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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Medincell SA | EU:MEDCL | Euronext | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.26 | -1.63% | 15.68 | 15.62 | 15.72 | 16.02 | 15.66 | 15.94 | 11,162 | 08:56:21 |
(April 1st, 2023 - March 31st, 2024)
Regulatory News:
Medincell (Paris:MEDCL):
Highlights
Commercial launch by Teva Pharmaceuticals (“Teva”) of UZEDY® (risperidone) in the U.S., the first product using Medincell BEPO® technology
Acceleration of phase 3 clinical trial of mdc-TJK (olanzapine, schizophrenia), second antipsychotic developed with Teva
Post-closing
End of phase 3 clinical trial of mdc-CWM (intraarticular celecoxib, post-op pain, developed in partnership with AIC)
Post-closing
Financing
Christophe Douat, CEO of Medincell: "2023 has been a transformative year, marked by the FDA approval and successful commercial launch of UZEDY in the United States by our partner Teva. The anticipated rise in UZEDY royalties and the expected revenue from the olanzapine LAI will generate net profit to fuel Medincell’s sustainable growth. We have entered a new era, demonstrating our ability to innovate and develop the enabling technologies to design innovative therapeutic solutions. We are now excited to welcome new partners, such as AbbVie, with whom we have recently signed a significant strategic agreement."
Consolidated financial statements for the year 2023-24
Operating result: €(21.0) million, a 13% improvement vs previous year
Net result: €(25.0) million, a 22% improvement vs previous year
Cash consumption from operating activities: €11.9 million, a 43% decrease vs previous year
Closing cash position: €19.5 million (of which €5.2 million in the form of non-risky financial assets)
Main post-closing cash-in: €32.5 million (AbbVie initial payment)
Audit procedures on the Company’s 2024 consolidated accounts were completed. The statutory auditors report on the 2024 consolidated financial statements will be issued after the completion of the procedures required for the filing of the Universal Registration Document with the French Financial Markets Authority (Autorité des Marchés Financiers or AMF).
Strategic co-development and licensing agreement with AbbVie (April 2024, post-closing)
On April 16, 2024, Medincell announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.
The first LAI program candidate has been selected and formulation activities are underway.
Under the terms of the co-development and licensing agreement covering up to 6 programs, Medincell has received a $35 million upfront payment and is eligible to receive up to $1.9 billion in development and commercial milestones ($315 million for each program). Medincell is also eligible to receive mid-single to low-double-digit royalties on net sales.
Successful commercial launch of UZEDY® (1-month and 2-month risperidone, schizophrenia)
UZEDY® is the first product based on Medincell long-acting injectable technology to reach the commercial stage:
mdc-TJK (olanzapine, schizophrenia): recruitment finalized 9 months earlier than planned
If approved by the FDA, mdc-TJK would be the first long-acting injectable olanzapine product with a favorable safety profile, potentially elevating this product to first-in-class status. mdc-TJK aims at offering an additional treatment solution for UZEDY for patients with more severe forms of schizophrenia.
1 The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme; the PANSS overall total score ranges from 30 to 210, with a higher score indicating greater symptom severity. The primary efficacy endpoint was measured by change from baseline to week 8 against the PANSS total score.
mdc-CWM (intra-articular celecoxib, post-operative pain): end of phase 3 clinical trial and encouraging results paving the way for future developments
A numerical improvement favoring F14 was observed for the primary endpoint. Secondary endpoints of time-weighted AUC of pain over 3 and 7 days also demonstrated numerical improvement favoring F14. The safety profile for F14 was consistent with the prior Phase 2 study, and no new safety signals were identified, and no SAEs2 were reported as related to F14 treatment.
Substantial improvement was observed for F14-treated patients for the key secondary endpoint of knee range of motion (ROM) at 6 weeks, as well as at 3 months (p<0.005 and p<0.0005 respectively; unadjusted for multiplicity). Treated-knee effusion (i.e., swelling) showed highly improved outcomes for the F14-treated patients compared to MMA at 6 weeks and 3 months (p<0.005 and p<0.05 respectively, unadjusted for multiplicity). The widely used clinical-performance based measure of lower extremity function, the Timed-Up-and-Go (TUG) test was also improved for the F14 group at 6 weeks. Notably, far greater improvements were observed for the endpoints of time-weighted AUC of pain, ROM, effusion, and TUG in a sub-group of patients representing over 70% of the trial population (108/151) who had not previously undergone TKR in their contralateral (non-study) knee. This subset analysis was pre-specified in the protocol, but not alpha-controlled for formal statistical testing. AIC intends to discuss the results from this trial with regulators and explore alternative approval pathways for F14 in this sub-group of patients.
1 Time-weighted Area Under the Curve (AUC) of pain is a statistical measure used in clinical trials and pain management studies to quantify the overall experience of pain over a specified period. It integrates both the intensity of pain and the duration for which that pain is experienced.
2 SAE: Severe adverse event
Progressing the preclinical pipeline
Other Research and Development activities
In parallel with the advancement of the R&D pipeline, Medincell teams have continued to strengthen the Company's technological portfolio, to increase its capacity to formulate innovative treatments with different types of molecules and different therapeutic objectives.
Selected financial information for fiscal year 2023-2024
Key consolidated figures - IFRS (in thousands of €)
INCOME STATEMENT
March 31, 2024 12 months
March 31,2023 12 months
Revenues
9 032
9 889
Other income
2 913
3 766
Current operating result
(20 940)
(24 025)
Operating result
(20 977)
(24 046)
Financial result
(3 973)
(7 964)
Net result
(25 038)
(32 010)
CASHFLOW
March 31, 2024
March 31,2023
Net cashflow from operating activities
(11 922)
(21 005)
Net cashflow from investing activities
(613)
1 298
Net cashflow from financing activities
25 528
1 556
BALANCE SHEET
March 31, 2024
March 31,2023
Equity of the consolidated group
(40 824)
(42 294)
Total non-current liabilities
61 304
14 608
Total current liabilities
16 466
57 025
Total non-current assets
9 690
9 772
Of which financial assets and other non-current assets
1 792
1 460
Total current assets
27 258
19 568
Of which cash and cash equivalents
19 460
6 467
FINANCIAL DEBT
March 31, 2024
March 31,2023
Financial debt, non-current portion
50 541
11 708
Financial debt, current portion
5 518
39 757
Non-current derivative liabilities
5 745
-
Current derivative liabilities
-
3 055
GROSS FINANCIAL DEBT
61 804
54 520
Cash and cash equivalents
19 460
6 467
NET FINANCIAL DEBT
42 344
48 053
Consolidated cash flow statements
(In thousands of euros)
March 31, 2024 12 months
March 31,2023 12 months
A
Net cashflow from operating activities
(11 922)
(21 005)
B
Net cashflow from investing activities
(613)
1 298
C
Net cashflow from financing activities
25 528
1 556
Impact of non-monetary items and foreign exchange rate changes
-
-
Change in net cash position
12 993
(18 150)
Cash and cash equivalents - opening balance
6 467
24 617
Cash and cash equivalents - closing balance
19 460
6 467
A- Net cashflow from operating activities
Cash expenses from operations decreased compared to previous year, in particular due to lower current operating expenses and the receipt of the first royalties from UZEDY® net sales.
B- Net cashflow from investing activities
Net cashflow from investing activities was down €1.9m on the previous year. The latter included the termination of a capitalization contract in the first quarter of 2023 for 2.6 M€, which was not repeated in the year ended March 31, 2024. In the year ended March 31, 2024, net cashflow from investing activities included the acquisition of laboratory equipment and instruments, and improvements to the Jacou site for €0.3 million, and the acquisition of intangible assets relating to intellectual property for €0.9 million, partially offset by the receipt of €0.5 million in income from cash interests on investments.
C- Net cashflow from financing activities
The €24 million increase over the previous year relates to proceeds of €23.2 million from capital raise in May 2023, net of issuance costs, and the receipt of the last 10 M€ tranche of the EIB loan in July 2023. The Company continued to repay its outstanding loans during the fiscal year.
Consolidated income statement
(In thousands of euros)
March 31, 2024 12 months
March 31,2023 12 months
Value
Variance
Variance
%
Revenues
9 032
9 889
(857)
-9%
Other income
2 913
3 766
(853)
-23%
REVENUES AND OTHER INCOME
11 945
13 655
(1 710)
-13%
Research and Development Expenses
(21 076)
(27 925)
6 849
-25%
Sales and Marketing Expenses
(2 639)
(2 588)
(51)
2%
General and Administrative Expenses
(9 170)
(7 167)
(2 003)
28%
TOTAL OPERATING EXPENSES
(32 885)
(37 680)
4 795
-13%
CURRENT OPERATING RESULT
(20 940)
(24 025)
3 085
13%
Other non-current operating income and expenses
(37)
(21)
(16)
76%
OPERATING INCOME
(20 977)
(24 046)
3 069
13%
Financial interest income
553
41
512
1249%
Cost of gross financial debt
(4 617)
(3 932)
(685)
17%
Change in fair value of financial liabilities
(53)
(5 206)
5 153
-99%
Other financial expenses
(1)
(57)
56
-98%
Other financial income
145
1 190
(1 045)
-88%
FINANCIAL RESULT
(3 973)
(7 964)
3 991
50%
PROFIT BEFORE TAX
(24 950)
(32 010)
7 060
22%
Income tax (expense)/income
(88)
-
88
N/A
NET RESULT
(25 038)
(32 010)
6 972
22%
- Attributable to Medincell shareholders
(25 038)
(32 010)
6 972
22%
- Attributable to non-controlling interests
-
-
-
-
Revenue and other revenue: 11.9 M€
For the year ended March 31, 2024, Company revenues include the following items:
Other income consists mainly of the Research Tax Credit for €2.8 million.
Current operating expenses: €32.9 million
Current operating expenses decreased by €4.8 million (13%) compared to the previous year.
R&D expenses decreased from €27.9 million in the previous year to €21.1 million, to represent 64% of the total operating expenses. Subcontracting expenses relating to CDMOs and CROs decreased following the end of phase 2 trial of the mdc-TTG program and because of reduced polymer purchases.
General and administrative expenses increased by €2.0 million (or 28%) compared to the previous year, due to various fees (consulting concerning the Research Tax Credit, lawyers, audit, investors relations in the United States), as well as higher personnel expenses (notably bonus, profit-sharing and free shares related expenses).
Net financial result: €(4.0) million
Net financial loss reduced by €4.0 million year-on-year. This variance is explained by the renegotiation of the EIB loan on November 22, 2022, which led to an increase in the average debt after the issue of tranches B and C of the loan, and to a reduction in the effective interest rate from 16.3% to 13.0% on tranche A, by the re-evaluation of the variable remuneration due to EIB and by the change in fair value of the warrants put options attributed to EIB as of March 31, 2024.
Net financial charge is mainly composed of interest payable on the EIB loan of €(4.4) million as of March 31, 2024, compared with €(3.5) million as of March 31, 2023. The change in fair value of the EIB loan amounted to €(0.1) million and comprises the following items:
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240609409426/en/
David Heuzé - Head of Corporate and Financial Communications, and ESG david.heuze@medincell.com / +33 (0)6 83 25 21 86
Grace Kim - Head of US Financial Strategy and IR grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France Louis-Victor Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71 94 94
Media Relations Nicolas Mérigeau medincell@newcap.eu / +33 (0)1 44 71 94 94
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