Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Corporate Update (January 2017)
22 slides from Eagle Pharmaceuticals's corporate update, Jan 11, 2017
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,” “determi
Slide 2: 2016 At A Glance
2016 At A Glance 3 David Pernock joined Eagle management team as President Enhanced Board of Directors Significantly enhanced Eagle’s long term value Bendamustine Launched Bendeka: 91% market conversion CMS issued unique J-Code 2 patents for Bendeka allowed Ryanodex Purchased royalty rights Submitte
Slide 3: Financial Update
Financial Update • Expenses: – – Reaffirm total operating expenses of $80m-$84m for full year 2016 Includes accelerated investment in R&D programs and pre-launch expenses during Q4’16 Recognized one-time expenses in Q4’16 – • Balance Sheet: – Approximately $50m in cash and cash equivalents and $37m
Slide 4: Bendeka: Long Life Cycle
Bendeka: Long Life Cycle 2016 • 91% market share • Unique J-code • Royalty increase from 20% to 25% • 2 newly listed patents through 2033 • Teva estimates $600 to $660 million in 2017, without price increase, due to lower 2016 run rate Now - 2019 • Royalty of 25% of US net sales • US and expansion t
Slide 5: Six Orange Book Listed Patents Running from 2026-2033
Six Orange Book Listed Patents Running from 2026-2033 6 U.S. Patent No. Patent Expiration 8,609,707 8/11/2031 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 2 Additional Patents Allowed Protecting
Slide 6: Ryanodex: Multiple Label Expansion Opportunities
Ryanodex®: Multiple Label Expansion Opportunities Creating additional value through line extensions Breakthrough formulation of dantrolene sodium Approved in July 2014 Potential to be the first drug to market for EHS Filed human data as part of rolling NDA; anticipate filing completion Q1 ’17 Precli
Slide 7: Eagle Research: EHS Under-Reported
Eagle Research: EHS Under-Reported 8 ~75K to 100K – estimated total annual EHS patient volume EHS Incidence Consistent Across Regions All respondents reported seeing multiple patients with EHS in 2016 56% ED physicians would use Ryanodex to treat EHS patients Significantly Higher Incidence than prev
Slide 8: MDMA (Ecstasy) 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. Use of i
Slide 9: Eagle Collaboration with NIH/NIDA
Eagle Collaboration with NIH/NIDA 10 Collaboration agreement to conduct nonclinical studies in a validated rodent model of MDMA and methamphetamine intoxication Initial data shows: Animals with MDMA-induced hyperthermia treated with Ryanodex® had a greater decrease in brain temperature compared to a
Slide 10: MDMA & Methamphetamine Intoxication: Positive pre-IND Meeting with FDA
MDMA (Ecstasy) & Methamphetamine Intoxication: Positive pre-IND Meeting with FDA FDA suggested 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 Ryan
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 RTU NDA was filed December 2016 $1.1B market opportunity1 12 1 Alimta® (pemetrexed) (Eli Lilly & Co.). Source: Eli Lilly & Co. Q2 2016 ear
Slide 12: Fulvestrant Opportunity
Fulvestrant Opportunity INDICATIONS for FASLODEX ® Monotherapy FASLODEX is indicated for the treatment of hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Combination Therapy FASLODEX in combination with palbocic
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 sciatic
Slide 14: Eagle's Solution
Eagle’s Solution Innovative formulation administered in less time vs. 1-2 minutes per injection Eagle formulation may allow warning on insert to be limited 1X Low viscosity 5mL dose 2X High viscosity 5mL doses vs. 15
Slide 15: Revised Warnings and Precautions Section of Faslodex Label (2016)
Revised Warnings and Precautions Section of Faslodex Label (2016) 16
Slide 16: Faslodex Market Opportunity
Faslodex Market Opportunity $400mm+ O.U.S. 2015 total sales of Faslodex were up 9% to $704 million worldwide 5% growth in US sales to $356m 2% growth in European sales to $207m 49% growth in Emerging Markets sales to $87m; supported by the launch of 500mg Faslodex China sales accelerated in the year
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 in the
Slide 18: Biologics Market Opportunity
Biologics Market Opportunity The global biologics market could exceed $390 billion in value of 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 - $26 bill
Slide 19: Building A Portfolio of Long Term Assets
Building A Portfolio of Long Term Assets 20 Bendamustine Unique J-Code & additional patents protect longevity of bendamustine franchise beyond 2020 Ryanodex Submission of NDA for EHS Potential EHS market entry in summer ’17 Positive early animal study results for MDMA and meth. intoxication Pemetrex
Slide 20: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 Ongoing Reinvestment of Cash Enhanced Management Team 21 Potential for multiple in-market products over the long-term 2017 - 2019 2020 - 2026 2016 2026+ Multiple in-market products Use of Capital R&D success Bendeka US & WW Ryanodex for MH Ryanodex for EHS Rya
Slide 21: 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 R&D success us & Ww Ryanodex for MH Ryanodex for EHS. Ryanodex for MDMA & Methamphetamine Intoxication Argatroban Diclofenac misoprostol Docetaxel
Slide 22: Thank You
Thank You January 2017 ate
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