EGRX Eagle Pharmaceuticals Inc.

39.83
+0.48  (+1%)
Previous Close 39.35
Open 39.66
52 Week Low 33.8
52 Week High 64.94
Market Cap $541,965,655
Shares 13,606,971
Float 8,557,797
Enterprise Value $470,761,654
Volume 514,116
Av. Daily Volume 172,750
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Upcoming Catalysts

Drug Stage Catalyst Date
Ryanodex
Nerve agent (NA) exposure
sNDA Filing
sNDA Filing
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Drug Pipeline

Drug Stage Notes
Ryanodex
Exertional heat stroke (EHS)
CRL
CRL
CRL announced August 10, 2020.
Fulvestrant
Breast cancer
Phase 3
Phase 3
Pivotal trial planned for 2020.
KANGIO (bivalirudin injection)
Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)
CRL
CRL
CRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product
Docetaxel Injection
Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer
Approved
Approved
Approved December 24, 2015.
Ryanodex
Malignant hyperthermia - cancer
Approved
Approved
Approved July 22, 2014 under priority review.
EP-3101 (bendamustine RTD)
Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma - cancer
Approved
Approved
Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively.
PEMFEXY,
Nonsquamous Non-Small Cell Lung Cancer (NSCLC) and Mesothelioma
Approved
Approved
Tentative approval announced October 27, 2017. Full approval pending patent litigation with Eli Lilly.

Latest News

  1. Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at two upcoming conferences in September.

    At the Morgan Stanley 18th Annual Virtual Global Healthcare Conference:

    Date:

    Monday, September 14, 2020

    Time:

    3:00 p.m. Eastern Time

    Webcast: https://morganstanley.webcasts.com/starthere.jsp?ei=1362588&tp_key=91c8ad632b

    At the Cantor Virtual Global Healthcare Conference:

    Date:

    Tuesday, September 15, 2020

    Time:

    10:00 a.m. Eastern Time

    Webcast: https://www.webcaster4.com/Webcast/Page/2495/37184

    The presentations will be webcast live at the aforementioned times, and archived for 30 days…

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at two upcoming conferences in September.

    At the Morgan Stanley 18th Annual Virtual Global Healthcare Conference:

    Date:

    Monday, September 14, 2020

    Time:

    3:00 p.m. Eastern Time

    Webcast: https://morganstanley.webcasts.com/starthere.jsp?ei=1362588&tp_key=91c8ad632b

    At the Cantor Virtual Global Healthcare Conference:

    Date:

    Tuesday, September 15, 2020

    Time:

    10:00 a.m. Eastern Time

    Webcast: https://www.webcaster4.com/Webcast/Page/2495/37184

    The presentations will be webcast live at the aforementioned times, and archived for 30 days thereafter, via the Company's website at www.eagleus.com, under the Investors + News Section.

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

    View Full Article Hide Full Article
  2. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that preclinical research on dantrolene sodium was published today in the peer-reviewed Journal of Alzheimer's Disease.1 The article reported results from an academic-based study that demonstrated dantrolene sodium administered intranasally improved both memory and cognition in a mouse model of Alzheimer's disease. Eagle markets a formulation of dantrolene sodium but did not sponsor the study.

    The study evaluated plasma and brain dantrolene concentrations, effectiveness, and safety when dantrolene sodium was given in doses of five milligrams per kilogram three times a week either intranasally or as a subcutaneous injection. The study also compared dosing…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that preclinical research on dantrolene sodium was published today in the peer-reviewed Journal of Alzheimer's Disease.1 The article reported results from an academic-based study that demonstrated dantrolene sodium administered intranasally improved both memory and cognition in a mouse model of Alzheimer's disease. Eagle markets a formulation of dantrolene sodium but did not sponsor the study.

    The study evaluated plasma and brain dantrolene concentrations, effectiveness, and safety when dantrolene sodium was given in doses of five milligrams per kilogram three times a week either intranasally or as a subcutaneous injection. The study also compared dosing when started early, before Alzheimer's disease symptoms develop, versus later, after onset of Alzheimer's disease symptoms. Intranasal and subcutaneous dantrolene sodium administration each significantly improved hippocampal-dependent and -independent memory in the early treatment group, but only intranasal dantrolene improved cognition in the late treatment group.

    1. Shi Y, Zhang L, Gao X, et al. Intranasal Dantrolene as a Disease-Modifying Drug in Alzheimer 5XFAD Mice [published online ahead of print, 2020 Jun 27]. J Alzheimers Dis. 2020;10.3233/JAD-200227. doi:10.3233/JAD-200227.

    About Alzheimer's disease

    About 50 million people have dementia globally, of whom 60 to 70 percent have Alzheimer's disease, according to the World Health Organization. In the US, 5.8 million people are living with Alzheimer's, which has no cure and is the sixth leading cause of death.

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

    Forward-Looking Statements

    This press release 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 and phrases such as "anticipated," "forward," "will," "would," "may," "remain," "potential," "prepare," "expected," "believe," "plan," "near future," "belief," "guidance," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including the potential of dantrolene sodium as a treatment for Alzheimer's disease. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle's control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 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 obligation 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 events.

    View Full Article Hide Full Article
  3. -- Q2 2020 net loss was ($0.02) per basic and diluted share and adjusted non-GAAP net income was $0.59 per basic and $0.57 per diluted share --

    -- Anticipate launch of vasopressin, maintaining our 180-day market exclusivity --

    -- 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-positive advanced breast cancer --

    -- Received a Complete Response Letter for NDA for RYANODEX for EHS --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three and six months ended June 30, 2020.

    Business and Recent

    -- Q2 2020 net loss was ($0.02) per basic and diluted share and adjusted non-GAAP net income was $0.59 per basic and $0.57 per diluted share --

    -- Anticipate launch of vasopressin, maintaining our 180-day market exclusivity --

    -- 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-positive advanced breast cancer --

    -- Received a Complete Response Letter for NDA for RYANODEX for EHS --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three and six months ended June 30, 2020.

    Business and Recent Highlights:

    • Centers for Medicare & Medicaid Services ("CMS") established unique Healthcare Common Procedure Coding System ("HCPCS") code, or J-code, for PEMFEXY™ (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA® effective October 1, 2020;
    • Granted a supplement approval by U.S. Food and Drug Administration ("FDA") for 500mg multiple-dose vial of PEMFEXY. The Company has initial market entry (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022;
    • The Company's strategic collaboration partner, Tyme Technologies, Inc. ("Tyme"), announced that FDA granted Orphan Drug Designation for its lead product candidate, SM-88, a treatment for patients with pancreatic cancer;
    • On August 7, 2020, the Company received a Complete Response Letter for its New Drug Application ("NDA") for RYANODEX® for the treatment of exertional heat stroke ("EHS"); Eagle has decided that it will no longer pursue this indication;
    • Received encouraging recent additional data for the Company's fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer; next steps are to meet with FDA to finalize clinical trial plans; product could potentially represent cornerstone of Eagle's oncology franchise treating HR positive breast cancer patients;
    • Favorable patent litigation decision issued by the U.S. District Court for the District of Delaware for Eagle and Teva Pharmaceutical Industries Ltd. for BENDEKA® upholding the asserted patent claims as valid and infringed by the defendants' proposed Abbreviated New Drug Application ("ANDA") products. Under this decision, defendants are enjoined from launching their ANDA products before 2031;
    • SymBio, the Company's Japanese licensing partner, announced that it expects regulatory approval of its TREAKISYM Ready-to-Dilute ("RTD") formulation late this year. Eagle is entitled to receive a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute or TREAKISYM Rapid Infusion, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its Rapid Infusion product; and
    • Despite the ongoing COVID-19 pandemic, the Company has not experienced significant disruptions to its supply chain to date, and believes it has sufficient supply chain inventory to continue manufacturing and to provide product without interruption consistent with its current business plan; the Company has experienced limited impacts on the timing of its pre-clinical programs due to the COVID-19 pandemic; the Company continues to monitor the ongoing pandemic and evaluate and evolve its business plans and response strategy thereto.

    Second Quarter 2020 Financial Highlights

    • Total revenue for Q2 2020 was $41.9 million, compared to $56.7 million in Q2 2019, primarily reflecting lower product sales of BELRAPZO® and BENDEKA, partially offset by higher product sales of RYANODEX.
    • Net loss for Q2 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income for Q2 2019 of $6.7 million, or $0.49 per basic and $0.48 per diluted share.
    • Adjusted non-GAAP net income for Q2 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income for Q2 2019 of $11.8 million, or $0.86 per basic and $0.84 per diluted share.
    • Cash and cash equivalents were $108.2 million, net accounts receivable was $46.8 million, and debt was $37.0 million as of June 30, 2020.

    "We had an excellent start to the first half of the year, advancing our exciting pipeline of oncology and critical care products. Our ANDA and orphan drug exclusivity legal wins for BENDEKA, CMS' decision to establish a separate J-Code and supplement approval for the 500mg dose for PEMFEXY, along with continued progress on our fulvestrant product candidate and the opportunity for vasopressin, supports the diversification and acceleration of Eagle's earnings power," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    "We're also pleased with our collaborations with Tyme, NorthShore University HealthSystem, and UPenn to advance important products. Furthermore, we have made progress on the study of RYANODEX for the treatment of brain damage secondary to Nerve Agent exposure, as we continue to pursue expanded indications. We have important work ahead in the second half of the year, regardless of EHS, and we will continue to identify opportunities that fulfill our strategic vision and bring innovative therapeutics to the patients who can benefit," concluded Tarriff.

    Second Quarter 2020 Financial Results

    Total revenue for Q2 2020 was $41.9 million, as compared to $56.7 million for Q2 2019.

    Q2 2020 BELRAPZO product sales were $4.1 million, compared to $15.4 million in Q2 2019. Second quarter 2019 BELRAPZO revenue reflected wholesaler stocking occasioned by the June 2019 transition to the branded name.

    Q2 2020 RYANODEX product sales were $4.7 million, compared to $2.9 million in Q2 2019.

    Royalty revenue was $27.6 million in the second quarter of 2020, compared to $27.3 million in the second quarter of 2019. BENDEKA royalties were $27.5 million in the second quarter of 2020, compared to $26.5 million in the second quarter of 2019. A summary of total revenue is outlined below:

     

    Three Months Ended March 31,

     

    2020

     

    2019

     

    (unaudited)

     

    (unaudited)

    Revenue (in thousands):

     

     

     

    Product sales

    $14,376

     

    $29,437

    Royalty revenue

    27,562

     

    27,265

    Total revenue

    $41,938

     

    $56,702

    Gross margin was 69% during the second quarter of 2020, as compared to 62% in the second quarter of 2019. The expansion in gross margin in the second quarter of 2020 was driven by an increase in RYANODEX product sales, lower BENDEKA product sales in the period to the Company's marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

    R&D expense was $7.1 million for the second quarter of 2020, compared to $9.0 million in the second quarter of 2019. The change primarily resulted from a decrease in spending for vasopressin, partly offset by an increase in spending for the Company's fulvestrant product candidate. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the second quarter of 2020 was $6.0 million.

    SG&A expense in the second quarter of 2020 increased to $18.0 million compared to $17.2 million in the second quarter of 2019. The change primarily resulted from an increase in stock compensation expense, partially offset by decreases in T&E, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2020 SG&A expense was $12.2 million.

    Net loss for the second quarter of 2020 was $0.3 million, or ($0.02) per basic and diluted share, compared to net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in the second quarter of 2019.

    Adjusted non-GAAP net income for the second quarter of 2020 was $8.0 million, or $0.59 per basic and $0.57 per diluted share, compared to adjusted non-GAAP net income of $11.8 million or $0.86 per basic and $0.84 per diluted share in the second quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

    2020 Expense Guidance

    • As a result of COVID-related delays, with respect to our pre-clinical programs, we are lowering our previously reported 2020 R&D Non-GAAP expense guidance to $40 million-$44 million, as compared to $31 million in 2019.
    • SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56 million in 2019.

    The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

    Liquidity

    As of June 30, 2020, the Company had $108.2 million in cash and cash equivalents plus $46.8 million in net accounts receivable, $35.7 million of which was due from Teva. The Company had $37.0 million in outstanding debt. Therefore, at June 30, 2020, the Company had net cash plus receivables of $118.0 million. In the second quarter of 2020, the Company repaid the full $110.0 million amount borrowed under its revolving credit facility.

    In the second quarter of 2020, the Company repurchased $4.0 million of Eagle's common stock as part of the share repurchase program. From August 2016 through June 30, 2020, the Company repurchased $176.9 million of its common stock.

    Conference Call

    As previously announced, Eagle management will host its second quarter 2020 conference call as follows:

    Date

    Monday, August 10, 2020

    Time

    8:30 A.M. ET

    Toll free (U.S.)

    877-876-9173

    International

    785-424-1667

    Webcast (live and replay)

    www.eagleus.com, under the "Investor + News" section

    Participants should dial in 15 minutes prior to the start of the call to ensure timely access.

    A replay of the conference call will be available for one week after the call's completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

    Forward-Looking Statements

    This press release 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 and phrases such as "anticipated," "forward," "will," "would," "may," "remain," "potential," "prepare," "expected," "believe," "plan," "near future," "belief," "guidance," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events such as: the Company's expectations regarding the current and anticipated impact of the ongoing COVID-19 pandemic on the Company's business and operations, including sales, marketing, manufacturing and supply chain interruptions; the number and timing of potential product launches, development initiatives and new indications for RYANODEX, including for the treatment of brain damage secondary to Nerve Agent exposure; 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 timing of the Company's PEMFEXY and vasopressin launches, if ever; the period of market exclusivity for vasopressin; the success of the Company's collaborations with its strategic partners; the Company's expense guidance for fiscal year 2020; the Company's expectations with respect to earnings power, including statements regarding the Company's ability to diversify and accelerate earnings power; the Company's ability to deliver value in 2020 and over the long term; 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 information and statements. Such risks and uncertainties include, but are not limited to: the impacts of the ongoing COVID-19 pandemic, including disruption or impact in the sales of the Company's marketed products, interruptions or other adverse effects to clinical trials, delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare 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 Company'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 continued spread of COVID-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; 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; whether the Company can successfully market and commercialize its product candidates, including RYANODEX, BENDEKA and BELRAPZO; the success of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme and NorthShore University HealthSystem and the parties' ability to work effectively together; the availability and pricing of third party sourced products and materials; 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 governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including the potential adverse effects 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 Company's intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from generic 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 Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 2, 2020 and its other subsequent filings with the Securities and Exchange Commission. 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 obligation 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 events.

    Non-GAAP Financial Performance Measures

    In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non-GAAP net 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, severance, non-cash interest expense, expense related 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 the Company not to be reflective of the Company's ongoing results. See the attached 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 prepared 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.

    -- Financial tables follow --

     
    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
    (In thousands, except share amounts)
     
     
    June 30, 2020 December 31, 2019
    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    108,213

     

    $

    109,775

     

    Accounts receivable, net

     

    46,781

     

     

    48,004

     

    Inventories

     

    7,891

     

     

    6,566

     

    Prepaid expenses and other current assets

     

    5,551

     

     

    15,104

     

    Total current assets

     

    168,436

     

     

    179,449

     

    Property and equipment, net

     

    2,118

     

     

    2,202

     

    Intangible assets, net

     

    14,250

     

     

    15,583

     

    Goodwill

     

    39,743

     

     

    39,743

     

    Deferred tax asset, net

     

    14,585

     

     

    13,669

     

    Other assets

     

    17,578

     

     

    3,908

     

    Total assets

    $

    256,710

     

    $

    254,554

     

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    13,708

     

    $

    5,462

     

    Accrued expenses and other liabilities

     

    19,778

     

     

    28,361

     

    Current portion of long-term debt

     

    7,000

     

     

    5,000

     

    Total current liabilities

     

    40,486

     

     

    38,823

     

    Other long-term liabilities

     

    3,361

     

     

    3,000

     

    Long-term debt, less current portion

     

    28,899

     

     

    33,557

     

    Total liabilities

     

    72,746

     

     

    75,380

     

    Commitments and Contingencies
    Stockholders' equity:
    Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of June 30, 2020 and December 31, 2019

     

     

     

     

    Common stock, $0.001 par value; 50,000,000 shares authorized; 16,621,681 and 16,537,846 shares issued as of June 30, 2020 and December 31, 2019, respectively

     

    17

     

     

    17

     

    Additional paid in capital

     

    291,434

     

     

    278,518

     

    Retained earnings

     

    69,373

     

     

    72,500

     

    Treasury stock, at cost, 3,017,710 and 2,907,687 shares as of June 30, 2020 and December 31, 2019, respectively

     

    (176,860

    )

     

    (171,861

    )

    Total stockholders' equity

     

    183,964

     

     

    179,174

     

    Total liabilities and stockholders' equity

    $

    256,710

     

    $

    254,554

     

     
    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
    (In thousands, except share and per share amounts)
     
     
    Three Months Ended June 30, Six Months Ended June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:
    Product sales

    $

    14,376

     

    $

    29,437

     

    $

    32,070

     

    $

    43,909

     

    Royalty revenue

     

    27,562

     

     

    27,265

     

     

    55,888

     

     

    53,578

     

    License and other revenue

     

     

     

     

     

     

     

    9,000

     

    Total revenue

     

    41,938

     

     

    56,702

     

     

    87,958

     

     

    106,487

     

    Operating expenses:
    Cost of product sales

     

    10,313

     

     

    18,175

     

     

    15,078

     

     

    27,729

     

    Cost of royalty revenue

     

    2,822

     

     

    3,109

     

     

    5,860

     

     

    6,655

     

    Research and development

     

    7,135

     

     

    8,957

     

     

    16,562

     

     

    15,332

     

    Selling, general and administrative

     

    17,959

     

     

    17,228

     

     

    42,714

     

     

    35,369

     

    Total operating expenses

     

    38,229

     

     

    47,469

     

     

    80,214

     

     

    85,085

     

    Income from operations

     

    3,709

     

     

    9,233

     

     

    7,744

     

     

    21,402

     

    Interest income

     

    150

     

     

    637

     

     

    496

     

     

    1,131

     

    Interest expense

     

    (786

    )

     

    (665

    )

     

    (1,675

    )

     

    (1,351

    )

    Other income (expense)

     

    2,300

     

     

     

     

    (4,200

    )

     

     

    Total other income (expense), net

     

    1,664

     

     

    (28

    )

     

    (5,379

    )

     

    (220

    )

    Income before income tax provision

     

    5,373

     

     

    9,205

     

     

    2,365

     

     

    21,182

     

    Income tax provision

     

    (5,629

    )

     

    (2,480

    )

     

    (5,492

    )

     

    (5,484

    )

    Net (Loss) Income

    $

    (256

    )

    $

    6,725

     

    $

    (3,127

    )

    $

    15,698

     

    (Loss) Earnings per share attributable to common stockholders:
    Basic

    $

    (0.02

    )

    $

    0.49

     

    $

    (0.23

    )

    $

    1.13

     

    Diluted

    $

    (0.02

    )

    $

    0.48

     

    $

    (0.23

    )

    $

    1.11

     

    Weighted average number of common shares outstanding:
    Basic

     

    13,664,951

     

     

    13,782,720

     

     

    13,666,279

     

     

    13,853,580

     

    Diluted

     

    13,664,951

     

     

    14,156,627

     

     

    13,666,279

     

     

    14,176,297

     

     
    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
    (In thousands)
     
     
    Six Months Ended June 30,

     

    2020

     

     

    2019

     

    Cash flows from operating activities:
    Net (loss) income

    $

    (3,127

    )

    $

    15,698

     

    Adjustments to reconcile net (loss) income to net cash provided by operating activities:
    Deferred income taxes

     

    (916

    )

     

    (127

    )

    Depreciation expense

     

    931

     

     

    1,005

     

    Amortization expense

     

    1,333

     

     

    1,260

     

    Fair value adjustments on equity investment

     

    4,200

     

     

     

    Stock-based compensation expense

     

    13,713

     

     

    11,164

     

    Amortization of debt issuance costs

     

    183

     

     

    188

     

    Changes in operating assets and liabilities which provided (used) cash:
    Accounts receivable

     

    1,223

     

     

    6,147

     

    Inventories

     

    (1,325

    )

     

    (3,290

    )

    Prepaid expenses and other current assets

     

    9,553

     

     

    4,665

     

    Accounts payable

     

    8,246

     

     

    7,379

     

    Accrued expenses and other liabilities

     

    (8,583

    )

     

    4,880

     

    Other assets and other long-term liabilities, net

     

    (1,321

    )

     

    (396

    )

    Net cash provided by operating activities

     

    24,110

     

     

    48,573

     

    Cash flows from investing activities:
    Purchase of equity investment security

     

    (17,500

    )

     

     

    Purchase of property and equipment

     

    (376

    )

     

    (343

    )

    Net cash used in investing activities

     

    (17,876

    )

     

    (343

    )

    Cash flows from financing activities:
    Proceeds from common stock option exercises

     

    513

     

     

    55

     

    Employee withholding taxes related to stock-based awards

     

    (1,310

    )

     

    (198

    )

    Proceeds from existing revolving credit facility

     

    110,000

     

     

     

    Repayment of existing revolving credit facility

     

    (110,000

    )

     

     

    Payment of debt

     

    (2,000

    )

     

    (3,750

    )

    Repurchases of common stock

     

    (4,999

    )

     

    (15,000

    )

    Net cash used in financing activities

     

    (7,796

    )

     

    (18,893

    )

    Net (decrease) increase in cash and cash equivalents

     

    (1,562

    )

     

    29,337

     

    Cash and cash equivalents at beginning of period

     

    109,775

     

     

    78,791

     

    Cash and cash equivalents at end of period

    $

    108,213

     

    $

    108,128

     

    Supplemental disclosures of cash flow information:
    Cash paid during the period for:
    Income taxes, net

    $

    502

     

    $

    2,874

     

    Interest

     

    1,458

     

     

    1,221

     

    Right-of-use asset obtained in exchange for lease obligation - lease amendment

     

    842

     

     

    2,871

     

     
    EAGLE PHARMACEUTICALS, INC.
    RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND
    ADJUSTED NON-GAAP EARNINGS PER SHARE (UNAUDITED)
    (In thousands, except share and per share amounts)
     
     
    Three Months Ended June 30, Six Months Ended June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Net (loss) income - GAAP

    $

    (256

    )

    $

    6,725

     

    $

    (3,127

    )

    $

    15,698

     

     
    Adjustments:
    Cost of product revenues:
    Amortization expense

     

    262

     

     

    225

     

     

    523

     

     

    450

     

    Research and development:
    Stock-based compensation expense

     

    1,034

     

     

    1,096

     

     

    2,584

     

     

    2,239

     

    Depreciation expense

     

    60

     

     

    70

     

     

    134

     

     

    139

     

    Selling, general and administrative:
    Stock-based compensation expense

     

    5,207

     

     

    4,286

     

     

    11,129

     

     

    8,925

     

    Expense related to collaboration with Tyme

     

    -

     

     

    -

     

     

    2,500

     

     

    -

     

    Amortization expense

     

    405

     

     

    405

     

     

    810

     

     

    810

     

    Depreciation expense

     

    149

     

     

    172

     

     

    326

     

     

    344

     

    Severance

     

    -

     

     

    -

     

     

    245

     

     

    -

     

     
    Other:
    Non-cash interest expense

     

    118

     

     

    94

     

     

    236

     

     

    188

     

    Fair value adjustments on equity investment

     

    (2,300

    )

     

    -

     

     

    4,200

     

     

    -

     

    Tax effect of the non-GAAP adjustments

     

    3,344

     

     

    (1,228

    )

     

    (3,457

    )

     

    (2,319

    )

     
    Adjusted non-GAAP net income

    $

    8,023

     

    $

    11,845

     

    $

    16,103

     

    $

    26,474

     

     
    Adjusted non-GAAP earnings per share:
    Basic

    $

    0.59

     

    $

    0.86

     

    $

    1.18

     

    $

    1.91

     

    Diluted

    $

    0.57

     

    $

    0.84

     

    $

    1.15

     

    $

    1.87

     

    Weighted number of common shares outstanding:
    Basic

     

    13,664,951

     

     

    13,782,720

     

     

    13,666,279

     

     

    13,853,580

     

    Diluted

     

    13,971,725

     

     

    14,156,627

     

     

    13,983,093

     

     

    14,176,297

     

     
    EAGLE PHARMACEUTICALS, INC.
    RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED)
    (In thousands)
     
     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

    Twelve Months Ended June 30,

     

    Twelve Months Ended December 31,

    2020

     

    2019

     

    2020

     

    2019

     

    2020

     

    2019

     
    Net (loss) income - GAAP

    $

    (256

    )

    $

    6,725

    $

    (3,127

    )

    $

    15,698

    $

    (4,512

    )

    $

    14,313

     
    Add back:
    Interest expense, net of interest income

     

    636

     

     

    28

     

    1,179

     

     

    220

     

    1,476

     

     

    517

    Income tax provision

     

    5,629

     

     

    2,480

     

    5,492

     

     

    5,484

     

    7,693

     

     

    7,685

    Depreciation and amortization expense

     

    876

     

     

    872

     

    1,793

     

     

    1,743

     

    3,542

     

     

    3,492

     
    Add back:
    Stock-based compensation expense

     

    6,241

     

     

    5,382

     

    13,713

     

     

    11,164

     

    24,547

     

     

    21,998

    Debt issuance cost

     

    -

     

     

    -

     

    -

     

     

    -

     

    88

     

     

    88

    Fair value adjustments on equity investment

     

    (2,300

    )

     

    -

     

    4,200

     

     

    -

     

    4,200

     

     

    -

    Expense of acquired in-process research & development

     

    -

     

     

    -

     

    -

     

     

    -

     

    500

     

     

    500

    Expense related to collaboration with Tyme

     

    -

     

     

    -

     

    2,500

     

     

    -

     

    2,500

     

     

    -

    Severance

     

    -

     

     

    -

     

    245

     

     

    -

     

    700

     

     

    455

    Adjusted Non-GAAP EBITDA

    $

    10,826

     

    $

    15,487

    $

    25,995

     

    $

    34,309

    $

    40,734

     

    $

    49,048

     

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  4. Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens.

    Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date

    Monday, August 10, 2020

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    877-876-9173

    International

    785-424-1667

    Webcast (live and replay)

    www.eagleus.com, under the "Investor Relations" section

    A replay of the conference call will be available for one week after the call's completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering…

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens.

    Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date

    Monday, August 10, 2020

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    877-876-9173

    International

    785-424-1667

    Webcast (live and replay)

    www.eagleus.com, under the "Investor Relations" section

    A replay of the conference call will be available for one week after the call's completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

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  5. -- Exclusive launch February 1, 2022 --

    -- Approval for 500mg multiple-dose vial from U.S. Food and Drug Administration (FDA) granted June 18, 2020 --

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code for PEMFEXY™ (pemetrexed for injection). This new Healthcare Common Procedure Coding System (HCPCS) code, or J-code, is J9304 (Injection, pemetrexed (PEMFEXY), 10 mg). The J-code will become effective on October 1, 2020.

    The new HCPCS code provides coding clarity to outpatient facilities and physicians who will administer PEMFEXY, facilitating access for patients and reimbursement from Medicare…

    -- Exclusive launch February 1, 2022 --

    -- Approval for 500mg multiple-dose vial from U.S. Food and Drug Administration (FDA) granted June 18, 2020 --

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code for PEMFEXY™ (pemetrexed for injection). This new Healthcare Common Procedure Coding System (HCPCS) code, or J-code, is J9304 (Injection, pemetrexed (PEMFEXY), 10 mg). The J-code will become effective on October 1, 2020.

    The new HCPCS code provides coding clarity to outpatient facilities and physicians who will administer PEMFEXY, facilitating access for patients and reimbursement from Medicare, Medicaid and commercial insurance.

    In February 2020, Eagle received final approval of its New Drug Application (NDA) from FDA for PEMFEXY™, a branded alternative to ALIMTA®, following settlement of patent litigation with Eli Lilly and Company. The Company is entitled to initial market entry (equivalent to approximately a three-week supply of current ALIMTA® utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

    The Company also received a supplement approval from FDA for a 500mg multiple-dose vial of PEMFEXY on June 18, 2020.

    About PEMFEXY

    PEMFEXY™ is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include RYANODEX®, BENDEKA®, BELRAPZO®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle's website at www.eagleus.com.

    Eagle's Forward-Looking Statements

    This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the timeline for effectiveness of the Company's J-code for PEMFEXY; the timing of the Company's PEMFEXY launch, if ever; and the ability of the J-code for PEMFEXY to facilitate access for patients and insurers. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect the Company's business, particularly those identified in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 2, 2020 and its other subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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