Pharma-Bio Serv, Inc. · OTC:PBSV
Pharma-Bio Serv — Investor Presentation (September 2015)
33 slides from Pharma-Bio Serv's investor presentation, Sep 1, 2015
Slide 1: Corporate Presentation September 2015
Corporate Presentation September 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 BOG ERV = Geurvzaians “ ia 4 seMETRQLOGX maar env
Slide 4: Validation & Compliance Consulting
Validation & Compliance Consulting services Global Life Sciences Industry Leader In Regulatory Compliance And Other Regulated Industry Support Services. FDA and International agencies regulatory compliance related ~ Pharmaceutical ~ Biotechnology + Chemical ~ Medical Device ~ Cosmetic ~ Food and All
Slide 5: Validation & Compliance Consulting
Validation & Compliance Consulting Clients include: ~ 8 of the Top 10 Global Bio-Pharma Companies ¥ 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 i
Slide 6: Core Business
Core Business manwacney TENZALABS QUALITY TESTING SERVICES me ® ° EUROPEAN MEDICINES AGENCY Consultancy & Industrial Services (PBSV) ~+ Validation, CSV & Project Management ~ Regulatory Affairs, Compliance & Quality Systems ~ Technology Transfer; Commissioning & Qualification ~ Quality Risk Manageme
Slide 7: Comprehensive Support Services
Comprehensive Support Services Training Services PHARMA’ ERV ~ Full suite of state-of-the-art multi-disciplinary Academy Technical And Regulatory Standards Training and Knowledge Management METROLOGIX Calibration Services CALIBRATION SERVICES ~ On-site Calibration Services ~ Risk-Based Calibration P
Slide 8: Investment Highlights
+ o + Investment Highlights Industry Leader In Regulatory Compliance Consulting Organic & Acquisition Growth Strategy 2M Share Buyback In Place $14M Cash On Balance Sheet (aio 4/3015) Top Tier T. R. Winston & Company M & AAdvisory Team members include Michael Meyers, M.P.H., Managing Director and He
Slide 9: Key Statistics
Key Statistics Pharma-Bio Serv Inc. Stock Symbol: PBSV Exchange: OTC.QB Recent Price: $1.03 (.s1.15) 52-Week Range: $0.83 to $1.40 Shares Outst: 23M (4:20.15) Market Cap: $23.7M (o31.18) 2014 Revenue $28M 2014NetIncome $2.4M Fiscal year End Oct 31 Industry: Regulatory Compliance Consulting Headquart
Slide 10: 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 11: Financial Highlights
Financial Highlights “> Revenues of $11.3M, Net Income of $0.6 million for the six months ended April 30, 2015, a decrease of $2.3M and $0.3M respectively vs. 2014. ~ Revenues of $27.6M, Net Income of $2.4 million for the year ended Oct 31, 2014, a decrease of $5.5M and $2.5M respectively vs. 2013.
Slide 12: Historical Perspective
Historical Perspective 138,000,000 36,000,200 4. 000,000 32,000,000 30,000,00 28,000,000 26,000,000 24,000,900 22,000,000 20,000,00 1,000,000 16,000,000 14,000,000 12,000,000: 41,000,000 8,000,00 6,900,000 4,000,000; 2,0,000 ° ~ Exceptional Corporate Management Culture ~ Never Experienced A Losing Q
Slide 13: Integrated Services in Context
Integrated Services in Context Services in Context Research & ae PBSV Integration Post-Marketing in the Product Life Cycle Scale-Up & Transfer Commercial Manufacturing 13 Pre-Approval
Slide 14: Our Results
Our Results Projects — Scale & Scope Client Project Scale: $1k to $200M+ Project Duration: 1 day to 5 years+ Projects Won: $1k to S5M+ PBSV Resources: 1 to 90+ m1
Slide 15: Integrated Services in Context
Integrated Services in Context PBSV Services through the Product Life-Cycle 1.ReD Pre-Clinical Studies Development Strategic Guide * Testing Documentation Fisid Support QbO Development Project Management Reg Affais Cheracter Tech Documantation Validation Corsuting Reg Affairs + Project Management 4,
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) ~ Manufacturing Process Validation (PV) ~~ SW Validation & CSV -—21 CFR Part 11 ~ Packaging Process Validation (Pkg V) <> Capit
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 Technology
Slide 18: Regulatory Compliance & Quality Systems
Regulatory Compliance & Quality Systems Projects - Scale and Scope ~ Enforcement — 483's, Waming Letters, <> Gap Analysis, Remediation & Consent Decrees Implementation Plans ~ PAI Readiness/Mock-ups ~ Stability Protocols & Programs ~ QS Compliance Audits CAPA, APR’s, <> Development and execution of
Slide 19: Quality Risk Management
Quality Risk Management Projects - Scale and Scope ~ Interpretation and Application of QRM + Guidelines ~ Risk Analysis & Assessment ~ Risk ID & Control (FMEA, FMECA, FTA, HAZOP) ~ QA Pyramid Compliance oo os manneKeny rs ICH Guidelines Compliance — Q8, Q9, Q10. Training & Education Auditing & Inspe
Slide 20: Regulatory Affairs
Regulatory Affairs mrananeeay 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 Preparation of CTD (all 5 modules) Prepara
Slide 21: TENZALABS
TENZALABS QUALITY TESTING SERVICES Quality, Compliance and Fast Results! Analytical, Microbiological testing, and Method Development and Validation Services to various industries: ~ Pharmaceutical ~ Medical Devices + Biotechnology / Life Sciences + Food & Cosmetics ~> Government Agencies ~ Others FD
Slide 22: Training Tailored To Accommodate Client Requirements Onsite
Training Tailored To Accommodate Client Requirements Onsite v cGMPs for Drugs, Biologics, Medical Devices, Cosmetics, Foods, and HCTIP Risk Based Cleaning Validation Quality Risk Management Workshop Process Validation —"Life Cycle Approach to Process Control" Risk Based Equipment Qualification Human
Slide 23: METROLOGIX
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 A
Slide 24: Our Standards
Our Standards We live by the same regulatory and quality standards as our customers. We are a Minority-Owned, FDA-Regulated, ISO Certified and SOX-Compliant Corporation. FDA frisdc ©) Certified as Minority-Business Enterprise (MBE) FDA Inspected and Regulated PA/NJ/DE/CA/CAROLINAS/PR We are a Public
Slide 25: Recognized Enterprise
Recognized Enterprise Excellence in Service Qualiy Award jacion de Productos de Puerto Rice of 2013, Scienza Labs was recognized on the Annual Meeing of Association af Poette Rice Products Awarded 2 Woman Enkepteneur ‘ofthe Year 2013, Johreon & Johnson Exe: DIT =Minerily Supplier 2008 & 2009 - Concu
Slide 26: Leadership in Industry Associations
Leadership in Industry Associations Regulatory affcirs Professional soctely (RAPS) Active rcownone series | emoats (US and Socin) wilh US RA Certicotion PUERTO RIC gees vie 8 [Carenunily serwce Phioninvepy Frocroms Brazil-ULS. | i2cciierins 2 ceoromicona Business Council remerciareictonsrp bekween w
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 Tal
Slide 28: Differentiators
Differentiators GRAS v v v v Y v ¥ v v <> Sustainable Long Term Customer Relationships Delivering Innovation and Cost Reduction results (Competitive Focus) Implementing Quality Risk Management Initiatives Delivering tangible results through Experience and Risk Based CQV Providing Full Product Life-C
Slide 29: Differentiators
Differentiators ~+ In June 2011, Pharma-Bio Serv obtained a new Grant of Industrial Tax Exemption pursuant to the terms and conditions set forth in Act No. 73 of May 28, 2008 (“the Grant”) issued by the Puerto Rico Industrial Development Company (“PRIDCO’). ~ The Grant provides relief on various Pue
Slide 30: Track Record of Success
Track Record of Success Over 22 Years of Experience ~ Successful Management Team ~ Headcount: 400+ ~* HQin Puerto Rico with offices in ULS., Ireland, Spain and Brazil 30
Slide 31: Highly Experienced International Management Team
Highly Experienced International Management Team Global United States Elizabeth Plaza Victor S4nchez Pedro Lasanta Magaly Aham lleana B. Ayala Founder & Chaiman, Frasdent & CEO, CFO, VP finance & Adminstration | Viee Presiden Business Developer Global Operations Giobal Operations Global Operations U
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 32
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] 38
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