Medincell Sa · EURONEXT:MEDCL
Medincell Sa — Investor Presentation (December 2024)
38 slides from Medincell Sa's investor presentation, December 2024
Slide 1: Breakthrough Medicines with Long-Acting Injectables (LAI)
BREAKTHROUGH MEDICINES BREAKTHROUGH MEDICINES WITH LONG-ACTING INJECTABLES (LAI) CONFIDENTIAL CORPORATE PRE SENTATION - December 2024
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 - December 2024 7
Slide 8: BEPO Long-Acting Injectable cutting-edge 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 CORPORATE PRE SENTATION - December 2024 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 Teva’s revenue o
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 75% during the first five years of treatment2, and each relapse carries a biological risk of loss of function
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 - December 2024 17
Slide 18: R&D Pipeline: Long-acting injectables based on BEPO
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 May be the first long-acting
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 - December 2024 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 - December 2024 36
Slide 37: Selected Financials
SELECTED FINANCIALS € million 6 month Year end 6 month Sept. 30, 2024 March 31, 2024 Sept 30, 2023 Operating result (7.5) (20.9) (9.0) Revenues 8.6 9.0 7.0 Other income 0.8 2.9 1.2 Operating expenses (17.0) (32.9) (17.1) Net result (14.6) (25.0) (8.2) Cash position 31.6 19.5 (1) 26.8 (2) Non-risky i
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