Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (August 2016)
23 slides from Eagle Pharmaceuticals's investor presentation, Aug 10, 2016
Slide 1: August 2016 Corporate Overview
August 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,”, “de
Slide 3: About Eagle Pharmaceuticals
3 About Eagle Pharmaceuticals Fully commercial specialty pharmaceutical company focused on hospitals and infusion centers • Developing & commercializing injectable products that improve upon existing formulations • 5 products in-market delivering profits • Key driver of profit through 2019 • Bendeka
Slide 4: Investment Highlights
4 • Profitable fully commercial specialty pharmaceutical company with a broad portfolio and deep near-term pipeline • Strong YoY growth anticipated beyond 2020 from product sales and royalty income in multiple attractive markets • 40+ salesforce focused on infusion centers, hospitals and oncology pu
Slide 5: Growing Product Portfolio in Attractive Markets
5 Growing Product Portfolio in Attractive Markets Mkt Size: $XX Products Market Size Bendamustine Bendeka™ • Launched January 2016; 80% market share • Exclusive marketing license with Teva • Orange book patents thru 2033 Bendamustine 500mL • Right to launch as of May 2016 ~$750M Ryanodex Malignant h
Slide 6: Eagle Value Drivers
6 Eagle Value Drivers Growing Commercial Product Portfolio Ryanodex Label Expansion Pipeline Development Strategic Cash Deployment • EHS & Ecstasy/Meth intoxication • Positive FDA meeting confirming hybrid (animal & human data) NDA submission for EHS • EHS Human data complete; animal work underway •
Slide 7: Bendamustine Opportunity
7 • $750 million market previously dominated by Teva’s Treanda® • Option to launch tentatively approved Bendamustine RTD (500mL) in the U.S. at any time • Final j-code ruling expected Q4 2016; pursuing legal action on FDA denial of seven years of orphan drug marketing exclusivity • Six patents issue
Slide 8: Multiple Benefits of Bendeka
8 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 requiredNurse • Sodium-free administration for patients requiring restricted sodium intake (e.g. cardiov
Slide 9: Bendeka showed a lower incidence of treatment emergent adverse events
9 Bendeka showed a lower incidence of treatment emergent adverse events (TEAEs) Bendeka™ vs. Treanda®: Fewer Observed AEs Open-label, randomized, crossover study compared Bendeka to Treanda 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%) 0.00
Slide 10: Ryanodex Opportunities
10 Ryanodex® Opportunities 1SOC: body cooling by physical methods (e.g. cold water immersion, cold water mist, ice packs application) and supportive measures Malignant Hyperthermia Exertional Heat Stroke Ecstasy & Methamphetamine Intoxication • Breakthrough formulation of dantrolene sodium • 5mL (1
Slide 11: Ryanodex for Malignant Hyperthermia (MH)
11 Ryanodex for Malignant Hyperthermia (MH) 1SOC: body cooling by physical methods (e.g. cold water immersion, cold water mist, ice packs application) and supportive measures No change to Standard of Care (SOC)1 for MH treatment in 30+ years Optimized breakthrough formulation of dantrolene sodium Re
Slide 12: Ryanodex for Exertional Heat Stroke
12 • Exertional Heat Stroke (EHS) unmet medical need ‒ 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 de
Slide 13: EHS Human Clinical Study
13 • Safety & Efficacy study to evaluate Ryanodex for treatment of EHS during the Hajj pilgrimage in Saudi Arabia (Sep 2015) • 34 patients randomized 1:1 to receive SOC or SOC + Ryanodex • Inclusion protocol criteria required that patients showed hallmark clinical features of EHS including: – 18-45
Slide 14: EHS Study Results
14 Ryanodex with current SOC showed substantial and consistent evidence of increased effectiveness in treating EHS vs. SOC alone EHS 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 Score ≥13
Slide 15: EHS Study Results Continued
15 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, Making Assessment of GCS Unfeasible) Pa
Slide 16: EHS Study: Safety Summary
16 EHS Study: 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 with its known and wel
Slide 17: Ryanodex for Ecstasy & Meth Intoxication
17 • 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 the US in 2011 due to Ecstasy and Methamphetamine use1 – Brain hyperthermia is one of the leading causes of death in Ecstas
Slide 18: Pemetrexed
18 • 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 19: RTU Bivalirudin Opportunity
19 RTU Bivalirudin Opportunity • Complete Response Letter received March 2016 • In discussions with FDA regarding human study 1 Angiomax® (bivalirudin) / Angiox® (bivalirudin) (The Medicines Company)
Slide 20: Building Pipeline for Long Term Growth
20 Building Pipeline for Long Term Growth • Ryanodex for the treatment of Ecstasy and Methamphetamine intoxication • AMRI Development Program • Joint development program for several new product candidates • AMRI to provide drug development and manufacturing once approved by the FDA • Eagle responsib
Slide 21: Strategic Cash Deployment
21 Strategic Cash Deployment • $127.6 million in cash and receivables as of June 30, 2016 • Focused on prudent deployment of cash on behalf of shareholders • Ryanodex royalty • Reduced royalty obligation from 15% to 3% • $15 million in cash • Share repurchase • Board authorized $75 million share buy
Slide 22: Summary Financials
22 $66.2 $29.6 $40.9 2015 Q1 2016 Q2 2016 Revenue Summary Financials $115.3 $104.8 $127.6 2015 Q1 2016 Q2 2016 Cash & Receivables $2.6 -$0.9 $13.1 2015 Q1 2016 Q2 2016 Net Income (Loss) $0.16 -$0.06 $0.80 2015 Q1 2016 Q2 2016 EPS (fully diluted)
Slide 23: Why Eagle? Why Now?
23 Why Eagle? Why Now? • Fully commercial specialty pharmaceutical company with 5 in-market products • Bendeka expected to deliver steady royalty stream driving near term profitability • 80% market share (and growing) of $750mm market • 20% royalty (~$125-$150mm+ annually) through 2019 • Next big pr
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