Stablecoin Development Corporation · AMEX:SDEV
Stablecoin Development — NovaBay Pharmaceuticals — Investor Day (May 2015)
105 slides from Stablecoin Development's investor day presentation, May 19, 2015
Slide 1: Avenova: Going Beyond Antibiotics
AVENOVA Going Beyond Antibiotics
Slide 2: Avenova – Going Beyond Antibiotics: Welcome
AVENOVA – Going Beyond Antibiotics Presented by NovaBay Pharmaceuticals Dr. Ron Najafi Founder, President and CEO Welcome
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the anticipated market acceptance of our p
Slide 4: Agenda – Avenova: Going Beyond Antibiotics
Agenda – Avenova: Going Beyond Antibiotics • Welcome and Company Overview • Dr. Ron Najafi, President & CEO, NovaBay Pharmaceuticals • Ophthalmology and Optometry Panel • Eric Donnenfeld, M.D. (Moderator) • Hank Perry, M.D. • Katherine Mastrota, O.D. • Brian Rosenblatt, O.D. • Ivan Mac, M.D. • Aveno
Slide 5: Eric D. Donnenfeld, M.D.
Eric D. Donnenfeld, M.D. Ophthalmic Consultants of Long Island Clinical Professor of Ophthalmology NYU Trustee Dartmouth Medical School 5
Slide 6: Ivan Mac, MD/MBA
Ivan Mac, MD/MBA Metrolina Eye Associates, PLLC 6
Slide 7: Katherine M. Mastrota, M.S., O.D., F.A.A.O.
Katherine M. Mastrota, M.S., O.D., F.A.A.O. Center Director of Omni Eye Surgery 7
Slide 8: Henry D. Perry, M.D.
Henry D. Perry, M.D. Ophthalmic Consultants of Long Island Chief of the Cornea Service at Nassau University Medical Center 8
Slide 9: Brian D. Rosenblatt, O.D.
Brian D. Rosenblatt, O.D. Rosenblatt Family Eye Care Associates Raritan, New Jersey 9
Slide 10: Strategic Focus on Eye Care
Strategic Focus on Eye Care Aimed at Commercial Growth and Business Success 1. Revenue growth from commercial products • Grow US sales of Avenova • Capitalize on large market opportunity in poorly served markets with FDA-cleared products 2. Innovation • Develop, introduce innovative eye care product
Slide 11: Value Proposition – US Avenova Launch
Value Proposition – US Avenova Launch Addressing Poorly •30 million blepharitis and dry eye patients Served Market •3 million cataract + 2 million refractive surgery patients Commercializing •35 medical reps in major U.S. markets FDA-Cleared •Ramp up to 50 reps = 80% market reach Product •Amerisourc
Slide 12: Financial Results: 1Q15 vs. 1Q14
Financial Results: 1Q15 vs. 1Q14 • Product revenue of $492,000 (Avenova and NeutroPhase) compared with $188,000 and gross profit of $344,000 compared with $58,000 • Increases in product revenue and gross profit due to Avenova commercialization • License, collaboration, distribution and other revenue
Slide 13: Sales Ramping Up ($000)
Sales Ramping Up ($000) Momentum Continues to Build in 2015 • Q1’15 more than doubled over Q4’14 • Q4’14 more than doubled over Q3’14 • Earning pharmaceutical- like margins 13
Slide 14: What is Blepharitis?
What is Blepharitis? Blepharon, Greek “eyelid”+ itis–inflammatory disease • Signs and symptoms: Itchy, sore, red eyelids; eyelids stick together; burning, gritty sensation; photophobia; edges of eyelids swollen; contact lenses uncomfortable to wear; abnormal eyelash growth or eyelash loss • High inc
Slide 15: Anatomy of Eye, Lid and Meibomian Gland
Anatomy of Eye, Lid and Meibomian Gland 15
Slide 16: Blepharitis: Infection and Inflammation of Eyelid
Blepharitis: Infection and Inflammation of Eyelid Typical Case • Vision: OD 20/30, OS 20/20- • TAP: OD 21, OS 23 • Exam • Blepharitis • Debris on lashes • Conjunctival hyperemia 16
Slide 17: White Blood Cell in Action: Foundation of NovaBay Technology
White Blood Cell in Action The Foundation of NovaBay Technology Invading Microbe White Blood Cell Red Blood Cells Neutrox™ N-Chlorotaurine (NCT) NovaBay’s proprietary, pure Natural compound Hypochlorous Acid solution Rapid acting effective BUT unstable 17
Slide 18: Broad-spectrum In-vitro Antimicrobial Activity
Broad-spectrum In-vitro Antimicrobial Activity • Excellent activity against a broad range of pathogens • Fast acting onset of activity • Effective against pathogens commonly found on the lids & lashes 18
Slide 19: Case Study #1 - Compelling Results
Case Study #1 - Compelling Results 19
Slide 20: Case Study #2 - Compelling Results
Case Study #2 - Compelling Results 20
Slide 21: Patient Case History: Chronic Blepharitis
Patient Case History: Chronic Blepharitis • 25 MD visits between late 2008 to late 2012 • Rx for antibiotics between visits • Received courses of bacitracin, neomycin, polymyxin, tobradex, maxitrol, zylet, oral doxy • Patient developed skin ulcer from OTC wipes • Eczema-type reaction due to detergen
Slide 22: Easy to Use
Easy to Use 1. Clean face 2. Apply NovaBay i-Lid Cleanser 3. Wipe side to side N@vaBay’ a Avenova’ 22
Slide 23: Ingredients = Pure Hypochlorous Acid + Saline
Ingredients = Pure Hypochlorous Acid + Saline OCuSoft SteriLid Oasis Lid and LIDCLENZ VisiCleanse Eye Scrub Lash Water , PEG-80 Water , PEG 80 , Sorbitan Water, non-foaming Water, Cocamidopropyl Water USP Sorbitan Laurate , Laurate , Sodium Trideceth Poloxamer, pH balanced Betaine, PEG-80 Sorbitan,
Slide 24: Removal, Anti-biofilm, Anti-Toxin
Does not ✓ generate Resistance ✓ Removal Bacterial ✓ Mechanical Debridement ✓ Anti-biofilm Activity ✓ Anti-Toxin 24
Slide 25: Intellectual Property
Intellectual Property • Aganocide® compounds (NVC-422 and others) • 10 issued US patents • 89 issued foreign patents • 37 other patent applications pending in 15 patent families • Composition-of-matter patent protection through at least 2024 • Neutrox™ hypochlorous acid (NVC-101) • 2 issued US paten
Slide 26: Avenova and the Importance of Ocular Surface Disease
Avenova and the Importance of Ocular Surface Disease Eric D. Donnenfeld, M.D. Ophthalmic Consultants of Long Island Clinical Professor of Ophthalmology NYU Trustee Dartmouth Medical School 26
Slide 27: Disclosure
Disclosure I am a consultant for: • Acufocus • Lacripen • RPS • Allergan • Lensx • Sarcode • Alcon • Mati Pharmaceuticals • Strathspey Crown • AMO • Merck • Tearlab • Aquesys • Mimetogen • TearScience • Bausch & Lomb • NovaBay • TLC Laser Centers • CRST • Odyssey • TrueVision • Elenza • Pfizer • Wav
Slide 28: Advanced Technology is Dramatically Improving Visual Outcomes
Advanced Technology is Dramatically Improving Visual Outcomes • Over the past decade major improvements in cataract and refractive surgery have dramatically increased safety and quality of vision • Aspheric IOLs • Multifocal and accommodating IOLs • Custom ablations in laser vision correction • Femt
Slide 29: The Tear Film is the Most Important Refracting Surface of the Eye
The Tear Film is the Most Important Refracting Surface of the Eye 29
Slide 30: Ocular Surface Disease and Refractive Surgery
Ocular Surface Disease and Refractive Surgery • Quality of vision starts with a healthy tear film. • All of the recent advances in technology are lost with even minimal disruption of the ocular surface. 30
Slide 31: The Prevalence of Dry Eye
The Prevalence of Dry Eye • Affects about 15% of the population in the US (about 5 million elderly) 1,2,3 • Potentially affects tens of millions more Americans.3 • With an aging demographic, environmental changes, and increasing visual tasking demands, dry eye remains one of the greatest unmet needs
Slide 32: Majority of DED Patients Have Evaporative Dry Eye
Majority of DED Patients Have Evidence of Evaporative Dry Eye (EDE) • 86% of patients with a classified DED subtype demonstrated signs of MGD • Pure ADDE subtype represented the smallest ADDE percentage of patients (~10%) EDE Mixed Non-ADDE + Non-EDE • 86% of patients with a classified DED subtype d
Slide 33: When You Think of Dry Eye
When You Think of Dry Eye aT 33
Slide 34: Don't Forget Meibomian Gland Disease
Don’t Forget Meibomian Gland Disease 34
Slide 35: Meibomian Gland Dysfunction
Meibomian Gland Dysfunction Pouting meibomian Chronic gland orifices with blepharitis neovascularization of the lid margin Saponification Acute (Foamy Tears) chalazion Ophthalmic Consultants of Long Island
Slide 36: Prevalence of Meibomian Gland Dysfunction
Prevalence of Meibomian Gland Dysfunction, A Leading Cause of Dry Eye Disease MGD is present in ~37% of entire ophthalmic practice patients and ~47% of optometric practice patients1 “Meibomian gland dysfunction (MGD) may well be the leading cause of dry eye disease throughout the world.”2 —The Inter
Slide 37: Summary
Summary • Dry eye is prevalent, chronic, and progressive • MGD is the most common cause of dry eye • Appropriate diagnosis is important • Traditional dry eye treatments are ineffective • Avenova is a novel and important treatment for this common problem 37
Slide 38: Prevention of Endophthalmitis
Prevention of Endophthalmitis Henry D. Perry, M.D. Ophthalmic Consultants of Long Island Chief of the Cornea Service at Nassau University Medical Center
Slide 39: Disclosures - Consultant or Grant Support
Disclosures- Consultant or Grant Support • Alcon • Ista • Allergan • Millenium • AMO • NovaBay • Bausch and Lomb • Omeros • Ciba • Santen • Eagle Vision • Sirion
Slide 40: Endophthalmitis
Endophthalmitis • Most devastating potential adverse event following cataract surgery • Can become severe within 12 hours and destroy vision within days • Organisms causing endophthalmitis usually originate from patient’s own lid margin1 1 Speaker et al. Ophthalmology. 1991.
Slide 41: Rising Incidence of Endophthalmitis
Rising Incidence of Endophthalmitis • Medicare data show increasing incidence of endophthalmitis following cataract surgery: • Rates increased between 1999 and 2009 to 2.5 per 1000 cases (0.25%) • Previously estimated between 0.07% and 0.2% • Based on Medicare record review of 477,627 cases2 2 West
Slide 42: Potential Causes for Increased Rates of Endophthalmitis
Potential Causes for Increased Rates of Endophthalmitis • Evolving antibiotic resistance • Trend towards self-sealing, clear corneal incisions • Wound leaks3 3 Wallin et al. J. Cataract Refract Surg. 2005. 42
Slide 43: Increasing Resistance to Fluoroquinolones Among Staphylococcal Isolates
Increasing Resistance to Fluoroquinolones Among Staphylococcal Endophthalmitis Isolates • In vitro evaluation of the susceptibility of coagulase- negative staphylococci to fluoroquinolones • 78 isolates from patients with clinical endophthalmitis • Evaluated both newer (gatifloxacin, moxifloxacin) a
Slide 44: Antibiotic Resistance 2008
Antibiotic Resistance 2008 Methicillin-resistant Staphylococcus aureus (MRSA) endophthalmitis isolates: 45% susceptible and 55% nonsusceptible for both gatifloxacin and moxifloxacin5 5Major et al. ARVO. 2007.
Slide 45: Role of external bacterial flora in postoperative endophthalmitis
Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis.1 Speaker, Milch et al 1Ophthalmology. 1991 May;98(5):639-49 45
Slide 46: Strategies to Prevent Endophthalmitis
Strategies to Prevent Endophthalmitis • Sterilize the surface • Use topical anti-infective and povidone iodine • Use sterile technique (draping, etc) • Promote proper wound management and closure • Suture when necessary 46
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Slide 48: Prevention of Endophthalmitis
Prevention of Endophthalmitis • Avenova allows for increased bacterial removal of the lid flora and most important may be carried out through the entire post-operative period. • Critically important since many cases of Endophthalmitis occur as late as 14 days and average 9.3 days post-op.6 6Moshirfa
Slide 49: Meibomian Gland Dysfunction
Meibomian Gland Dysfunction Katherine M. Mastrota, M.S., O.D., F.A.A.O. Center Director of Omni Eye Surgery 49
Slide 50: Oculus Keratograph
Oculus Keratograph 50
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Slide 52: Anterior Blepharitis—Staphylococcal
Anterior Blepharitis— Staphylococcal • Bacteria on the lid margin release exotoxins causing inflammation and keratinization of the lid margin. • Scurf, collerettes, ulceration • Staph keratitis 52
Slide 53: Eyelid Margin Keratinization
Eyelid Margin Keratinization • Chronic inflammation of the ocular surface, such as in dry eye, activates genes responsible for differentiation, such as keratins. • Leads to orifice plugging. 53
Slide 54: Meibomian Gland Capping
Meibomian Gland Capping • Capped by a dome of solidified oil. • The underlying orifice is ulcerated. • Early sign of MGD, with early keratinization of the lid margin. 54
Slide 55: Hordeolum/Chalazia
Hordeolum/Chalazia Chalazia occur when pressure from congested meibum breaks the walls of the glands and liberates its contents within the lid causing a non- infectious inflammation. 55
Slide 56: Meibomian Gland Expression
Meibomian Gland Expression 56
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Slide 59: The Line of Marx
The Line of Marx 59
Slide 60: Changes triggered by intense pulsed light
The changes triggered by intense pulsed light appear to have multiple beneficial effects. 60
Slide 61: LipiFlow
LipiFlow 61
Slide 62: Maskin Intraductal Probes
Maskin Intraductal Probes 62
Slide 63: Diagnosing Demodex
Diagnosing Demodex • Eyelid itching • “Cylindrical cuffs/sleeves/dandruff” around base of eyelashes • Abnormal lash integrity/growth • In some cases corneal and conjunctival inflammation • Demodex folliculorum is identified by microscopic evaluation of epilated eyelash • Demodex brevis is generally
Slide 64: Cylindrical Dandruff
Cylindrical Dandruff 64
Slide 65: Under the Surface
Under the Surface 65
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Slide 67: Lid Hygiene
Lid Hygiene 67
Slide 68: Avenova: A Day in the Life of a Clinical Practice
Avenova A Day in the Life of a Clinical Practice Brian D. Rosenblatt, O.D. Rosenblatt Family Eye Care Associates Raritan, New Jersey (908) 725-3331 [email protected] 68
Slide 69: Avenova: A few Clinical Indications
Avenova: A few Clinical Indications • Surgical • Blepharitis • Meibomian Gland Dysfunction • Rosacea • Allergy Sufferers • Contact Lens Wearers 69
Slide 70: Blepharitis
Blepharitis • “Lid Margin disease” • Inflammation of glands & follicles • Dry Eye Syndrome (DES) • Anterior • Posterior • Prevalence: 12-47% • (Overlapping Syndromes) 70
Slide 71: Bacterial Blepharitis (Anterior Blepharitis)
Bacterial Blepharitis (Anterior Blepharitis) 71
Slide 72: Ocular Rosacea
Ocular Rosacea • Symptoms • >50% ocular manifestations • Clinical Signs • Pathophysiology • Autoimmune dysregulation • Cathelicidin (antimicrobial peptide) • Kallikrein-5 (cathelicidin processing enzyme) • Triggers • Demodex mites • Staphylococcus epidermidis • Prevalence • US: 10% general populatio
Slide 73: Ocular Rosacea (Posterior Blepharitis)
Ocular Rosacea (Posterior Blepharitis) 73
Slide 74: Ocular Rosacea
Ocular Rosacea 74
Slide 75: As an Aside . . . Allergy Sufferers
As an Aside . . . • Allergy Sufferers . . . • 40-50 Million Americans – 1 or more allergens • >70% Systemic Allergies → ocular manifestations • 81% Sneezing • 76% Stuffy Nose • 76% Runny Nose • 73% Itchy eyes • Cross Roads between Allergic & Dry Eye Diseases 75
Slide 76: Contact Lens Wear
Contact Lens Wear 76
Slide 77: US Contact Lens Market
US Contact Lens Market • 37-38 Million Wearers • $2.4 Billion Industry • 27% Net Practice Revenue • 16-20% Drop-Outs Annually • Tear Film & Ocular Surface Society • “dryness is main cause of contact lens intolerance” 77
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Slide 79: Avenova US Contact Lens Market Potential
Avenova US Contact Lens Market Potential • 37 Million wearers • 16% Drop Outs • 5,920,000 Patients • ¼ of Drop Outs: 1,480,000 Patients • 10 units Avenova/year • 14,800,000 Units x $20(wholesale) • $296,000,000 Annual Sales! 79
Slide 80: Avenova in the Ophthalmology Practice
Avenova in the Ophthalmology Practice Ivan Mac, MD/MBA Metrolina Eye Associates, PLLC 80
Slide 81: Avenova Roles
Avenova Roles • Dry Eye Disease • Cataract and LASIK surgery • Blepharitis/MGD • Intravitreal Injections • Oculoplastic Surgery 81
Slide 82: Dry Eye Disease
Dry Eye Disease • Most common ocular problem in U.S. • 90% co-existent MGD/posterior blepharitis • Synergy with Restasis® • Avenova BID for 1st bottle, qDay maintenance • IPL therapy and Avenova 82
Slide 83: Cataract and LASIK Surgery
Cataract and LASIK Surgery • Premium IOL/Laser Cataract Surgery • Traditional cataract surgery • Dropless cataract surgery • Broad spectrum activity • Rapid-onset 83
Slide 84: Blepharitis/MGD
Blepharitis/MGD • OTC products vs. Avenova • Baby shampoo • Topical corticosteroids • Improvement with Avenova 84
Slide 85: Intravitreal Injections
Intravitreal Injections • ARMD/DME/Retinal Vein Occlusions • Usage increasing/ chronic therapy • Risk of endophthalmitis • Betadine vs. Avenova 85
Slide 86: Oculoplastic Surgery
Oculoplastic Surgery • Blepharoplasty/Ptosis repair • Ectropion/entropion • Pre-op and post-op Avenova 86
Slide 87: Average Day
Average Day • 5-6 cataract evaluations • 10-15 patients with dry eye disease • 1 LASIK evaluation • 10-15 patients with blepharitis • Avenova has high unmet clinical need. 87
Slide 88: Questions and Answers
Questions and Answers Dr. Eric Donnenfeld 88
Slide 89: Avenova in the Market
Avenova in the Market Glenn Moro Vice President of Sales and Marketing – Avenova NovaBay Pharmaceuticals 89
Slide 90: Commercial Strategy
Commercial Strategy • 30 million patient population • 24 million blepharitis and 6 million MGD dry eye* • Called-on Ophthalmologists and Optometrists account for 80% of opportunity • Commercial introduction April 2014 at ASCRS • Stage 1: Sept 2014 – medical reps target top 10 U.S. markets • Stage 2:
Slide 91: Current Market Coverage
Current Market Coverage Medical Representatives Cover 35 Major Markets Northeast: Boston, Wash, DC Philadelphia, Pittsburgh Patterson, NJ, Cherry Hill, NJ, Richmond Hartford, Providence Midwest: Chicago-No, Chicago-So, Detroit Cleveland, Cincinnati, St Louis Memphis, Milwaukee Western: Southern: LA-
Slide 92: KOL from Across US Support Ophthalmic Advisory Board
KOL from Across US Support Ophthalmic Advisory Board Dr. Richard L. Lindstrom Founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology. Dr. Edward J. Holland Director of Cornea Services at the Cincinnati Eye
Slide 93: Advertising – KOL Endorsements
Advertising – KOL Endorsements Placements in Top Trade Journals 93 93
Slide 94: KOLs from Across US Support Optometry Advisory Board
KOLs from Across US Support Optometry Advisory Board Dr. Arthur Epstein Director of Dry Eye – Ocular Surface Disease Center and Director of Clinical Research at Phoenix Eye Care; heads practice’s Dry-Eye – Ocular Surface Disease Center and serves as Director of Clinical Research. Internationally rec
Slide 95: Interactive Website Helps Locate Prescribing Physicians and Pharmacies
Interactive Website Helps Locate Prescribing Physicians and Pharmacies Stocking Find a Physician Find a Pharmacy 95
Slide 96: Collateral Marketing Materials
Collateral Marketing Materials 96
Slide 97: Closing Remarks
Closing Remarks Dr. Ron Najafi 97
Slide 98: Pipeline–Eye Care Products
Pipeline–Eye Care Products 2014 2015 2016 Therapeutic U.S. Market Area Size ($M) 1H 2H 1H 2H 1H 2H $600 (1 Bottle Avenova Launch /patient /year) Eye Next Gen. FDA Launch Contact Lens $200 Care Care System Clearance Avenova Launch Cream / Ointment $600 98 98
Slide 99: Neutrox Family of Products
Neutrox™ Family of Products (FDA-cleared, Commercial) NovaBay Sales Force Introduced in Deployed Sept. Apr. 2014 2014 U.S. Launch by PBE Apr. 2014 China Launch March 2015 99
Slide 100: NeutroPhase: The Future of Wound Care Has Arrived
NeutroPhase® The Future of Wound Care Has Arrived 100
Slide 101: NeutroPhase Value Proposition
NeutroPhase Value Proposition • Significant markets • >6 million U.S. patients with diabetic, venous, pressure ulcers* • Proprietary technology • Patented formulation – 0.01% Pure hypochlorous acid • No resistance expected based on novel mechanism of action • Extensive clinical experience • Peer-rev
Slide 102: China Pioneer Pharma
China Pioneer Pharma March 2015 Launch in China 200,000 units ordered and initial shipments underway Covered every province in China 510 Regional Distributors Covering 26,000 Hospitals Covering >95,000 Pharmacies 102
Slide 103: Management Team
Management Team Ron Najafi, Ph.D. Tom Paulson Glenn Moro Chief Executive Officer Chief Financial Officer VP, Avenova Sales & Marketing (Aldrich, Rhone Poulenc (Abbott, Quidel,. Ciba-Corning, (Alcon) Rorer, Applied Biosystems) Neurogen, Avigen) David Stroman, Ph.D. Russell Hoon Roy Wu SVP, Ophthalmol
Slide 104: In Summary
In Summary 1. Revenue growth from commercial products • Grow US sales of Avenova • Capitalize on large market opportunity in poorly served markets with FDA-cleared products 2. Innovation • Develop, introduce innovative eye care products in next 12-18 months 3. Monetization of non-strategic assets •
Slide 105: Avenova: Going Beyond Antibiotics
AVENOVA Going Beyond Antibiotics