Eagle Pharmaceuticals, Inc. · OTC:EGRX

Eagle Pharmaceuticals — Investor Presentation (March 2015)

21 slides from Eagle Pharmaceuticals's investor presentation, Mar 30, 2015

  1. Slide 1: Eagle Pharmaceuticals

    Eagle Pharmaceuticals NASDAQ: EGRX Scott Tarriff, CEO David Riggs, CFO March 2015

  2. Slide 2: Forward Looking Statements

    CONFIDENTIAL MARCH 2015 2 Forward Looking Statements This presentation contains certain forward-looking information about Eagle Pharmaceuticals that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amen

  3. Slide 3: Experienced Management Team

    CONFIDENTIAL MARCH 2015 3 NAME TITLE EXPERIENCE Scott Tarriff President & Chief Executive Officer David E. Riggs Chief Financial Officer Steven L. Krill Ph.D. Chief Scientific Officer Adrian Hepner, MD, Ph.D. Executive VP, Clinical Research, Medical & Regulatory Affairs Peter Grebow, Ph.D. Executive

  4. Slide 4: In-market Products + Attractive Late Stage Portfolio

    CONFIDENTIAL MARCH 2015 4 Products Market Opp1 Status / Milestone Orphan Drug Ryanodex® (dantrolene sodium) for Injectable Suspension Malignant Hyperthermia $75M+ Marketed US exclusivity granted EMA ODD granted Argatroban $75M Marketed Diclofenac/misoprostol (legacy ANDA) Generic Arthrotec2 $40-50M

  5. Slide 5: Key Achievements Since IPO

    CONFIDENTIAL MARCH 2015 5 Key Achievements Since IPO Bendamustine hydrochloride (HCL) • 500mL admixture  Tentative approval -for indolent B-cell non-Hodgkin Lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab- containing regimen. • 50mL admixt

  6. Slide 6: Multiple Milestones in 2015 to Drive Value

    CONFIDENTIAL MARCH 2015 6 Multiple Milestones in 2015 to Drive Value Apr:15 Acceptance for filing of Rapid NDA + decision on Priority Review 2Q:15 Submit NDA for Bivalirudin RTU Aug:15 PDUFA date for Rapid if Priority Review granted* 3Q:15 Acceptance for filing of Bivalirudin RTU NDA Mid:15 Decision

  7. Slide 7: Bendamustine HCl RTD

    CONFIDENTIAL MARCH 2015 7 Bendamustine HCl RTD NDA 1: in 500 mL admixture, 30- or 60-minute infusion time (same as Treanda) – Tentative approval received July 2014 for NHL indication – One patent infringement lawsuit dismissed, one settled NDA 2: in 50 mL admixture, 10-minute infusion time (Rapid In

  8. Slide 8: Bendamustine HCl RTD -- DMA-free

    CONFIDENTIAL MARCH 2015 8 Bendamustine HCl RTD -- DMA-free • FDA warned against use of Treanda liquid with CSTDs, adapters, and syringes containing polycarbonate or ABS1 • Most marketed CSTDs • DMA2, an ingredient in Treanda, is incompatible with polycarbonate or ABS • Devices containing polycarbona

  9. Slide 9: Exclusive Agreement with Teva for Bendamustine RTD Rapid Infusion

    CONFIDENTIAL MARCH 2015 9 Responsibilities TEVA • U.S. regulatory approvals and reimbursement • Supply product to Teva for a specified period while Teva or a third party second-source supplier is qualified • Any post-approval clinical studies, if required • Market Rapid Infusion Bendamustine for CLL

  10. Slide 10: Teva Agreement: Other Material Terms

    CONFIDENTIAL MARCH 2015 10 Teva Agreement: Other Material Terms  Agreed to settle all patent litigation  Eagle has the option to terminate agreement and commercialize Rapid: – If, by a specified date, certain milestones for Rapid have not been obtained/achieved and certain generic Bendamustine pro

  11. Slide 11: Multiple Benefits of Rapid Infusion Bendamustine RTD

    CONFIDENTIAL MARCH 2015 11 Multiple Benefits of Rapid Infusion Bendamustine RTD • Less chair time: 30 or 60 min. reduced to 10 min. • Less volume & issues related to 50mL vs. 500mL admixture Patient • Less nursing time required Nurse • 90% reduction in NaCl – renal suppressed population Medical/ Pat

  12. Slide 12: Large Near-Term Market Opportunity

    CONFIDENTIAL MARCH 2015 12 Large Near-Term Market Opportunity  Treanda sales over $750M1  Teva expected to launch shortly after approval – Substantial conversion anticipated  We believe Rapid, with 10 minutes infusion time, has multiple benefits that will lead to uptake in the market and no DMA i

  13. Slide 13: Ryanodex (dantrolene sodium) for Malignant Hyperthermia

    CONFIDENTIAL MARCH 2015 13 Ryanodex® (dantrolene sodium) for Malignant Hyperthermia (MH)  No change to SOC for MH treatment in over 30 years – Often fatal if untreated  Ryanodex approved in July 2014 – Optimized formulation of dantrolene sodium – Reduces to 5mL (1 vial) vs. 720 mL (12 vials) for o

  14. Slide 14: U.S. Commercial Landscape

    CONFIDENTIAL MARCH 2015 14 U.S. Commercial Landscape  All U.S. hospitals required to stock dantrolene – ~9,000 outlets – MHAUS1 recommends a minimum 36 vials = 3 vials Ryanodex  Repurchase required every 2 years – Premium pricing supported by Ryanodex advantages  Faster administration  Reduced v

  15. Slide 15: U.S. Launch Update

    CONFIDENTIAL MARCH 2015 15 U.S. Launch Update Launched August 2014  15 field force representatives  Premium pricing to old formulation – Expands addressable market  Early conversions include multiple top-tier hospitals ~$20M $75M+ Ryanodex Premium Pricing Old Product Pricing1 Ryanodex Market Oppo

  16. Slide 16: Initial Label Expansion Opportunity: EHS

    CONFIDENTIAL MARCH 2015 16 Initial Label Expansion Opportunity: EHS  Exertional Heat Stroke (EHS) – A leading cause of student athlete death (US) & non-combat military deaths – Similarities to MH  Potential for Ryanodex to be first to market for EHS if approved  Orphan drug designation for EHS –

  17. Slide 17: EHS: Development Update

    CONFIDENTIAL MARCH 2015 17 EHS: Development Update  Held Type C meeting with FDA on March 11th  Productive discussion regarding regulatory pathway and required development program to support label expansion  We believe the Agency recognizes the importance of this rare, life- threatening condition

  18. Slide 18: Bivalirudin RTU

    CONFIDENTIAL MARCH 2015 18  Enhanced RTU version of the anticoagulant Angiomax1 – Brand sales over $635M2 – Benefits versus Angiomax include no reconstitution & dilution – Increases work flow, reduces dosing errors  Two patents issued; third patent filed 1Q:14  Near-term opportunity: – NDA submis

  19. Slide 19: Capital Structure and Financial Statistics

    CONFIDENTIAL MARCH 2015 19 Capital Structure and Financial Statistics Exchange: Ticker NASDAQ: EGRX Market Capitalization1 $560M Cash Position2 ~ $113M LTM3 Revenue as of December 31, 2014 $15.7M Profitability Expected to be profitable in 2015 Stock Price Appreciation Since IPO ~ 207% Financial Summ

  20. Slide 20: Why Eagle? Why now?

    CONFIDENTIAL MARCH 2015 20 Why Eagle? Why now?  Transformative partnership with Teva for Bendamustine RTD Rapid Infusion drives profitability in 2015  Significant near-term R&D opportunities • Two product approvals anticipated • Rapid infusion bendamustine by YE 2015 $1.4 billion market • RTU biva

  21. Slide 21: March 2015

    CONFIDENTIAL MARCH 2015 21 March 2015

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