(April 1(st) , 2024 - March 31(st) , 2025)
Consolidated financial statements for the year 2024-25 (IFRS standards)
--
Revenues: EUR25.4 million, multiplied by 2.8x compared to previous
year
-> Other income: EUR2.3 million, bringing total income to EUR27.7
million
--
Operating expenses: EUR38.5 million, a 17% increase compared to
previous year
--
Operating result: EUR(10.8) million, a 48% year-over-year improvement
--
Net result: EUR(18.4) million, a 26% year-over-year improvement
--
Cash, cash equivalents and low-risk financial investments at the
closing: EUR71.9 million
-> Composed of EUR59.0 million in cash and cash
equivalent and EUR12.9 million in low-risk financial investments
MONTPELLIER, France--(BUSINESS WIRE)--June 17, 2025--
Regulatory News:
Medincell (Paris:MEDCL):
Christophe Douat, CEO of Medincell: "2024 marked the beginning of a new era for Medincell with the surge in our revenues notably fueled by the strong performance of UZEDY. Looking ahead, we anticipate further revenue acceleration with the expected 2026 approval and launch our olanzapine LAI, which has first-in-class potential. Building on this momentum, we are executing a growth strategy anchored in three pillars: 1) continuing to engage top-tier partners, 2) focusing on first- and best-in-class LAIs that deliver meaningful impact for patients and strong value for stakeholders, 3) maintaining and strengthening our technological leadership."
Stéphane Postic, CFO of Medincell: "With revenue increasing by a factor of 2.8 and operational losses cut in half, we have taken a decisive step toward achieving operational profitability, anticipated for the next fiscal year ending on March 31, 2027. In addition, we have significantly strengthened our balance sheet, enabling us to optimize our financial strategy moving forward. These strong results provide a robust foundation to support our growth ambitions and drive long-term value creation."
The audit procedures on the consolidated financial statements are ongoing.
Highlights of year
UZEDY$(R)$ , robust growth momentum in the US
(1- and 2-Month Long-Acting Injectable Risperidone, approved by FDA for the treatment of schizophrenia, partnership with Teva)
--
EUR6.5 million in royalties invoiced by Medincell, a 3.8x increase
year-over-year
--
sNDA for new additional indication in bipolar disorder under review by
FDA after acceptance in February 2025
--
Notice of allowance received by Medincell in April 2025 from the USPTO1
for an additional patent application, providing protection until 2042
Olanzapine LAI (mdc-TJK) on track for U.S. submission in H2 2025, Europe to follow
(Investigational 1-Month Long-Acting Injectable Olanzapine for the treatment of schizophrenia, partnership with Teva)
--
A year of progress toward FDA submission and review for approval
->
Positive efficacy results of the Pivotal Phase 3 trial in schizophrenia
presented in May 2024 and September 2024
-> Study completion in January
2025
-> No cases of post-injection delirium/sedation syndrome (PDSS)
observed after > 100% of injections requested by FDA for regulatory
submission
-> Pre-NDA meeting held by Teva with FDA in April 2025
(post-closing)
-> NDA submission planned for H2 2025
--
New specific patent granted by the USPTO for Medincell's olanzapine
formulation, providing protection until 2044
R&D Portfolio progress
--
Results of the mdc-CWM Phase 3 study
(Investigational intraarticular
celecoxib for pain management after Total Knee Replacement, partnership
with Arthritis Innovation Corporation, AIC, that funds and conducts the
regulatory development)
-> The study did not meet its primary endpoint
but demonstrated statistically significant results on several key
endpoints assessing inflammation and opioid use in the total population
-> The analysis of a subgroup of patients experiencing their first knee
replacement (TKR-naïve) representing more than 2/3 of study
participants (108/151) showed a statistically significant reduction in
pain
-> This subgroup of TKR-naïve patients will be the primary
study population in the next stages of clinical development
-> A meeting
with FDA in Q1 2025 provided further guidance on the next steps to
regulatory approval
-> AIC is actively preparing the next Phase 3 study
--
Progress on preclinical and CMC activities (Chemistry, Manufacturing &
Control)
-> mdc-WWM (contraception) Phase 1 clinical study to start in
2025
-> mdc-STM (malaria) Phase 1 clinical study is planned to start in
2026
-> Start of preclinical and CMC activities for the first LAI
candidate in co-development with AbbVie
--
Deployment of advanced BEPO Star technology
-> Expansion of
formulation capabilities
-> Potential to obtain BEPO Star technology
patent protection until 2040
Strategic co-development and licensing agreement signed with AbbVie (April 2024)
--
Up to six long-acting injectable therapies in different therapeutic
areas and indications
--
Upfront payment of $35 million received in May 2024
--
Up to $1.9 billion in milestone and commercialization payments ($315
million for each program) and mid-single to low double-digit royalties on
net sales
Financing
--
Successful fund raising of EUR42.9 million performed in February 2025,
with the participation of American and European healthcare-focused
investors such as Adage Capital Partners, Invus, Polar Capital LP, and
Wellington Management, alongside the company's main historical
shareholders, including Mirova, Syquant Capital, and SITAM Belgique
(Dassault Group).
Selected financial information for fiscal year 2024-2025
Key consolidated figures - IFRS (in thousands
of EUR)
March 31, 2025 March 31,2024
INCOME STATEMENT 12 months 12 months
---------------------------------------------- -------------- --------------
Revenues 25 419 9 032
---------------------------------------------- -------------- --------------
Other income 2 308 2 913
---------------------------------------------- -------------- --------------
Current operating result (10 762) (20 940)
---------------------------------------------- -------------- --------------
Operating result (10 840) (20 977)
---------------------------------------------- -------------- --------------
Financial result (7 438) (3 973)
---------------------------------------------- -------------- --------------
Net result (18 438) (25 038)
---------------------------------------------- -------------- --------------
CASHFLOW March 31, 2025 March 31,2024
---------------------------------------------- -------------- --------------
Net cashflow from operating activities 19 465 (11 922)
---------------------------------------------- -------------- --------------
Net cashflow from investing activities (13 210) (613)
---------------------------------------------- -------------- --------------
Net cashflow from financing activities 33 324 25 528
---------------------------------------------- -------------- --------------
BALANCE SHEET March 31, 2025 March 31,2024
---------------------------------------------- -------------- --------------
Equity of the consolidated group (16 367) (40 824)
---------------------------------------------- -------------- --------------
Total non-current liabilities 76 945 61 304
---------------------------------------------- -------------- --------------
Total current liabilities 29 874 16 466
---------------------------------------------- -------------- --------------
Total non-current assets 9 835 9 690
---------------------------------------------- -------------- --------------
Of which financial assets and other
non-current assets 1 900 1 792
---------------------------------------------- -------------- --------------
Total current assets 80 617 27 258
---------------------------------------------- -------------- --------------
Of which cash and cash equivalents 59 040 19 460
---------------------------------------------- -------------- --------------
Of which low-risk financial investments 12 857 -
---------------------------------------------- -------------- --------------
FINANCIAL DEBT March 31, 2025 March 31,2024
---------------------------------------------- -------------- --------------
Financial debt, non-current portion 49 417 50 541
---------------------------------------------- -------------- --------------
Financial debt, current portion 6 621 5 518
---------------------------------------------- -------------- --------------
Non-current derivative liabilities 8 564 5 745
---------------------------------------------- -------------- --------------
Current derivative liabilities - - ---------------------------------------------- -------------- -------------- GROSS FINANCIAL DEBT 64 601 61 804 ---------------------------------------------- -------------- -------------- Cash and cash equivalents 59 040 19 460 ---------------------------------------------- -------------- -------------- Low-risk financial investments 12 857 - ---------------------------------------------- -------------- -------------- NET FINANCIAL DEBT (7 296) 42 344 ---------------------------------------------- -------------- --------------
Consolidated cash flow statements
March 31, 2025 March 31,2024
(In thousands of euros) 12 months 12 months
---------------------------------------------- -------------- --------------
A Net cashflow from operating activities 19 465 (11 922)
------------------------------------------ -------------- --------------
B Net cashflow from investing activities (13 210) (613)
------------------------------------------ -------------- --------------
C Net cashflow from financing activities 33 324 25 528
------------------------------------------ -------------- --------------
Impact of non-monetary items and foreign
exchange rate changes - -
------------------------------------------ -------------- --------------
Change in net cash position 39 580 12 993
--------------------------------------------- -------------- --------------
Cash and cash equivalents - opening balance 19 460 6 467
--------------------------------------------- -------------- --------------
Cash and cash equivalents - closing balance
(*) 59 040 19 460
--------------------------------------------- -------------- --------------
(*) The closing balance does not include EUR12.9 million of low-risk short-term financial investments.
A- Net cashflow from operating activities
Net cashflow from operating activities was positive this year, thanks to the collection of the $35 million upfront received from AbbVie at partnership execution and of higher royalties from UZEDY(R) net sales. This was partially offset by slightly higher operating expenses.
B- Net cashflow from investing activities
Net cashflow from investing activities include EUR12.9 million of low-risk short-term investments made by the Company to generate additional financial income from the available cash. Financial income is higher than in previous year (EUR1.4 million vs EUR0.6 million) and compensates slightly higher capital expenditures (EUR0.7 million vs EUR0.3 million).
C- Net cashflow from financing activities
The EUR33.3 million increase over fiscal year closed on March 31, 2025, relates to proceeds of EUR42.9 million from the capital raise in February 2025 (EUR39.7 million net of issuance costs). The EUR25.5 million increase over the previous year related to proceeds of EUR23.2 million from the capital raise in May 2023, net of issuance costs, and the receipt of the last EUR10 million tranche of the EIB loan in July 2023. The Company continued to repay its outstanding loans during the fiscal year.
Consolidated income statement
March 31, 2025 March 31,2024 Value Variance
(In thousands of euros) 12 months 12 months Variance %
------------------------- -------------- -------------- --------- --------
Revenues 25 419 9 032 16 387 181%
------------------------- -------------- -------------- --------- --------
Other income 2 308 2 913 (605) -21%
------------------------- -------------- -------------- --------- --------
REVENUES AND OTHER INCOME 27 727 11 945 15 580 132%
------------------------- -------------- -------------- --------- --------
Research and Development
Expenses (24 313) (21 076) (3 237) 15%
------------------------- -------------- -------------- --------- --------
Sales and Marketing
Expenses (3 259) (2 639) (620) 23%
------------------------- -------------- -------------- --------- --------
General and
Administrative Expenses (10 917) (9 170) (1 747) 19%
------------------------- -------------- -------------- --------- --------
TOTAL OPERATING EXPENSES (38 489) (32 885) (5 604) 17%
------------------------- -------------- -------------- --------- --------
CURRENT OPERATING RESULT (10 762) (20 940) (10 178) 48%
------------------------- -------------- -------------- --------- --------
Other non-current
operating income and
expenses (78) (37) (41) 111%
------------------------- -------------- -------------- --------- --------
OPERATING INCOME (10 840) (20 977) 9 935 48%
------------------------- -------------- -------------- --------- --------
Financial interest income 1 398 553 845 153%
------------------------- -------------- -------------- --------- --------
Cost of gross financial
debt (5 088) (4 617) (471) -10%
------------------------- -------------- -------------- --------- --------
Change in fair value of
financial liabilities (3 518) (53) (3 465) na
------------------------- -------------- -------------- --------- --------
Other financial expenses (230) (1) (229) na
------------------------- -------------- -------------- --------- --------
Other financial income - 145 (145) -100%
------------------------- -------------- -------------- --------- --------
FINANCIAL RESULT (7 438) (3 973) (3 465) -87%
------------------------- -------------- -------------- --------- --------
PROFIT BEFORE TAX (18 278) (24 950) 6 672 27%
------------------------- -------------- -------------- --------- --------
Income tax
(expense)/income (160) (88) (72) 82%
------------------------- -------------- -------------- --------- --------
NET RESULT (18 438) (25 038) 6 600 26%
------------------------- -------------- -------------- --------- --------
- Attributable to
Medincell shareholders (18 438) (25 038) 6 600 26%
------------------------- -------------- -------------- --------- --------
- Attributable to - - - -
non-controlling
interests
Revenue and other income: EUR27.7 million
For the year ended March 31, 2025, Company revenues and other income include the following items:
--
Royalties on net sales from UZEDY(R) invoiced to Teva for a total of
EUR6.5 million (vs EUR1.7 million last year, a 3.8x increase) showing the
strong momentum of UZEDY(R) on its first year of commercialization.
--
Royalties on intellectual property from the CMB Joint-Venture accounted
for EUR0.6 million, stable compared to last year.
--
A EUR4.8 million milestone payment invoiced to Teva following the
completion of the Phase 3 study on LAI olanzapine (vs EUR3.6 million in
previous year, invoiced to Teva following FDA approval of UZEDY(R)).
--
Other partnership revenues represented EUR13.5 million (vs EUR3.1
million in previous year):
--
Revenues from the 1st program in development under the AbbVie
collaboration accounted for EUR9.5 million,
--
Revenues from the Gates Foundation to develop a contraceptive
long-acting injectable accounted for EUR2.6 million,
--
Revenues from other collaborations and from proof-of-feasibility
studies accounted for EUR1.4 million.
--
Other income consisted mainly of the Research Tax Credit for EUR2.4
million.
Current operating expenses: EUR38.5 million
Current operating expenses increased by EUR5.6 million (17%) compared to the previous year, showing a good control of their growth.
R&D expenses increased from EUR21.1 million in the previous year to EUR24.3 million and represented 63% of the total operating expenses. The main drivers explaining this increase are: higher salaries and benefits for the R&D team, higher subcontracting expenses relating to CDMOs and CROs, all of this being partially offset by reduced polymer purchases.
Marketing and business development expenses and General and administrative expenses respectively increased by EUR0.6 million and EUR1.7 million compared to the previous year, due to higher salaries and benefits.
Net financial result: EUR(7.4) million
Net financial loss increased from EUR(4.0) million to EUR(7.4) million year-on-year. This variance is mainly explained a EUR3.5 million non-cash fair value adjustment of the warrants put option granted to the EIB, this adjustment being itself a direct consequence of the strong increase in the Company stock price over the period. Higher debt costs (since Tranche C of the EIB loan did not fully impact the previous year as it was drawn down in July 2023) were offset by higher financial income generated by the Company cash deposits and short-term investments.
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(R) 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(R) 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(R) (BEPO(R) technology is licensed to Teva under the name SteadyTeq$(TM)$). 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(R) and SteadyTeq(TM) are registered trademarks of Teva Pharmaceuticals.
www.medincell.com
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.
(1) United States Patent and Trademark Office
View source version on businesswire.com: https://www.businesswire.com/news/home/20250617518997/en/
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
June 17, 2025 11:45 ET (15:45 GMT)
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