(April 1(st) , 2025 - September 30, 2025)
MONTPELLIER, France--(BUSINESS WIRE)--December 09, 2025--
Regulatory News:
Christophe Douat, CEO of Medincell (Paris:MEDCL): "We are pleased with the company's growth and momentum. We have entered the most transformative years in Medincell's history. UZEDY delivers strong performance and the expected launch of olanzapine LAI next year is poised to be a major catalyst for Medincell's growth. We keep advancing the third engine of our Shift to Growth strategy, with our first program in partnership with AbbVie leading the way, while further expanding and diversifying our pipeline and collaborations with leading pharmaceutical partners."
Stéphane Postic, CFO of Medincell: "Revenues are growing and are expected to accelerate in the coming years with Olanzapine LAI. We have refined our investment plan to allocate resources strategically, with discipline and ambition. This approach is designed to create sustainable value and position Medincell for long-term success."
Consolidated financial statements for the first half of the 2025-2026 fiscal year, ending September 30, 2025 (IFRS)
-- Total income: EUR14.1 million, +50% year-over-year
-- Including revenues of EUR11.6 million, +35% year-over-year
-- Operating expenses: EUR20.8 million, +22% year-over-year
-- Including R&D expenses: EUR13.3 million, +29% year-over-year
-- Operating result: EUR(6.6) million, a 13% year-over-year improvement
-- Cash and cash equivalents and low-risk financial investments at the
closing: EUR53.5 million
-- Composed of EUR49.8 million in cash and cash equivalent and EUR3.7
million in low-risk financial investments
Key highlights
Risperidone LAI (UZEDY$(R)$ )
-- UZEDY(R) Accelerates in the United States
-- EUR4.2 million in royalties invoiced by Medincell over the period,
+50% year-over-year
-- As communicated by Teva, upward revision of UZEDY(R)'s 2025 net
sales forecast from $160 million to $190-200 million
-- Additional patent granted by USPTO in June 2025, valid until 2042
-- FDA approval in October 2025 for an expanded indication as
treatment for adults with Bipolar I Disorder (post-closing)
-- Approval for Risperidone LAI obtained by Teva in Canada and in South
Korea
New Drug Application submitted by Teva to FDA for Olanzapine LAI on December 9, 2025, typically initiating a period of about 2 months to determine acceptance for review, followed by an additional 8 months for a standard review
-- Olanzapine LAI has been designed to avoid post-injection
delirium/sedation syndrome (PDSS) and eliminate the need for
post-injection monitoring
-- New pivotal Phase 3 long-term data support Olanzapine LAI with a
favorable safety profile
-- No suspected or confirmed PDSS (Post-injection Delirium/Sedation
Syndrome) events observed with Olanzapine LAI through week 56 in
the pivotal Phase 3 SOLARIS trial
-- The long-term systemic safety profile was consistent with other
olanzapine formulations
-- 20-30% of oral schizophrenia patients are on olanzapine, and are
potentially suitable for a LAI
-- Preparation of submission in Europe by Teva
First program with AbbVie
-- Advancement of preclinical and supportive CMC activities conducted by
Medincell
-- Regulatory package to initiate first human trials is expected to
be ready in 2026, enabling AbbVie to advance candidate into
clinical development
Other pipeline updates
-- mdc-CWM (postoperative pain)
-- Medincell's partner, Arthritis Innovation Corporation $(AIC)$, which
funds and conducts the clinical development activities, is
progressing with preparations for the second Phase 3 study with
initiation planned in 2026.
-- Global Health
-- The optimal regulatory pathway that could lead to phase 1 of
mdc-WWM (contraception) in 2026 is still under evaluation
-- New $3 million financing envelope from the Gates Foundation to
advance mdc-STM malaria program toward first in human trial
(post-closing)
-- Initiation of a feasibility study for a new program against
tuberculosis with the support of Innovative Medicines for
Tuberculosis Foundation (IM4TB)
-- Launch of new feasibility studies and formulation activities for several
programs, including some in partnership To protect strategic interests
and comply with confidentiality obligations, the Company does not provide
details on early-stage programs, the identity of specific partners, the
status of collaborations, or the terms of potential or existing
agreements.
Technology upgrade: BEPO(R) Star
-- US patent granted, offering protection until 2040, further strengthening
the long-term IP position of Medincell's technology
Appointment of Dr. Sharon Mates, Dr. Charles Kunsch, and Dr. Pascal Touchon to Medincell's Board of Directors
-- Dr. Sharon Mates, PhD, is the co-founder and former Chair and CEO of
Intra-Cellular Therapies, a CNS focused biotech that developed the
successful drug CAPLYTA(R), acquired by Johnson & Johnson for $14.6
billion in April 2025.
-- Dr. Charles Kunsch, PhD, is a seasoned life sciences executive with over
30 years of experience, including as former Managing Director at AbbVie
Ventures, where he led investments in pioneering biotech companies.
-- Dr. Pascal Touchon, DVM, has over 40 years of international leadership in
the biopharmaceutical industry, including key roles at Novartis Oncology
and Atara Biotherapeutics and current board positions at Ipsen, CDR-Life,
RoslinCT, Catalym and Xylocor.
Selected financial information for the first half of fiscal year 2025-2026
Key consolidated figures - IFRS (in thousands of EUR)
The consolidated summary half-year financial statements in accordance with IFRS as of September 30, 2025 were approved by the Board of Directors on December 8, 2025. These financial statements have been subject to a limited review by the Statutory Auditors.
September 30, 2025 September 30, 2024
INCOME STATEMENT 6 months 6 months
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Revenues 11 608 8 620
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Other income 2 539 815
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Current operating result (6 612) (7 598)
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Operating result (6 612) (7 529)
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Financial result (9 459) (6 910)
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Net result (16 078) (14 568)
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Total income (revenues and other income) up by 50%: EUR14.1 million
Revenues for the first half of the 2025-2026 financial year were 35% higher than in the same period last year, mainly driven by the following components:
-- Royalties on net sales from UZEDY(R) invoiced to Teva for a total of
EUR4.2 million (vs EUR2.8 million year-on-year, a 50% increase)
reflecting the strong momentum of UZEDY(R) which is partially offset by
the weakness of USD vs EUR over the period.
-- Other partnerships revenues represented EUR7.3 million (vs EUR5.5 million
in the first half of the previous year):
-- Revenues from the 1st program in development under the AbbVie
collaboration accounted for EUR4.9 million,
-- Revenues from the Gates Foundation to develop a contraceptive
long-acting injectable accounted for EUR1.4 million,
-- Revenues from other collaborations and from proof-of-feasibility
studies accounted for EUR1.0 million.
Other income consisted mainly of the Research Tax Credit for EUR2.5 million.
Operating expenses up by 22%: EUR20.8 million
The increase in operating expenses is primarily related to R&D, which accounts for nearly 64% of total spending. The increase is mainly driven by the maturity of the portfolio, with more late-stage assets. The Company has also decided to accelerate certain activities related to technological innovation, to further extend its capabilities in terms of formulation.
Operating result: EUR(6.6) million, a 13% year-over-year improvement
Operating result is improving despite the unfavorable impact of the weak US dollar against the euro. The Company indicates that if the weakness of US dollar vs euro persists, operational profitability might occur later than the fiscal year 2026-2027.
Financial result impacted by the non-cash fair value adjustment of EIB warrants: EUR(9.5) million
The net financial loss increased from EUR6.9 million to EUR9.5 million over one year. This change is mainly due to a EUR6.8 million accounting revaluation with no cash impact related to the fair value of the BSA warrants allocated to the EIB, a direct consequence of the sharp rise in the Company's share price over the period (+65% from EUR14.4 on March 31, 2025 to EUR23.8 on September 30, 2025). Discussions are progressing with the EIB regarding a potential waiver of the put option clause allowing for cash repayment upon the occurrence of certain events.
The financial result was also impacted by financial exchange losses totaling EUR1 million, due to the unfavorable movement in the EUR/USD exchange rate, that affected cash held in USD.
BALANCE SHEET September 30, 2025 March 31, 2025
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Equity of the consolidated group (30 633) (16 367)
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Total non-current liabilities 83 877 76 945
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Total current liabilities 21 332 29 874
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Total non-current assets 13 221 9 835
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Of which financial assets and other
non-current assets 5 332 1 900
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Total current assets 61 356 80 617
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Of which cash and cash equivalents 49 767 59 040
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Of which low-risk financial investments 3 735 12 857
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FINANCIAL DEBT September 30, 2025 March 31 ,2025
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Financial debt, non-current portion 50 835 49 417
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Financial debt, current portion 4 976 6 621
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Non-current derivative liabilities 15 320 8 564
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GROSS FINANCIAL DEBT 71 131 64 601
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Cash and cash equivalents 49 767 59 040
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Low-risk financial investments 3 735 12 857
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NET FINANCIAL DEBT 17 629 (7 296)
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Consolidated cash flow statements
September 30, 2025 September 30, 2024
(In thousands of euros) 6 months 6 months
------------------------------------- ------------------ -------------------
Net cashflow from operating
A activities (14 803) 21 559
--------------------------------- ------------------ -------------------
Net cashflow from investing
B activities 8 363 (6 993)
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Net cashflow from financing
C activities (2 834) (2 398)
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Impact of non-monetary items and
foreign exchange rate changes - -
--------------------------------- ------------------ -------------------
Change in net cash position (9 273) 12 176
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Cash and cash equivalents - opening
balance (*) 59 040 19 460
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Cash and cash equivalents - closing
balance (**) 49 767 31 636
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(*) The opening balance does not include EUR12.9 million of low-risk, short-term financial investments.
(**) The closing balance does not include EUR3.7 million of low-risk, short-term financial investments.
A- Net cashflow from operating activities
The change in net cash flow generated by operations is attributable to the receipt of the initial upfront payment from AbbVie ($35 million) as well as the receipt of UZEDY(R) royalties and the payment from Unitaid in the first half of the 2024-2025 financial year. During this half-year period, only UZEDY(R) royalties were received, as well as payments relating to feasibility studies.
B- Net cashflow from investing activities
Net cash flow from investing activities is mainly explained by the change in financial investments over the period. For the half-year ended September 30, 2024, EUR7.2 million was invested in these financial investments, while for the half-year ended September 30, 2025, EUR9.1 million was divested to meet the Company's operational needs. These financial investments of EUR3.7 million consist exclusively of short-term deposits with high liquidity and no risk of capital loss. They can be easily mobilized if necessary and generate additional financial income.
C- Net cashflow from financing activities
The net cash flow from financing activities in the first half of the year ended September 30, 2025, was mainly due to the repayment of financial debt and lease liabilities (total disbursements of EUR2.7 million), as in the first half of the previous financial year (EUR2.4 million).
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(R) 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(R) 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(R) (BEPO(R) technology is licensed to Teva as SteadyTeq(TM)). Medincell's risperidone LAI was also approved for schizophrenia in Canada and South Korea in 2025.
Our 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(R) and SteadyTeq$(TM)$ are trademarks 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.
These statements may include, but are not limited to, any statements beginning with, followed by or including words or expressions such as "objective", "believe", "expect", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words or expressions of similar meaning or used in the negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control which may cause actual results, performance or achievements of the Company to differ materially from those anticipated or implied by such statements.
A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in documents and reports to be published subsequently by the Company. Furthermore, these forward-looking statements only apply as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update these forward-looking statements, nor to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available. The Company's updating of one or more forward-looking statements does not imply that it will or will not update these or any other forward-looking statements.
This press release is published 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 securities of the Company in any jurisdiction whatsoever, particularly in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not intended to address the investment objectives, financial situation or specific needs of any particular recipient. It should not be relied upon as a substitute for the exercise of your own judgement. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be restricted by law in certain jurisdictions. Persons into whose possession this press release comes are required to inform themselves about and to observe any such restrictions.
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CONTACT: 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
(END) Dow Jones Newswires
December 09, 2025 12:02 ET (17:02 GMT)