Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2017)
21 slides from Eagle Pharmaceuticals's investor presentation, Sep 13, 2017
Slide 1: Eagle Pharmaceuticals
Eagle Pharmaceuticals September 2017 ©2017 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 2: 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 3: Eagle 2017 At A Glance
Eagle 2017 At A Glance Driving long term value Bendamustine Launched Bendeka: 97% market conversion • Unique J-Code effective January 1, 2017 • Orphan Drug Designation • 13 Orange Book Listed patents for Bendeka • In litigation for ODE • Sued three ANDA filers for patent infringement Ryanodex Promot
Slide 4: Bendeka: Long Life Cycle
Bendeka: Long Life Cycle • 97% market share • Unique J-code • Royalty increase from 20% to 25% 2016 • 8 newly listed patents through 2033 • $89mm in royalties earned in 2016 • $89mm in milestones earned 2015/2016 • $70mm in royalties earned in 1H2017 • Royalty of 25% of US net sales Now - 2019 • $25
Slide 5: Thirteen Orange Book Patents Running from 2026-2033
Thirteen Orange Book Patents Running from 2026-2033 Protecting the longevity of the bendamustine franchise U.S. Patent No. Patent Expiration 8,609,707 1/28/2031 8,791,270*PED 7/12/2026 (owned by Teva Pharmaceutical Industries Ltd.) 9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033 9,265,83
Slide 6: RYANODEX: Multiple Label Expansion Opportunities
RYANODEX®: Multiple Label Expansion Opportunities Creating additional value by addressing life-threatening, unmet needs Marketed Potential Label Expansion Malignant Hyperthermia Exertional Heat Stroke MDMA & Methamphetamine Nerve Agent Intoxication • Breakthrough • Potential to be the first • Precli
Slide 7: Eagle Research: EHS Under-Reported
Eagle Research: EHS Under-Reported Significantly higher incidence than previously documented Total U.S. Estimated EHS Incidence ~75K • EHS incidence consistent across regions • All respondents reported seeing multiple patients with EHS in 2016 • 56% ED physicians would use RYANODEX to treat EHS pati
Slide 8: RYANODEX for Exertional Heat Stroke
RYANODEX® for Exertional Heat Stroke • Received a CRL from the FDA on July 26, 2017 • Type A meeting with FDA in September – Label expansion for an already approved drug – No safety or CMC issues – Priority review and Fast Track designation • We believe the results of our human and animal studies ar
Slide 9: MDMA (Ecstasy) and Methamphetamine Intoxication
MDMA (Ecstasy) and Methamphetamine Intoxication • Use of illegal stimulants constitutes a growing public health problem in the US and EU1 • Over 125,000 ED visits related to MDMA (ecstasy) and methamphetamine use in the US alone (2011)1 • ED visits involving MDMA among patients 21 years and younger
Slide 10: MDMA & Methamphetamine Intoxication: Positive pre-IND Meeting with FDA
MDMA (Ecstasy) & Methamphetamine Intoxication: Positive pre-IND Meeting with FDA • 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 e
Slide 11: Pemetrexed Opportunity
Pemetrexed Opportunity • At this time, Lilly’s Alimta patent infringement lawsuit prevents current ANDA filers from launching until May 24, 2022 • Eagle’s Pemetrexed RTD NDA was filed December 2016 • NDA accepted with PDUFA date of October 30, 2017 • Lilly sued Eagle on August 14, 2017 • There are t
Slide 12: Fulvestrant Opportunity
Fulvestrant Opportunity INDICATIONS for FASLODEX ® Monotherapy FASLODEX is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-posit
Slide 13: 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
Slide 14: Positive Regulatory Feedback from FDA regarding Fulvestrant Clinical Protocol
Positive Regulatory Feedback from FDA regarding 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 – Expect study to recruit and complete within 12 months • FDA h
Slide 15: Eagle's Solution
Eagle’s Solution 1X 2X Low High viscosity viscosity 5mL vs. 5mL dose doses • 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 15 ©2017 Eagle Ph
Slide 16: FASLODEX Market Opportunity
FASLODEX Market Opportunity 12 months ended June 30th 2017 total sales of the branded form of fulvestrant, FASLODEX, were up 15% to $891 million worldwide • 16% growth in US sales to $468mm • 13% growth in EU sales to $248mm $400mm+ • 22% growth in Established ROW sales to $72mm O.U.S. • 12% growth
Slide 17: Eagle Biologics (Arsia Acquisition)
Eagle Biologics (Arsia Acquisition) • Marks Eagle’s entry into Biologics – Fastest growing pharmaceutical sector • Enhances Eagle’s formulation capabilities and expands product development opportunities • Secures a patent portfolio of viscosity-reducing technology • Provides access to leading minds
Slide 18: Biologics Market Opportunity
Biologics Market Opportunity • The global biologics market could exceed $390 billion in value over the next five years1 • Growing at nearly 2X the rate of pharma1 • By the end of 2020, biologics could account for 28% of the global pharmaceuticals market1 • The global biosimilar market may reach $20
Slide 19: Financial Highlights
Financial Highlights • LTM 6/30/17 EBITDA: $96mm • 6/30/17: $55.4mm cash; $53.2mm A/R; no debt • Share Repurchase Plan – $75.8mm repurchased (1.1mm shares at $65.91) since August 2016 – $100mm additional authorization approved by the Board August 2017 • 14.9mm basic shares outstanding as of 9/05/17
Slide 20: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Potential for multiple in-market products over the long-term 2026+ Multiple in-market products Use of Capital Bendeka 2020 - 2026 R&D success US & WW Bendeka Ryanodex for MH, EHS, 2017 - 2019 US & WW MDMA & Methamphetamine Bendeka US Ryanodex for MH Intoxicati
Slide 21: Thank You
Thank You September 2017 21 ©2017 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
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