PrOKEDI (75 mg and 100 mg) significantly improved symptoms versus placebo over 12 weeks. Treatment resulted in greater reductions in PANSS total scores and CGI-S scores, with differences versus placebo reaching statistical significance (p less than 0.0001). Improvements were also observed across symptom domains. In the published study, higher response rates were observed with PrOKEDI compared to placebo. The safety profile was consistent with known risperidone effects, including prolactin-related events, headache and weight gain.

In the 12-month open-label extension study (PRISMA-3 OLE; N equals 215), continued treatment with PrOKEDI was associated with sustained symptom improvement and disease stability. The long-term safety profile was consistent with that observed in the pivotal trial, with no new safety signals identified.

For patients who have never taken risperidone, tolerability with oral risperidone prior to initiating treatment with PrOKEDI should be established. Health Canada has not authorized the use of PrOKEDI in pediatric patients (less than 18 years).

About Bausch Health Companies Inc.

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

The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, chronic weight management, allergy, neuropsychiatry and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Que., and Steinbach, Man.

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