Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (January 2022)
29 slides from Eagle Pharmaceuticals's investor presentation, Jan 11, 2022
Slide 1: Company Overview January 2022
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 1 1 Company Overview January 2022
Slide 2: Forward-Looking Statements
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 2 Forward - Looking Statements This presentation contains “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 19 95, as amended, and other securities laws. Forward - loo
Slide 3: Eagle Overview: A Mainstream Pharmaceutical Company Specializing in Oncology + Acute Care
3 CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 3 CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Eagle Overview: A Mainstream Pharmaceutical Company Specializing in Oncology + Acute Care Specialty Pharma Company Pharmaceutical Co
Slide 4: Eagle Pharmaceuticals Financial Position, Portfolio & Pipeline
4 CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Eagle Pharmaceuticals Financial Position, Portfolio & Pipeline *As of 12/31/21 **As of 9/30/21 Share Buybacks $230M or 24%* Net Working Capital of $123.3M** Total Cash and Cash Equivalents $99.7M** No net debt suppor
Slide 5: Near Term Business Highlights
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 5 Near Term Business Highlights » Vasopressin: Shipping to commence on Monday, January 17, 2022, with 180 days of marketing exclusivity. An important product for Eagle, as Vasostrict ® U.S. sales totaled $890 million f
Slide 6: CNS/Metabolic Critical Care Pipeline Opportunities: Vasopressin
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 6 6 CNS/Metabolic Critical Care Pipeline Opportunities Vasopressin
Slide 7: Vasopressin Overview
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 7 Vasopressin Overview Vasopressin injection is FDA - approved to increase blood pressure in adults with vasodilatory shock (e.g., post - cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Slide 8: CNS/Metabolic Critical Care Pipeline Opportunities: CAL02 and Landiolol
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 8 8 CNS/Metabolic Critical Care Pipeline Opportunities CAL02 and Landiolol
Slide 9: CAL02 Overview
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 9 CAL02 Overview Novel first - in - class antitoxin agent in development for combination use with antibiotics for the treatment of severe pneumonia Proposed injectable treatment for severely infected patients Applying
Slide 10: CAL02 – Novel, First-in-Class Antitoxin Agent
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 10 CAL02 – Novel, First - in - Class Antitoxin Agent Mechanism of Action Address the downstream effects of bacterial Virulence Effectors/ Pore Forming Toxins through competitive inhibition » Binds to virulence effector
Slide 11: CAL02: Therapeutic Benefit & Unique Potential
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 11 CAL02: Therapeutic Benefit & Unique Potential Potential to become first line empirical therapy* • Excellent safety profile • Does not prompt any new resistance • Unique broad - spectrum activity • No impact on flora
Slide 12: Landiolol: Beta-Adrenergic Blocker; Leading Hospital Emergency Use Product
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 12 Landiolol : Beta - 1 Adrenergic Blocker; Leading Hospital Emergency Use Product Signed licensing agreement for U.S. commercial rights from AOP Orphan Pharmaceuticals (AOP) in August 2021 Eagle will facilitate regula
Slide 13: CNS/Metabolic Critical Care Pipeline Opportunities: Ryanodex
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 13 13 CNS/Metabolic Critical Care Pipeline Opportunities RYANODEX ® ®
Slide 14: RYANODEX (dantrolene sodium) injectable suspension
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 14 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 patient
Slide 15: RYANODEX: Building a Successful Franchise
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 15 RYANODEX ® : Building a Successful Franchise Ten U.S. patents issued to date, expiring between 2022 and 2025 New indications under development* Nerve Agent (NA) Exposure* Acute Radiation Syndrome (ARS)* FDA - Approv
Slide 16: Oncology Pipeline Opportunities: PEMFEXY
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 16 16 Oncology Pipeline Opportunities PEMFEXY Ρ
Slide 17: Eagle's PEMFEXY is FDA-Approved for
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 17 Eagle’s PEMFEXY Œ is FDA - Approved for: Nonsquamous Non - Small Cell Lung Cancer Nonsquamous Non - Small Cell Lung Cancer in combination with cisplatin for initial treatment or locally in combination for advanced o
Slide 18: ALIMTA (Eli Lilly) - PEMFEXY (Eagle)
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 18 ALIMTA ® (Eli Lilly) - PEMFEXY Œ (Eagle) Currently marketed by Lilly as ALIMTA ® (pemetrexed) 100mg and 500mg powder single dose vials – U.S. market totaled $1.2 billion for the LTM ended September 30, 2021* 1.2B Ea
Slide 19: Eagle's Differentiated PEMFEXY (pemetrexed)
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 19 Eagle’s Differentiated PEMFEXY Œ (pemetrexed): Other pemetrexed formulations are single - dose powder, which require reconstitution Some patients may need 2 - 3 vials; time - consuming for pharmacist/nurse and wasta
Slide 20: Oncology Pipeline Opportunities: EA-114 (Fulvestrant)
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 20 20 Oncology Pipeline Opportunities EA - 114 (Fulvestrant)
Slide 21: EA-114: Our Fulvestrant Product Candidate for HR+/HER2- Advanced Breast Cancer
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 21 EA - 114: Our Fulvestrant Product Candidate for HR+/HER2 - Advanced Breast Cancer Impact of Advanced Breast Cancer • Eagle’s 600 - subject PK trial yielded ~18,000 data points, which we mined for insights • For fulv
Slide 22: Existing Product Partnerships
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 22 Existing Product Partnerships SM - 88 • In 2020 Eagle and TYME entered into a share purchase agreement and a co - promotion agreement for SM - 88 • SM - 88 is a novel investigational agent in a Phase II/III trial fo
Slide 23: Inflection Points
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 23 23 CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Inflection Points
Slide 24: Eagle Pharmaceuticals Summary
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 24 Eagle Pharmaceuticals Summary Well positioned to capitalize on near - term opportunities Mainstream pharmaceutical company with over 40 representatives calling into Hospital & Oncologists Commercial infrastructure i
Slide 25: Thank You!
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 25 CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. Thank You!
Slide 26: CAL02 Clinical Data: First-In-Human Study Results
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 26 CAL02 Clinical Data First - In Human Study Results » Randomized, double - blind, placebo - controlled » 3 arms / 19 patients: • CAL02 Low dose (4 mg/kg) + Standard of Care • CAL02 High dose (16 mg/kg) + Standard of
Slide 27: Efficacy Outcomes
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 27 Efficacy Outcomes Low - dose CAL02 (n=3) High - dose CAL02 (n=10) Placebo (n=5) Cured at early test of cure (day 8) 0 5 (56%)* 1 (20%) Cured at test of cure (between days 15 – 22) 2 (100%)* 10 (100%) 5 (100%) Median
Slide 28: CAL02 Competitive Advantages
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 28 CAL02 Competitive Advantages Limitations of current approaches (approved / in development) Limited use » Restrictions imposed by stewardship measures and purchasers, as antibiotics are inevitably linked to the emerg
Slide 29: CAL02 Phase Clinical Development Plan
CONFIDENTIAL AND INTERNAL © 2022 Eagle Pharmaceuticals, Inc. All rights reserved. 29 CAL02 Phase 2 Clinical Development Plan Development Costs through Interim Results 1. IND Filing 2. Start P2B/3 Multicenter Global Study – Part 1 3. P2B/3 Multicenter Global Study – Part 1 4. Interim Analysis Results
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