going beyond antibiotics harnessing the anti-infective power of...
TRANSCRIPT
NYSE MKT: NBYwww.novabay.com
June 2017
Harnessing the Anti-Infective Power of White Blood Cell Chemistry to Address Ophthalmic Diseases Afflicting 41 Million Americans
Forward-Looking Statements
This presentation contains forward-looking statements, within the meaning of applicable U.S.
securities laws, which statements can, in some cases, be identified with terms such as “project,”
“believe,” “may,” “plan,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “target,”
“potential” and other similar expressions. These forward-looking statements reflect NovaBay’s
current expectation and assumptions, such as expected market potential and market acceptance of
our products and are subject to a number of risks and uncertainties that could cause actual results to
differ materially from those anticipated. These risks and uncertainties include, but are not limited to,
changing market conditions, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process and other risks detailed in the
Company's filings with the SEC, which filings can be found at www.sec.gov. Given these risks and
uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The
Company undertakes no obligation to publicly update or revise any forward-looking statements either
as a result of new information, future events or otherwise, except as required by applicable U.S.
securities laws.
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Summary Highlights
• Specialty Pharma – Commercial stage; Sold by Prescription
• Company founded to address antibiotic resistance crisis
• Turnaround in 2016
• 2016 sales tripled over 2015
• Cash Flow breakeven achieved for month of Dec’16
• Strong experienced management team
• High-growth in large market of 41 million U.S. patients
• High gross margins (>85%)
• Patents on methods of formulation and manufacturing
• Pure hypochlorous acid (HOCl), branded as Neutrox®3
Leading the NovaBay Commercial Transition
Mark Sieczkarek – Chairman, CEO & President
• 40 years in the Life Sciences—Large and Small Companies
• Pharmaceutical, Consumer; Diagnostics and Medical Devices; Finance, Sales & Marketing; Manufacturing; Mergers and Acquisitions; General Management
• Bristol-Myers - Senior Vice-President
• Sanofi - COO of U.S. Diagnostics Unit
• Kos - VP, CFO - Sold to Abbott for $6.2B
• Bausch & Lomb - President of the Americas & Europe
• Conceptus - CEO and President - Sold to Bayer for $1.1B
• Solta - Chairman, CEO and President - Sold to Valeant for $250M
Thomas Paulson - CFO
• 40 Years in senior financial positions
• Tatum LLC – partner, The Paulson Group-President & CEO
• Senior management at Avigen, Neurogen, Ciba-Corning Diagnostics, Quidel and Abbott Laboratories
Glenn Moro – Vice President, Marketing
• 26 years in sales and marketing at Alcon including as Global Director of Marketing for the contact lens care products
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The Foundation of NovaBay TechnologyCommercializing Products That Mimic the Anti-Microbial Power of Neutrophils
White Blood Cell
NovaBay’s Breakthrough:
Neutrox® • Proprietary formulation, pure hypochlorous acid (HOCl)
• Identical to molecule produced by neutrophils to kill bacteria
• Highly effective against microbial invaders
• Neutralizes bacterial toxins and breaks up biofilms
• Non-toxic to mammalian cells
• Three year stability
• FDA-cleared / Commercial-stage
Bacteria
Neutrophil
Red blood cells
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Avenova Package Insert Lists Confirmed Time-Kills and Broad Spectrum ActivityRelated to Most Common Eye Infections
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Advantages
Does not generate
Resistance
Mechanical debridement
Anti-toxinAnti-biofilm
activity
Bacterial removal
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✓
✓ ✓
✓
✓
What is Blepharitis?Blepharon, Greek “eyelid” + itis – inflammatory disease
• Caused by constant high bacterial load around eyes
• Condition is chronic and incurable
• Signs and symptoms
• Itchy, sore, red eyelids; eyelids stick together; burning, gritty sensation
• High incidence
• 37% of patients seen by ophthalmologists
• 47% of patients seen by optometrists
• Most common cause is staphylococcus bacteria
• Complications include dry eye syndrome, conjunctivitis, meibomian cysts, sties, cornea damage
• Standard of care is warm compresses, lid wipes, antibiotics
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2016 ARVO Presentation Clinical study confirmed Avenova’s Rapid Time-Kill and Broad Antimicrobial Effects
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ARVO,May, 2016
Addressing 41 Million Potential Patients in U.S.
Blepharitis24M
Dry eye6M
Surgery -Cataract
3M
Surgery -Lasik1M
Retinal injections
3M
Contact lens intolerance
4M
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Dry Eye Is the only market segment addressed by Restasis® and Xiidra®
(Effects of these two drugs may be enhanced when used in combination with Avenova)
Commercial Targets
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Market Coverage
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Western (11):LA-North, LA-SouthSan Francisco, San Jose, Sacramento, San Diego, Seattle, Phoenix, Denver, Dallas, Austin
Northeast (11):Albany, Brooklyn,Manhattan, Nassau County, White Plains, Cherry Hill, Boston, Hartford, Patterson, Wash, DC, Philadelphia
Southeast (11):Miami, Jacksonville, Ft. Myers, West Palm, Raleigh-Durham, Charlotte, Memphis, Atlanta, Baton Rouge, Houston, Nashville
Midwestern (10):Chicago-No, Chicago-So, Detroit, St. Louis, Buffalo, St. Paul, Kansas City, KS, Cleveland, Cincinnati, Pittsburg
50 Direct Medical Reps in Key Metro Areas
Reimbursement: Insurance Coverage Continues to Grow
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Extensive Media Campaigns Targeting Dry Eye Underway
Defensive Ads for Restasis® Xiidra® Launch Promotions
(57,000 Rx/Week) (17,000 Rx/Week)
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How Products Compare in the Management of MGD Dry EyeU.S. Market of 30 Million Patients
Avenova Restasis® Xiidra®
Benefits Launch Date Q4, 2014 2003 Q4, 2016
- Blocks Cytokines
- Kills Bacteria
- Penetrates Biofilm
- Blocks Bacterial Toxins
- Blocks Lipase
Side Effects
NoneRefreshing
Burning, redness, discharge, pain, watery eyes, blurred
vision
Stinging, irritation, bad taste in mouth, reduced
visual acuity
Uses (41 M U.S. Patients)
- Dry Eye (6M)
- Blepharitis (24M)
- Pre/Post Cataract (3M)
- Pre/Post Lasik (1M)
- Contact Lens Intolerance (4M)
- Retinal injections (3M) 16
contains only 2 Ingredients = 1. Pure Hypochlorous Acid + 2. Saline
OCuSoft SteriLidOasis
Lid and Lash LIDCLENZ VisiCleanse Eye Scrub Hypochlor Acuicyn
Water , PEG-80 Sorbitan Laurate , Sodium Tricedeth Sulfate , PEG-150 Distearate , Disodium Lauroamphodiacetate, Cocamidopropyl Hydroxysultaine , Sodium Laureth-13 Carboxylate , Sodium Chloride , Quaternium-15
Water , PEG 80 , Sorbitan Laurate , Sodium Trideceth Sulfate Cocamidopropyl Betaine , Sodium, Lauroamphoacetate , PEG 150 Distearate , Sodium Laureth 13 Carboxylate , Linalool Oil , Hepes Acetate , Sodium Perborate Monohydrate , Panthenol , Allantoin (Comfrey Root) , Sodium Chloride , Tea Tree (Melaleuca Alternifolia) Oil , Tris EDTA , Boric Acid , Cocamidopropyl PG Dimonium Chloride , Etridronic Acid , Citric Acid for pH
Water, Poloxamer, Polyethylene, Glycol,Borate,Hyaluronan,Methylparaben, Carbopol 940
Non-foaming pH balanced formulation of non-ionic surfactant in purified water
Water, Cocamidopropyl Betaine, PEG-80 Sorbitan, Laurate, Sodium Trideceth Sulfate, PEG-150 Distearate, Aloe, Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower, Extract, Cucumis Sativus (Cucumber) Fruit Extract, Althaea Officinalis, Root Extract, Avena Sativa (Oat) Kernel Extract, Tetrasodium EDTA, Citric
Water USP (Purified), PEG 200 Hydrogenated Glyceryl Palmate, Disodium Laureth Sulfosuccinate, Cocoamidopropylamine Oxide, PEG 80 Glyceryl Cocoate, Benzyl Alcohol, Edetate Disodium
HOCl 60%Bleach 40%
In saline
HOCl 60%Bleach 40%
In saline
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Avenova Beneficial at All Severity Levels of Dry Eye
Treatment Recommendations by Severity Levels
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18
40 122321 465 553
1,664
2,085
3,0232,778
425
684
797
1,115 813
914
1,003
882
842
465
806
1,118
1,580
1,366
2,578
3,088
3,905
3,620
1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 3Q16 4Q16 1Q17
Direct Buy & Bill Sales
Prescriptions Sales
70%
30%
23%
77%
Weekly Trend of Lid Disease Rx ProductsOctober, 2016 to May 12, 2017Only Avenova Is Now Exceeding Dec’16 Rx Highs
Multipronged Commercial Strategy
• Focus on Rx marketing strategy• Ophthalmology channel has greatest growth potential
• Avenova pricing model recognizes full value/benefits
• Strategy supported by insurance coverage exceeding 90%
• Accessible in 90+% of retail pharmacies through distribution agreements with McKesson, Cardinal Health and AmerisourceBergen
• Continue building market and increasing prescriptions• Expand sales organization
• Support of KOLs – press releases and presentations
• Advertising and media coverage
• Accumulate additional clinical validation
• Monetize non-core assets to support commercial success
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Ophthalmic Advisory Board
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Dr. Eric DonnenfeldPast president of Ocular Microbiology and Immunology Group and serves on the Board of Directors of American Society of Cataract and Refractive Surgery. Dr. Donnenfeld has published over 175 journal articles, and >20 book chapters and books.
Dr. Richard L. LindstromFounder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology.
Dr. Russell N. Van Gelder, M.D., PhD.Current President of The American Academy of Ophthalmology; University of Washington Professor and Chair of the Department of Ophthalmology.
Dr. Francis MahDirector of Cornea and External Disease and Co-Director of Refractive Surgery, Scripps Clinic Medical Group, La Jolla, CA.
Dr. Terry KimProfessor of Ophthalmology at Duke University School of Medicine, and Associate Director of the Corneal and External Disease Service and Refractive Surgery Service at the Duke University Eye Center.
Dr. Edward J. HollandDirector of Cornea Services at the Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati.
Optometry Advisory Board
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Dr. Arthur EpsteinDirector 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 recognized expert in complex contact lens management and medical complications of contact lenses, dry eye and anterior segment disease.
Dr. Christine SindtFounded Scleral Lens Education Society is nationally recognized expert on specialty contact lenses for children, practice specializes in treatment of anterior segment disease.
Dr. Katherine M. MastrotaCenter Director of Omni Eye Surgery in New York City; Contributing Editor to Contact Lens Spectrum and Optometric Physician and authored numerous articles. Named Secretary to the Ocular Surface Society of Optometry. Serves on Board of Directors of Optometric Society of the City of New York.
Dr. Brian Rosenblatt Owner of Rosenblatt Family Eye Care Associates, a group practice in Raritan, NJ focusing on Contact Lenses, Glaucoma, Anterior Segment Disease, and Ocular Manifestations of Systemic Diseases. Member of the AOA, NJSOP, and is currently a candidate for fellowship of the American Academy of Optometry.
Dr. Bill TownsendServed 11 years as consultant at VA Medical Center in Amarillo, TX. Currently an adjunct professor at University of Houston, College of Optometry. Special emphasis on ocular surface disease and dry eye. Fellow of American Academy of Optometry and President of Ocular Surface Society of Optometry.
Advertising
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Placements in Top Trade Journals
Collateral Marketing Materials
Interactive Website
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Find a Physician
Find a Pharmacy
Success Stories Written by NovaBay KOLs
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Avenova With Neutrox Is ‘Breakthrough’ in Fight Against Contact Lens Intolerance
New Therapy Introduced for Chronic Dry Eye
Success Stories Written by NovaBay KOLs
Success Stories Written by NovaBay KOLs
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Dry Eye: A Growing Problem in an Aging Population New Treatments for Contact Lens Intolerance On The Rise
Financial Overview
Million
Market Cap (6/2/17) $36
Cash (3/31/17) $7.4
Debt $0
Shares Outstanding (3/31/17)(Excludes: Stock Options of 2.2M; Warrants of 0.5M)
15.3
2017 Guidance – Total Annual Sales $19
2017 Guidance – Annual Net Cash Burn ($3)
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In Summary…
• Significant commercial opportunity with Avenova• Proprietary formulation with proven antimicrobial properties
• Addresses largely untapped market of 41 million Americans
• Proven commercial strategy to increase prescriptions and capitalize on insurance reimbursement to drive revenues and enhance margins
• Leadership with extensive experience in ophthalmology and product launches
• Significant progress toward sustained Revenue Growth
• Strong balance sheet to support continued growth
• Commercial and developmental pipeline provides for licensing and partnering opportunities
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