Introduction Opportunity Market potential of recombinant drugs Problem Lack of manufacturing capacity Solution PharmOut: Contract BioManufacturing
Industry Projected Biotech Industry Growth $28.3 Billion $48.5 Billion $16.1 Billion Year
Expanding Pipeline Pre-Mapping of Human Genome 500 targets 175 biotech drugs Post-Mapping of Human Genome 10,000 targets 3,500 > potential biotech drugs
Industry Capacity Shortage 800,000 L VOID
Industry Year Commercialization FDA Review & Approval Phase II Phase I Pre-Clinical Testing Research and Development Phase III 16 YEARS $500 Million Drug Development Timeline
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
Competition Capacity (Small) Flexibility (High) Capacity (Large) Flexibility (Low) Large Pharma In-House Other CMO’s PharmOut Future Expansion
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
Why PharmOut? Biotech Wants:PharmOut Provides: Minimize Capital Risk Gain Capacity & Expertise Maximize Internal Resources; Saves in CapEx & Bad Batches Reduce Time to Market by 12 to 24 months Scalable Facilities & Support Services Improved Scheduling & Capacity Utilization Improved Manufacturing Process Process & Manufacturing Expertise
Service Strategy Outsourced BioManufacturing Brokerage Services Client/Customer Relationships in Place Improved Manufacturing Processes Leads to Improved Efficiency BioManufacturing Facilities Process Development Support Services
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
Fermentation Recovery Purification Packaging 4 Main Steps … Operations Manufacturing Process Fermentation Recovery Purification Fill = Recombinant Protein = Bacterial Protein Cell Solution Provided
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: Maintain Core Comptency Optimized Process Customized Solutions Operational Excellence Flexible Facility Asset Utilization Mnfg. Expertise
Operations Capital Needed $2.5 Million $3.4 Million $7.8 Million Year
Revenue Pricing Model Asset Utilization Lease versus Build $35.5 Million $59.5 Million $16.6 Million 43% = Gross Margin Year
$5.4 Million $8.5 Million Net Earnings $1.8 Million $8.5 Million in Year 5 14% = Profit Margin Year
Cash Flow $ Millions Year 1 Year 2 Year 3 Year 4 Year 5
Risks/Financial Plan RisksRemedy Biotechs Produce In-House Relationship Marketing Government Regulation Friendly FDA Attitude
Offering Three Rounds of Financing………….
Offering Year 1 A Mnfg. Lease 51% 85% $8 M Year 3 C $16 M in Rev. 5% 50% $5 M Year 1.5 B FDA Approval 6% 60% $4 M
Management CEO Jennifer Eby CFO Jay Behringer VP, Marketing Cecily Ford Maguire COO Douglas Gier
Advisory Board HighTech Business Decisions Sandra Fox, President 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 Matt Lombardi, Sr. Project Manager
Conclusion Opportunity Market potential of recombinant drugs Problem Lack of manufacturing capacity Solution PharmOut: Contract BioManufacturing
Questions?