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- 1. Beyond Antibiotics Corporate Update Ron Najafi Chairman & CEO Annual Shareholder Meeting June 11, 2013 NYSE-MKT: NBY
- 2. 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
- 3. 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
- 4. 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
- 5. 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?
- 6. 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
- 7. 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
- 8. 7 $2B (WW) $400-600 Mil (WW) $100-200 Mil (US) Four Distinct Business Units Pursuing Independent Opportunities
- 9. 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
- 10. 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 20091998-2003 2006 2012 20122012 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
- 11. 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*
- 12. Clinical Trials Update Pink Eye (Infectious Conjunctivitis) David Stroman, Ph.D. Senior Vice President Ophthalmology
- 13. 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
- 14. 13 • Number 1 unmet medical need in ocular infections • Epidemic Keratoconjunctivitis (EKC) – Can be sight threatening – Highly contagious – Causes large epidemic outbreaks Adenoviral Conjunctivitis
- 15. 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
- 16. 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
- 17. 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
- 18. 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
- 19. 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
- 20. 19 BAYnovation Adenoviral Conjunctivitis US Investigators
- 21. 20 BAYnovation Adenoviral Conjunctivitis India Investigators
- 22. 21 BAYnovation Adenoviral Conjunctivitis Brazil Investigators
- 23. 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
- 24. 23 BACTOvation Adenoviral Conjunctivitis US Investigators
- 25. 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
- 26. Business Unit Updates – MediBay Russell Hoon Vice President, Advanced Wound Care
- 27. 26
- 28. 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
- 29. 2828 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
- 30. 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
- 31. 30 Global Partnering Brazil (25) Advanced Negotiations Distributor in Place Partnering Discussions
- 32. 31 Pioneer Pharma Coverage in China • Covers every region • 510 regional distributors • 7000 hospitals covered P P P
- 33. 32 Necrotizing Fasciitis CBS News San Francisco
- 34. 33
- 35. Corporate Update Annual Shareholder Meeting Tom Paulson Chief Financial Officer NYSE-MKT: NBY
- 36. 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
- 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)
- 38. 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
- 39. 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
- 40. 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
- 41. Annual Shareholder Meeting Q&A Session
- 42. Beyond Antibiotics Corporate Update Annual Shareholder Meeting June 11, 2013 NYSE-MKT: NBY