Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (May 2020)
33 slides from Eagle Pharmaceuticals's investor presentation, May 19, 2020
Slide 1: Eagle Pharmaceuticals May 2020
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Eagle Pharmaceuticals NASDAQ: EGRX May 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 $210mm (21%+ of revenue) in R&D since 2013 Sustainable profitability: $258mm* in cash flow from operations (2015 – 1Q 2020) Successful cap
Slide 6: Culmination of Effort
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 Settle
Slide 7: CNS/Metabolic Critical Care Programs: RYANODEX Indications
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. Exertional Heat Stroke (EHS) First in class Refiled NDA; July 8 PDUFA (i
Slide 8: Oncology Programs - Potential for 5 Launches in 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 9. 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. 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 (N
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 Potential in Alzheimer's Disease
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX 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 of dementi
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) • We conducted a recent animal study demonstrating: • A novel route of administration: • Greater passage of dantrolene across the blood brain barrier • Highe
Slide 16: RYANODEX for Exertional Heat Stroke
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • 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 • Eagle has co
Slide 17: 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 18: 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 19: RYANODEX Potential Antiviral Treatment for COVID-19
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX Potential Antiviral Treatment for COVID - 19 Intracellular calcium may play a role in virus entry, replication, and release 19 19 • Eagle, in partnership with Hackensack University Medical Center (HUMC), is exploring an in
Slide 20: 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 21: Vasopressin
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 21 21 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 22: Oncology Pipeline Opportunities
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Oncology Pipeline Opportunities 22
Slide 23: EA-114: Fulvestrant Product Candidate for HR+ 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 rst diagnosed with early - stage disease eventually develop metastatic disease 2 • 27% ve - year survival for patients in U.S. with metastatic b
Slide 24: 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 24
Slide 25: EA-114 (Fulvestrant) Research Progress
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. EA - 114 (Fulvestrant) Research Progress 25 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
Slide 26: New Collaboration with Tyme Technologies for Pancreatic Cancer
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. New Collaboration with Tyme Technologies for Cancer Metabolism - Based Compounds for Pancreatic Cancer, Currently in Late - Stage Trials • Tyme is a biotechnology company focused on exploring novel therapeutic approaches designed t
Slide 27: 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 • Recently launched the Tyme - 88 -
Slide 28: Eagle and Tyme SM-88 Agreements
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 29: BENDEKA and PEMFEXY Franchise
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 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; defend
Slide 30: Multiple Near-Term Value Inflection Points
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Multiple Near - Term Value Inflection Points • 11 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 31: Appendix
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Appendix 31
Slide 32: 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 33: 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) 33 Twelve Months Ended March 31, Twelve Months Ended December 31, (in thousands) 2020 2019 2018 2017 2016 2015 Net income - GAAP $ 2,469 $ 14,313 $ 31,903 $ 51,943 $
Eagle Pharmaceuticals — Investor Presentation (May 2020) on 6ix