Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2014)
18 slides from Eagle Pharmaceuticals's investor presentation, September 2014
Slide 1: Eagle Pharmaceuticals September 2014
NASDAQ: EGRX September 2014 Scott Tarriff, CEO David Riggs, CFO
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: 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
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 Eagle formulation No patent Launched designed 33% infringeme Sept. 2011; to avoid share of nt lawsuit Sold infringeme total through nt of By
Slide 5: Late Stage Portfolio Targeting Proven Markets
Late Stage Portfolio Targeting Proven Markets Preclinica Clinical NDA filing Approval In-market Market Orpha l Opp1 n Drug Argatroban $99M Tentative Bendamustine RTD Approval $709 7/2/14 M+ Bendamustine RTD Low-volume, shorter infusion $709 time M+ √ Ryanodex (dantrolene): Launched Malignant Hyperth
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 pat
Slide 7: Lower-volume Shorter Infusion Time Bendamustine RTD Highlights
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 n
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 o
Slide 9: Lower-volume Shorter Infusion Time Bendamustine RTD
Lower-volume Shorter Infusion Time Bendamustine RTD Randomized, blinded clinical trial – Phase I PK/Safety Study Enrollment complete, data results anticipated by year-end 9
Slide 10: Ryanodex for Malignant Hyperthermia (MH)
Ryanodex (dantrolene) for Malignant Hyperthermia (MH) 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 Launc
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 st
Slide 12: Why Dantrolene?
Why Dantrolene? Malignant Hyperthermia is just the tip of the iceberg Initial indication: MH Malignant Hyperthermia Exertional Heat Stroke Larger markets Ecstasy Overdose + Duchenne Unmet needs Rhabdomyolysis Europe Further opportunity for ROW all indications 12
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
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 14
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) 15
Slide 16: Combination Approach for Long Life Cycle
Combination Approach for Long Life Cycle US Patents Longevity Orphan FDA Issue Filed Drug Action d Argatroban 2 1 Sept 2027 In-market Tentative Bendamustine RTD: NHL & Jan 2031- CLL 1 4 Mar 2033 Yes Approval 7/2/14 Jul 2022- Ryanodex (dantrolene): MH 3 1 Jul 2025 Yes In-market Ryanodex: Heat stroke/
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 ma
Slide 18: Eagle Pharmaceuticals, Inc. September 2014
EAGLE PHARMACEUTICALS, INC. September 2014
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