Medincell Sa · EURONEXT:MEDCL
Medincell Sa — Investor Presentation (June 2025)
41 slides from Medincell Sa's investor presentation, June 2025
Slide 1: Breakthrough Medicines with Long-Acting Injectables (LAI)
BREAKTHROUGH MEDICINES BREAKTHROUGH MEDICINES WITH LONG-ACTING INJECTABLES (LAI) CONFIDENTIAL CORPORATE PRE SENTATION - June 2025
Slide 2: Important Notice
IMPORTANT NOTICE - YO U MUST READ THE FOLLO WING BEFORE CONTINUING This pre sen tation contains forward-looking sta temen ts, including sta temen ts reg arding Company’s expectatio ns for (i) the timing, pro gress and outcome of its clinical trials; (ii) the clinical ben efits and competitive positi
Slide 3: Content
CONTENT Corporate overview - 4 BEPO®, Long-Acting Injectable cutting-edge technology platform - 9 Product on market - 13 • UZEDY® (marketed by Teva Pharmaceuticals) Monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia R&D pipeline - 20 • mdc-TJK Monthly subcutaneous ola
Slide 4: Corporate Overview
CORPORATE OVERVIEW BEPO ® Pioneering Long-Acting Injectable (LAI) innovator with breakthrough technology platform First product marketed by Teva Pharmaceuticals in the U.S. since May 2023 • UZEDY®, monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia UZE DY ® • Approved
Slide 5: Shift to Growth Financial Strategy
“SHIFT TO GROWTH” FINANCIAL STRATEGY 3 ENGINES FIRING IN PARALELL Sustained 3 Growth R&D PIPELINE Accelerated • AbbVie #1, mdc-CWM, • Others 2 Growth Operational TECHNOLOGY INNOVATION 1 Profitability OLANZAPINE LAI UZEDY® CORPORATE PRE SENTATION - June 2025 5
Slide 6: Product Portfolio and R&D Pipeline
PRODUCT PORTFOLIO AND R&D PIPELINE CLINICAL NDA FORMULATION PRECLINICAL MARKET PHASE 3 PREPARATION Celecoxib Intraarticular Olanzapine LAI UZEDY® AbbVie (1/6) (mdc-CWM) (mdc-TJK) Risperidone Postoperative pain Schizophrenia Schizophrenia ~10 in-house and partnered programs Progestin 6-Month (mdc-WWM
Slide 7: Strong IP Portfolio Supporting Long-Term Exclusivity
STRONG IP PORTFOLIO SUPPORTING LONG-TERM EXCLUSIVITY UZEDY® Core technology patents/patent US patent protection applications in the US • BEPO: protection until 2033 (granted) • BEPO Star: protection until 2040 (pending) 2042 + Multiple specific patents for individual Olanzapine LAI products and prog
Slide 8: Strategic Collaboration with AbbVie
STRATEGIC COLLABORATION WITH ABBVIE CO-DEVELOPMENT AND LICENSING AGREEMENT Up to 6 Long-Acting Injectable therapies • Multiple therapeutic areas and indications • First program candidate selected; preclinical and CMC activities underway Medincell to conduct formulation and preclinical activities Abb
Slide 9: BEPO
BEPO® Long-acting injectables cutting-edge technology platform CORPORATE PRE SENTATION - June 2025 9
Slide 10: BEPO Long-Acting Injectable Technology Platform
BEPO® Long-Acting Injectable cutting-edge technology platform SUBCUTANEOUS INJECTION FORMATION OF A CONTROLLED Customized formulation for each indication SUBCUTANEOUS DEPOT RELEASE OF API • PEG/PLA polymers Immediate precipitation • Biocompatible solvent API entrapped in depot Bioresorbable depot •
Slide 11: BEPO Polymers Secured Through Joint Venture with Corbion
BEPO® POLYMERS SECURED THROUGH INDUSTRIAL JOINT VENTURE WITH CORBION Limited scale-up risk Research and clinical batch polymers come from same production line as commercial polymers Secure supply, ensure quality & preserve manufacturing IP Dual GMP manufacturing facilities – Europe and U.S. DMF file
Slide 12: Product on Market: UZEDY
PRODUCT ON MARKET UZEDY® Monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia Supplemental NDA for the maintenance treatment of bipolar I disorder (BP-I) in adults under review by FDA CORPORATE PRE SENTATION - June 2025 12
Slide 13: UZEDY
UZEDY® Market authorization by U.S. FDA on April 28, 2023 Commercialization by Teva Pharmaceuticals since May 2023 Targeting primarily US $4.4 billion 12% CAGR market Medincell eligible for • mid-to high-single digit royalties on net sales • up to $105m in commercial milestones 2024 net sales: $117m
Slide 14: Adherence to Treatment Is Crucial in Schizophrenia
ADHERENCE TO TREATMENT IS CRUCIAL IN SCHIZOPHRENIA ca. 1% of the worldwide population will develop schizophrenia in their lifetime1 Approximately 80% of patients experience multiple relapses 75% during the first five years of treatment2, and each relapse carries a biological risk of loss of function
Slide 15: UZEDY, Strong Differentiation Thanks to BEPO
UZEDY®, STRONG DIFFERENTIATION THANKS TO BEPO ® SUBCUTANEOUS INJECTION (vs. intramuscular) • Smaller needle (16mm; 21 gauge) • Multiple injection sites (upper arm and abdomen) • Lower injection volume (0.1 –0.7 ml) PREFILLED SYRINGE • Ready-to-use (no reconstitution needed) • Can be left out of the
Slide 16: UZEDY, Differentiated Profile for Schizophrenia Patients
UZEDY®, DIFFERENTIATED PROFILE FOR SCHIZOPHRENIA PATIENTS Invega Sustenna® Molecule Risperidone Paliperidone Efficacy Efficacy profile consistent with risperidone Efficacy profile consistent with paliperidone Safety 3M Invega Trinza® and 6M Invega Safety profile consistent with risperidone Safety pr
Slide 17: UZEDY, Efficacy and Safety in Schizophrenia
UZEDY®, EFFICACY AND SAFETY IN SCHIZOPHRENIA Phase 3, Randomized, Double-Blind, Relapse Prevention Study (RISE Study) CGI-S = Clinical Global Impressio n-Severity, CGI-SS = Clinical Global Impression-Severity of Suicidality, PANSS = Positive an d Negative Syndrome Scale, q1m, once month ly; q 2m, on
Slide 18: UZEDY, Key Outcomes from the Pivotal Phase 3 Study
UZEDY®, KEY OUTCOMES FROM THE PIVOTAL PHASE 3 STUDY EFFICACY mdc-IRM significantly prolonged time to impending relapse compared to placebo1 • 80.0% and 62.5% reduction in risk of relapse vs placebo for monthly and every two-month UZEDY®, respectively • x5 and x2.7 increase in time to impending relap
Slide 19: UZEDY Shows Strong Real-World Benefits
UZEDY®, SHOWS STRONG REAL-WORLD BENEFITS May 2025, Psych Congress Elevate INPATIENT RATE: -47% Outcomes from real-world claims studies comparing UZEDY® to second-generation UZEDY® 15.6% oral antipsychotics (SGOAs) SGOAs 29.6% RELAPSE RATE: -42% MEAN LENGTH OF HOSPITAL STAY: -50% UZEDY® 9.0% UZEDY® 8
Slide 20: R&D Pipeline
R&D PIPELINE Long-acting injectables based on BEPO CORPORATE PRE SENTATION - June 2025 20
Slide 21: R&D Pipeline
R&D PIPELINE Long-acting injectables based on BEPO® CLINICAL NDA FORMULATION PRECLINICAL MARKET PHASE 3 PREPARATION Celecoxib Intraarticular Olanzapine LAI UZEDY® AbbVie (1/6) (mdc-CWM) (mdc-TJK) Risperidone Postoperative pain Schizophrenia Schizophrenia ~10 in-house and partnered programs Progestin
Slide 22: mdc-TJK Olanzapine 1-Month
CLINICAL PHASE 3 I mdc-TJK Olanzapine 1-Month Once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine • Positive Phase 3 efficacy results in adult patients with schizophrenia • No suspected or confirmed PDSS in Phase 3 > Clinical evidence suggests no risk of PDSS • N
Slide 23: mdc-TJK, Medical Need and Product Rationale
mdc-TJK, MEDICAL NEED AND PRODUCT RATIONALE Impact of relapse Approved Olanzapine IM LAI Envisaged mdc-TJK and psychosis in schizophrenia Monthly long-acting subcutaneous injectable : Existing olanzapine LAI has limited use: High non-adherence rates with oral medication, • Black box warning for PDSS
Slide 24: mdc-TJK Potential to Be the First LAI Olanzapine with Favorable Safety Profile
mdc-TJK - POTENTIAL TO BE THE FIRST LAI OLANZAPINE WITH FAVORABLE SAFETY PROFILE 1990’s Today Oral olanzapine Zyprexa Relprevv® (LAI) mdc-TJK Target profile Expect efficacy consistent Efficacy with olanzapine Expected in line with oral olanzapine2 Safety Well-characterized safety profile1 Well chara
Slide 25: Olanzapine Is the Most-Used Oral Antipsychotic in Schizophrenia
OLANZAPINE IS THE MOST-USED ORAL ANTIPSYCHOTIC IN SCHIZOPHRENIA BOTH IN US AND EU 19% Others 38% 13% 17% Clozapine 18% 14% Aripiprazole 8% Risperidone 16% 37% Olanzapine 20% US Europe Sou rce : Teva Innovation & Strategy Day, May 2 9, 202 5 - Note: Sha re per tr eatme nt are ba sed on IQVIA MIDAS MA
Slide 26: mdc-TJK Phase 1 SAD/MAD Study Design
mdc-TJK PHASE 1 SAD/MAD STUDY DESIGN • Overall, 127 participants enrolled • 101 participants were administered mdc-TJK Healthy subjects (n=30) Patients (n=71) Single-dose mdc-TJK (sub-therapeutic doses) Single-dose mdc-TJK Multiple-dose mdc-TJK (therapeutic doses) (therapeutic doses) 1** 2 3 4 5 6 8
Slide 27: mdc-TJK Phase 1 SAD/MAD
mdc-TJK PHASE 1 SAD/MAD Pharmacokinetics in healthy volunteers and patients with schizophrenia or schizoaffective disorder mdc-TJK exhibited favorable characteristics of extended-release profile: • By reaching clinically relevant therapeutic olanzapine plasma concentrations (≥ 10 ng/mL) within a 1 t
Slide 28: mdc-TJK, Efficacy and Safety in Schizophrenia
mdc-TJK, EFFICACY AND SAFETY IN SCHIZOPHRENIA • A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study (SOLARIS) Study is designed to identify both safety and efficacy, including to identify PDSS event occurrence. MedinCell and Teva believe that BEPO® technology and subcutaneous administration
Slide 29: mdc-TJK, Efficacy and Safety in Schizophrenia
mdc-TJK, EFFICACY AND SAFETY IN SCHIZOPHRENIA May 2024: Positive Phase 3 efficacy results in adult patients with schizophrenia Olanzapine LAI for all doses demonstrated statistically significant greater efficacy versus placebo1 Primary endpoint Significantly greater change from baseline to week 8 in
Slide 30: mdc-TJK, Addressing the PDSS Challenge
mdc-TJK, ADDRESSING THE PDSS CHALLENGE The use of the only available Olanzapine LAI is limited by a risk of serious side effect (PDSS) due to injection method • PDSS: Sudden and unexpected onset of delirium or sedation after injection Phase 3 (SOLARIS) • <0.1% of injections and ≈2% of patients No PD
Slide 31: Strong Opportunity for Olanzapine LAI with Favorable Safety Profile
STRONG OPPORTUNITY FOR OLANZAPINE LAI WITH FAVORABLE SAFETY PROFILE LAIs franchise was successfully built … when current Olanzapine LAI does not reach potential with risperidone + paliperidone1… • Commercial failure of existing Olanzapine LAIs • Compensates sales fall after patent expiry of • Black
Slide 32: mdc-CWM Intraarticular Celecoxib
CLINICAL PHASE 3 I mdc-CWM (F14) Intraarticular celecoxib 50/50 profit collaboration with AIC Intraarticular celecoxib for post-operative pain and inflammation management First Phase 3 in Total Knee Replacement (TKR) completed Next steps of regulatory development in 2025 Potential “first-in-class” f
Slide 33: mdc-CWM (F14), Medical Need and Product Rationale
mdc-CWM (F14), MEDICAL NEED AND PRODUCT RATIONALE GROWING TKR MARKET Up to 1 million procedures performed annually • Procedures have doubled over the past two decades • 90% are primary (first-time) TKR • Number of procedures is expected to grow to between 1.5 million and 3 million annually by 2040 R
Slide 34: mdc-CWM (F14), Efficacy and Safety in TKR
mdc-CWM (F14), EFFICACY AND SAFETY IN TKR • A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study – Study completed Screening F14 (sustained release celecoxib) administrated during surgery Eligibility Criteria + Multimodal Analgesia • 0.25 % Bupivacaine HCl (local anesthetic) • Male and/or fe
Slide 35: mdc-CWM, Efficacy and Safety in Total Knee Replacement
mdc-CWM, EFFICACY AND SAFETY IN TOTAL KNEE REPLACEMENT • Phase 3 results Primary endpoint not met, but favorable data on measures of inflammation supports differentiation from approved products in this indication as well as therapies in development • Statistically significant outcomes related to inf
Slide 36: mdc-CWM, Sub-Group Analysis
mdc-CWM, SUB-GROUP ANALYSIS AUC OF NRS PAIN All timepoints were numerically improved for F14 OPIOID CONSUMPTION (no-TKR subgroup) RANGE-OF-MOTION At 3 months, 14% of MMA patients were still taking opioids compared to only 4% of F14 patients All timepoints were numerically improved for F14 CORPORATE
Slide 37: mdc-WWM 6-Month Contraception
PRECLINICAL I mdc-WWM 6-Month contraception mdc-WWM could be the first contraceptive to combine essential features to make it a best-in-class product worldwide • Progestin molecule (non-MPA) • 6-month duration • Subcutaneous injection • Self injectable • Full bio resorption • Affordability All comme
Slide 38: mdc-STM Ivermectin / Malaria
PRECLINICAL I mdc-STM Ivermectin / Malaria Objective: a new tool to fight malaria transmission • mdc-STM enables sustained release of ivermectin following a single subcutaneous injection • Administered at beginning of transmission season to people living in malaria- endemic areas • Mosquitoes feedin
Slide 39: Financials & Extra-Financial Performance
FINANCIALS & EXTRA-FINANCIAL PERFORMANCE CORPORATE PRE SENTATION - June 2025 39
Slide 40: Selected Financials
SELECTED FINANCIALS Analyst coverage € million Year end Year end March 31, 2025 March 31, 2024 Michael DiFiore Operating result (10.8) (20.9) Revenues 25.4 9.0 Raghuram SELVARAJU Other income 2.3 2.9 Operating expenses (38.5) (32.9) Shan HAMA Net result (18.4) (25.0) Cash position 59.0 19.5(1) Low-r
Slide 41: ESG Performance
ESG PERFORMANCE C+ 51.05/100 CSA score: 43 (92nd percentile) ESG Score: 51 (Average panel pharma 20/100) “Our mission is to contribute to the improvement and protection of the health of populations across Medium Risk (high): 25,9 the world. (rank 68/430°) The fair sharing of the value created with a