Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2012)
32 slides from Mesoblast's shareholder meeting presentation, Nov 29, 2012
Slide 1: Consolidating Our Future - Chairman's Address
For personal use only CONSOLIDATING OUR FUTURE Address by Mesoblast Chairman Brian Jamieson 2012 Annual General Meeting On behalf of the Board of Directors, I am very pleased to welcome you to the 2012 Annual General Meeting of Mesoblast Limited. At Mesoblast we are proud of the Company’s continued
Slide 2: Chairman's address continued
For personal use only The mix of skills and international expertise of Mesoblast’s Board of Directors was boosted this year with the appointment of Dr Ben-Zion Wiener as Teva’s representative. Dr Weiner’s extensive pharmaceutical industry experience and many successful regulatory approvals in his va
Slide 3: CEO presentation - Annual General Meeting
For personal use only CEO presentation Annual General Meeting Melbourne, 29 November 2012
Slide 4: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation, including any comments made during or following the presentation, may contain forward-looking statements that are inherently subject to risks and uncertainties, some of which cannot be predicted or quantifi
Slide 5: Corporate overview
For personal use only Corporate overview
Slide 6: Shareholder value and ownership
Shareholder value and ownership For personal use only Market valuation Issued shares 287 million Current share price* $5.74 Market capitalization (approx) $1,647 million Shareholder ownership 19% Institutions/sophisticatediInvestors 26% Retail investors Management Strategic Investors 10% 45% * 28 No
Slide 7: Cash and development spend
Cash and development spend For personal use only Cash 30 September 2012 = $190 million Cash spend for FY 2012 $ million Clinical programs 19.9 • Clinical trials 10.0 • Cell production 9.9 Research & development 13.0 • Manufacturing processes 7.7 • Research & translational programs 5.3 People (labour
Slide 8: Our people - the most valuable asset
Our people … the most valuable asset For personal use only 69 50 Growth 163% 29 US 19 19 Growth 90% Australia 10 30-Jun-2011 30-Jun-2012 5
Slide 9: Major accomplishments - highlights of 2012
Major accomplishments – highlights of 2012 For personal use only 1. Clinical and preclinical development of intravenous product formulation for a wide range of systemic diseases • generated positive preclinical results in primate model of type 2 diabetes • commenced Phase 2 trial for type 2 diabetes
Slide 10: Major accomplishments - highlights of 2012
Major accomplishments – highlights of 2012 For personal use only 3. Completed Phase 2 trial in congestive heart failure (CHF), identifying an MPC dose which prevented any hospitalization or death for a mean follow-up period approaching three years 4. Held positive meetings, together with Teva, with
Slide 11: Corporate partnerships - Teva alliance
Corporate partnerships manage execution risk – Teva alliance For personal use only Partnership focus on neurologic, cardiovascular diseases Lead product for congestive heart failure – number 1 cause of hospitalization in industrialized world Provides Phase 3 clinical and regulatory expertise
Slide 12: Corporate partnerships - Lonza alliance
Corporate partnerships manage execution risk – Lonza alliance For personal use only Lonza partnership provides global process development and manufacturing capability Exclusive access to state-of-the-art Lonza Singapore facility for allogeneic cell manufacture New Singapore site will support c
Slide 13: Mesenchymal Precursor Cell (MPC) technology
For personal use only Mesenchymal Precursor Cell (MPC) technology
Slide 14: Our proprietary MPC technology platform
Our proprietary MPC technology platform For personal use only 1. Patented adult stem cell technology platform for Stro-1/Stro-3 cells 2. Highly purified populations of earliest precursors of mesenchymal lineage cells present in multiple tissue sites, e.g. bone marrow, adipose, dental pulp 3. Scienti
Slide 15: Leveraging our proprietary MPC technology platform
Leveraging our proprietary MPC technology platform For personal use only Products specifically target major medical conditions where proprietary technology offers unique scientific and clinical advantages Multiple products developed in parallel to increase probability of success Strong cash po
Slide 16: MPC technology platform delivers product diversity
MPC technology platform delivers product diversity For personal use only 1. Products in partnership with Teva, primarily in cardiovascular and neurological diseases 2. Products for intravenous delivery in type 2 diabetes and its complications including kidney disease 3. Products delivered intravenou
Slide 17: Product manufacturing
For personal use only Product manufacturing
Slide 18: Product manufacturing strategy
Product manufacturing strategy For personal use only Our objectives are to ensure: Regulatory compliance with best practice Product delineation supporting partnering/reimbursement New product development Commercial scale-up Capacity for commercial product supply Reduced COGS 15
Slide 19: Regulatory compliance with best manufacturing practice
Regulatory compliance with best manufacturing practice For personal use only Agreement reached with United States Food and Drug Administration (FDA) for supply of MPCs in Phase 3 clinical trials and on a clear pathway for commercial manufacturing supply The FDA agreed: That Mesoblast’s extensive c
Slide 20: Control of manufacturing ensures product delineation
Control of manufacturing ensures product delineation For personal use only Mesoblast can delineate products to support and separate partner markets, optimize reimbursement strategies, and manage product lifecycles. Innovative R&D delivers product delineation through: Changes in formulation or dosa
Slide 21: Product pipeline
18 For personal use only Product pipeline
Slide 22: Platform delivers multi-product pipeline
Platform delivers multi-product pipeline For personal use only 19
Slide 23: Products for intravenous administration
Products for intravenous administration For personal use only Intravenous products to treat prevalent systemic disorders affecting the metabolic, inflammatory and immune systems type 2 early diabetes kidney failure and cardiovascular complications liver fibrosis Inflammatory/immune mediated di
Slide 24: Integrated metabolic mechanisms of action of MPCs
Integrated metabolic mechanisms of action of MPCs For personal use only 21
Slide 25: Intravenous delivery - Type 2 diabetes
Intravenous delivery – Type 2 diabetes For personal use only Randomized, placebo-controlled Phase 2 trial in 60 patients with type 2 diabetes actively recruiting under FDA guidance Patients evaluated over 12 weeks for blood glucose control and inflammatory markers such as C-reactive protein (C-R
Slide 26: Intravenous delivery - renal complications of diabetes
Intravenous delivery – renal complications of diabetes For personal use only Plan to evaluate whether single dose of MPCs can stabilize or reverse end-stage kidney disease Nearly 10% annual rate of cardiovascular disease and death in diabetic patients with end-stage kidney disease Non-human pr
Slide 27: Intravenous delivery - immune-mediated diseases
Intravenous delivery – immune-mediated diseases For personal use only Preclinical data indicate MPCs have immunomodulatory properties Single intravenous injection may provide sustained benefits for immune- mediated diseases Mechanism of action (MOA) may be unique, shutting down multiple cytoki
Slide 28: Products for local administration - cardiovascular
Products for local administration – cardiovascular For personal use only With Teva, developing therapies for cardiovascular diseases including congestive heart failure (CHF) and acute myocardial infarction (AMI) Phase 2 trial for CHF showed patients treated with single intra-cardiac injection of h
Slide 29: Products for local administration - spine disease
Products for local administration – spine disease For personal use only Diseases of the spine represent largest growing market segment in orthopedics Spinal fusion product for patients with advanced disc degeneration who need surgery ̶ Phase 2 spinal fusion trials completed enrollment ̶ 12-month f
Slide 30: Other products - eye diseases and bone marrow transplantation
Other products – eye diseases and bone marrow transplantation For personal use only Developing stem cell therapeutic product for treating various vascular and inflammatory diseases of the eye including wet and dry age-related macular degeneration (AMD) Wet and dry AMD are the major causes of blind
Slide 31: The year ahead, what we expect
The year ahead, what we expect: For personal use only Commencement of Phase 3 trial for congestive heart failure involving an early interim analysis to evaluate evidence of efficacy Clinical results in Phase 2 trials with early type 2 diabetes, spinal fusion and intervertebral disc repair Ongo
Slide 32: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies