Partnering and Product Development A Case Study of Inspiration Biopharmaceuticals, Inc.

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1 Partnering and Product Development A Case Study of Inspiration Biopharmaceuticals, Inc. LIFE SCIENCES LAW, PLLC Prepared for Carolina Innovations Seminar The Office of Technology Development at The University of North Carolina Chapel Hill Sheila Mikhail, JD, MBA 870 Martin Luther King, Jr. Blvd. Chapel Hill, NC May 5, 2011 Copyright 2011 by Life Sciences Law, PLLC

2 Introduction to Inspiration Initial Financings Overview of Ipsen Transaction Transaction Assessment AGENDA Closing/Questions/Comments 2

3 Revolutionizing Hemophilia Treatment Company Overview Founders: Two dedicated fathers of children with hemophilia Mission: Reduce treatment costs for greater access High annual cost of treatment ($200,000/adult) Only 25% of patients worldwide receive treatment Costs impact healthcare choices, career choices, and financial stability 3

4 About Hemophilia Hemophilia is a bleeding disorder in which blood does not clot properly. Injury, surgery, or no obvious cause leads to uncontrolled bleeding Result is severe joint, neurological, and organ damage, or death. Primarily inherited approximately 1 in 10,000 male births Acquired hemophilia is rare, but potentially life-threatening Over 400,000 worldwide sufferers Famous sufferers of hemophilia include Ryan White, Richard Burton, and multiple members of European royal families in England, Spain, Germany, and Russia through Queen Victoria s descendants (including Alexei Romanov, Anastasia s brother and son of the last Tsar of Russia) Company Overview 4

5 Revolutionizing Hemophilia Treatment Business Proposition: Expand Access by Lowering Production Costs and Passing on Savings to Patients Technology Platform: UNC Innovation Darrel Stafford, Ph.D.; Professor, Department of Pathology and Laboratory Medicine at UNC-Chapel Hill Protein Manufacturing Technology Greater Yields of Higher Quality Product at a Lower Cost Company AGENDA Overview Secondary Objectives: Alternative Delivery and Long-Acting Forms: Currently, FIX is Effective Only When Injected Intravenously 2 nd Generation Products in Development 5

6 Unique Company Structure Run as a Virtual Company No Corporate Headquarters Laboratory Services Outsourced Manufacturing Outsourced Use of CROs Company AGENDA Overview Hired Best Managers from Leaders in the Field (Bayer, Baxter, Wyeth) Founders Remain Actively Involved in the Business 6

7 Initial Financings Seed Rounds: Founders (Wealthy Angels) and Select Others Background AGENDA Founders Subsequent Rounds: Institutional (VC) Investments Founders 7

8 Initial Financings Profits Interest Sale Focuses Investment Avoids Further Equity Dilution Enables Investors to Monetize Return Avoids Governance Issues Background AGENDA Inspiration $ Expertise Celtic Pharma FIX J.V. Profits Interest 8

9 Ipsen Transaction Ipsen PS (19.9%) OBI-1 $85M Mfg Pmts Royalties CN Founders/ Celtic (80.1%) Partnering AGENDA Total Investment: $259 M Inspiration Initial Investment: $85 M Avoid Consolidation Avoid Earnings Drag FIN 46 Rules = <20% ownership Post-Money Valuation = $425 M Acquisition of Product from Ipsen Leverage Inspiration Expertise Issue Convertible Note to Avoid Consolidation Royalties/Milestones License and Manufacturing Agreements 9

10 Ipsen Transaction Ipsen Milestone Payments $179M CNs Founders/ Celtic Partnering AGENDA (19.9%) Inspiration (80.1%) Additional $179 M Investment Paid as Milestone Payments Tied to Advancement of Two Lead Products Structured as Convertible Notes Possible Exits Call Right Upon Market Approval of Two Lead Products/ Attainment of Sales Level Target Purchase Price Equals then FMV Expiration Period Drag-Along Founders Force Sale QPO Founders Force Public Offering 10

11 Ipsen Transaction Ipsen 47% Inspiration 53% Founders/ Celtic Partnering AGENDA Control Issues If Call Not Exercised, Ipsen converts notes into PS Ipsen Owns Less Than 50% (If All Notes Converted) Board: Founders/Celtic Control the Board So Long as Ipsen Owns <50% When Ipsen Acquires >50%, Ipsen Controls Board Certain Preferential Rights to Founders Preferred Class Veto Rights Joint Steering Committee 11

12 What s Good re: Structure? Inspiration Provides Significant Funding Provides an Exit Path Ipsen Benefits Stock Price Drug Development Without Earnings Drag Partnering AGENDA Computes Exit Price After Advancement of Product Allows Inspiration to Exercise Control Reduces Risk for Acquisition of Early Stage Products Leverages Therapeutic Expertise Maintains Incentives Ensures Focus 12

13 Any Thoughts/Comments? Conclusion AGENDA 13

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