Mesoblast Limited · ASX:MSB
Mesoblast — Q1 FY2021 Earnings Presentation
31 slides from Mesoblast's earnings presentation, Nov 20, 2020
Slide 1: Financial Results for First Quarter Ended September 30, 2020
For personal use only Financial Results for First Quarter Ended September 30, 2020 Strategic Collaboration with Novartis ASX: MSB; Nasdaq: MESO
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, le
Slide 3: Our Mission
For personal use only Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses |3
Slide 4: Strategic Collaboration with Novartis, Initial Focus on Respiratory Indications
Strategic Collaboration with Novartis, Initial Focus on Respiratory Indications For personal use only In early 2020, Mesoblast recognized that the extensive safety data of remestemcel-L and its anti- inflammatory mechanism of action made a compelling rationale for evaluating its potential to reduc
Slide 5: Overview of Collaboration with Novartis for Remestemcel-L
Overview of Collaboration with Novartis for Remestemcel-L For personal use only Worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of remestemcel-L Initial focus is on the treatment of ARDS, including that associated with COVID-19,
Slide 6: Key Terms of Collaboration with Novartis
Key Terms of Collaboration with Novartis For personal use only Novartis will make a US$50 million upfront payment including US$25 million in equity* Mesoblast may receive a total of US$505 million pending achievement of pre-commercialization milestones for ARDS indications Mesoblast may receiv
Slide 7: Product Pipeline
Product Pipeline For personal use only MESOBLAST PRODUCT THERAPEUTIC PHASE 1/2 PHASE 3 REGISTRATION COMMERCIAL COMMERCIAL CANDIDATE AREA RIGHTS PARTNERS COVID-19 Acute Respiratory Distress Syndrome (ARDS) All Cause ARDS Global Other Respiratory Collaboration Pediatric & adult Remestemcel-L systemic
Slide 8: Platform Technology – Mechanism of Action
Platform Technology – Mechanism of Action Our mesenchymal precursor/stromal cells respond to and are activated by multiple inflammatory cytokines through For personal use only surface receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Mesenchymal Proliferation Cytok
Slide 9: Commercial Scale Manufacturing Capability
Commercial Scale Manufacturing Capability Manufacturing Remestemcel-L For personal use only Scalable allogeneic “off-the-shelf” cellular platforms Manufacturing meets stringent criteria of international regulatory agencies Robust quality assurance processes ensure final product with batch-to-b
Slide 10: Global IP Estate Provides Substantial Competitive Advantage
Global IP Estate Provides Substantial Competitive Advantage For personal use only Extensive patent portfolio with protection extending through 2040 in all major markets Over 1,100 patents and patent applications (82 patent families) across all major jurisdictions Therapeutic Areas Covers compo
Slide 11: Financial Results for the Quarter Ended September 30, 2020
For personal use only Financial Results for the Quarter Ended September 30, 2020
Slide 12: Strengthened Balance Sheet
Strengthened Balance Sheet For personal use only At September 30, 2020, cash on hand was US$108.1 million Proforma cash on hand of US$158.1 million includes an additional US$50 million upfront payment from the collaboration with Novartis* Over the next 12 months Mesoblast, pending achievement
Slide 13: Capital Raised in May 2020 Supported Increased Investment in COVID-19 Related R&D and Manufacturing
Capital Raised in May 2020 Supported Increased Investment in COVID-19 Related R&D and Manufacturing For personal use only September 30, September 30, Profit and Loss for the three months ending (US$m) 2020 2019 Commercialization revenue 1.3 1.9 Milestone revenue - 15.0 Interest revenue - 0.2 Total R
Slide 14: Remestemcel-L: Potential New Treatment Paradigm in Inflammatory Respiratory Conditions
For personal use only Remestemcel-L: Potential New Treatment Paradigm in Inflammatory Respiratory Conditions
Slide 15: Overview – Remestemcel-L for ARDS due to COVID-19
Overview – Remestemcel-L for ARDS due to COVID-19 For personal use only COVID-19 is a respiratory virus with a high mortality due to a severe inflammatory condition of the lungs called acute respiratory distress syndrome (ARDS) ARDS is caused by cytokine storm in lungs of patients infected with
Slide 16: ARDS due to COVID-19, Influenza & Bacterial Infection – Major Unmet Need
ARDS due to COVID-19, Influenza & Bacterial Infection – Major Unmet Need For personal use only Normal alveolus Injured alveolus during the acute phase Acute respiratory distress syndrome (ARDS) Alveolar Sloughing of bronchial epithelium A major area of unmet medical need airspace Inactivated surfa
Slide 17: Immunomodulatory Activities of Remestemcel-L in Response to Inflammation
Immunomodulatory Activities of Remestemcel-L in Response to Inflammation For personal use only | 17
Slide 18: Promising Pilot Data in Adults & Children with COVID-19
Promising Pilot Data in Adults & Children with COVID-19 Compassionate Use Emergency IND in Ventilator-Dependent Adults with COVID-19 ARDS For personal use only 12 patients with moderate or severe ARDS received two infusions of remestemcel-L within five days at Mt. Sinai Hospital in New York City
Slide 19: Remestemcel-L: Phase 3 Randomized Controlled Trial in COVID-19 ARDS
Remestemcel-L: Phase 3 Randomized Controlled Trial in COVID-19 ARDS For personal use only Multi-center, randomized, controlled, blinded study to assess safety and efficacy of remestemcel-L versus placebo in ventilator-dependent patients with moderate/severe ARDS due to COVID-19 Up to 300 patient
Slide 20: Key Milestones for Remestemcel-L in COVID-19 ARDS
Key Milestones for Remestemcel-L in COVID-19 ARDS For personal use only DSMB recommended continuation of the trial after reaching first (30%) and second (45%) interim analyses Trial enrollment has now surpassed 180 patients Plan to seek Emergency Use Authorization (EUA) subject to positive dat
Slide 21: Remestemcel-L: Acute Graft Versus Host Disease
For personal use only Remestemcel-L: Acute Graft Versus Host Disease
Slide 22: Acute GVHD: Serious and Fatal Complication of Allogeneic Bone Marrow Transplantation
Acute GVHD: Serious and Fatal Complication of Allogeneic Bone Marrow Transplantation (BMT) For personal use only PHASE 1 PHASE 2 PHASE 3 Host Tissue Damage Immune Cell Activation Inflammation and End by BMT Conditioning & Cytokine Storm Organ Damage Conditioning Activation of CD4 regimen, Tissue Mac
Slide 23: Children with Steroid-Refractory Acute GVHD at High Risk of Treatment Failure and Death
Children with Steroid-Refractory Acute GVHD at High Risk of Treatment Failure and Death For personal use only Extremely high unmet medical need More than 2,000 allogeneic BMTs in children and adolescents in US annually1 Despite prophylaxis, ~50% will develop aGVHD2 First-line treatment is cort
Slide 24: Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD
Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD Consistent efficacy and safety outcomes in a total of 309 children from three studies: For personal use only − Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SR-aGVHD, includin
Slide 25: Remestemcel-L Improved Dismal Survival in Children with SR-aGVHD
Remestemcel-L Improved Dismal Survival in Children with SR-aGVHD For personal use only 2 Steroid Refractory – Remestemcel-L Steroid Refractory – Best Available Therapies 1. Adapted and redrawn from Figure 2 of MacMillan, M.L. et al. Pediatric acute GVHD: clinical phenotype and response to upfront st
Slide 26: SR-aGVHD Regulatory & Commercial Update
SR-aGVHD Regulatory & Commercial Update For personal use only As part of the broad license and collaboration agreement with Novartis for remestemcel-L, Mesoblast will retain full rights and economics for GVHD On August 13 2020, results from 309 children with SR-aGVHD treated with remestemcel-L w
Slide 27: Update on Other Phase 3 Product Candidates - Heart Failure - Chronic Low Back Pain
For personal use only Update on Other Phase 3 Product Candidates - Heart Failure - Chronic Low Back Pain
Slide 28: Partnerships and License Agreements
Partnerships and License Agreements Partnerships and License Agreements Phase 3 Product Candidates for Heart Failure and Chronic Low Back Pain Product candidates For personal use only MPC-06-ID CHRONIC LOW BACK PAIN - DEGENERATIVE DISC DISEASE Strategic partnership to develop and commercialize MPC
Slide 29: REVASCOR for Advanced and End-Stage Heart Failure
REVASCOR® for Advanced and End-Stage Heart Failure For personal use only In December 2019, the Phase 3 trial in advanced heart failure surpassed the number of primary endpoint events required for trial completion − Final study visits for all surviving patients have been completed − Ongoing quality
Slide 30: MPC-06-ID for Chronic Low Back Pain
MPC-06-ID for Chronic Low Back Pain For personal use only Phase 3 trial of MPC-06-ID for chronic low back pain in 404 patients: − Final study visits for all patients have been completed − Ongoing quality review of all data is being completed at the study sites − Data readout expected during Q4 CY2
Slide 31: For personal use only
For personal use only