Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Jefferies 2014 Global Healthcare Conference
19 slides from Eagle Pharmaceuticals's conference presentation, Jun 5, 2014
Slide 1: Jefferies 2014 Global Healthcare Conference
Jeffries 2014 Global Healthcare Conference - June 5, 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 Two PDUFA dates in July 2014 7/6 Bendamustine RTD Near-term high-margin 7/22 Ryanodex commercial opportunities Long life cycles = significant value Strong IP around diff
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 can enter Undifferentiated ANDAs must await patent expiry (6/30/14) Our partners net sales & margi
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 7/6/14 PDUFA date 7/22/14 PDUFA date 1 Source: publicly filed reports
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 7/6/14 PDUFA date – expecting tentative approval Commercial launch early 2015 through early 2016 Patent litigation, Orphan Drug, FDA Approval
Slide 7: Bendamustine Commercialization Strategy
Expect to launch prior to generics/other 505(b)(2) entrants Market with small specialty sales force Cover corporate accounts & infusion centers Switch to superior product Bendamustine Commercialization Strategy 2014 2017 2015 2016 EGRX bendamustine launch window Potential exclusivity window ANDA lau
Slide 8: Shorter Infusion Time Highlights Patient Benefit
Eagle Shorter Infusion Time Highlights Patient Benefit Less chair time 30 or 60 minutes reduced to 10 minutes Less volume and the issues related to 500ml vs. 50ml Nurse Less nursing time required Medical/Patient 90% reduction in NaCl – renal suppressed population Economic Benefit Additional patient
Slide 9: Lower-volume Shorter Infusion Time Bendamustine RTD
Lower-volume Shorter Infusion Time Bendamustine RTD Same product as bendamustine RTD Potential to convert market based on improved product attributes Orphan drug designation, if granted, may afford 7 years exclusivity on approval One issued patent to June 2031
Slide 10: Ryanodex (dantrolene) for Malignant Hyperthermia
No change to SOC for MH treatment in over 30 years Often fatal if untreated Current product requires 720 ml (12 vials) Eagle optimized formulation reduces to 5ml (1 vial) Breakthrough change Expected to take over market 3 patents issued + 1 filed Orphan drug designation for MH PDUFA date 7/22/14 (pr
Slide 11: Ryanodex US Commercial Landscape
Ryanodex US Commercial Landscape Branded dantrolene sales for MH ~$20M in 2013 Ryanodex advantages support premium pricing Faster administration Reduced volume Significant reduction of Mannitol (diuretic) All US hospitals required to stock dantrolene MHAUS1 recommends a minimum of 36 vials Market un
Slide 12: Why Dantrolene?
Why Dantrolene? MH Exertional Heat Stroke Ecstasy Overdose Duchenne Europe ROW Initial indication: Malignant Hyperthermia $20M+ US market Larger markets + Unmet needs Further opportunity for all indications Malignant Hypothermia 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 and Longevity
US Patents Longevity Orphan Drug PDUFA Date Issued Filed Argatroban 2 1 Sept 2027 In-market Bendamustine 1 4 Jan 2031- Mar 2033 Jul 22 2014 Ryanodex (dantrolene): MH 3 1 Jul 2022- Jul 2025 Yes Jul 6 2014 Ryanodex: Heat stroke/EHS 1 Feb 2023 Yes RTU bivalirudin 21 1 Aug 2029- May 2034 Other 2 3 Feb 2
Slide 17: Timeline: Key Value Drivers
Timeline: Key Value Drivers Bendamustine RTD Ready-to-Dilute bendamustine LV bendamustine: low-volume, short infusion time RTD bendamustine Product Milestone Timing Bendamustine RTD PDUFA Date 06 Jul 2014 Ryanodex PDUFA Date 22 Jul 2014 Ryanodex Launch in MH (if approved) Summer 2014 LV bendamustine
Slide 18: Investment Considerations
Investment Considerations Over $3.4 billion opportunity in injectable products space Two PDUFA dates next month (bendamustine RTD & Ryanodex) Near term product launch opportunities with high margins 2 Orphan Drugs: Ryanodex EHS & MH Strong IP portfolio to protect market position: 11 patents issued L
Slide 19: June 2014
June 2014
Eagle Pharmaceuticals — Jefferies 2014 Global Healthcare Conference on 6ix