Medincell Publishes its Consolidated Half-Year Financial Results
MONTPELLIER, France--( BUSINESS WIRE)--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)
Key highlights
Risperidone LAI (UZEDY ®)
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
First program with AbbVie
Other pipeline updates
Technology upgrade: BEPO ® Star
Appointment of Dr. Sharon Mates, Dr. Charles Kunsch, and Dr. Pascal Touchon to Medincell’s Board of Directors
Selected financial information for the first half of fiscal year 2025-2026
Key consolidated figures - IFRS (in thousands of €)
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.
INCOME STATEMENT
September 30, 2025
6 months
September 30, 2024
6 months
Revenues
11 608
8 620
Other income
2 539
815
Current operating result
(6 612)
(7 598)
Operating result
(6 612)
(7 529)
Financial result
(9 459)
(6 910)
Net result
(16 078)
(14 568)
Total income (revenues and other income) up by 50%: €14.1 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:
Other income consisted mainly of the Research Tax Credit for €2.5 million.
Operating expenses up by 22%: €20.8 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: €(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: €(9.5) million
The net financial loss increased from €6.9 million to €9.5 million over one year. This change is mainly due to a €6.8 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 €14.4 on March 31, 2025 to €23.8 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 €1 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
Equity of the consolidated group
(30 633)
(16 367)
Total non-current liabilities
83 877
76 945
Total current liabilities
21 332
29 874
Total non-current assets
13 221
9 835
Of which financial assets and other non-current assets
5 332
1 900
Total current assets
61 356
80 617
Of which cash and cash equivalents
49 767
59 040
Of which low-risk financial investments
3 735
12 857
FINANCIAL DEBT
September 30, 2025
March 31 ,2025
Financial debt, non-current portion
50 835
49 417
Financial debt, current portion
4 976
6 621
Non-current derivative liabilities
15 320
8 564
GROSS FINANCIAL DEBT
71 131
64 601
Cash and cash equivalents
49 767
59 040
Low-risk financial investments
3 735
12 857
NET FINANCIAL DEBT
17 629
(7 296)
Consolidated cash flow statements
(In thousands of euros)
September 30, 2025
6 months
September 30, 2024
6 months
A
Net cashflow from operating activities
(14 803)
21 559
B
Net cashflow from investing activities
8 363
(6 993)
C
Net cashflow from financing activities
(2 834)
(2 398)
Impact of non-monetary items and foreign exchange rate changes
-
-
Change in net cash position
(9 273)
12 176
Cash and cash equivalents - opening balance (*)
59 040
19 460
Cash and cash equivalents - closing balance (**)
49 767
31 636
(*) The opening balance does not include €12.9 million of low-risk, short-term financial investments.
(**) The closing balance does not include €3.7 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 ® royalties and the payment from Unitaid in the first half of the 2024-2025 financial year. During this half-year period, only UZEDY ® 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, €7.2 million was invested in these financial investments, while for the half-year ended September 30, 2025, €9.1 million was divested to meet the Company's operational needs. These financial investments of €3.7 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 €2.7 million), as in the first half of the previous financial year (€2.4 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 ® 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 ® (BEPO ® technology is licensed to Teva as SteadyTeq™). 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 ® and SteadyTeq™ 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.