Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Q4 2020 Earnings Presentation
31 slides from Eagle Pharmaceuticals's earnings presentation, Mar 2, 2021
Slide 1: Investor Update March 2, 2021
1 1 INVESTOR Update March 2, 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: Agenda: Q4 Earnings & Pipeline Update
4 Agenda: Q4 Earnings & Pipeline Update Eagle Vision & Strategy Quarterly Results Pipeline Review Question & Answer 1 2 3 4 Scott Tarriff Brian Cahill David Pernock and Judi Ng - Cashin All SPEAKER TOPIC
Slide 5: Today's Speakers
5 Todays Speakers Scott Tarriff Founder, Chief Executive Officer and Director Brian Cahill Chief Financial Officer Judi Ng - Cashin Chief Medical Officer David Pernock Chief Operating Officer
Slide 6: Eagle Vision & Strategy
6 6 Eagle Vision & Strategy Scott Tarriff
Slide 7: Strong Foundation for Potential Long-Term Growth
7 Strong Foundation for Potential Long - Term Growth Invested $231mm (21%+ of revenue) in R&D (2013 – 2020) $257mm in cash flow from operations (2015 – 2020) $207mm repurchased since August 2016; approx. 13 mm basic shares outstanding as of December 2020 Highly Efficient Business Model Successful Ca
Slide 8: Q4 2020 Results
8 8 Q4 2020 Results Brian Cahill
Slide 9: Pipeline Review
9 9 Pipeline Review David Pernock and Judi Ng - Cashin
Slide 10: External Partnerships
10 10 External Partnerships David Pernock
Slide 11: External Partnerships
11 External 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 two Phase II/III studies for pancreatic cancer • For SM - 88 Eagle shall earn 15% of U.S. net sales and will be r
Slide 12: PEMFEXY
PEMFEXY™ EAGLE
Slide 13: Lung Cancer
13 Lung Cancer *cancer.net Lung cancer is the 2nd most common cancer*, second to skin cancer in the U.S. Non - small cell lung cancer is the most common type, accounting for 84% of all lung cancer diagnoses* Mesothelioma, another type of lung cancer, has an annual U.S. incidence of approximately 3,3
Slide 14: PEMFEXY Is FDA-Approved For Nonsquamous NSCLC and Mesothelioma
14 PEMFEXY ΠIs 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 disease ha
Slide 15: PEMFEXY vs ALIMTA: Launch Planned February 2022
15 Currently marketed by Lilly as ALIMTA® (pemetrexed) 100mg and 500mg powder single dose vials ALIMTA ® (Eli Lilly) - PEMFEXY Œ (Eagle) – U.S. Sales of $1.265B* 1.2B Eagle first to market 505(b)(2) PEMFEXY Ρ (pemetrexed) 500mg liquid multi - dose vial – Granted unique J - code by CMS – Launch plann
Slide 16: Eagle's Differentiated PEMFEXY (pemetrexed)
16 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 17: Key Opinion Leader Survey Findings
17 Key Opinion Leader Survey Findings During a recent KOL survey* performed by an outside firm 90% of the respondents would prefer a liquid multi - dose product over a powder, and 44% indicated moderate wastage. *December 2019 Quantitative Market Research N=150
Slide 18: Vasopressin
Vasopressin EAGLE f
Slide 19: Vasopressin Overview
19 Vasopressin 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 Trial date for patent trial with Par entities reschedul
Slide 20: EA-114 (Fulvestrant)
EA-114 (Fulvestrant) EAGLE,
Slide 21: Current Treatment Landscape in HR+/HER2- Breast Cancer
21 Current Treatment Landscape in HR+ / HER2 – Breast Cancer Blocking ovarian function permanently with surgery or temporary with drugs called gonadotropin - releasing hormone (GnRH) agonists Blocking estrogen production using drugs called aromatase inhibitors (AI), such as letrozole, anastrozole an
Slide 22: EA-114 (Fulvestrant) Insights and Path Forward
22 EA - 114 (Fulvestrant) Insights and Path Forward ▪ Eagle conducted two clinical trials comparing Eagle’s formulation to Faslodex® ▪ These studies followed 750 subjects for 140 - 280 days ▪ Analyzed thousands of collected data points and discerned the need for a distinctive delivery system ▪ Sough
Slide 23: Nerve Agent Medical Countermeasure
23 23 Nerve Agent Medical Countermeasure
Slide 24: RYANODEX Potential for Nerve Agent Exposure
24 RYANODEX Potential for Nerve Agent (NA) Exposure Nerve agents are the most toxic of the known chemical warfare agents • Rapid treatment with available agents decreases risk of mortality but does not ameliorate risk of brain damage. NA survivors may experience permanent neurologic damage and death
Slide 25: EA-111 (New Chemical Entity)
25 EA - 111 (New Chemical Entity) Developing the next generation of ryanodine receptor antagonists • 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 26: Eagle's Nerve Agent Medical Countermeasure Program
26 Eagle’s Nerve Agent Medical Countermeasure Program Eagle has put forth a significant amount of effort in developing Ryanodex for the treatment of brain damage secondary to nerve agent toxicity. Proof of Concept study using rat soman model conducted at MRIGlobal ( EGL - DTL - NC - 1704 ) Pivotal G
Slide 27: Proof-of-Concept Study: MRIGlobal
27 Proof - of - Concept Study: MRIGlobal - EGL - DTL - NC - 1704 The positive outcome of this study provided the basis for the design of an adequately powered GLP study in a well - established rat model of soman exposure. Fronto - Parietal Cortex: Photomicrographs Fronto - Parietal Cortex: Mean Necr
Slide 28: Pivotal GLP Study in Rat Soman Model
28 Pivotal GLP Study in Rat Soman Model: USAMRICD - SR - 1 - 19 - U - 1091 Photomicrographs: Fronto - Parietal Cortex Most neurons were necrotic (denoted by black arrows) and only a few neurons (denoted by white arrows) were unaffected
Slide 29: Nerve Agent Medical Countermeasure Program Next Steps
29 Nerve Agent Medical Countermeasure Program Next Steps 29 We are planning further studies in Non - Human Primate soman models The FDA agrees with our model selection and has requested that Eagle submit a SPA for review prior to conducting the pivotal GLP studies Eagle will conduct preliminary PK/P
Slide 30: Question & Answer
Question & Answer EAGLE,
Slide 31: Thank You!
Thank You! EAGLE |
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