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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 • 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 500 targets 175 biotech drugs Post-Mapping of Human Genome 10,000 targets 3,500 > potential biotech drugs Expanding Pipeline
800,000 L VOID Industry • Capacity Shortage
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
Marketplace • Industry Manufacturing Options • Build own plant • License technology • Outsource production
Marketplace • Market Conditions • Expanding Pipeline • Capacity Shortage Solution: Outsourcing • Lowers Costs • Speeds Time to Market • Decreases Risk
Services • The PharmOut Service Platform • BioManufacturing • Process Development • Support Services
Future Expansion PharmOut Competition Flexibility (High) Capacity (Small) Capacity (Large) Other CMO’s Large Pharma In-House Flexibility (Low)
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
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
Service Strategy • Outsourced BioManufacturing • BioManufacturing Facilities • Process Development • Support Services • Brokerage Services • Client/Customer Relationships in Place • Improved Manufacturing Processes Leads to Improved Efficiency
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
Revenue Model • Process Development • $300,000 per development • PharmOut shares process development rights • BioManufacturing • $100,000 average per production run
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
Marketing Strategy • Relationship Marketing • In-House, Expert Sales Force • Team Based Project Management • Comprehensive Website • Significant Industry Presence
= Recombinant Protein = Bacterial Protein Cell Solution Provided Recovery Fermentation Purification Fill Operations • Manufacturing Process Fermentation Recovery Purification Packaging 4 Main Steps …
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
Competitive Advantage: Operational Excellence • Mnfg. Expertise Optimized Process • Flexible Facility Customized Solutions • Asset Utilization Maintain Core Comptency
Operations • Capital Needed $7.8 Million $3.4 Million $2.5 Million Year
Revenue $59.5 Million • Pricing Model • Asset Utilization • Lease versus Build $35.5 Million 43% = Gross Margin $16.6 Million Year
Net Earnings $8.5 Million $5.4 Million $8.5 Million in Year 5 14% = Profit Margin $1.8 Million Year
Cash Flow $ Millions Year 2 Year 3 Year 1 Year 4 Year 5
Risks/Financial Plan • Risks Remedy • Biotechs Produce • In-House • Relationship • Marketing • Government Regulation • Friendly FDA Attitude
Offering Three Rounds of Financing………….
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
Management CEO Jennifer Eby VP, Marketing Cecily Ford Maguire COO Douglas Gier CFO Jay Behringer
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
Conclusion • Opportunity • Market potential of recombinant drugs Problem • Lack of manufacturing capacity Solution • PharmOut: Contract BioManufacturing
Questions? PharmOut