1. -- Q4 2020 net income was $0.62 per basic and $0.60 per diluted share and adjusted non-GAAP net income was $0.98 per basic and $0.96 per diluted share

    -- FY 2020 net income was $0.89 per basic and $0.87 per diluted share and adjusted non-GAAP net income was $3.62 per basic and $3.54 per diluted share --

    -- Posted strong 36% adjusted non-GAAP earnings growth 2020 over 2019 --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs.

    Business and Recent Highlights:

    • Posted strong year-over-year adjusted non-GAAP earnings growth of 36%;
    • Received a complete response letter ("CRL") from U.S. Food and Drug…

    -- Q4 2020 net income was $0.62 per basic and $0.60 per diluted share and adjusted non-GAAP net income was $0.98 per basic and $0.96 per diluted share

    -- FY 2020 net income was $0.89 per basic and $0.87 per diluted share and adjusted non-GAAP net income was $3.62 per basic and $3.54 per diluted share --

    -- Posted strong 36% adjusted non-GAAP earnings growth 2020 over 2019 --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs.

    Business and Recent Highlights:

    • Posted strong year-over-year adjusted non-GAAP earnings growth of 36%;
    • Received a complete response letter ("CRL") from U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for vasopressin. Eagle had a post-CRL meeting with FDA late last week and believes it has clear agreement on how to proceed. As previously disclosed, FDA restated that it has prioritized Eagle's ANDA, and it is also flagged as a COVID priority. Eagle plans to re-submit its ANDA by mid-year. The 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 180 days of exclusivity.
    • Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development, and
    • Continued productive engagement with FDA for EA-114, the Company's fulvestrant product candidate. The Company now has agreement for the clinical design and study endpoints, and following additional formulation work, intends to begin a clinical trial in patients.

    Financial Highlights

    Fourth Quarter 2020

    • Total revenue for Q4 2020 was $49.9 million, compared to $48.3 million in Q4 2019, primarily reflecting increased product sales of Ryanodex and Belrapzo.
    • Q4 2020 net income was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share in Q4 2019.
    • Q4 2020 adjusted non-GAAP net income was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in Q4 2019.
    • Cash and cash equivalents were $103.2 million, net accounts receivable was $51.1 million, and debt was $34 million as of December 31, 2020.

    Full Year 2020

    • Total revenue for the 12 months ended December 31, 2020 was $187.8 million, compared to $195.9 million in 2019. 2020 included a $5.0 million milestone from SymBio for regulatory approval of Treakisym ready-to-dilute (250 ml) liquid bendamustine formulation.
    • 2020 net income was $12.0 million, or $0.89 per basic and $0.87 per diluted share, compared to net income of $14.3 million, or $1.04 per basic and $1.01 per diluted share in 2019.
    • 2020 adjusted non-GAAP net income was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.
    • From August 2016 through December 31, 2020, Eagle has repurchased $206.9 million of its common stock.

    "2020 proved to be a strong earnings year for Eagle, with 36% year-over-year growth, despite the significant challenges brought about by the COVID-19 pandemic. Our balance sheet remains healthy and provides a solid basis to support our development programs and future growth prospects. Our key pipeline products – vasopressin, fulvestrant and Ryanodex for nerve agent exposure – represent significant opportunities, and we are pleased to have a path forward. We remain committed to completing the additional work to advance them through the regulatory process," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    "Looking ahead, we have our exclusive Pemfexy launch in February 2022 and SymBio sales ramping in Japan. At the same time, we will continue pursuing both organic and inorganic opportunities that will deliver growth for many years to come," concluded Tarriff.

    Fourth Quarter 2020 Financial Results

    Total revenue for the three months ended December 31, 2020 was $49.9 million, as compared to $48.3 million for the three months ended December 31, 2019.

    Q4 2020 BELRAPZO product sales were $10.2 million, compared to $7.6 million in Q4 2019.

    Q4 2020 RYANODEX product sales were $7.9 million, compared to $3.5 million in Q4 2019.

    Royalty revenue was $27.0 million in the fourth quarter of 2020, compared to $32.8 million in the fourth quarter of 2019. BENDEKA royalties were $27.0 million in the fourth quarter of 2020, compared to $32.4 million in the fourth quarter of 2019. A summary of total revenue is outlined below:

     

    Three Months Ended December 31,

     

    2020

     

    2019

     

    (unaudited)

     

    (unaudited)

    Revenue (in thousands):

     

     

     

    Product sales, net

    $22,936

     

    $15,421

    Royalty revenue

    26,980

     

    32,837

    Total revenue

    $49,916

     

    $48,258

    Gross Margin was 75% during the fourth quarter of 2020, as compared to 76% in the fourth quarter of 2019. The compression in gross margin for the fourth quarter of 2020 was primarily driven by the launch of Treakisym product sales to our partner, on which Eagle earns no profit.

    R&D expense was $9.4 million for the fourth quarter of 2020, compared to $11.3 million in the fourth quarter of 2019. The decrease is largely attributable to lower spend on fulvestrant and Ryanodex for EHS programs, partially offset by higher spend on vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter of 2020 was $8.7 million.

    SG&A expense in the fourth quarter of 2020 decreased to $18.2 million compared to $22.5 million in the fourth quarter of 2019. External legal spend associated with litigation on pemetrexed, a decrease of travel and entertainment and other expenses due to COVID-19, as well as differences in incentive pay, account for the year-over-year decrease. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2020 SG&A expense was $11.2 million.

    Net income for the fourth quarter of 2020 was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share, in the fourth quarter of 2019, due to the factors discussed above.

    Adjusted non-GAAP net income for the fourth quarter of 2020 was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million or $0.49 per basic and $0.48 per diluted share in the fourth 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.

    Full Year 2020 Financial Results

    Total revenue for the year ended December 31, 2020 was $187.8 million, as compared to $195.9 million for the year ended December 31, 2019. A summary of total revenue is outlined below:

     

    Twelve Months Ended December 31,

     

    2020

     

    2019

     

     

     

     

    Revenue (in thousands):

     

     

     

    Product sales, net

    $72,323

     

    $73,989

    Royalty revenue

    110,479

     

    112,903

    License and other income

    5,000

     

    9,000

    Total revenue

    $187,802

     

    $195,892

    Product sales decreased by $1.7 million in the year ended December 31, 2020, primarily driven by decreases in product sales of Bendeka of $15.7 million, coupled with decreases in Belrapzo's product sales of $2.1 million, primarily due to volume decreases. In addition, the COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly and specifically have led to a reduction in the utilization of physician-administered oncology products including Belrapzo and Bendeka. The decreased sales were partially offset by increases in product sales of Ryanodex of $15.2 million due to higher volume coupled with product sales of $0.9 million from the 2020 product launch of Treakisym.

    Gross margin was 76% in 2020, as compared to 69% in 2019. The increase in gross margin in 2020 was primarily related to an increase in product sales of Ryanodex and a decrease in product sales of Bendeka.

    R&D expense decreased to $30.8 million in 2020, compared to $36.8 million in 2019, primarily reflecting a decrease in project spending for Ryanodex for the EHS indication. This decrease was partially offset by increased spend related to the Company's fulvestrant formulation initiative. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2020 was $27.8 million.

    SG&A expenses increased by $2.2 million to $78.6 million in 2020, compared to $76.4 million in 2019. The increase primarily reflects costs related to the collaboration with Tyme and increases in stock compensation, partially offset by travel and entertainment expense which decreased due to COVID-19 restrictions on travel coupled with lower external legal fees. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2020 was $50.9 million.

    Net income for the year ended December 31, 2020 was $12.0 million or $0.89 per basic and $0.87 per diluted share as compared to net income of $14.3 million or $1.04 per basic and $1.01 per diluted share for the year ended December 31, 2019, as a result of the factors discussed above.

    Adjusted non-GAAP net income for 2020 was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.

    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 $56-$60 million, as compared to $50.9 million in 2020.

    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 December 31, 2020, the Company had $103.2 million in cash and cash equivalents plus $51.1 million in net accounts receivable, $29.9 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $34 million in outstanding debt. Therefore, as of December 31, 2020, the Company had net cash plus receivables of $120.3 million.

    In the fourth quarter of 2020, the Company purchased $4.0 million of Eagle's common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through December 31, 2020, the Company has repurchased $206.9 million of its common stock.

    Conference Call

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

    Date

    Tuesday, March 2, 2020

    Time

    8:30 A.M. EST

    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 800-934-7612 (US) or 402-220-6980 (International) and entering conference call ID EGRXQ420. 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 its fulvestrant product candidate, EA-114, as well as the development efforts for the other product candidates in its portfolio; the potential benefits and efficacy of RYANODEX, including the potential for RYANODEX as a treatment for nerve agent exposure and additional indications; the ability of the Company's executive team to execute on the Company's strategy and build shareholder 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, and the timing of the potential product launch of TREAKISYM; the ability of the Company's fulvestrant product candidate, EA-114, to improve clinical outcomes for post-menopausal metastatic breast cancer patients; the Company's timing and ability to enroll patients in ongoing and upcoming clinical trials; the ability of the Company to obtain and maintain coverage and adequate reimbursement for its products; the implementation of certain healthcare reform measures; the Company's timing and ability to 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; risks that results from in vitro laboratory tests of RYANODEX are not necessarily predictive of future clinical trial and in vivo results; whether the Company will successfully implement its development plan for its fulvestrant product candidate, EA-114, or other product candidates; delay in or failure to obtain regulatory approval of the Company's product candidates; whether the Company can successfully market and commercialize its product candidates; the success of the Company's relationships with its partners, including the University of Pennsylvania, Teva, Tyme, NorthShore University HealthSystem and SymBio and the parties' ability to work effectively together; the availability and pricing of third party sourced products and 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, which the Company expects to file on March 2, 2021, as updated by the Company's 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, debt issuance costs, non-cash interest expense, expense of acquired in-process research and development, expense related to collaboration with Tyme, fair value adjustments on equity investment, fair value adjustment on settled accelerated share repurchase agreement 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.
    CONSOLIDATED BALANCE SHEETS
    (In thousands, except share amounts)
     
     

    December 31, 2020

    December 31, 2019

    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    103,155

     

    $

    109,775

     

    Accounts receivable, net

     

    51,117

     

     

    48,004

     

    Inventories

     

    8,075

     

     

    6,566

     

    Prepaid expenses and other current assets

     

    3,718

     

     

    15,104

     

    Total current assets

     

    166,065

     

     

    179,449

     

    Property and equipment, net

     

    2,077

     

     

    2,202

     

    Intangible assets, net

     

    12,917

     

     

    15,583

     

    Goodwill

     

    39,743

     

     

    39,743

     

    Deferred tax asset, net

     

    15,180

     

     

    13,669

     

    Other assets

     

    17,208

     

     

    3,908

     

    Total assets

    $

    253,190

     

    $

    254,554

     

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    6,268

     

    $

    5,462

     

    Accrued expenses and other liabilities

     

    23,817

     

     

    28,361

     

    Current portion of long-term debt

     

    8,000

     

     

    5,000

     

    Total current liabilities

     

    38,085

     

     

    38,823

     

    Other long-term liabilities

     

    3,959

     

     

    3,000

     

    Long-term debt, less current portion

     

    25,135

     

     

    33,557

     

    Total liabilities

     

    67,179

     

     

    75,380

     

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

     

     

     

     

    Common stock, $0.001 par value; 50,000,000 shares authorized; 16,739,203 and 16,537,846 shares issued as of December 31, 2020 and 2019, respectively

     

    17

     

     

    17

     

    Additional paid in capital

     

    305,403

     

     

    278,518

     

    Retained earnings

     

    84,489

     

     

    72,500

     

    Treasury stock, at cost, 3,682,176 and 2,907,687 shares as of December 31, 2020 and 2019, respectively

     

    (203,898

    )

     

    (171,861

    )

    Total stockholders' equity

     

    186,011

     

     

    179,174

     

    Total liabilities and stockholders' equity

    $

    253,190

     

    $

    254,554

     

     
    EAGLE PHARMACEUTICALS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (In thousands, except share and per share amounts)
     
     

    Three Months Ended December 31,

     

    Year Ended December 31,

    2020

     

    2019

     

    2020

     

    2019

    (unaudited)

    (unaudited)

    Revenue:
    Product sales, net

    $

    22,936

     

    $

    15,421

     

    $

    72,323

     

    $

    73,989

     

    Royalty revenue

     

    26,980

     

     

    32,837

     

     

    110,479

     

     

    112,903

     

    License and other revenue

     

     

     

     

     

    5,000

     

     

    9,000

     

    Total revenue

     

    49,916

     

     

    48,258

     

     

    187,802

     

     

    195,892

     

    Operating expenses:
    Cost of product sales

     

    9,843

     

     

    8,025

     

     

    33,647

     

     

    47,891

     

    Cost of royalty revenue

     

    2,698

     

     

    3,566

     

     

    11,818

     

     

    13,006

     

    Research and development

     

    9,395

     

     

    11,306

     

     

    30,785

     

     

    36,810

     

    Selling, general and administrative

     

    18,187

     

     

    22,464

     

     

    78,598

     

     

    76,370

     

    Total operating expenses

     

    40,123

     

     

    45,361

     

     

    154,848

     

     

    174,077

     

    Income from operations

     

    9,793

     

     

    2,897

     

     

    32,954

     

     

    21,815

     

    Interest income

     

    20

     

     

    468

     

     

    562

     

     

    2,169

     

    Interest expense

     

    (413

    )

     

    (707

    )

     

    (2,577

    )

     

    (2,686

    )

    Other income (expense)

     

    1,987

     

     

    700

     

     

    (8,262

    )

     

    700

     

    Total other income (expense), net

     

    1,594

     

     

    461

     

     

    (10,277

    )

     

    183

     

    Income before income tax provision

     

    11,387

     

     

    3,358

     

     

    22,677

     

     

    21,998

     

    Income tax provision

     

    3,330

     

     

    2,353

     

     

    10,688

     

     

    7,685

     

    Net Income

    $

    8,057

     

    $

    1,005

     

    $

    11,989

     

    $

    14,313

     

    Earnings per share attributable to common stockholders:
    Basic

    $

    0.62

     

    $

    0.07

     

    $

    0.89

     

    $

    1.04

     

    Diluted

    $

    0.60

     

    $

    0.07

     

    $

    0.87

     

    $

    1.01

     

    Weighted average number of common shares outstanding:
    Basic

     

    13,066,189

     

     

    13,646,043

     

     

    13,481,525

     

     

    13,754,516

     

    Diluted

     

    13,331,149

     

     

    14,121,179

     

     

    13,771,393

     

     

    14,138,733

     

     
    EAGLE PHARMACEUTICALS, INC.
    CONSOLIDATED STATEMENTS OF CASH FLOWS
    (In thousands)
     
     

    Year Ended December 31,

    2020

     

    2019

    Cash flows from operating activities:
    Net income

    $

    11,989

     

    $

    14,313

     

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

     

    (1,511

    )

     

    152

     

    Depreciation expense

     

    872

     

     

    972

     

    Amortization expense of right-of-use assets

     

    1,228

     

     

    1,159

     

    Amortization expense of intangible assets

     

    2,666

     

     

    2,520

     

    Stock-based compensation expense

     

    24,756

     

     

    21,998

     

    Fair value adjustments on equity investment

     

    5,300

     

     

     

    Amortization of debt issuance costs

     

    419

     

     

    480

     

    Fair value adjustments on settled accelerated share repurchase agreement

     

    2,962

     

     

     

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

     

    (3,113

    )

     

    18,481

     

    Inventories

     

    (1,509

    )

     

    1,739

     

    Prepaid expenses and other current assets

     

    11,386

     

     

    (4,841

    )

    Other assets

     

    (2,325

    )

     

    (599

    )

    Accounts payable

     

    806

     

     

    (4,455

    )

    Accrued expenses and other liabilities

     

    (4,429

    )

     

    4,067

     

    Net cash provided by operating activities

     

    49,497

     

     

    55,986

     

    Cash flows from investing activities:
    Purchase of property and equipment

     

    (747

    )

     

    (777

    )

    Purchase of equity investment security

     

    (17,500

    )

     

     

    Net cash used in investing activities

     

    (18,247

    )

     

    (777

    )

    Cash flows from financing activities:
    Repurchases of common stock

     

    (34,999

    )

     

    (17,961

    )

    Proceeds from existing revolving credit facility

     

    110,000

     

     

     

    Repayment of existing revolving credit facility

     

    (110,000

    )

     

     

    Payment of debt

     

    (5,000

    )

     

    (6,000

    )

    Payment of debt financing costs

     

     

     

    (326

    )

    Payment of employee withholding tax upon vesting of stock-based awards

     

    (1,525

    )

     

    (198

    )

    Proceeds from common stock option exercises

     

    3,654

     

     

    260

     

    Net cash used in financing activities

     

    (37,870

    )

     

    (24,225

    )

    Net (decrease) increase in cash and cash equivalents

     

    (6,620

    )

     

    30,984

     

    Cash and cash equivalents at beginning of period

     

    109,775

     

     

    78,791

     

    Cash and cash equivalents at end of period

    $

    103,155

     

    $

    109,775

     

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

    $

    6,428

     

    $

    6,673

     

    Interest

     

    2,224

     

     

    2,478

     

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

     

    885

     

     

    3,716

     

     
    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 December 31,

     

    Twelve Months Ended December 31,

    2020

     

    2019

     

    2020

     

    2019

    Net income - GAAP

    $

    8,057

     

    $

    1,005

     

    $

    11,989

     

    $

    14,313

     

     
    Adjustments:
    Cost of product revenues:
    Amortization expense

     

    262

     

     

    225

     

     

    1,046

     

     

    900

     

    Research and development:
    Stock-based compensation expense

     

    612

     

     

    1,122

     

     

    2,682

     

     

    4,442

     

    Depreciation expense

     

    63

     

     

    76

     

     

    269

     

     

    286

     

    Expense of acquired in-process research & development

     

    -

     

     

    500

     

     

    -

     

     

    500

     

    Severance

     

    -

     

     

    455

     

     

    -

     

     

    455

     

    Selling, general and administrative:
    Stock-based compensation expense

     

    5,709

     

     

    4,061

     

     

    22,074

     

     

    17,556

     

    Expense related to collaboration with Tyme

     

    -

     

     

    -

     

     

    2,500

     

     

    -

     

    Amortization expense

     

    405

     

     

    405

     

     

    1,620

     

     

    1,620

     

    Depreciation expense

     

    153

     

     

    171

     

     

    603

     

     

    686

     

    Debt issuance costs

     

    -

     

     

    88

     

     

    -

     

     

    88

     

    Severance

     

    679

     

     

    -

     

     

    924

     

     

    -

     

     
    Other:
    Non-cash interest expense

     

    118

     

     

    198

     

     

    472

     

     

    480

     

    Fair value adjustments on equity investment

     

    (2,400

    )

     

    -

     

     

    5,300

     

     

    -

     

    Fair value adjustments on settled accelerated share repurchase agreement

     

    413

     

     

    -

     

     

    2,962

     

     

    -

     

    Tax effect of the non-GAAP adjustments

     

    (1,233

    )

     

    (1,558

    )

     

    (3,699

    )

     

    (4,433

    )

     
    Adjusted non-GAAP net income

    $

    12,838

     

    $

    6,748

     

    $

    48,742

     

    $

    36,893

     

     
    Adjusted non-GAAP earnings per share:
    Basic

    $

    0.98

     

    $

    0.49

     

    $

    3.62

     

    $

    2.68

     

    Diluted

    $

    0.96

     

    $

    0.48

     

    $

    3.54

     

    $

    2.61

     

    Weighted number of common shares outstanding:
    Basic

     

    13,066,189

     

     

    13,646,043

     

     

    13,481,525

     

     

    13,754,516

     

    Diluted

     

    13,331,149

     

     

    14,121,179

     

     

    13,771,393

     

     

    14,138,733

     

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

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

    2020

     

    2019

     

    2020

     

    2019

     
    Net income - GAAP

    $

    8,057

     

    $

    1,005

    $

    11,989

    $

    14,313

     
    Add back:
    Interest expense, net of interest income

     

    393

     

     

    239

     

    2,015

     

    517

    Income tax provision

     

    3,330

     

     

    2,353

     

    10,688

     

    7,685

    Depreciation and amortization expense

     

    883

     

     

    877

     

    3,538

     

    3,492

     
    Add back:
    Stock-based compensation expense

     

    6,321

     

     

    5,183

     

    24,756

     

    21,998

    Debt issuance cost

     

    -

     

     

    88

     

    -

     

    88

    Fair value adjustments on equity investment

     

    (2,400

    )

     

    -

     

    5,300

     

    -

    Fair value adjustments on settled accelerated share repurchase agreement

     

    413

     

     

    -

     

    2,962

     

    -

    Expense of acquired in-process research & development

     

    -

     

     

    500

     

    -

     

    500

    Expense related to collaboration with Tyme

     

    -

     

     

    -

     

    2,500

     

    -

    Severance

     

    679

     

     

    455

     

    924

     

    455

    Adjusted Non-GAAP EBITDA

    $

    17,676

     

    $

    10,700

    $

    64,672

    $

    49,048

     

     

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  2. Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 fourth quarter and full year financial results on Tuesday, March 2, 2021, before the market opens.

    Scott Tarriff, Chief Executive Officer, Brian Cahill, Chief Financial Officer, senior members of Eagle's executive leadership team, and other distinguished external speakers will host a 90- minute conference call as follows:

    Date

    Tuesday, March 2, 2021

    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…

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 fourth quarter and full year financial results on Tuesday, March 2, 2021, before the market opens.

    Scott Tarriff, Chief Executive Officer, Brian Cahill, Chief Financial Officer, senior members of Eagle's executive leadership team, and other distinguished external speakers will host a 90- minute conference call as follows:

    Date

    Tuesday, March 2, 2021

    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 800-934-7612 (US) or 402-220-6980 (International) and entering conference call ID EGRXQ420. 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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  3. -Company Expects It Will Have 180 Days of Exclusivity-

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its Abbreviated New Drug Application ("ANDA") for vasopressin. Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days. Importantly, Eagle has completed an extensive amount of developmental work and continues to do so for its first-to-file polypeptide, where brand sales of the product are over $700 million annually. In its communication with the Company, FDA restated that it has prioritized Eagle's ANDA, and it is also flagged as a COVID…

    -Company Expects It Will Have 180 Days of Exclusivity-

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its Abbreviated New Drug Application ("ANDA") for vasopressin. Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days. Importantly, Eagle has completed an extensive amount of developmental work and continues to do so for its first-to-file polypeptide, where brand sales of the product are over $700 million annually. In its communication with the Company, FDA restated that it has prioritized Eagle's ANDA, and it is also flagged as a COVID priority.

    Eagle believes it can fully respond to the questions raised. There is one additional short duration study that will need to be completed and analyzed. The study will be run either in mid-February or mid-March. Based on similar studies previously run on the Company's vasopressin product, Eagle expects the results will be satisfactory. In addition, the Company expects it will have 180 days of exclusivity.

    Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, stated, "Eagle is aligned with FDA in its desire to approve products that meet all possible safety concerns, especially polypeptides like vasopressin that may be administered to COVID patients. Although this adds some time and cost, we believe all ANDA holders are likely to be held to the same high standards. We will be meeting again with FDA and will respond completely to the CRL shortly."

    In other vasopressin news, the patent case against Endo Par Innovation Company, LLC is now scheduled to begin on July 7, 2021. Eagle remains confident about this litigation. Par's asserted patents claim a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that range. The Company is confident that its ANDA will be approved in a reasonable timeframe.

    "We look forward to being able to continue to show the strength of our positions regarding Endo's patents in court and hope to bring this very important, lower price, high-quality product to market as soon as possible," concluded Tarriff.

    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 the Company's ability to address the questions raised in the CRL for its ANDA for vasopressin and to communicate with FDA regarding the same; the Company's ability to obtain and maintain regulatory approval of its products and product candidates, including vasopressin; the timing, progress and results of the Company's clinical trials, including the additional short duration study with respect to vasopressin; the period of market exclusivity for vasopressin; and the status and timing of pending or future litigation and the strength of the Company's position in any such litigation, including the litigation between the Company and Endo Par Innovation Company, LLC, et al. with respect to vasopressin. 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, 2019 filed with the Securities and Exchange Commission on March 2, 2020 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, filed with the SEC on May 11, 2020, August 10, 2020 and November 2, 2020, respectively, 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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  4. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that, on January 29, 2021, the United States District Court for the District of Delaware (the "Court") postponed the February 1, 2021 vasopressin trial between Eagle and Endo Par Innovation Company, LLC, et al. The Court expects to hold a call with the parties today to discuss a new trial date.

    Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, stated, "Par's asserted patent claims require a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that claimed in Par's patents. We are therefore looking forward to having the trial as soon as possible, especially considering that we expect to have 180 days of exclusivity…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that, on January 29, 2021, the United States District Court for the District of Delaware (the "Court") postponed the February 1, 2021 vasopressin trial between Eagle and Endo Par Innovation Company, LLC, et al. The Court expects to hold a call with the parties today to discuss a new trial date.

    Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals, stated, "Par's asserted patent claims require a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that claimed in Par's patents. We are therefore looking forward to having the trial as soon as possible, especially considering that we expect to have 180 days of exclusivity."

    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 the status and timing of pending or future litigation and the strength of the Company's position in any such litigation, including the litigation between the Company and Endo Par Innovation Company, LLC, et al. with respect to vasopressin. 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 further disruption or delay of any pending or future litigation; the outcome of litigation involving any of our products or that may have an impact on any of our products; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; 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 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, filed with the SEC on May 11, 2020, August 10, 2020 and November 2, 2020, respectively, 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 Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that, on January 8, 2021, the United States District Court for the District of Delaware postponed the January 11, 2021 vasopressin trial between Eagle and Endo Par Innovation Company, LLC, et al. due, in part, to ensure the health and safety of the trial teams in light of a COVID-19 concern. The trial is now scheduled to begin remotely starting February 1, 2021 and is expected to be concluded by February 5, 2021.

    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…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that, on January 8, 2021, the United States District Court for the District of Delaware postponed the January 11, 2021 vasopressin trial between Eagle and Endo Par Innovation Company, LLC, et al. due, in part, to ensure the health and safety of the trial teams in light of a COVID-19 concern. The trial is now scheduled to begin remotely starting February 1, 2021 and is expected to be concluded by February 5, 2021.

    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 the status and timing of pending or future litigation. 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 further disruption or delay of any pending or future litigation, 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 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, filed with the SEC on May 11, 2020, August 10, 2020 and November 2, 2020, respectively, 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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  6. 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 39th Annual J.P. Morgan Healthcare Conference as follows:

    Date:

    Wednesday, January 13, 2021

    Time:

    4:30 p.m. Eastern Standard Time

    Webcast:

    https://jpmorgan.metameetings.net/events/healthcare21/sessions/35699-eagle-pharmaceuticals/webcast?gpu_only=true&kiosk=true

    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…

    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 39th Annual J.P. Morgan Healthcare Conference as follows:

    Date:

    Wednesday, January 13, 2021

    Time:

    4:30 p.m. Eastern Standard Time

    Webcast:

    https://jpmorgan.metameetings.net/events/healthcare21/sessions/35699-eagle-pharmaceuticals/webcast?gpu_only=true&kiosk=true

    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.

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  7. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the Company's pre-recorded presentation at the Piper Sandler 32nd Annual Virtual Healthcare Conference is now available for viewing via the link below:

    https://pipersandler.zoom.us/rec/play/0TlXfXVGZ3QG7IgEE4PyzFEfiG8HyD57XqSaO9Uq1Rsb_J29jmyS2ZvqWskPC1MJPA_AP6kFUMjJQfFd.vyuNfKmJI0FvhIOg

    It is also available on the Company's website at www.eagleus.com, under the Investors section, where it will be archived for 30 days.

    Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will be participating in 1x1 meetings on December 1, 2020. Meetings can be requested exclusively via Piper Sandler.

    About Eagle Pharmaceuticals, Inc.

    Eagle…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the Company's pre-recorded presentation at the Piper Sandler 32nd Annual Virtual Healthcare Conference is now available for viewing via the link below:

    https://pipersandler.zoom.us/rec/play/0TlXfXVGZ3QG7IgEE4PyzFEfiG8HyD57XqSaO9Uq1Rsb_J29jmyS2ZvqWskPC1MJPA_AP6kFUMjJQfFd.vyuNfKmJI0FvhIOg

    It is also available on the Company's website at www.eagleus.com, under the Investors section, where it will be archived for 30 days.

    Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will be participating in 1x1 meetings on December 1, 2020. Meetings can be requested exclusively via Piper Sandler.

    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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  8. Details the Incumbent Board's History of Presiding Over Dismal Governance Practices, Numerous Commercial and Strategic Missteps, and Hundreds of Millions of Dollars in Value Destruction

    Highlights That Chairman Scott Tarriff has Fostered an Anti-Shareholder Culture Defined by Dilutive Actions, Poor Investor Engagement, and a Misaligned Management Team

    Urges Shareholders to Vote on the WHITE Consent Card to Reconstitute the Board with WaterMill's Three Highly-Qualified and Independent Director Candidates

    Warns Shareholders to Avoid Being Misled by Mr. Tarriff and his Allies, Especially Given That Their Last Self-Directed Board Refresh was Followed by a ~40% Share Price Decline

    WaterMill Asset Management Corp. (together with its affiliates…

    Details the Incumbent Board's History of Presiding Over Dismal Governance Practices, Numerous Commercial and Strategic Missteps, and Hundreds of Millions of Dollars in Value Destruction

    Highlights That Chairman Scott Tarriff has Fostered an Anti-Shareholder Culture Defined by Dilutive Actions, Poor Investor Engagement, and a Misaligned Management Team

    Urges Shareholders to Vote on the WHITE Consent Card to Reconstitute the Board with WaterMill's Three Highly-Qualified and Independent Director Candidates

    Warns Shareholders to Avoid Being Misled by Mr. Tarriff and his Allies, Especially Given That Their Last Self-Directed Board Refresh was Followed by a ~40% Share Price Decline

    WaterMill Asset Management Corp. (together with its affiliates, "WaterMill" or "we"), which collectively with the other participants in its consent solicitation beneficially owns approximately 3.3% of the outstanding shares of Ziopharm Oncology, Inc. (NASDAQ:ZIOP) ("Ziopharm" or the "Company"), today issued the below letter to shareholders in support of the proposals included in its definitive consent statement filed with the U.S. Securities and Exchange Commission on October 30, 2020. Notably, WaterMill has put forth proposals to reconstitute Ziopharm's Board of Directors, including a proposal to remove four incumbent directors and a proposal to elect three highly-qualified and independent nominees: Robert Postma, Jaime Vieser, and Holger Weis.

    We are asking shareholders to consent to all of our proposals by voting on the WHITE consent card. We urge shareholders to sign, date, and return their WHITE consent card today. Please return each and every WHITE consent card received. Do not return any green revocation card (even as a protest vote).

    Please note that important information pertaining to WaterMill's campaign, including the below letter, is available at www.FixZiopharm.com.

    ***

    November 5, 2020

    Fellow Shareholders:

    WaterMill Asset Management Corp. (together with its affiliates, "WaterMill" or "we") invested in Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") because we believe in the innovation and science behind the Company's immuno-oncology platform. Like many of you, we have spent years investing in the biotechnology sector and understand that considerable patience is required on the road to value creation. This is why we have never before engaged in an "activist campaign" and strive to maintain cordial, productive relationships with corporate leadership teams. Unfortunately, we have been forced to deviate from our long-preferred posture due to the extraordinarily anti-shareholder actions and value-destructive reign of Ziopharm's Board of Directors (the "Board").

    After assessing the various ways in which we could potentially catalyze change at Ziopharm, we determined that it was in the best interest of all shareholders for WaterMill to launch a consent solicitation to reconstitute the Board in a pragmatic and targeted manner. This is why we are soliciting shareholder support to remove four incumbent directors – Scott Braunstein, J. Kevin Buchi, Elan Z. Ezickson, and Scott Tarriff – and elect three highly-qualified and independent individuals – Robert Postma, Jaime Vieser, and Holger Weis – who we believe possess the type of business acumen and strategic vision that has been lacking in the boardroom for far too long.

    In our view, a seven-member Board that includes four of the incumbents and all three of our director candidates will have the ideal mix of institutional knowledge, industry expertise, commercial intensity, and meaningful ownership perspectives. We believe a Board that is truly focused on running Ziopharm like a high-potential business can finally establish value-enhancing partnerships, line up appropriate financing sources, incentivize the right management team, and reverse the Company's five-year tailspin. These are the types of outcomes that will benefit all of Ziopharm's stakeholders, ranging from shareholders and employees to patients and caregivers.

    THE CASE FOR MEANINGFUL, SHAREHOLDER-DRIVEN CHANGE ATOP ZIOPHARM IS CRYSTAL CLEAR

    Since Chairman Scott Tarriff and Chief Executive Officer Laurence Cooper joined Ziopharm in 2015, we contend that shareholders have been systemically disregarded and deprioritized. This is evidenced by the Company's negative total shareholder returns ("TSR") and staggering underperformance over several time horizons:

     

    1-Year TSR*

    3-Year TSR*

    5-Year TSR*

    Ziopharm

    -39.31%

    -52.43%

    -76.28%

    S&P 500

    18.50%

    44.63%

    90.33%

    Russell 3000

    19.18%

    43.19%

    87.84%

    SPDR S&P Biotech ETF

    52.53%

    39.17%

    83.19%

    *Source: Bloomberg (TSR figures reflect share price and performance up until October 15, 2020, which is the day before WaterMill filed its preliminary consent statement).

    We believe it is critical for shareholders to see through Ziopharm's brazenly misrepresentative investor communications and realize that value has eroded at an even faster pace following the Company's self-directed Board refreshment in 2018. In fact, Ziopharm's share price is down nearly 40% over the past twelve months alone.1 Mr. Tarriff and Dr. Cooper apparently chose to ignore this fact in their November 2nd letter that claims "Ziopharm continues to drive value with fresh Board perspectives."2 We question how shareholders can have any faith in Ziopharm's current leadership when it is so willing to disseminate consultant-manufactured spin and disregard shareholder suffering.

    Although the incumbent Board has signaled its intent to distort and ignore reality, we feel shareholders deserve to be reacquainted with data and facts that underscore the need for expedited boardroom change:

    • The incumbent Board has repeatedly shown that it is unwilling to accept and address shareholder feedback.
      • A majority of voting shareholders withheld support for three directors – Mr. Braunstein, Mr. Ezickson, and Douglas Pagán – at this year's annual meeting. Rather than engage with shareholders to finally commence a credible Board overhaul, Ziopharm allowed two of the aforementioned directors to retain their positions and replaced Mr. Pagán (Chief Financial Officer of Dicerna Pharmaceuticals, Inc.) with Mr. Buchi (Chairman of Dicerna Pharmaceuticals, Inc.). We question how it improves the Board's damaged credibility and serves shareholders' interests to replace Mr. Pagán – who clearly lost investors' confidence – with one of his current bosses.
      • Long-term shareholders have suffered through sustained losses in recent years. In an apparent attempt to add insult to injury, Ziopharm asked shareholders to increase the Company's authorized share count by 195 million shares at this year's annual meeting. This dilutive, poorly-conceived proposal was voted down.
      • Instead of assuming accountability for the hundreds of millions of dollars destroyed during their tenures, Mr. Tarriff and Dr. Cooper boasted about purported accomplishments and hurled unsubstantiated smears at WaterMill in its November 2nd letter. We encourage shareholders to examine their insulting communication, which we believe reads like it was ghost written by individuals with no pulse on Ziopharm's attentive and engaged investor base.
    • The incumbent Board lacks alignment with shareholders and important ownership perspectives.
      • According to Ziopharm's consent revocation statement, the Board paid out $1.84 million in total compensation to seven directors in the year ended on December 31, 2019. It underscores just how out of touch Ziopharm's Board is that directors received an average compensation of more than $260,000. In our view, this represents egregious compensation for a small market capitalization company that has been going in the wrong direction for years.
      • WaterMill's three-member slate, which collectively owns more than 3.3% of the Company's outstanding shares, has a significantly larger ownership position than all eight of the incumbent directors combined. We question how shareholders can trust the Board to urgently correct years of underperformance when it is so misaligned and maintains such meager shareholdings.
    • The incumbent Board is plagued by what appears to be a troubling web of performance issues and interlocking relationships among directors.
      • Among Ziopharm's incumbent directors, we have uncovered numerous instances of possible conflicts and overlap in Board service at other companies, including:
        • Mr. Ezickson serves on the Board of Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), where fellow Ziopharm director Dr. Braunstein also serves as Chief Executive Officer and President.
        • Since 2007, Mr. Tarriff has served as a director and the Chief Executive Officer at Eagle Pharmaceuticals, Inc. ("Eagle") (NASDAQ:EGRX). The brother of Mr. Tarriff's fellow Ziopharm director, Scott Braunstein, served on Eagle's Board of Directors from July 2016 to November 2019.
        • Since February 2012, Mr. Tarriff has also been a director on the Board of Synthetic Biologics, Inc. (NYSE:SYN), where shareholders have seen Synthetic Biologic's stock drop from over $70 to less than $1. Ziopharm did not disclose this mark on Mr. Tarriff's record in its November 2nd letter to shareholders.
        • As noted, Mr. Pagán's replacement on the Board – Mr. Buchi – is the Chairman of Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), where Mr. Pagán also serves as Chief Financial Officer.
    • The incumbent Board has rewarded management with excessive and unjustifiable compensation as shareholders have endured unrelenting pain.
      • Ziopharm's consent revocation statement notes that all of the Company's eligible named executive officers received base compensation raises from 2018 to 2019. Dr. Cooper was rewarded with a 14.6% raise in his base compensation. All of this occurred despite the fact that the Company's share price declined by more than 50% over the course of the year ended December 31, 2018.
      • In January 2019, the Board awarded restricted shares and options with a total equity value of more than $3 million to Dr. Cooper and three other executives. Once again, this was provided after the Company's share price declined by more than 50% in 2018.
      • For performance in the year 2019, the Board determined that each member of the executive team met 100% of his individual objectives and paid out more than $1.5 million in bonuses. Dr. Cooper was showered with a more than $1 million bonus despite the fact that Ziopharm's share price has dramatically declined over his tenure. We believe this excessively generous and misaligned compensation system reflects the low-bar objectives set by the Board and is symptomatic of the disease of poor boardroom stewardship.
    • The incumbent Board has championed dilutive actions and tolerated dismal business execution.
      • Since 2017, the Board has overseen multiple public offerings and private placements that have diluted existing shareholders by more than 50%. These share issuances were at prices significantly below the market and led to only $255 million raised.
      • Ziopharm has failed to accelerate the monetization of its attractive immuno-oncology assets, going on for years without a partnership that further validates the Company's therapies and its commercial prospects. We feel the evidence of this failure is embedded within the Company's beaten down shares – and the Board's attempts to point to qualitative accomplishments does not change reality.
      • The Board and management have rewarded themselves with lofty compensation but have not invested in the type of transformative business development and commercialization talent that Ziopharm needs to completely or partially monetize assets.
    • The incumbent Board, under Mr. Tarriff's leadership, has amassed an industry-worst governance profile.
      • One of the leading independent proxy advisory firms, Institutional Shareholder Services, Inc. ("ISS"), shares our view that the Board fosters anti-shareholder practices, as evidenced by its issuance of a score "9" (on a scale of 1-10, with "10" representing the highest governance risk) in its QualityScore Governance Profile Report. It is very unfortunate that this ISS assessment did not serve as a wakeup call to Mr. Tarriff, Dr. Cooper, and other incumbent directors that we believe are focused on their self-interests.
      • ISS recommended shareholders vote "WITHHOLD" with respect to the election of Mr. Braunstein to the Board at the 2020 Annual Meeting due to his service on more than three public company boards while also serving as Chief Executive Officer of a separate public company, noting that "[a] CEO cannot reasonably be expected to balance the responsibilities of serving on more than three public boards while also fulfilling full-time executive duties."
      • In 2019, Mr. Ezickson attended less than 75% of Board and committee meetings. How can directors address investor concerns and effectively evaluate management with 75% participation? Effective boards of directors have strong, robust engagement from all members.

    CHANGE ATOP ZIOPHARM IS NEEDED NOW – SHAREHOLDERS CANNOT AFFORD TO CONTINUE ROLLING THE DICE ON MR. TARRIFF AND THE INCUMBENTS

    Ziopharm's shares are currently trading near a ten-year low because leadership has failed to provide a credible path to unlocking value. To the contrary, it seems to us that Mr. Tarriff and Dr. Cooper only have a roadmap for enriching insiders at the expense of shareholders. We fear that another year under the incumbent Board's leadership may lead Ziopharm toward a de-listing and joining the long list of biotechnology firms that have squandered their potential on route to becoming a penny stock. This is why we have taken the extraordinary action of running a consent solicitation and are seeking to facilitate targeted boardroom changes as quickly as possible.

    Now that WaterMill has exposed Ziopharm's contempt for shareholders and prioritization of insiders, we expect the Company and its growing army of high-priced external consultants – who are paid for with our capital – to continue attacking our slate and disseminating misrepresentations. We urge shareholders to see through the incumbent Board's empty spin and reject any attempts to pass off cosmetic changes as substantive improvements. In our view, any reactionary moves announced by Ziopharm in the weeks to come will represent nothing more than self-preservation tactics and entrenchment maneuvers.

    There is no need for shareholders to continue to roll the dice on Mr. Tarriff and the other three underperforming incumbent directors we are targeting. It is clear to us – and hopefully now other shareholders – that these individuals appear content to run Ziopharm like a rudderless non-profit organization. By removing these individuals and installing our slate of proven business and financial experts, we believe shareholders will finally have a Board that is capable of running the Company like a publicly-traded entity that is supposed to produce value for its shareholders.

    OUR THREE-MEMBER SLATE OF DIRECTOR CANDIDATES IS ALIGNED, EXPERIENCED AND FULLY FOCUSED ON UNLOCKING VALUE

    Although Ziopharm boasts it has "directors with diverse skills and experiences relevant to our industry and operations," recent evidence suggests its Board is most skilled and experienced in presiding over rapid and significant value destruction. We also find it odd that Mr. Tarriff and Dr. Cooper are trying to score points with shareholders by saying they are "executing on the Company's long-term strategy," particularly in light of the fact that this so-called "strategy" has been a recipe for years of losses. Fortunately, our slate will not allow Ziopharm to continue bleeding cash, overpaying underperforming leadership, and wagering all of its remaining equity value on three partnerships that are yet to yield even a hint of value for shareholders.

    We believe a properly reconstituted Board that includes our three director candidates will be able to oversee the implementation of a superior corporate strategy – one that leads to enhanced governance, improved financing decisions that serve shareholders' best interests, and value-enhancing business development opportunities. Our slate's business and financial acumen, commercial vision, and ownership perspectives are the ideal complement to the four Board members that we are not seeking to remove. Our slate includes:

    Director Candidate

    Relevant Experience

    Notable Qualifications and Skills

    Robert Postma

    • Principal and founder of WaterMill Asset Management Corp.
    • Four decades of experience investing across equity and fixed income markets
    • Frequently analyzes, invests in, and engages with healthcare and biotechnology companies
    • Sizable and long-term shareholder of Ziopharm
    • Extensive knowledge of Ziopharm's assets, governance, and financials
    • Strong capital allocation acumen
    • Valuable relationships with prospective industry and financial partners

    Jaime Vieser

    • Manager of Brushwood LLC, a private investment firm
    • Previously Co-Founder and Chief Investment Officer of Castle Hill Asset Management LLC, a multi-billion dollar asset manager
    • Former banker at Deutsche Bank AG and Bankers Trust Company
    • Sizable and long-term shareholder of Ziopharm
    • Deep understanding of Ziopharm's assets, governance, and financials
    • Strong and useful relationships with banks and prospective sources of capital
    • MBA

    Holger Weis

    • Two decades of various c-level business and strategy roles at life science companies
    • Currently Chief Financial Officer of PhenoTarget Biosciences, Inc.
    • Co-author of several scientific papers and presentations
    • Former Ernst & Young executive
    • Deep knowledge of the biotech industry and operational, financial, and strategic planning practices
    • Valuable expertise in financial management, planning, audits, and accounting
    • Extensive knowledge of Ziopharm's assets, governance, and financials
    • Certified Public Accountant

    In the weeks to come, we will release additional information pertaining to our slate and its strategic vision. We are committed to communicating with shareholders in a frequent and transparent manner in order to demonstrate how our slate will act and think upon entering the boardroom.

    Please visit www.FixZiopharm.com and sign up for e-mail alerts in order to receive our updates.

    Thank you for your support.

    Robert Postma

    Principal and Founder

    WaterMill Asset Management Corp.

    ***

    We urge Ziopharm shareholders to consent to all five proposals on the WHITE consent card today and return it in your postage-paid envelope provided. December 11, 2020 is our goal for the submission of written consents. Effectively, this means that you have until December 11, 2020 to consent to the proposals.

    Should you have any questions or need assistance with voting, please contact Saratoga Proxy Consulting LLC at (888) 368-0379 or (212) 257-1311 or by email at .

    PROTECT YOUR INVESTMENT. SIGN, DATE AND RETURN YOUR FILLED OUT WHITE CONSENT CARD TODAY.

    ____________________________

    1 Ziopharm's share price was $4.35 as of market close on October 15, 2019 and the Company's share price was $2.64 as of market close on October 15, 2020 (the day prior to WaterMill filing a preliminary consent statement).

    2 Press release entitled "Ziopharm Files Definitive Consent Revocation Statement and Sends Letter to Shareholders" issued on November 2, 2020.

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  9. -- Q3 2020 net income was $0.52 per basic and $0.51 per diluted share and adjusted non-GAAP net income was $1.19 per basic and $1.17 per diluted share --

    -- Granted Priority Review by U.S. Food and Drug Administration ("FDA") for vasopressin; trial date set for January 11, 2021 --

    -- Held positive Type C meeting with FDA on fulvestrant (EA-114); next step is to submit formal protocol for clinical study --

    -- Promoted Brian Cahill as Eagle's new Chief Financial Officer --

    -- Added experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams --

    -- Japanese licensing partner, SymBio, received approval of TREAKISYM ready-to-dilute formulation, triggering $5.0 million milestone payment to Eagle…

    -- Q3 2020 net income was $0.52 per basic and $0.51 per diluted share and adjusted non-GAAP net income was $1.19 per basic and $1.17 per diluted share --

    -- Granted Priority Review by U.S. Food and Drug Administration ("FDA") for vasopressin; trial date set for January 11, 2021 --

    -- Held positive Type C meeting with FDA on fulvestrant (EA-114); next step is to submit formal protocol for clinical study --

    -- Promoted Brian Cahill as Eagle's new Chief Financial Officer --

    -- Added experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams --

    -- Japanese licensing partner, SymBio, received approval of TREAKISYM ready-to-dilute formulation, triggering $5.0 million milestone payment to Eagle --

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

    Business and Recent Highlights:

    • Received formal notification from FDA granting Priority Review for the Company's abbreviated new drug application ("ANDA") filed for vasopressin. A trial date of January 11, 2021 has been set;
    • Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development;
    • Promoted Brian Cahill as the Company's new Chief Financial Officer. Mr. Cahill has served as Eagle's VP, Finance for the last four years and brings more than 20 years of public company and public accounting experience to the Company;
    • Received Board approval for a $25.0 million accelerated share repurchase transaction with JPMorgan as part of the Company's existing $160.0 million share repurchase program. To date, Eagle has purchased $205.0 million, or approximately 22% of the Company's issued shares, at approximately $55.00 per share;
    • Announced the publication of preclinical research on dantrolene sodium in the peer-reviewed Journal of Alzheimer's Disease. The academic-based study, conducted by Eagle's collaboration partner, the University of Pennsylvania, demonstrated dantrolene sodium improved memory and cognition in a mouse model of Alzheimer's disease;
    • Initiating dose ranging studies in another animal model using intravenous administration of RYANODEX® for the treatment of brain damage secondary to nerve agent exposure and will include an arm using an intramuscular formulation of EA-111. Eagle believes that the preliminary results will allow the Company to update its Special Protocol Assessment with the FDA; 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 plans and projections; the Company has experienced variable financial impacts and has also experienced delays in the timing of certain of its pre-clinical programs and delays in its ongoing litigation matters 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.

    Oncology Highlights:

    • Held a positive Type C meeting with FDA on fulvestrant and is in the process of gaining agreement on the details of the formal protocol for the clinical study;
    • Japanese licensing partner, SymBio, received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency in Japan. The approval covers all currently approved TREAKISYM indications (low-grade non-Hodgkin's lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia) and triggered a $5.0 million milestone payment to Eagle. SymBio's conversion of its current lyophilized formulation of TREAKISYM to Eagle's RTD liquid formulation and commercial launch are expected in January 2021;
    • Centers for Medicare & Medicaid Services established unique Healthcare Common Procedure Coding System 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 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; and
    • 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.

    Third Quarter 2020 Financial Highlights

    • Total revenue for Q3 2020 was $49.9 million, compared to $41.1 million in Q3 2019, primarily reflecting increased product sales of BELRAPZO® and RYANODEX, as well as the $5.0 million milestone from SymBio, partially offset by lower product sales of BENDEKA.
    • Net income for Q3 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss for Q3 2019 of $2.4 million, or ($0.17) per basic and diluted share.
    • Adjusted non-GAAP net income for Q3 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income for Q3 2019 of $3.7 million, or $0.27 per basic and $0.26 per diluted share.
    • Cash and cash equivalents were $89.7 million, net accounts receivable was $52.2 million, and debt was $36.0 million as of September 30, 2020.

    "Our strong third-quarter results demonstrate the efficiency of our business model as we continue to reinvest in our company. This momentum is further supported by multiple near-term product opportunities we are advancing, including vasopressin, fulvestrant, RYANODEX for several indications and PEMFEXY, along with our key partnerships with SymBio for bendamustine and Tyme for pancreatic cancer and other oncology indications. We are also excited to welcome a talented group of pharmaceutical executives to the Eagle team and look forward to their contributions in support of our promising lineup of products and anticipated upcoming launches. The next 12-18 months look to be an active period for Eagle, and I am optimistic about our prospects going forward," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    Third Quarter 2020 Financial Results

    Total revenue for Q3 2020 was $49.9 million, as compared to $41.1 million for Q3 2019.

    Q3 2020 BELRAPZO product sales were $8.7 million, compared to $3.4 million in Q3 2019.

    Q3 2020 RYANODEX product sales were $4.2 million, compared to $2.6 million in Q3 2019.

    Royalty revenue was $27.6 million in the third quarter of 2020, compared to $26.5 million in the third quarter of 2019. BENDEKA royalties were $27.6 million in the third quarter of 2020, compared to $26.2 million in the third quarter of 2019. A summary of total revenue is outlined below:

     

    Three Months Ended September 30,

     

    2020

     

    2019

     

    (unaudited)

     

    (unaudited)

    Revenue (in thousands):

     

     

     

    Product sales

    $17,317

     

    $14,659

    Royalty revenue

    27,611

     

    26,488

    License and other revenue

    5,000

     

    -

    Total revenue

    $49,928

     

    $41,147

    Gross Margin was 76% during the third quarter of 2020, as compared to 64% in the third quarter of 2019. The expansion in gross margin in the third quarter of 2020 was driven by an increase in RYANODEX sales, lower BENDEKA product sales in the period to our marketing partner, on which Eagle earns no profit, the increase in BENDEKA royalty revenue, and the $5.0 million milestone payment from SymBio.

    R&D expense was $4.8 million for the third quarter of 2020, compared to $10.2 million in the third quarter of 2019. The decrease primarily resulted from lower spending on vasopressin and RYANODEX for the treatment of exertional heat stroke, as well as lower stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2020 was $5.3 million.

    SG&A expense in the third quarter of 2020 decreased to $17.7 million compared to $18.5 million in the third quarter of 2019, primarily due to decreases in travel and entertainment expenses, trade show costs, and external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2020 SG&A expense was $11.9 million.

    Net income for the third quarter of 2020 was $7.1 million, or $0.52 per basic and $0.51 per diluted share, compared to net loss of $2.4 million, or ($0.17) per basic and diluted share, in the third quarter of 2019.

    Adjusted non-GAAP net income for the third quarter of 2020 was $16.1 million, or $1.19 per basic and $1.17 per diluted share, compared to adjusted non-GAAP net income of $3.7 million or $0.27 per basic and $0.26 per diluted share in the third 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

    • R&D expense in 2020, on a non-GAAP basis, is expected to be $40-$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 September 30, 2020, the Company had $89.7 million in cash and cash equivalents plus $52.2 million in net accounts receivable, $34.3 million of which was due from Teva. The Company had $36.0 million in outstanding debt. Therefore, as of September 30, 2020, the Company had net cash plus receivables of $105.9 million.

    In the third quarter of 2020, the Company repurchased $28.0 million of its common stock as part of the Company's $160.0 million share repurchase program. From August 2016 through September 30, 2020, the Company repurchased $205.0 million of its common stock.

    Conference Call

    As previously announced, Eagle management will host its Q3 2020 conference call as follows:

    Date

     

     

     

     

     

     

     

     

     

     

     

     

    Monday, November 2, 2020

    Time

     

     

     

     

     

     

     

     

     

     

     

     

    8:30 A.M. ET

    Toll free (U.S.)

     

     

     

     

     

    866-342-8591

    International

     

     

     

     

     

    203-518-9713

    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 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. 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 and ability to update its Special Protocol Assessment with the FDA; the Company's clinical development plan for its fulvestrant product candidate, EA-114, including potential approval of its submitted ANDA for vasopressin, 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 near-term product opportunities and commercial launches and the ability of the leadership team to support the Company's growth; statements regarding the efficiency and strength of the Company's business model; 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 SymBio 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 (the "SEC") on March 2, 2020 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 10, 2020, respectively, 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, except as required by law.

    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 amortization expense, stock-based compensation expense, depreciation expense, expense related to collaboration with Tyme, severance, non-cash interest expense, fair value adjustments on equity investment, fair value adjustments on unsettled accelerated share repurchase agreement 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)
     
     
    September 30, 2020 December 31, 2019
    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    89,681

     

    $

    109,775

     

    Accounts receivable, net

     

    52,199

     

     

    48,004

     

    Inventories

     

    6,586

     

     

    6,566

     

    Prepaid expenses and other current assets

     

    15,330

     

     

    15,104

     

    Total current assets

     

    163,796

     

     

    179,449

     

    Property and equipment, net

     

    2,123

     

     

    2,202

     

    Intangible assets, net

     

    13,584

     

     

    15,583

     

    Goodwill

     

    39,743

     

     

    39,743

     

    Deferred tax asset, net

     

    15,340

     

     

    13,669

     

    Other assets

     

    13,575

     

     

    3,908

     

    Total assets

    $

    248,161

     

    $

    254,554

     

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    13,068

     

    $

    5,462

     

    Accrued expenses and other liabilities

     

    24,445

     

     

    28,361

     

    Current portion of long-term debt

     

    8,000

     

     

    5,000

     

    Total current liabilities

     

    45,513

     

     

    38,823

     

    Other long-term liabilities

     

    2,844

     

     

    3,000

     

    Long-term debt, less current portion

     

    27,017

     

     

    33,557

     

    Total liabilities

     

    75,374

     

     

    75,380

     

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

     

     

     

     

    Common stock, $0.001 par value; 50,000,000 shares authorized; 16,624,681 and 16,537,846 shares issued as of September 30, 2020 and December 31, 2019, respectively

     

    17

     

     

    17

     

    Additional paid in capital

     

    296,198

     

     

    278,518

     

    Retained earnings

     

    76,432

     

     

    72,500

     

    Treasury stock, at cost, 3,594,551 and 2,907,687 shares as of September 30, 2020 and December 31, 2019, respectively

     

    (199,860

    )

     

    (171,861

    )

    Total stockholders' equity

     

    172,787

     

     

    179,174

     

    Total liabilities and stockholders' equity

    $

    248,161

     

    $

    254,554

     

     
    EAGLE PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDTED)
    (In thousands, except share and per share amounts)
     
     
    Three Months Ended September 30, Nine Months Ended September 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:
    Product sales

    $

    17,317

     

    $

    14,659

     

    $

    49,387

     

    $

    58,568

     

    Royalty revenue

     

    27,611

     

     

    26,488

     

     

    83,499

     

     

    80,066

     

    License and other revenue

     

    5,000

     

     

     

     

    5,000

     

     

    9,000

     

    Total revenue

     

    49,928

     

     

    41,147

     

     

    137,886

     

     

    147,634

     

    Operating expenses:
    Cost of product sales

     

    8,726

     

     

    12,137

     

     

    23,804

     

     

    39,866

     

    Cost of royalty revenue

     

    3,260

     

     

    2,785

     

     

    9,120

     

     

    9,440

     

    Research and development

     

    4,828

     

     

    10,172

     

     

    21,390

     

     

    25,504

     

    Selling, general and administrative

     

    17,697

     

     

    18,537

     

     

    60,411

     

     

    53,906

     

    Total operating expenses

     

    34,511

     

     

    43,631

     

     

    114,725

     

     

    128,716

     

    Income (loss) from operations

     

    15,417

     

     

    (2,484

    )

     

    23,161

     

     

    18,918

     

    Interest income

     

    46

     

     

    570

     

     

    542

     

     

    1,701

     

    Interest expense

     

    (489

    )

     

    (628

    )

     

    (2,164

    )

     

    (1,979

    )

    Other expense

     

    (6,049

    )

     

     

     

    (10,249

    )

     

    Total other expense, net

     

    (6,492

    )

     

    (58

    )

     

    (11,871

    )

     

    (278

    )

    Income (loss) before income tax (provision) benefit

     

    8,925

     

     

    (2,542

    )

     

    11,290

     

     

    18,640

     

    Income tax (provision) benefit

     

    (1,866

    )

     

    152

     

     

    (7,358

    )

     

    (5,332

    )

    Net Income (Loss)

    $

    7,059

     

    $

    (2,390

    )

    $

    3,932

     

    $

    13,308

     

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

    $

    0.52

     

    $

    (0.17

    )

    $

    0.29

     

    $

    0.96

     

    Diluted

    $

    0.51

     

    $

    (0.17

    )

    $

    0.28

     

    $

    0.94

     

    Weighted average number of common shares outstanding:
    Basic

     

    13,531,372

     

     

    13,668,091

     

     

    13,620,981

     

     

    13,791,071

     

    Diluted

     

    13,786,803

     

     

    13,668,091

     

     

    13,917,800

     

     

    14,147,658

     

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

     

    2020

     

     

    2019

     

    Cash flows from operating activities:
    Net income

    $

    3,932

     

    $

    13,308

     

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

     

    (1,671

    )

     

    (175

    )

    Depreciation expense

     

    656

     

     

    725

     

    Amortization expense of right-of-use assets

     

    980

     

     

    754

     

    Amortization expense of intangible assets

     

    1,999

     

     

    1,890

     

    Fair value adjustments on equity investment

     

    7,700

     

     

     

    Stock-based compensation expense

     

    18,435

     

     

    16,815

     

    Amortization of debt issuance costs

     

    301

     

     

    282

     

    Fair value adjustments on unsettled accelerated share repurchase agreement

     

    2,549

     

     

     

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

     

    (4,195

    )

     

    21,674

     

    Inventories

     

    (20

    )

     

    1,057

     

    Prepaid expenses and other current assets

     

    (2,774

    )

     

    (253

    )

    Accounts payable

     

    7,606

     

     

    1,315

     

    Accrued expenses and other liabilities

     

    (3,916

    )

     

    3,608

     

    Other assets and other long-term liabilities, net

     

    (1,845

    )

     

    (1,813

    )

    Net cash provided by operating activities

     

    29,737

     

     

    59,187

     

    Cash flows from investing activities:
    Purchase of equity investment security

     

    (17,500

    )

     

     

    Purchase of property and equipment

     

    (577

    )

     

    (647

    )

    Net cash used in investing activities

     

    (18,077

    )

     

    (647

    )

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

     

    555

     

     

    78

     

    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

     

    (3,000

    )

     

    (5,000

    )

    Repurchases of common stock

     

    (27,999

    )

     

    (15,000

    )

    Net cash used in financing activities

     

    (31,754

    )

     

    (20,120

    )

    Net (decrease) increase in cash and cash equivalents

     

    (20,094

    )

     

    38,420

     

    Cash and cash equivalents at beginning of period

     

    109,775

     

     

    78,791

     

    Cash and cash equivalents at end of period

    $

    89,681

     

    $

    117,211

     

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

    $

    3,036

     

    $

    6,587

    Interest

     

    1,878

     

     

    1,787

     

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

     

    842

     

     

    1,700

     

     
    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 September 30, Nine Months Ended September 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Net income (loss) - GAAP

    $

    7,059

     

    $

    (2,390

    )

    $

    3,932

     

    $

    13,308

     

     
    Adjustments:
    Cost of product revenues:
    Amortization expense

     

    261

     

     

    225

     

     

    784

     

     

    675

     

    Research and development:
    Stock-based compensation expense

     

    (514

    )

     

    1,081

     

     

    2,070

     

     

    3,320

     

    Depreciation expense

     

    72

     

     

    71

     

     

    206

     

     

    210

     

    Selling, general and administrative:
    Stock-based compensation expense

     

    5,236

     

     

    4,570

     

     

    16,365

     

     

    13,495

     

    Expense related to collaboration with Tyme

     

    -

     

     

    -

     

     

    2,500

     

     

    -

     

    Amortization expense

     

    405

     

     

    405

     

     

    1,215

     

     

    1,215

     

    Depreciation expense

     

    124

     

     

    171

     

     

    450

     

     

    515

     

    Severance

     

    -

     

     

    -

     

     

    245

     

     

    -

     

     
    Other:
    Non-cash interest expense

     

    118

     

     

    94

     

     

    354

     

     

    282

     

    Fair value adjustments on equity investment

     

    3,500

     

     

    -

     

     

    7,700

     

     

    -

     

    Fair value adjustments on unsettled accelerated share repurchase agreement

     

    2,549

     

     

    -

     

     

    2,549

     

     

    -

     

    Tax effect of the non-GAAP adjustments

     

    (2,663

    )

     

    (556

    )

     

    (2,466

    )

     

    (2,875

    )

     

    Adjusted non-GAAP net income

    $

    16,147

     

    $

    3,671

     

    $

    35,904

     

    $

    30,145

     

     
    Adjusted non-GAAP earnings per share:
    Basic

    $

    1.19

     

    $

    0.27

     

    $

    2.64

     

    $

    2.19

     

    Diluted

    $

    1.17

     

    $

    0.26

     

    $

    2.58

     

    $

    2.13

     

    Weighted number of common shares outstanding:
    Basic

     

    13,531,372

     

     

    13,668,091

     

     

    13,620,981

     

     

    13,791,071

     

    Diluted

     

    13,786,803

     

     

    14,120,025

     

     

    13,917,800

     

     

    14,147,658

     

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

    September 30,
    Nine Months Ended

    September 30,
    Twelve Months Ended

    September 30,
    Twelve Months Ended

    December 31,

    2020

    2019

    2020

    2019

    2020

    2019

    Net income (loss) - GAAP

    $

    7,059

    $

    (2,390

    )

    $

    3,932

    $

    13,308

    $

    4,937

    $

    14,313

     
    Add back:
    Interest expense, net of interest income

     

    443

     

    58

     

     

    1,622

     

    278

     

    1,861

     

    517

    Income tax provision (benefit)

     

    1,866

     

    (152

    )

     

    7,358

     

    5,332

    $

    9,711

     

    7,685

    Depreciation and amortization expense

     

    862

     

    872

     

     

    2,655

     

    2,615

     

    3,532

     

    3,492

     
    Add back:
    Stock-based compensation expense

     

    4,722

     

    5,651

     

     

    18,435

     

    16,815

    $

    23,618

     

    21,998

    Debt issuance cost

     

    -

     

    -

     

     

    -

     

    -

     

    88

     

    88

    Fair value adjustments on equity investment

     

    3,500

     

    -

     

     

    7,700

     

    -

    $

    7,700

     

    -

    Fair value adjustments on unsettled accelerated share repurchase agreement

     

    2,549

     

    2,549

     

    2,549

     

    -

    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

    $

    21,001

    $

    4,039

     

    $

    46,996

    $

    38,348

    $

    57,696

    $

    49,048

     

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  10. -- Key additions deepen scientific, analytics and commercial expertise; positions Eagle to advance product pipeline and prepare for future commercial launches in oncology and critical care businesses --

    -- Promoted Brian Cahill as Eagle's New Chief Financial Officer --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced four additions to its clinical, formulations and commercialization leadership teams: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D. is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development. Dr. Ng-Cashin, Mr. Kimmet, Dr. Curt, and Dr. Zhu will report to David…

    -- Key additions deepen scientific, analytics and commercial expertise; positions Eagle to advance product pipeline and prepare for future commercial launches in oncology and critical care businesses --

    -- Promoted Brian Cahill as Eagle's New Chief Financial Officer --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced four additions to its clinical, formulations and commercialization leadership teams: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D. is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development. Dr. Ng-Cashin, Mr. Kimmet, Dr. Curt, and Dr. Zhu will report to David Pernock, Eagle's President and Chief Operating Officer. In addition, on October 29, 2020, Brian Cahill, Eagle's VP, Finance, was promoted to the role of Chief Financial Officer, and Pete Meyers, Eagle's former Chief Financial Officer, left the Company to pursue other opportunities.

    Eagle's executive team is now comprised of Scott Tarriff, Founder and Chief Executive Officer; David Pernock, President and Chief Operating Officer; Brian Cahill, Chief Financial Officer; Daniel O'Connor, Chief Strategy Officer, Head of Corporate Development; Michael Moran, Executive Vice President, Sales, Business Development and Government Affairs; Michael Cordera, Executive Vice President, General Counsel, Chief Compliance Officer; Judith ("Judi") Ng-Cashin, M.D., EVP and Chief Medical Officer; and John Kimmet, EVP, Oncology and Acute Care Marketing.

    "We are delighted to welcome Judi, John, Valentin, and Gaozhong to the Eagle team. As we strive to advance our programs through the clinical phase and ultimately to the market, we believe we have significantly strengthened our team with the necessary expertise to offer us the best opportunity for near- and long-term success. These new additions, along with our current strong team, provides us with highly focused and experienced individuals to enable us to take full advantage of the opportunities ahead. David Pernock, our President and Chief Operating Officer, continues to be instrumental in providing direction, expertise and leadership; he will coordinate and be responsible for many of the activities of the expanded executive team. Lastly, I would like to congratulate Brian Cahill on his new role and thank Pete Meyers for his many contributions to the Company. With this leadership team in place, we are confident that we are now in the best possible position to execute our strategy and drive future growth," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    Judi Ng-Cashin, M.D., EVP, Chief Medical Officer of Eagle Pharmaceuticals, is an accomplished pharmaceuticals executive and brings more than 17 years of industry experience, with expertise in clinical strategy and drug development across large pharmaceutical companies, contract research organizations ("CROs"), and small biotech entities. Prior to joining Eagle, Dr. Ng-Cashin served as Chief Medical Officer of AoBiome Therapeutics ("ApBiome"). In that role, she was responsible for AoBiome's clinical development function, overseeing the research and development strategy and pipeline, manufacturing strategy, and quality across consumer and pharmaceutical products. Prior to AoBiome, Dr. Ng-Cashin spent several years in leadership roles at CROs, including Syneos Health, where she was responsible for building and leading the Safety and Pharmacovigilance business line, Medical and Scientific Strategy (leveraging scientific expertise and expanding brand), and Biotechnology Strategy functions. Prior to that, Dr. Ng-Cashin held positions of increasing responsibility at GlaxoSmithKline, including clinical development strategy, regulatory and safety oversight, and R&D prioritization. Dr. Ng-Cashin earned a BS in Psychology and a BA in Mathematics from Duke University, and a Doctor of Medicine degree from Rush Medical College. Her areas of medical expertise include infectious diseases, hematology/oncology, and dermatology.

    John Kimmet, EVP, Marketing Oncology and Acute Care of Eagle Pharmaceuticals, brings more than 20 years of experience in the fields of sales, operations, marketing, and data analytics. Prior to joining Eagle, Mr. Kimmet served as Head of Strategic Planning & Decision Analysis at Bristol Myers Squibb ("BMS"). In this role, he led the Strategic Planning & Decision Analysis organization for the U.S. Hematology and Oncology franchise, including responsibility for franchise strategy, digital programs, data and analytics, finance, sales and marketing operations, and market research. Mr. Kimmet led the integration for the commercial franchise as part of the merger between Celgene and BMS. Prior to his Celgene and BMS roles, Mr. Kimmet spent 17 years in the telecom industry with key leadership roles at Verizon and Vodafone, including Executive Director, Marketing for Verizon Enterprise Solutions and Head of Customer Solutions and Service Operations for the Americas at Vodafone. Mr. Kimmet holds a Master's Degree in Business Analytics from New York University and a Master of Business Administration from the Fuqua School of Business at Duke University. Mr. Kimmet also serves on the Forbes (CMO) Marketing Executive Council.

    Valentin R. Curt, M.D., SVP, Clinical Drug Development of Eagle Pharmaceuticals, has over 25 years of experience providing clinical leadership and medical monitoring support for U.S. and global clinical development programs, across multiple therapeutic areas and in all phases of development. His expertise includes managing interactions with global health authorities and contributions to the filing of seven NDAs/BLAs. Dr. Curt joins Eagle from Imbrium Therapeutics, a subsidiary of Purdue Pharma, where he was Executive Medical Director, Clinical R&D and served as Clinical Lead for its oncology portfolio and additional compounds in the CNS space. In prior roles at Daiichi Sankyo and Novartis, Dr. Curt provided clinical leadership for the global registration programs of the novel oral anticoagulant edoxaban (Savaysa®) and of the antihypertensives Diovan®, Co-Diovan® and Exforge® for the Asian markets, respectively, and led the development of additional programs in the thrombosis, acute coronary syndrome, heart failure, and lipid management areas. Previously, Dr. Curt worked with Boehringer Ingelheim as an external Clinical Advisor on neurology/cardiology (Micardis®, Aggrenox®, Mirapex®) and virology (Aptivus®) programs, and has held director-level positions with several biotechnology companies, leading clinical development programs in the areas of oncology and immunology. Dr. Curt holds an M.D. degree from the University of Medicine and Pharmacy of Craiova, in Romania, where he practiced medicine for four years before moving to the United States and joining the pharmaceutical industry.

    Gaozhong Zhu, Ph.D., SVP, Pharmaceutical Development of Eagle Pharmaceuticals, has more than 20 years of industrial experience in developing and implementing chemistry, manufacturing and control strategies for various types of pharmaceuticals, with a proven track record of bringing new products from conception to commercialization. Dr. Zhu joins Eagle from Corvidia Therapeutics, where he was Vice President and Head of Pharmaceutical Development and Manufacturing, bringing expertise in developing various injectables, as well as in new product and technology development. Prior to that, Dr. Zhu held positions of increasing responsibility at Shire and Biogen, where he contributed to the successful development and launch of several major products in various therapeutic areas. Dr. Zhu is an inventor of multiple patents in drug delivery and formulations. He holds a Ph.D. in Pharmaceutics from The Ohio State University and a BS/MS in Chemistry from Peking University.

    Brian Cahill, Chief Financial Officer of Eagle Pharmaceuticals, is a finance and accounting professional with more than 20 years of public company and public accounting experience. His expertise spans financial reporting, GAAP, Securities and Exchange Commission ("SEC") filings, mergers and acquisitions and corporate income tax. Over the past four years, in his roles of Corporate Controller and then VP, Finance, he led Eagle's financial reporting, accounting and treasury functions and played a pivotal role in designing and overseeing the Company's business analytics process that is used for financial controls, management review, and financial reporting. Prior to joining Eagle, Mr. Cahill held Corporate Controller positions at Aralez Pharmaceuticals and Par Pharmaceuticals, where he had broad responsibility for the technical accounting, management and SEC reporting, income tax, revenue controls, payroll, and accounts payable functions. Mr. Cahill also held positions of increasing responsibility at PricewaterhouseCoopers LLP, where he focused on complex accounting, financial statements and reporting and disclosure issues. Mr. Cahill is a Certified Public Accountant and earned a BS in Accounting from Manhattan College.

    "Each of these talented pharmaceutical industry professionals brings a depth and breadth of experience that strengthens our team at this exciting juncture for Eagle. We believe that their collective experience will position us to advance and commercialize our key pipeline products, including EA-114, our fulvestrant product candidate, and multiple potential new RYANODEX indications. Eagle has a number of significant near-term prospects ahead, and we welcome their contributions to capitalize on these opportunities across our oncology and critical care portfolios," stated David Pernock, President and Chief Operating Officer of Eagle Pharmaceuticals.

    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 timing and success of potential product launches and development initiatives for its fulvestrant product candidate, EA-114, and Ryanodex, including new indications for Ryanodex; the Company's expectations with respect to near- and long-term product opportunities and commercial launches; the ability of the leadership team to execute the Company's strategy and support its future growth; statements regarding the strength of the Company's business model; statements regarding the accomplishments, experience and capabilities of individual members of the Company's leadership team and the ability of such qualities to drive the Company's success; 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 SymBio 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 its products or that may have an impact on any of its 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 SEC on March 2, 2020 as updated by its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, filed with the SEC on May 11, 2020 and August 10, 2020, respectively, 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, except as required by law.

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  11. Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 third quarter financial results on Monday, November 2, 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, November 2, 2020

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    866-342-8591

    International

    203-518-9713

    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 800-934-3336 (US) or 402-220-1148 (International) and entering conference…

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that the Company will release its 2020 third quarter financial results on Monday, November 2, 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, November 2, 2020

    Time

    8:30 a.m. ET

    Toll free (U.S.)

    866-342-8591

    International

    203-518-9713

    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 800-934-3336 (US) or 402-220-1148 (International) and entering conference call ID EGRXQ320. 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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  12. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that its Board of Directors has approved a $25 million accelerated share repurchase ("ASR") transaction with JPMorgan Chase Bank, National Association ("JP Morgan") as part of the Company's existing $160 million share repurchase program.

    The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of the Company's common stock, less a discount, during the term of the ASR program. Based on yesterday's closing price, the $25 million ASR would represent approximately 5% of the Company's basic outstanding shares. Upon completion of the ASR, Eagle will have bought back a total of approximately…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that its Board of Directors has approved a $25 million accelerated share repurchase ("ASR") transaction with JPMorgan Chase Bank, National Association ("JP Morgan") as part of the Company's existing $160 million share repurchase program.

    The specific number of shares to be repurchased pursuant to the ASR is based on the average of the daily volume weighted average share prices of the Company's common stock, less a discount, during the term of the ASR program. Based on yesterday's closing price, the $25 million ASR would represent approximately 5% of the Company's basic outstanding shares. Upon completion of the ASR, Eagle will have bought back a total of approximately $205 million of its stock since its IPO in 2014.

    "The $25 million ASR reflects our ongoing confidence in our pipeline and continued earnings potential. With multiple opportunities to expand our RYANODEX franchise, the anticipated near-term launch of vasopressin, and three potential oncology launches in 2022 including PEMFEXY, fulvestrant and SM-88, along with the recent approval received by our Japanese marketing partner, SymBio, for its ready-to-dilute TREAKISYM product, we remain committed to building shareholder value," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    Under the terms of the agreement, Eagle will pay $25 million to JP Morgan on September 24, 2020, and receive 505,817 shares, representing approximately 80% of the notional amount of the ASR, based on the closing price of $39.54 on September 23, 2020. Upon settlement of the ASR, the final number of shares repurchased will be trued up based on the average of the daily volume weighted average share prices of the Company's common stock, less a discount, during the term of the accelerated share repurchase program. Eagle expects the ASR to be completed in the fourth quarter of 2020. As of September 23, 2020, the Company had 13.5 million common shares outstanding.

    The Company intends to use cash on hand to fund the ASR program. As of June 30, 2020, cash and cash equivalents were $108.2 million, net accounts receivable was approximately $46.8 million, and debt was $37 million.

    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 Company's plans to repurchase shares of common stock pursuant to the ASR and the timing of such repurchases; the anticipated outcome of the ASR and the Company's existing share repurchase program; the Company's expectations with respect to financing the ASR; the anticipated growth opportunities for the products and product candidates of the Company and its partners; the Company's expectations with respect to earnings potential; and the Company's ability to deliver value to its stockholders. 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 fluctuation of interest rates; 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, 2019 as updated by the Company's 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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  13. - Eagle to receive $5 million milestone payment -

    - RTD and Rapid Infusion ("RI") formulations could generate $10 million - $25 million annually for Eagle -

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin's lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which…

    - Eagle to receive $5 million milestone payment -

    - RTD and Rapid Infusion ("RI") formulations could generate $10 million - $25 million annually for Eagle -

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today announced that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin's lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which will create another large market opportunity beyond the current indications. As a result of the approval of TREAKISYM, Eagle will receive a $5 million milestone payment.

    With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.

    In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in the second half of 2022. Upon approval of the RI formulation, SymBio intends to convert from the RTD product to the new 50 ml liquid version licensed from Eagle. The RTD and RI liquid formulations bring key benefits to patients and healthcare providers in Japan by eliminating the need for manual reconstitution and significantly reducing preparation time.

    "We are pleased that SymBio has received regulatory approval for TREAKISYM in Japan. SymBio is an innovator, and we look forward to their successful commercialization of the ready-to-dilute bendamustine product, enabling patients in Japan to benefit from TREAKISYM's key advantages. This approval represents another significant extension of the durability of this important franchise and the successful execution of our business development activities to bring value for Eagle and our shareholders," stated Scott Tarriff, Chief Executive Officer.

    According to SymBio, sales in Japan for its current TREAKISYM product totaled $84.8 million in the twelve months ended June 30, 2020. Together, milestones and royalty payments for the RTD and RI formulations could generate from $10 million to $25 million annually for Eagle.

    In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of 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.

    The $5 million milestone payment due upon approval of TREAKISYM RTD is in addition to a $12.5 million upfront milestone payment Eagle received upon execution of the agreement with SymBio. Eagle is entitled to royalties on future net sales and an additional milestone payment upon achievement of a cumulative sales threshold.

    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 Company's ability to successfully collaborate with its Japanese licensing partner, SymBio, with respect to the commercialization of SymBio's product TREAKISYM; the timing of the potential product launch of TREAKISYM; the Company's and SymBio's commercialization strategy for TREAKISYM; the timing of potential future milestone payments from SymBio to the Company, if ever, and the amount of such payments, if any; the timing of approval for the additional indication of r/r/ DLBCL, if at all; and the future commercial success of the 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, 2019 as updated by the Company's 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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  14. 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.

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  15. 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.

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  16. -- 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.