Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (May 2016)
24 slides from Eagle Pharmaceuticals's investor presentation, May 3, 2016
Slide 1: Corporate Overview May 2016
EAGLE . | PHARMACEUTICALS Orporate Overview May 2016
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
4 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 action filed in April • Existing J-code adeq
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: Spectrum sales team and Eagle direct sales reps
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
7 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 Bendeka (50mL) – 20% royalty owed by Eagle to Teva if we take Bendeka back • O
Slide 8: Six Orange Book Listed Patents Running from 2026-2033
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)
9 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
Slide 10: Bivalirudin RTU
10 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 ma
Slide 11: Multiple Benefits vs. Angiomax
11 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 M
Slide 12: Ryanodex for Malignant Hyperthermia
12 • 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 13: Ryanodex Initial Label Expansion Opportunity: Exertional Heat Stroke
13 • 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 14: EHS Clinical Study: September 2015
14 • 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 15: EHS Main Study Results
15 • Ryanodex with current SOC showed substantial and consistent evidence of increased effectiveness in treating EHS than 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 S
Slide 16: EHS Main Study Results (cont.)
16 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 17: EHS Initial Study Results (cont.)
17 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.) Ryanodex + SOC1 n=17 SOC Only n=17 N (%) of Patients Mean Change (SD) Withi
Slide 18: EHS Initial Study Results (cont.)
18 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 19: EHS Initial Study Results: Safety Summary
19 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 20: Eagle & NIH/NIDA Agreement
20 • 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 use1 – Brain hyperthermia is one of the leading causes of death in Ecstasy a
Slide 21: Pemetrexed
21 • 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 22: First Docetaxel Injection Concentrate, Non-Alcohol Formulation Approved in the U.S.
22 • 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,
Slide 23: Building Pipeline for Long Term Growth
23 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 24: Short-term 2016 Activity
24 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 Court action filed in April • Existing J-cod
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