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Introduction

Introduction. Opportunity Market potential of recombinant drugs. Problem Lack of manufacturing capacity. Solution PharmOut: Contract BioManufacturing. $48.5 Billion. $28.3 Billion. $16.1 Billion. Industry. Projected Biotech Industry Growth. Year. Pre-Mapping of Human Genome

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Introduction

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  1. Introduction • Opportunity • Market potential of recombinant drugs Problem • Lack of manufacturing capacity Solution • PharmOut: Contract BioManufacturing

  2. $48.5 Billion $28.3 Billion $16.1 Billion Industry Projected Biotech Industry Growth Year

  3. Pre-Mapping of Human Genome 500 targets 175 biotech drugs Post-Mapping of Human Genome 10,000 targets 3,500 > potential biotech drugs Expanding Pipeline

  4. 800,000 L VOID Industry • Capacity Shortage

  5. Industry Drug Development Timeline Research and Development 16 YEARS $500 Million Pre-Clinical Testing Phase I Phase II Phase III FDA Review & Approval Commercialization 0 4 6 8 10 12 14 16 Year

  6. Marketplace • Industry Manufacturing Options • Build own plant • License technology • Outsource production

  7. Marketplace • Market Conditions • Expanding Pipeline • Capacity Shortage Solution: Outsourcing • Lowers Costs • Speeds Time to Market • Decreases Risk

  8. Services • The PharmOut Service Platform • BioManufacturing • Process Development • Support Services

  9. Future Expansion PharmOut Competition Flexibility (High) Capacity (Small) Capacity (Large) Other CMO’s Large Pharma In-House Flexibility (Low)

  10. Target Customer • Small Biotechnology Companies • Recently Funded • 1,040 Private Biotech Companies Now • 140 Target Companies • Recombinant Protein Drugs in Development • Limited Resources to Manufacture In-House

  11. Biotech Wants: PharmOut Provides: Why PharmOut? • Scalable Facilities & Support Services • Minimize Capital Risk • Improved Scheduling & Capacity Utilization • Gain Capacity & Expertise • Improved Manufacturing Process • Maximize Internal Resources; Saves in CapEx & Bad Batches • Process & Manufacturing Expertise • Reduce Time to Market by 12 to 24 months

  12. Service Strategy • Outsourced BioManufacturing • BioManufacturing Facilities • Process Development • Support Services • Brokerage Services • Client/Customer Relationships in Place • Improved Manufacturing Processes Leads to Improved Efficiency

  13. Value Proposition • “Our competency in manufacturing allows clients to focus on their competency, research and development.” • Excellence in Process Development and BioManufacturing • Regulatory Compliance • Expert Staff • Strong Relationship Management • BioManufacturing Innovation

  14. Revenue Model • Process Development • $300,000 per development • PharmOut shares process development rights • BioManufacturing • $100,000 average per production run

  15. Market Possibility • Market Potential • 140 Target Biotech Companies • 1 Drug per Company • Revenue Generated for Full Services = $1.3 Million • Total Market Potential = $182 Million

  16. Marketing Strategy • Relationship Marketing • In-House, Expert Sales Force • Team Based Project Management • Comprehensive Website • Significant Industry Presence

  17. = Recombinant Protein = Bacterial Protein Cell Solution Provided Recovery Fermentation Purification Fill Operations • Manufacturing Process Fermentation Recovery Purification Packaging 4 Main Steps …

  18. Operations • Facility Snapshot • 20,000 SF Leased Facility • ISO9001 and cGMP Validation • Equipment • 10,000 SF Clean Room • Fermenters, centrifuges, homogenizers, protein purification suites and cold rooms

  19. Competitive Advantage: Operational Excellence • Mnfg. Expertise Optimized Process • Flexible Facility Customized Solutions • Asset Utilization Maintain Core Comptency

  20. Operations • Capital Needed $7.8 Million $3.4 Million $2.5 Million Year

  21. Revenue $59.5 Million • Pricing Model • Asset Utilization • Lease versus Build $35.5 Million 43% = Gross Margin $16.6 Million Year

  22. Net Earnings $8.5 Million $5.4 Million $8.5 Million in Year 5 14% = Profit Margin $1.8 Million Year

  23. Cash Flow $ Millions Year 2 Year 3 Year 1 Year 4 Year 5

  24. Risks/Financial Plan • Risks Remedy • Biotechs Produce • In-House • Relationship • Marketing • Government Regulation • Friendly FDA Attitude

  25. Offering Three Rounds of Financing………….

  26. Year 1 $8 M 51% A Mnfg. Lease 85% Year 1.5 $4 M 6% B FDA Approval 60% Year 3 $5 M 5% C $16 M in Rev. 50% Offering

  27. Management CEO Jennifer Eby VP, Marketing Cecily Ford Maguire COO Douglas Gier CFO Jay Behringer

  28. Matt Lombardi, Sr. Project Manager Vicki Jenings, Director of Operations Dr. Steve Orndorff, President Dr. David Drubin, Professor of Genetics Dr. James Powell, Assoc. Director, Mnfg Mike Green, Director, Mnfg  HighTech Business Decisions Sandra Fox, President Advisory Board

  29. Conclusion • Opportunity • Market potential of recombinant drugs Problem • Lack of manufacturing capacity Solution • PharmOut: Contract BioManufacturing

  30. Questions? PharmOut

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