Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (March 2016)
20 slides from Eagle Pharmaceuticals's investor presentation, Mar 24, 2016
Slide 1: 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 2: Activity through May 2016
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 Anticipate J-code decision In discussions with FDA regardi
Slide 3: 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 Ryanodex
Slide 4: Eagle Will Have Over 50 Sales Reps Calling on Hospitals and Cancer Centers
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 total paymen
Slide 5: Exclusive Marketing Agreement with Teva for Bendeka (50 mL Rapid Infusion)
Significant market opportunity: Up to $65M in additional milestone payments subject to: Achievement of certain sales levels Achievement of certain reimbursement criteria Royalty payments: 20% royalty on net sales of Bendeka (50mL) Eagle may earn an incremental step-up royalty upon the achievement of
Slide 6: 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 1 Owned by Teva Pharmaceutical Industries
Slide 7: Multiple Benefits of Bendeka (50mL)
Multiple Benefits of Bendeka® (50mL) Less chair time: 30 or 60 min. reduced to 10 min. Less volume & issues related to 50mL vs. 500mL admixture Patient Less nursing time required Nurse 90% reduction in NaCl – renal suppressed population Medical/ Patient Additional patients treated in the cancer clin
Slide 8: 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 market contract
Slide 9: Ryanodex 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 change Protected market position Five patents issued + two filed Orphan dru
Slide 10: Exertional Heat Stroke (EHS): 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-combat military deaths Similarities to MH Potent
Slide 11: 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 patients showed hallmark clinical features
Slide 12: EHS Initial Study Results
Ryanodex with current standard of care1 (SOC) showed substantial evidence of increased effectiveness in treating EHS than SOC alone EHS Initial Study Results Cumulative Incidence of Glasgow Coma Scale (GCS) Score ≥13 at 90 min. Post-Randomization 1SOC: body cooling by physical methods (e.g. cold wat
Slide 13: 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) EHS Initial Study Results (cont.) 1SOC: body cooling by physical methods (e.g. cold water immersion, cold water
Slide 14: EHS Initial Study Results (cont.)
EHS Initial Study Results (cont.) 1SOC: body cooling by physical methods (e.g. cold water immersion, cold water mist, ice packs application) and supportive measures 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
Slide 15: EHS Initial Study Results (cont.) Safety Summary
EHS Initial Study Results (cont.) Safety Summary 1SOC: body cooling by physical methods (e.g. cold water immersion, cold water mist, ice packs application) and supportive measures Overall incidence of adverse events (AEs) was comparable in both treatment groups. Most AEs in Group A (Ryanodex + SOC)
Slide 16: 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 market as early as Q4 2
Slide 17: 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 hours after treatment For treatment of breast cancer, non-small cell lung cancer, prostate
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 AMRI to provi
Slide 19: Activity through May 2016
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 Anticipate J-code decision In discussions with FDA regardi
Slide 20: 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 Anticipate J-c
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