UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item7.01 | Regulation FD Disclosure. |
On September 28, 2020, Eagle Pharmaceuticals, Inc., or the Company, released an updated investor presentation of the Company’s business model, products, and product candidates. The investor presentation will be used from time to time in meetings with investors.
A copy of the above-referenced presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information furnished pursuant to Item 7.01 of this current report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing. The furnishing of the information in this Current Report on Form 8-K is not intended to, and does not, constitute a determination or admission by the Company that the information in this Current Report on Form 8-K is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Presentation of the Company dated September 2020 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: September 28, 2020 | EAGLE PHARMACEUTICALS, INC. | |
| By: | /s/ Scott Tarriff | |
| Scott Tarriff | ||
| Chief Executive Officer | ||
Exhibit 99.1
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Eagle Pharmaceuticals NASDAQ: EGRX September 2020
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Forward Looking Statements • This presentation contains forward - looking information within the meaning of the Private Securities Litigation Reform Act of 199 5, as amended, and other securities laws. Forward - looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “wo uld,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward - loo king statements. These statements include, but are not limited to, statements regarding future events such as: the number and timing of potential product launches, development init iat ives and new indications for RYANODEX; the timing of potential product launches for Vasopressin; the Company's clinical development plan for its fulvestrant product candidate, EA - 114, as well as the development efforts for the other product candidates in its portfolio; the potential benefits and efficacy of RYANODEX, including the potential for RYANODEX as a treatment for nerve agent exposure, acute radiation syndrome, traumatic brain injury, Alzheimer’s disease (EA - 112) and additional indications; the timing, scope or likelihood of re gulatory filings and approvals from the FDA for the Company’s product candidates, including the Company’s ability to work with the FDA to finalize the Special Protocol Assessmen t a nd advance the development of RYANODEX for brain damage secondary to nerve agent exposure; the potential for other products treating the same indication as BENDEKA ente rin g the market before 2022; the timing of the Company's PEMFEXY launch, if ever; the success of the Company's collaborations with its strategic partners and the timing and re sults of these partners’ preclinical studies and clinical trials, including the Company’s collaboration with its Japanese licensing partner, SymBio , with respect to the commercialization of SymBio’s product TREAKISYM, and the timing of the potential product launch of TREAKISYM; the ability of the Company’s fulvestrant product candidate, EA - 114, to improve clinical outcomes for post - menopausal metastatic breast cancer patients; the Company’s timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain healthcare reform measures; the Company's timing and ability to re purchase additional shares of the Company's common stock, if any, under its share repurchase program; the Company's ability to deliver value in 2020 and over the long te rm; and the Company's plans and ability to advance the products in its pipeline. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the Company's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward - looking informa tion and statements. Such risks and uncertainties include, but are not limited to: the impacts of the COVID - 19 pandemic, including disruption or impact in the sales of the Compan y's marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on hea lth care systems, disruption in the operations of the Company's third party partners and disruption of the global economy, and the overall impact of the COVID - 19 pandemic on the Comp any's business, financial condition and results of operations; risks that the Company's business, financial condition and results of operations will be impacted by the spread o f C OVID - 19 in the geographies where the Company's third - party partners operate; whether the Company will incur unforeseen expenses or liabilities or other market factors; risks t hat results from in vitro laboratory tests of RYANODEX are not necessarily predictive of future clinical trial and in vivo results; whether the Company will successfully implement its development plan for its fulvestrant product candidate, EA - 114, or other product candidates; delay in or failure to obtain regulatory approval of the Company's product candidates; whet her the Company can successfully market and commercialize its product candidates; the success of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme , NorthShore University HealthSystem and SymBio and the parties' ability to work effectively together; the availability and pricing of third party sourced products and mater ia ls; the outcome of litigation involving any of our products or that may have an impact on any of our products; successful compliance with the FDA and other go vernmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including the potential adverse ef fects of public health issues, including the COVID - 19 pandemic, on economic activity and the performance of the financial markets generally; the strength and enforceability of the Co mpany's intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from gener ic entrants into the market; the risks inherent in the early stages of drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Fa ctors” sections of the Company's Annual Report on Form 10 - K for the year ended December 31, 2019 as updated by the company’s subsequent filings with the Securities and Exchange Commis sion. Readers are cautioned not to place undue reliance on these forward - looking statements that speak only as of the date hereof, and the Company does not undertake any oblig ation to revise and disseminate forward - looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non - occurrence of any ev ents. 2
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 3 In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non - GAAP n et income and adjusted non - GAAP earnings per share attributable to Eagle. The Company believes these measures provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. Adjusted non - GAAP net income excludes stock - based compensation expense, depreciation expense, amortization expense, expense of acquired in - process research and development, severance, non - cash interest expense, debt issuance costs, gain on sale of asse ts, changes in fair value of contingent consideration, asset impairment charge, restructuring charge, legal settlement expense re lat ed to collaboration with Tyme , fair value adjustments on equity investment, and the tax effect of these adjustments. The Company believes these non - GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non - GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by th e Company not to be reflective of the Company’s ongoing results. See the annexed Reconciliation of GAAP to Adjusted Non - GAAP Net Income and Adjusted Non - GAAP Earnings per Share and Reconciliation of GAAP to Adjusted Non - GAAP EBITDA for details of the amounts excluded and included to arrive at adjusted non - GAAP net income, adjusted non - GAAP earnings per share amounts, and adjusted non - GAAP EBITDA amounts, respectively. These adjusted measures are non - GAAP and should be considered in addition to, but not as a substitute for, the information prepa red in accordance with U.S. GAAP. The Company strongly encourages investors to review its consolidated financial statements and publicly - filed reports in their entirety and cautions investors that the non - GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Non - GAAP Financial Performance Measures
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Fully integrated R&D, clinical, manufacturing, quality, and commercial Profitable with foundation for continued long - term growth CNS/metabolic critical care and oncology focus Pipeline at near - term inflection point Eagle Pharmaceuticals Snapshot Committed to developing innovative medicines that result in meaningful improvements in patients’ lives with a focus on underserved therapeutic areas 4
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Strong Foundation for Potential Long - Term Growth Highly efficient business model: Invested $217mm (21%+ of revenue) in R&D since 2013 Sustainable profitability: $271mm* in cash flow from operations (2015 – 2Q 2020) Successful capital reinvestment: $205mm repurchased since August 2016; only 13.0mm basic shares outstanding** Robust balance sheet: No net debt and flexibility to actively deploy capital for opportunities 5 * Excluding receivables build **As of 9/24/2020
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Recent Developments 6 1/13/20 9/24/20 9/23/20 3/25/20 Submitted responses to all of FDA’s outstanding questions for vasopressin on September 25th Japanese licensing partner SymBio announced completion of clinical trial enrollment for TREAKISYM for liquid bendamustine formulation for NHL/CLL 4/28/20 7/9/20 6 CMS establishes unique J - code for PEMFEXY™ (pemetrexed for injection); FDA granted supplement approval for 500mg multiple - dose vial Received positive additional data for the Company’s fulvestrant product candidate, EA - 114, for HR+/HER2 - advanced breast cancer 8/10/20 8/28/20 Tyme announced that FDA granted Orphan Drug Designation for its lead product candidate, SM - 88, a treatment for patients with pancreatic cancer Submitted Special Protocol Assessment (SPA) to FDA for RYANODEX for the treatment of brain damage secondary to nerve agent exposure 9/25/20 FDA’s petition for re - hearing en banc of Appellate ODE decision denied confirming bendamustine franchise exclusivity through December 2022 Favorable patent decision issued by U.S. District Court of Delaware for Eagle and Teva for BENDEKA; Defendants will be enjoined from launching their ANDA products before 2031 8/17/20 8/3/20 8/10/20 9/24/20 9/23/20 Commenced $25mm Accelerated Share Repurchase as part of existing $160mm share repurchase program SymBio received approval of TREAKISYM Ready - To - Dilute (“RTD”) formulation, triggering $5mm milestone payment; launch expected in January 2021 8/28/20
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 7 Product Indication Potential Market Advantage Development Stage In - House/Partnership 1. Nerve Agent (NA) Exposure First in class Submitted SPA on 8/28 to FDA; plan to start second animal species study and file NDA in 1H 2021 United States Army Medical Research Institute of Chemical Defense RYANODEX* 2. Acute Radiation Syndrome (ARS) First in class Completed POC study; entering first of two registration animal studies under FDA Animal Rule; n ext, Eagle will conduct a GLP study in a validated animal model (in - house) 3. Traumatic Brain Injury (TBI)/ Concussion First in class Preclinical animal study in progress; expect study results with NorthShore University HealthSystem before year - end NorthShore University HealthSystem Dr. Julian Bailes 4. Alzheimer’s Disease (AD) First in class Completed preclinical animal study University of Pennsylvania 5. Anti - viral First in class Preclinical (in - house) EA - 111 6. NCE related to dantrolene First in class Preclinical and toxicology studies in progress (in - house) VASOPRESSIN* 7. Increase blood pressure during vasodilatory shock First to file † Anticipate launch with 180 - day market exclusivity; patent trial delayed due to COVID - 19 – no date set yet; submitted responses to all of FDAs outstanding questions on 9/25 (in - house) 10 Programs - Potential for 5 Launches in the Next 3 Years * † First to file ANDA referencing VASOSTRICT; submission accepted for filing by FDA March 2018 * * Royalty obligation CNS/METABOLIC CRITICAL CARE
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Product Indication Potential Market Advantage Development Stage In - House/Partnership SM - 88 8. Pancreatic and Other Cancers First in class Pivotal studies underway for pancreatic cancer Tyme Technologies EA - 114 (fulvestrant) 9. HR+/HER2 - Advanced Breast Cancer (BC) Best in class Received additional positive data from pilot study ; will meet with FDA in late October (in - house) PEMFEXY* (liquid injection) 10. Nonsquamous Non - Small Cell Lung Cancer (NSCLC) – malignant pleural mesothelioma First to market Approval granted on February 10, 2020; Q1 2022 launch; unique J - code established by CMS; granted supplement approval for 500mg multiple - dose vial (in - house) * * Royalty obligation 10 Programs - Potential for 5 Launches in the Next 3 Years 8 ONCOLOGY Anticipating three new product launches in 2022 (PEMFEXY, EA - 114, & SM - 88)
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. CNS/Metabolic Critical Care Pipeline Opportunities 9
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX® (dantrolene sodium) injectable suspension Breakthrough formulation • Approved July 2014 • Launched August 2014 Currently indicated for the treatment of malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of MH in patients at high risk 10
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. FDA - Approved for Malignant Hyperthermia (MH) Nerve Agent (NA) Exposure Acute Radiation Syndrome (ARS) Alzheimer’s Disease (AD) Traumatic Brain Injury/ Concussion (TBI) RYANODEX: Building a Successful Franchise New indications under development* Nine U.S. patents issued to date, expiring between 2022 and 2025 11 11 *Potential indications under development Anti - viral
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 12 Mechanism of action v
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • Currently there is no FDA - approved drug to treat TBI/concussion, which is estimated to affect 69 million people worldwide 1 • The CDC estimates that in 2014, there were nearly 2.8 million TBI - related emergency department visits in the U.S, some of which resulted in long - term harm or death. Up to 1/3 of cases occurred in children 2 • Eagle announced a research partnership with NorthShore University HealthSystem in January 2020 • Studying dantrolene sodium for TBI/concussion in animal models to determine if it can help halt or repair the harm caused by these traumas • Expect study results with NorthShore University HealthSystem before year - end 13 RYANODEX Potential in Traumatic Brain Injury (TBI)/Concussion 1. Dewan, MC, et al. Estimating the global incidence of traumatic brain injury. J. Neurosurg. 2018;(130): 1 – 18. doi: 10.3171/2017.10. 2. Centers for Disease Control and Prevention (CDC). Surveillance Report of Traumatic Brain Injury - related Emergency Department Visits, Hospitalizations, and Deaths — United States, 2014. CDC, U.S. Department of Health and Human Services. 2019. Accessed at https://www.cdc.gov/traumaticbraininjury/pdf/TBI - Surveillance - Report - FINAL_508.pdf.
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX (EA - 112) Potential in Alzheimer’s Disease A completely novel approach to the disease • Alzheimer’s disease is one of the greatest medical challenges of our time, with limited treatment options. It is the most common form of dementia and fifth - leading cause of death 1 affecting more than 30 million people worldwide 2 • Eagle and UPenn concluded that calcium dysregulation may play a unique role in Alzheimer’s disease • Results from a proof - of - concept preclinical study presented at the July 2019 Alzheimer’s Association International Conference showed that intranasal administration of dantrolene sodium provided therapeutic effects on memory and cognition in a mouse model of Alzheimer’s 14 1. World Health Organization. Global Health Estimates 2016: Disease burden by Cause, Age, Sex, by Country and by Region, 2000 - 2016. 2018. 2. World Health Organization. Dementia. Sept 19, 2019. Accessed at https://www.who.int/news - room/fact - sheets/detail/dementia.
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Promising Progress in Research on Dantrolene for Alzheimer’s Disease (AD) • Our partner UPenn conducted a recent animal study demonstrating: • A novel route of administration: • Greater passage of dantrolene across the blood brain barrier • Higher brain concentrations of dantrolene • A disease modifying effect: • Significantly improved memory • Significantly improved cognition • No significant side effects were detected in mortality, olfaction, motor or liver functions • Results were pronounced, especially after the start of amyloid accumulation and cognitive dysfunction • Publication of Preclinical Study of Intranasal Dantrolene in August 18, 2020 Journal of Alzheimer’s Disease 15
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. RYANODEX Potential for Nerve Agent (NA) Exposure First - of - its kind neuroprotective treatment for the amelioration of brain damage due to nerve agent exposure and, if approved, may receive orphan drug exclusivity (ODE) for organophosphate exposure Nerve agents are the most toxic of the known chemical warfare agents • Rapid treatment with available agents decreases risk of mortality but does not ameliorate risk of brain damage. NA survivors may experience permanent neurologic damage and death 16 • Agreement with the United States Army Medical Research Institute of Chemical Defense (USAMRICD) to evaluate the neuroprotective effects of RYANODEX in an accepted NA model • Results of study conducted with USAMRICD demonstrated a statistically significant reduction in brain damage secondary to NA exposure in RYANODEX - treated animals, compared with controls (p value ≤0.04) • Submitted a Special Protocol Assessment to FDA on August 28 th ; 45 - day review period. If mutual agreement on protocol with FDA, plan to start study and file NDA in 1H 2021
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • Exploring investigational indication for RYANODEX for treatment of hematopoietic syndrome in individuals exposed to high doses of radiation, such as nuclear power plant leakage or nuclear weapons. Potential to apply to certain cancer patients undergoing radiation therapy; additional research opportunity. • In a proof - of - concept study in a Total - Body Irradiation Animal Model, the RYANODEX treatment group had overall less mortality post - treatment than nontreated animals • Next, Eagle will conduct a GLP study in a validated animal model 17 RYANODEX Potential in Acute Radiation Syndrome Acute radiation syndrome (ARS), or radiation sickness, is a serious illness that can happen when a person is exposed to very high levels of radiation, usually over a short period of time
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. • Significant benefits of an intramuscular (IM) formulation • EA - 111 would allow for easier and more rapid administration in emergency situations (military and civilian) • Enables point - of - care administration to patients in need • Eliminates IV - infusion 18 18 EA - 111 (New Chemical Entity) Developing the next generation of ryanodine receptor antagonists
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. 19 19 Vasopressin • Indicated to increase blood pressure in adults with vasodilatory shock (e.g., post - cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines • Generic version of Par Sterile Products, LLC (an Endo International plc company) original VASOSTRICT® • $694 million in brand sales LTM 1 • Eagle is first - to - file an ANDA referencing VASOSTRICT for the 20 units per ml presentation, which ANDA was submitted in March 2018 • Patent trial with the Par entities delayed due to COVID - 19 – no date set yet; FDA’s 30 month stay from approving VASOSTRICT ANDA ends in October 2020 • Anticipate vasopressin launch with 180 - day market exclusivity • Submitted responses to all of FDA’s outstanding questions on September 25 th 1 As of June 30, 2020
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Oncology Pipeline Opportunities 20
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Impact of Advanced Breast Cancer • ~75% of breast cancers are HR+ 1 • ~30% of patients first diagnosed with early - stage disease eventually develop metastatic disease 2 • 27% five - year survival for patients in U.S. with metastatic breast cancer 3 An Unmet Need • Eagle’s 600 - subject PK trial yielded ~18,000 data points, which we mined for insights • For fulvestrant to work, it needs to bind to and block the estrogen receptor (ER) • Not everyone treated with fulvestrant achieves the desired result – a substantial number of women with advanced HR+ breast cancer receiving standard treatment experience early disease progression • Currently, low ER inhibition is an important factor resulting in suboptimal treatment, which may lead to faster progression of the disease • Our research suggests Eagle’s product could substantially improve the clinical outcomes for these post - menopausal metastatic breast cancer patients 21 EA - 114: Our Fulvestrant Product Candidate for HR+/HER2 - Advanced Breast Cancer 1. Keen JC, Davidson NE. The biology of breast carcinoma. Cancer 2003;97:825 – 33. DOI: 10.1002/cncr.11126 2. Zhao H, et al. Inci dence and prognostic factors of patients with synchronous liver metastases upon initial diagnosis of breast cancer: a population - based study. Dove Pr ess. 27 September 2018. DOI https://doi.org/10.2147/CMAR.S178395. 3. Howlader N, et al (eds). SEER Cancer Statistics Review, 1975 - 2016, National Cancer Institute, Bethesda, MD, https://seer.cancer. gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER website, April 2 019 .
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Fulvestrant competitively inhibits estrogen - stimulated cell division by binding to the estrogen receptor 22
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. EA - 114 (Fulvestrant) Research Progress 1 23 Clinical trial in 600 healthy, post - menopausal (PM) women Met with FDA twice to propose study design for Eagle’s proprietary new delivery platform informed by clinical trial results FDA accepted Eagle’s proposal; Eagle began pilot study in healthy PM women Next steps are to meet with FDA in late October to finalize clinical trial plans Received additional positive data from pilot study for the Company’s fulvestrant product candidate, EA - 114, for HR+/HER2 - advanced breast cancer 2018 2019 December 2019 August 2020 Next Steps 1. As of the date of this presentation
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Collaboration with Tyme Technologies for Cancer Metabolism - Based Compound for Pancreatic Cancer, Currently in Late - Stage Trials • Tyme is a biotechnology company focused on exploring novel therapeutic approaches designed to target cancer’s unique metabolism • Tyme is advancing proprietary Cancer Metabolism - Based Therapies (CMBTs™) for difficult - to - treat cancers • SM - 88 is a novel investigational agent in two Phase II/III studies for pancreatic cancer, one phase II trial in sarcoma and recently completed a Phase II study for prostate cancer • SM - 88 has demonstrated encouraging tumor responses in 15 different cancer types 24 SM - 88
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Oral SM - 88 Represents Novel Therapeutic Approach • Designed to selectively disrupt protein synthesis in cancer cells with demonstrated tumor responses in 15 cancer types across multiple studies • Tyme - 88 - PANC pivotal trial launched in January 2020 to evaluate oral SM - 88 for third - line treatment of patients with metastatic pancreatic cancer • In a Phase II study of patients with actively progressing metastatic pancreatic cancer who had failed previous therapy, evaluable patients on SM - 88 demonstrated median overall survival of 6.4 months as of April 25, 2019 • SM - 88 was well tolerated with 2% of patients reporting a grade 3/4 serious adverse event across trials • Patients who achieved stable disease or better demonstrated a statistically significant (p value =0.02) improvement in survival with a 92% reduction in risk of death 25
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Brain/Glioma Nasal • Eagle and Tyme have entered into a share purchase agreement (SPA) and a co - promotion agreement for SM - 88 in the U.S. Eagle paid an initial $20 million up front • In addition, Eagle may invest an additional $20 million in Tyme upon achievement of certain milestones, $10 million of which would be an additional purchase of equity in Tyme. Eagle has certain promotion rights to all indications for SM - 88 in the U.S. Tyme retains all commercial rights to SM - 88 outside the U.S. and may buy out Eagle’s U.S. rights under the co - promotion agreement at any time for $200 million • Under the co - promotion agreement, Tyme will be responsible for all development, regulatory, manufacturing and marketing costs associated with SM - 88, as well as 75% of the promotional effort. Eagle will be responsible for 25% of the promotional effort and shall receive 15% of all net sales in the U.S. 26 PROGRAM FORMULATION CANCER INDICATION DEVELOPMENT STAGE PHASE I PHASE II PHASE II/III Pancreatic: 3 rd Line Monotherapy Pancreatic: 2 nd Line Monotherapy Sarcoma Monotherapy Tyme - 88 - PANC Pivotal Part 2: Enrolling Enrollment Completed Initiated in Q2 - 19 Precision Promise: Phase II enrolling Precision Promise: Phase II enrolling Oral SM - 88 Injectable SM - 88i Brain/Glioma SM - 88 Data from Pivotal Trial Expected in 2021
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Highly successful franchise BENDEKA royalty increase: from 25% to 30% on 10/1/19 and then increases by 1 percentage point on each anniversary thereafter until it reaches 32% Courts upheld patent infringement claims as valid; defendants enjoined from launching ANDA products before 2031 Appellate Court confirmed ODE for BENDEKA through 12/7/2022 Established royalty revenue beyond 2025 Long - term cash flow stream 15 Orange Book listed patents through 2031 and unique J - code FDA’s petition for re - hearing en banc of Appellate ODE decision denied, confirming bendamustine franchise exclusivity through December 2022 Reached settlement agreement with Lilly on 12/13/2019 Approval granted on February 10, 2020; a llows for initial entry of PEMFEXY – a liquid formulation – of approximately three - week supply of current ALIMTA® utilization on Feb. 1, 2022, and a subsequent uncapped entry on April 1, 2022 ALIMTA® U.S. LTM sales as of June 30, 2020 were $1.2 billion 1 Generic entrants blocked until 05/24/22 CMS established unique J - Code; FDA granted supplement approval for 500mg multiple - dose vial SymBio TREAKISYM, Japanese licensing partner SymBio received approval of TREAKISYM Ready - To - Dilute (“RTD”) formulation on 9/23, triggering $5mm milestone payment to Eagle Launch of RTD formulation expected in January 2021 Royalties and milestones of $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its RI product Oncology Assets: Building From Our Successes 27 Anticipating three new product launches in 2022 (PEMFEXY, EA - 114, & SM - 88) 27 1 Eli Lily 6/30/20 Earnings Report
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Multiple Near - Term Value Inflection Points • 10 key initiatives underway with the potential for 5 product launches over the next 3 years • Each has the potential to be either first - in - class, first - to - market, or best - in - class • Seven CNS/metabolic critical care products (TBI/concussion, ARS, NA, Alzheimer’s, anti - viral, EA - 111, vasopressin) • Three oncology products (pancreatic cancer, advanced breast cancer, and lung cancer) • BENDEKA: ODE affirmed/ en banc petition denied; patent infringement claims upheld against ANDA holders • All focus on underserved therapeutic areas • Complementary scientific and research partnerships/collaborations • U.S. Military (nerve agent exposure) • NorthShore University HealthSystem (TBI/concussion) • University of Pennsylvania (Alzheimer’s disease) • Comprehensive IP portfolio to ensure future growth • Robust growth plan includes organic development and strategic transactions Profitable with a robust balance sheet, no net debt, and ample capital for strategic transactions 28
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Appendix 29
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Reconciliation of GAAP to Adjusted Non - GAAP Net Income and Adjusted Non - GAAP EPS (unaudited) EXPLANATION OF ADJUSTMENTS: 1) Amortization of intangible assets for RYANODEX and Docetaxel 2) Amortization of intangible assets for Eagle Biologics 3) Gain on divestiture of diclofenac - misoprostol 4) Changes in the fair value of contingent consideration (Docetaxel and Eagle Biologics) 5) Reflects the estimated tax effect of the pretax adjustments, $3.4 million of tax expense from U.S. tax reform, which is reflected in 2017 and the reversal of a tax valuation allowance in 2016 30 (In thousands, except share and per share amounts) 2019 2018 2017 2016 2015 $ 14,313 $ 31,903 $ 51,943 $ 81,453 $ 2,571 Amortization of acquired intangible assets (1) 900 895 1,194 746 - Share-based compensation expense 4,442 4,014 3,942 2,914 1,271 Depreciation 286 470 74 - - Expense of acquired in-process research & development 500 1,700 1,000 - - Severance 455 466 - - - Share-based compensation expense 17,556 15,068 11,487 6,853 2,780 Amortization of acquired intangible assets (2) 1,620 1,620 1,620 203 - Depreciation 686 685 858 640 112 Debt issuance costs 88 - 286 - - Severance - - 268 - - Gain on sale of asset (3) - - - (1,750) - Non-cash interest expense 480 376 238 8 - Change in fair value of contingent consideration (4) - (763) (7,378) 957 - Asset impairment charge - 2,704 7,235 - - Restructuring charge - 7,911 - - - Legal settlement - - 1,650 - - (4,433) (7,894) (5,368) (46,103) - $ 36,893 $ 59,155 $ 69,049 $ 45,921 $ 6,734 $ 2.68 $ 4.01 $ 4.57 $ 2.96 $ 0.44 $ 2.61 $ 3.87 $ 4.34 $ 2.79 $ 0.41 13,754,516 14,768,625 15,102,890 15,533,681 15,250,154 14,138,733 15,278,651 15,908,211 16,434,104 16,253,781 Adjusted Non-GAAP earnings per share Basic Diluted Weighted number of common shares outstanding: Basic Diluted Cost of product revenues: Research and development: Selling, general and administrative: Other: Tax effect of the Non-GAAP adjustments (5) Adjusted Non-GAAP Net income Twelve Months Ended December 31, Net income - GAAP Adjustments:
CONFIDENTIAL © 2020 Eagle Pharmaceuticals, Inc. All rights reserved. Reconciliation of GAAP to Adjusted Non - GAAP EBITDA (unaudited) 31 Twelve Months Ended June 30, Twelve Months Ended December 31, (in thousands) 2020 2019 2018 2017 2016 2015 Net income - GAAP $ (4,512) $ 14,313 $ 31,903 $ 51,943 $ 81,453 $ 2,571 Add back: Interest expense (income), net 1,476 517 2,579 1,045 (76) (14) Income tax provision 7,693 7,685 2,135 21,002 (28,026) 3 Depreciation and amortization 3,542 3,492 3,670 3,746 1,589 112 Stock - based compensation 24,547 21,998 19,082 15,429 9,768 4,051 Change in fair value of contingent consideration - - (763) (7,378) 957 - Debt issuance costs 88 88 - 286 - - Fair value adjustments on equity investment 4,200 - - - - - Asset impairment charge - - 2,704 7,235 - - Gain on sale of asset - - - - (1,750) - Expense of acquired in - process research & development 500 500 1,700 1,000 - - Expense related to collaboration with Tyme 2,500 Severance 700 455 466 268 - - Restructuring charge - - 7,911 - - - Legal settlement - - - 1,650 - - Adjusted Non - GAAP EBITDA $40,734 $49,048 $71,387 $96,226 $63,915 $6,723