Medincell: UZEDY® Surges to $117M in Sales in 2024, First Full Year of Commercialization

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

Medincell’s (Paris:MEDCL) partner Teva Pharmaceuticals shared today the following information:

About UZEDY^®

• 2024 sales: $117 million with $43 million in Q4
  • + 17% compared to $100 million updated Teva outlook in November 2025

Q1	Q2	Q3	Q4
$40 million		$35 million	$43 million

• Initial 2025 Teva outlook: $160 million
  • vs. initial 2024 Teva outlook: $80 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 (TEV-749 / mdc-TJK)

• Preparation for Filing and Launch
  • Last patient, last visit of Phase 3 pivotal trial expected imminently
  • Long term full safety released data anticipated in Q2 2025
  • NDA^* submission anticipated in H2 2025

Teva 2024 Results press release:
https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Delivers-Second-Consecutive-Year-of-Growth-Announces-Strong-Financial-Results-in-Fourth-Quarter-and-Full-Year-2024-Led-by-Generics-Performance-and-Innovative-Portfolio-Growth/default.aspx

Teva 2024 Results earnings conference call today at 8:00am ET, webcast and replay: https://events.q4inc.com/attendee/899170090

^* NDA (New Drug Application): Formal request for approval to market a new pharmaceutical product, containing detailed data on its safety, efficacy, manufacturing, and labeling.

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

This press release contains forward-looking statements, including statements regarding Company’s expectations for (i) the timing, progress and outcome of its clinical trials; (ii) the clinical benefits and competitive positioning of its product candidates; (iii) its ability to obtain regulatory approvals, commence commercial production and achieve market penetration and sales; (iv) its future product portfolio; (v) its future partnering arrangements; (vi) its future capital needs, capital expenditure plans and ability to obtain funding; and (vii) prospective financial matters regarding our business. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are forward-looking statements and subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", “expect”, "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", “potential”, "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance, or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (the "AMF") pursuant to its regulatory obligations, including the Company's registration document, registered with the AMF on September 4, 2018, under number I. 18-062 (the "Registration Document"), as well as in the documents and reports to be published subsequently by the Company. In particular, readers' attention is drawn to the section entitled "Facteurs de Risques" on page 26 of the Registration Document.

Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements.

This press release is for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for the Company's shares in any jurisdiction, in particular in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation, or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be subject to legal restrictions in certain jurisdictions.