Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (January 2018)
22 slides from Eagle Pharmaceuticals's investor presentation, Jan 8, 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 Phase II clinical trial for MDMA/meth
Slide 3: 2018 Tax Reform Impact
2018 Tax Reform Impact Eagle, as a US-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 As Eagle expands its portfolio globally, we may benefit further from even lower corporate rates in certain foreign jurisdiction
Slide 4: 2018: Poised for Growth
2018: Poised for Growth 5 Multiple potential regulatory filings in 2018 Ryanodex EHS MDMA and Meth Intoxication Nerve agent Intramuscular AMRI Anticipate 1 filing 1st half of 2018; and, 1 filing 2nd half of 2018 Fulvestrant Complete study enrollment in first half of 2018 File Q4 2018 pending study r
Slide 5: RYANODEX: Multiple Label Expansion Opportunities
RYANODEX®: Multiple Label Expansion Opportunities Creating additional value by addressing life-threatening, unmet needs Seven patents issues to date expiring from 2022 to 2025 Breakthrough formulation of dantrolene sodium Approved in July 2014; launched in August 2014 Potential to be the first drug
Slide 6: Illegal stimulant use a growing public health problem
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. Use of i
Slide 7: RYANODEX for MDMA (Ecstasy) & Methamphetamine Intoxication
RYANODEX® for MDMA (Ecstasy) & Methamphetamine Intoxication FDA suggested and we are broadening the indication to evaluate ‘organ damage and/or severe dysfunction’ in patients with MDMA and Methamphetamine intoxication No additional preclinical work required to support the efficacy of RYANODEX for t
Slide 8: Received a CRL from the FDA on July 26, 2017
Received a CRL from the FDA on July 26, 2017 Eagle and FDA continue to discuss a plan forward Believe strongly in RYANODEX given that there is no pharmacological option available for patients in need for this life-threatening condition Label expansion for an already approved drug No safety or CMC is
Slide 9: 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 10 Faslodex ® is a registered trademark of AstraZeneca. Lab
Slide 10: 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 11: 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 12: Fulvestrant Clinical Protocol
Fulvestrant Clinical Protocol Pre-IND meeting responses are aligned with Eagle’s development plan 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 file an NDA by the early
Slide 13: FASLODEX Market Opportunity
FASLODEX Market Opportunity $400mm+ O.U.S. Source: AstraZeneca Financial Summary Full Year and Q4 2016 & AstraZeneca H1 2017 Results Results)www.londonstockexchange.com/exchange/news/market-news/market-news 14 12 months ended June 30th 2017 total sales of the branded form of fulvestrant, FASLODEX, w
Slide 14: 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 ar
Slide 15: Bendeka: Long Life Cycle
Bendeka: Long Life Cycle 16 1/1/15-9/30/17: $126 mm in aggregate milestones earned 1/1/16-9/30/17: $200 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 20%
Slide 16: Thirteen Orange Book Patents Running from 2026-2033
Thirteen Orange Book Patents Running from 2026-2033 17 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 17: 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 18: Eagle Biologics Market Opportunity
Eagle Biologics Market Opportunity Acquired Arsia Therapeutics in 2017 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” $7
Slide 19: Financial Highlights
Financial Highlights LTM EBITDA: $111 mm LTM cash flow from operating activities, excluding A/R build: $97 mm Cash: $97.5 mm A/R: $71.6 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 mm
Slide 20: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Ongoing Reinvestment of Cash Including Additional $100 million Share Repurchase 21 Potential for multiple in-market products over the long-term 2017 - 2019 2020 - 2026 2026+ Multiple in-market products Use of Capital R&D success Bendeka US & WW Big bag Ryanode
Slide 21: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Potential for multiple in-market products over the long-term Multipte in-market Bendeka US & WW Big bag Ryanodex for MH, EH jendeka US & WW. MDMA Bendeka vs 2] Methamphetamine Big bag = Intoxication and Nerve Ryanodex for MH, EHS, > Agent MDMA & AQ ‘AMRI Metha
Slide 22: Thank You
Thank You January 2018 Mt pretary and Confidential. For Eagle Pharmaceuticals’ use only. PHARMACEUTICALS
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