Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2020)
31 slides from Eagle Pharmaceuticals's investor presentation, Sep 14, 2020
Slide 1: Eagle Pharmaceuticals September 2020
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Eagle Pharmaceuticals NASDAQ: EGRX September 2020
Slide 2: Forward Looking Statements
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Forward Looking Statements This presentation contains forward - looking information within the meaning of the Private Securities Litigation Reform Act of 199 5, as amended, and other securities laws. Forward - looking statements ar
Slide 3: Non-GAAP Financial Performance Measures
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 3 In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non - GAAP n et income and adjusted non - GAAP earnings per share attributable to Eagle. The Company believes t
Slide 4: Eagle Pharmaceuticals Snapshot
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Fully integrated R&D, clinical, manufacturing, quality, and commercial Profitable with foundation for continued long - term growth CNS/metabolic critical care and oncology focus Pipeline at near - term inflection point Eagle Pharma
Slide 5: Strong Foundation for Potential Long-Term Growth
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Strong Foundation for Potential Long - Term Growth Highly efficient business model: Invested $217mm (21%+ of revenue) in R&D since 2013 Sustainable profitability: $271mm* in cash flow from operations (2015 – 2Q 2020) Successful cap
Slide 6: Recent Developments
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. NorthShore University HealthSystem agreement to study dantrolene sodium for TBI/ concussion in animal models Tyme Technologies, Inc. (“ Tyme ”) agreement for stock purchase and co - promotion of SM - 88 for pancreatic cancer Recent
Slide 7: CNS/Metabolic Critical Care Product Pipeline
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Product Indication Potential Market Advantage Development Stage In - House/Partnership 1. Nerve Agent (NA) Exposure First in class Submitted SPA on 8/28 to FDA; p
Slide 8: Oncology Programs - Potential for 5 Launches in the Next 3 Years
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Product Indication Potential Market Advantage Development Stage In - House/Partnership SM - 88 8. Pancreatic Cancer (multiple indications) First in class Pivotal
Slide 9: CNS/Metabolic Critical Care Pipeline Opportunities
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CNS/Metabolic Critical Care Pipeline Opportunities 9
Slide 10: RYANODEX (dantrolene sodium) injectable suspension
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX® (dantrolene sodium) injectable suspension Breakthrough formulation • Approved July 2014 • Launched August 2014 Currently indicated for the treatment of malignant hyperthermia (MH) in conjunction with appropriate supportiv
Slide 11: RYANODEX: Building a Successful Franchise
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. FDA - Approved for Malignant Hyperthermia (MH) Nerve Agent (NA) Exposure Acute Radiation Syndrome (ARS) Alzheimer’s Disease (AD) Traumatic Brain Injury/ Concussion (TBI) RYANODEX: Building a Successful Franchise New indications und
Slide 12: Mechanism of action
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 12 Mechanism of action v
Slide 13: RYANODEX Potential in TBI/Concussion
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • Currently there is no FDA - approved drug to treat TBI/concussion, which is estimated to affect 69 million people worldwide 1 • The CDC estimates that in 2014, there were nearly 2.8 million TBI - related emergency department visi
Slide 14: RYANODEX (EA-112) Potential in Alzheimer's Disease
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX (EA - 112) Potential in Alzheimer’s Disease A completely novel approach to the disease • Alzheimer’s disease is one of the greatest medical challenges of our time, with limited treatment options. It is the most common form
Slide 15: Promising Progress in Research on Dantrolene for Alzheimer's Disease
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Promising Progress in Research on Dantrolene for Alzheimer’s Disease (AD) • Our partner UPenn conducted a recent animal study demonstrating: • A novel route of administration: • Greater passage of dantrolene across the blood brain
Slide 16: RYANODEX Potential for Nerve Agent Exposure
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 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 organ
Slide 17: RYANODEX Potential in Acute Radiation Syndrome
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • 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. Potential to apply to certain ca
Slide 18: EA-111 (New Chemical Entity)
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • 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 administration to patients in n
Slide 19: Vasopressin
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 19 19 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
Slide 20: Oncology Pipeline Opportunities
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Oncology Pipeline Opportunities 20
Slide 21: Impact of Advanced Breast Cancer
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Impact of Advanced Breast Cancer • ~75% of breast cancers are HR+ 1 • ~30% of patients diagnosed with early - stage disease eventually develop metastatic disease 2 • 27% - year survival for patients in U.S. with metastatic breast c
Slide 22: Fulvestrant mechanism of action
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Fulvestrant competitively inhibits estrogen - stimulated cell division by binding to the estrogen receptor 22
Slide 23: EA-114 (Fulvestrant) Research Progress
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. EA - 114 (Fulvestrant) Research Progress 1 23 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 F
Slide 24: Collaboration with Tyme Technologies for SM-88
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Collaboration with Tyme Technologies for Cancer Metabolism - Based Compound for Pancreatic Cancer, Currently in Late - Stage Trials • Tyme is a biotechnology company focused on exploring novel therapeutic approaches designed to tar
Slide 25: Oral SM-88 Represents Novel Therapeutic Approach
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 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 • Tyme - 88 - PANC pivotal trial la
Slide 26: Eagle and Tyme Agreement Terms
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Brain/Glioma Nasal • Eagle and Tyme have entered into a share purchase agreement (SPA) and a co - promotion agreement for SM - 88 in the U.S. Eagle paid an initial $20 million up front • In addition, Eagle may invest an additional
Slide 27: Oncology Assets: Building From Our Successes
Oncology Assets: Building From Our Successe 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% Courts upheld patent infringement claims as valid; defendants enjoined from launch
Slide 28: Multiple Near-Term Value Inflection Points
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Multiple Near - Term Value Inflection Points • 10 key initiatives underway with the potential for 5 product launches over the next 3 years • Each has the potential to be either first - in - class, first - to - market, or best - in
Slide 29: Appendix
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Appendix 29
Slide 30: Reconciliation of GAAP to Adjusted Non-GAAP Net Income and EPS
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Reconciliation of GAAP to Adjusted Non - GAAP Net Income and Adjusted Non - GAAP EPS (unaudited) EXPLANATION OF ADJUSTMENTS: 1) Amortization of intangible assets for RYANODEX and Docetaxel 2) Amortization of intangible assets for E
Slide 31: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Reconciliation of GAAP to Adjusted Non - GAAP EBITDA (unaudited) 31 Twelve Months Ended June 30, Twelve Months Ended December 31, (in thousands) 2020 2019 2018 2017 2016 2015 Net income - GAAP $ (4,512) $ 14,313 $ 31,903 $ 51,943 $
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