Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — J.P. Morgan Healthcare Conference 2020
34 slides from Eagle Pharmaceuticals's conference presentation, Jan 13, 2020
Slide 1: Eagle Pharmaceuticals J.P. Morgan Healthcare Conference 2020
Eagle Pharmaceuticals J.P. Morgan Healthcare Conference 2020 Scott Tarriff , CEO NASDAQ: EGRX Exhibit 99.1
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,” “
Slide 3: Non-GAAP Financial Performance Measures
Non - GAAP Financial Performance Measures In addition to financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted non - GAAP ne t income, adjusted non - GAAP earnings per share and adjusted non - GAAP EBITDA attributable to the Company. As required by Reg
Slide 4: Eagle Pharmaceuticals Snapshot
Eagle Pharmaceuticals Snapshot Committed to developing innovative medicines that result in meaningful improvements in patients’ lives Fully integrated R&D, clinical, manufacturing and commercial Pipeline at near - term inflection point CNS/metabolic critical care and oncology focus Profitable with f
Slide 5: Fully Integrated Pharmaceutical Company
Focus on underserved therapeutic areas Manufacturing & quality Commercial capabilities Complementary scientific & research partnerships Strong internal preclinical and clinical capabilities State - of - the - art R&D lab in Cambridge Fully Integrated Pharmaceutical Company Established infrastructure
Slide 6: Strong Foundation for Potential Long-Term Growth
Strong Foundation for Potential Long - Term Growth Sustainable Profitability: $250mm* in cash flow from operations (2015 – 9 months YTD 2019) Highly Efficient Business Model: Invested $200mm (21%+ of revenue) in R&D since 2013 Successful Capital Reinvestment: $172mm repurchased since August 2016; on
Slide 7: Financial Performance
Financial Performance Highly profitable since 2014 IPO; durable cash flow; no net debt $45 $50 $38 $0 $7 $64 $96 $71 $5 $69 $71 $65 $0.41 $2.79 $4.34 $3.87 2015 2016 2017 2018 (US$MM, except per share data) Milestone & Licensing Revenues EBITDA Cash Flow From Operations Non-GAAP EPS 7 © 2020 Eagle P
Slide 8: Culmination of Effort
© 2020 Eagle Pharmaceuticals, Inc. All rights reserved NorthShore University HealthSystem agreement to study dantrolene sodium for TBI/ concussion in animal models TYME Technologies agreement for stock purchase and co - promotion of SM - 88 for pancreatic cancer Settlement agreement with Eli Lilly f
Slide 9: Product Indication Potential Market Advantage Development Stage
Product Indication Potential Market Advantage Development Stage In - House/Partnership 1. Exertional Heat Stroke (EHS) First in class Phase 3 complete; refiled (in - house) 2. Nerve Agent (NA) Exposure First in class Commencing second species animal study under FDA Animal Rule United States Army Med
Slide 10: CNS/Metabolic Critical Care Pipeline Opportunities
CNS/Metabolic Critical Care Pipeline Opportunities 10
Slide 11: RYANODEX (dantrolene sodium) injectable suspension
RYANODEX® (dantrolene sodium) injectable suspension Currently indicated for the treatment of malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of MH in patients at high risk • Approved July 2014 • Launched August 2014 Breakthrough formulation © 2
Slide 12: RYANODEX: Building a Successful Franchise
RYANODEX: Building a Successful Franchise New indications under development Nine U.S. patents issued to date, expiring between 2022 and 2025 FDA - Approved for Malignant Hyperthermia (MH) Exertional Heat Stroke (EHS) Nerve Agent (NA) Exposure Acute Radiation Syndrome (ARS) Alzheimer’s Disease (AD) T
Slide 13: Mechanism of action
© 2020 Eagle Pharmaceuticals, Inc. All rights reserved 13 Mechanism of action
Slide 14: RYANODEX Potential in Traumatic Brain Injury (TBI)/Concussion
RYANODEX Potential in Traumatic Brain Injury (TBI)/Concussion Eagle’s recently announced research partnership with NorthShore University HealthSystem • Focused on studying dantrolene sodium for TBI/concussion in animal models to determine if it can help halt or repair the harm caused by these trauma
Slide 15: RYANODEX Potential in Alzheimer's Disease
RYANODEX Potential in Alzheimer’s Disease A completely novel approach to the disease Eagle and UPenn concluded that calcium dysregulation may play a unique role in Alzheimer’s • Results from a proof - of - concept preclinical study presented at the July 2019 Alzheimer’s Association International Con
Slide 16: Promising Progress in Research on Dantrolene for Alzheimer's Disease
Promising Progress in Research on Dantrolene for Alzheimer’s Disease (AD) 16 © 2020 Eagle Pharmaceuticals, Inc. All rights reserved • Using dantrolene to treat Alzheimer’s is unique • Intranasal dantrolene achieved greater passage across the blood brain barrier and higher brain concentrations compar
Slide 17: RYANODEX for Exertional Heat Stroke (EHS)
RYANODEX for Exertional Heat Stroke (EHS) Currently there is no FDA - approved drug for EHS, and efficient body cooling is not always available Eagle returned to the Hajj in 2019 and enrolled additional EHS patients in its novel controlled clinical study We have now completed two clinical trials, ha
Slide 18: RYANODEX Potential for Nerve Agent Exposure
RYANODEX Potential for Nerve Agent (NA) Exposure First - of - its kind neuroprotective treatment for the amelioration of brain damage due to nerve agent exposure and, if approved, may receive Orphan Drug Exclusivity (ODE) for organophosphate exposure Nerve agents are the most toxic of the known chem
Slide 19: RYANODEX Potential in Acute Radiation Syndrome
RYANODEX Potential in Acute Radiation Syndrome Exploring investigational indication for RYANODEX for treatment of hematopoietic syndrome in individuals exposed to high doses of radiation, such as nuclear power plant leakage or nuclear weapons In a proof - of - concept (POC) study in a Total - Body I
Slide 20: © 2020 Eagle Pharmaceuticals, Inc. All rights reserved 20
© 2020 Eagle Pharmaceuticals, Inc. All rights reserved 20
Slide 21: EA-111 (New Chemical Entity)
EA - 111 (New Chemical Entity) © 2020 Eagle Pharmaceuticals, Inc. All rights reserved 21 Significant benefits of an intramuscular (IM) formulation • EA - 111 would allow for easier and more rapid administration in emergency situations (military and civilian) • Enables point - of - care administratio
Slide 22: Vasopressin
Vasopressin • Indicated to increase blood pressure in adults with vasodilatory shock (e.g., post - cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines • Generic version of Par Sterile Products, LLC (an Endo International plc company) original VASOSTRICT® • $506 million in
Slide 23: Oncology Pipeline Opportunities
Oncology Pipeline Opportunities 23
Slide 24: EA-114: Our Fulvestrant Product Candidate for HR+ Advanced Breast Cancer
EA - 114: Our Fulvestrant Product Candidate for HR+ Advanced Breast Cancer • ~75% of breast cancers are HR+ 1 • ~30% of patients rst diagnosed with early - stage disease eventually develop metastatic disease 2 • 27% ve - year survival for patients in U.S. with metastatic breast cancer 3 • Eagle’s 60
Slide 25: Fulvestrant competitively inhibits estrogen-stimulated cell division
Fulvestrant competitively inhibits estrogen - stimulated cell division by binding to the estrogen receptor © 2020 Eagle Pharmaceuticals, Inc. All rights reserved 25
Slide 26: EA-114 (Fulvestrant) Research Progress
26 © 2020 Eagle Pharmaceuticals, Inc. All rights reserved EA - 114 (Fulvestrant) Research Progress Clinical trial in 600 healthy, post - menopausal (PM) women Met with FDA twice to propose study design for Eagle’s proprietary new delivery platform informed by clinical trial results FDA accepted Eagl
Slide 27: New Collaboration with TYME Technologies for SM-88
New Collaboration with TYME Technologies for Cancer Metabolism - Based Compounds for Pancreatic Cancer, Currently in Late - Stage Trials SM - 88 is a novel investigational agent in two Phase III studies for pancreatic cancer and in a Phase II study for prostate cancer SM - 88 is used with three othe
Slide 28: Oral SM-88 Represents Novel Therapeutic Approach
Oral SM - 88 Represents Novel Therapeutic Approach Designed to selectively disrupt protein synthesis in cancer cells with demonstrated tumor responses in 15 cancer types across multiple studies Recently launched the TYME - 88 - PANC pivotal trial to evaluate oral SM - 88 for third - line treatment o
Slide 29: SM-88 Data From Pivotal Trial Expected in 2021
Brain/Glioma Nasal SM - 88 Data From Pivotal Trial Expected in 2021 PROGRAM FORMULATION CANCER INDICATION DEVELOPMENT STAGE PHASE I PHASE II PHASE II/III Pancreatic: 3 rd Line Monotherapy Prostate: Biomarker Recurrent Metastatic Sarcomas* Other Tumor Types Pancreatic: 2 nd Line Monotherapy Pancreati
Slide 30: Oncology Assets: Building From Our Successes
Highly successful franchise BENDEKA royalty increase: from 25% to 30% on 10/1/19 and then increases by 1 percentage point on each anniversary thereafter until it reaches 32% Established royalty revenue beyond 2025 Long - term cash flow stream 15 Orange Book listed patents through 2031 and unique J -
Slide 31: Helping Medicines Do More
31 HELPING MEDICINES DO MORE Pushing healthcare forward requires us to propel Medicines to their full potential. We make possible what others consider impossible. Take a look at our product portfolio to see what the right mix of technology and heart can accomplish.
Slide 32: Appendix
Appendix J, = /
Slide 33: Reconciliation of GAAP to Adjusted Non-GAAP Net Income
Twelve Months Ended December 31, 2018 2017 2016 2015 Net income - GAAP $ 31,903 $ 51,943 $ 81,453 $ 2,571 Adjustments: Cost of product revenues: Amortization of acquired intangible assets (1) 895 1,194 746 - Research and development: Share - based compensation expense 4,014 3,942 2,914 1,271 Depreci
Slide 34: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non - GAAP EBITDA (unaudited) Twelve Months Ended September 30, Twelve Months Ended December 31, 2019 2018 2017 2016 2015 Net income - GAAP $ 25,898 $ 31,903 $ 51,943 $ 81,453 $ 2,571 Add back: Interest expense (income), net 774 2,579 1,045 (76) (14) Income tax pro
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