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Transcript of Nby 6112013
Beyond Antibiotics
Corporate Update
Ron Najafi
Chairman & CEO
Annual Shareholder Meeting
June 11, 2013
NYSE-MKT: NBY
1
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“, “targets”, “potential”, and other similar expressions. These forward-looking statements reflect NovaBay’s current expectation and assumptions, such as expected efficacy of compounds, timing of clinical trials, future results of clinical trials, other expected or targeted events and potential market sizes 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.
Forward-Looking Statements
2
Antibiotic Resistance Crisis
Pre-Antibiotic Era - Pre-1930’s - Minor injury = Death - Life Expectancy (LE) 45
Alexander Fleming Bread Mold Observation
Antibiotic Era
- 1930 – 2010 - Penicillin - 150 Antibiotics - Wonder Drugs - Save Millions of Lives - LE 85
3
Disease Pre-Antibiotic Death Rate
Death With Antibiotics
Change in Death
Community Pneumonia1 35% 10% -25%
Hospital Pneumonia2 60% 30% -30%
Heart Infection3 100% 25% -75%
Brain Infection4 >80% <20% -60%
Skin Infection5 11% <0.5% -10%
By comparison…treatment of myocardial infarction with aspirin or fibrinolytic drugs6
-3%
1IDSA Position Paper ’08 Clin Infect Dis 47(S3):S249-65; 2IDSA/ACCP/ATS/SCCM Position Paper ’10 Clin Infect Dis In Press; 3Kerr AJ. Subacute Bacterial Endocarditis. Springfield IL: Charles C. Thomas, 1955 & Lancet 1935 226:383-4; 4Lancet ’38 231:733-4 & Waring et al. ’48 Am J Med 5:402-18; 5Spellberg et al. ’09 Clin Infect Dis 49:383-91 & Madsen ’73 Infection 1:76-81; 6’88 Lancet 2:349-60
Power of Antibiotics
4
Antibiotic Resistance Crisis
Pre-Antibiotic Era - Pre-1930’s - Minor injury = Death - Life Expectancy (LE) 45
Alexander Fleming Bread Mold Observation
Antibiotic Era
- 1930 – 2010 - Penicillin - 150 Antibiotics - Wonder Drugs - Save Millions of Lives - LE 85
Megatrend
Bacteria containing NDM-1 enzyme
Post-Antibiotic Era - Confirmed by WHO - Widespread Resistance - “Super Bugs”/ MRSA - Flesh Eating - Will this effect LE?
5
• Good safety profile
• Fast
• Broad spectrum of activity
• Effective against multi-drug resistant bacteria
• Effective against biofilm
Our Solution Compounds that Mimic Nature
(N,N-dichloro-2,2-dimethyltaurine) Effective and Stable, Broad Patent Protection
Auriclosene
6
6 Million U.S. Patients
Two Distinct Anti-Infective Product Groups
WW: $600M
US: $100M
WW: $700M
Aganocides® Lead: Auriclosene
(NVC-422)
Wound Care Chronic
Non-healing Wounds
Dermatology Impetigo
Ophthalmology Pink Eye
Urology UCBE
7
$2B (WW) $400-600 Mil (WW)
$100-200 Mil (US)
Four Distinct Business Units Pursuing Independent Opportunities
8
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Begin Ph. I
Begin Ph. II
Begin Ph. III
File for
Approval
Anti-infective
• $21 B Market • Development cost & time is less • Few new products – Escalating need • Higher probability of success
Anti-Infective Advantages
Source: CMR International
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Begin Ph. I
Begin Ph. II
Begin Ph. III
File for
Approval
CNS
Anti-cancer
Cardiac
Anti-infective
9
Company History / Major Milestones Corporate Partners Have Contributed ~$60 million
Founded
Novato, CA
NVC-101
Discovery and development of NeutroPhase for
wound care
Partnership
Licenses right to develop Aganocide compounds for ophthalmology uses
Initial Public Offering October
Listing on NYSE-Amex NBY
$20,000,000
Partnership i
NovaBay licenses the right to Aganocide for Impetigo
and Acne
Partnership
Strategic marketing agreement with Pioneer
Pharma for China
Largest Trial For Viral Conjunctivitis Ever
Launched
Launch Global Phase 2b Clinical Trial
Impetigo Represents “Gateway” Indication
Launch Global Phase 2b Clinical Trial
Granted in Multiple Ex-US Countries
Aganocides Issued Additional Composition of
Matter Patents
2000
2012
2007 2009 1998-2003 2006 2012
2012 2012 2012 2012
Strategic Marketing Agreement Added for
Southeast Asia
Partnership Expansion Equity Investment
Up to $5.5 million
Partnership
Licenses right to Aganocide for Animal Health
2013
10
Pipeline Continues to Advance Results From Three Advanced Clinical Trials in 2013
* FDA has agreed that conjunctivitis Phase 2b trial could be considered pivotal
Therapeutic Area
Delivery Scope
(Patients)
2013
Q1 Q2 Q3 Q4
Aganocides®
(auriclosene)
Urology Irrigation Solution
US (30)
Dermatology
Topical Gel
Global (300+)
Ophthalmology Eye drops Global (500+)
NeutroPhase®
(NVC-101) Advanced
Wound Care
Pure HOCl
Solution
Commercial Launch
Underway
Enrolling Phase 2, Part 2
Partnered in China, SE Asia and S. Korea ; Seeking WW Partners
Enrolling Global Phase 2b
Enrolling Global Phase 2b*
Clinical Trials Update
Pink Eye
(Infectious Conjunctivitis) David Stroman, Ph.D.
Senior Vice President Ophthalmology
12
Bacterial (US) $457
Bacterial (Ex-US)
$768
Viral (US)
$300 (1)
Viral (Ex-US) $400 (1)
WW = $2 billion
(1) Extrapolated from Japanese incidence data of 1 million cases of adenoviral conjunctivitis per year. Other published estimates of incidence support greater frequencies in US and other countries.
Worldwide Conjunctivitis Market Bacterial and Viral
13
• Number 1 unmet medical need in ocular infections
• Epidemic Keratoconjunctivitis (EKC)
– Can be sight threatening
– Highly contagious
– Causes large epidemic outbreaks
Adenoviral Conjunctivitis
14
15% Separation from Vehicle
Sustained clinical cure is attained if the sum of bulbar conjunctival injection and foreign body sensation is zero and remains zero for all subsequent visits
6
13 13
19
38
69
0 0 0
8
31
54
0
10
20
30
40
50
60
70
80
Day 3 Day 5 Day 7 Day 9 Day 11 Day 18
NVC-422 Vehicle
% of Patients 15%
Clinical Success: 69% on Day 18 in EKC Adenoviral Patients
15
31
46
62 69
85 92
-
13 13
25
38
50
-
10
20
30
40
50
60
70
80
90
100
Day 3 Day 5 Day 7 Day 9 Day 11 Day 18
NVC-422 Vehicle
42% Separation from Vehicle
Sustained clearing of blurred vision is obtained if symptom is zero and remains zero for all subsequent visits
42%
Blurred Vision Clearing 92% on Day 18 in EKC Adenoviral Patients
% of Patients
16
• Sustained Microbiological success
• Sustained Clinical cure
• Sustained clearing of blurred vision
• Resolution of SEIs
• Safe and well tolerated
Summary of Proof-of-Concept Study Patients with EKC Serotypes
17
• Phase I: US Escalating Exposure Study – Completed
• Phase 2a: US Adenoviral Proof-of-Concept Study – Completed
• Phase 2b: BAYnovation – Global Safety/Efficacy Study
– Enrollment began May 4, 2012
– Completion expected in late-2013
• Phase 2a: BACTOvation – US Bacterial Proof-of-Concept Study
– FPI – June, 2013
– Completion expected 1st Qtr 2014
Infectious Conjunctivitis -- Time-line
18
• Ages – 1 year and older
• Signs and Symptoms of viral infection of 3 days or less
• Pre-screened with Adeno Detector Plus test
• Treatment is for 10 days – 8 times per day
• Visit schedule – Day 1, 3, 6, 11, 18 , and 42
BAYnovation Study Design
19
BAYnovation Adenoviral Conjunctivitis US Investigators
20
BAYnovation Adenoviral Conjunctivitis India Investigators
21
BAYnovation Adenoviral Conjunctivitis Brazil Investigators
22
• Ages – 1 year and older
• Signs and Symptoms of bacterial infection of 3 days or less
• Treatment is for 4 days – 4 times per day
• Visit schedule – Day 1, 3, and 5
BACTOvation Study Design
23
BACTOvation Adenoviral Conjunctivitis US Investigators
24
• Successful completion of Phase 2b/3 adenoviral conjunctivitis will be one of the two registration studies needed for “approval” of adenoviral conjunctivitis in the US and elsewhere
• Successful completion of POC bacterial conjunctivitis study will provide clinical basis to pursue the indication for the second most important cause of infectious conjunctivitis
Summary of Infectious Conjunctivitis
Will be the first product indicated for adenoviral conjunctivitis
Will be first product indicated for both viral and bacterial conjunctivitis
Business Unit Updates – MediBay
Russell Hoon Vice President,
Advanced Wound Care
26 26
27
• A natural agent produced by white blood cells as part of the innate immune system
• Broad spectrum antimicrobial that doesn’t give rise to resistance
• Effective against bacteria (gram positive and negative), fungi, and biofilm destruction
• Rapid time-kill (less than 60 seconds-in vitro) with effectiveness greater than 99.9%
• NeutroPhase concentration: 0.01%
NeutroPhase® Pure Hypochlorous Acid in Saline
28 28
HOCl produced by neutrophils is unstable
with very limited shelf-life
(rendering it not commercially viable)
This slide is the first frame of a video demonstrating
how a Neutrophil captures, engulfs, and then
produces HOCl to kill invading microbes
Microbe
Neutrophil
HOCl
NovaBay’s NeutroPhase® Mimics Neutrophils
29
• NeutroPhase® addresses the greater than six million patient U.S. chronic wound care market
• Three 510(k) notifications
• NBY business model is to form partnerships with Medical device/pharma companies
– Collaboration for late stage development and commercialization
– Early stage collaboration with companies with complementary expertise/technology
NeutroPhase® Marketing
30
Global Partnering
Brazil
(25)
Advanced Negotiations
Distributor in Place
Partnering Discussions
31
Pioneer Pharma Coverage in China
• Covers every region
• 510 regional distributors
• 7000 hospitals covered
P P
P
32
Necrotizing Fasciitis CBS News San Francisco
33 33
Corporate Update
Annual Shareholder Meeting
Tom Paulson
Chief Financial Officer
NYSE-MKT: NBY
35
Financial Overview Key Statistics
Million
Market Cap (June 6)
$49
March 31 Cash and Equivalents (Plus an additional ~$1M of Acc/Rec from Partners)
$13.2
Debt $0
Shares Outstanding (only common outstanding)
37
36
Anticipated Upcoming Milestones*
*Expected as of June 2013
Year Date Event
2013
H1 NeutroPhase Partnerships USA / ROW
H2 Data - Part 2 of Phase 2a Urology (UCBE)
H2 Data - Phase 2b Impetigo Global study
H2 Data - Phase 2b BAYnovation Global Study
2014
H1 Sign Conjunctivitis Partner
H1 Initiate Impetigo Phase 3 Global Studies
H2 Commercialize Conjunctivitis Product in Brazil
H2 Begin 2nd Conjunctivitis Phase 3 (BAYnovation II)
37
NBY Management Team
Roy Wu Senior Vice President
Business Development
Ron Najafi, Ph.D. Chief Executive Officer
Tom Paulson Chief Financial Officer
Kenneth Krantz, MD, Ph.D. Vice President Medical Affairs
David Stroman, Ph.D. Senior Vice President
Ophthalmology
Russell Hoon Vice President
Advance Wound Care
Keith Bley, Ph.D. Senior Vice President Product Development
38
Experienced Leadership Board of Directors
38
Paul Freiman Former CEO, NTII; Former Chairman & CEO, Syntex
Alex McPherson, MD, Ph.D. Lead Independent Director, Chair-N&GC
Former President & CEO, Biomira Inc. Past President CMA, Deputy Minister Health
Gail Maderis President and CEO, BayBio Former CEO of Five Prime Therapeutics Former president of Genzyme Oncology
Charles Cashion Chair- Audit Committee
SVP, CFO at Conatus Pharma Former CFO at IDUN Pharmaceuticals, Inc.
Robert Tufts Partner, Tufts, Stephenson & Kasper
Tony Wicks Chair-Compensation Committee
Former CEO of several mining companies
Tony Dailley, D.D.S. Co-founder 1-800-Dentist
Ron Najafi, Ph.D. Chairman and CEO, NovaBay
39
• Confirmed New Anti-Infective Paradigm
– Auriclosene effective against bacteria, viruses and fungi
– Does not give rise to resistance
• Multiple Phase 2 Global Trial Results in 2013
– Impetigo
– Infectious Conjunctivitis
– Urinary Catheter Blockage and Encrustation
• Commercial Launch of NeutroPhase® Underway
– Partners finalized in China, South East Asia, and South Korea
– Future partnerships will target US, EU, MENA, LATAM
• Validating Partnerships for auriclosene
– Galderma for Impetigo
– Virbac for animal health
• Risk-Mitigating Strategy
Value Proposition
Annual Shareholder Meeting
Q&A Session
Beyond Antibiotics
Corporate Update
Annual Shareholder Meeting
June 11, 2013
NYSE-MKT: NBY