Mesoblast Limited · ASX:MSB
Mesoblast — Q1 FY2020 Earnings Presentation
33 slides from Mesoblast's earnings presentation, Nov 27, 2019
Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
Nasdaq: MESO ASX: MSB Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases First Quarter Ended September 30, 2019 Exhibit 99.2
Slide 2: Cautionary Note Regarding Forward-Looking Statements
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, levels of activity, perf
Slide 3: Our Mission
Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses |
Slide 4: Corporate History
2004: Mesoblast founded in Melbourne, Australia and listed on the ASX 2014: Granted manufacturing pioneer status by Economic Development Board of Singapore 2013: Acquired MSC business from Osiris Therapeutics with future earn-outs 2011: Entered into manufacturing partnership with Lonza Group in Sing
Slide 5: Premier Global Cellular Medicines Company
Premier Global Cellular Medicines Company Commercialization Innovative Technology Platform1 Innovative technology targets some of the most severe disease states refractory to conventional therapies Well characterized multimodal mechanisms of action Underpinned by extensive, global IP estate Mesenchy
Slide 6: Commercial Scale Manufacturing Capability
Commercial Scale Manufacturing Capability 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 batch-to-batch consistency and r
Slide 7: Global IP Estate Provides Substantial Competitive Advantage
Markets U.S., Europe, China, and Japan Diseases All Tier 1 & Tier 2 Indications, and multiple additional conditions Sources Allogeneic, Autologous, (Bone Marrow, Adipose, Dental Pulp, Placenta), Pluripotent (iPS) ~1,000 patents and patent applications (68 patent families) across all major jurisdicti
Slide 8: Commercial and Late-Stage Product Pipeline
IN DEVELOPMENT PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MSC (Bone Marrow) TEMCELL® HS Inj1 Acute Graft Versus Host Disease Japan MSC (Adipose) Alofisel®2 Perianal Fistula Global MARKETED Commercial and Late-Stage Product Pipeline This chart is figurative and does not purport to s
Slide 9: Strategic Partnerships and Licensees
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 for Europe and Latin America Mesoblast will receive up to US$1
Slide 10: Financials First Quarter FY2020
Financials First Quarter FY2020
Slide 11: Substantial Increase in Revenues
| 11 Substantial Increase in Revenues | For the quarter ending (US$m) September 30, 2019 September 30, 2018 September 30, 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 revenue 17.0 11.6 1.2 Strategic partnerships drive upfront a
Slide 12: Loss After Tax Reduced by 72%
Loss after tax reduced by US$14.0 million (72%) predominantly due to: US$6.1 million reduction in R&D expenditure; and US$5.4 million increase in milestone revenues from strategic partnerships and increased commercialization revenues from product sales in Japan. Loss After Tax Reduced by 72% (US$14.
Slide 13: Strong Balance Sheet and 20% Reduction in Operating Net Cash Outflows
| ` Strong Balance Sheet and 20% Reduction in Operating Net Cash Outflows As of (US$m) September 30, 2019 June 30, 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 strategic partnership with
Slide 14: Operational Highlights First Quarter FY2020
Operational Highlights First Quarter FY2020
Slide 15: Acute Graft Versus Host Disease Market Opportunity
Minimal Treatment Options Market Opportunity Burden of Illness aGVHD is a life-threatening complication that occurs in ~50% of patients receiving allogeneic bone marrow transplants (BMTs)1 Steroid-refractory aGVHD is associated with mortality rates as high as 90%1,7 and significant extended hospital
Slide 16: Remestemcel-L: U.S. Regulatory and Commercial Strategy
Remestemcel-L: U.S. Regulatory and Commercial Strategy 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 product launch Ramp-up for inve
Slide 17: SR-aGVHD Burden of Illness in Children in the U.S.
Average Additional Hospitalization LOS: 28 days Average Additional Outpatient Visits: 30 Average Additional Prescription Fills: 7 Average Additional All-Cause Cost: ~US$500k Pediatric SR aGVHD vs. No GVHD Remestemcel-L: SR-aGVHD is Associated with Significant Burden of Illness in Children in the U.S
Slide 18: Remestemcel-L: Provider and Payer Research on Product Attributes
0 7 6 Reaction to Tested Target Profile2 Max Rating Product Attributes Data on file. ZS Associates June 2018 Qualitative Market Research: MCO Medical Directors n=5, Transplant Center Directors n= 5, Hospital Pharmacy Directors n=5, AMC-based Hem/Oncs / KOLs n=3 Most Significant Value Drivers for Rem
Slide 19: Remestemcel-L: Life Cycle Strategy
Remestemcel-L: Life Cycle Strategy Mesoblast has over 10 years of experience in hematology-oncology space Remestemcel-L: Positive Phase 3 Results Q12018 Large US Pediatric GVHD Expanded Access Program (>240 patients) October 2013 Mesoblast acquires MSC-100-IV from Osiris Therapeutics Product develop
Slide 20: Remestemcel-L for Acute GVHD Recent Highlights
Remestemcel-L for Acute GVHD 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 remestemcel-L in aGVHD US add
Slide 21: Heart Failure Treatment Pathway and Mesoblast Target Market
Source: Simon-Kucher & Partners 2017. Primary research 2017; Payers n=35, KOLs n=15,Cath lab managers n=4. Corlanor® (ivabradine) approved by FDA (April 2015). ENTRESTO® (sacubitril/valsartan) approved by FDA (July 2015). GlobalData-PharmaPoint Heart Failure (2016); McMurray et al., 2012;Yancy et al
Slide 22: Advanced Heart Failure Market Opportunity
Market Opportunity Burden of Illness Limited Options / Unmet Need ~ 8 million patients with chronic heart failure by 2030 in US alone1 17-45% globally die within 1 year of hospital admission1 Majority of advanced heart failure patients die within 5 years1 Despite recent advances in newly approved dr
Slide 23: Revascor Phase 3 Trial Fully Enrolled
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 February 2019 Primary endpoint: reduction in recurrent heart failure-related major adver
Slide 24: Revascor for Advanced Heart Failure Key Milestones
Revascor for Advanced Heart Failure 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 support regulatory approval in
Slide 25: End-Stage Heart Failure in LVAD Patients Market Opportunity
Market Opportunity Burden of Illness In the US there are ~ 250,000–300,000 patients annually who suffer from advanced systolic heart failure (NYHA Class III–IV)1 Despite optimal medical therapy, mortality exceeds 50% in class IV patients1 LVADs have improved survival, but morbidity remains high with
Slide 26: Revascor Reduced GI Bleeding Events in Two Randomized Trials
Rate of major GI bleeding events over six months in LVAD patients reduced by 70% and 76% with MPCs in two randomized controlled trials 1.Mesoblast internal data post-hoc analysis 2017 (clinicaltrials.gov; identifier: NCT01442129). 2. Presented at American Heart Association Scientific Sessions 2018.
Slide 27: Revascor in LVAD Patients Recent Highlights
Revascor for End-Stage Heart Failure in LVAD Patients 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 trial of Revascor In line
Slide 28: MPC-06-ID: A New Paradigm for Chronic Low Back Pain
MPC-06-ID: A New Paradigm for Treatment of Chronic Low Back Pain Due to Degenerative Disc Disease | Minimal Treatment Options Market Opportunity Burden of Illness Unmet Need Back pain causes more disability than any other condition1 Inflicts substantial direct and indirect costs on the healthcare sy
Slide 29: MPC-06-ID Development Strategy for US & Europe
MPC-06-ID – Development Strategy for US & Europe 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 commercial manufacturing in par
Slide 30: Key Terms of the Strategic Partnership with Grünenthal
Key Terms of the Strategic Partnership with Grünenthal 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 receive Up to US$150 mil
Slide 31: Transaction Benefits to Mesoblast
Transaction Benefits to Mesoblast Strong commercial partner 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 (physicians, pharmacists & heal
Slide 32: MPC-06-ID for Chronic Low Back Pain Key Milestones
MPC-06-ID for Chronic Low Back Pain 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 clearance in CY20 from Europea
Slide 33: Questions
Questions