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2. disease

AVENOVA
Going Beyond Antibiotics
AVENOVA – Going Beyond
Antibiotics
Presented by NovaBay Pharmaceuticals
Dr. Ron Najafi
Founder, President and CEO
Welcome
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 products, future sales of our products, and the
company’s expected future financial results. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results or achievements to be materially different and
adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or
contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or
delays in manufacturing, distributing, and selling the company's products, unexpected adverse side effects or
inadequate therapeutic efficacy of our product, the uncertainty of patent protection for the company's
intellectual property, and the company's ability to obtain additional financing as necessary. Other risks
relating to NovaBay’s business, including risks that could cause results to differ materially from those
projected in the forward-looking statements in this press release, are detailed in NovaBay's latest Form 10-K
and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk
Factors." The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any
intent or obligation to revise or update publicly any forward-looking statement except as required by law.
3
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.
• Avenova in the Market
• Glenn Moro, Vice President of Sales and Marketing, NovaBay
Pharmaceuticals
• Conclusion – Dr. Ron Najafi
4
Eric D. Donnenfeld, M.D.
Ophthalmic Consultants of Long Island
Clinical Professor of Ophthalmology NYU
Trustee Dartmouth Medical School
5
Ivan Mac, MD/MBA
Metrolina Eye Associates, PLLC
6
Katherine M. Mastrota,
M.S., O.D., F.A.A.O.
Center Director of Omni Eye Surgery
7
Henry D. Perry, M.D.
Ophthalmic Consultants of Long Island
Chief of the Cornea Service at Nassau
University Medical Center
8
Brian D. Rosenblatt, O.D.
Rosenblatt Family Eye Care Associates
Raritan, New Jersey
9
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 products in next
12-18 months
3. Monetization of non-strategic assets
• Remain committed to existing partnerships
• License / sell select assets in urology, dermatology,
wound care and plastic surgery to monetize assets
Achieve near-term revenue growth
and ultimately profitability
10
Value Proposition –
US Avenova Launch
Addressing Poorly
Served Market
•30 million blepharitis and dry eye patients
•3 million cataract + 2 million refractive surgery patients
Commercializing
FDA-Cleared
Product
•35 medical reps in major U.S. markets
•Ramp up to 50 reps = 80% market reach
•AmerisourceBergen, Cardinal, McKesson = 90% of pharmacies
Effectively No
Competition
•OTC products – dilute soap
•Systemic antibiotics, anti-inflammatory - resistance issues
•Only product based on proprietary anti-infective compound
Validated
Platform/
Important IP
•Anti-infective activity validated by clinical studies
•Formulation & Methods of Use to 2030
•Large-scale manufacturing in place
Well-conceived
Product Launch
Strategy
•VP Sales with 27 years at Alcon as Global Marketing Head
•Head of Ophthalmology with 21 years at Alcon, Head of Antiinfective Drug Development
11
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 of $46,000
• Net loss of $4.6 million, or $0.09 per share, compared with a net loss of $3.6
million, or $0.08 per share,
• Reflects increased spending on sales and marketing activities for
Avenova; lower spending on R&D
• R&D expenses of $1.6 million; SG&A of $3.4 million
• Cash, cash equivalents and short-term investments of $5.6 million as of
March 31, 2015, included $4.5 million from equity financing in March 2015
12
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 pharmaceuticallike margins
13
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 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,
styes, cornea damage
• Standard of care is warm compresses, lid wipes, antibiotics
14
Anatomy of Eye, Lid
and Meibomian Gland
15
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
White Blood Cell in Action
The Foundation of NovaBay Technology
Invading Microbe
White Blood Cell
Red
Blood Cells
Neutrox™
NovaBay’s proprietary, pure
Hypochlorous Acid solution
N-Chlorotaurine (NCT)
Natural compound
Rapid acting
effective
BUT unstable
17
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
Case Study #1 Compelling Results
19
Case Study #2 Compelling Results
20
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 detergent-based components
• 10% using OTC wipes develop contact dermatitis
• Using Avenova since early 2013 and has not required any antibiotics or
steroids
21
Easy to Use
22
Ingredients =
Pure Hypochlorous Acid + Saline
OCuSoft
SteriLid
Oasis Lid and
Lash
LIDCLENZ
VisiCleanse
Eye Scrub
Water , PEG-80
Sorbitan Laurate ,
Sodium Tricedeth
Sulfate , PEG-150
Distearate ,
Disodium
Lauroamphodiacetat
e, 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 adjustment , Sodium
Hydroxide for pH adjustment
Water,
Poloxamer,
Polyethylene,
Glycol,
Borate,
Hyaluronan,
Methylparabe
n, 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
Acid, Polyaminopropyl
Biguanide
Water USP
(Purified), PEG
200
Hydrogenated
Glyceryl Palmate,
Disodium Laureth
Sulfosuccinate,
Cocoamidopropyl
amine Oxide, PEG
80 Glyceryl
Cocoate, Benzyl
Alcohol, Edetate
Disodium
23
Does not
generate
Resistance
✓
✓
✓
Bacterial
Removal
✓
Anti-biofilm
Activity
✓
Mechanical
Debridement
Anti-Toxin
24
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 patents
• 8 issued foreign patents
• 2 other patent applications pending in 1 patent family
25
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
Disclosure
I am a consultant for:
•
•
•
•
•
•
•
•
•
•
Acufocus
Allergan
Alcon
AMO
Aquesys
Bausch & Lomb
CRST
Elenza
Glaukos
Kala
•
•
•
•
•
•
•
•
•
•
Lacripen
Lensx
Mati Pharmaceuticals
Merck
Mimetogen
NovaBay
Odyssey
Pfizer
PRN
QLT
•
•
•
•
•
•
•
•
RPS
Sarcode
Strathspey Crown
Tearlab
TearScience
TLC Laser Centers
TrueVision
Wavetec
27
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
• Femtosecond laser cataract surgery
• Cataract surgery and refractive surgery are merging into a
single entity
28
The Tear Film is the Most
Important Refracting Surface of the Eye
29
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
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 for your patients!
1. Moss SE, et al. Prevalence and risk factors for dry eye syndrome. Arch Ophthalmol. 2000;118:1264-8.
2. Schein OD, Muñoz B, Tielsch JM, et al. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997;124(6):723-8.
3. Lemp MA, Baudouin C, Baum J, et al. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of
the International Dry Eye Workshop (2007).Ocul Surf. 2007 Apr;5(2):93-107.
31
Majority of DED Patients
Have Evidence of Evaporative Dry Eye (EDE)
• 86% of patients with a classified DED subtype
demonstrated signs of MGD
ADDE
• Pure ADDE subtype represented the smallest
EDE
percentage of patients (~10%)
Mixed
Non-ADDE +
Non-EDE
• 86% of patients with a classified DED subtype demonstrated signs of MGD
• Pure ADDE subtype represented the smallest percentage of patients (~10%)
Lemp MA, et al. Cornea. 2012;31:472-478.
32
When You Think of Dry Eye
33
Don’t Forget
Meibomian Gland Disease
34
Meibomian Gland Dysfunction
Chronic
blepharitis
Saponification
(Foamy Tears)
Ophthalmic Consultants of Long Island
Pouting meibomian
gland orifices with
neovascularization
of the lid margin
Acute
chalazion
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 International Workshop on Meibomian Gland Dysfunction:
Executive Summary
1. Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on prevalence and
treatment. Ocul Surf. 2009;7(2 Suppl):S1-S14.
2. Nichols KK, et al. The international workshop on meibomian gland dysfunction: executive summary.
Invest Ophthalmol Vis Sci. 2011;52(4):1922-1929.
36
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
Prevention of Endophthalmitis
Henry D. Perry, M.D.
Ophthalmic Consultants of Long Island
Chief of the Cornea Service at Nassau University
Medical Center
Disclosures- Consultant or Grant Support
• Alcon
• Allergan
• AMO
• Bausch and Lomb
• Ciba
• Eagle Vision
• Ista
• Millenium
• NovaBay
• Omeros
• Santen
• Sirion
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.
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 et al. Ophthalmology. 2014.
41
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
Increasing Resistance to
Fluoroquinolones Among
Staphylococcal Endophthalmitis Isolates
• In vitro evaluation of the susceptibility of coagulasenegative staphylococci to fluoroquinolones
• 78 isolates from patients with clinical endophthalmitis
• Evaluated both newer (gatifloxacin, moxifloxacin) and
older (ciprofloxacin, ofloxacin, levofloxacin)
fluoroquinolones
• Looked at susceptibility changes from 1990 to 2008
• The percentage of resistant organisms increased over time
for all fluoroquinolones tested4
4
Miller et al. Arch Ophthalmology. 2009.
43
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.
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
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
47
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
6Moshirfar et
al. Ophthalmology. 2008.
48
Meibomian Gland Dysfunction
Katherine M. Mastrota,
M.S., O.D., F.A.A.O.
Center Director of Omni Eye Surgery
49
Oculus Keratograph
50
51
Anterior Blepharitis—
Staphylococcal
• Bacteria on the lid margin
release exotoxins causing
inflammation and
keratinization of the lid
margin.
• Scurf, collerettes,
ulceration
• Staph keratitis
52
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
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
Hordeolum/Chalazia
Chalazia occur when pressure
from congested meibum
breaks the walls of the glands
and liberates its contents
within the lid causing a noninfectious inflammation.
55
Meibomian Gland Expression
56
58
The Line of Marx
59
60
LipiFlow
61
Maskin Intraductal Probes
62
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 not
isolated as it is often within the
meibomian gland itself.
63
Cylindrical Dandruff
64
Under the Surface
65
66
Lid Hygiene
67
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
Avenova: A few Clinical
Indications
• Surgical
• Blepharitis
• Meibomian Gland Dysfunction
• Rosacea
• Allergy Sufferers
• Contact Lens Wearers
69
Blepharitis
• “Lid Margin disease”
• Inflammation of glands & follicles
• Dry Eye Syndrome (DES)
• Anterior
• Posterior
• Prevalence: 12-47%
• (Overlapping Syndromes)
70
Bacterial Blepharitis
(Anterior Blepharitis)
71
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 population
• Estonia: 22%
72
Ocular Rosacea
(Posterior Blepharitis)
73
Ocular Rosacea
74
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
Contact Lens Wear
76
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
78
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
Avenova in the Ophthalmology
Practice
Ivan Mac, MD/MBA
Metrolina Eye Associates, PLLC
80
Avenova Roles
• Dry Eye Disease
• Cataract and LASIK surgery
• Blepharitis/MGD
• Intravitreal Injections
• Oculoplastic Surgery
81
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
Cataract and LASIK Surgery
• Premium IOL/Laser Cataract Surgery
• Traditional cataract surgery
• Dropless cataract surgery
• Broad spectrum activity
• Rapid-onset
83
Blepharitis/MGD
• OTC products vs. Avenova
• Baby shampoo
• Topical corticosteroids
• Improvement with Avenova
84
Intravitreal Injections
• ARMD/DME/Retinal Vein Occlusions
• Usage increasing/ chronic therapy
• Risk of endophthalmitis
• Betadine vs. Avenova
85
Oculoplastic Surgery
• Blepharoplasty/Ptosis repair
• Ectropion/entropion
• Pre-op and post-op Avenova
86
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
Questions and Answers
Dr. Eric Donnenfeld
88
Avenova in the Market
Glenn Moro
Vice President of Sales and Marketing – Avenova
NovaBay Pharmaceuticals
89
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: Feb 2015 - Increase medical reps to 35
• Stage 3: 2015 – Planned growth to 50
• Distribution agreements: AmerisourceBergen, Cardinal, McKesson
• Accessible in ~90% of U.S. retail pharmacies
* Medscape Ophthalmology-Blepharitis July 9th, 2009; The Epidemiology of dry eye DEWS Report 2010;
* U.S. Dept of Health and Human Services Survey of Eye Glasses and Eyecare 2009;
* U.S. Dept of Health Education and Welfare Office Visits to Ophthalmologists 1978; U.S. Census 2010
* A Guide for Breaking Down Blepharitis, Review of Ophthalmology, Feb 2, 2011;
* Facts About Dry Eye, NIH, National Eye Institute, August, 2009
90
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:
LA-North, LA-South
San Francisco, San
Diego
Sacramento, Seattle
Phoenix, Denver, Dallas
Southern:
Miami, Jacksonville, Tampa
West Palm, Atlanta, Columbia, SC
Raleigh-Durham, NC, Charlotte,
NC, Birmingham
91
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 Institute and Professor of Ophthalmology at the University of
Cincinnati.
Dr. Terry Kim
Professor 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. Francis Mah
Director of Cornea and External Disease and Co-Director of Refractive Surgery, Scripps Clinic Medical Group, La
Jolla, CA; Russell N. Van Gelder, M.D., PhD., University of Washington Professor and Chair of the Department of
Ophthalmology.
Dr. Eric Donnenfeld
Past 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.
92
92
Advertising –
KOL Endorsements
Placements in Top Trade Journals
93
93
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
recognized expert in complex contact lens management and medical complications of contact lenses, dry eye and
anterior segment disease.
Dr. Katherine M. Mastrota
Center 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 and medical director of Rosenblatt Family Eyecare Associates, Raritan New Jersey. Extensive experience in
treatment of diseases of the cornea, lids and lashes. Noted lecturer on dry eye, contact lenses and care and contact
lens intolerance.
Dr. Christine Sindt
Founded Scleral Lens Education Society is nationally recognized expert on specialty contact lenses for children,
practice specializes in treatment of anterior segment disease.
Dr. Bill Townsend
Served 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.
94
Interactive Website Helps
Locate Prescribing Physicians
and Pharmacies Stocking
Find a
Physician
Find a
Pharmacy
95
Collateral Marketing Materials
96
Closing Remarks
Dr. Ron Najafi
97
Pipeline–Eye Care Products
2014
Therapeutic U.S. Market
Size ($M)
Area
1H
2015
2H
1H
2016
2H
1H
2H
$600
Avenova
Eye
Care
Next Gen.
Contact Lens
Care System
(1 Bottle
/patient
/year)
Launch
FDA
$200
Clearance
Avenova
Cream / Ointment $600
Launch
Launch
98
98
Neutrox™
Family of Products
(FDA-cleared, Commercial)
NovaBay Sales Force
Deployed Sept.
2014
U.S. Launch by
PBE Apr. 2014
Introduced in
Apr. 2014
China Launch March 2015
99
NeutroPhase®
The Future of
Wound Care
Has Arrived
100
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-reviewed publication in medical journal WOUNDS
• Current clinical use with KOLs
• Commercial launch underway
• FDA-cleared for sale in U.S. and China
• PBE in the U.S.; Pioneer Pharma in China and SE Asia
* Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy, Wound Repair
and Regeneration, Nov, 2009
101
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
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Management Team
Ron Najafi, Ph.D.
Tom Paulson
Chief Executive Officer
(Aldrich, Rhone Poulenc
Rorer, Applied Biosystems)
Chief Financial Officer
(Abbott, Quidel,. Ciba-Corning,
Neurogen, Avigen)
David Stroman, Ph.D.
Russell Hoon
SVP, Ophthalmology
(Alcon, Upjohn)
SVP, Advance Wound Care
(Xylos, Tutogen, Integra)
Glenn Moro
VP, Avenova Sales & Marketing
(Alcon)
Roy Wu
SVP, Business Development
(Genelabs, Kissei, Syntex)
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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
• Remain committed to existing partnerships
• License / sell select assets in urology, dermatology,
wound care and plastic surgery to monetize assets
Achieve near-term revenue growth
and ultimately profitability
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AVENOVA
Going Beyond Antibiotics