Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2022)
29 slides from Mesoblast's shareholder meeting presentation, Nov 23, 2022
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 & Financial Results for the Quarter Ended September 30, 2022 and Annual General Meeting 2022 November 2022 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: Remestemcel-L: BLA Response to FDA CRL for Steroid-Refractory GVHD
Remestemcel-L: BLA Response to FDA CRL for Steroid-Refractory Graft Versus Host Disease Survival outcomes have not improved over the past two decades for children or adults with the most severe For personal use only forms of SR-aGVHD. The lack of any approved treatments for children under 12 means t
Slide 5: Remestemcel-L: Long-Term Survival Data a Cornerstone of BLA Resubmission
Remestemcel-L: Long-Term Survival Data a Cornerstone of BLA Resubmission to FDA for SR-aGVHD Today Mesoblast provided new results from a four-year observational survival study performed by the Center For personal use only for International Blood and Marrow Transplant Research (CIBMTR) on 51 evaluabl
Slide 6: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline For personal use only 1. JCR Pharmaceuticals Co., Ltd. (JCR), has the right to develop mesenchymal stromal cells (MSCs) in certain fields for the Japanese market, including for the treatment of hematological malignancies, such as Graft vs Host Disease, and for hypoxic is
Slide 7: Financial Results for the Period Ended September 30, 2022
For personal use only Financial Results for the Period Ended September 30, 2022 Rexlemestrocel-L Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD) Commercialization – Market Overview 7 Manufacturing Remestemcel-L mesoblast © Lonza, reproduced with permission
Slide 8: Financial Highlights
Financial Highlights For personal use only ❑ At September 30, 2022, cash-on-hand was US$85.5 million. ❑ Up to an additional US$40.0 million may be drawn from existing financing facilities subject to achieving certain milestones, with current discussions to extend the period for the drawdown option.
Slide 9: Reduction in Expenditure on R&D and Manufacturing, Improved Loss Before Tax
Reduction in Expenditure on R&D and Manufacturing, Improved Loss Before Tax Sep 30, Sep 30, P&L for the 3 months ended For personal use only 2022 2021 ❑ Revenue (US$m) Majority of change due to one-off licensing milestone in prior Total Revenue 1.5 3.6 period and impact of currency movement Research
Slide 10: Quarterly Net Operating Cash Burn has been significantly reduced
Quarterly Net Operating Cash Burn has been significantly reduced For personal use only Rolling 12 months to Sep 2021 - US$92m US$m 33% reduction of US$30 million 30.0 Rolling 12 months to Sep 2022 – US$62m 25.0 20.0 15.0 10.0 5.0 0.0 Dec-20 Mar-21 Jun-21 Sep-21 Dec-21 Mar-22 Jun-22 Sep-22 ❑ Quarterl
Slide 11: Clinical Pipeline: Current Status and Anticipated Milestones
For personal use only Clinical Pipeline Current Status and Anticipated Milestones 11 mesoblast
Slide 12: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline MID-STAGE LATE STAGE For personal use only THERAPEUTIC AREA Phase 2 Phase 3 COMMERCIAL Acute Graft Versus Host Disease (aGVHD)1 steroid-refractory Remestemcel-L Rexlemestrocel-L This chart is figurative and does not purport to show individual trial progress within a clin
Slide 13: Remestemcel-L: Steroid-Refractory Acute GVHD, Significant Unmet Need
Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease Significant Unmet Need with High Mortality For personal use only Treatment Options Burden of Illness Market Opportunity Corticosteroids are first-line Acute GVHD is a life- More than 30,000 allogeneic therapy for aGVHD threatening com
Slide 14: Remestemcel-L Improved Early Survival in Children with SR-aGVHD
Remestemcel-L Improved Early Survival in Children with SR-aGVHD Remestemcel-L improved early survival in three controlled studies: For personal use only 1. First-line therapy after steroids • 27 children in a randomized controlled Phase 3 trial of 260 patients with SR-aGVHD • 54 children in open-lab
Slide 15: Remestemcel-L Long-Term Survival in Children with SR-aGVHD
Remestemcel-L Long-Term Survival in Children with SR-aGVHD Data received from CIBMTR from Phase 3 study of remestemcel-L in 54 children, 89% with Grade C/D disease. For personal use only Overall survival through 4 years follow-up in 51 children: • 1-year 63%; 2-year 51%; 3-year 49%; 4-year 49% SR-aG
Slide 16: Remestemcel-L Potential to Improve Long-Term Survival in Pediatric SR-aGVHD
Remestemcel-L has the Potential to Improve Bleak Long-Term Survival (>2 Years) in Pediatric SR-aGVHD For personal use only 2-Year Survival in Pediatric Patients 2-Year Survival in Pediatric Patients 2 Treated with Steroids1 GVHD0012 N=370 N=51 180 2 1 Days Years 0.8 69% 0.6 51% Steroid Refractory –
Slide 17: Remestemcel-L in Highest-Risk Patients
Remestemcel-L for Steroid-Refractory Graft Versus Host Disease in Highest-Risk Patients 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 Response by baseline MAP
Slide 18: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline MID-STAGE LATE STAGE For personal use only THERAPEUTIC AREA Phase 2 Phase 3 COMMERCIAL Chronic Low Back Pain (CLBP)2 due to inflammatory degenerative disc disease Remestemcel-L Rexlemestrocel-L This chart is figurative and does not purport to show individual trial progre
Slide 19: Rexlemestrocel-L – Opportunity in Chronic Low Back Pain
Rexlemestrocel-L – Opportunity in Chronic Low Back Pain A New Paradigm for Treatment of Chronic Low Back Pain due to Degenerative Disc Disease For personal use only Burden of Illness Treatment Options Market Opportunity • Back pain causes more • Minimal treatment options • Over 7m patients are disab
Slide 20: The Patient Treatment Journey
The Patient Treatment Journey Rexlemestrocel-L Potential for First-Line CLBP associated with DDD, Refractory to Conservative Treatment For personal use only Rexlemestrocel-L targeting moderate-to-severe DCLBP Conservative Interventional Opioid Surgery Treatments Therapies Analgesics ❑ NSAIDs ❑ Epidu
Slide 21: Phase Trial Outcomes – Rexlemestrocel-L for Chronic Low Back Pain
Phase 3 Trial Outcomes – Rexlemestrocel-L for Chronic Low Back Pain Single Injection of Rexlemestrocel-L + HA Results in >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
Slide 22: Market Access & Pricing Insights
Market Access & Pricing Insights: Pricing will be Driven by Overall Value Offering; US Reference Pricing Suggests Higher Price Points for Disease Modifying Agents For personal use only ~$1.2k - $2.5k ~$9k - $15k+ ~$32.2k ~$45.2k ~$77.5k Annual Cost of Branded Pain Annual Cost of Branded Disease Modi
Slide 23: Rexlemestrocel-L – Phase Trial in Chronic Low Back Pain
Rexlemestrocel-L – Phase 3 Trial in Chronic Low Back Pain For personal use only FDA Office of Tissues and Advanced Therapies (OTAT) agreed with Mesoblast’s proposal for mean pain reduction at 12 months to serve as the primary endpoint of the second Phase 3 trial and as an approvable indication for t
Slide 24: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline MID-STAGE LATE STAGE For personal use only THERAPEUTIC AREA Phase 2 Phase 3 COMMERCIAL Chronic Heart Failure Reduced Ejection Fraction (HFrEF)3 focus on ischemics and diabetics Remestemcel-L Rexlemestrocel-L This chart is figurative and does not purport to show individua
Slide 25: Rexlemestrocel-L – Chronic Heart Failure
Rexlemestrocel-L – Chronic Heart Failure Rising Incidence & High Mortality For personal use only ❑ Cardiovascular disease (CVD) remains the leading cause of death in the United States 1 ❑ Heart failure affects 6.5 million patients in the US and 26 million patients globally. As populations age, the p
Slide 26: The Patient Treatment Journey: Chronic Heart Failure
The Patient Treatment Journey Rexlemestrocel-L for Chronic Heart Failure For personal use only Treatment Algorithm in Progressive Heart Failure Progressive Vascular (Endothelial) Dysfunction and Heart Failure Early Mesoblast Target Market ▪ ACEI or ARB ▪ Statins Chronic Heart Failure1 ▪ Beta blocker
Slide 27: Rexlemestrocel-L: Phase Trial in HFrEF
Rexlemestrocel-L: Phase 3 Trial in Heart Failure with Reduced Ejection Fraction (HFrEF) Rexlemestrocel-L Improved Left Ventricular Systolic Function, as Measured by Left Ventricular Ejection Fraction (LVEF) at 12 Months: Potential Early Surrogate Endpoint For personal use only ➢ In all treated patie
Slide 28: DREAM-HF Phase Trial in HFrEF
DREAM-HF Phase 3 Trial in HFrEF Rexlemestrocel-L Reduced Incidence of 3-Point Composite MACE - CV Death, MI or Stroke - Compared to Controls Across All 537 Treated Patients, with Enhanced Effect in Those with Active Inflammation as Measured by CRP >2 For personal use only Time-to-First-Event (TTFE)
Slide 29: Thank You
For personal use only Thank You mesoblast