Medincell: UZEDY® Surges to $117M in Sales in 2024, First Full Year of Commercialization
January 29 2025 - 8:42AM
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20250129326163/en/
David Heuzé Head of Corporate and Financial
Communications, and ESG david.heuze@Medincell.com / +33 (0)6 83 25
21 86
Grace Kim Chief Strategy Officer, U.S. Finance
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
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