Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2016)
23 slides from Eagle Pharmaceuticals's investor presentation, Sep 13, 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,”, “determ
Slide 2: About Eagle Pharmaceuticals
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 Teva’s establishm
Slide 3: Investment Highlights
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 purchasing
Slide 4: Growing Product Portfolio in Attractive Markets
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 hyperthermi
Slide 5: Eagle Value Drivers
Eagle Value Drivers EHS & Ecstasy/Meth intoxication Positive FDA meeting confirming hybrid (animal & human data) NDA submission for EHS EHS Human data complete; animal work underway EHS NDA submission upon completion of animal work; potential launch 2017 NIH Ecstasy & Meth study initiated 5 in-marke
Slide 6: Bendamustine Opportunity
$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 issued and list
Slide 7: Multiple Benefits of Bendeka
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. cardiovascular a
Slide 8: Bendeka showed a lower incidence of treatment emergent adverse events
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 (overall) 56 117 Fatigue 1 (4.8%) 9 (31%) 0.007 Nausea 1 (4.8%) 9 (3
Slide 9: Ryanodex Opportunities
Ryanodex® Opportunities Breakthrough formulation of dantrolene sodium 5mL (1 vial) vs. 720mL (12 vials) Approved in July 2014 28% of dantrolene unit sales in Q2 2016 Marketed Potential Label Expansion Potential to be the first drug to market for EHS Hybrid development program (human and animal data)
Slide 10: Ryanodex for Malignant Hyperthermia (MH)
Ryanodex® for Malignant Hyperthermia (MH) 12.5 mg/kg loading dose for a 100 kg person, as recommended by the Malignant Hyperthermia Association of US (mhaus.org) No change to drug treatment for MH treatment in 30+ years Optimized breakthrough formulation of dantrolene sodium, requiring 1 vial1 to be
Slide 11: Exertional Heat Stroke (EHS) unmet medical need
Exertional Heat Stroke (EHS) unmet medical need Sudden, unpredictable and life-threatening condition Patient population most impacted: military personnel, firemen, professional athletes, college and high school student athletes, construction workers, farmers, people performing physically intense rec
Slide 12: EHS Human Clinical Study
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 Standard of Care (SOC)1 + Ryanodex Inclusion protocol criteria required that patients showed hallmark clinical features of EHS including: 18-4
Slide 13: EHS Study Results
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 at
Slide 14: EHS Study Results Continued
Ryanodex + SOC 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) Patien
Slide 15: EHS Study: Safety Summary
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 well charact
Slide 16: Ryanodex for Ecstasy & Meth Intoxication
Research Agreement 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 and disabili
Slide 17: 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 18: RTU Bivalirudin Opportunity
RTU Bivalirudin Opportunity Complete Response Letter received March 2016 In discussions with FDA regarding human study
Slide 19: Building Pipeline for Long Term Growth
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 responsible clinical t
Slide 20: Strategic Cash Deployment
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 buyback program Comp
Slide 21: Summary Financials
Summary Financials $105.4 $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 $0.8 0 2015 Q1 2016 Q2 2016 EPS (fully diluted)
Slide 22: Why Eagle? Why Now?
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 product: Ryanod
Slide 23: Why Eagle? Why Now?
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 produ
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