Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (February 2019)
25 slides from Eagle Pharmaceuticals's investor presentation, Feb 21, 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 (1) © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 4
Slide 4: Strong EBITDA Margin
Strong EBITDA Margin © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 5 10% 34% 41% 2015 2016 2017 EBITDA Margin
Slide 5: 2018 in Review
2018 in Review: First-to-file Vasopressin ANDA Launched 500 ml bendamustine (“big bag”) Orphan Drug Exclusivity granted for BENDEKA EHS enrollment of 2nd study completed; preliminary analysis of the data replicated treatment effect of 2015 Hajj Nerve agent: signed CRADA with US Military Acute Radiat
Slide 6: 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 Breakthrough formulation of dantrolene sodium Approved in July 2014; launched in August 2014 Completed enrollment of 2nd safety and efficacy study Meet with FDA to discu
Slide 7: 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 Q4 2018: Entered into agreement with the United States Army Medical Research Institute of Chemical Defense (USAMRICD) Study to evaluate the n
Slide 8: RYANODEX for NA Pilot Study Summary
RYANODEX for NA Pilot Study Summary Over 50 rodents exposed to a high dose of the NA soman Treated with the known antidote for acute poisoning (atropine and HI-6) All surviving study rodents developed severe status epilepticus and were treated with standard AEDs according to protocol Study rodents w
Slide 9: 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 10: 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 11: 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 12: Seven Year Orphan Drug Exclusivity Granted for BENDEKA
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 13: Bendamustine Long Life Cycle
Bendamustine Long Life Cycle 1/1/15-9/30/18: $126 mm in aggregate milestones earned 1/1/16-9/30/18: $337 mm in royalties earned Significant BENDEKA royalties and milestones earned © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 14 2016 - 2025 Improved product profile and unique J-code for BEN
Slide 14: 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 (owned by Teva Pharmaceutical Industries Ltd.) 1/12/2026 9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033 9,265,831 1/2
Slide 15: Launch of "big bag" Ready-to-dilute bendamustine
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 16: Fulvestrant Opportunity
Fulvestrant Opportunity Data released October 31, 2018 Trial did not meet PK endpoints Safety profile consistent with expectations We continue to review the details of the study to determine if there might be a path forward © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 17
Slide 17: Pemetrexed Opportunity
Pemetrexed Opportunity At this time, Lilly’s Alimta patent litigations prevent 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 sue
Slide 18: 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” $45 million investment The global bio
Slide 19: 2019 & Beyond: Poised for Growth
2019 & Beyond: Poised for Growth EA-111 Intramuscular © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 20 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 20: Financial Highlights
LTM 9/30/18 EBITDA: $65.7 mm Cash: $91.2 mm A/R: $78.5 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 through OMR 1.0 mm shares repurchased through ASR $150 mm new authorizat
Slide 21: Thank You
Thank You January 2019 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 22
Slide 22: Appendix
APPENDIX © 2019 Eagle Pharmaceuticals, Inc. All rights reserved 23
Slide 23: 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 Changes in the fair value of contingent consideration (Docetaxel and Eagle Biologics) Gain on divestit
Slide 24: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non-GAAP EBITDA 25 © 2019 Eagle Pharmaceuticals, Inc. All rights reserved (unaudited, in thousands) 2015 2016 2017 2018 Net income - GAAP $ 2,571 $ 81,453 $ 51,943 $ 28,398 Add back: Interest expense (income), net (14) (76) 1,045 2,585 Provision for income taxes 3
Slide 25: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non- GAAP EBITDA ‘Twelve Months Ended December 3, September 30 (wmudited, in thousands) 2018 2016 2017 2018 Netincome - GAAP. S251 S$ 81483 $5198 S 28,398 ‘Ada back: Interest expense income), net ay i) 1,045 2,585 Provision for income taxes 3 @8026 21,002 35 Deprec
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