Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (October 2021)
32 slides from Eagle Pharmaceuticals's investor presentation, Oct 14, 2021
Slide 1: Company Overview October 2021
1 1 Company Overview October 2021
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 199 5, as amended, and other securities laws. Forward - looking statements are statements that are not historical facts. Words and phrases suc
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 press release also contains adjusted non - GAAP n et income and adjusted non - GAAP earnings per share attributable to Eagle. The Company believes these measures provide inves
Slide 4: Eagle Pharmaceuticals Overview
4 Eagle Pharmaceuticals Overview Leading hospital and oncology pharmaceutical company with over 40 representatives calling into hospitals and oncologists Strong Financial Position – Share Buybacks $211M or 23%* – Net Working Capital of $130.8M* – Total Cash and Cash Equivalents $108.7M* – No net deb
Slide 5: Eagle is Evolving into a Mainstream Pharmaceutical Company
CONFIDENTIAL AND INTERNAL © 2021 Eagle Pharmaceuticals, Inc. All rights reserved. 5 5 Eagle is Evolving into: A Mainstream Pharmaceutical Company Specializing in Oncology + Acute Care Specialty Pharma Company Pharmaceutical Company Specializing in Acute Care & Oncology Opportunistic 505b2’s Maintain
Slide 6: CNS/Metabolic Critical Care Pipeline Opportunities
6 CNS/Metabolic Critical Care Pipeline Opportunities
Slide 7: Vasopressin Potential Overview
Vasopressin Potential 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 E endo 042020 €arings Currently Endo/Par markets VASOSTRICT® (vasopressin) 202
Slide 8: Vasopressin Potential Overview
8 Vasopressin Potential Overview Currently Endo/Par markets VASOSTRICT ® (vasopressin) 2020 U.S. annual sales of $785mm* Eagle is first - to - file an ANDA referencing VASOSTRICT ® for the 20 units per ml presentation 180 - day market exclusivity expected; FDA prioritization of ANDA; GDUFA date of 1
Slide 9: Vasopressin Potential Overview
9 Vasopressin Potential Overview On August 26, 2021, Eagle received a 30 - day information request (IR ) from the FDA . Eagle believes an IR at this point of the review process may be indicative that the ANDA is advancing towards an approval. The request asked four questions: three questions pertain
Slide 10: CAL02 Overview
CALO2 Overview > Novel first-in-class antitoxin agent in development for combination use with antibiotics for the treatment of severe pneumonia P Proposed injectable treatment for severely infected patients > Phase 2b/3 adaptive design > Applying for Quali Product Designi ied Infectious Disease mn u
Slide 11: CAL02 Overview
11 CAL02 Overview ▪ Patented composition of matter ▪ Sterile liquid solution ready for injection ▪ Stable for 36 months when refrigerated ( 6 months when stored at room temperature) ▪ Route of administration: IV Infusion 2 doses separated 24 hours apart CAL02 (drug product) Specific mixture of re -
Slide 12: CAL02 – Novel, First-in-Class Antitoxin Agent Mechanism of Action
12 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 molecules secreted by infecting bacteria, prohibiting host tissue cell binding »
Slide 13: CAL02 Clinical Data First-In-Human Study Results
13 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 Care • Placebo (saline) + Standard of Care » 2 IV administration 24h apart » Sever
Slide 14: Efficacy Outcomes
14 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 time to cure (days) 15·0 (14 to 16)† 8·0 (6 to 16) 10·0 (7 to 14) All - cause mor
Slide 15: CAL02: Therapeutic Benefit & Unique Potential
15 CAL02: Therapeutic Benefit & Unique Potential Positive trends over placebo in efficacy parameters *+ ▪ Reduction of mortality risk + ▪ Potentially f aster and complete recovery of organ function + ▪ Shorter duration of mechanical ventilation ▪ Immediate decrease in inflammatory biomarkers (e.g. I
Slide 16: CAL02 Competitive Advantages
16 CAL02 Competitive Advantages Limited use » Restrictions imposed by stewardship measures and purchasers, as antibiotics are inevitably linked to the emergence of new resistances Slow and laborious market penetration » Based on non - inferiority results » Last - resort treatments » Increasingly com
Slide 17: CAL02 Phase Clinical Development Plan
17 CAL02 Phase 2 Clinical Development Plan Development Costs through Interim Results $10M Deal Signing Milestone 1 $1M Phase I – Drug - Drug Interaction $21M P2B/3 Multicenter Global Study – Part 1 Through Interim Analysis Results $3M Clinical Trial Materials 1 2 3 4 $35M TOTAL COST ITEM • IND Filin
Slide 18: Therapeutic Benefit & Unique Potential
18 Laterre et al. Lancet Infect Dis 2019 19(6):629 - 630 Therapeutic Benefit & Unique Potential Positive trends over placebo in efficacy parameters ▪ Reduction of mortality risk * ▪ Faster and complete recovery of organ function * ▪ Shorter duration of mechanical ventilation ▪ Immediate decrease in
Slide 19: Landiolol: Beta-Adrenergic Blocker; Leading Hospital Emergency Use Product
19 Landiolol 1,2 : Beta - 1 Adrenergic Blocker; Leading H ospital E mergency U se P roduct Signed licensing agreement for U.S. commercial rights from AOP Orphan Pharmaceuticals (AOP) in August 2021 Approved in Europe for the treatment of non - compensatory sinus tachycardia and tachycardic supravent
Slide 20: RYANODEX (dantrolene sodium) injectable suspension
RYANODEX® (dantrolene sodium) injectable suspension Breakthrough formulation Approved Launched —@—-- ® July 2014 August 2014 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
Slide 21: RYANODEX (dantrolene sodium) injectable suspension
21 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 July 2014 Approved August 2014 Launched Breakthrough formulation
Slide 22: RYANODEX: Building a Successful Franchise
22 Ten U.S. patents issued to date, expiring between 2022 and 2025 RYANODEX ® : Building a Successful Franchise Nerve Agent (NA) Exposure* Acute Radiation Syndrome (ARS)* FDA - Approved for Malignant Hyperthermia (MH) Traumatic Brain Injury/ Concussion (TBI)* Alzheimer’s Disease (AD)* New indication
Slide 23: Oncology Pipeline Opportunities
23 Oncology Pipeline Opportunities
Slide 24: Eagle's PEMFEXY is FDA-Approved for:
Eagle’s PEMFEXY™ is FDA-Approved for: Nonsquamous 5 a Mesothelioma Non-Small Cell Lung Cancer Nonsquamous Non-Small Cell Lung Cancer in combination Mesothelioma in combination with cisplatin for vith eispiatin fori ‘of locally in for ignant pleural when disease is advanced or metastatic disease unre
Slide 25: Eagle's PEMFEXY is FDA-Approved for:
25 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 or metastatic disease Nonsquamous Non - Small Cell Lung Cancer maintenance, when di
Slide 26: PEMFEXY vs. ALIMTA U.S. Sales and Launch Plan
26 Currently marketed by Lilly as ALIMTA® (pemetrexed) 100mg and 500mg powder single dose vials ALIMTA ® (Eli Lilly) - PEMFEXY Œ (Eagle) – U.S. Sales in 2020 of $1.265B* 1.2B Eagle first to market 505(b)(2) PEMFEXY Œ (pemetrexed) 500mg liquid multi - dose vial – Granted unique J - code by CMS – Laun
Slide 27: Eagle's Differentiated PEMFEXY (pemetrexed)
27 Eagle’s Differentiated PEMFEXY Œ (pemetrexed): Other pemetrexed formulations are single - dose powder, which require reconstitution Eagle’s formulation is available in a 500mg liquid ready - to - dilute multi - dose vial Some patients may need 2 - 3 vials; time - consuming for pharmacist/nurse an
Slide 28: EA-114: Our Fulvestrant Product Candidate for HR+/HER2- Advanced Breast Cancer
EA-114: Our Fulvestrant Product Candidate for HR+/HER2- Advanced Breast Cancer Impact of Adi ~75% of breast cancers are HR! ~30% of patients frst diagnosed with early-stage disease eventually develop metastatic disease? 27% five-year survival for patients in U.S. with metastatic breast cancer? ‘An U
Slide 29: An Unmet Need: EA-114 Fulvestrant Product Candidate
29 An Unmet Need EA - 114: Our Fulvestrant Product Candidate for HR+/HER2 - Advanced Breast Cancer • Eagle’s 600 - subject PK trial yielded ~18,000 data points, which we mined for insights • For fulvestrant to work, it needs to bind to and block the estrogen receptor (ER) • Not everyone treated with
Slide 30: Existing Product Partnerships
30 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 for pancreatic cancer • For SM - 88 Eagle shall earn 15% of U.S. net sales and will
Slide 31: Eagle is Well Positioned for Future Growth
Eagle is Well Positioned for Future Growth Historical Development Eagle has historically developed its pipeline organically through the 50Sb2 pathway Commercial calling on Hospitals, C 1 Academic & Surgical Oncology Expansion with the commercial infrastructure to take on additional assets as we tran
Slide 32: Eagle is Well Positioned for Future Growth
32 Eagle is Well Positioned for Future Growth Eagle has historically developed its pipeline organically through the 505b2 pathway Profitable organization calling on Hospitals, Community, Academic & Surgical Oncology with the commercial infrastructure to take on additional assets as we transition To
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