Medincell Publishes its Consolidated Annual Financial Results

MONTPELLIER, France--(BUSINESS WIRE)--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^®, 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)

• €6.5 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 €42.9 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

Consolidated cash flow statements

(*) The closing balance does not include €12.9 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^® net sales. This was partially offset by slightly higher operating expenses.

B- Net cashflow from investing activities

Net cashflow from investing activities include €12.9 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 (€1.4 million vs €0.6 million) and compensates slightly higher capital expenditures (€0.7 million vs €0.3 million).

C- Net cashflow from financing activities

The €33.3 million increase over fiscal year closed on March 31, 2025, relates to proceeds of €42.9 million from the capital raise in February 2025 (€39.7 million net of issuance costs). The €25.5 million increase over the previous year related to proceeds of €23.2 million from the capital raise in May 2023, net of issuance costs, and the receipt of the last €10 million tranche of the EIB loan in July 2023. The Company continued to repay its outstanding loans during the fiscal year.

Consolidated income statement

Revenue and other income: €27.7 million

For the year ended March 31, 2025, Company revenues and other income include the following items:

• Royalties on net sales from UZEDY^® invoiced to Teva for a total of €6.5 million (vs €1.7 million last year, a 3.8x increase) showing the strong momentum of UZEDY^® on its first year of commercialization.
• Royalties on intellectual property from the CMB Joint-Venture accounted for €0.6 million, stable compared to last year.
• A €4.8 million milestone payment invoiced to Teva following the completion of the Phase 3 study on LAI olanzapine (vs €3.6 million in previous year, invoiced to Teva following FDA approval of UZEDY^®).
• Other partnership revenues represented €13.5 million (vs €3.1 million in previous year):
  • Revenues from the 1^st program in development under the AbbVie collaboration accounted for €9.5 million,
  • Revenues from the Gates Foundation to develop a contraceptive long-acting injectable accounted for €2.6 million,
  • Revenues from other collaborations and from proof-of-feasibility studies accounted for €1.4 million.
• Other income consisted mainly of the Research Tax Credit for €2.4 million.

Current operating expenses: €38.5 million

Current operating expenses increased by €5.6 million (17%) compared to the previous year, showing a good control of their growth.

R&D expenses increased from €21.1 million in the previous year to €24.3 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 €0.6 million and €1.7 million compared to the previous year, due to higher salaries and benefits.

Net financial result: €(7.4) million

Net financial loss increased from €(4.0) million to €(7.4) million year-on-year. This variance is mainly explained a €3.5 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^® 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.

¹ United States Patent and Trademark Office