Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (November 2018)
24 slides from Eagle Pharmaceuticals's investor presentation, Nov 8, 2018
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 (US$MM, except per share data) $96 $71 $69 $64 $50 $45 $5 $7 $0.41 2015 Milestone & Licensing Revenues 2016 2017 EBITDA Non-GAAP EPS (1) Cash Flow From Operations • #16 on Fortune’s 100 List of Fastest-Growing Companies with #1 ranking for both 3-year EPS and revenue gro
Slide 4: Strong EBITDA Margin
Strong EBITDA Margin EBITDA Margin 41% 2015 2016 2017 CONFIDENTIAL © 2018 Eagle Pharmaceuticals, Inc. All rights reserved. 5 34% 10%
Slide 5: 2018 to date
2018 to date: 1st half of 2018 2nd half of 2018 EHS enrollment of 2nd study completed; preliminary analysis of the data replicated treatment effect of 2015 Hajj Nerve agent: signed CRADA with US Military EA-111 (IM product in RYANODEX® franchise) Biostudy planning ongoing for second ANDA Fulvestrant
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 Marketed Malignant Hyperthermia Breakthrough formulation of dantrolene sodium Approved in July 2014; launched in August
Slide 7: 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 r
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 Q4 2018: Entered into agreement with the United States Army Medical Research Institute of Chemical Defense (USAMRICD) • • Study to evaluate
Slide 9: 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 r
Slide 10: 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,
Slide 11: Seven Year Orphan Drug Exclusivity Granted for BENDEKA by Court
Seven Year Orphan Drug Exclusivity (ODE) Granted for BENDEKA by Court • 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 FDA will not be able to approve any drug applications referencing BENDEKA until ODE expires in
Slide 12: Bendamustine Long Life Cycle Orphan Drug Exclusivity Granted
Bendamustine Long Life Cycle Orphan Drug Exclusivity Granted • • • • • • • • Improved product profile and unique J-code for BENDEKA 15 OB listed patents through 2033 Up to 97% market share for BENDEKA BENDEKA Royalty of 25% of US net sales (increased from 20% in Q4 2016) FDA approval for 2nd manufac
Slide 13: Fifteen Orange Book Patents Running from 2026-2033
Fifteen Orange Book Patents Running from 2026-2033 Protecting U.S. Patent No. the longevity of the bendamustine franchise Patent Expiration 8,791,270*PED (owned by Teva Pharmaceutical Industries Ltd.) 7/12/2026 9,034,908 3/15/2033 9,265,831 1/28/2031 9,572,797 1/28/2031 9,579,384 3/15/2033 9,579,398
Slide 14: Launch of "big bag" Ready-to-dilute bendamustine
Launch of “big bag” Ready-to-dilute (RTD) bendamustine hydrochloride (HCl) solution • • • 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 Enabl
Slide 15: Fulvestrant Opportunity
Fulvestrant Opportunity • Data released 10/31/18 • • • 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 CONFIDENTIAL © 2018 Eagle Pharmaceuticals, Inc. All rights reserved.
Slide 16: 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 s
Slide 17: 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
Slide 18: 2018 & Beyond: Poised for Growth
2018 & Beyond: Poised for Growth Multiple potential regulatory filings in 2018 ROW Bendeka/ bendamustine family • Launched “big” bag” May 2018 • OUS markets • ODE granted Eagle ANDA Assets • Filed vasopressin Q1 2018; first to file status • Advancing 2nd product Ryanodex • EHS • Nerve agent • Intram
Slide 19: Financial Highlights
Financial Highlights As of 09/30/18 • • LTM 9/30/18 EBITDA: $65.7 mm Cash: A/R: Share $91.2 mm $78.5 mm Repurchase Plan • •$154 mm repurchased since August 2016, including $50 mm ASR executed 10/30/18 •$150 mm new authorization (including $50mm ASR) approved by the Board October 2018 14.2 mm basic s
Slide 20: Thank You
Thank You November 2018 CONFIDENTIAL © 2018 Eagle Pharmaceuticals, Inc. All rights reserved. 21
Slide 21: Appendix
APPENDIX CONFIDENTIAL © 2018 Eagle Pharmaceuticals, Inc. All rights reserved. 22
Slide 22: Reconciliation of GAAP to Adjusted Non-GAAP Net Income
Reconciliation of GAAP to Adjusted Non-GAAP Net Income Twelve Months Ended December 31, (unaudited, in thousands, except share and per share amounts) 2015 2016 2017 Explanation of Adjustments: 1) Amortization of intangible assets for Ryanodex and Docetaxel Amortization of intangible assets for Eagle
Slide 23: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation GAAP EBITDA (unaudited, in thousands) of GAAP to Adjusted Non-Twelve Months Ended September 30, December 31, 2015 2016 2017 2018 Interest expense (income), net (14) (76) 1,045 2,585 Depreciation and amortization 112 1,589 3,746 3,790 Add back: Changes in fair value of contingent consi
Slide 24: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non- GAAP EBITDA “Twelve Months Ended December 31. September 30, 201s 2016 207 2018 S251 $ S148 $5198 Ss 28398 a (76) 1048 2585 3 @so26) 2,002 34s ry 1589 36 3190 4051 976818829 i833 ‘Changes in fir value of contingent consideration 5 997 37%) e337, Debtisnanee cos
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