Pharma-Bio Serv, Inc. · OTC:PBSV
Pharma-Bio Serv — Investor Presentation (December 2015)
33 slides from Pharma-Bio Serv's investor presentation, Dec 1, 2015
Slide 1: Corporate Presentation December 2015
PHARMABIGRERV CORPORATE PRESENTATION DECEMBER 2015
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which statements may include information regarding the plans, intentions, expectations, future financial performance, or future operating performance of Pharma-B
Slide 3: Integrated Services Overview
Integrated Services Overview PHARMA GEE RV y TENZALABS 4 < & METROLOGIX UN ad Aeecory
Slide 4: Pharma-Bio Serv Industries Served
Pharma-Bio Serv Industries Served o/ ~“S*. Global Life Sciences Industry Leader In Regulatory Compliance ~ And Other Regulated Industry Support Services. FDA and ional agencies reg y i related services ~ Pharmaceutical ~+ Biotechnology ~ Chemical ~> Medical Device ~ Cosmetic ~ Food and Allied Produc
Slide 5: Core Business
Core Business PHARMA BIO) Vaidatn & Complanee ENZALABS QUALITY TESTING SERVICES ° EUROPEAN MEDICINES AGENCY INC. Consultancy & Industrial Services (PBSV) ~ Validation, CSV & Project Management ~ Regulatory Affairs, Compliance & Quality Systems + Technology Transfer; Commissioning & Qualification ~ Q
Slide 6: Validation & Compliance Consulting
Validation & Compliance Consulting Clients include: Y 8 ofthe Top 10 Global Bio-Pharma Companies Y 7 of the Top 10 Global Medical Technology Companies ~ Recognized for 10 consecutive years as one of the top Validation & Compliance Service companies in Puerto Rico by Caribbean Business. + Offices in
Slide 7: Comprehensive Support Services
Comprehensive Support Services ERV Academy METROLOGIX CALIBRATION SERVICES Training Services + Full suite of state-of-the-art multi-disciplinary Technical And Regulatory Standards Training and Knowledge Management Calibration Services + On-site Calibration Services + Risk-Based Calibration Program M
Slide 8: Investment Highlights
Investment Highlights ~ Industry Leader In Regulatory Compliance Consulting + Organic & Acquisition Growth Strategy ~ 2M Share Buyback In Place ~ $14M Cash On Balance Sheet (ao 7/31/15) ~ Top Tier T. R. Winston & Company M & AAdvisory Team members include Michael Meyers, M.P.H., Managing Director an
Slide 9: Key Statistics
Key Statistics Stock Symbol: Exchange: Recent Price: 52-Week Range: Shares Outst: Market Cap: 2014 Revenue 2014 Net Income Fiscal year End Industry: Headquarters: Pharma-Bio Serv Inc. PBSV OTC.QB $0.94 (11.30.15) $0.85 to $1.40 23M (731.15) $21.6M (11.30.15) $28M $2.4M Oct 31 Regulatory Compliance C
Slide 10: Our Results
Our Results Projects — Scale & Scope Client Project Scale: $1k to $200M+ Project Duration: 1 day to 5 years+ Projects Won: $1k to SSM+ PBSV Resources: 1 to 90+
Slide 11: Recent Developments
Recent Developments ~ April 2015 — Formed Pharma-Brazil subsidiary to provide Latin American Compliance Consulting, Calibrations and support services. ~ December 2014 — Retained T.R. Winston & Company to assist Pharma-Bio Serv in enhancing the Company's growth strategy through business development a
Slide 12: Financial Highlights
Financial Highlights ~ Revenues of $17.5M, Net Income of $1.1 million for the nine months ended July 31, 2015. ~ Revenues of $27.6M, Net Income of $2.4 million for the year ended Oct 31, 2014.
Slide 13: Historical Perspective
Historical Perspective ~ Exceptional Corporate Management Culture ~ Never Experienced A Losing Quarter 4,000,000 Revenues- All Divisions 11,479,083
Slide 14: Lifecycle Support with Integrated Services
Lifecycle Support with Integrated Services Research & io PBSV Integration Post-Marketing in the Product Life Cycle Pre-Approval =] Scale-Up & Transfer Commercial Manufacturing 1
Slide 15: Integrated Services in Context
Integrated Services in Context PBSV Services through the Product Life-Cycle 4, Commercial 3. Scale-Up & Transfer Manufacturing aun :
Slide 16: Validation & Project Management
Validation & Project Management Projects - Scale and Scope ~ Validation Master Plans ~ Cleaning Validation (CV) ~ Risk Based Validation ~ Analytical Methods Validation (MV) + ‘ing Process (PV) ~< SW Validation & CSV -21 CFR Part 11 ~ Packaging Process Validation (Pkg V) > Capital Projects Management
Slide 17: Technology Transfer Commissioning & Qualification
Technology Transfer Commissioning & Qualification Projects - Scale and Scope ~ Tech Transfer/Process Change Filings ~ Equipment/Manufacturing Changes ~ Tech Transfer Strategies —1Q, OQ, PQ & Qualification + Quality by Design / Risk Management ~ Site, Component, Packaging, Batch & + NPI/New Technolog
Slide 18: Regulatory Compliance & Quality Systems
Regulatory Compliance & Quality Systems Projects - Scale and Scope ~ Enforcement — 483’s, Warning Letters, < Gap Analysis, Remediation & Consent Decrees Implementation Plans ~ PAI Readiness/Mock-ups ~ Stability Protocols & Programs ~ QS Compliance Audits - CAPA, ~ Development and execution of GMP. A
Slide 19: Quality Risk Management
Quality Risk Management Projects - Scale and Scope ~ Interpretation and Application of QRM + ICH Guidelines Compliance - Q8, Guidelines Q9, Q10. ~ Risk Analysis & Assessment ~ Training & Education ~ Risk ID & Control (FMEA, FMECA, ~ Auditing & Inspections FTA, HAZOP) ~ Change Management & Control ~
Slide 20: Regulatory Affairs
Regulatory Affairs rranwaneReny Projects - Scale and Scope US Agents Establishment Registrations Listing of Products Regulatory Dossiers Compliance Assessments Preparation of responses to FDA for 483's, Warning Letters, and Consent + Decrees oo os + + Preparation of CTD (all 5 modules) Preparation o
Slide 21: Analytical Laboratory Testing Services
Geunzalass Quality, Compliance and Fast Results! Analytical, Microbiological testing, and Method bi i 3 rt Development and Validation Services to various REGISTERED industries: ~+ Pharmaceutical ~ Medical Devices + Biotechnology / Life Sciences + Food & Cosmetics ~ Government Agencies ~ Others — ~)
Slide 22: Pharma-Bio Serv Academy
PHARMA’ Academy RV d Client Requir Onsite ining Tailored To A v oe % Sy RRS, aR AR cGMPs for Drugs, Biologics, Medical Devices, Cosmetics, Foods, and HCT/P Risk Based Cleaning Validation Quality Risk Management Workshop Process Validation — “Life Cycle Approach to Process Control” Risk Based Equipme
Slide 23: Metrologix Calibration Services
METROLOGIX ‘CALIBRATION SERVICES, Metrologix provides cost-effective, compliant calibration services Calibration Program Management Laboratory & On-site Calibration Services Calibration Program Risk Assessment Compliance Auditing & Remediation Services Instrument Tolerance and Calibration Frequency
Slide 24: Our Standards
Our Standards We live by the same regulatory and quality standards as our customers. We are Minority-Owned, FDA-Regulated and ISO Certified. FDA FDA Inspected and Regulated jority-Business Enterprise (MBE) oyA/NU/DE/CA/CAROUNAS PR ISO 9001 Certified C) Categorized as "Critical Industry Supplier” by
Slide 25: Recognized Enterprise
Recognized Enterprise feciciert ofthe Presient'= rd, for Es Sgntcant contbutonsto he increase of US exports. Throughout our history we have been recognized by y and ps reecartionst
Slide 26: Leadership in Industry Associations
Leadership in Industry Associations (ISPE) Active! ‘ond Spain) conencio yexecicioh ltematonal Societyortrarmace ‘DE PUERTO RICO bers 12 Eeonomic Develop sce 2010. Board Member tthe Puerto Export Commer syritarsof the Process Valisation mma ParertlDog Asociaton FDA. Active embers US sy Waster PDA Tec
Slide 27: Global Growth Strategy
Global Growth Strategy ~ Provide Additional Regulatory Compliance Services in U.S., South America & European Markets Organically And Through Strategic Acquisition ~ Expand Geographic Reach Organically And Through Strategic Acquisition ~+ Invest In U.S., South America & European Infrastructure And Ta
Slide 28: Differentiators
Differentiators ~ Sustainable Long Term Customer Relationships Y Delivering Innovation and Cost Reduction results (Competitive Focus) v Implementing Quality Risk Management Initiatives v Delivering tangible results through Experience and Risk Based CQV ¥ Providing Full Product Life-Cycle Solutions (
Slide 29: Differentiators
Differentiators ~ In June 2011, Pharma-Bio Serv obtained a new Grant of Industrial Tax Exemption pursuant to the terms and ‘iggr conditions set forth in Act No. 73 of May 28, 2008 (“the Ad } Grant”) issued by the Puerto Rico Industrial aa 2. Development Company (“PRIDCO”). - ~ The Grant provides rel
Slide 30: Track Record of Success
Track Record of Success Over 22 Years of Experience ~ Successful Management Team ~ Headcount: 400+ ~ HQ in Puerto Rico with offices in U.S., Ireland, Spain and Brazil
Slide 31: Highly Experienced International Management Team
Highly Experienced International Management Team United States Global Elizabeth Plaza —VictorS4nchez —_— Pedro Lasanta MagalyAham _lleanaB. Ayala Founder & Chaieman President & CEO, CFO, VP-Finance & Adminiskation | Vice President Business Developer. Global Operations Global Operations a one US Oper
Slide 32: Esteemed Board of Directors
Esteemed Board of Directors + Elizabeth Plaza - Chairman of the Board since 2006, Founder ~ Kirk Michel - Director since 2006 ~ Dov Perlysky - Director since 2004 ~ Howard Spindel - Director since 2006 ~ Irving Wiesen - Director since 2006
Slide 33: For More Information
For More Information Investor Relations Scott Gordon, President CorProminence 377 Oak Street Concourse 2 Garden City, NY 11530 Office: 631.703.4900 Email: [email protected]
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