EGRX Eagle Pharmaceuticals Inc.

41.77
-0.08  -0%
Previous Close 41.85
Open 41.39
52 Week Low 36.48
52 Week High 55.43
Market Cap $547,578,260
Shares 13,109,367
Float 7,866,782
Enterprise Value $479,463,008
Volume 41,643
Av. Daily Volume 109,103
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Drug Pipeline

Drug Stage Notes
Ryanodex
Nerve agent (NA) exposure
sNDA Filing
sNDA Filing
sNDA filing planned.
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. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will present at the 2021 RBC Capital Markets Global Healthcare Conference as follows:

    Date:

    Tuesday, May 18, 2021

    Time:

    1:20 p.m. Eastern Time

    Webcast:

    https://event.on24.com/wcc/r/3173733/CEA9B803E5C77274A4417D4FE2A0EAB0

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

    About Eagle Pharmaceuticals, Inc.

    Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will present at the 2021 RBC Capital Markets Global Healthcare Conference as follows:

    Date:

    Tuesday, May 18, 2021

    Time:

    1:20 p.m. Eastern Time

    Webcast:

    https://event.on24.com/wcc/r/3173733/CEA9B803E5C77274A4417D4FE2A0EAB0

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.eagleus.com, under the Investors 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. Q1 2021 net loss was $0.03 per basic and diluted share and adjusted non-GAAP net income was $0.24 per basic and diluted share

    Anticipate vasopressin approval and launch this year; completed last required study; expect to respond to vasopressin Complete Response Letter ("CRL") in full by mid-year

    Expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) Ready-to-Dilute ("RTD") and Rapid Infusion ("RI") formulations

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three months ended March 31, 2021.

    Business and Recent Highlights:

    • Completed the last study required by FDA for the Company's vasopressin product and expect…

    Q1 2021 net loss was $0.03 per basic and diluted share and adjusted non-GAAP net income was $0.24 per basic and diluted share

    Anticipate vasopressin approval and launch this year; completed last required study; expect to respond to vasopressin Complete Response Letter ("CRL") in full by mid-year

    Expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) Ready-to-Dilute ("RTD") and Rapid Infusion ("RI") formulations

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three months ended March 31, 2021.

    Business and Recent Highlights:

    • Completed the last study required by FDA for the Company's vasopressin product and expect to have the results shortly. Eagle plans to respond to the CRL issued for its first-to-file Abbreviated New Drug Applicable ("ANDA") for vasopressin in full by mid-year. The Company's patent trial against Endo Par Innovation Company, LLC was postponed and is now scheduled to begin on July 7, 2021. The Company believes it will have first-to-file 180 day exclusivity for vasopressin;
    • Approval of TREAKISYM (bendamustine) RTD formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") received from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. This represents a meaningful extension of Eagle's bendamustine franchise and is expected to significantly increase the market opportunity;
    • Filing of TREAKISYM RI (50ml) liquid formulation with the PMDA in Japan. Eagle expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) RTD and RI formulations;
    • Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and
    • In active discussions for several promising in-licensing and acquisition candidates that the Company believes will strengthen its portfolio and pipeline going forward.

    Financial Highlights

    First Quarter 2021

    Total revenue for Q1 2021 was $41.2 million, compared to $46.0 million in Q1 2020, primarily reflecting decreased product sales of RYANODEX® and royalty revenue of BENDEKA®.

    • Q1 2021 net loss was $0.4 million, or $0.03 per basic and diluted share, compared to net loss of $2.9 million, or $0.21 per basic and diluted share in Q1 2020.
    • Q1 2021 adjusted non-GAAP net income was $3.2 million, or $0.24 per basic and diluted share, compared to adjusted non-GAAP net income of $11.7 million, or $0.86 per basic and $0.84 per diluted share, in Q1 2020.
    • Cash and cash equivalents were $105.2 million, net accounts receivable was $44.9 million, and debt was $32.0 million as of March 31, 2021.

    "Vasopressin is tracking as expected. The trial is now less than two months away and we have now completed the last study required to submit our response to the CRL to the FDA. Our expectation remains that we will receive final approval in time to bring the product to market this year. We believe we also have an outstanding and large opportunity with TREAKISYM in Japan representing another extension of our bendamustine franchise. Equally important and exciting is the PEMFEXY launch early next year, which gives us four months of initial exclusivity," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    "We are now in late-stage diligence for several in-licensing opportunities that would leverage our capabilities, meet our criteria and broaden our portfolio and pipeline. We will aim to finalize a few such transactions that have the potential to bolster our earnings both in the short and longer term," concluded Tarriff.

    First Quarter 2021 Financial Results

    Total revenue for the three months ended March 31, 2021 was $41.2 million, as compared to $46.0 million for the three months ended March 31, 2020.

    Q1 2021 BELRAPZO® product sales were $5.7 million, compared to $4.6 million in Q1 2020.

    Q1 2021 RYANODEX product sales were $6.8 million, compared to $11.4 million in Q1 2020.

    Royalty revenue was $24.1 million in the first quarter of 2021, compared to $28.3 million in the first quarter of 2020. BENDEKA royalties were $23.8 million in the first quarter of 2021, compared to $28.0 million in the first quarter of 2020. A summary of total revenue is outlined below:

     

    Three Months Ended March 31,

     

    2021

     

    2020

     

    (unaudited)

     

    (unaudited)

    Revenue (in thousands):

     

     

     

    Product sales, net

    $17,120

     

    $17,694

    Royalty revenue

    24,129

     

    28,326

    Total revenue

    $41,249

     

    $46,020

    Gross Margin was 74% during the first quarter of 2021, as compared to 83% in the first quarter of 2020. The compression in gross margin for the first quarter of 2021 was driven by revenue mix including the launch of TREAKISYM product sales to our partner in the first quarter of 2021, on which we earn no profit.

    R&D expense was $14.3 million for the first quarter of 2021, compared to $9.4 million in the first quarter of 2020. The increase is largely attributable to $2.6 million in development costs for vasopressin, a $0.9 million increase in the cost for fulvestrant, and a $0.9 million increase in development costs for RYANODEX related projects. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter of 2021 was $13.1 million.

    SG&A expenses in the first quarter of 2021 totaled $19.9 million compared to $24.8 million in the first quarter of 2020. The decrease is primarily related to the non-recurrence of a $2.5 million charge for the Tyme transaction, and lower marketing, travel, entertainment, and trade show expenses as a result of reduced travel due to the COVID-19 pandemic. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2021 SG&A expense was $13.4 million.

    Net loss for the first quarter of 2021 was $0.4 million, or $0.03 per basic and diluted share, compared to net loss of $2.9 million, or $0.21 per basic and diluted share, in the first quarter of 2020, due to the factors discussed above.

    Adjusted non-GAAP net income for the first quarter of 2021 was $3.2 million, or $0.24 per basic and diluted share, compared to adjusted non-GAAP net income of $11.7 million or $0.86 per basic and $0.84 per diluted share in the first quarter of 2020. 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.

    2021 Expense Guidance

    • R&D spend in 2021, on a non-GAAP basis, is expected to be $26-$30 million, as compared to $27.8 million in 2020.
    • SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020. This represents a reduction from earlier guidance for 2021 SG&A spend of $56-60 million.

    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 March 31, 2021, the Company had $105.2 million in cash and cash equivalents plus $44.9 million in net accounts receivable. The Company had $32.0 million in outstanding debt. Therefore, as of March 31, 2021, the Company had net cash plus receivables of $118.1 million.

    In the first quarter of 2021, the Company purchased $1.4 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through March 31, 2021, the Company has repurchased $208.3 million of its common stock.

    Conference Call

    As previously announced, Eagle management will host its first quarter 2021 conference call as follows:

    Date

     

     

     

     

     

     

     

     

     

     

     

     

    Monday, May 10, 2021

    Time

     

     

     

     

     

     

     

     

     

     

     

     

    8:30 A.M. EDT

    Toll free (U.S.)

     

     

     

     

     

    877-876-9173

    International

     

     

     

     

     

    785-424-1667

    Webcast (live and replay)

     

     

     

     

     

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

    A replay of the conference call will be available for one week after the call's completion by dialing 800-839-6980 (US) or 402-220-6062 (International) and entering conference call ID EGRXQ121. 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 number and timing of potential product launches, development initiatives or new indications for the Company's product candidates; the period of market exclusivity for any of the Company's product candidates; the Company's clinical development plan for the product candidates in its portfolio; the potential benefits and efficacy of RYANODEX, including the potential for RYANODEX as a treatment for additional indications; the ability of the Company's executive team to execute on the Company's strategy and build stockholder value; the timing, scope or likelihood and timing of regulatory filings and approvals from the FDA for the Company's product candidates; 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 results 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; the future commercial success of TREAKISYM RTD and, if approved, TREAKISYM RI, including anticipated royalty and milestone revenue and potential market opportunity; 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 repurchase additional shares of the Company's common stock, if any, under its Share Repurchase Program; the Company's ability to deliver value in 2021 and over the long term; the Company's ability to utilize its cash and other assets to increase shareholder value; the Company's ability to effectively manage and control expenses in line with its budget; 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 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 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 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; the success of the Company's relationships with its partners; 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" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the "SEC") on March 5, 2021, as updated by the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which the Company expects to file with the SEC on May 10, 2021, and its other subsequent filings with the SEC. 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)
     
     
    March 31, 2021 December 31, 2020
    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    105,229

     

    $

    103,155

     

    Accounts receivable, net

     

    44,868

     

     

    50,678

     

    Inventories

     

    6,862

     

     

    8,075

     

    Prepaid expenses and other current assets

     

    7,027

     

     

    4,157

     

    Total current assets

     

    163,986

     

     

    166,065

     

    Property and equipment, net

     

    2,270

     

     

    2,077

     

    Intangible assets, net

     

    12,211

     

     

    12,917

     

    Goodwill

     

    39,743

     

     

    39,743

     

    Deferred tax asset, net

     

    14,278

     

     

    15,180

     

    Other assets

     

    27,480

     

     

    17,208

     

    Total assets

    $

    259,968

     

    $

    253,190

     

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    12,559

     

    $

    6,268

     

    Accrued expenses and other liabilities

     

    21,414

     

     

    23,817

     

    Current portion of long-term debt

     

    8,000

     

     

    8,000

     

    Total current liabilities

     

    41,973

     

     

    38,085

     

    Other long-term liabilities

     

    3,664

     

     

    3,959

     

    Long-term debt, less current portion

     

    23,253

     

     

    25,135

     

    Total liabilities

     

    68,890

     

     

    67,179

     

    Commitments and Contingencies
    Stockholders' equity:
    Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of March 31, 2021 and December 31, 2020

     

     

     

     

    Common stock, $0.001 par value; 50,000,000 shares authorized; 16,858,031 and 16,739,203 shares issued as of March 31, 2021 and December 31, 2020, respectively

     

    17

     

     

    17

     

    Additional paid in capital

     

    312,323

     

     

    305,403

     

    Retained earnings

     

    84,068

     

     

    84,489

     

    Treasury stock, at cost, 3,712,571 and 3,682,176 shares as of March 31, 2021 and December 31, 2020, respectively

     

    (205,330

    )

     

    (203,898

    )

    Total stockholders' equity

     

    191,078

     

     

    186,011

     

    Total liabilities and stockholders' equity

    $

    259,968

     

    $

    253,190

     

    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
    (In thousands, except share and per share amounts)
     
     
    Three Months Ended March 31,

     

    2021

     

     

    2020

     

     
    Revenue:
    Product sales, net

    $

    17,120

     

    $

    17,694

     

    Royalty revenue

     

    24,129

     

     

    28,326

     

    License and other revenue

     

     

     

     

    Total revenue

     

    41,249

     

     

    46,020

     

    Operating expenses:
    Cost of product sales

     

    8,442

     

     

    4,765

     

    Cost of royalty revenue

     

    2,413

     

     

    3,038

     

    Research and development

     

    14,288

     

     

    9,427

     

    Selling, general and administrative

     

    19,879

     

     

    24,755

     

    Total operating expenses

     

    45,022

     

     

    41,985

     

    (Loss) income from operations

     

    (3,773

    )

     

    4,035

     

    Interest income

     

    35

     

     

    346

     

    Interest expense

     

    (422

    )

     

    (889

    )

    Other income (expense)

     

    5,500

     

     

    (6,500

    )

    Total other income (expense), net

     

    5,113

     

     

    (7,043

    )

    Income (loss) before income tax (provision) benefit

     

    1,340

     

     

    (3,008

    )

    Income tax (provision) benefit

     

    (1,761

    )

     

    137

     

    Net Loss

    $

    (421

    )

    $

    (2,871

    )

    Loss per share attributable to common stockholders:
    Basic

    $

    (0.03

    )

    $

    (0.21

    )

    Diluted

    $

    (0.03

    )

    $

    (0.21

    )

    Weighted average number of common shares outstanding:
    Basic

     

    13,069,373

     

     

    13,667,606

     

    Diluted

     

    13,069,373

     

     

    13,667,606

     

    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
    (In thousands)
     
     
    Three Months Ended March 31,

     

    2021

     

     

    2020

     

     
    Cash flows from operating activities:
    Net loss

    $

    (421

    )

    $

    (2,871

    )

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

     

    902

     

     

    (90

    )

    Depreciation expense

     

    190

     

     

    251

     

    Noncash operating lease expense related to right-of-use assets

     

    252

     

     

    221

     

    Amortization expense of intangible assets

     

    706

     

     

    666

     

    Fair value adjustments on equity investment

     

    (5,600

    )

     

    6,500

     

    Stock-based compensation expense

     

    6,508

     

     

    7,472

     

    Convertible promissory note related credit losses

     

    100

     

     

     

    Amortization of debt issuance costs

     

    118

     

     

    65

     

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

     

    5,810

     

     

    (6,487

    )

    Inventories

     

    1,213

     

     

    (1,868

    )

    Prepaid expenses and other current assets

     

    (2,870

    )

     

    4,473

     

    Accounts payable

     

    6,291

     

     

    4,294

     

    Accrued expenses and other liabilities

     

    (2,403

    )

     

    (8,238

    )

    Other assets and other long-term liabilities, net

     

    (318

    )

     

    (1,230

    )

    Net cash provided by operating activities

     

    10,478

     

     

    3,158

     

    Cash flows from investing activities:
    Purchase of equity investment security

     

     

     

    (17,500

    )

    Purchase of property and equipment

     

    (384

    )

     

    (472

    )

    Purchase of convertible promissory note

     

    (5,000

    )

     

     

    Net cash used in investing activities

     

    (5,384

    )

     

    (17,972

    )

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

     

    1,963

     

     

    330

     

    Employee withholding taxes related to stock-based awards

     

    (1,551

    )

     

    (1,276

    )

    Proceeds from existing revolving credit facility

     

     

     

    110,000

     

    Payment of debt

     

    (2,000

    )

     

    (1,000

    )

    Repurchases of common stock

     

    (1,432

    )

     

    (999

    )

    Net cash (used in) provided by financing activities

     

    (3,020

    )

     

    107,055

     

    Net increase in cash and cash equivalents

     

    2,074

     

     

    92,241

     

    Cash and cash equivalents at beginning of period

     

    103,155

     

     

    109,775

     

    Cash and cash equivalents at end of period

    $

    105,229

     

    $

    202,016

     

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

    $

    267

     

    $

    24

     

    Interest

     

    321

     

     

    576

     

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

     

     

     

    842

     

    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 March 31,

     

    2021

     

     

    2020

     

     
    Net loss - GAAP

    $

    (421

    )

    $

    (2,871

    )

     
    Adjustments:
    Cost of product revenues:
    Amortization expense

     

    301

     

     

    261

     

    Research and development:
    Stock-based compensation expense

     

    895

     

     

    1,550

     

    Depreciation expense

     

    53

     

     

    177

     

    Severance

     

    274

     

     

     

    Selling, general and administrative:
    Stock-based compensation expense

     

    5,613

     

     

    5,922

     

    Expense related to collaboration with Tyme

     

     

     

    2,500

     

    Amortization expense

     

    405

     

     

    405

     

    Depreciation expense

     

    137

     

     

    74

     

    Severance

     

    306

     

     

    245

     

     
    Other:
    Non-cash interest expense

     

    118

     

     

    118

     

    Fair value adjustments on equity investment

     

    (5,600

    )

     

    6,500

     

    Tax effect of the non-GAAP adjustments

     

    1,086

     

     

    (3,179

    )

     
    Adjusted non-GAAP net income

    $

    3,167

     

    $

    11,702

     

     
    Adjusted non-GAAP earnings per share:
    Basic

    $

    0.24

     

    $

    0.86

     

    Diluted

    $

    0.24

     

    $

    0.84

     

    Weighted number of common shares outstanding:
    Basic

     

    13,069,373

     

     

    13,667,606

     

    Diluted

     

    13,276,283

     

     

    14,000,932

     

    EAGLE PHARMACEUTICALS, INC.
    RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP EBITDA (UNAUDITED)
    (In thousands)
     
     
    Three Months Ended March 31, Twelve Months

    Ended March 31,
    Twelve Months Ended

    December 31,

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     
    Net (loss) income - GAAP

    $

    (421

    )

    $

    (2,871

    )

    $

    14,439

     

    $

    11,989

     
    Add back:
    Interest expense, net of interest income

     

    387

     

     

    543

     

     

    1,859

     

     

    2,015

    Income tax provision (benefit)

     

    1,761

     

     

    (137

    )

     

    12,586

     

     

    10,688

    Depreciation and amortization expense

     

    896

     

     

    917

     

     

    3,517

     

     

    3,538

     
    Add back:
    Stock-based compensation expense

     

    6,508

     

     

    7,472

     

     

    23,792

     

     

    24,756

    Fair value adjustments on equity investment

     

    (5,600

    )

     

    6,500

     

     

    (6,800

    )

     

    5,300

    Fair value adjustments on settled accelerated share repurchase agreement

     

     

     

     

     

    2,962

     

     

    2,962

    Expense related to collaboration with Tyme

     

     

     

    2,500

     

     

     

     

    2,500

    Severance

     

    580

     

     

    245

     

     

    1,259

     

     

    924

    Adjusted Non-GAAP EBITDA

    $

    4,111

     

    $

    15,169

     

    $

    53,614

     

    $

    64,672

     

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  3. - Eagle expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) Ready-to-Dilute ("RTD") and Rapid Infusion ("RI") formulations -

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that TREAKISYM RI (50ml) liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan.

    The application is based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYMRTD administered by 10-minute intravenous infusion.

    "We are pleased that the RI application has been submitted ahead of schedule, which will enable patients and providers alike to reap the benefits of this formulation. We…

    - Eagle expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) Ready-to-Dilute ("RTD") and Rapid Infusion ("RI") formulations -

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that TREAKISYM RI (50ml) liquid formulation has been filed with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan.

    The application is based on the results of clinical studies investigating the safety and pharmacokinetics of TREAKISYM RTD administered by 10-minute intravenous infusion.

    "We are pleased that the RI application has been submitted ahead of schedule, which will enable patients and providers alike to reap the benefits of this formulation. We believe we can get close to peak income of $20-$25 million as early as next year from the RTD and RI products. This is an important extension of the bendamustine franchise, and we value the relationship with Symbio," stated Scott Tarriff, Chief Executive Officer.

    In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle's proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

    TREAKISYM RI has the advantage of reducing infusion time to 10 minutes (from the current 60 minutes), eliminating the need for manual reconstitution and significantly reducing preparation time, benefitting both patients and healthcare providers.

    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 timing of regulatory approvals for the TREAKISYM RI formulation, if ever; the future commercial success of TREAKISYM RTD and, if approved, TREAKISYM RI, including anticipated royalty and milestone revenue and potential market opportunity; expectations regarding the potential benefits of TREAKISYM RTD and TREAKISYM RI for patients and healthcare providers; and the Company's ability to successfully collaborate with Symbio with respect to the commercialization of TREAKISYM RTD and RI formulations. 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: risks that the Company's or its partners' business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where such parties operate; whether the Company will incur unforeseen expenses or liabilities or other market factors in connection with COVID-19; the success of the Company's collaborations with its strategic partners; successful compliance with 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" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the "SEC") on March 5, 2021, as updated by the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which the Company expects to file with the SEC on May 10, 2021, and its other subsequent filings with the SEC. 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.

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  4. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced the appointment of Luciana ("Lu") Borio, MD, to its Board of Directors. Dr. Borio brings more than a dozen years of high-level experience advancing major regulatory and policy initiatives on behalf of the U.S. government, notably in her roles at the U.S. Food and Drug Administration ("FDA" or "Agency").

    "We are delighted to welcome Lu to the Eagle Board of Directors. Lu is deeply committed to public health, having served in prominent roles at FDA and the National Security Council. Lu has spent her career at the forefront of U.S. healthcare policy, addressing some of the world's most complex challenges. Her unique mix of clinical, public health and government…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced the appointment of Luciana ("Lu") Borio, MD, to its Board of Directors. Dr. Borio brings more than a dozen years of high-level experience advancing major regulatory and policy initiatives on behalf of the U.S. government, notably in her roles at the U.S. Food and Drug Administration ("FDA" or "Agency").

    "We are delighted to welcome Lu to the Eagle Board of Directors. Lu is deeply committed to public health, having served in prominent roles at FDA and the National Security Council. Lu has spent her career at the forefront of U.S. healthcare policy, addressing some of the world's most complex challenges. Her unique mix of clinical, public health and government experience is highly relevant to our business, and her expertise in infectious diseases and medical product development makes her an ideal addition to the team. We look forward to her valuable insights and perspectives as we continue to work to advance our pipeline of product candidates and maximize our growth potential," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    Dr. Borio has served as Senior Vice President of In-Q-Tel, an independent strategic investment firm that supports the mission of the United States national security community, since 2019, and served as a member of President Biden's Transition COVID-19 Advisory Board from November 2020 to January 2021. Previously, Dr. Borio was Director, Medical and Biodefense Preparedness Policy, for the White House National Security Council from 2017 to 2019. In this role, Dr. Borio coordinated the U.S. government's response and policy regarding national preparedness for, and response to, infectious diseases and biothreats, including Ebola and pandemic influenza.

    Previously, Dr. Borio spent nearly ten years at the FDA in roles of increasing responsibility, serving as Acting Chief Scientist from 2015 to 2017, where she delivered strategic leadership and support for the Agency's regulatory science programs and oversaw a portfolio of projects and initiatives totaling approximately $180 million. Dr. Borio was Assistant Commissioner for Counterterrorism Policy from 2010 to 2017 where she was appointed as principal architect of the Agency's Medical Countermeasures Initiative, and Director of the Office of Counterterrorism and Emerging Threats from 2010 to 2015. From 2008 to 2010, Dr. Borio served as Medical Officer where she managed and reviewed a portfolio of vaccines, including those for tuberculosis, malaria, dengue, and other neglected tropical diseases.

    Dr. Borio also currently serves as a Senior Fellow for Global Health at the Council on Foreign Relations and on the Scientific Advisory Board of Codagenix, Inc. Dr. Borio earned a Bachelor of Science in Zoology from George Washington University and a Doctor of Medicine from George Washington University School of Medicine.

    "Eagle has an attractive mix of established and new areas of investigation, and I believe that my professional background and experiences are well-suited to help Eagle achieve its strategic goals. I am delighted to join the Eagle team and look forward to contributing to the Company's continued growth and success in addressing unmet medical needs," stated Dr. Luciana Borio.

    The Board of Eagle Pharmaceuticals retained Heidrick & Struggles for advice and council regarding this search.

    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 statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities law. 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 concerning expected financial performance and future business or product developments; the success of development efforts with respect to the product candidates in the Company's portfolio; the ability of the Company's executive team to execute on the Company's strategy, build shareholder value and maximize growth; and the Company's ability to deliver value in 2021 and over the long term. 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 interruptions or other adverse effects on clinical trials and delays in regulatory review or further disruption or delay of any pending or future litigation; delay in or failure to obtain regulatory approval of the Company's product candidates and successful compliance with FDA and other governmental regulations applicable to product approvals; whether the Company will successfully implement its development plan for its product candidates; whether the Company can successfully market and commercialize its product candidates; the outcome of litigation involving any of its products or that may have an impact on any of its products; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; the risks inherent in 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, 2020 filed with the Securities and Exchange Commission on March 5, 2021 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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  5. -Eagle believes new indication could allow for a significant expansion of the overall market opportunity-

    -RTD and Rapid Infusion ("RI") formulations anticipated to generate approximately $25 million of combined royalty and milestone revenue at peak-

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan.

    "This latest approval is another meaningful extension of our bendamustine franchise…

    -Eagle believes new indication could allow for a significant expansion of the overall market opportunity-

    -RTD and Rapid Infusion ("RI") formulations anticipated to generate approximately $25 million of combined royalty and milestone revenue at peak-

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan.

    "This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25 million at peak," stated Scott Tarriff, Chief Executive Officer.

    In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle's proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

    SymBio received approval for the TREAKISYM RTD (250 ml) liquid formulation in September 2020 and is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation, for which it plans to seek approval in the second half of 2022.

    Key benefits to patients and healthcare providers of these products include eliminating the need for manual reconstitution and significantly reducing preparation time as compared to the lyophilized formulation.

    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 ability to advance TREAKISYM RTD in combination with BR therapy as a treatment for r/r/ DLBCL; the future commercial success of TREAKISYM RTD and TREAKISYM RI, including anticipated royalty and milestone revenue and potential market opportunity; the timing of regulatory approvals for the TREAKISYM RI formulation, if ever; expectations regarding the potential benefits of TREAKISYM RTD and TREAKISYM RI for patients and healthcare providers; and the Company's ability to successfully collaborate with Symbio with respect to the commercialization of TREAKISYM RTD and RI formulations. 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: risks that the Company's or its partners' business, financial condition and results of operations will be impacted by the spread of COVID-19 in the geographies where such parties operate; whether the Company will incur unforeseen expenses or liabilities or other market factors in connection with COVID-19; the success of the Company's collaborations with its strategic partners; successful compliance with 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" sections of the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 5, 2021 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.

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