Mesoblast Limited · ASX:MSB
Mesoblast — FY2021 Earnings Presentation
34 slides from Mesoblast's earnings presentation, Aug 31, 2021
Slide 1: Operational Highlights & Financial Results for the Year Ended June 30, 2021
For personal use only mesoblast the regenerative medicine company Operational Highlights & Financial Results for the Year Ended June 30, 2021 AUGUST 2021 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
Slide 4: Pipeline
Pipeline For personal use only ⃰ Mesoblast has the right to use data generated by JCR Pharmaceuticals Co Ltd in Japan to support its development and commercialization plans for remestemcel-L in the US and other major healthcare markets, including for GVHD and Hypoxic Ischemic Encephalopathy # The ag
Slide 5: 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 surface For personal use only receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Proliferation Mesenchymal Cytok
Slide 6: 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 Therapeutic Areas Core commercial and Over 1,000 patents and patent applications (~80 patent families) across non-core indicati
Slide 7: Commercial-scale Manufacturing Capabilities
Commercial-scale Manufacturing Capabilities For personal use only Scalable allogeneic “off-the-shelf” cellular platforms Manufacturing meets stringent criteria of international regulatory Manufacturing Remestemcel-L agencies Robust quality assurance processes ensure final product with batch-to
Slide 8: Financial Results
For personal use only Financial Results
Slide 9: Financial Highlights
Financial Highlights For personal use only US$136.9 million cash on hand at June 30, 2021 Sales of TEMCELL® HS Inj.1 in Japan by licensee JCR for the treatment of aGVHD have re-established a steady growth trajectory after plant capacity was expanded to meet growing demand2 Revenue from TEMCELL
Slide 10: Continued Growth in Revenues from Sales of TEMCELL in Japan for SR-aGVHD
Continued Growth in Revenues from Sales of TEMCELL in Japan for SR-aGVHD For personal use only Annual Revenue from TEMCELL Royalties in Japan JCR Pharmaceuticals has exclusive rights to 8.0 millions US$ Mesoblast’s MSC technology for acute GVHD in Japan 7.0 7.2 6.0 6.6 FY2021 revenue from TEMCEL
Slide 11: Ongoing Investment in Remestemcel-L Platform
Ongoing Investment in Remestemcel-L Platform to Support the Regulatory Pathway to Approval, Manufacturing Scale Up & Life Cycle Management Revenue: For personal use only FY2020 included rexlemestrocel-L upfront & milestone payments from June 30, June 30, Grünenthal and Tasly P&L for the 12 mths ende
Slide 12: Remestemcel-L
For personal use only Remestemcel-L - Acute Graft versus Host Disease (aGVHD) - Acute Respiratory Distress Syndrome (ARDS)
Slide 13: Acute GVHD: Serious and Fatal Complication of Allogeneic BMT
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 Organ by BMT Conditioning & Cytokine Storm Damage Conditioning Activation of Macrophage regimen, Tis
Slide 14: 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 US1 Despite prophylaxis, ~50% will develop aGVHD2 First-line treatment is corticosteroi
Slide 15: Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD
Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD For personal use only Consistent efficacy and safety outcomes in a total of 309 children from three studies: Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SR- aGVHD, including
Slide 16: 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 17: Remestemcel-L: Regulatory & Commercial Update for SR-aGVHD
Remestemcel-L: Regulatory & Commercial Update for SR-aGVHD For personal use only Mesoblast continues to be in discussion with the FDA through a well-established regulatory process that may include a BLA resubmission with a six month review with the aim of achieving approval Following the recomme
Slide 18: 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 disease syndrome (ARDS) ARDS is caused by cytokine storm in lungs of patients infected with C
Slide 19: Age Associated with Reduced Naïve T Cell Response to SARS-CoV-2
Age > 65 years is Associated with Reduced Naïve T Cell Response to SARS-CoV-2, Delayed Viral Clearance and Greater Disease Severity For personal use only Naïve CD4 and CD8 T Cells reduced in age > 65 Age > 65 associated with greater COVID-19 peak disease severity SARS-CoV-2-specific CD4 T cells and
Slide 20: Clinical Experience with Remestemcel-L in COVID-19 ARDS
Clinical Experience with Remestemcel-L in COVID-19 ARDS For personal use only Emergency IND in Ventilator-Dependent COVID-19 ARDS 11 patients (10/11 were < 65 years) with moderate/severe ARDS on ventilators at Mt. Sinai Hospital in New York Patients received two infusions of remestemcel-L 2 mill
Slide 21: Greater Mortality in Control Patients Older than 65
Greater Mortality through Day 60 in Control Patients Older than 65, Consistent with Other Trials For personal use only Controls Age < 65 vs ≥ 65 (n=110) | 21
Slide 22: Greatest Mortality Reduction in Remestemcel-L Treated Patients < 65 years
Greatest Mortality Reduction seen in Remestemcel-L Treated Patients < 65 years For personal use only All Modified Intent to Treat (mITT) Patients (n=217) Modified Intent to Treat (mITT) Patients < 65 years old Remestemcel-L vs Control (n=123), Remestemcel-L vs Control REM Risk Reduction: 46% REM Ris
Slide 23: Remestemcel-L Improved ARDS Severity in Patients
Remestemcel-L Improved ARDS Severity* in Patients < 65 years at All Time Points, and in Patients ≥ 65 years at Day 7: Supports Requirement for Higher or More Prolonged Dosing Regimen in ≥ 65 years For personal use only Treated Patients (mITT) < 65 years old (n=123) Treated Patients (mITT) ≥ 65 years
Slide 24: Remestemcel-L Plus Dexamethasone Shows Synergy in Mortality Reduction
Remestemcel-L Plus Dexamethasone Shows Synergy in Mortality Reduction and Improvement in ARDS Severity in Exploratory Population < 65 years old Treated Patients (mITT) < 65 years old For personal use only on Dexamethasone (n=73) Treated Patients (mITT) < 65 years old through 90-Days on Dexamethasone
Slide 25: Outcome of Meeting with FDA on Regulatory Pathway for EUA in COVID ARDS
Outcome of Meeting with FDA on Regulatory Pathway for EUA in COVID ARDS For personal use only Mesoblast met with the United States Food & Drug Administration (FDA) in regard to potential emergency use authorization (EUA) for remestemcel-L in the treatment of ventilator-dependent patients with modera
Slide 26: Rexlemestrocel-L
For personal use only Rexlemestrocel-L - Chronic Heart Failure (CHF) - Chronic Low Back Pain (CLBP)
Slide 27: Chronic Heart Failure: Rising Incidence & High Mortality
Chronic Heart Failure: Rising Incidence & High Mortality For personal use only Cardiovascular disease (CVD) remains the leading cause of death in the United States1 Heart failure affects 6.5 million patients in the US and 26 million patients globally. As populations age, the prevalence is increa
Slide 28: DREAM-HF: Overview of Phase 3 Trial
DREAM HF: Overview of Phase 3 Trial For personal use only Mesoblast’s allogeneic cell therapy rexlemestrocel-L has a dual mechanism of action that involves immunomodulation and improvement in blood vessel integrity/function DREAM-HF Phase 3 trial was designed to evaluate whether rexlemestrocel-L
Slide 29: Conclusions: Rexlemestrocel-L Phase 3 Trial in Chronic Heart Failure
Conclusions: Rexlemestrocel-L Phase 3 Trial in Chronic Heart Failure For personal use only Rexlemestrocel-L may provide a major breakthrough in reducing heart failure progression and mortality when used early (class II disease), and may provide durable protection from heart attacks or strokes in h
Slide 30: Rexlemestrocel-L: A New Paradigm for Treatment of Chronic Low Back Pain
Rexlemestrocel-L: A New Paradigm for Treatment of Chronic Low Back Pain due to Degenerative Disc Disease For personal use only Back pain causes more disability than any other condition1 Burden of Inflicts substantial direct and indirect costs on the healthcare Illness system1, including excessiv
Slide 31: Phase 3 Trial MSB-DR003 – Rexlemestrocel-L (MPC-06-ID)
Phase 3 Trial MSB-DR003 – Rexlemestrocel-L (MPC-06-ID) For personal use only Randomized placebo-controlled three-arm trial Patients with >6 months chronic discogenic low back pain not responsive to conservative measures, including NSAIDs, opioids or epidural steroid injection Diagnosis of dege
Slide 32: Single Injection of Rexlemestrocel-L + HA Results in Two Years of Pain Reduction
Single Injection of Rexlemestrocel-L + HA in Phase 3 Trial, Results in at Least Two Years of Pain Reduction with Opioid Sparing Activity in Patients with CLBP For personal use only Achievement of substantial and durable reductions in CLBP through 24 months across the entire evaluable study populat
Slide 33: Key Initiatives and Upcoming Milestones
Key Initiatives and Upcoming Milestones For personal use only Remestemcel-L for children and adults with systemic inflammatory diseases Mesoblast continues to be in discussion with the FDA through a well-established regulatory process for potential approval of remestemcel-L in the treatment of SR-
Slide 34: For personal use only
For personal use only mesoblast the regenerative medicine company