Spectral Medical Inc · TSX:EDT
Spectral Medical — Investor Presentation (July 2016)
18 slides from Spectral Medical's investor presentation, Jul 11, 2016
Slide 1: Advancing a Novel Treatment for Septic Shock
ADVANCING A NOVEL TREATMENT FOR SEPTIC SHOCK Investor Update 11 July 2016 1
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements contained in this presentation constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to our future outlook and anticipated events or results and may include statements regarding our future fi
Slide 3: Sepsis: A Significant Unmet Medical Need
Sepsis: A Significant Unmet Medical Need Common: >30% of ICU admissions Over 1M patients/annum are diagnosed with sepsis in the U.S. Current cost of managing sepsis at ~$20B/annum in the U.S. Sepsis is a global problem with no targeted treatments available Extremely fatal with ~300K deaths/annum in
Slide 4: Our Focus is Endotoxin
Our Focus is Endotoxin Endotoxin is a component of all Gram negative bacteria. Endotoxin is released from replicating or dying Gram negative bacteria. Endotoxin in the blood stream initiates the inflammatory cascade of sepsis 4 4
Slide 5: Spectral Targets Septic Shock due to Endotoxemia
Spectral Targets Septic Shock due to Endotoxemia (>50% of all septic shock patients) Endotoxemia Endotoxin shed from local bacterial infection Endotoxin translocation from GI Tract Every human has 25-30 grams of Endotoxin in their GI tract Less than 0.001 grams of Endotoxin is enough to kill a p
Slide 6: Treatment Guided by a Diagnostic
Treatment Guided by a Diagnostic Endotoxin Activity Assay (EAA™) – FDA cleared in 2003 Remove endotoxin Measure Resolve endotoxin levels Increase survival rate Toraymyxin™ – (PMX) • A device that removes endotoxin • Approved outside of North America • >150,000 patients treated 6 6
Slide 7: Ex-North America Evidence shows PMX Works
EX-North America Evidence shows PMX Works • EUPHAS Study in Italy (2009) showed a reduction in mortality of 64 patients from 53% to 32% • EUPHAS 2 registry of over 400 treated patients showed same survival rate as the EUPHAS study • Analysis of over 2,000 patients in Japan (2014) showed a reduction
Slide 8: Our Trial – EUPHRATES
Our Trial – EUPHRATES Septic Shock EAA™ > + 0.60 Vasopressor EUPHRATES April 2014 Protocol Amendment Organ Dysfunction MODS >9 8 8
Slide 9: EUPHRATES Trial
EUPHRATES Trial • Patients meeting all clinical criteria for septic shock 914 • Patients Randomized (EAA>0.60) 446 270 176 April ‘14 • All MODS >9 ~311* 15% Absolute Mortality Reduction • MODS >9 (Post April 2014) 176 20% Absolute Mortality Reduction * (50% x 270) + 176 = 311 9 9
Slide 10: How Are We Tracking?
How Are We Tracking? • Sample size of 176 based on estimated 60% placebo and 40% treated mortality • Placebo (untreated) mortality (EAA>0.60/Not Randomized) is 60%+ • Composite mortality of all randomized patients is 46% • Treated + Untreated = Composite 2 • Suggests we are within successful range 1
Slide 11: U.S. Market Opportunity
U.S. Market Opportunity 300K Toraymyxin cartridges HIGH High EAA EAA™ 750K EAA™ diagnostic tests LEVELS levels 150K 125, 000 patients/year patients/year $3 Billion Opportunity Severe sepsis SEVERE SEPSIS AND SEPTIC SHOCK and septic shock 350K patients/year 250, 000 patients/year SEPSIS 1M Seps
Slide 12: EAA/PMX Annual Revenue & EBITDA Potential
EAA™/PMX Annual Revenue & EBITDA Potential Base Case - Revenue/Patient of US$20K 25% Market Penetration Revenue/Patient: $20K Total Revenues: $0.75B Gross Margin @ 80% $0.6B EBITDA @ 50% (net of royalties) $0.4B 50% Market Penetration Revenue/Patient: $20K Total Revenues: $1.5B Gross Margin @ 80% $1
Slide 13: Market Exclusivity
Market Exclusivity • Intellectual Property o Patent protection for EAA expires 2022 o Patent protection for PMX expires 2019 o Patent Term Protection for up to 5 years can be added • Regulatory o 6 year rules prevents dissemination of important knowledge to competitors o PMA approval demands a simil
Slide 14: Path To Commercialization
Path To Commercialization H1 2017 FDA Approval Q3 2016 Top Line Results June 2016 Partnership/ Enrolment Completion Go Alone? (42 Hospitals/$60M Expanded Access Program Revenue Potential) 14
Slide 15: Manufacturing Scale Up and Supply
Manufacturing Scale Up and Supply EAA Manufacturing Spectral has a clear plan for scale up of manufacturing,• supply chain andautomation Manufacturing • Sourcing of raw logistic capabilities materials • Process optimization • Automation and personnel • Vendor management Supply Chain • Supply agreeme
Slide 16: Stand Alone Pump
Stand Alone Pump • A blood pump is needed to run PMX • Dialysis or CRRT machines are currently available and being used in our trial • A proprietary blood pump optimized for running PMX could help with faster adoption of therapy 23 16 16
Slide 17: Potential Partnership Opportunities
Potential Partnership Opportunities • Interest is increasing • Advisors engaged • Data room ready • Will evaluate all options based on what is best for shareholders 17 17
Slide 18: Milestones
Milestones The Final Steps to Commercialization Q2 - Trial enrolment complete - Expanded Access Program approved Q3 - 510K and Health Canada approval of Stand Alone Pump - Launch of Expanded Access Program - Primary end point data available (Sept 30) COMMERCIALIZATION 2016 2017 Q4 - Pre-submission m