Nexstim Plc · OMXHEX:NXTMH
Nexstim — Corporate Update (September 2015)
33 slides from Nexstim's corporate update, Sep 28, 2015
Slide 1: Targeting a paradigm shift in stroke rehabilitation
Targeting a paradigm shift in stroke rehabilitation Janne Huhtala | CEO | Nexstim Mikko Karvinen | CFO | Nexstim Interim Analysis Conference Call, 28 September 2015 @NexstimOyj
Slide 2: Important information
Important information This document and the information contained herein are being presented by Nexstim Oyj Certain of the information contained herein concerning industry and market data, economic (“Nexstim” or the “Company”). In connection with any presentation or review of this trends, market pos
Slide 3: Introduction to Nexstim
Introduction to Nexstim Pioneered Use of Navigated Brain Stimulation Technology for Stroke Rehabilitation Therapy Ongoing CE mark & pivotal Phase Significant FDA III study in unmet need clearance for stroke in post acute e-field based rehabilitation stroke navigation rehabilitation Targeted growth i
Slide 4: Company Overview
Company Overview Navigated Brain Therapy (NBT) Navigated Brain Stimulation(NBS) Uses validated navigation technology for post-acute Validates the navigation technology in demanding stroke rehabilitation diagnostic indication ● Navigation is achieved by visualizing the electric field ● Only CE marked
Slide 5: Overview of Key Personnel
Overview of Key Personnel Management Board of Directors Janne Huhtala Olli Riikkala CEO Chairman (Independent) Henri Hannula Juha Vapaavuori VP, Sales Europe Sitra John Hardin VP, Global PSM Commercialisation Dr Johan Christenson HealthCap Rainer Harjunpää VP, Quality Assur. and Regulatory Affairs,
Slide 6: Company Highlights
Company Highlights ● Stroke Rehabilitation Phase II Data published in International Stroke Conference ● Successful listing of the company’s shares to Nasdaq First North Finland and Nasdaq First North Sweden raising new equity of EUR 15.3 million in November 2014 ● Pivotal Phase III multi-centre tria
Slide 7: Stroke Therapy
Stroke Therapy Huge unmet need and commercial opportunity 7
Slide 8: Targeting a paradigm shift in stroke rehabilitation
Targeting a paradigm shift in stroke rehabilitation Nexstim’s Nexstim’sNavigated NavigatedBrain BrainTherapy® Therapy®solution (NBT) Targeting Targetingaablockbuster blockbustermarket… market for stroke solution rehabilitation for stroke rehabilitation (market for post-acute stroke treatment) 2.1 mi
Slide 9: Positioned within Stroke Care Path
Positioned within Stroke Care Path Days 0-10 Days 10-90 3-12 months from stroke 12 months onwards Acute Stabilization and Post-acute rehab, Broken care path care spontaneous recovery chronic patients NBT® Acute care to Early rehab and normal healing Currently, patients are discharged from Annual reh
Slide 10: NBT for stroke rehabilitation – How it works
NBT® for stroke rehabilitation – How it works Validated e-Field Navigation gives Competitive Edge Using a patient’s own MRI scan as a guide, Nexstim Because the injured side is no longer dominated by provides precisely targeted, personalized, the healthy side of the brain, it is more responsive magn
Slide 11: Nexstim's unique technology provides distinct benefits
Nexstim’s unique technology provides distinct benefits Integration of TMS and navigation Several distinct benefits Enhanced limb move ● TMS-navigation integration ● Improved accuracy ● Substantially improved hand ● Navigation is the key differentiator ● Dosing precision movement after treatment ● Re
Slide 12: Highlights in Stroke Rehabilitation (NBT)
Highlights in Stroke Rehabilitation (NBT®) – 2.1m strokes each year in the US and Europe Huge unmet need – Stroke is the leading cause of long-term disability in Western world – While current standard treatment of physical/occupational therapy is not very Few effective alternatives effective, $8.5bn
Slide 13: Current Development Status and Outlook
Current Development Status and Outlook Progressing as planned with milestones 13
Slide 14: Efficacy demonstrated in Phase II trial
Efficacy demonstrated in Phase II trial The Phase II clinical trial in brief: ● Single centre at Rehabilitation Institute of Chicago (#1 rehabilitation hospital in US for 25 consecutive years) ● 29 patients of which 19 (10) in treatment (sham) group ● End-point = 6 months post-treatment Change in up
Slide 15: Lead Investigator Profile
Lead Investigator Profile Dr. Richard L. Harvey, PI for Contrastim & Niche trials ● Medical Director, Center for Stroke Rehabilitation, Rehabilitation Institute of Chicago (RIC) ● Wesley and Suzanne Dixon Stroke Chair, RIC ● Director, Stroke Program, RIC Biography ● Principal Investigator, Contrasti
Slide 16: Phase III trials - Laying the groundwork for commercialisation
Phase III trials - Laying the groundwork for commercialisation Study in brief Study goals Conducted at 12 top US rehab sites ● Establish clinical efficacy ● Document Rehabilitation Institute of Chicago (central site) of NBT® in upper-limb effects/efficacy of TIRR Memorial Hermann Hospital (Houston)
Slide 17: Status of Clinical Development
Status of Clinical Development Progressing as Planned ● The clinical Phase III multi-center trial is progressing and enrolling according to plans. ● First interim data analysis by an independent Data Safety Monitoring Board shows that safety criteria are met and trial now further de-risked to contin
Slide 18: Overview of Interim Phase III Results
Overview of Interim Phase III Results ● Interim data analysis by an independent Data Safety Monitoring Board shows that safety criteria are met ● Trial now further de-risked and to continue without any modifications towards the primary endpoint of demonstrating a clinically important functional impr
Slide 19: IP position
IP position 67 granted patents 71 pending patents Right to software: Nexstim owns rights to its NBT® and NBS Systems’ software developed in- house. Creating hurdles for competitors: e.g. by seeking patent protection on different parts of the products and making it more difficult for potential compet
Slide 20: IPR Strategy
IPR Strategy 3-level approach to protect our proprietary E- Integration, field navigation Algorithms, E- ● The Core is the algorithms and integration to Field allow precise E-field based navigation with Validation user friendly visualization ● Next level is the IPR portfolio ● And the outer rim is t
Slide 21: Regulatory Interaction
Regulatory Interaction Nexstim is proceeding with De Novo 510(k) –process according to original plans ● Phase II interim data was initially presented to FDA with Phase III protocol to get feedback ● FDA responded that NBT device and use of the device in patients with stroke according to the NICHE tr
Slide 22: Commercialisation Strategy Overview
Commercialisation Strategy Overview Initial Demand Early adoption ● Physicians determining the patient’s ● Providers to adopt based on the treatment OR Patients themselves initial demand ● Clinical efficacy evidence drives ● Clinical results in care path needed initial entry to support the benefits
Slide 23: Key Stakeholders & Messaging
Key Stakeholders & Messaging Nexstim positioned for Stroke Stakeholders with targeted messaging ● Outpatient treatment Facilities offer Occupational Therapy for post-acute stroke patients ● Clear Entry Point targeted patient group with upper limb rehabilitation ● Physicians (PM&R) are key decision m
Slide 24: Financials
a Sa Zz yi Financials Car @) Mexstim \ © 24
Slide 25: Key Performance Indicators
Key Performance Indicators EUR in thousands H1 2015 H1 2014 FY 2014 6 months 6 months 12 months Net sales 643.2 413.9 2,210.4 Personnel expenses -1,906.1 -1,641.9 -3,660.2 Depreciation and amortisation -168.7 -125.3 -377.4 Includes 1,745.4 Other operating expenses -3,422.9 -1,672.3 -5,498.5 of Phase
Slide 26: Summary and Future Outlook
Summary and Future Outlook Targeting a Paradigm Shift in Stroke Rehabilitation ● World-leading medical technology and software with game changing potential in stroke rehabilitation ● Good progress since IPO ● NBT® Phase III study proceeding well with next interim data due in Q1 2016 ● Based on its b
Slide 27: Appendix
Appendix Management and owners 27
Slide 28: Management team
Management and owners Management team Name Current position Education Relevant experience Nationality (Nexstim since) Janne Huhtala CEO Master in economics at Turku School of CFO 2008-2013. Previously manager at Finland 2008 Economics (2001) financial consultant firm Gutta Various roles at Nexstim s
Slide 29: The Board
Management and owners The Board Name Education Relevant experience Nationality Currently board member of several Finnish medical MSc Helsinki U. of Technology (1974), MSc Olli Riikkala, Chairman 2007 industry firms. He has served 26 consecutive years in Helsinki School of Economics (1976), MBA Finla
Slide 30: Value-adding owners with commercial and medtech industry expertise
Management and owners Value-adding owners with commercial and medtech industry expertise, possessing indispensable networks Initial IPO Owner investm. lock-up Brief description – Among largest specialized VCs in life sciences in Europe 2007 1 yr – Raised €900m+ since inception in 1996 – The Finnish
Slide 31: Details of completed single-centre Phase II clinical trial
Details of completed single-centre Phase II clinical trial Contrastim stroke study details Upper extremity Fugl-Meyer Results discussion 84% of NBT group above threshold ● At 6 months post treatment 84% of the active group showed improvement above the minimum clinically important difference of 5 Fug
Slide 32: Overview of Competitive Landscape
Overview of Competitive Landscape Device Efficacy* Comment* Nexstim NBT System Multi-centre clinical trial structure in place with 12 US Promising Phase II results published in sites (Phase III trials). February 2014. Non-navigated rTMS Repetitive transcranial magnetic stimulation given Difficult to
Slide 33: Thank you
Targeting a paradigm shift in stroke rehabilitation Thank you @NexstimOyj