Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (May 2019)
26 slides from Eagle Pharmaceuticals's investor presentation, May 8, 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 4 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved #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 5 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 10% 34% 41% 33% 2015 2016 2017 2018 EBITDA Margin
Slide 5: Recent Developments
Recent Developments: 6 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved FDA rules in Eagle’s favor on ODE scope for BENDEKA Licensing agreement expanded for BENDEKA Royalty increases from 25% to 30%, and 1% annually until it reaches 32% Term of agreement extended from 2025 until product no lon
Slide 6: RYANODEX: Multiple Label Expansion Opportunities
RYANODEX: Multiple Label Expansion Opportunities Creating additional value by addressing life-threatening, unmet needs Eight U.S. patents issued to date expiring from 2022 to 2025 7 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved Breakthrough formulation of dantrolene sodium Approved in July
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 liqu
Slide 8: RYANODEX for the Treatment of Nerve Agent Exposure
RYANODEX for the Treatment of Nerve Agent Exposure Nerve agent (NA) exposure is often deadly; survivors frequently experience severe neurological consequences. Federal Agencies, including the Departments of Homeland Security and Health and Human Services, have issued multiple documents highlighting
Slide 9: Nerve Agent Topline Study Results
Nerve Agent Topline Study Results Statistically significant neuroprotective effects of RYANODEX in critical cortical areas of the brain In all 6 areas of the brain examined, RYANODEX-treated animals experienced a lower level of brain damage 10 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved
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 Objective of the study was to evaluate the efficacy of intravenous administration of RYANODEX to prevent or mitigate ARS in a total body irradiated C57BL/6 male mouse
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 .07-.08 92%-93% chance that the results we have are not random Trea
Slide 12: EA-111 Development
EA-111 Development Developed new chemical entities (“NCE”) related to dantrolene Continue advancing IM formulations with NCE IM product to provide in vivo dantrolene levels similar to RYANODEX IM product allows easier and even more rapid administration than RYANODEX Enables immediate, non-profession
Slide 13: Seven Year Orphan Drug Exclusivity Granted for BENDEKA by Court
In June 2018, U.S. District Court for the District of Columbia issued a decision requiring FDA to grant seven years of ODE in the U.S. for BENDEKA On February 20, 2019, FDA issued a decision in favor of Eagle regarding the scope of BENDEKA’s exclusivity Pursuant to that decision no bendamustine prod
Slide 14: Bendamustine Long Life Cycle
Bendamustine Long Life Cycle 15 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 1/1/15-3/31/19: $135 mm in aggregate milestones earned 1/1/16-3/31/19: $395 mm in royalties earned Significant BENDEKA royalties and milestones earned FDA ODE scope TREANDA generics not expected before December 20
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 16 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved U.S. Patent No. Patent Expiration 8,609,707 1/28/2031 8,791,270 (owned by Teva Pharmaceutical Industries Ltd.) 1/12/2026 9,000,021 3/15/
Slide 16: BELRAPZO Ready-to-Dilute Bendamustine Launch
500 ml admixture for the treatment of patients with CLL and NHL Launched our ready-to-dilute product with our internal sales force Expands our bendamustine product offering and is complementary to BENDEKA Enables us to provide value to a cost-conscious segment of the market Anticipate over time achi
Slide 17: Fulvestrant Opportunity
Fulvestrant Opportunity Data released October 31, 2018 Trial did not meet PK endpoints Safety profile consistent with expectations We believe that 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 Plan to meet wit
Slide 18: Pemetrexed Opportunity
Pemetrexed Opportunity At this time, Lilly’s Alimta patent prevents current ANDA filers from launching until May 24, 2022 FDA granted tentative approval of Eagle’s Pemetrexed RTD PEMFEXY™ Oct. 27, 2017 Lilly sued Eagle on August 14, 2017 in Indiana. That case was dismissed. Lilly then sued Eagle in
Slide 19: Eagle Biologics Market Opportunity
Eagle Biologics Market Opportunity Acquired Arsia Therapeutics in 2016 Enhances Eagle’s formulation capabilities and expands product development opportunities Extends Eagle’s strategy: plan to partner with key Biosimilar or Bioinnovator companies to alter their existing pipeline into “Biobetters” $4
Slide 20: 2019 & Beyond: Poised for Growth
2019 & Beyond: Poised for Growth 21 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved EA-111 Intramuscular RYANODEX EHS Nerve agent Acute Radiation Syndrome Eagle ANDA Assets Filed vasopressin Q1 2018; first to file status Advancing 2nd product BENDEKA/ bendamustine family Launched “big” bag” M
Slide 21: Financial Highlights
Financial Highlights LTM EBITDA $80.7 mm LTM Cash Flow from Operations, excluding A/R shifts $84.1mm Cash $102.1 mm A/R $63.9 mm Share Repurchase Plan $154 mm repurchased since August 2016, including $50 mm ASR executed 10/30/18 2.6 mm shares repurchased since August 2016 1.6 mm shares repurchased t
Slide 22: Thank You
Thank You May 2019 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 23
Slide 23: Appendix
APPENDIX © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 24
Slide 24: Reconciliation of GAAP to Adjusted Non-GAAP Net Income
Reconciliation of GAAP to Adjusted Non-GAAP Net Income 25 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved Explanation of Adjustments: Amortization of intangible assets for Ryanodex and Docetaxel Amortization of intangible assets for Eagle Biologics Changes in the fair value of contingent cons
Slide 25: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non-GAAP EBITDA 26 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 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
Slide 26: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non- GAAP EBITDA ‘Net income - GAAP. ‘Add back: Interest expense (income), net Income tax provision Depreciation and amortization ‘Stock-based compensation ‘Change in fair value of contingent consideration ‘Debt issuance costs Asset impairment charge Gain on sale o
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