Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (June 2016)
25 slides from Eagle Pharmaceuticals's investor presentation, Jun 8, 2016
Slide 1: June 2016 Corporate Overview
June 2016 Corporate Overview
Slide 2: Forward Looking Statements
2 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
3 Eagle is a fully commercial specialty company with a broad portfolio and deep near-term pipeline
Slide 4: Short-term Activity – Bendeka launch with Teva
4 Short-term Activity – Bendeka™ launch with Teva: • Expect near-complete conversion to Bendeka; shared goal with Teva of 90% market share • 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 a
Slide 5: Growing Product Portfolio + Attractive Late-Stage Pipeline + Commercial Platform
5 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) •
Slide 6: Eagle Will Have Over 50 Sales Reps Calling on Hospitals and Cancer Centers
6 • 32 proven and seasoned Spectrum professionals focused in the hematology and oncology space – Devote 80% of time to selling up to six Eagle products – Target infusion centers, hospitals and oncology purchasing groups • Attractive financial terms for both parties – Eagle to pay Spectrum potential
Slide 7: Exclusive Marketing Agreement with Teva for Bendeka (50 mL Rapid Infusion)
7 Significant market opportunity: • Current shared market share goal with Teva is 90% – Achieved 71% total market share • $25M in additional milestone payments subject to: – Achievement of certain sales levels • Royalty payments: – 20% royalty on net sales of Bendeka (50mL) – 20% royalty owed by Eag
Slide 8: Six Orange Book Listed Patents Running from 2026-2033 Protects Longevity of Bendamustine Franchise
8 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 1 Owned by Teva Pharmaceutical Industrie
Slide 9: Multiple Benefits of Bendeka (50mL in min)
9 Multiple Benefits of Bendeka™ (50mL in 10 min) • Less chair time: 30 or 60 min. reduced to 10 min. • Less volume & potential related issues: 50mL vs. 500mL admixture Patient • Less nursing time required Nurse • Sodium-free administration for patients requiring restricted sodium intake (e.g. cardio
Slide 10: Bendeka vs. Treanda: Fewer Observed AEs
10 Bendeka™ vs. Treanda®: Fewer Observed AEs Bendeka showed a lower incidence of treatment emergent adverse events (TEAEs) Bendeka (n=21) Treanda (n=29) p-value TEAEs 56 117 Fatigue 1 (4.8%) 9 (31%) 0.007 Nausea 1 (4.8%) 9 (31%) 0.007 Vomiting 1 (4.8%) 6 (20.7%) 0.032 Peripheral edema 1 (4.8%) 3 (10
Slide 11: RTU Bivalirudin
11 RTU Bivalirudin • 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 ma
Slide 12: Multiple Benefits vs. Angiomax RTU Bivalirudin
12 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 1 Angiomax® (bivalirudin) / Angiox® (bivalirudin) (The
Slide 13: Ryanodex (dantrolene sodium) for Malignant Hyperthermia
13 • 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 product • Breakthrough change • Protected market position – Fi
Slide 14: Ryanodex Market Share
14 • 2014: Achieved 10% of all Dantrolene sales since launch in July • Ryanodex grew to 17% of unit sales through 2015 • Q1 2016: Grew Ryanodex share of dantrolene market to 23% of unit sales (normalized to 12-vials (MHAUS)) Ryanodex Market Share 10 17 23 0 5 10 15 20 25 % of Dantrolene Unit Sales (
Slide 15: Initial Label Expansion Opportunity: Exertional Heat Stroke
15 • 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-combat military deaths ‒ Similarities
Slide 16: EHS Clinical Study: September 2015
16 • 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 hallmark clinical features of EHS inc
Slide 17: EHS Main Study Results
17 Ryanodex with current SOC showed substantial and consistent evidence of increased effectiveness in treating EHS vs. SOC alone EHS Main Study Results Ryanodex + SOC (N=17) SOC Only (N=17) Treatment Odds Ratio n (%) n (%) GCS Score ≥13 at 90 Minutes Post-Randomization 5 (29.4) 2 (11.8) 3.1 GCS Scor
Slide 18: EHS Main Study Results (cont.)
18 Patients in Group A (Ryanodex + SOC) reached desired cooling outcome faster than patients in Group B (SOC Only) EHS Main Study Results (cont.) Cooling Time to Normal Temperature All Patients Duration of SOC (in Minutes) Ryanodex + SOC n=17 SOC Only n=17 Mean 57.1 70.4 Minimum 15 24 Maximum 105 18
Slide 19: EHS Initial Study Results (cont.)
19 EHS Initial Study Results (cont.) Ryanodex + SOC1 n=17 SOC Only n=17 N (%) of Patients Mean Percent Change 10 (59%) 55.6 14 (82%) 25 Percent Change from Baseline in GCS at 90 minutes Post-Randomization in Patients Not-Intubated at Baseline (Endotracheal Intubation Requires Use of Narcotics, Makin
Slide 20: EHS Initial Study Results (cont.) Safety Summary
20 EHS Initial Study Results (cont.) Safety Summary • Overall incidence of adverse events (AEs) was comparable in both treatment groups. • Most AEs in Group A (Ryanodex + SOC) were mild to moderate and assessed as not related to study drug. • Safety profile of Ryanodex in EHS patients was consistent
Slide 21: Eagle & NIH/NIDA Agreement
21 • Joint effort with the NIH to explore the potential of Ryanodex to treat hyperthermia related to Ecstasy and Methamphetamine intoxication – 125,000 emergency room visits in 2011 due to Ecstasy and Methamphetamine use1 – Brain hyperthermia is one of the leading causes of death in Ecstasy and Meth
Slide 22: Pemetrexed
22 • 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 market as ea
Slide 23: First Docetaxel Injection Concentrate, Non-Alcohol Formulation Approved in the U.S.
23 • 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 two or more hours after treatment • For treatment of breast cancer, non-small cell lung cance
Slide 24: Building Pipeline for Long Term Growth
24 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 candidate
Slide 25: Short-term Activity – Bendeka launch with Teva
25 Short-term Activity – Bendeka™ launch with Teva: • Expect near-complete conversion to Bendeka; shared goal with Teva of 90% market share • 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
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