Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (October 2019)
28 slides from Eagle Pharmaceuticals's investor presentation, Oct 21, 2019
Slide 1: Innovation in Pharmaceuticals: Transforming Patient Care
Eagle Pharmaceuticals October 2019 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved Innovation in Pharmaceuticals: Transforming Patient Care by Targeting Best - in - Class Solutions
Slide 2: Forward Looking Statements
2 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
3 Non - GAAP Financial Performance Measures In addition to financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted non - GAAP net income, adjusted non - GAAP earnings per share and adjusted non - GAAP EBITDA attributable to the Company. The Company belie
Slide 4: The Eagle Story: Building from Our Successes
4 The Eagle Story: Building from Our Successes Two significant initial successes : bendamustine and RYANODEX ® From 2015 - 1H2019: generated $250 mm+ in cash flow from operations * creating substantial profitability Efficient business model and successful cash re - investment: x Share repurchase: bo
Slide 5: Built a Highly Profitable Company Since Our IPO
5 Built a Highly Profitable Company Since Our IPO; Durable Cash Flow Generation; 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
Slide 6: The Eagle Story: Building from Our Successes
6 The Eagle Story: Building from Our Successes Our innovative products make a significant difference in patient care : • Improve the treatment of underlying conditions • New indications for existing drugs • Address urgent problems for patient populations Our marketed products and significant near -
Slide 7: Oncology Portfolio: Targeting Best-in-Class Solutions
Oncology Portfolio: Targeting Best - in - Class Solutions
Slide 8: Oncology Assets: Building from Our Successes
8 Oncology Assets: Building from Our Successes Bendamustine: highly successful franchise • Established royalty revenue beyond 2025 • TREANDA generics: not expected before Dec 2022 • Long - term cash flow stream • 15 OB listed patents through 2033 and unique J - code • BENDEKA royalty increase: from
Slide 9: Fulvestrant: Breast Cancer Overview
9 Oncology Assets: Building from Our Successes Fulvestrant: Breast Cancer Overview • Multi - billion - dollar worldwide market opportunity targeting patients across estrogen receptor positive (ER+) breast cancer • 2018 sales of branded product1: • LTM U.S. $529 mm • WW: $1+ B 1 2018 Sales of AstraZe
Slide 10: Fulvestrant Opportunity: Potential to Change Treatment of ER+ Breast Cancer
10 • Approximately 75% of breast cancers are ER+ • Fulvestrant is a selective estrogen receptor (ER) degrader (SERD) • Acts as an antagonist at the ER • Does not exhibit any known agonist activity • Fulvestrant acts in ER+ breast cancer by binding competitively to the ER • Inhibits estrogen - stimul
Slide 11: Fulvestrant Opportunity: Potential to Change Treatment of ER+ Breast Cancer
11 Fulvestrant Opportunity: Potential to Change Treatment of ER+ Breast Cancer • Eagle’s original fulvestrant formulation studied in 2018 clinical trial in 600 healthy post - menopausal (PM) women over 140 days • 300 subjects received the branded product FASLODEX® • 300 subjects received Eagle’s for
Slide 12: Fulvestrant Development Progress
12 Fulvestrant Development Progress • Following Eagle’s 2018 clinical s tudy , t he Company has met with FDA twice to propose the study design for Eagle’s new delivery platform • FDA accepted Eagle’s proposal • A pilot study in healthy PM women is starting shortly • Based on the results of the pilot
Slide 13: Critical Care: Targeting Best-in-Class Solutions
Critical Care (including medical countermeasures for terrorism) Targeting Best - in - Class Solutions
Slide 14: RYANODEX: Building from Our Successes
14 RYANODEX: Building from Our Successes RYANODEX today : Approved for malignant hyperthermia (MH): a life - saving drug • Innovative formulation of dantrolene sodium allowing for fast and efficient treatment • Approved July 2014; launched August 2014 • Eight U.S. patents issued to date, expiring be
Slide 15: RYANODEX: Building a Successful Franchise
15 RYANODEX: Building a Successful Franchise RYANODEX Exertional Heat Stroke (EHS) Nerve Agent (NA) Exposure MH (Approved) Undisclosed indications Acute Radiation Syndrome (ARS) New Indications Under Development
Slide 16: Understanding Medical Countermeasures (MCMs)
16 Understanding Medical Countermeasures 1 (MCMs) • Medical Countermeasures : FDA - regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a
Slide 17: Overview of Strategic National Stockpile
17 Overview of Strategic National Stockpile • Designed to supplement and resupply state and local inventories of medicines and supplies during emergencies severe enough to exhaust local supplies. 1 • HHS and the CDC look at multiple factors, including the medical vulnerability of the U.S. population
Slide 18: RYANODEX: Development of NA Exposure Countermeasures
18 RYANODEX: Development of NA Exposure Countermeasures Addresses Global Concern About Potential for an NA Attack Public Health Initiatives Federal Agencies, including the Departments of Homeland Security and Health and Human Services, have issued multiple documents highlighting the risks of exposur
Slide 19: Promising Results for a Critical Product: NA Countermeasures
19 Promising Results for a Critical Product: NA Countermeasures Topline Study with U.S. Military • Statistically significant neuroprotective effects of RYANODEX in critical cortical areas of the brain • In six areas of the brain examined, animals treated with RYANODEX experienced a lower level of br
Slide 20: RYANODEX: Animal Study for Acute Radiation Syndrome
20 RYANODEX: Animal Study for Acute Radiation Syndrome (ARS) Study Objective Evaluate efficacy of IV administration of RYANODEX to prevent or mitigate ARS in a total body irradiated C57BL/6 male mouse hematopoietic model Positive Animal Testing Results Positive results of a proof - of - concept (POC
Slide 21: RYANODEX: Exertional Heat Stroke (EHS)
21 RYANODEX: Exertional Heat Stroke (EHS) Evaluate efficacy and safety of Ryanodex in addition to standard of care (body cooling) in patients with EHS Currently there is no drug treatment for EHS. Efficient body cooling is not always available and is randomly administered. If approved, Ryanodex woul
Slide 22: EA-111 Development Is Under Way
22 EA - 111 Development Is Under Way • Developed new chemical entities (NCE) related to dantrolene • 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 a
Slide 23: Vasopressin and Future In-Licensing Opportunities
23 Vasopressin and Future In - Licensing Opportunities Vasopressin • Indicated to increase blood pressure in adults with vasodilatory shock ( eg post - cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamine • Generic version of Endo International plc’s original VASOSTRICT® • A
Slide 24: Financial Highlights
24 Financial Highlights • L TM EBITDA $80.2 mm LTM Cash Flow from Operations, excluding A/R shifts $81.3 mm Cash $108.1 mm A/R $60.3 mm • Share Repurchase Plan as of 6/30/19 • $169 mm repurchased since August 2016, including $50 mm ASR executed 10/30/18 • 2.9 mm shares repurchased since August 2016
Slide 25: Thank you
25 Thank you October 2019 Our Passion and Commitment to Patient Care: Building for Continued Success
Slide 26: Appendix
26 APPENDIX
Slide 27: Reconciliation of GAAP to Adjusted Non-GAAP Net Income
27 Reconciliation of GAAP to Adjusted Non - GAAP Net Income Explanation of Adjustments: 1) Amortization of intangible assets for Ryanodex and Docetaxel 2) Amortization of intangible assets for Eagle Biologics 3) Gain on divestiture of diclofenac - misoprostol 4) Changes in the fair value of continge
Slide 28: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
28 Reconciliation of GAAP to Adjusted Non - GAAP EBITDA (000’s) Twelve Months Ended June 30, Twelve Months Ended December 31, 2019 2018 2017 2016 2015 Net income - GAAP $ 42,326 $ 31,903 $ 51,943 $ 81,453 $ 2,571 Add back: Interest expense (income), net 1,450 2,579 1,045 (76) (14) Income tax provisi
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