Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2015)
16 slides from Eagle Pharmaceuticals's investor presentation, Sep 21, 2015
Slide 1: September 2015 Corporate Overview
September 2015 Corporate Overview
Slide 2: Forward Looking Statements
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 amended. Forward-looking state
Slide 3: Growing Commercialized Portfolio + Attractive Late Stage Pipeline
Growing Commercialized Portfolio + Attractive Late Stage Pipeline Significant near- and long-term growth potential: Product sales and royalty income from growing commercialized portfolio Late-stage product pipeline poised to address very large markets In Market Late Stage R&D Pipeline Ryanodex® (dan
Slide 4: Bendamustine HCl RTD – Key Milestones
Bendamustine HCl RTD – Key Milestones 1 Treanda® (bendamustine HCl) (Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.) 2 CLL: chronic lymphocytic leukemia 3 NHL: indolent B-cell non-Hodgkin lymphoma Lead product candidate is an improved formulation of Treanda1 NDA 1 (
Slide 5: Exclusive Marketing Agreement with Teva for Bendamustine RTD Rapid Infusion
Significant market opportunity: Teva responsible for all commercial activities with Eagle supplying product for specified time period $30M upfront cash payment from Teva Up to $85M in additional milestone payments subject to: FDA approval Achievement of certain sales levels Achievement of certain re
Slide 6: Multiple Benefits of Bendamustine RTD Rapid Infusion
Multiple Benefits of Bendamustine RTD Rapid Infusion 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/ Patient Additional patients treated in
Slide 7: Large Near-Term Market Opportunity
Large Near-Term Market Opportunity Treanda sales over $760M1 Uptake expected due to multiple benefits of Bendamustine RTD Rapid with 10 minute infusion time Plan to file for unique J-code in 4Q:15 1 Treanda® (bendamustine HCl) sales in 2014 of $767 million, source: Teva Pharmaceuticals press release
Slide 8: Bivalirudin RTU
Bivalirudin RTU Stable, liquid intravenous formulation version of the anticoagulant Angiomax1 Brand sales over $635M2 Multiple benefits versus Angiomax Near-term opportunity: NDA submitted May ‘15 Potential U.S. launch March ‘16 Reduced licensing payment to SciDose to 15% of net profit, increasing s
Slide 9: Benefits vs. Angiomax
Benefits vs. Angiomax RTU Bivalirudin Angiomax1 API Bivalirudin Bivalirudin Formulation Ready-to-Use Liquid Lyophilized Powder Administration IV Solution IV Solution Reconstitution Required? NO Yes Initial Dilution Required? NO Yes 1 Angiomax® (bivalirudin) / Angiox® (bivalirudin) (The Medicines Com
Slide 10: Ryanodex 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 old product Breakthrough change Protected market position Three patents issued + one filed Orphan dr
Slide 11: 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 volume Significant reduction of Mannitol (diuretic) U.S. Commercial
Slide 12: U.S. Launch Update
Launched Aug ‘14 Premium pricing to old formulation expands addressable market from $20M1 to $75M (over two years) 95% of unit vial volume sold to hospitals and medical centers in Q2 ‘15 Multiple top-tier hospital conversions: Mayo Clinic, NIH, VAs, among others Sales force realigned Q2 ‘15 U.S. Lau
Slide 13: Exertional Heat Stroke (EHS): Initial Label Expansion Opportunity
Exertional Heat Stroke (EHS) Sudden, unpredictable and life threatening condition Patient population impacted: military, student athletes, athletes, construction workers, migrant workers, and firemen A leading cause of student athlete death (US) & non-combat military deaths Similarities to MH Potent
Slide 14: EHS: Development Update
Held Type C meeting with FDA on Mar ’15 We believe the Agency recognizes the potential benefit Ryanodex may afford patients Path forward: a ‘hybrid’ development program including human and animal efficacy and safety data IND filed Jul ‘15 Human study planned for Sep ‘15 in Saudi Arabia during Hajj C
Slide 15: Pemetrexed Update
Lilly’s Alimta patent infringement lawsuit win should prevent current ANDA filers from launching until May 24, 2022 Eagle plans to file Pemetrexed RTU late 2016 We believe our patent position may enable us to bring the product to market as early as Q4 2017 30 month stay to expire 1st half of 2019 $1
Slide 16: Why Eagle? Why Now?
Growing portfolio of commercialized products delivering top line growth 3 potential product launches in the next 12 months Significant near-term opportunities Bendamustine RTD Rapid approval expected by December 2015 RTU bivalirudin approval anticipated in March 2016 Potential for label expansion fo
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