Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Day (November 2016)
116 slides from Eagle Pharmaceuticals's investor day presentation, Nov 14, 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: We've Built a Valuable Asset
We’ve Built a Valuable Asset Argatroban, Docetaxel, Diclofenac Founded IPO 2007 2014 2016 • Reformulate drugs to solve those gaps 3 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. How? •Isolate problems with how drugs are delivered
Slide 3: Bendamustine: Eagle's Strategy At Work
Bendamustine: Eagle’s Strategy At Work ( ~ $ 7 5 0 M M + m a r k e t ) 1. Week ending November 6, 2016 4 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. Best-In-Class Formulation 6 Orange Book Patents Extending 2026 - 2033 Unique J
Slide 4: Six Orange Book Listed Patents Running from 2026-2033
Six Orange Book Listed Patents Running from 2026-2033 • Protects the longevity of the bendamustine franchise U.S. Patent No. Patent Expiration 8,791,270*PED (owned by Teva Pharmaceutical Industries Ltd.) 7/12/2026 9,034,908 3/15/2033 9,265,831 1/28/2031 5 ©2016 Eagle Pharmaceuticals. All rights rese
Slide 5: Long Life Cycle = Significant Value in Bendeka
Long Life Cycle = Significant Value in Bendeka 2016 Now - 2019 2020 – 2026 2026 – 2033 6 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. • 5-7 years of additional patent protection • 6 years of royalty of 25% net sales • Assuming l
Slide 6: Ryanodex: Multiple Label Expansion Opportunities
Ryanodex®: Multiple Label Expansion Opportunities • Creating additional value through line extensions Malignant Hyperthermia Exertional Heat Stroke Potential to be the first drug to market for EHS Rolling NDA – first part submitted Drug-Induced Hyperthermia • Breakthrough formulation of dantrolene s
Slide 7: Arsia Acquisition
Arsia Acquisition + • • • Early-stage biotechnology firm founded by Drs. Langer and Klibanov of MIT, focused on biologics Up to $78 million; $30 million upfront and $48 million in milestone payments 4-5 years from now Significantly enhances Eagle’s formulation capabilities and greatly expands produc
Slide 8: Eagle Year in Review
Eagle Year in Review • • • • Launched Bendeka: 88% market conversion CMS issued unique J-Code Purchased Ryanodex royalty rights Bought back $32 million in Eagle shares as part of repurchase plan Announced Arsia acquisition • Received Fast Track designation and submitted human data as part of rolling
Slide 9: Multiple Near-Term Catalysts to Drive Value
Multiple Near-Term Catalysts to Drive Value Bendeka market share approaching 90% Unique J-code (Bendeka) Ryanodex for EHS Ryanodex for DIH New Product Arsia • 88% as of 11.6.16 • • Effective Q1 ’17 Immediate increase in royalty rate to 25% Triggers milestone payment Added Bendeka clarity post 2019 •
Slide 10: Ryanodex for Exertional Heat Stroke and Drug-Induced Hyperthermia
Ryanodex® for the Treatment of: Exertional Heat Stroke (EHS) and Drug-Induced Hyperthermia Adrian Hepner, MD, PhD, Chief Medical Officer (DIH) ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 11: Disclaimer
Disclaimer Ryanodex® (dantrolene sodium) for injectable suspension is FDA-approved for the treatment of Malignant Hyperthermia (MH) and for the prevention of MH in patients at high risk. Ryanodex is an investigational drug for the treatment of Exertional Heat Stroke (EHS) and for the treatment of Dr
Slide 12: Ryanodex for the Treatment of Exertional Heat Stroke
Ryanodex® (dantrolene sodium) for the Treatment of Exertional Heat Stroke ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 13: What is Exertional Heat Stroke (EHS)?
What is Exertional Heat Stroke (EHS)? • • • Life-threatening, sudden, unpredictable and rare medical condition Mostly affecting young, active, and otherwise healthy individuals No drug treatment is currently available Hallmark Features • • • • • Brain injury Acute renal injury Rhabdomyolysis (skelet
Slide 14: EHS Has Been Recognized for Centuries
EHS Has Been Recognized for Centuries heavy armor. particularly on the head.’ Other Diseases (James Currie). 16 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. 400 BC Herodotus described the death of military personnel was due to e
Slide 15: Current Standard of Care (SOC)
Current Standard of Care (SOC) SOC is currently limited to body cooling by physical methods (e.g., water immersion, ice-packs, water mist), and supportive measures (e.g., IV fluids, respiratory support) Goals Facts & Limitations • • Immediate implementation Lower core body temperature below 40°C wit
Slide 16: Limited Availability and Utilization of Efficient Body Cooling
Limited Availability Evaporative Cooling & Utilization of Efficient Body Cooling Commonly Used Methods Cold Water Immersion Limited efficiency and usually restricted to ice packs, wet blankets, and cold gastric lavage Often limited to well-organized sporting events (eg, marathons, professional footb
Slide 17: Brain-Body Temperature
Brain-Body Temperature • Average brain temperature is 0.9°C higher than core body temperature under normal physiologic conditions1,2 Brain accounts for 2-3% of total body mass, but consumes 25% of total glucose and 20% of total oxygen3 Brain has high metabolic rate and heat generation4 – The oxygen-
Slide 18: Brain Thermal Regulation
Distribution of Cardiac Output at Rest and During Maximal Exercise 4 Brain Thermal Regulation Brain temperature largely depends on 3 variables1: • – – – Brain metabolism Cerebral blood flow (CBF) and volume Blood temperature • CBF is the main mechanism to maintain brain and body temperature ‘couplin
Slide 19: Blood-Brain Barrier Permeability (BBBP)
Blood-Brain Barrier Permeability (BBBP) • Highly temperature dependent1 – – Hypothermia (<35°C) increases BBBP 2x-4x Hyperthermia (>38°C) increases BBBP up to 26x • Brain hyperthermia > BBBP – – – – BBB leakage2 Glial activation Brain edema Brain cell damage • Known causes of brain hyperthermia incl
Slide 20: Hyperthermic/Hypermetabolic Crisis Mechanism of CNS Dysfunction and Injury
Hyperthermic/Hypermetabolic Crisis Mechanism of CNS Dysfunction and Injury Hyperthermic/ Hypermetabolic Crisis Brain Edema 22 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. Brain Damage Neuronal Cell Dysfunction & Cell Death Excit
Slide 21: Brain Damage Is A Major Risk of Heat Stroke
Brain Damage Is A Major Risk of Heat Stroke Common Imaging Findings • • Early cerebral edema Loss of gray-white matter differentiation Patchy high signal intensity of the white matter of cerebral hemispheres and corpus striatum Central pontine myelinolysis Vascular boundary zone infarcts • Li et al.
Slide 22: RYRs Receptors & Dantrolene
RYRs Receptors & Dantrolene • Intracellular Ca2+-release channels expressed on the surface of the sarco/endoplasmic reticulum1 Regulated by the Ca2+-dependent protein, calmodulin (CaM)2 Three different RyR isoforms identified in mammalian tissues3 • • – – – RyR1: predominant in skeletal muscle RyR2:
Slide 23: Ryanodex Mechanism of Action: Addressing Calcium Dysregulation
Ryanodex Mechanism of Action: Addressing Calcium Dysregulation Endoplasmic reticulum (ER)-to-cytosol Ca2+ • Calcium (Ca2+) as a second messenger has a critical role in:1,2 regulates survival and death of neural cells – – – – – Cell growth and differentiation Membrane excitability and permeability Sy
Slide 24: Why Ryanodex?
Why Ryanodex®? • Dantrolene inhibits ryanodine receptors (RyRs), which are intracellular Ca2+-release channels expressed on the surface of the sarco/endoplasmic reticulum Intracellular Ca2+ dysregulation often leads to cell damage and cell death Innovative formulation of Ryanodex was designed with p
Slide 25: Ryanodex May Be a Potential Treatment Option for EHS
Ryanodex® May Be a Potential Treatment Option for EHS Ryanodex (dantrolene sodium) Has Unique Properties Protects against glutamate-induced neurotoxicity by reducing [Ca2+]i1 Reduces cell apoptosis by modulating calmodulin, which produces nitric oxide, and is activated by Ca2+1 Inhibits Ca2+ release
Slide 26: Ryanodex Development Program for the Treatment of EHS
Ryanodex® Development Program for the Treatment of EHS ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 27: Ryanodex for EHS: Brief Regulatory History
Ryanodex® for EHS: Brief Regulatory History 2015 FDA & Eagle agree to hybrid development plan: 2012 ODD granted Designation #12-3775 • Clinical: open-label case series in EHS patients, and safety data from patients with any heat-related illness Nonclinical: 2 pivotal GLP studies in ‘MH Susceptible’
Slide 28: EHS Pivotal Animal Studies
EHS Pivotal Animal Studies • • Nonclinical efficacy studies conducted under the ‘Animal Rule’ are currently ongoing Previous pilot nonclinical studies in swine: – – Determined the appropriateness of a large animal model for EHS Informed the design of pivotal studies • Data demonstrated: – Passive he
Slide 29: Clinical Study EGL-4104-C-1502 Summary of Study Design
Clinical Study EGL-4104-C-1502 Summary of Study Design • Randomized, 2-arm parallel, open-label study to evaluate the safety and efficacy of Ryanodex® + SOC compared to SOC-only for the treatment of patients with EHS – SOC (standard of care) was defined as efficient body cooling plus supportive meas
Slide 30: The 2015 Hajj
The 2015 Hajj • Location: Makkah region, Kingdom of Saudi Arabia Temp.: Highs: 106-117° F; lows in the 90s Humidity: > 60% Over 12 hours of sunlight per day Most pilgrims are foreigners, not acclimated to hot desert conditions Pilgrims walk over 20 miles (32 km) just in the first 2 days of the Hajj
Slide 31: Characteristics of Clinical Study EGL-4104-C-1502
Characteristics of Clinical Study EGL-4104-C-1502 • Conducted in ‘real-world’ emergency setting during the 2015 Hajj, by experienced and well-trained medical personnel GCP ICH compliant study (site monitoring, data management, data analysis, and QA/QC were conducted by Quintiles CRO) Clinically mean
Slide 32: Clinical Study Efficacy Summary
Clinical Study Efficacy Summary • A greater proportion of Ryanodex®-treated patients achieved a clinically meaningful improvement in their neurological functioning, as early as 45 minutes post-randomization • A greater proportion of Ryanodex-treated patients showed a clinically meaningful neurologic
Slide 33: Clinical Study Safety Summary
Clinical Study Safety Summary • • • • Safety and tolerability findings in EHS patients were similar in both treatment groups No new and/or unexpected safety signals identified No treatment-related adverse events were reported Safety profile of Ryanodex® in EHS patients was consistent with its known
Slide 34: Conclusions
Conclusions • Eagle’s low-volume high-concentration Ryanodex® formulation, makes it a potentially suitable therapy for the treatment of EHS in emergency settings • Clinical data demonstrates the efficacy and safety of Ryanodex for the treatment of EHS – Ryanodex provided clinically meaningful benefi
Slide 35: Ryanodex: Managing Crises, Improving Patient Outcomes
Ryanodex®(dantrolene sodium) Managing Crises, Improving Patient Outcomes Sherry Korczynski – Senior Vice President, Marketing ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 36: Disclaimer
Disclaimer Ryanodex® (dantrolene sodium) for injectable suspension is FDA-approved for the treatment of Malignant Hyperthermia (MH) and for the prevention of MH in patients at high risk. Ryanodex is an investigational drug for the treatment of Exertional Heat Stroke (EHS) and for the treatment of Dr
Slide 37: We Are a Nation That Pushes the Limits on Our Body Temperature
W EA R EAN AT I O N THAT PUSHES ANDT H O S E H AV EAREAL THE L I M I T S I M PA C T LIMITS ONO U R B O D YT E M P E R AT U R E 39 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 38: July and August 2016 Were the Hottest Months Ever Recorded
July and August 2016 Were the Hottest Months Ever Recorded On July 23, the heat index exceeded 105 degrees throughout most of the US, reaching 115 degrees in some locations Source: NOAA/NWS July 23, 2016 40 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pha
Slide 39: Heat Illness and EHS Are Serious and On the Rise
Heat Illness and EHS Are Serious and On the Rise h ea t s t r o k e res ul t i n d ea t h (2x as much as the next reason for an ER visit)1 Increase in Exertional Long-term neurological impairment3,4 133% 30% Heat Illness (EHI) in 10-year period2 a 3rd 2X References: 1. Hess JJ et al. Summertime Acut
Slide 40: Driven by the Many Athletes, Military, and Others Affected by EHS
I N C L U D I N GO U R H E A LT H I E S T, W I T H F U L L L I V E S A H E A D W EA R E D R I V E NB YT H EM A N Y AT H L E T E S , M I L I TA RY, T H EP R I M E A N D O FT H E I R P E O P L E I N L I V E S W H O S U F F E RT H ET R A G I C C O N S E Q U E N C E S -SCOTT TARRIFF O FE H S 42 ©2016 Ea
Slide 41: So Why Has Medical Innovation Ignored Exertional Heat Stroke?
S O W H Y H A S M E D I C A LI N N O VAT I O N IGNORED S T R O K E ? E X E R T I O N A L H E AT 43 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 42: Primary Method of Cooling EHS Far From Innovative
Primary Method of Cooling EHS Far From Innovative… Patients in Emergency Departments: 36.36% (140) 26.75% (103) 1.3% (5) (13) Full-body immersion in ice water Evaporative cooling: Spraying water over the patient and facilitating evaporation and convection with fans Cooling blanket(s) Strategic ice p
Slide 43: If Cooling Is Ineffective, Patients Risk Organ Damage and Long-Term Issues
IF COOLING IS INEFFECTIVE, AND PATIENTS SURVIVE, THEY RISK: ORGAN DAMAGE LONG-TERM ISSUES 45 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 44: The Shocking Realities for EHS Patients
The Shocking Realities for EHS Patients T H O S E A T H I G H E S T • • EHS can result in death Survivors are at risk for long-term morbidities, including cognitive deficits1,2 Time matters, and time is not likely to be on a patient’s side R I S K R A R E L Y H A V EI M M E D I A T E • – – – – – – H
Slide 45: When the Clock Is Ticking, Ambulance Transport May Not Be Optimal
When the Clock Is Ticking, Ambulance Transport Followed by ED Treatment May Not be the Optimal Protocol 37 MINUTES: Average national EMS response and delivery time 10-15 MINUTES: Additional time it typically takes upon ED arrival, for further assessment and administration of treatment 2012 NEDARC (N
Slide 46: EHS Patients Deserve a New Standard
E H S PAT I E N T S D E S E R V E A N E W S TA N D A R D T H AT SAVES LIVES A N D P R E V E N T S L O N G - T E R M M O R B I D I T I E S N E U R O L O G I C I N C L U D I N G D A M A G E 48 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ us
Slide 47: Ryanodex: Opportunity EHS Market
Ryanodex® (dantrolene sodium): Opportunity EHS Market ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 48: Reported EHS Incidence
Reported EHS Incidence • In the United States, very few estimates of EHS incidence are available in medical literature • Estimating is made more difficult due to ambiguity in ICD-9/10 codes • In 2009 and 2010, there were an estimated 8,251 ED visits for heat stroke1 – Importantly, this estimate was
Slide 49: To Help Define the Opportunity Eagle Conducted Market Research
TO HELP DEFINE THE OPPORTUNITY EAGLE CONDUCTED M A R K E T R E S E A R C H 51 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 50: Three Separate Market Research Studies
Three Separate Market Research Studies • 22 respondents • EMS Medical & Operations Directors, Hospital Pharmacy Directors, Emergency Department Directors Qualitative Exploratory • 385 respondents • Emergency Department Physicians Quantitative Survey 1 • 393 respondents • Emergency Department Physici
Slide 51: Research Findings: EHS Under-Reported; Significantly Higher Incidence
Research Findings: EHS Under-Reported; Significantly Higher Incidence ~75K to 100K – estimated total annual EHS patient volume Study 3 Data • EHS Incidence Consistent Across Regions • All respondents reported seeing multiple patients with EHS in 2016 • 56% ED physicians would use Ryanodex to treat E
Slide 52: The EHS Market Is Composed of Distinct Purchaser Segments
The EHS Market Is Composed of 3 Distinct Purchaser Segments
Slide 53: Hospital Emergency Departments
Hospital Emergency Departments • The US has approximately 5,000 hospital-based emergency rooms/departments EHS decision makers/influencers include: • – – – – – Pharmacy Chief ED Department Chief Attending/staff ED physicians Risk managers Head of nursing 55 ©2016 Eagle Pharmaceuticals. All rights re
Slide 54: Government/Military
Government/Military • Targeting a range of military bases/installations Large bases: N=1241 Medium bases: N=1171 Small bases: N=4,0001 Permanent and semi-permanent overseas Naval ships Reserves, etc. – – – – bases – – It will be critical to have Ryanodex® for EHS in military protocol • – Key partner
Slide 55: EMS
EMS • ~43,000 Advanced Life Saving (ALS) ambulances in the US* EMS decision makers include several stakeholders who are influenced by state and regional guidelines: • – – State Medical Directors EMS executive staff *According to a 2011 National Association of State EMS Officials (NASEMSO) survey. 57
Slide 56: Ryanodex Market Opportunity
Ryanodex Market Opportunity 58 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. Market Opportunity • ~1-2 vials per patient • ASP 2016 ~$2,300 Use Opportunity • ~75K-100K Annual EHS Cases ~56% Physicians indicated they would use Rya
Slide 57: 2017 Market Challenges
2017 Market Challenges • Product on the market a partial year in 2017 • Need to educate the market place and build awareness • Launches usually ramp over time • Pricing not finalized yet Approval 59 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuti
Slide 58: The EHS Stakeholder Universe Is Large, Diverse, and Interconnected
The EHS Stakeholder Universe Is Large, Diverse, and Interconnected INFLUENCERS Government/Policy Managed Care Associations/academia Public Parents POLICY ED and EMS Directors Pharmacy Directors Military Medical Directors Government/Policy MAKERS Hospital ED ilitary MS PURCHASERS Military EMS USERS 6
Slide 59: Our Objective: Identify and Reach the Right Organizations
Our Objective: MEDICAL AFFILIATIONS Identify and Reach the Right Organizations ATHLETIC AND YOUTH ASSOCIATIONS POLICY AND GUIDELINES MILITARY AND FIRE RESCUE OCCUPATIONAL 61 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 60: Heat Illness and EHS Are Serious and On the Rise
Heat Illness and EHS Are Serious and On the Rise h ea t s t r o k e res ul t i n d ea t h (2x as much as the next reason for an ER visit)1 Increase in Exertional Long-term neurological impairment3,4 133% 30% Heat Illness (EHI) in 10-year period2 a 3rd 2X References: 1. Hess JJ et al. Summertime Acut
Slide 61: At Eagle, Our Mission Is to Help Take These EHS Numbers to Zero
At Eagle, Our Mission Is to Help Take These EHS Numbers to… 0 63 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. ZERO long-term consequences and ZERO deaths
Slide 62: Ryanodex: EHS Marketing Plan
Ryanodex® (dantrolene sodium): EHS Marketing Plan ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 63: Brand Objective
Brand Objective Drive significant sales by ensuring Ryanodex is stocked and readily available for any HCP treating an EHS crisis TODAY Current treatment is often inconsistent and delayed, with low recognition of risks, symptoms, and severity of EHS WITH RYANODEX®: Stakeholders demand and have access
Slide 64: Brand Vision
Brand Vision With Ryanodex®, patients with EHS: • Receive a fast and appropriate diagnosis (resulting from Eagle-driven awareness and education efforts) Have access to and are administered Rx treatment in addition to traditional cooling methods Have improved outcomes • • 66 ©2016 Eagle Pharmaceutica
Slide 65: Highly Integrated and Engaging Marketing and PR Campaign
Highly Integrated and Engaging Marketing and PR Campaign Patient stories Print ads Precisely identify audiences and platforms HCP materials IDENTIFY Website & Digital ads Reach identified segments with awareness education points EDUCATE Marketing & PR Tactics Facilitate/support product trial SUPPORT
Slide 66: Eagle Has Selected Award-Winning Agency Partners
Eagle Has Selected Award-Winning Agency Partners Rx Club Gold Awards Cannes Lions Awards Holmes Global Agency of the Year MM&M Gold Awards Clios Health MM&M Agency of the Year PR Week Global Agency of the Year MM&M Most Creative Agency Ad Age Agency A-List 68 ©2016 Eagle Pharmaceuticals. All rights
Slide 67: We Will Reach All Purchaser Segments
We Will Reach All 3 Purchaser Segments 5,000 emergency departments 4,000+ bases/installations 43,000 ALS ambulances 69 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 68: EHS: A Growing Problem, A Large Market, Eagle Uniquely Positioned
EHS, A GROWING PROBLEM WITH DEVASTATING CONSEQUENCES A LARGEMARKET WITH NO ADEQUATE TREATMENT OPTIONS, AND MANY STAKEHOLDERS READY TO BE ACTIVATED EAGLE,UNIQUELY POSITIONED WITH RYANODEX®, TO BE THE FIRST AND ONLY MEDICAL TREATMENT 70 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and
Slide 69: EHS: A Growing Problem, A Large Market, Eagle Uniquely Positioned
EHS, A GROWING PR' DEVASTATING CONSEQUE A LARGE MARKET WITH NO ADEQUATE TREATMENT OPTIONS, AND MANY STAKEHOLDERS READY TO BE ACTIVATED EAGLE, UNIQUELY POSITIONED WITH RYANODEX®, TO BE THE FIRST AND ONLY MEDICAL TREATMENT
Slide 70: Ryanodex for the Treatment of Drug-Induced Hyperthermia (DIH)
Ryanodex® (dantrolene sodium) for the Treatment of Drug-Induced Adrian Hepner Hyperthermia (DIH) ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 71: Drug-Induced Hyperthermia (DIH) Overview
Drug-Induced Hyperthermia (DIH) Overview • Use of illegal stimulants is a growing public health problem in the US and EU • Current treatment is limited to supportive measures and cooling No drug treatment currently available DIH could be fatal or lead to permanent damage, if not treated promptly May
Slide 72: Non-Infectious Hyperthermia
Non-Infectious Hyperthermia • ~50% of adult patients admitted into intensive medical care have elevated body temperature1 Elevated body temperature is associated with higher mortality in critically ill patients, including those with acute neurological dysfunction and non-infectious hyperthermia2 Ele
Slide 73: Clinical Features of DIH
Clinical Features of DIH • DIH is an acute life-threatening disorder that may progress rapidly into severe CNS dysfunction, increasing the risk of a poor neurologic outcome Changes in mental status: • • • • • Hypoxia Cardiac dysfunction Renal failure Skeletal muscle damage DIC (disseminated intravas
Slide 74: Hyperthermic Disorders: Is there a Common Pathophysiological Pathway?
Hyperthermic Disorders: Is there a Common Pathophysiological Pathway? • The overlap in clinical features between DIH and heat stroke, NMS, serotonergic syndrome and MH cannot be ignored. • These pathological entities may share a final common pathway associated with the consequences of severe hyperth
Slide 75: Eagle Collaboration With NIH/NIDA
Eagle Collaboration With NIH/NIDA MDMA-Treated Animals Brain Temperature Mean Percent Change From Peak Value, • Collaboration agreement to conduct nonclinical studies in a validated rodent model of DIH (MDMA and methamphetamine) Initial data show: by Group (N=5) Over Time 30 Min Post Peak 60 Min Pos
Slide 76: Treatment with DSS Led to Complete Reversal of MDMA-Induced Crisis
78 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. Treatment with DSS (dantrolene sodium suspension) led to complete reversal of MDMA (Ecstasy)-induced hypermetabolic/hyperthermic crisis in MH-susceptible and ‘wild-type’ swine Eur
Slide 77: Dantrolene and MDMA-Induced Hyperthermia
Dantrolene and MDMA-Induced Hyperthermia1 • Data from a meta-analysis of 71 cases strongly support that administration of dantrolene was: – – Safe Provided clinically meaningful benefit to patients with MDMA-induced hyperthermia, by lowering mortality and severe complications Reference: 1. Grunau et
Slide 78: Summary
Summary • Nonclinical and clinical data show that dantrolene for the treatment of DIH was safe and did not exhibit any new safety signal Administration of Ryanodex® led to improvement of DIH crises in two species (swine and rat), consistent with the positive results for MH and EHS in a relevant swin
Slide 79: Ryanodex for the Treatment of Drug-Induced Hyperthermia
Ryanodex® (dantrolene sodium) for the Treatment Sherry Korczynski of Drug-Induced Hypertension (DIH) 81
Slide 80: When Youth and Experimentation Mix, the Consequences Can Be Deadly
WHEN THE YOUTH AND EXPERIMENTATION MIX, THE CONSEQUENCES CAN BE DEADLY… “ S H EWA S J U S T 2 0 Y E A R S O L DA N D I ’ L LN E V E RS E E H E RA G A I N . ” -F AT H E R 82
Slide 81: Body and Brain Hyperthermia in MDMA and Methamphetamine Intoxication
BODY AND BRAIN HYPERTHERMIA ARE ONE OF THE LEADING CAUSES OF SEVERE MORBIDITY AND DEATH IN MDMA (ECSTASY) AND METHAMPHETAMINE INTOXICATION 83
Slide 82: Drug Induced Hyperthermia
Drug Induced Hyperthermia • • 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 (ecstasy) among patients 21 years and younger grew over 128
Slide 83: It Is Irresponsible to Be Unprepared for a Drug-Induced Hyperthermic Crisis
WITH KNOWN RISKS AND EVEN DEATH, IT IS IRRESPONSIBLE TO BE UNPREPARED FOR A DRUG-INDUCED CRISIS HYPERTHERMIC 85
Slide 84: Opportunity in DIH
Opportunity in DIH DIH expands the Ryanodex® label expansion and helps solidify Eagle as the leader in the treatment of hyperthermic illness • Malignant Hyperthermia July 2014 Exertional Heat Stroke Summer 2017 • DIH helps solidify the case for Ryanodex as the gold-standard in a hyperthermia emergen
Slide 85: DIH Commercial Opportunity
DIH Commercial Opportunity • Synergistic: – – – Customer base mirrors EHS DIH commercialization efforts and spending will be mostly inclusive versus additive to EHS Less seasonality than EHS • A sizable unmet need and patient population – According to the 2011 Drug Abuse Warning Network (DAWN)1: 125
Slide 86: Salesforce Overview 2016/2017
Salesforce Overview 2016/2017 Michael Moran, Vice President – US Head of Sales ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 87: Current Eagle Salesforce
Current Eagle Salesforce • Eagle’s salesforce is currently focused on malignant hyperthermia • 2 Regional Sales Directors; 16 Key Account Managers • 2 National Account Managers – – – Group Purchasing Organizations Integrated Delivery Networks Wholesalers • Targeting 4,500 US hospitals 89 ©2016 Eagle
Slide 88: Exertional Heat Stroke Sales Strategy
Exertional Heat Stroke Sales Strategy Expanded Salesforce Dedicated Sales Specialists Inside & Outside Sales Reps 90 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. All channels are supported by a team of GPO/Wholesaler contracting
Slide 89: Hospital Emergency Departments
Hospital Emergency Departments To target the majority of the 5,000 hospitals in the U.S. with EDs, Eagle plans to: • • Increase number of Key Account Managers Currently evaluating size of salesforce required Call Points: – – – ED Physicians Nurses Pharmacy Directors Expanded Salesforce 91 ©2016 Eagl
Slide 90: Government / Military
Government / Military Requires a dedicated team with a track record of success in selling to government channels Call points: • • • • • DoD/Defense Health Agency Pharmacoeconomic Center (P & T) AF, USN, USA Rx Chiefs CPOC (Rx Operations) ED and Flight Medicine Physicians, Rx Chiefs Medical Commands
Slide 91: Emergency Medical Services
Emergency Medical Services Build a specialized selling team focused exclusively on ALS ambulances Call points: • • • Medical Directors EMS Company Medical ED Physicians Mix of Inside (ie, Telesales) and Outside Sales Reps 93 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confident
Slide 92: We Plan to Scale the Salesforce to Address the Larger Market
We Plan to Scale the Salesforce to Address the Larger Market Profit Optimization Product & Business Strategy Sales Force Size & Structure Field Motivation And Turnover Long-term Viability Existing Customer Relationships 94 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidentia
Slide 93: Customer Segmentation: Key to Rapid Uptake
Customer Segmentation: Key to Rapid Uptake • Develop customer segmentation and valuation Prioritize and value customer segments Understand workload requirements for customer groups umulative ales Opportunity • • High-potential Customers Moderate-potentialLow-potential Customers Customers 95 ©2016 Ea
Slide 94: Hospital, Military, EMS Opportunity
75K-100K 125K+ 5K EDs, 4.5K bases, 43,000 HOSPITAL, MILITARY, EMS ambulances 96 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 95: ©2016 Eagle Pharmaceuticals. All rights reserved.
97 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 96: Ryanodex Q&A Session
Ryanodex® Q&A Session 98 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 97: Fulvestrant Opportunity
Fulvestrant Opportunity Michael Moran, Vice President - US Head of Sales ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 98: Product Overview
Product Overview 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 palbociclib is
Slide 99: 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 sciati
Slide 100: Eagle's Solution
Eagle’s Solution 1X Low viscosity 5mL dose 2X High viscosity 5mL doses vs. • Innovative formulation administered in less time vs. 1-2 minutes per injection • Eagle formulation may allow warning on insert to be limited 102 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential
Slide 101: Revised Warnings and Precautions Section of Faslodex Label (2016)
Revised Warnings and Precautions Section of Faslodex Label (2016) WARNINGS AND PRECAUTIONS 5.3 Injection Site Reaction Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with FASLODEX injection. Caution should be taken while ad
Slide 102: Market Opportunity
Market Opportunity • 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 50$04m0g 0mm+ Faslodex O.U.S. • China sales accelerated in the yea
Slide 103: Key Milestones
Key Milestones • Eagle anticipates filing its NDA for an improved formulation in Q1 2018 • AstraZeneca settlement licensing ANDA entry on March 25, 2019 • Eagle believes its formulation does not infringe any AstraZeneca patent • Anticipate negotiating with private payors 105 ©2016 Eagle Pharmaceutic
Slide 104: Eagle Beyond 2020
Eagle Beyond 2020 106 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 105: Significant Value Creation So Far
Significant Value Creation So Far YTD 2016 Revenue (as of 9/30/16) Fully Diluted (Q3 2016) EPS Cash & Receivables (as of 9/30/16) +125% YOY +$1.38 YOY +26% YOY ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. $106 million $0.73 $108
Slide 106: Building A Portfolio of Long Term Assets
Building A Portfolio of Long Term Assets Bendamustine • Unique J-Code protects longevity of bendamustine franchise beyond 2020 Ryanodex (EHS) • Submission of NDA for EHS means potential market entry in summer ‘17 Ryanodex (DIH) • Positive early animal study results Fulvestrant • Improved formulation
Slide 107: Arsia Acquisition
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 field who will wor
Slide 108: 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 - $2
Slide 109: Key Biologics Losing Patent Protection
Key Biologics Losing Patent Protection $250 $1408 BILLION COULD BE SAVED IN THE NEXT DECADE IF THESE 11 BIOSIMILARS ARE APPROVED $5 7 B POTENTIAL •SAVINGS Avastin® (bevacizurnab) Epogen® (epoetin alta) Herceptin<> (trastuzumab) Humirae (adalimumab) lntron A® (interferon alfa-2a) Neulasta..,(pegfilgr
Slide 110: Biologic, Biosimilar, Biobetter?
Biologic, Biosimilar, Biobetter? Type Development Timeline Cost Patentable Pricing 112 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. Novel therapeuticCompetitive bioequivalence Improved efficacy/safety 15 years8-10 years 10 years
Slide 111: Poised for Continued Growth Beyond 2020
Poised for Continued Growth Beyond 2020 US & WW Ryanodex MH Dicloflenac Cash Position 113 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only. 2016 2017 - 2019 2020 - 2026 2026+ Growing Bendeka US Argatroban Docetaxel Bendeka Ryanodex f
Slide 112: Multiple Near-Term Catalysts to Drive Value
Multiple Near-Term Catalysts to Drive Value Bendeka market share approaching 90% Unique J-code (Bendeka) Ryanodex for EHS Ryanodex for DIH New Product Arsia • 88% as of 11.6.16 • • Effective Q1 ’17 Immediate increase in royalty rate to 25% Triggers milestone payment Added Bendeka clarity post 2019 •
Slide 113: Investment Highlights
Investment Highlights • Fully commercial specialty pharmaceutical company • Track record of success developing improved formulations • Demonstrated commercial execution through strategic partnerships and internal salesforce • Growing portfolio of long term assets • Promising pipeline with multiple s
Slide 114: Q&A
Q&A 116 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 115: Thank You
Thank You November 11, 2016 117 ©2016 Eagle Pharmaceuticals. All rights reserved. Proprietary and Confidential. For Eagle Pharmaceuticals’ use only.
Slide 116: Thank You
Thank You November 11, 2016 EAGLE roprietary and Confidential. For Eagle Pharmaceuticals use only. PHARMACEUTICALS