Mesoblast Limited · ASX:MSB

Mesoblast — Q3 FY2016 Earnings Presentation

24 slides from Mesoblast's earnings presentation, May 10, 2016

  1. Slide 1: Financial Results for the Nine Months and Third Quarter Ended 31 March 2016

    For personal use only Financial Results for the Nine Months And Third Quarter Ended 31 March 2016 May 2016

  2. Slide 2: Cautionary Note Regarding Forward-Looking Statements

    For personal use only CAUTIONARY NOTE REGARDING FORWARD-­‐LOOKING STATEMENTS This presenta,on includes forward-­‐looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertain,es and other factors that may cause our actual results, l

  3. Slide 3: Agenda

    Agenda For personal use only FINANCIAL RESULTS OVERVIEW REVIEW OF OPERATIONS TIMELINES 3

  4. Slide 4: Agenda: Financial Results Overview

    Agenda For personal use only FINANCIAL RESULTS OVERVIEW 4

  5. Slide 5: Financial Highlights for the Nine Months Ended March 2016

    Financial Highlights for the Nine Months Ended 31 March 2016 US$m For personal use only • Cash on hand at 31 March 2016 -­‐ US$100 million • Cash ouIlows for Q3FY2016 were US$22 million. Total cash ouIlows of the second and third quarters of 2016 were US$42 million, a reducRon of 25% in comparison t

  6. Slide 6: Profit and Loss - Expenditure Reduced Over Prior Period

    Profit and Loss -­‐ Expenditure Reduced Over Prior Period US$m For personal use only 9 months 9 months ending ending $ Change % 31 Mar 2016 31 Mar 2015 Revenue 15.7 15.6 0.1 1% Loss Before Income Tax (56.6) (65.7) 9.1 14% Revenue increased by 1% ($0.1) vs comparaZve period in FY15: • Milestone revenu

  7. Slide 7: Cash Management

    Cash Management US$m For personal use only Q3 Q2 Q1 Q4 FY2016 FY2016 FY2016 FY2015 3 months 3 months 3 months 3 months ended ended ended ended 31 Mar 2016 31 Dec 2015 30 Sep 2015 30 Jun 2015 Net Cash Oualows in OperaZng AcZviZes (22.0) (19.8) (28.1) (27.3) Cash at the end of the period 99.9 120.8 77

  8. Slide 8: Agenda: Review of Operations

    Agenda For personal use only REVIEW OF OPERATIONS 8

  9. Slide 9: Product Candidates in Major Markets with High Unmet Need

    Product Candidates in Major Markets with High Unmet Need For personal use only First Product on market -­‐ Three Tier 1 Product Candidates in Phase 3 Programs P R O D U C T C A N D I D AT E S PROGRAMS PRECLINICAL PHASE 2 PHASE 3 A P P R O VA L TIER 1 TEMCELL HS INJ. Acute GVHD (Japan) MSC-100-IV Acu

  10. Slide 10: Operational Highlights for the Nine Months Ended March

    OperaRonal Highlights for the Nine Months Ended 31 March 2016 For personal use only • MPC-­‐150-­‐IM for Advanced Heart Failure: Phase 3 trial was significantly reduced from 1,165 to 600 subjects following meeRng between Teva PharmaceuRcal Industries Ltd (Teva) and the FDA. The trial is recruiRng wel

  11. Slide 11: Operational Highlights for the Nine Months Ended March

    OperaRonal Highlights for the Nine Months Ended 31 March 2016 For personal use only • TEMCELL: Mesoblast’s licensee in Japan, JCR PharmaceuRcals Co. Ltd., launched the first allogeneic regeneraRve medicine in Japan, TEMCELL for steroid-­‐refractory acute Graj Versus Host Disease (aGVHD) in children a

  12. Slide 12: Results Highlighted in Public Presentations and Peer Reviewed Articles

    Results Highlighted in Public PresentaRons and Peer Reviewed ArRcles For personal use only • MPC-­‐150-­‐IM and MPC-­‐300-­‐IV: Phase 2 trial results in CHF and Type 2 Diabetes published in leading peer reviewed journals, Circula,on Research and Diabetes Care, respecRvely. • Technology developed at

  13. Slide 13: MPC-150-IM: Chronic Heart Failure - Market Opportunity

    MPC-­‐150-­‐IM: Chronic Heart Failure (CHF) – Market Opportunity For personal use only MPC-­‐150-­‐IM is in development for pa@ents with New York Heart Associa@on Class II-­‐IV CHF § 5.7m paRents (2% of the populaRon) diagnosed with CHF in the US1 § 915,000 new cases diagnosed in the US each year1

  14. Slide 14: MPC-150-IM: Phase 2 Results Show Promise in Prevention of HF-MACE

    MPC-­‐150-­‐IM: Phase 2 Results Show Promise in the PrevenRon of HF-­‐MACE* For personal use only HF-­‐MACE Kaplan-­‐Meier Curve over 36 months HF-­‐MACE Kaplan-­‐Meier Curve over 36 months following treatment in all paZents following treatment in paZents with LVESV>100ml § Over 36 months, paRents

  15. Slide 15: MPC-150-IM: Phase 3 Trial Targets Advanced Heart Failure

    MPC-­‐150-­‐IM: Phase 3 Trial Targets Advanced Heart Failure Where Medical Need Is Greatest For personal use only • PaRents with large baseline LVESV and advanced heart failure are at highest risk of HF-­‐MACE • For these paRents exisRng therapies are inadequate and economic burden is greatest • To

  16. Slide 16: MPC-150-IM: Phase 3 Trial Operational Update

    MPC-­‐150-­‐IM: Phase 3 Trial OperaRonal Update For personal use only • Phase 3 trial for 600 total paRents with advanced heart failure is recruiRng well across North American sites • The trial’s primary endpoint is a comparison of recurrent HF-­‐MACE between MPC treated paRents and controls • Durin

  17. Slide 17: MPC-150-IM: DMC Recommendation and Upcoming Clinical Milestones

    MPC-­‐150-­‐IM: RecommendaRon Of The Data Monitoring Commilee (DMC) and Upcoming Clinical Milestones For personal use only • The trial’s DMC convened on April 4th 2016 to review the safety of the trial based on clinical data from the first 175 paRents • Ajer reviewing the data, the DMC recommended th

  18. Slide 18: MPC-06-ID: Chronic Low Back Pain - Market Opportunity

    MPC-­‐06-­‐ID: Chronic Low Back Pain Due to Disc DegeneraRon (CLBP) – Market Opportunity For personal use only MPC-­‐06-­‐ID is in development for the treatment of CLBP las@ng >6 months as a result of moderate degenera@ve disc disease § Prevalent CLBP populaRon to grow to 21.9m paRents in the U.S.

  19. Slide 19: MPC-06-ID: Composite Endpoint For Pain and Function Over 24 Months - Phase 2 Data

    MPC-­‐06-­‐ID: Composite Endpoint For Both Pain and FuncRon Over 24 Months – Phase 2 Data For personal use only % PaZents with treatment success % PaZents with treatment success at 6 & 12 months at 12 & 24 months 50.0% 50.0% 44.4%a,b 45.0% 45.0% 40.0% 37.9%c 40.0% 37.0%d 35.0% 35.0% 32.1% % Responde

  20. Slide 20: MPC-06-ID: Phase 3 Trial Update, Including FDA Guidance

    MPC-­‐06-­‐ID: Phase 3 Trial Update, including Recently Implemented FDA Guidance For personal use only • Current 360 paRent Phase 3 trial conRnues to expand across US sites • FDA has provided wrilen guidance: – Use of a composite primary endpoint is acceptable for approval – Agreed thresholds for pa

  21. Slide 21: Japan: an Important Commercial Opportunity

    Japan: an important Commercial Opportunity For personal use only Japan is the 2nd Largest Established Healthcare Market First Product Launched • Mesoblast licensee, JCR PharmaceuRcals received full approval (non-­‐condiRonal) and launched TEMCELL for treatment of aGVHD in Japan in February 2016; the

  22. Slide 22: MSC-100-IV: Trial in Children With Steroid Refractory Acute GVHD

    MSC-­‐100-­‐IV: Phase 3 Trial In Children With Steroid Refractory Acute Graj Versus Host Disease (SR-­‐aGVHD) For personal use only MSC-­‐100-­‐IV in children with SR-­‐aGVHD who failed MSC-­‐100-­‐IV as first line therapy in children with mulZple other modaliZes1 SR-­‐aGVHD2 82% Open-­‐label Respons

  23. Slide 23: Agenda: Timelines

    Agenda For personal use only TIMELINES 23

  24. Slide 24: Product Candidate Deliverables (Calendar Year)

    Tier 1 Product Candidate Deliverables (Calendar Year) For personal use only 2016 2017 Product Candidate Programs Milestones Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Temcell® HS Inj. Launched in Japan Interim Results MSC-­‐100-­‐IV / Acute Graft Versus Host Temcell® HS Inj. Disease Phase 3 Top Line Results US Approva

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