Mesoblast Limited · ASX:MSB
Mesoblast — H1 FY2020 Earnings Presentation
26 slides from Mesoblast's earnings presentation, Feb 27, 2020
Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
For personal use only Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial and Operational Highlights for the Half Year Ended December 31, 2019 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: Allogeneic Cellular Medicines for Inflammatory Diseases
Allogeneic Cellular Medicines for Inflammatory Diseases For personal use only Innovative Technology Lead Product Late Stage Platform Candidate Product Pipeline Allogeneic mesenchymal precursor RYONCILTM (remestemcel-L) BLA Lifecycle expansion of cells (MPCs) and their progeny filed with US FDA
Slide 5: Mesoblast Pipeline
Mesoblast Pipeline For personal use only MESOBLAST PRODUCT THERAPEUTIC PHASE 1/2 PHASE 3 REGISTRATION COMMERCIAL COMMERCIAL CANDIDATE AREA RIGHTS PARTNERS RYONCILTM Acute GVHD - Pediatric Global ex-Japan Acute GVHD - Adult Chronic GVHD Pediatric & adult Global rare diseases Remestemcel-L Biologic-re
Slide 6: Partnerships and License Agreements: Commercial products
Partnerships and License Agreements Commercial products For personal use only TEMCELL® ANNUAL REVENUE FROM TEMCELL ROYALTIES IN JAPAN ACUTE GRAFT VERSUS HOST DISEASE + OTHER INDICATIONS 7.0 Rights to use MSC technology for acute GVHD in Japan 6.6 6.0 US$6.6 million royalties received in last 12
Slide 7: Partnerships and License Agreements: Products in development
Partnerships and License Agreements Partnerships and License Agreements Products in development Product candidates For personal use only MPC-06-ID CHRONIC LOW BACK PAIN - DEGENERATIVE DISC DISEASE Strategic partnership to develop and commercialize MPC-06-ID in Europe & Latin America PREVALENCE EUR
Slide 8: Global IP Estate Provides Substantial Competitive Advantage
Global IP Estate Provides Substantial Competitive Advantage For personal use only ~1,000 patents and patent applications (68 patent families) across all major jurisdictions Covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells Therapeutic Areas Co
Slide 9: Commercial Scale Manufacturing Capability
Commercial Scale Manufacturing Capability 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-batch consistency and reprodu
Slide 10: Financials
For personal use only Financials
Slide 11: Financial Highlights
Financial Highlights For personal use only First Half FY2020 Compared to First Half FY2019 43% increase in total revenue to US$19.2m from US$13.5m 73% growth in commercialization revenue from sales of TEMCELL to US$3.8m from US$2.2m 36% increase in milestone revenues from strategic partnership
Slide 12: Substantial Increase in Revenues and Reduced Loss After Tax
Substantial Increase in Revenues and Reduced Loss After Tax For personal use only December 31, December 31, Profit and Loss for the six months ending (US$m) 2019 2018 Commercialization revenue 3.8 2.2 Milestone revenue 15.0 11.0 Interest revenue 0.4 0.3 Total Revenue 19.2 13.5 Research and developme
Slide 13: Operational & Corporate Highlights
For personal use only Operational & Corporate Highlights
Slide 14: Acute Graft Versus Host Disease (aGVHD)
Acute Graft Versus Host Disease (aGVHD) Significant market opportunity for RYONCIL For personal use only aGVHD is a life-threatening complication that occurs in ~50% of patients receiving Burden of allogeneic bone marrow transplants (BMTs)1 Illness Steroid-refractory aGVHD is associated with mor
Slide 15: RYONCIL: U.S. Regulatory and Commercial Strategy
RYONCIL: U.S. Regulatory and Commercial Strategy For personal use only US strategy for RYONCIL informed by TEMCELL sales experience in Japan Fast Track designation provides eligibility for FDA priority review Commercialization strategy in place for product launch Ramp-up for inventory build
Slide 16: Remestemcel-L: Lifecycle Extension Strategy
Remestemcel-L: Lifecycle Extension Strategy For personal use only Chronic GVHD SR-aGVHD pediatric Ex-US launch Label extension 2018 - Crohn’s Pediatric Phase 3 - HIE US top line data SR-aGVHD adult - EB US/Ex-US parallel Product development/ launch manufacturing 2020 targeted US optimization launch
Slide 17: RYONCIL: Recent Highlights and Key Milestones
RYONCIL: Recent Highlights and Key Milestones For personal use only Recent Highlights Filed BLA for RYONCIL with the US FDA for SR-aGVHD in children Consistent outcomes using RYONCIL as first line treatment or salvage therapy in 309 children with SR- aGVHD were presented at the annual meeting of
Slide 18: Chronic Heart Failure: Rising Incidence & High Mortality
Chronic Heart Failure: Rising Incidence & High Mortality Rates Highlight Large Clinical Unmet Need For personal use only More than 26 million people worldwide living with heart failure1 Burden of 8.5 million patients in the US alone, expected to be living with heart failure by 20301 Illness 17
Slide 19: REVASCOR for Advanced and End-Stage Heart Failure
REVASCOR for Advanced and End-Stage Heart Failure For personal use only Common Treatment Pathway in Progressive Heart Failure Class I Progressive Vascular (Endothelial) Dysfunction and Heart Failure ClassIV Mesoblast Target Market: Early ACEI orARB Advanced Statins & End-Stage patients1 Beta b
Slide 20: REVASCOR: Phase 3 trials for Advanced & End-Stage Heart Failure
REVASCOR: Phase 3 trials for Advanced & End-Stage Heart Failure For personal use only Advanced Heart Failure Trial design: 1:1 randomized, controlled, double blinded; conducted over 55 sites across North America using 150 million cell dose vs control in 566 patients Target patient population enr
Slide 21: REVASCOR for Advanced and End-Stage Heart Failure
REVASCOR for Advanced and End-Stage Heart Failure For personal use only Recent Highlights In December 2019, the Phase 3 trial in advanced heart failure surpassed the number of primary endpoint events required for trial completion The independent DMC held its 10th and final scheduled meeting and
Slide 22: Disease Modifying Therapies Needed for Chronic Low Back Pain
Disease Modifying Therapies Needed for 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 system1,2, including excessive use of
Slide 23: MPC-06-ID: Development Strategy for US & Europe
MPC-06-ID: Development Strategy for US & Europe For personal use only Phase 3 trial in chronic low back pain completed enrolment in March 2018 with 404 patients randomized to receive MPC-06-ID or placebo Initiate confirmatory Phase 3 trial in Europe in partnership with Grünenthal Complete comm
Slide 24: MPC-06-ID for Chronic Low Back Pain
MPC-06-ID for Chronic Low Back Pain For personal use only Recent Highlights Entered into strategic partnership with Grünenthal to develop and commercialize MPC-06-ID in Europe and Latin America Key Milestones Last patient last visit at 24-months of follow up in the Phase 3 trial of MPC-06-ID for
Slide 25: Major Operational Milestones for the Next Months
Major Operational Milestones for the Next 12 Months For personal use only Remestemcel-L for SR-aGVHD and Other Rare Diseases Updates on RYONCIL Priority Review and Prescription Drug User Fee Act (PDUFA) date If approved, US launch of RYONCIL planned for 2020 Expand investigator-initiated clini
Slide 26: Thank You
For personal use only Thank You