Medincell: 25% Raise in 2024 UZEDY® Revenue Outlook & Key Milestone Reached for Olanzapine LAI clinical Phase 3

06 Nov 2024 13:42 CET

Regulatory News:

Medincell’s (Paris:MEDCL) partner Teva Pharmaceuticals shared today as part of its Q3 2024 results, the following information:

About UZEDY^®

• Updated 2024 Revenue Outlook: Increased from $80 million to $100 million

• U.S. Revenues Year-to-Date 2024: $75 million
• U.S. Revenues for Q3 2024: $35 million

• Medincell receives mid- to high-single digit royalties on all sales and is eligible for $105 million of commercial milestones

About Olanzapine Long-Acting Injectable (TV-‘749 / mdc-TJK)

• Completion of 100% of targeted injections for submission without PDSS^*

Teva Q3 results press release: https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Announces-Strong-Financial-Results-for-the-Third-Quarter-of-2024-led-by-Generics-Performance-and-Innovative-Portfolio-Growth-Raises-2024-Financial-Outlook-including-on-Revenues-Adjusted-EBITDA-and-Non-GAAP-EPS/default.aspx

Teva Q3 2024 earnings conference call today at 8:00am ET, webcast and replay: https://events.q4inc.com/attendee/714898512

^* Post-Injection Delirium/Sedation Syndrome (PDSS) is a rare but significant complication associated with existing long-acting injectable formulation of olanzapine. PDSS occurs when a portion of the injected medication unintentionally enters the bloodstream too quickly, causing sudden sedation, confusion, and potentially serious side effects such as respiratory issues. For healthcare providers and patients, PDSS remains a barrier to the widespread use of olanzapine LAI. The requirement for close post-injection monitoring limits the convenience and flexibility of this treatment option. Medincell’s olanzapine LAI is designed to eliminate the risk of PDSS, potentially making it a safer and more accessible treatment option.

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO^® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO^® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY^® (BEPO^® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

UZEDY^® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

medincell.com

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David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Head of US Financial Strategy & IR
grace.kim@Medincell.com / +1 (646) 991-4023

Nicolas Mérigeau/ Arthur Rouillé
Media Relations
Medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier/Alban Dufumier
Investor Relations France
Medincell@newcap.eu / +33 (0)1 44 71 94 94