Mesoblast Limited · ASX:MSB
Mesoblast — Q2 FY2023 Earnings Presentation
29 slides from Mesoblast's earnings presentation, Feb 28, 2023
Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
mesoblast For personal use only Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Operational Highlights and Financial Results for the Quarter Ended December 31, 2022 February 2023 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: Investment Highlights
Investment Highlights Developing off-the-shelf, allogeneic cellular medicines based on proprietary Novel Allogeneic For personal use only mesenchymal stromal cell (MSC) technology platforms to enable treatment without the Cell Therapy Platform need for donor matching or immunosuppression Remestemcel
Slide 5: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline Based on the Proprietary Allogeneic Mesenchymal Stromal Cell Platforms For personal use only Product Indication Phase 2 Phase 3 Regulatory Filing Approved Status/Next Steps Remestemcel-L SR-aGVHD • BLA resubmitted Jan 2023 • RMAT granted Rexlemestrocel-L CLBP • Planning
Slide 6: Mesoblast's Proprietary Stromal Cell Technology
Mesoblast’s Proprietary Stromal Cell Technology Based on mesenchymal lineage adult stromal cells (MLCs/SCs) For personal use only Mesenchymal Lineage Defined Stromal Cells Allogenic Properties Scalable Production MLCs are derived from Biologically-defined, Expanded without Scalable “off-the-shelf” h
Slide 7: Manufacturing Remestemcel-L
For personal use only for the Period Ended December 31, 2022 Manufacturing Remestemcel-L 7 © Lonza, reproduced with permission mesoblast
Slide 8: Financial Highlights
Financial Highlights For personal use only Revenue from royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our licensee were US$1.9 million for Royalty Revenue the quarter ended December 31, 2022. On a constant currency basis, sales for the quarter ended December 31, 2022, were US$2.1 million2
Slide 9: Reduction in Expenditure on R&D, Improved Loss Before Tax
Reduction in Expenditure on R&D, Improved Loss Before Tax For personal use only Dec 31, Dec 31, Revenue: Revenue predominately from royalties on sales of P&L for the quarter ended (US$m) 2022 2021 TEMCELL® HS Inj.1 sold in Japan by our licensee. Total Revenue 2.1 2.4 Reduction in R&D Expenditure: re
Slide 10: Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
For personal use only Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) 10 mesoblast
Slide 11: Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease
Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) SR-aGVHD is associated with mortality rates as high as 90% For personal use only Treatment Options Burden of Illness Market Opportunity Corticosteroids are first-line Acute GVHD is a life- More than 30,000 therapy for aGVHD
Slide 12: BLA Resubmission Contains New Data on Product Potency and Clinical Outcomes
BLA Resubmission Contains New Data on Product Potency and Clinical Outcomes in Pediatric Patients with SR-aGVHD For personal use only New data showing remestemcel-L’s treatment benefit in high-risk disease activity and on survival in propensity-matched studies of children in the Phase 3 trial and co
Slide 13: Use of Validated Biomarker for Assessment of Treatment Effect in Severe SR-aGVHD
Use of Validated Biomarker for Assessment of Treatment Effect in Severe SR-aGVHD Remestemcel-L Results in Significantly Greater Day 28 Overall Responses and Day 180 Survival in Highest-Risk Patients (Baseline MAP ≥ 0.29) For personal use only Response by Baseline MAP Survival by Baseline MAP Respons
Slide 14: Remestemcel-L Treatment Outcomes
Remestemcel-L Treatment Outcomes Significantly Greater Survival in Steroid-Refractory Patients with Baseline MAP ≥ 0.29 For personal use only Kaplan-Meier Estimates of 6-month Overall Survival for the Two Patient Cohorts by Baseline MAP Abbreviations: MAP: MAGIC algorithm probability; BAT: best avai
Slide 15: Remestemcel-L for SR-aGVHD: Improved Early Survival in Children
Remestemcel-L for SR-aGVHD Improved Early Survival in Children Across Three Studies For personal use only Day 100 Survival Remestemcel-L Protocol Remestemcel-L Matched Controls Matched Control Protocol First Line Therapy after Steroids Treatment Setting Pediatric Subset of Protocol 280: randomized c
Slide 16: Extended Survival Data in Children with SR-aGVHD
Extended Survival Data in Children with SR-aGVHD Remestemcel-L Treatment Resulted in Durable Survival Over 4 Years For personal use only Survival Outcomes in Pediatric & Adult SR-aGVHD (Remestemcel-L data from the Center for International Blood and Marrow Transplant Research (CIBMTR) dbase) Study GV
Slide 17: Long term Survival in Pediatric Patients with SR-aGVHD Treated with Remestemcel-L
Long term Survival in Pediatric Patients with SR-aGVHD Treated with Remestemcel-L Presented at the 2023 Remestemcel-L Remestemcel-L Tandem has has the Meeting the Potential Potential of ASTCT to Improve to Improve andLong-Term BleakBleak CIBMTR Long-Term Survival Survival (>2 Years) (>2 Years) in in
Slide 18: Chronic Low Back Pain due to Degenerative Disc Disease (CLBP)
For personal use only Chronic Low Back Pain due to Degenerative Disc Disease (CLBP) 18 mesoblast
Slide 19: Chronic Low Back Pain Due to Degenerative Disc Disease Impacts 7M+
Chronic Low Back Pain Due to Degenerative Disc Disease (CLBP) Impacts 7M+ Rexlemestrocel-L represents a potential new paradigm for the treatment of CLBP For personal use only Burden of Illness Treatment Options Market Opportunity Back pain causes more Minimal treatment options Over 7m patients are d
Slide 20: Patients with CLBP Refractory to Standard Treatment Have Minimal Options
Patients with CLBP Refractory to Standard Treatment Have Minimal Options Rexlemestrocel-L has the Potential to be First-Line Treatment for Patients with CLBP Refractory to Conservative Treatment For personal use only Rexlemestrocel-L targeting moderate-to-severe CLBP Conservative Opioid Intervention
Slide 21: RMAT Designation Granted by FDA for Rexlemestrocel-L in CLBP
Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by FDA for Rexlemestrocel-L in the treatment of CLBP RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including For personal use only rolling review and eligibility for priority review on filing
Slide 22: Phase 3 Trial Outcomes based on a Single Injection of Rexlemestrocel-L + HA
Phase 3 Trial Outcomes based on a Single Injection of Rexlemestrocel-L + HA Results in More than Three Years of Pain Reduction For personal use only Greatest pain reduction was observed in the pre-specified population of subjects with CLBP duration shorter than the baseline study median of 68 months
Slide 23: Rexlemestrocel-L / CLBP
Rexlemestrocel-L / CLBP For personal use only In Prep for US/EU Commence Pivotal P3 Regulatory Alignment Phase 3 Protocol Submissions Mid-CY2023 Gained alignment with FDA has agreed with The planned Phase 3 RMAT designation for the FDA on the Mesoblast plans for Program will include 80% CLBP receive
Slide 24: Chronic Heart Failure Reduced Ejection Fraction (HFrEF)
For personal use only Chronic Heart Failure Reduced Ejection Fraction (HFrEF) 24 mesoblast
Slide 25: Chronic Heart Failure: Rising Incidence and High Mortality
Chronic Heart Failure (CHF): Rising Incidence and High Mortality New therapies reduce recurrent hospitalization but do not materially improve mortality or major ischemic event rates For personal use only Cardiovascular disease remains the leading cause of death in the United States1 Heart failure af
Slide 26: Patients Experience Progressive Vascular Dysfunction and Heart Failure
Patients Experience Progressive Vascular Dysfunction and Heart Failure Rexlemestrocel-L has the potential to improve endothelial dysfunction in patients from Class II thru IV For personal use only Treatment Algorithm in Progressive Heart Failure (HF) Progressive Vascular (Endothelial) Dysfunction an
Slide 27: Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Heart Failure
ORIGINAL INVESTIGATIONS Precursor Cell Therapy in Patients Randomized Trial of Targeted With Heart Failure Transendocardial Mesenchymal Emerson C. Perin, MD, PHD,a Kenneth M. Borow, MD,b Timothy D. Henry, MD,c Farrell O. Mendelsohn, MD,d Leslie W. Miller, MD,e Elizabeth Swiggum, MD,f Eric D. Adler,
Slide 28: Rexlemestrocel-L / HFrEF: Defining the Regulatory Path to FDA Approval
Rexlemestrocel-L / HFrEF Defining the Regulatory Path to FDA Approval For personal use only Significant Need Promising Data Targeting Inflammation H1 CY2023 FDA Meeting Cardiovascular disease Recent data from the Effects on LVEF and MACE Mesoblast plans to meet remains the leading DREAM-HF P3 trial
Slide 29: Thank You
mesoblast For personal use only Thank You 29 mesoblast