Medincell Sa · EURONEXT:MEDCL

Medincell Sa — Q2 2026 Earnings Presentation

31 slides from Medincell Sa's earnings presentation, Dec 9, 2025

  1. Slide 1: Half-Year Results

    Half-Year Results December 9, 2025 1

  2. Slide 2: Important Notice - You Must Read the Following Before Continuing

    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 cl

  3. Slide 3: New Drug Application Submitted today to U.S. FDA for Olanzapine LAI

    New Drug Application Submitted today to U.S. FDA for Olanzapine LAI 3

  4. Slide 4: The next two years will be the most transformative of Medincell's history

    The next two years will be the most transformative of Medincell’s history 4

  5. Slide 5: Olanzapine LAI Timeline

    Olanzapine LAI Timeline 10-Month review following U.S. FDA Filing U.S. commercial launch expected in late 2026 5

  6. Slide 6: "Shift to Growth" Strategy Engines Firing in Parallel

    “Shift to Growth” Strategy 3 Engines Firing in Parallel ABBVIE #1, PIPELINE & INNOVATION 03 OLANZAPINE LAI 02 RISPERIDONE LAI (UZEDY®) 01 6

  7. Slide 7: Competitive Landscape

    Competitive Landscape RISPERIDONE OLANZAPINE Johnson & Johnson Eli Lilly UZEDY®’s MAIN TARGET LONG-ACTING ORAL INJECTABLE* $5.0bn ORAL $4.8bn (peak sales) $3.5bn LONG-ACTING INJECTABLE (peak sales) $40m 2005 2024 2010 2024 Sources: 7 Major Markets - Companies reported sales, IQVIA * Risperidone and

  8. Slide 8: Olanzapine LAI, Medincell is Eligible for Royalties

    Olanzapine LAI, Medincell is Eligible for Royalties Mid- to high-single digit on net sales (subject to approval and launch) Approval: $ 4 M Milestones Commercial: $105 M 8

  9. Slide 9: Olanzapine LAI is Designed to Address High Unmet Medical Need

    Olanzapine LAI is Designed to Address High Unmet Medical Need Most-used oral antipsychotic in schizophrenia Used for most severe and refractory patients Source: Teva Innovation & Strategy Day, May 29, 2025 - Note: Share per treatment are based on IQVIA MIDAS MATQ4 2024 for EU (covering 17 countries)

  10. Slide 10: The PDSS Risk of the Existing Olanzapine LAI (Eli Lilly)

    The PDSS Risk of the Existing Olanzapine LAI (Eli Lilly) Incidence of PDSS is low (less of 0.1% of injections) Low commercial penetration due to • Mandatory 3-hour monitoring after each injection • Restricted distribution (Risk Evaluation and Mitigation Strategy 10

  11. Slide 11: Strong Evidence that Olanzapine LAI will not cause PDSS

    Strong Evidence that Olanzapine LAI will not cause PDSS In vitro release tested in human plasma - worst case 120 Rapid uncontrolled release 100 from Zyprexa Relprevv®, which may Percent release of Olanzapine cause PDSS in combination with 80 intra-muscular injection ~4,000 injections 60 across multi

  12. Slide 12: Long-Term Safety Profile of TEV-'749 is Consistent With Other Olanzapine Formulations

    Long-Term Safety Profile of TEV-’749 is Consistent With Other olanzapine Formulations, With No PDSS Events 318mg 425 mg 531mg Total Most Common Adverse Events in SOLARIS Integrated Trial Period ( 04) Participants with treatment-emergent AEs, n (%) Weight increased 73 (36) 78 (38) 69 (35) 220 (36) In

  13. Slide 13: Olanzapine LAI

    Olanzapine LAI 10-Month review following U.S. FDA Filing U.S. commercial launch expected in late 2026 Submission in Europe to follow 13

  14. Slide 14: "Shift to Growth" Strategy Engines Firing in Parallel

    “Shift to Growth” Strategy 3 Engines Firing in Parallel ABBVIE #1, PIPELINE & INNOVATION 03 OLANZAPINE LAI 02 RISPERIDONE LAI (UZEDY®) 01 14

  15. Slide 15: Robust Momentum for UZEDY

    Robust Momentum for UZEDY® Trend of UZEDY® prescriptions in the US May-23 Source : Bloomberg (data from Symphony Health) October-25 15

  16. Slide 16: 2025 guidance reaffirmed by Teva: $190-200 M

    2025 guidance reaffirmed by Teva: $190-200 M 54 43 44 39 Non-recurring Medicaid adjustment 35 in Q3 25 24 2025 guidance reaffirmed by Teva 15 $190-200 M Implied Q4 outlook for $55 M - $65 M Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2024 2025 16

  17. Slide 17: UZEDY: Medincell's Technology Enables Best-in-Class Features

    UZEDY®: Medincell’s Technology Enables Best-in-Class Features Subcutaneous vs intramuscular No loading dose or oral supplementation* Ready-to-use vs reconstitution Same effect regardless of location of injection *Therapeutic levels are reached within 6 to 24 hours after administration 17

  18. Slide 18: UZEDY Shows Strong Real-World Benefits

    UZEDY® Shows Strong Real-World Benefits UZEDY® vs second-generation oral antipsychotics (SGOAs) – May 2025 RELAPSE RATE: -42% INPATIENT RATE: -47% UZEDY® 9.0% UZEDY® 15.6% SGOAs 15.4% SGOAs 29.6% MEAN TIME TO RELAPSE: +54% MEAN LENGTH OF HOSPITAL STAY: -50% UZEDY® 94 days UZEDY® 8 days SGOAs 61 days

  19. Slide 19: UZEDY

    UZEDY® FDA approval for an expanded indication in Bipolar I Disorder Risperidone LAI approved in South Korea and in Canada 19

  20. Slide 20: "Shift to Growth" Strategy Engines Firing in Parallel

    “Shift to Growth” Strategy 3 Engines Firing in Parallel ABBVIE #1, PIPELINE & INNOVATION 03 OLANZAPINE LAI 02 RISPERIDONE LAI (UZEDY®) 01 20

  21. Slide 21: AbbVie#1 Expected to Be Ready for Launch of Clinical Development in 2026

    AbbVie#1 Expected to Be Ready for Launch of Clinical Development in 2026 All pre-IND activities conducted by Medincell AbbVie to conduct all clinical development $315 million in potential milestones Mid-single to low-double digit royalties* *Up to 6 programs with AbbVie are possible under the same f

  22. Slide 22: Advancing Innovation Across the Pipeline

    Advancing Innovation Across the Pipeline FORMULATION PRECLINICAL CLINICAL PHASE 3 NDA MARKET ~10-15 AbbVie #1 Celecoxib Intraarticular Olanzapine LAI Risperidone LAI Confidential API and indication (mdc-CWM) (mdc-TJK) UZEDY® in-house and Postoperative pain Schizophrenia Schizophrenia / BP-I partnere

  23. Slide 23: Early-Stage Pipeline

    Early-Stage Pipeline FORMULATION In-house programs & partnerships (Big Pharma, Late-Stage Biotech, Global Health) ~10-15 in-house and partnered programs Commercial stage & development stage drugs 5+ therapeutic areas Several candidates with blockbuster potential ~ ~ CORPORATE PRESENTATION – December

  24. Slide 24: Financials

    Financials medincell.

  25. Slide 25: +50% Year-on-Year Total H1 Revenue Growth

    +50% Year-on-Year Total H1 Revenue Growth +50% 14.1 M€ UZEDY® Royalties: 4.2 M€ 9.4 M€ R&D Partnerships: 7.3 M€ Research Tax Credit: 2.5 M€ H1 2024-25 H1 2025-26 25

  26. Slide 26: +50% Increase in UZEDY Royalties in Euro, +65% in US$

    +50% Increase in UZEDY® Royalties in Euro +65% in US$ +50% 4.2 3.7 2.8 1.1 0.6 H1 2023-24 H2 2023-24 H1 2024-25 H2 2024-25 H1 2025-26 26

  27. Slide 27: +22% YoY Increase in Operating Expenses

    +22% YoY Increase in Operating Expenses 2/3 dedicated to R&D, Mostly Partner-Funded G&A 27% BD & Marketing R&D BD 6% 64% & Marketing 9% 27

  28. Slide 28: H1 FY2025-26 Income Statement

    H1 FY2025-26 Income Statement Total income 14.1 +50% YoY of which revenue 11.6 +35% YoY Operating expenses 20.8 +22% YoY Operating result -6.6 13% improvement YoY Financial result -9.5 Discussion progressing with EIB of which non-cash Impact of the change in the fair value of EIB Warrants -6.8 to el

  29. Slide 29: Cash Position

    Cash Position 71.9 M€ 53.5 M€ 38.8 M€ Cash & Cash Equivalents: 49.8 M€ Financial Deposits: 3.7 M€ Sept 30, 2024 Mar 31, 2025 Sept 30, 2025 29

  30. Slide 30: Q&A

    Q&A 30

  31. Slide 31: Thank you

    medincell. Thank you

Medincell — Q2 2026 Earnings Presentation on 6ix