Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (May 2016)
24 slides from Eagle Pharmaceuticals's investor presentation, May 2016
Slide 1: Corporate Overview
EAGLE pHARMAceuticacs COrporate Overview May 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 Short-term Activity – Bendeka™ launch with Teva: • Expect near-complete conversion to Bendeka • FDA decision on 3 years of exclusivity pending; seeking to overturn the recent FDA decision to deny 7 years of marketing exclusivity – Federal District Court ac
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 • 5 products marketed addressing large markets Marketed Near-Term New Pipeline Ryanodex® (dantrolene sodium) Kan
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 hired 11 of 20 new direct professionals focused in the sales reps and 2 district hematology and oncology space managers who will work with – Devote 80% of time to se
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: • Current market share goal is 90% in May • Up to $25M in additional milestone payments subject to: – Achievement of certain sales levels • Royalty payments: – 20% royalty on net sales of Bend
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 • Limited market offers significant opportunity – Hospira’s marketed generic at risk on 1st day of launch due to Appellate Court decision being vacated – Sandoz’s authorized generic can come off the marke
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 for Malignant Hyperthermia (MH)
Ryanodex® (dantrolene sodium) for Malignant Hyperthermia (MH) • No change to Standard of Care (SOC)1 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 prod
Slide 13: Initial Label Expansion Opportunity
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 SOC or SOC + Ryanodex • Inclusion protocol criteria required that patients showed hallm
Slide 15: EHS Main Study Results
EHS Main Study Results • Ryanodex with current SOC showed substantial and consistent evidence of increased effectiveness in treating EHS than SOC alone Ryanodex + SOC SOC Only (N=17) (N=17) Treatment Odds Ratio n (%) n (%) GCS Score ≥13 at 90 Minutes 5 (29.4) 2 (11.8) 3.1 Post-Randomization GCS Scor
Slide 16: EHS Main Study Results (cont.)
EHS Main Study Results (cont.) Patients in Group A (Ryanodex + SOC) reached desired cooling outcome faster than patients in Group B (SOC Only) Cooling Time to Normal Temperature Cooling Time to Normal Temperature All Patients Patients who Resolve from Glasgow Coma Scale Duration of SOC Ryanodex Dura
Slide 17: EHS Initial Study Results (cont.)
EHS Initial Study Results (cont.) Change from Baseline in GCS at 90 minutes Post-Randomization in Patients Not-Intubated at Baseline (Endotracheal Intubation Requires Use of Narcotics, Making Assessment of GCS Unfeasible) Ryanodex + SOC1 SOC Only n=17 n=17 N (%) of Patients 10 (59%) 14 (82%) Mean Ch
Slide 18: EHS Initial Study Results (cont.)
EHS Initial Study Results (cont.) Percent Change from Baseline in GCS at 90 minutes Post-Randomization in Patients Not-Intubated at Baseline (Endotracheal Intubation Requires Use of Narcotics, Making Assessment of GCS Unfeasible) Ryanodex + SOC1 SOC Only n=17 n=17 N (%) of Patients 10 (59%) 14 (82%)
Slide 19: EHS Initial Study Results (cont.) Safety Summary
EHS Initial Study Results (cont.) Safety Summary Ryanodex and SOC1 SOC Only Type of Event (N=17) (N=17) n (%) n (%) Any Adverse Event 11 (64.7) 13 (76.5) Any Serious Adverse Event 4 (23.5) 3 (17.6) Any Adverse Event (AE) by Maximum Intensity Severe AE 2 (11.8) 2 (11.8) Moderate AE 2 (11.8) 5 (29.4)
Slide 20: Eagle & NIH/NIDA Agreement
Eagle & NIH/NIDA Agreement • Joint effort with the NIH to explore the potential of Ryanodex to treat hyperthermia related to MDMA (Ecstasy) and Methamphetamine intoxication – 125,000 emergency room visits in 2011 due to Ecstasy and Methamphetamine use 1 – Brain hyperthermia is one of the leading cau
Slide 21: 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 22: 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 23: Building Pipeline for Long Term Growth
Building Pipeline for Long Term Growth • Ryanodex for the treatment of Ecstasy and Methamphetamine intoxication (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 •
Slide 24: Eagle Poised for Strong Growth through 2020
Eagle Poised for Strong Growth through 2020 Short-term 2016 Activity – Bendeka™ launch with Teva: • Expect near-complete conversion to Bendeka • FDA decision on 3 years of exclusivity pending; seeking to overturn the recent FDA decision to deny 7 years of marketing exclusivity – Federal District Cou
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