Introduction Opportunity n Market potential of recombinant drugs Problem n Lack of manufacturing capacity Solution n Pharm. Out: Contract Bio. Manufacturing
Industry $48. 5 Billion Projected Biotech Industry Growth $28. 3 Billion $16. 1 Billion Year
Expanding Pipeline Pre-Mapping of Human Genome Post-Mapping of Human Genome n 500 targets n 10, 000 targets n 175 biotech drugs n 3, 500 > potential biotech drugs
Industry Capacity Shortage 800, 000 L VOID
Industry Drug Development Timeline Research and Development 16 YEARS Pre-Clinical Testing $500 Million Phase III FDA Review & Approval Commercialization 0 4 6 8 10 Year 12 14 16
Marketplace Industry Manufacturing Options n Build own plant n License technology n Outsource production
Marketplace Market Conditions n Expanding Pipeline n Capacity Shortage Solution: Outsourcing n Lowers Costs n Speeds Time to Market n Decreases Risk
Services The Pharm. Out Service Platform n Bio. Manufacturing n Process Development n Support Services
Competition Flexibility (High) Future Pharm. Out Capacity (Small) Expansion Capacity (Large) Other CMO’s Large Pharma In-House Flexibility (Low)
Target Customer Small Biotechnology Companies n Recently Funded 1, 040 Private Biotech Companies Now 140 Target Companies n Recombinant Development n Limited House Protein Drugs in Resources to Manufacture In-
Why Pharm. Out? Biotech Wants: Pharm. Out Provides: n Minimize Capital Risk n Scalable Facilities & Support Services n Gain Capacity & Expertise n Improved Scheduling & Capacity Utilization n Maximize Internal Resources; Saves in Cap. Ex & Bad Batches n Improved Manufacturing Process n Reduce Time to Market by 12 to 24 months n Process & Manufacturing Expertise
Service Strategy Outsourced Bio. Manufacturing n Bio. Manufacturing Facilities n Process Development n Support Services n Brokerage Services n Client/Customer Relationships in Place n Improved Manufacturing Processes Leads to Improved Efficiency
Value Proposition “Our competency in manufacturing allows clients to focus on their competency, research and development. ” n Excellence in Process Development and Bio. Manufacturing n Regulatory Compliance n Expert Staff n Strong Relationship Management n Bio. Manufacturing Innovation
Revenue Model Process Development n $300, 000 per development n Pharm. Out shares process development rights Bio. Manufacturing n $100, 000 average per production run
Market Possibility Market Potential n 140 n 1 Target Biotech Companies Drug per Company n Revenue Generated for Full Services = $1. 3 Million n Total Market Potential = $182 Million
Marketing Strategy Relationship Marketing n In-House, n Team Expert Sales Force Based Project Management n Comprehensive n Significant Website Industry Presence
Operations Manufacturing Process 1. 2. 3. Fermentation = Recombinant Protein = Bacterial Protein Recovery 4 Main Steps … Purification Packaging Cell Solution Provided 4. Fermentation Recovery Purification Fill
Operations Facility Snapshot n 20, 000 SF Leased Facility n ISO 9001 and c. GMP Validation n Equipment 10, 000 SF Clean Room Fermenters, centrifuges, homogenizers, protein purification suites and cold rooms
Competitive Advantage: Operational Excellence n. Mnfg. Expertise n. Flexible n. Asset Facility Utilization Optimized Process Customized Solutions Maintain Core Comptency
Operations Capital Needed $7. 8 Million $3. 4 Million $2. 5 Million Year
Revenue $59. 5 Million n. Pricing n. Asset Model Utilization $35. 5 Million n. Lease versus Build 43% $16. 6 Million Year = Gross Margin
Net Earnings $8. 5 Million $5. 4 Million $8. 5 Million in Year 5 14% $1. 8 Million Year = Profit Margin
Cash Flow $ Millions Year 1 Year 2 Year 3 Year 4 Year 5
Risks/Financial Plan Risks n. Biotechs Remedy Produce In-House n. Government n. Relationship Marketing Regulation n. Friendly FDA Attitude
Offering Three Rounds of Financing………….
Offering Year 1 A $8 M Mnfg. Lease 51% 85% Year 1. 5 B $4 M FDA Approval 6% 60% Year 3 C $5 M $16 M in Rev. 5% 50%
Management CEO Jennifer Eby COO Douglas Gier VP, Marketing Cecily Ford Maguire CFO Jay Behringer
Advisory Board 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 High. Tech Business Decisions Sandra Fox, President
Conclusion Opportunity n Market potential of recombinant drugs Problem n Lack of manufacturing capacity Solution n Pharm. Out: Contract Bio. Manufacturing
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