Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (September 2018)
20 slides from Eagle Pharmaceuticals's investor presentation, Sep 13, 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 net income and adjusted earnings per share from continuing operations attributable to the Company. The Company believes these measures provide
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 CF from Operations (1) expected to significantly increase in 2018 (1) (1) Cash Flow excludes receivables build 4
Slide 4: Strong EBITDA Margin
Strong EBITDA Margin 5 10% 34% 41% 2015 2016 2017 EBITDA Margin
Slide 5: 2018 to date
2018 to date: 6 1st half of 2018 First-to-file Vasopressin ANDA Launched 500 ml bendamustine (“big bag”) Orphan Drug Exclusivity granted 2nd half of 2018 EHS enrollment of 2nd study completed; preliminary analysis of the data replicated treatment effect of 2015 Hajj Nerve agent: on schedule EA-111 (
Slide 6: RYANODEX: Multiple Label Expansion Opportunities
Creating additional value by addressing life-threatening, unmet needs Eight patents issued to date expiring from 2022 to 2025 7 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 discuss
Slide 7: 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 animals developed severe status epilepticus and were treated with standard AEDs according to protocol Study animals w
Slide 8: Bendamustine Long Life Cycle
Bendamustine Long Life Cycle 11 1/1/15-6/30/18: $126 mm in aggregate milestones earned 1/1/16-6/30/18: $303 mm in royalties earned Significant BENDEKA royalties and milestones earned Orphan Drug Exclusivity Granted 2016 - 2025 Improved product profile and unique J-code for BENDEKA 15 OB listed paten
Slide 9: Fifteen Orange Book Patents Running from 2026-2033
Fifteen Orange Book Patents Running from 2026-2033 Protecting the longevity of the bendamustine franchise 12 U.S. Patent No. Patent Expiration 8,609,707 1/28/2031 8,791,270*PED (owned by Teva Pharmaceutical Industries Ltd.) 7/12/2026 9,000,021 3/15/2033 9,034,908 3/15/2033 9,144,568 3/15/2033 9,265,
Slide 10: 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 11: Fulvestrant Opportunity
Fulvestrant Opportunity INDICATIONS for FASLODEX® Currently marketed by AstraZeneca Administered monthly in a doctor’s office as 2 separate intramuscular injections, one in each buttock FDA has recently required revising the FASLODEX label 14 Faslodex ® is a registered trademark of AstraZeneca. Labe
Slide 12: The Problem
The Problem 15 2 deep intramuscular injections of high viscosity product per dose of treatment (5 mL each) Administered over 1-2 minutes into each buttock Painful procedure FASLODEX injection reactions have been associated with peripheral nerve adverse reactions, including risk of damaging the sciat
Slide 13: 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. Trial scheduled to begin on Sept. 9, 2019; 30 mont
Slide 14: 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 15: Financial Highlights
LTM 6/30/18 EBITDA: $72.5 mm Cash: $100.2 mm A/R: $69.4 mm Share Repurchase Plan $102.5 mm repurchased (1.6 mm shares at $65.36) since August 2016 $11 million during August 2018; majority purchased after EHS data release $100 mm additional authorization approved by the Board August 2017 14.9 mm basi
Slide 16: Financial Highlights
Financial Highlights As of 06/30/18 * LTM 6/30/18 EBITDA: $72.5 mm * Cash: $100.2 mm AJR: $69.4 mm ¢ Share Repurchase Plan * $102.5 mm repurchased (1.6 mm shares at $65.36) since August 2016 + $11 million during August 2018; majority purchased after EHS data release * $100 mm additional authorizatio
Slide 17: Thank You
Thank You September 2018
Slide 18: 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 Gain on divestiture of diclofenac-misoprostol Amortization of intangible assets for Eagle Biologics Changes in the fair value of contingent consideration (D
Slide 19: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non-GAAP EBITDA 23 (in thousands) 2015 2016 2017 Net income from operations - GAAP 2,571 $ 81,453 $ 51,943 $ Add back: Interest expense (income), net (14) (76) 1,045 Provision for income taxes 3 (28,026) 21,002 Depreciation and amortization 112 1,589 3,746 Add back
Slide 20: Reconciliation of GAAP to Adjusted Non-GAAP EBITDA
Reconciliation of GAAP to Adjusted Non- GAAP EBITDA ‘Twelve Months Ended Cn thousands) Net income from operations - GAAP. $2571 S81453. $51,943 ‘Add back: Interest expense (income), net (4) (76) 1.045 Provision for income taxes 3 (28,026) 21,002 Depreciation and amortization 121889 3,746 ‘Add back:
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