Medincell - UZEDY®: Net Sales Increased from $117M in 2024 to $191M in 2025 (+63%)

OLANZAPINE LAI: EU Submission Expected in Q2 2026

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

Medincell’s (Paris:MEDCL) partner, Teva Pharmaceuticals, today shared the following information in connection with the publication of its Q4 and full‑year 2025 results:

About UZEDY^®

• 2025 net sales reached $191 million, including $55 million in the fourth quarter
• Teva’s initial 2026 net sales outlook is in the range of $250 - $280 million

Medincell receives mid‑to high‑single-digit royalties on UZEDY^® net sales and is eligible for up to $105 million in commercial milestone payments, subject to the achievement of annual sales thresholds.

About OLANZAPINE LAI

Olanzapine Long-Acting Injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation for a broad population of patients living with schizophrenia.¹

• Submission of Olanzapine LAI in the European Union for the treatment of schizophrenia in adults is expected in Q2 2026

Following submission to the European Medicines Agency (EMA), regulatory review process begins with a two‑week validation phase, followed by a standard assessment typically lasting 9 to 15 months. A major milestone in this process is the CHMP² opinion, which is typically issued around two months before the final decision delivered by the European Commission.

Christophe Douat, CEO of Medincell, said: “Teva’s stated intention to seek marketing authorization for the long-acting olanzapine formulation in Europe is an important milestone. It reflects our partner’s commitment to making this therapeutic option available to as many people living with schizophrenia as possible worldwide. Europe represents a significant opportunity, as olanzapine is a widely used treatment for schizophrenia in the region.”

As previously disclosed, in the United States, Teva submitted a New Drug Application (NDA) for Olanzapine LAI to the FDA on December 9, 2025. An NDA filling typically initiates a period of about 2 months to determine acceptance for review, followed by an additional 8 months for a standard review.

Medincell is eligible to receive mid‑to high‑single-digit royalties on all sales, a $4 million payment upon approval, and for up to $105 million in commercial milestone payments, subject to the achievement of annual sales thresholds.

Teva Q4 and annual 2025 results press release: https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Innovative-Portfolio-and-Consistent-Execution-of-Pivot-to-Growth-Strategy-Deliver-Third-Consecutive-Year-of-Growth-Pipeline-Positioned-to-Unlock-Significant-Value-Potential/default.aspx

Teva Q4 2025 earnings conference call today at 8:00am ET, webcast and replay:
https://events.q4inc.com/attendee/448187955

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.
These treatments combine active pharmaceutical ingredients with our proprietary BEPO^® / BEPO^® Star technologies, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable deposit.
Risperidone LAI was the first treatment based on BEPO^® technology to receive FDA approval, initially for schizophrenia in April 2023, and subsequently for Bipolar I Disorder in October 2025. It is marketed in the United States by Teva under the brand name UZEDY^®. Medincell’s risperidone LAI was also approved for schizophrenia in Canada and South Korea in 2025.
A New Drug Application (NDA) for Olanzapine LAI as a once-monthly treatment for schizophrenia in adults was submitted to the U.S. FDA in December 2025 by Medincell’s partner, Teva.
Medincell’s investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options.
Headquartered in Montpellier, France, Medincell employs over 140 people representing more than 25 nationalities.
medincell.com
UZEDY^® is a trademark of Teva Pharmaceuticals. Medincell’s BEPO^® technology is licensed to Teva as SteadyTeq™, a trademark of Teva Pharmaceuticals.

This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities.

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¹ Teva’s press release: https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Pharmaceuticals-Submits-New-Drug-Application-to-FDA-for-Olanzapine-Extended-Release-Injectable-Suspension-TEV-749-for-the-Once-Monthly-Treatment-of-Schizophrenia-in-Adults/default.aspx

² The CHMP (Committee for Medicinal Products for Human Use) is the European Medicines Agency’s scientific committee responsible for evaluating and issuing opinions on the quality, safety, and efficacy of all human medicines in the EU.