Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (February 2016)
19 slides from Eagle Pharmaceuticals's investor presentation, February 2016
Slide 1: Corporate Overview
Corporate Overview February 2016
Slide 2: Forward Looking Statements
Forward Looking Statements • This presentation contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,”
Slide 3: Eagle is a fully commercial specialty company with a broad portfolio and deep near-term pipeline
Eagle is a fully commercial specialty company with a broad portfolio and deep near-term pipeline 3
Slide 4: Eagle Poised for Strong Growth through 2020
Eagle Poised for Strong Growth through 2020 Activity through May 2016 – Bendeka™ launch with Teva: • Expect complete / near-complete conversion to Bendeka by April 1 • Anticipate FDA decision on 3 years of exclusivity due to running a clinical trial, and for 7 years of marketing exclusivity • Antici
Slide 5: Growing Product Portfolio + Attractive Late-Stage Pipeline + Commercial Platform
Growing Product Portfolio + Attractive Late-Stage Pipeline + Commercial Platform • Significant growth potential with product sales and royalty income from growing commercialized portfolio • 7 products marketed by May 1, 2016 addressing large markets Marketed by May 1, ‘16 Near-Term New Pipeline Ryan
Slide 6: Eagle Will Have Over 50 Sales Reps Calling on Hospitals and Cancer Centers
Eagle Will Have Over 50 Sales Reps Calling on Hospitals and Cancer Centers External Internal • 32 proven and seasoned Spectrum • Eagle to hire up to 20 new direct professionals focused in the sales reps by end of Q1 who will hematology and oncology space work with Spectrum Sales Team – Devote 80% of
Slide 7: Exclusive Marketing Agreement with Teva for Bendeka (50 mL Rapid Infusion)
Exclusive Marketing Agreement with Teva for Bendeka® (50 mL Rapid Infusion) Significant market opportunity: • Teva responsible for all commercial activities with Eagle supplying product for specified time period • $45M cash payment received from Teva • Up to $65M in additional milestone payments sub
Slide 8: Six Orange Book Listed Patents Running from 2026-2033
Six Orange Book Listed Patents Running from 2026-2033 Protects Longevity of Bendamustine Franchise U.S. Patent No. Patent Expiration 8,609,707 8/11/2031 8,791,270*PED1 7/12/2026 9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033 9,265,831 1/28/2031 8 1 Owned by Teva Pharmaceutical Industrie
Slide 9: Multiple Benefits of Bendeka (50mL)
Multiple Benefits of Bendeka® (50mL) • 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 treated in the c
Slide 10: Bivalirudin RTU
Bivalirudin RTU • Stable, liquid intravenous formulation of Angiomax1 – Brand sales over $635M2 • Near-term Opportunity – PDUFA date: March 19, 2016 – Eagle is likely the next entrant in March ‘16 in a limited market • Hospira’s marketed generic at risk on 1st day of launch due to Appellate Court de
Slide 11: Multiple Benefits vs. Angiomax
Multiple 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 ri
Slide 12: 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 13: Initial Label Expansion Opportunity: Exertional Heat Stroke
Initial Label Expansion Opportunity • Exertional Heat Stroke (EHS) ‒ Sudden, unpredictable and life-threatening condition ‒ Patient population impacted: military, student athletes, athletes, construction workers, migrant workers, and firemen ‒ A leading cause of student athlete death (US) & non-comb
Slide 14: EHS Clinical Study: September 2015
EHS Clinical Study: September 2015 • Completed Safety & Efficacy study to evaluate Ryanodex for treatment of EHS during during Hajj pilgrimage in Saudi Arabia (Sept. 22-27) • 34 patients randomized 1:1 to receive standard of care1 (SOC) or SOC + Ryanodex • Inclusion protocol criteria required that p
Slide 15: EHS Initial Study Results
EHS Initial Study Results • Ryanodex with current standard of care1 (SOC) showed substantial evidence of increased effectiveness in treating EHS than SOC alone Cumulative Incidence of Glasgow Coma Scale (GCS) Score ≥13 at 90 min. Post-Randomization Ryanodex + SOC SOC Only n=17 n=17 N (%) of Patients
Slide 16: Pemetrexed
Pemetrexed • Lilly’s Alimta patent infringement lawsuit win should prevent current ANDA filers from launching until May 24, 2022 • Eagle plans to file Pemetrexed RTU NDA in late 2016 • Registration batches have been produced • We believe our patent position may enable us to bring the product to mark
Slide 17: First Docetaxel Injection Concentrate, Non-Alcohol Formulation Approved in the U.S.
First Docetaxel Injection Concentrate, Non-Alcohol Formulation Approved in the U.S. • Need for alcohol-free docetaxel after FDA issued Drug Safety warning that docetaxel may cause symptoms of alcohol intoxication after treatment • Some U.S. hospitals and clinics require patients to wait 2 or more ho
Slide 18: Building Pipeline for Long Term Growth
Building Pipeline for Long Term Growth • Ryanodex for the treatment of Ecstasy overdose and Methamphetamine (over 125,000 new cases per year) • Label expansion opportunity with potential fourth indication • AMRI Development Program • Joint development program for several new product candidates • AMR
Slide 19: Eagle Poised for Strong Growth through 2020
Eagle Poised for Strong Growth through 2020 Activity through May 2016 – Bendeka™ launch with Teva: • Expect complete / near-complete conversion to Bendeka by April 1 • Anticipate FDA decision on 3 years of exclusivity due to running a clinical trial, and for 7 years of marketing exclusivity • Antici
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