Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2019)
33 slides from Mesoblast's shareholder meeting presentation, Nov 27, 2019
Slide 1: 2019 Annual General Meeting
For personal use only 2019 Annual General Meeting Dr Silviu Itescu, Chief Executive November 27, 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: Corporate History
Corporate History For personal use only Over a decade of scientific, manufacturing, clinical development and corporate development experience targeted at bringing to market allogeneic, off-the-shelf cellular medicines for inflammatory diseases 2004: 2013: 2015: 2017: 2019: 2019: Mesoblast founded in
Slide 5: Premier Global Cellular Medicines Company
Premier Global Cellular Medicines Company For personal use only Innovative Technology Platform1 Late Stage Pipeline Commercialization Innovative technology targets Initiated rolling filing with US Building US sales force for some of the most severe disease FDA for approval for steroid- potenti
Slide 6: Commercial Scale Manufacturing Capability
Commercial Scale Manufacturing Capability For personal use only Scalable allogeneic “off-the-shelf” cellular medicine platform Manufacturing meets stringent criteria set by international regulatory agencies including FDA and EMA Robust quality assurance processes ensure final product with batc
Slide 7: 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 Diseases Enables l
Slide 8: Commercial and Late-Stage Product Pipeline
Commercial and Late-Stage Product Pipeline For personal use only PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MARKETED TEMCELL® MSC Acute Graft Versus Host Japan 1st allogeneic regen med approved in Japan (Bone Marrow) HS Inj1 Disease MSC (Adipose) Alofisel®2 Perianal Fistula 1st a
Slide 9: Partnerships and License Agreements
Partnerships and License Agreements For personal use only Strategic partnership to develop and commercialize MPC-06-ID for chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options Grünenthal will have exclusive commercialization rights
Slide 10: Continued Growth in Revenues & Strong Balance Sheet
For personal use only Continued Growth in Revenues & Strong Balance Sheet
Slide 11: Revenues from Royalties on Japan Product Sales – 37% Year on Year Growth
Revenues from Royalties on Japan Product Sales – 37% Year on Year Growth US$m For personal use only 6.0 5.0 5.0 4.0 3.6 3.0 2.0 1.0 1.5 - 0.4 FY16 FY17 FY18 FY19 37% growth in royalty revenue for the FY2019 year compared to FY2018 from sales of TEMCELL in Japan for SR-aGVHD by Mesoblast licensee J
Slide 12: Substantial Increase in Revenues for the Quarter Ending September 30, 2019
Substantial Increase in Revenues for the Quarter Ending September 30, 2019 For personal use only September 30, September 30, September 30, For the quarter ending (US$m) 2019 2018 2017 Upfront/milestone revenue 15.0 10.5 0.5 Commercialization revenue 1.9 1.0 0.6 Interest revenue 0.1 0.1 0.1 Total rev
Slide 13: Strong Balance Sheet and 20% Reduction in Operating Net Cash Outflows
Strong Balance Sheet and 20% Reduction in Operating Net Cash Outflows For personal use only September 30, June 30, As of (US$m) 2019 2019 Cash on Hand 34.5 50.4 ` Pro forma cash on hand 100.0 50.4 Pro forma cash on hand at September 30, 2019 includes a US$15.0 million upfront payment for the strat
Slide 14: Operational Highlights
For personal use only Operational Highlights
Slide 15: Acute Graft Versus Host Disease (aGVHD)
Acute Graft Versus Host Disease (aGVHD) Significant market opportunity for Remestemcel-L 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 wi
Slide 16: Remestemcel-L: U.S. Regulatory and Commercial Strategy
Remestemcel-L: U.S. Regulatory and Commercial Strategy For personal use only US strategy for remestemcel-L informed by TEMCELL sales experience in Japan Rolling BLA submission to FDA Fast Track designation provides eligibility for FDA priority review Commercialization strategy in place for p
Slide 17: SR-aGVHD is Associated with Significant Burden of Illness in Children
Remestemcel-L: SR-aGVHD is Associated with Significant Burden of Illness in Children in the U.S.1 For personal use only Average Average Average Average Additional Pediatric SR Additional Hospitalization Additional Additional All-Cause Cost: aGVHDvs. Outpatient Prescription ~US$500k LOS: 28 days Visi
Slide 18: Remestemcel-L: Results from Providers/Payers Indicate Near Maximal Rating
Remestemcel-L: Results from Providers/Payers Indicate Near Maximal Rating on Product Attributes1 For personal use only Median Response Reaction to 0 Tested Target Profile2 6 7 Most Significant Value Drivers for Remestemcel-L Max Rating Product (n=20) Attributes Day 28 overall response rate (especi
Slide 19: Remestemcel-L: Life Cycle Strategy
Remestemcel-L: Life Cycle Strategy Mesoblast has over 10 years of experience in hematology-oncology space For personal use only Remestemcel-L: − Positive Phase 3 Results Q12018 Chronic GVHD − Large US Pediatric GVHD Expanded Access Program (>240 patients) SR-aGVHD pediatric Ex-US launch Label extens
Slide 20: Remestemcel-L for Acute GVHD: Recent Highlights
Remestemcel-L for Acute GVHD For personal use only Recent Highlights Continued growth in revenues from royalties on sales of TEMCELL in Japan for steroid refractory aGVHD Product adoption and reimbursement seen in the Japan GVHD market for TEMCELL informs Mesoblast US commercial strategy for rem
Slide 21: Advanced and End-Stage Heart Failure
Advanced and End-Stage Heart Failure For personal use only Common Treatment Pathway in Progressive Heart Failure1 Class I Progressive Vascular (Endothelial) Dysfunction and Heart Failure ClassIV Mesoblast Target Market: Early ACEI orARB Advanced Statins and End-Stage HF patients3 Beta blockers
Slide 22: Advanced Heart Failure: Revascor Commercial Opportunity
Advanced Heart Failure Revascor – Commercialopportunity For personal use only ~ 8 million patients with chronic heart failure by 2030 in US alone1 Burden of 17-45% globally die within 1 year of hospital admission1 Illness Majority of advanced heart failure patients die within 5 years1 Despit
Slide 23: Advanced Heart Failure: Revascor Phase 3 Trial Fully Enrolled
Advanced Heart Failure Revascor - Phase 3 trial fully enrolled For personal use only Trial design is 1:1 randomized, controlled, double blinded; conducted over 55 sites across North America using 150 million cell dose vs control Events-driven Phase 3 trial completed enrollment of 566 patients in
Slide 24: Revascor for Advanced Heart Failure: Key Milestones
Revascor for Advanced Heart Failure For personal use only Key milestones Full accrual of primary endpoints events in the Phase 3 trial of Revascor for advanced heart failure around the end of CY19 Data read-out for this Phase 3 trial planned in H1 CY20 Results will be considered pivotal to sup
Slide 25: End-Stage Heart Failure: Revascor Commercial Opportunity
End-Stage Heart Failure Revascor – Commercial opportunity in reducing GI bleeding in patients with LVADs For personal use only In the US there are ~ 250,000–300,000 patients annually who suffer from Burdenof advanced systolic heart failure (NYHA Class III–IV)1 Illness Despite optimal medical the
Slide 26: End-Stage Heart Failure in LVAD Patients
End-Stage Heart Failure in LVAD Patients Revascor reduced GI bleeding events causing hospitalizations in two randomized trials For personal use only MPCs prolong time-to-first major GI bleeding event and reduced cumulative major GI bleeding events in two randomized controlled trials in LVAD patients
Slide 27: Revascor for End-Stage Heart Failure in LVAD Patients
Revascor for End-Stage Heart Failure in LVAD Patients For personal use only Recent Highlights Mesoblast and the International Center for Health Outcomes Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai in New York have agreed on the protocol for a confirmatory Phase 3 t
Slide 28: MPC-06-ID: A New Paradigm for Treatment of Chronic Low Back Pain
MPC-06-ID: 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 system1,2, including excessive use
Slide 29: 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 com
Slide 30: Key Terms of the Strategic Partnership with Grünenthal
Key Terms of the Strategic Partnership with Grünenthal For personal use only Grünenthal has obtained An exclusive license for Europe and Latin America to develop and commercialize MPC-06-ID in the treatment of chronic low back pain due to degenerative disc disease In consideration, Mesoblast will
Slide 31: Transaction Benefits to Mesoblast
Transaction Benefits to Mesoblast Strong commercial partner For personal use only Delivers commercialization, distribution, sales & marketing Field force comprises around 1,600 people across Europe, Latin America & US – overall focus is on pain – visited nearly 300,000 stakeholders in 2018 (ph
Slide 32: MPC-06-ID for Chronic Low Back Pain: Key Milestones
MPC-06-ID for Chronic Low Back Pain For personal use only Key Milestones Last patient last visit at 24-months of follow up in the Phase 3 trial of MPC-06-ID for chronic low back pain H1 CY20, with the primary endpoint being a composite outcome of pain and function at 12 and 24 months Obtain clea
Slide 33: Questions
For personal use only Questions