Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (March 2018)
21 slides from Eagle Pharmaceuticals's investor presentation, Mar 7, 2018
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,” “underwa
Slide 2: Eagle 2018 At A Glance
Eagle 2018 At A Glance 3 Driving near-term, sustainable value Pivotal trial commenced Q4 2017 Fulvestrant Positive regulatory feedback Innovative formulation offers opportunity similar to Bendeka Promoted by Eagle salesforce; pursuing add’l indications Ryanodex Agreed to a path forward on EHS with F
Slide 3: 2018: Poised for Growth
2018: Poised for Growth 4 Multiple potential regulatory filings in 2018
Slide 4: Fulvestrant Opportunity
Fulvestrant Opportunity INDICATIONS for FASLODEX® Currently marketed by AstraZeneca Administered monthly in a doctor’s office as 2 separate intramuscular injections, one in each buttock FDA has recently required revising the FASLODEX label 5 Faslodex ® is a registered trademark of AstraZeneca. Label
Slide 5: The Problem
The Problem 2 deep intramuscular injections of high viscosity product per dose of treatment (5 mL each) Administered over 1-2 minutes into each buttock Painful procedure FASLODEX injection reactions have been associated with peripheral nerve adverse reactions, including risk of damaging the sciatic
Slide 6: Eagle's Solution
Eagle’s Solution Innovative formulation administered in far less time (seconds) vs. 1-2 minutes per injection Eagle formulation may allow warning on insert to be eliminated Eagle formulation does not contain castor oil Eagle’s lower viscosity formulation allows for administration with smaller 23-gau
Slide 7: Fulvestrant Clinical Protocol
Fulvestrant Clinical Protocol Completed randomization of 600 subjects ahead of schedule during the first quarter of 2018 A single PK and safety study in healthy female volunteers may be sufficient for filing Commenced dosing Q4 2017 with last patient being dosed around end of April 2018 Aiming to fi
Slide 8: FASLODEX Market Opportunity
FASLODEX Market Opportunity $400mm+ O.U.S. Source: AstraZeneca Financial Summary Full Year and Q4 2017 Results Results) https://www.astrazeneca.com/content/dam/az/PDF/2017/Full-Year/Full-Year%202017%20Results%20announcement%20.pdf 9 2017 total sales of the branded form of fulvestrant, FASLODEX, were
Slide 9: RYANODEX: Multiple Label Expansion Opportunities
RYANODEX®: Multiple Label Expansion Opportunities Creating additional value by addressing life-threatening, unmet needs Eight patents issued to date expiring from 2022 to 2025 Breakthrough formulation of dantrolene sodium Approved in July 2014; launched in August 2014 Agreed to path forward with FDA
Slide 10: RYANODEX for Exertional Heat Stroke
Based on our recent meeting with the FDA, we have agreed on a path forward for an additional clinical trial for RYANODEX for EHS Originally received a CRL from the FDA on July 26, 2017 Will conduct additional clinical trial in August 2018 during the Hajj pilgrimage Similar to study conducted during
Slide 11: MDMA and Methamphetamine Intoxication
References: 1. Center for Behavioral Health Statistics and Quality, SAMHSA, Drug Abuse Warning Network, National Estimates of Drug-Related Emergency Department Visits, 2011. 2. E Musselman M, Saely S. Diagnosis and treatment of drug-induced hyperthermia. Am J Health-Syst Pharm. 2013 Vol 70. Over 125
Slide 12: Pemetrexed Opportunity
Pemetrexed Opportunity At this time, Lilly’s Alimta patent litigations prevent current ANDA filers from launching until May 24, 2022 FDA granted tentative approval of Eagle’s Pemetrexed RTD PEMFEXY™ Oct. 27, 2017 Lilly sued Eagle on August 14, 2017. Trial scheduled to begin on Sept. 9, 2019. There a
Slide 13: Bendeka: Long Life Cycle
Bendeka: Long Life Cycle 14 1/1/15-12/31/17: $126 mm in aggregate milestones earned 1/1/16-12/31/17: $235 mm in royalties earned Significant royalties and milestones earned 2016 - 2019 Unique J-code 8 newly listed patents through 2033 97% market share Royalty of 25% of US net sales (increased from 2
Slide 14: Thirteen Orange Book Patents Running from 2026-2033
Thirteen Orange Book Patents Running from 2026-2033 15 U.S. Patent No. Patent Expiration 8,609,707 1/28/2031 8,791,270*PED (owned by Teva Pharmaceutical Industries Ltd.) 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 9,572,796 1/28/2031 9,572,797 1/28/2031
Slide 15: Licensed Japanese Rights for Bendamustine to SymBio
Licensed Japanese Rights for Bendamustine Hydrochloride Products to SymBio Pharmaceuticals Limited in Q4 2017 Develop, market and sell Eagle’s bendamustine HCI ready-to-dilute (RTD) and rapid infusion injection (RI) products $12.5 mm upfront payment plus future potential milestones and royalty payme
Slide 16: Eagle Biologics Market Opportunity
Eagle Biologics Market Opportunity Acquired Arsia Therapeutics in 2016 Enhances Eagle’s formulation capabilities and expands product development opportunities Extends Eagle’s strategy: plan to partner with key Biosimilar or Bioinnovator companies to alter their existing pipeline into “Biobetters” $4
Slide 17: 2018 Tax Reform Impact
2018 Tax Reform Impact Eagle, as a U.S.-based tax payer, is expecting to benefit directly from the reduction in the U.S. Corporate tax rate from 35% to 21% beginning in 2018 Estimated combined effective tax rate of 24% As Eagle expands its portfolio globally, we may benefit further from even lower c
Slide 18: Financial Highlights
Financial Highlights 2017 EBITDA: $96 mm LTM cash flow from operating activities, excluding A/R build: $71 mm Cash: $114.7 mm A/R: $53.8 mm Share Repurchase Plan $80.8 mm repurchased (1.2 mm shares at $65.09) since August 2016 $100 mm additional authorization approved by the Board August 2017 14.9 m
Slide 19: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Ongoing Reinvestment of Cash Including Additional Share Repurchase Enhanced Management Team 20 Potential for multiple in-market products over the long-term
Slide 20: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Potential for multiple in-market products over the long-term Multiple in-market products Use of Capital Bendeka US & WW Bijcesco Big bag NA Ryanodex for MH, EHS, Bendeka US & WW HMA ‘amphetamine Big bag Intoxication and Nerve 4 Agent Methamphetamine Ca) Intoxi
Slide 21: Thank You
Thank You March 2018 aif Proprietary and Confidential. For Eagle Pharmaceuticals use only. PHARMACEUTICALS
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