Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2018)
27 slides from Mesoblast's shareholder meeting presentation, Nov 30, 2018
Slide 1: 2018 Annual General Meeting
For personal use only 2018 Annual General Meeting Dr Silviu Itescu, Chief Executive November 30, 2018 Nasdaq: MESO ASX: MSB
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 bring to market disruptive cellular medicines to treat serious and life-threatening illnesses |3
Slide 4: Premier Global Cellular Medicines Company
Premier Global Cellular Medicines Company For personal use only Disruptive Technology Commercialization Late Stage Pipeline Platform1 Disruptive technology which targets First approved products 2 blockbuster product the most severe disease states commercialized by licensees in candidates in he
Slide 5: Multiple Commercial Opportunities
Multiple Commercial Opportunities 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 allogeneic
Slide 6: Partnerships and License Agreements
Partnerships and License Agreements For personal use only JCR has rights to use our MSC technology to treat acute GVHD in Japan Its product, TEMCELL ® HS Inj., was the first fully approved allogeneic cellular medicine in Japan Royalties and milestones received in last twelve months exceed US$5
Slide 7: Global IP Estate Provides Substantial Competitive Advantage
Global IP Estate Provides Substantial Competitive Advantage For personal use only ~800 Patents and patent applications (69 Patent families) across all major jurisdictions Covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells Diseases All Tier 1 &
Slide 8: Commercial-Scale Manufacturing Capability
Commercial-Scale Manufacturing Capability For personal use only Immune privileged nature of mesenchymal lineage cells enables allogeneic “off the shelf” product candidates Culture expansion scalable to produce anticipated commercial quantities Management know-how in regulatory activities neces
Slide 9: Commercial Organizational Transition
Commercial Organizational Transition For personal use only Board of Directors – Structured Succession Plan to Bring Complementary Skills: Proven FDA product approval capabilities Commercial launch expertise Reimbursement and health system expertise Extensive global transactional record Manag
Slide 10: Remestemcel-L: Graft Versus Host Disease Pathway to Market
Remestemcel-L: Graft Versus Host Disease Pathway to Market For personal use only TEMCELL® HS Inj. sales experience in Japan informs commercial strategy for the U.S. Phase 3 successfully completed Fast Track designation provides eligibility for FDA priority review Commercialization strategy i
Slide 11: Revascor: Targeting Patients with Advanced Heart Failure
Revascor: Targeting Patients with Advanced Heart Failure Refractory to Standard of Care For personal use only Common Treatment Pathway in Progressive Heart Failure1 Mesoblast Target Market: Early ACEI or ARB Advanced Statins and End-Stage HF patients3 Beta blockers Re-vascularization or valv
Slide 12: Endothelial Dysfunction at the Core of Progressive Heart Failure
Blood Vessel (Endothelial) Dysfunction in the Heart and Major Organs is at the Core of Progressive Heart Failure For personal use only NFkB Inflammation in HF M1 Cardiomyocyte Survival M2 IL-1β TNFα Smooth muscle cells Neovascularization MPC `M1 TNFα PGE2 IL-1𝛃𝛃 IL-6 SDF-1 VEGF Ang1 Endothelial…
Slide 13: GI Bleeding in LVAD Patients due to Endothelial Dysfunction
GI Bleeding in LVAD Patients due to Inflammation-Related Endothelial Dysfunction For personal use only GI Blood Vessels are Right Ventricular Failure and Increased Abnormal in LVAD Patients Pressure in GI Blood Vessels Enlarged right atrium Mesoblast MPCs significantly reduced GI bleeding in two ran
Slide 14: Revascor: End-stage LVAD Heart Failure Program
Revascor: End-stage LVAD Heart Failure Program Pathway to Market For personal use only In end-stage heart failure patients with LVADs, inflammation-related endothelial dysfunction results in severe GI bleeding and recurrent hospitalizations Treatment of end-stage heart failure patients with our
Slide 15: Blockbuster Product Opportunities
Blockbuster Product Opportunities For personal use only Revascor: Advanced Heart Failure New therapies needed to reduce hospitalizations and mortality Phase 3 trial in advanced heart failure has enrolled >90% of patients Majority of patients in this Phase 3 trial have ischemic heart failure
Slide 16: Global Partnerships to Commercialize Blockbuster Assets
Global Partnerships to Commercialize Blockbuster Assets For personal use only Advanced discussions with multiple potential partners for global commercialization of cell therapies for: advanced heart failure chronic low back pain due to disc degeneration Partners will bring: access to high
Slide 17: Significant Increase in Revenue
Significant Increase in Revenue For personal use only Revenue for the quarter ending September 30, 2018 (US$m) September 30, September 30, For the quarter ending $ Change % Change 2018 2017 Milestone revenue 10.5 0.5 10.0 NM Commercialization revenue 1.0 0.6 0.4 66% Interest revenue 0.2 0.1 0.1 93%
Slide 18: Cash Position Strengthened through Strategic Transactions
Cash Position Strengthened through Strategic Transactions Balance sheet cash (US$m) For personal use only September 30, June 30, $Change 2018 2018 Reported cash on hand 55.1 37.8 17.3 NovaQuest financing agreement - 39.0 (39.0) Tasly strategic partnership 40.0 40.0 - Pro forma cash on hand 95.1 116.
Slide 19: Corporate Milestones
Corporate Milestones For personal use only Remestemcel-L for Acute Graft Versus Host Disease Successfully met all efficacy and safety endpoints through six months FDA meetings and BLA filing (Q4 CY18 – Q1 CY19) Revascor for Advanced and End-Stage Heart Failure Meet with FDA to discuss the re
Slide 20: Questions?
For personal use only Questions? | 20 | 20
Slide 21: Commercial Launch Plans
For personal use only Commercial Launch Plans Eric Strati Pharm.D., MBA November 30, 2018 Nasdaq: MESO ASX: MSB | 21
Slide 22: Committed to Patient Access and Maximizing Value for Stakeholders
Mesoblast is Committed to Patient Access and Maximizing Value for all Key Stakeholders For personal use only Mesoblast • Highly driven and passionate organization focused on improving the lives of those suffering from life threatening Culture diseases Experienced • High commercial acumen underpinned
Slide 23: Planned Commercial Launch Activities for Lead Products
Mesoblast Planned Commercial Launch Activities for Lead Products Targeted for > $1bn Market Combined1,2,3 For personal use only US aGVHD US End-Stage HF EU aGVHD aGVHD High-Risk Pediatric Launch Launch Pediatric Launch Adult Launch Near-Term Mid-Term Long-Term Build targeted highly Right size ex
Slide 24: Remestemcel-L: US Launch Strategy to Maximize Patient Access
Remestemcel-L: US Launch Strategy to Maximize Patient Access with Limited Investment For personal use only Pre-Launch Activities Engage with key payers pre-launch to solidify market access and pricing strategy; support with appropriate health care economic information Pricing and Reimbursement d
Slide 25: Results from Providers/Payers Qualitative US Market Research
Results from Providers/Payers Qualitative US Market Research1 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 100 Survival rate Day 28 overall response rate “Remestemcel-L is
Slide 26: Revascor: Adjunct Therapy to LVAD Commercial Strategy
Revascor: Adjunct Therapy to LVAD Indication Commercial Strategy will Leverage Commercial Infrastructure For personal use only Pre-Launch Activities Engage with key payers pre-launch to develop and solidify market access and pricing strategy Pricing and Reimbursement driven by cost savings from
Slide 27: Questions?
For personal use only Questions? | 27 | 27