Medincell Sa · EURONEXT:MEDCL
Medincell Sa — Investor Presentation (January 2024)
36 slides from Medincell Sa's investor presentation, January 2024
Slide 1: Breakthrough Medicines with Long-Acting Injectables (LAI)
BREAKTHROUGH MEDICINES BREAKTHROUGH MEDICINES WITH LONG-ACTING INJECTABLES (LAI) CORPORATE PRESENTATION - January 2024 CONFIDENTIAL
Slide 2: Important Notice
IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUING This presentation contains 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
Slide 3: Content
CONTENT Corporate overview - 4 BEPO®, Long-Acting Injectable cutting-edge technology platform - 5 Product on market - 8 • UZEDY™ (marketed by Teva Pharmaceuticals) Monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia R&D pipeline - 16 • mdc-TJK Monthly subcutaneous olan
Slide 4: Corporate Overview
CORPORATE OVERVIEW BEPO® Best positioned Long-Acting Injectable (LAI) player with breakthrough technology platform “We view MEDCL as the best positioned LAI player underpinned by best-in-class drug delivery technology, which should see it outperform competitors in growing blockbuster indications.” (
Slide 5: BEPO: Long-acting injectables cutting-edge technology platform
BEPO® Long-acting injectables cutting-edge technology platform CORPORATE PRESENTATION - January 2024 5
Slide 6: 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 7: 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 8: Product on Market: UZEDY
PRODUCT ON MARKET UZEDY™ Monthly and every 2 months subcutaneous risperidone for treatment of schizophrenia CORPORATE PRESENTATION - January 2024 8
Slide 9: 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 First royalties received in 2023 • up to $105m in commercial
Slide 10: 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 11: 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 r
Slide 12: 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 13: 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 Impression-Severity, CGI-SS = Clinical Global Impression-Severity of Suicidality, PANSS = Positive and Negative Syndrome Scale, q1m, once monthly; q2m, once e
Slide 14: UZEDY, Key Outcomes from the Pivotal Phase 3 Study
UZEDY™, KEY OUTCOMES FROM THE PIVOTAL PHASE 3 STUDY EFFICACY UZEDY™ 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 relaps
Slide 15: UZEDY Targets Primarily U.S. 4.4 Billion 12% CAGR Market
UZEDY™ TARGETS PRIMARILY U.S. 4.4 BILLION 12% CAGR MARKET Antipsychotic long-acting injectables market Global sales $6.8 Billion 10% 5-Year CAGR Only 13% of U.S. treated patients (200.000 out of 1,6m) use LAIs source: Teva earnings call – Feb 2023 US sales $4.4bn 70% comprised of risperidone and its
Slide 16: R&D Pipeline
R&D PIPELINE Long-acting injectables based on BEPO CORPORATE PRESENTATION - January 2024 16
Slide 17: R&D Pipeline: Long-acting injectables based on BEPO
R&D PIPELINE Long-acting injectables based on BEPO® FORMULATION PRECLINICAL PHASE 1 / 2 PHASE 3 mdc-TJK Partnership with Recruitment completed Schizophrenia Top line efficacy and safety results expected in in H2 2024 mdc-CWM Partnership with Recruitment completed, Postop pain Efficacy results expect
Slide 18: mdc-TJK
R&D PIPELINE I CLINCIAL PHASE 3 mdc-TJK Once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine Ongoing clinical Phase 3 for the treatment of schizophrenia: • Recruitment completed • Top line results expected in H2 2024 May be the first long-acting olanzapine with a
Slide 19: mdc-TJK May Address a Significant Unmet Need in Schizophrenia
mdc-TJK MAY ADDRESS A SIGNIFICANT UNMET THERAPEUTIC NEED FOR PATIENTS WITH SCHIZOPHRENIA Olanzapine is a second-generation atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder For schizophrenia, it can be used for crisis and relapse treatment and for long-term maintenanc
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 Existing olanzapine LAI has limited use: Monthly long-acting subcutaneous injectable : 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
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 with Well
Slide 22: mdc-TJK, Complementing UZEDY
mdc-TJK, COMPLEMENTING WITH UZEDY Large market mainly covered by 4 drugs Risperidone 457 (25%) UZEDY™ aiming for improved convenience for patients Most likely patient target for UZEDY™ mostly suffering from mild-to-severe forms2 Paliperidone 204 (11%) Olanzapine mdc-TJK to offer treatment for severe
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 Mean (±SD) olanzapine plasma concentrations following single dose Mean (±SD) olanzapine plasma concentrations fol
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) • Phase 3 data expected in H2 2024 Study is designed to identify both safety and efficacy, including to identify PDSS event occurrence. MedinCell and Teva believe that BEPO® technol
Slide 26: 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 27: mdc-CWM
R&D PIPELINE I CLINCIAL PHASE 3 mdc-CWM Intraarticular celecoxib for post-operative pain and inflammation management Ongoing clinical Phase 3 in Total Knee Replacement (TKR) efficacy results expected in Q1 2024 May be the first product to provide pain relief over several weeks post-surgery 15% oflon
Slide 28: mdc-CWM, Medical Need and Product Rationale
mdc-CWM, MEDICAL NEED AND PRODUCT RATIONALE One-time local delivery during surgery aiming at facilitating patient recovery by: • Providing post-operative pain relief for weeks (vs. days for existing products) • Accelerating improvement in knee function • Potentially decreasing the need for addictive
Slide 29: mdc-CWM, Efficacy and Safety in Total Knee Replacement
mdc-CWM, EFFICACY AND SAFETY IN TOTAL KNEE REPLACEMENT A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Screening F14 (sustained release celecoxib) administrated during surgery Eligibility Criteria + Multimodal Analgesia • 0.25 % Bupivacaine HCl (local anesthetic) • Male and/or females i
Slide 30: mdc-WWM
R&D PIPELINE I PRECLINICAL mdc-WWM 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 commercial rig
Slide 31: mdc-GRT
R&D PIPELINE I PRECLINICAL mdc-GRT mdc-GRT could the first Long-Acting Injectable tacrolimus to prevent solid organ graft rejection Tacrolimus is a gold standard treatment across all solid organ transplantation in graft rejection prophylaxis Objective is to improved quality of life of patients thank
Slide 32: mdc-STM
R&D PIPELINE I PRECLINICAL mdc-STM 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 feeding on peo
Slide 33: Financials & ESG Performance
FINANCIALS & ESG PERFORMANCE CORPORATE PRESENTATION - January 2024 33
Slide 34: Selected Financials
SELECTED FINANCIALS Market Cap: ca. $230m as of January 1st, 2024 as of September 30, 2023 Outstanding Shares: 28.7M € million 6-Month period 6-Month period 1-Year period 1-Year period Sept. 30, 2023 Sept. 30, 2022 March 31, 2023 March 31, 2022 Revenue 8.2 7.7 13.7 8.3 Main cash payments received af
Slide 35: 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): 29,7 the world. (rank 68/430°) The fair sharing of the value created with a
Slide 36: www.medincell.com
www.medincell.com communication@medincell.com CORPORATE PRESENTATION - January 2024 36