Slides
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FY 2024-25 Annual Results June 17, 2025
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IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUING This presentation and the Fiscal Year 2024-25 results conference (French and English sessions) contain forward-looking statements, including statements regarding Company’s expectations for (i) the timing, progress and outcome of its clinical trials; (ii) the clinical benefits and competitive positioning of its product candidates; (iii) the ability of its products to obtain regulatory approvals, commence commercial production and achieve market penetration and sales; (iv) its future product portfolio; (v) its future partnering arrangements; (vi) its future capital needs, capital expenditure plans and ability to obtain funding; and (vii) prospective financial matters regarding our business. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this This presentation and the Fiscal Year 2024-25 results conference (French and English sessions) relating to future events are forward-looking statements and subject to change without notice, factors beyond the Company's control and the Company's financial capabilities. These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", “expect”, "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", “potential”, "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance, or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (the "AMF") pursuant to its regulatory obligations, including the Company's universal registration document, filed with the AMF on July 28, 2022, (the "Universal Registration Document"), as well as in the documents and reports to be published subsequently by the Company. In particular, readers' attention is drawn to the section entitled "Facteurs de Risques" on page 24 of the Universal Registration Document. Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements. This presentation and the Fiscal Year 2024-25 results conference (French and English sessions) are 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 the Company's shares in any jurisdiction, in particular in France. Similarly, this presentation does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation, or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this presentation may be subject to legal restrictions in certain jurisdictions. Persons who come to know about this presentation are encouraged to inquire about, and required to comply with, these restrictions All information in the presentation and the Fiscal Year 2024-25 results conference (French and English sessions) speaks only as of (1) the date hereof, in the case of information about the Company and (2) the date of such information, in the case of information from persons other than the Company. The Company does not undertake any duty to update or revise the information contained herein, publicly or otherwise. The Company has not independently verified any third-party information and makes no representation as to the accuracy or completeness of any such information. UZEDY® is a trademark of Teva Pharmaceuticals.
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OVERVIEW
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UZEDY® Operational Profitability1 OLANZAPINE LAI Accelerated Growth2 R&D PIPELINE • AbbVie #1, mdc-CWM, • Others TECHNOLOGY INNOVATION Sustained Growth3 “Shift to Growth” Financial Strategy 3 Engines Firing in Parallel
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FY 2024-25: A “Spectacular” Year (1) UZEDY®: Great first commercial year, robust growth Olanzapine LAI: no PDSS, Phase 3 completed R&D Pipeline & Technology Innovation • AbbVie Agreement, 1st program already in preclinical • Progression of R&D pipeline • BEPO Star implementation 1 2 3
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9 25.4 FY2023-24 FY2024-25 -21.0 -10.8 FY2023-24 FY2024-25 Operating Losses Cut in Half FY 2024-25: A “Spectacular” Year (2) Revenue Up 2.8x
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May-23 May-25 Robust Growth Momentum for UZEDY® during FY 2024-25 Medincell royalties: 6.5 M€ from $141 M net sales during the period What’s next? • Bipolar disorder indication under FDA review • Multi-year ramp-up to peak sales Trend of UZEDY prescriptions Source : Bloomberg (data from Symphony Health) FY 2024-25
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Olanzapine LAI Offers Blockbuster Potential Olanzapine is the most-used antipsychotic in schizophrenia Used for most severe patients and/or refractory to other treatments First Long-Acting Olanzapine failed commercially
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FY 2024-25 Study completion No PDSS, positive efficacy results Pre-NDA meeting with FDA (April 9, 2025) Next Anticipated Steps FDA submission: H2 2025 • 10-Month review by FDA Target U.S. commercial launch:2026 (pending FDA approval) Olanzapine LAI on track for FDA filing in H2 2025
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UZEDY® US patent protection 2033 2042 New Patents Granted on UZEDY® and Olanzapine Support Long-Term Exclusivity 2044 Olanzapine LAI US patent protection 2033
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PORTFOLIO & R&D PIPELINE UPDATE
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Advancing Innovation Across the Pipeline 12 3 UZEDY® Risperidone Schizophrenia MARKETNDA PREPARATION Olanzapine LAI (mdc-TJK) Schizophrenia AbbVie (1/6) PRECLINICAL Ivermectin 3-Month (mdc-STM) Malaria CLINICAL PHASE 3 Celecoxib Intraarticular (mdc-CWM) Postoperative pain ~10 in-house and partnered programs FORMULATION Progestin 6-Month (mdc-WWM) Contraception
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Subcutaneous vs intramuscular Immediate onset vs several weeks Ready-to-use vs reconstitution Same effect regardless of location of injection UZEDY®: Fully Differentiated, Best-in-Class Features
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UZEDY® Shows Strong Real-World Benefits RELAPSE RATE: -42% UZEDY® SGOAs 9.0% 15.4% UZEDY® SGOAs 94 days 61 days MEAN TIME TO RELAPSE: +54% UZEDY® SGOAs 15.6% 29.6% INPATIENT RATE: -47% UZEDY® SGOAs 8 days 16 days MEAN LENGTH OF HOSPITAL STAY: -50% UZEDY® SGOAs $18,796 $26,376 MEAN ALL-CAUSE HCRU COSTS: -29% HCRU: healthcare resource utilization Source: Poster presented by Teva Pharmaceuticals at the Annual Psych Congress Elevate; May 28 –31, 2025; Las Vegas, NV : Treatment Patterns and Healthcare Resource Utilization Among Patients Receiving the Long -Acting Injectable Antipsychotic TV-46000 Versus Second -Generation Oral Antipsychotics Outcomes from real -world claims studies comparing UZEDY ® to second-generation oral antipsychotics (SGOAs) May 2025, Psych Congress Elevate
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Olanzapine is the Most-Used Oral Antipsychotic in Schizophrenia both in US and EU Source: Teva Innovation & Strategy Day, May 29, 2025 - Note: Share per treatment are based on IQVIA MIDAS MATQ4 2024 for EU ( covering 17 countries) and IQVIA NPA Dec24 Trx data for US 20% 37% 16% 14% 8% 17% 18% 13% 38% 19% Olanzapine Risperidone Aripiprazole Clozapine Others US Europe
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First Olanzapine LAI with Potential for No Monitoring of PDSS Existing Olanzapine LAI • Risk of PDSS at each injection • <0.1% of injections, ~2% of patients • FDA Black Box Warning, 3-hour monitoring post-injection and restricted distribution Medincell Olanzapine LAI • No suspected or confirmed PDSS in Phase 3 • Clinical evidence suggests no risk of PDSS
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Clear differentiation from approved and investigational therapies Unique impact on long-term functional outcomes FDA Q1 2025 meeting confirmed clear guidance for a second Phase 3 design focused on TKR-naïve subgroup AIC is actively preparing the next Phase 3 study mdc-CWM: Regulatory Path to Approval F14 Intra-articular administration of celecoxib at the time of the surgery for targeted and sustained delivery
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FINANCIALS
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Revenues Up 2.8x, Royalties Surge CMB Royalties: 0.6 M€ FY2023-24 FY2024-25 UZEDY® Royalties: 6.5 M€ 3.8x increase vs. previous year x2.8 9.0 M€ 25.4 M€ Milestone: 4.8 M€ Olanzapine LAI Phase 3 completion Services: 13.5 M€ Including 9.5M€ revenue recognition from AbbVie’s 33M€ upfront payment
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Total income of which revenue 27.7 25.4 +130% YoY +180% YoY Operating expenses 38.5 +17% YoY Operating result -10.8 48% improvement YoY Financial result of which Non-cash Impact of the change in the fair value of EIB Warrants -7.4 -2.8 Ongoing discussion with EIB to eliminate warrants impact Net result -18.4 26% improvement YoY FY 2024-25 Income Statement
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Strong Cash position 19.5 M€ 71.9 M€ March 31, 2024 March 31, 2025 Cash and Cash Equivalent Successful fundraising of 43 M€ in February 2025 AbbVie’s 33M€ upfront payment received in May 2024
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Next Fiscal Year (2026-27) • Operational Profitability 2030 • Potential for $XXX million annual pure profit revenues from UZEDY and Olanzapine LAI products • Revenue from other partners • EBIT > 70% of revenue Shift to Profitability and Profit Growth
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Expanding our Investor Base Globally and Increasing our Liquidity US, UK, Australia (Adage Capital Partners LP , Invus, Polar Capital, Wellington Management, etc.) France & Europe (Mirova, Groupe Dassault, BNP Paribas Development, Syquant, etc.) international Institutional Investors 17.0% European Institutional Investors 34.0% Current and former employees & affiliates / Management / co-founders 37.5% Individuals 11.5% Based on the best of the Company's knowledge Liquidity (January 1st – June 11) Average Daily Volume: 119,387 shares Average Daily Value: 1.80 M€ Other platforms Average Daily Volume 70,271 shares Average Daily Value 1.06 M€ Average Daily Volume 49,116 shares Average Daily Value 0.75 M€
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KEY TAKEAWAYS
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Key Takeaways ► UZEDY®: Great first commercial year, robust growth ► Olanzapine LAI: no PDSS, phase 3 completed, on track for filing in H2 ► R&D Pipeline progression, including 1st program with AbbVie in preclinical ► BEPO Star implementation ► Record Financials results • Total Income x2.3 / Operating losses cut in half • Strong cash position to bridge profitability in FY 2026/27
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Q&A
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UZEDY® Operational Profitability1 OLANZAPINE LAI Accelerated Growth2 R&D PIPELINE • AbbVie #1, mdc-CWM, • Others TECHNOLOGY INNOVATION Sustained Growth3 “Shift to Growth” Financial Strategy 3 Engines Firing in Parallel