Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (June 2015)
18 slides from Eagle Pharmaceuticals's investor presentation, June 2015
Slide 1: Eagle Pharmaceuticals
Eagle Pharmaceuticals NASDAQ: EGRX Scott Tarriff, CEO David Riggs, CFO June 2015
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: In-market Products + Attractive Late Stage Portfolio
In-market Products + Attractive Late Stage Portfolio Products Market Opp1 Status / Milestone Orphan Drug Ryanodex® (dantrolene sodium) for US exclusivity granted Injectable Suspension $75M+ Marketed EMA ODD granted Malignant Hyperthermia Argatroban $75M Marketed Diclofenac/misoprostol (legacy ANDA)
Slide 4: Bendamustine HCl RTD
Bendamustine HCl RTD Improved formulation of Treanda1 NDA 1: in 500 mL admixture, 30- or 60-minute infusion time (same as Treanda) – Tentative approval received July 2014 – One patent infringement lawsuit dismissed, one settled NDA 2: in 50 mL admixture, 10-minute infusion time (Rapid Infusion Produ
Slide 5: Exclusive Agreement with Teva for Bendamustine RTD Rapid Infusion
Exclusive Agreement with Teva for Bendamustine RTD Rapid Infusion Summary Financial Terms $30M upfront cash payment from Teva Up to $90M in additional milestone payments: – Timing of FDA approval – Achievement of certain sales levels – Achievement of certain reimbursement criteria Royalty paym
Slide 6: Multiple Milestones in 2015 to Drive Value
Multiple Milestones in 2015 to Drive Value Apr:15 Acceptance for filing of Rapid NDA May:15 Submitted NDA for Bivalirudin RTU 3Q:15 Acceptance for filing of Bivalirudin RTU NDA Mid:15 Decision expected: Hospira vs. MDCO patent litigation (bivalirudin) Dec:15 PDUFA date for Rapid with Standard Review
Slide 7: Teva Agreement: Other Material Terms
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 products are launched in the U
Slide 8: Multiple Benefits of Rapid Infusion Bendamustine RTD
Multiple Benefits of Rapid Infusion Bendamustine RTD • Less chair time: 30 or 60 min. reduced to 10 min. Patient • Less volume & issues related to 50mL vs. 500mL admixture Nurse • Less nursing time required Medical/ Patient • 90% reduction in NaCl – renal suppressed population • Additional patients
Slide 9: Large Near-Term Market Opportunity
Large Near-Term Market Opportunity Treanda sales over $760M1 Teva expected to launch shortly after approval Uptake expected due to multiple benefits of our bendamustine RTD in 50mL admixture with 10 minute infusion time Plan to file for unique J-code in 4Q:15 1 Treanda® (bendamustine HCl) sa
Slide 10: Ryanodex (dantrolene sodium) for Malignant Hyperthermia (MH)
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 old product Breakthrough c
Slide 11: U.S. Commercial Landscape
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 reducti
Slide 12: Commercialization Snapshot
Commercialization Snapshot U.S. Launch Update Sales Growth Since Launch Launched Aug:14 $2.0 15 field force $1.5 representatives $1.0 Premium pricing to old $0.5 formulation expands $- addressable market from Q3 '14 Q4 '14 Q1 '15 $20M1 to $75M (over two years) Conversions to date: Trending
Slide 13: Initial Label Expansion Opportunity: EHS
Initial Label Expansion Opportunity: EHS Exertional Heat Stroke (EHS) – Est. 23,000-38,000 cases/year1 – 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 Orphan drug designation for EHS – Potent
Slide 14: EHS: Development Update
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 and the potential benefit R
Slide 15: 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 1Q:16 Two patents issued; third patent filed 1Q:14 Very strong non
Slide 16: 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 Immediate administration Increases work flow Reduces risk of dos
Slide 17: Why Eagle? Why now?
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 bivalirudin in mid-2016 opp. (a
Slide 18: June 2015
June 2015 CONFIDENTIAL JUNE 2015 18
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