Medincell Sa · EURONEXT:MEDCL
Medincell Sa — Investor Presentation (March 2025)
38 slides from Medincell Sa's investor presentation, March 2025
Slide 1: Breakthrough Medicines with Long-Acting Injectables (LAI)
BREAKTHROUGH MEDICINES BREAKTHROUGH MEDICINES WITH LONG-ACTING INJECTABLES (LAI) CONFIDENTIAL CORPORATE PRE SENTATION - March 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 - 7 Product on market - 10 • UZEDY® (marketed by Teva Pharmaceuticals) Monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia R&D pipeline - 17 • 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: Product Portfolio and R&D Pipeline
PRODUCT PORTFOLIO AND R&D PIPELINE FORMULATION PRECLINICAL CLINICAL PHASE 3 MARKET UZEDY® mdc-WWM Progestin 6-Month Olanzapine 1-Month mdc--IRM mdc-TJK Risperidone 1- & 2-Month Contraception Schizophrenia 10 Schizophrenia in-house and partnered programs mdc-CWM Ivermectin 3-Month Celecoxib - Intraar
Slide 6: Strategic Collaboration with AbbVie
April 2024 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 act
Slide 7: BEPO: Long-acting injectables cutting-edge technology platform
BEPO® Long-acting injectables cutting-edge technology platform CORPORATE PRE SENTATION - March 2025 7
Slide 8: 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 9: BEPO Polymers Secured Through Industrial 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 10: 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 - March 2025 10
Slide 11: 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 12: 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 during the first five years of treatment2, and each relapse carries a biological risk of loss of function, tr
Slide 13: 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 14: 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 15: 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 16: 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 17: R&D Pipeline
R&D PIPELINE Long-acting injectables based on BEPO CORPORATE PRE SENTATION - March 2025 17
Slide 18: R&D Pipeline
R&D PIPELINE Long-acting injectables based on BEPO® FORMULATION PRECLINICAL CLINICAL PHASE 3 mdc-WWM Progestin 6-Month Olanzapine 1-Month mdc--IRM mdc-TJK Contraception Schizophrenia 10 in-house and partnered programs mdc-CWM Ivermectin 3-Month Celecoxib - Intraarticular mdc-STM Malaria Postoperativ
Slide 19: 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 • May 2024: Positive Phase 3 efficacy results in adult patients with schizophrenia • Phase 3 safety data topline readout expected in H1 2025 • NDA submission anticip
Slide 20: 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 21: 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 22: Olanzapine LAI Significant Potential
OLANZAPINE LAI SIGNIFICANT POTENTIAL Olanzapine is the most prescribed antipsychotic for schizophrenia in the U.S. Source: Teva earnings call presentation - May 8, 2024 CORPORATE PRE SENTATION - March 2025 22
Slide 23: 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 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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 • Auto injectable • Full bio resorption • Affordability All comme
Slide 35: 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 36: Financials & Extra-Financial Performance
FINANCIALS & EXTRA-FINANCIAL PERFORMANCE CORPORATE PRE SENTATION - March 2025 36
Slide 37: Selected Financials
SELECTED FINANCIALS Market Cap: ca. $500m as of March 1st, 2025 € million 6 month Year end 6 month Outstanding Shares: 33.1M Sept. 30, 2024 March 31, 2024 Sept 30, 2023 Operating result (7.5) (20.9) (9.0) Revenues 8.6 9.0 7.0 Analyst coverage (average TP: €20,36) Other income 0.8 2.9 1.2 Operating e
Slide 38: 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