Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (November 2014)
20 slides from Eagle Pharmaceuticals's investor presentation, Nov 19, 2014
Slide 1: November 2014
November 2014 Scott Tarriff, CEO David Riggs, CFO NASDAQ: EGRX
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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 sta
Slide 3: Eagle Pharmaceuticals
Eagle Pharmaceuticals Nasdaq: EGRX Specialty pharmaceutical company Differentiated forms of branded injectables Revenues from three products Ryanodex (launched Aug. 2014 in MH) Argatroban Diclofenac/misoprostal Significant near-term commercial opportunities Preparing for 2015 launch of Bendamustine
Slide 4: In-Market Products + Attractive Late Stage Portfolio
In-Market Products + Attractive Late Stage Portfolio Bendamustine RTD 30/60 min. admin in 500 mL admixture Bendamustine RTD 10 min. admin in 50 mL admixture Diclofenac/misoprostol (legacy ANDA; generic Arthotec) Ryanodex Exertional Heat Stroke RTU bivalirudin Pemetrexed Argatroban Tentative approval
Slide 5: Bendamustine RTD
Bendamustine RTD Improved formulation of Treanda1 In 500 mL admixture, 30- or 60-minute infusion time (same as Treanda) Tentative approval received 7/02/14 One patent infringement lawsuit dismissed, one pending No 30-month stay 1 Treanda® (bendamustine HCl) (Cephalon, Inc., a wholly-owned subsidiary
Slide 6: Bendamustine RTD
Bendamustine RTD Improved formulation of Treanda1 In 500 mL admixture, 30- or 60-minute infusion time (same as Treanda) Tentative approval received 7/02/14 One patent infringement lawsuit dismissed, one pending No 30-month stay In 50 mL admixture, 10-minute infusion time Positive clinical data repor
Slide 7: Bendamustine RTD in 50mL Admixture Positive Clinical Data
Bendamustine RTD in 50mL Admixture Positive Clinical Data Open-label, crossover, randomized, blinded Phase I clinical trial in 81 patients Bioequivalence & safety vs. Treanda Met primary endpoint: bioequivalent to Treanda Met safety endpoints: incidence & profile of AEs (infusion-related & general)
Slide 8: Bendamustine RTD Market Opportunity
Bendamustine RTD Market Opportunity Treanda sales over $700M Preparing for 2015 launch: 2Q or 3Q Conversion expected due to multiple benefits of our bendamustine RTD in 50mL admixture with 10 minute infusion time Plan to file for unique J-code 1 12 months ended 9/30/2014 sales of $718M, source: Teva
Slide 9: Multiple Benefits of Bendamustine RTD in 50mL Admixture
Multiple Benefits of Bendamustine RTD in 50mL Admixture
Slide 10: Ryanodex for Malignant Hyperthermia (MH)
No change to SOC for MH treatment in over 30 years Often fatal if untreated Ryanodex approved July 2, 2014 Optimized formulation Reduces to 5mL (1 vial) vs. 720 mL (12 vials) for old product Breakthrough change Expected to take over market Protected market position 3 patents issued + 1 filed Orphan
Slide 11: Ryanodex: US Commercial Landscape
Ryanodex: US Commercial Landscape Ryanodex launched Aug 29, 2014 Small sales force Premium pricing to old formulation Supported by Ryanodex advantages Faster administration Reduced volume Significant reduction of Mannitol (diuretic) Expands addressable market ~$20M $75-80M Ryanodex Premium Pricing O
Slide 12: Ryanodex: US Commercial Landscape
Ryanodex: US Commercial Landscape All US hospitals required to stock dantrolene ~9,000 outlets MHAUS1 recommends a minimum 36 vials = 3 vials Ryanodex Repurchase required every 2 years Ryanodex advantages = unlikely to revert to old 720mL formulation Early conversions include multiple top-tier hospi
Slide 13: Why Dantrolene?
Why Dantrolene? MH Exertional Heat Stroke Ecstasy Overdose Duchenne Europe ROW Initial indication: Malignant Hyperthermia Larger markets + Unmet needs Further opportunity for all indications Malignant Hyperthermia is just the tip of the iceberg Rhabdomyolysis
Slide 14: Ryanodex for EHS: Initial Label Expansion Opportunity
Ryanodex for EHS: Initial Label Expansion Opportunity 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 Potenti
Slide 15: Bivalirudin RTU
Enhanced RTU version of the anticoagulant Angiomax1 Brand sales over $580M 2 Two patents issued; third patent filed 1Q:14 NDA submission targeted for 2Q:15 US launch planned as early as 1Q:16 Very strong non-infringement arguments Different from existing ANDA litigation Bivalirudin RTU 1 Angiomax® (
Slide 16: Pemetrexed
Pemetrexed Liquid version of Alimta1, a powder cytotoxic API indicated for pleural mesothelioma & NSCLC No reconstitution No dilution Less exposure to cytotoxic vapors for healthcare staff $2.7B global market opportunity2 Expect to launch with generics (2017-21) 1 Alimta® (pemetrexed) (Eli Lilly & C
Slide 17: Combination Approach for Long Life Cycle
US Patents Longevity Orphan Drug FDA Action Issued Filed Argatroban 2 1 Sept 2027 In-market Ryanodex (dantrolene): MH 3 1 Jul 2022- Jul 2025 US EU pending In-market Bendamustine RTD: NHL & CLL 1 7 Jan 2031- Mar 2033 US 500mL Tentative Approval 7/2/14 50mL meeting w. FDA 12/14 Ryanodex: Heat stroke/E
Slide 18: YTD 2014 Achievements and Near-term Milestones
YTD 2014 Achievements Near-term Milestones Ryanodex® NDA filed: MH Mar:14 ODD from EMA: MH 4Q:14 Patent issued: heat stroke 1Q:14 File with EMA: MH Mid:15 FDA approval: MH Jul:14 Initiate pilot study: EHS TBD:15 US Launch: MH Aug:14 Bendamustine Tentative approval (500mL) Jul:14 2nd patent issuance
Slide 19: Investment Considerations
Investment Considerations Multi-billion opportunity in injectable products space Revenues from three in-market products Near term product launch opportunities with high margins 3 Orphan Drugs: Ryanodex EHS & MH and bendamustine 50mL admixture Strong IP portfolio to protect market position: 12 patent
Slide 20: November 2014
November 2014
Eagle Pharmaceuticals — Investor Presentation (November 2014) on 6ix