Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2014)
18 slides from Eagle Pharmaceuticals's investor presentation, Sep 26, 2014
Slide 1: September 2014 Investor Presentation
September 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 Validated strategy Near-term Commercial Opportunities Bendamustine RTD Tentative Approval July 2, 2014 Ryanodex approved July 22 & launched August 2014 Diclofenac/misoprostol approved Marc
Slide 4: Validated Business Model
Validated Business Model In-market product: Argatroban Improved formulation of branded drug Ready-to-use; no dilution Significant reduction in drug waste Entered market three years before first generic Our partners net sales & margins over last 12 months 1 Source: IMS Net Sales $ 24.6M COGS 4.9 Gros
Slide 5: Late Stage Portfolio Targeting Proven Markets
Late Stage Portfolio Targeting Proven Markets Bendamustine RTD Bendamustine RTD Low-volume, shorter infusion time Ryanodex (dantrolene): Malignant Hyperthermia Ryanodex: Exertional Heat Stroke RTU bivalirudin Pemetrexed Argatroban Tentative Approval 7/2/14 Launched 8/29/14 1 Source: publicly filed r
Slide 6: Bendamustine RTD
Bendamustine RTD Improved formulation of Treanda1 for CLL2 & NHL3 Ready-to-dilute concentrated liquid of cytotoxic API Same volume diluent, same infusion time 7/2/14 received tentative approval for NHL Commercial launch Window - 2015 through early 2016 Longevity post-launch: 1 issued patent & 4 file
Slide 7: Lower-volume Shorter Infusion Time Bendamustine RTD Highlights Patient Benefit
Lower-volume Shorter Infusion Time Bendamustine RTD Highlights Patient Benefit Less chair time: 30 or 60 minutes reduced to 10 minutes Less volume and the issues related to 50ml vs. 500mL Longer Shelf Life (less degradation products) Eliminates the need for exposure to DMA Nurse Less nursing time re
Slide 8: Lower-volume Shorter Infusion Time Bendamustine RTD
Lower-volume Shorter Infusion Time Bendamustine RTD Same product as bendamustine RTD Dilute in 50mL admixture rather than in 500mL Potential to convert market based on improved product attributes Received Orphan drug designation for CLL and NHL July 2, 2014 May afford 7 years exclusivity on approval
Slide 9: Bendamustine RTD Clinical Trial
Lower-volume Shorter Infusion Time Bendamustine RTD Randomized, blinded clinical trial Phase I PK/Safety Study Enrollment complete, data results anticipated by year-end
Slide 10: Ryanodex (dantrolene) for Malignant Hyperthermia
No change to SOC for MH treatment in over 30 years Can be fatal if untreated Old product typically requires 720 ml (12 vials) Eagle optimized formulation reduces to 5ml (1 vial) Breakthrough change Expected to take over market Launched Ryanodex 8/29/14 Protected market position 3 patents issued + 1
Slide 11: Ryanodex US Commercial Landscape
Ryanodex US Commercial Landscape Branded dantrolene sales for MH ~$20M in 2013 Ryanodex pricing expands addressable market Ryanodex advantages support premium pricing Faster administration Reduced volume Significant reduction of Mannitol (diuretic) All 6,000 US hospitals required to stock dantrolene
Slide 12: 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 13: Ryanodex Label Expansion Opportunity
Ryanodex 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 Potential for 7-10 year
Slide 14: Bivalirudin: $550M Approximate Brand Sales
Bivalirudin: $550M – Approximate Brand Sales Enhanced RTU version of the anticoagulant Angiomax Completed three registration batches for NDA submission 2 patents issued; third patent filed 1Q:14 NDA submission targeted for Q2:15 US launch planned as early as Q1:16
Slide 15: Pemetrexed: $1.21B Opportunity
Pemetrexed: $1.21B Opportunity Liquid version of Alimta, a powder cytotoxic API No reconstitution & dilution Less exposure to cytotoxic vapors for healthcare staff Expect to launch with generics (2017-21)
Slide 16: US Patents Longevity Orphan Drug FDA Action
US Patents Longevity Orphan Drug FDA Action Issued Filed Argatroban 2 1 Sept 2027 In-market Bendamustine RTD: NHL & CLL 1 4 Jan 2031- Mar 2033 Yes Tentative Approval 7/2/14 Ryanodex (dantrolene): MH 3 1 Jul 2022- Jul 2025 Yes In-market Ryanodex: Heat stroke/EHS 1 Feb 2023 Yes RTU bivalirudin 21 1 Au
Slide 17: Investment Considerations
Investment Considerations Over $3.4 billion opportunity in injectable products space Recent Bendamustine tentative approval and Ryanodex approval Near term product launch opportunities with high margins 3 Orphan Drugs: Ryanodex EHS & MH and bendamustine LV Strong IP portfolio to protect market posit
Slide 18: September 2014
September 2014
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