Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (June 2019)
23 slides from Eagle Pharmaceuticals's investor presentation, Jun 4, 2019
Slide 1: Forward Looking Statements
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,” “underwa
Slide 2: Non-GAAP Financial Performance Measures
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 believes these
Slide 3: Significant Growth Since IPO
Significant Growth Since IPO #16 on Fortune’s 100 List of Fastest-Growing Companies with #1 ranking for both 3-year EPS and revenue growth
Slide 4: Strong EBITDA Margin
Strong EBITDA Margin 10% 34% 41% 33% 2015 2016 2017 2018
Slide 5: Recent Developments
Recent Developments FDA rules in Eagle’s favor on ODE scope for BENDEKA® Licensing agreement expanded for BENDEKA Royalty increases from 25% to 30% on 10/1/19, and then increases by 1 percentage point on each anniversary thereafter until it reaches 32% Term of agreement extended from 2025 until prod
Slide 6: Strong Near-term Pipeline
Strong Near-term Pipeline 7 BENDEKA BELRAPZO RYANODEX for Malignant Hyperthermia (MH) RYANODEX for Nerve Agent (NA) exposure PEMFEXY™ Vasopressin Fulvestrant EA-111 RYANODEX for EHS Expect further clarity following upcoming FDA meeting RYANODEX for Acute Radiation Syndrome (ARS)
Slide 7: What are Nerve Agents?
What are Nerve Agents? Nerve agents (NA) are the most toxic of the known chemical warfare agents, synthesized in the 1930s; they are chemically similar to organophosphate pesticides and exert their biological effects by inhibiting certain enzymes These agents are clear, colorless, and tasteless subs
Slide 8: RYANODEX: Treatment of Nerve Agent Exposure
RYANODEX: Treatment of Nerve Agent Exposure If approved, RYANODEX would be a first of its kind neuroprotective treatment for the amelioration of brain damage due to NA exposure Federal Agencies, including the Departments of Homeland Security and Health and Human Services, have issued multiple docume
Slide 9: Nerve Agent Topline Study with U.S. Military Results
Nerve Agent Topline Study with U.S. Military Results Statistically significant neuroprotective effects of RYANODEX in critical cortical areas of the brain In six areas of the brain examined, RYANODEX-treated animals experienced a lower level of brain damage
Slide 10: RYANODEX for Acute Radiation Syndrome (ARS)
RYANODEX for Acute Radiation Syndrome (ARS) Positive results of a proof-of-concept (POC) study in a Total-Body Radiation Animal Model 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 Anima
Slide 11: RYANODEX for Exertional Heat Stroke
RYANODEX for Exertional Heat Stroke P-value of 0.05 means that study results reported are 95% due to treatment effect rather than randomness Treatment effect observed after two distinct trials, regardless of sample size: p-value of 0.07 - 0.08 92%-93% chance that the positive efficacy results are at
Slide 12: EA-111 Development
EA-111 Development Developed new chemical entities (“NCE”) related to dantrolene Advancing IM-formulation NCE IM version would allow for easier and more rapid administration Enables point-of-care administration to patients in need Eliminates IV-infusion Anticipate 5-year NCE regulatory exclusivity p
Slide 13: Orphan Drug Exclusivity (ODE) Granted for BENDEKA
Orphan Drug Exclusivity (ODE) Granted for BENDEKA June 2018 - U.S. District Court for the District of Columbia issued decision requiring FDA to grant seven years of ODE in the U.S. for BENDEKA February 20, 2019 - FDA issued decision favoring Eagle regarding scope of BENDEKA’s exclusivity Pursuant to
Slide 14: Bendamustine Longevity Beyond 2025
Bendamustine Longevity Beyond 2025 Significant BENDEKA royalties and milestones earned 1/1/15-3/31/19: $135 mm in aggregate milestones earned 1/1/16-3/31/19: $395 mm in royalties earned Unique J-code for BENDEKA Bendeka royalty increases from 25% to 30% on 10/1/19, and then increases by 1 percentage
Slide 15: Fifteen Orange Book Patents Running from 2026-2033
Fifteen Orange Book Patents Running from 2026-2033 Protecting the longevity of the bendamustine franchise U.S. Patent No. Patent Expiration 8,609,707 1/28/2031 8,791,270* 1/12/2026 9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033 9,265,831 1/28/2031 9,572,796 1/28/2031 9,572,797 1/28/2031
Slide 16: Fulvestrant Opportunity
Fulvestrant Opportunity Data released October 30, 2018 Trial did not meet PK endpoints Safety profile consistent with expectations We believe we can reformulate our product in a way that may result in a better drug than the current brand Met with the FDA regarding reformulation Next meeting with FDA
Slide 17: Pemetrexed Opportunity
Pemetrexed Opportunity Multi-billion market opportunity (LTM Sales: $1.17B U.S., $0.97B Ex-U.S., $2.14B WW)1 Currently, Lilly’s Alimta® patent prevents current ANDA filers from launching until May 24, 2022 Four 505(b)(2) filers (DRL, Hospira, Actavis/Teva, Apotex) were all sued in Indiana DRL and Ho
Slide 18: Financial Highlights
Financial Highlights LTM EBITDA $80.7 mm LTM Cash Flow from Operations, excluding A/R shifts $84.1 mm Cash $102.1 mm A/R $63.9 mm Share Repurchase Plan as of 5/17/19 $169 mm repurchased since August 2016, including $50 mm ASR executed 10/30/18 2.9 mm shares repurchased since August 2016 1.9 mm share
Slide 19: Financial Highlights
Financial Highlights As of 3/31/19 * LTM EBITDA $80.7 mm LTM Cash Flow from Operations, excluding A/R shifts $84.1 mm Cash $102.1 mm AR $63.9 mm Share Repurchase Plan as of 5/17/19 + $169 mm repurchased since August 2016, including $50 mm ASR executed 10/30/18 + 2.9 mm shares repurchased since Augus
Slide 20: Thank you
Thank you June 2019 EAGEE
Slide 21: Reconciliation of GAAP to Adjusted Non-GAAP Net Income
Reconciliation of GAAP to Adjusted Non-GAAP Net Income Explanation of Adjustments: Amortization of intangible assets for Ryanodex and Docetaxel Amortization of intangible assets for Eagle Biologics Gain on divestiture of diclofenac-misoprostol Changes in the fair value of contingent consideration (D
Slide 22: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non-GAAP EBITDA Twelve Months Ended March 31, Twelve Months Ended December 31, 2019 2018 2017 2016 2015 Net income - GAAP $ 38,260 $ 31,903 $ 51,943 $ 81,453 $ 2,571 Add back: Interest expense (income), net 2,123 2,579 1,045 (76) (14) Income tax provision 6,098 2,1
Slide 23: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non-GAAP EBITDA ‘Twelve Months Ended March 31, ‘Twelve Months Ended December 31, 2019 2018 2017 2016 2015 Net income - GAAP $38,260 $ 31903 -$ 51.983 $81,453 $2571 ‘Add back: Interest expense (income), net 2123 2579 11045, (76) (aa) Income tax provision 6,098 2335
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