EGRX Eagle Pharmaceuticals Inc.

48.46
-0.44  -1%
Previous Close 48.9
Open 49.58
52 Week Low 33.8
52 Week High 64.94
Market Cap $663,180,818
Shares 13,685,118
Float 8,635,944
Enterprise Value $618,688,270
Volume 285,726
Av. Daily Volume 168,549
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Ryanodex
Exertional heat stroke (EHS)
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Ryanodex
Nerve agent (NA) exposure
sNDA Filing
sNDA Filing
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

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

Latest News

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

    Conference:

    Jefferies Virtual Healthcare Conference

    Date:

    Thursday, June 4, 2020

    Time:

    1:00 p.m. ET

    Webcast:

    http://wsw.com/webcast/jeff126/egrx/

     

    Conference:

    William Blair Virtual 40th Annual Growth Stock Conference

    Date:

    Thursday, June 11, 2020

    Time:

    10:00 a.m. CT / 11:00 a.m. ET

    Webcast:

    http://www.wsw.com/webcast/blair56/egrx

    The presentations will be webcast live at the aforementioned times, and archived for 30 days thereafter, via the Company's…

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

    Conference:

    Jefferies Virtual Healthcare Conference

    Date:

    Thursday, June 4, 2020

    Time:

    1:00 p.m. ET

    Webcast:

    http://wsw.com/webcast/jeff126/egrx/

     

    Conference:

    William Blair Virtual 40th Annual Growth Stock Conference

    Date:

    Thursday, June 11, 2020

    Time:

    10:00 a.m. CT / 11:00 a.m. ET

    Webcast:

    http://www.wsw.com/webcast/blair56/egrx

    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 section.

    About Eagle Pharmaceuticals, Inc.

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

    View Full Article Hide Full Article
  2. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle") announced today that, due to public health and safety concerns related to the ongoing COVID-19 global pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees and others, Eagle is changing its 2020 Annual Meeting of Stockholders (the "Annual Meeting") to a virtual-only format that will be held via live audio webcast. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    The previously announced date and time of the Annual Meeting, Tuesday, June 23, 2020, at 10:00 a.m. Eastern Time, as disclosed…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle") announced today that, due to public health and safety concerns related to the ongoing COVID-19 global pandemic, recommendations and orders from federal, state and local authorities, and to support the health and well-being of its stockholders, employees and others, Eagle is changing its 2020 Annual Meeting of Stockholders (the "Annual Meeting") to a virtual-only format that will be held via live audio webcast. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    The previously announced date and time of the Annual Meeting, Tuesday, June 23, 2020, at 10:00 a.m. Eastern Time, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive Proxy Statement, has not changed. Online access to the Annual Meeting will begin at approximately 9:45 a.m. Eastern Time. Stockholders will not be able to attend the Annual Meeting in person.

    Attending the Virtual Meeting as a Stockholder of Record

    Eagle stockholders of record as of April 27, 2020 (the "Record Date") can register to attend the Annual Meeting by accessing the meeting center at www.virtualshareholdermeeting.com/EGRX and entering the 16-digit control number on the proxy card or Notice of Internet Availability of Proxy Materials previously received. The webcast of the Annual Meeting will be archived for one year after the date of the Annual Meeting at www.virtualshareholdermeeting.com/EGRX. Instructions on how to connect to the Annual Meeting and participate via the Internet, including how to demonstrate proof of stock ownership, are posted at www.virtualshareholdermeeting.com/EGRX.

    If you do not have your 16-digit control number, you will be able to access and listen to the Annual Meeting, but you will not be able to vote your shares or submit questions during the Annual Meeting. See caption below titled caption "Attending the Annual Meeting as a Guest."

    Attending the Annual Meeting as a Beneficial Owner

    We have been advised by Broadridge that beneficial stockholders as of the Record Date (i.e. shares held in "street name" through an intermediary, such as a bank or broker) who want to attend the Annual Meeting virtually can attend using the 16-digit control number found on the notice and instructions received from their broker or other nominee.

    Asking Questions

    If you are attending the Annual Meeting as stockholder of record or beneficial owner, questions can be submitted by accessing the meeting center at www.virtualshareholdermeeting.com/EGRX and entering your 16-digit control number. Instructions on how to participate in the Annual Meeting are posted at www.virtualshareholdermeeting.com/EGRX.

    Voting Shares

    Stockholders of record and beneficial owners who have obtained a legal proxy from the holder of record will be able to vote their shares electronically during the Annual Meeting by using their 16-digit control number. Instructions on how to vote while participating in the Annual Meeting live via the Internet are posted at www.virtualshareholdermeeting.com/EGRX.

    Whether or not stockholders plan to virtually attend the Annual Meeting, Eagle urges them to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.

    The proxy materials, including the proxy card and Notice of Internet Availability of Proxy Materials, previously distributed along with the definitive proxy statement will not be updated to reflect the change in location and may continue to be used to vote shares in connection with the Annual Meeting.

    Attending the Annual Meeting as a Guest

    Guests may enter the Annual Meeting in "listen-only" mode by entering the Annual Meeting at www.virtualshareholdermeeting.com/EGRX and entering the information requested in the "Guest Login" section. Guests will not have the ability to vote or ask questions during the Annual Meeting.

    List of Stockholders

    A list of stockholders entitled to vote at the Annual Meeting will be available for examination for any purpose germane to the Annual Meeting during normal business hours for ten days prior to the Annual Meeting at our corporate headquarters. To the extent office access is impracticable due to the recent COVID-19 pandemic, you may email us at for alternative arrangements. The stockholder list will also be available during the Annual Meeting at www.virtualshareholdermeeting.com/EGRX. Instructions on how stockholders of record can view the stockholder list during the Annual Meeting are posted at www.virtualshareholdermeeting.com/EGRX.

    About Eagle Pharmaceuticals, Inc.

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

    View Full Article Hide Full Article
  3. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference as follows:

    Date:   Tuesday, May 19, 2020
    Time:   3:05 p.m. Eastern Time
    Webcast:   https://www.veracast.com/webcasts/rbc/healthcare2020/01112239705.cfm

    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…

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference as follows:

    Date:   Tuesday, May 19, 2020
    Time:   3:05 p.m. Eastern Time
    Webcast:   https://www.veracast.com/webcasts/rbc/healthcare2020/01112239705.cfm

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

    About Eagle Pharmaceuticals, Inc.

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

    View Full Article Hide Full Article
  4. -- Q1 2020 net loss was ($0.21) per basic and diluted share and adjusted non-GAAP net income was $0.86 per basic and $0.84 per diluted share --

    -- Advanced novel fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition in advanced hormone-receptor ("HR")-positive breast cancer --

    -- Received favorable patent litigation decision for BENDEKA® (bendamustine hydrochloride injection); ANDA holders to be enjoined from launching prior to 2031 --

    -- Preparing for multiple potential product launches in the next three years; 13 ongoing initiatives underway including six additional potential new indications for RYANODEX --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company…

    -- Q1 2020 net loss was ($0.21) per basic and diluted share and adjusted non-GAAP net income was $0.86 per basic and $0.84 per diluted share --

    -- Advanced novel fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition in advanced hormone-receptor ("HR")-positive breast cancer --

    -- Received favorable patent litigation decision for BENDEKA® (bendamustine hydrochloride injection); ANDA holders to be enjoined from launching prior to 2031 --

    -- Preparing for multiple potential product launches in the next three years; 13 ongoing initiatives underway including six additional potential new indications for RYANODEX --

    Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced financial results for the three months ended March 31, 2020.

    Business and Recent Highlights:

    • Despite the ongoing COVID-19 pandemic, the Company has not experienced any impact 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;
    • Advanced pilot work on proprietary formulation of fulvestrant product candidate, EA-114, for HR-positive advanced breast cancer, met internal objectives, and requested additional meeting with U.S. Food and Drug Administration ("FDA") to discuss regulatory path forward;
    • Submitted Investigational New Drug ("IND") application to FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of RYANODEX (dantrolene sodium) in patients infected with SARS-CoV-2, the virus causing the COVID-19 pandemic;
    • 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 ANDA products. Defendants will be enjoined from launching their ANDA products before 2031;
    • Received United States Court of Appeals for the D.C. Circuit affirmation of district court decision requiring FDA to recognize seven years of orphan drug exclusivity for BENDEKA. Accordingly, the Company does not believe other bendamustine products to treat the same indication, unless clinically superior to BENDEKA, will enter the market before 2022;
    • July 8, 2020 Prescription Drug User Fee Act ("PDUFA") date for the Company's resubmitted New Drug Application ("NDA") for RYANODEX for the treatment of exertional heat stroke ("EHS"), in conjunction with body cooling;
    • Letter requesting summary judgment of non-infringement related to vasopressin filed with the United States District Court for the District of Delaware on April 17, after May trial date was postponed due to the COVID pandemic. Eagle is the first to file an ANDA referencing VASOSTRICT, 20 units/1mL;
    • SymBio, the Company's Japanese licensing partner, announced completion of patient enrollment in its clinical trial for TREAKISYM Rapid Infusion ("RI"), a liquid bendamustine injection with a ten-minute administration time, with expected regulatory approval in the second half of 2022. Eagle is entitled to a $5 million milestone payment upon approval of either TREAKISYM Ready-to-Dilute, filed on October 7, 2019, or RI, as well as royalties and milestones that could total $10 to $25 million per year if SymBio first launches TREAKISYM RTD and then its RI product;
    • Received final approval from FDA for PEMFEXY™, a branded alternative to ALIMTA®, following settlement of patent litigation with Eli Lilly and Company. This allows for 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;
    • Announced collaboration and agreement on terms for an exclusive worldwide license with the University of Pennsylvania to develop dantrolene sodium for the potential treatment of people living with Alzheimer's disease;
    • Entered into strategic collaboration with Tyme Technologies Inc. ("Tyme") to advance SM-88, a modified tyrosine derivative, for the treatment of cancer patients. Eagle made an initial investment of $20 million and will be responsible for 25% of the promotional sales efforts of SM-88 and will receive 15% royalty on net revenues of SM-88 in the United States. Tyme retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase Eagle's U.S. co-promotion right for $200 million; and
    • Entered into a research agreement with NorthShore University HealthSystem to study RYANODEX for the treatment of traumatic brain injury, including concussion, for which there are currently no drug treatments.

    Financial Highlights

    • Total revenue for Q1 2020 was $46.0 million, compared to $49.8 million in Q1 2019, primarily reflecting lower product sales of BENDEKA, partially offset by higher product sales of RYANODEX and BELRAPZO®.
    • Net loss for Q1 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income for Q1 2019 of $9.0 million, or $0.64 per basic and $0.62 per diluted share.
    • Adjusted non-GAAP net income for Q1 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income for Q1 2019 of $14.6 million, or $1.05 per basic and $1.01 per diluted share.
    • Cash and cash equivalents were $202.0 million, net accounts receivable was $54.5 million, and debt was $148.0 million as of March 31, 2020.
    • Approved a new share repurchase program, which replaced the Company's existing share repurchase program, providing for the repurchase of up to an aggregate of $160.0 million of the Company's outstanding common stock.

    "The momentum from late last year has continued into the first quarter of 2020, including advancing fulvestrant, receiving extended patent protection and orphan drug exclusivity affirmation for BENDEKA, and proceeding with other initiatives for RYANODEX. We believe that we are well positioned to realize the full potential of our robust portfolio of oncology and CNS/metabolic critical care products and pipeline candidates, given our strong cash flow and several potential near-term catalysts," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    First Quarter 2020 Financial Results

    Total revenue for Q1 2020 was $46.0 million, as compared to $49.8 million for Q1 2019.

    Q1 2020 BELRAPZO product sales were $4.6 million, compared to $3.2 million in Q1 2019.

    Q1 2020 RYANODEX product sales were $11.4 million, compared to $4.0 million in Q1 2019.

    Royalty revenue was $28.3 million in the first quarter of 2020, compared to $26.3 million in the first quarter of 2019. BENDEKA royalties were $28.0 million in the first quarter of 2020, compared to $26.0 million in the first 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

    $17,694

     

    $14,472

    Royalty revenue

    28,326

     

    26,313

    License and other revenue

    -

     

    9,000

    Total revenue

    $46,020

     

    $49,785

    Gross margin was 83% during the first quarter of 2020, as compared to 74% in the first quarter of 2019. The expansion in gross margin in the first 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 $9.4 million for the first quarter of 2020, compared to $6.4 million in the first quarter of 2019. The year-over-year increase is largely attributable to spending related to its fulvestrant product candidate as well as payroll expenses. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the first quarter of 2020 was $7.8 million.

    SG&A expense in the first quarter of 2020 increased to $24.8 million compared to $18.1 million in the first quarter of 2019. External legal spend, external sales and marketing spend, and stock-based compensation expense, as well as a $2.5 million expense related to the collaboration with Tyme, account for most of the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, first quarter 2020 SG&A expense was $15.5 million.

    Net loss for the first quarter of 2020 was $2.9 million, or ($0.21) per basic and diluted share, compared to net income of $9.0 million, or $0.64 per basic and $0.62 per diluted share, in the first quarter of 2019.

    Adjusted non-GAAP net income for the first quarter of 2020 was $11.7 million, or $0.86 per basic and $0.84 per diluted share, compared to adjusted non-GAAP net income of $14.6 million or $1.05 per basic and $1.01 per diluted share in the first 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 spend in 2020, on a non-GAAP basis, is expected to be $46-$50 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 March 31, 2020, the Company had $202.0 million in cash and cash equivalents plus $54.5 million in net accounts receivable, $34.5 million of which was due from Teva. The Company had $148 million in outstanding debt, including $110.0 million drawn on its revolving credit facility. Therefore, at March 31, 2020, the Company had net cash plus receivables of $108.5 million. Since March 31, the Company has re-paid the full $110.0 million drawn under its revolving credit facility.

    On March 17, 2020, the Company announced that Eagle's Board of Directors approved a new share repurchase program, which replaced the Company's existing share repurchase program providing for the repurchase of up to an aggregate of $160.0 million of the Company's outstanding common stock. In the first quarter of 2020, the Company repurchased $1.0 million of Eagle's common stock as part of the share repurchase program. From August 2016 through March 31, 2020, the Company repurchased $172.9 million of its common stock.

    Conference Call

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

     

    Date

     

     

     

     

     

     

     

     

     

     

     

     

    Monday, May 11, 2020

     

    Time

     

     

     

     

     

     

     

     

     

     

     

     

    8:30 A.M. ET

     

    Toll free (U.S.)

     

     

     

     

     

    877-876-9173

     

    International

     

     

     

     

     

    785-424-1667

     

    Webcast (live and replay)

     

     

     

     

     

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

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

    A replay of the conference call will be available for one week after the call's completion by dialing 800-839-6803 (US) or 402-220-6056 (International) and entering conference call ID EGRXQ120. 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 anticipated and potential 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; 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 to be a possible therapeutic option for patients with SARS-CoV-2 infection and expansion into other potential indications; preclinical data of RYANODEX for the treatment of patients with SARS-CoV-2 infection and the progress and development of RYANODEX in a Phase 2 clinical trial evaluating RYANODEX as a treatment for patients with SARS-CoV-2 infection; the potential for other products treating the same indication as BENDEKA entering the market before 2022; the potential of dantrolene sodium as a treatment for Alzheimer's disease; the timing of the Company's PEMFEXY launch, if ever; the success of the Company's collaborations with its strategic partners; 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 expense guidance for fiscal year 2020; 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 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, including RYANODEX, BENDEKA and BELRAPZO; the success of the Company's relationships with its partners, including Hackensack University Medical Center, the University of Pennsylvania, Teva, Tyme and NorthShore University HealthSystem and the parties' ability to work effectively together; the availability and pricing of third party sourced products and materials; the outcome of litigation involving any of our products or that may have an impact on any of our products; successful compliance with the FDA and other governmental regulations applicable to product approvals, manufacturing facilities, products and/or businesses; general economic conditions, including the potential adverse effects of public health issues, including the COVID-19 pandemic, on economic activity and the performance of the financial markets generally; the strength and enforceability of the Company's intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology companies and the potential for competition from generic entrants into the market; the risks inherent in the early stages of drug development and in conducting clinical trials; and those risks and uncertainties identified in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 2, 2020 and its other subsequent filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

    Non-GAAP Financial Performance Measures

    In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted non-GAAP net income and adjusted non-GAAP earnings per share attributable to Eagle. The Company believes these measures provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.

    Adjusted non-GAAP net income excludes stock-based compensation expense, depreciation expense, amortization expense, severance, non-cash interest expense, expense related to collaboration with Tyme, fair value adjustments on equity investment, and the tax effect of these adjustments. The Company believes these non-GAAP financial measures help indicate underlying trends in the Company's business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company's baseline performance before items that are considered by the Company not to be reflective of the Company's ongoing results. See the attached Reconciliation of GAAP to Adjusted Non-GAAP Net Income and Adjusted Non-GAAP Earnings per Share and Reconciliation of GAAP to Adjusted Non-GAAP EBITDA for details of the amounts excluded and included to arrive at adjusted non-GAAP net income, adjusted non-GAAP earnings per share amounts, and adjusted non-GAAP EBITDA amounts, respectively.

    These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. The Company strongly encourages investors to review its consolidated financial statements and publicly-filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.

    -- Financial tables follow –

     

    EAGLE PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except share amounts)
     
    March 31, 2020 December 31, 2019
    (unaudited)
    ASSETS
    Current assets:
    Cash and cash equivalents

    $

    202,016

     

    $

    109,775

     

    Accounts receivable, net

     

    54,491

     

     

    48,004

     

    Inventories

     

    8,434

     

     

    6,566

     

    Prepaid expenses and other current assets

     

    10,631

     

     

    15,104

     

    Total current assets

     

    275,572

     

     

    179,449

     

    Property and equipment, net

     

    2,423

     

     

    2,202

     

    Intangible assets, net

     

    14,917

     

     

    15,583

     

    Goodwill

     

    39,743

     

     

    39,743

     

    Deferred tax asset, net

     

    13,759

     

     

    13,669

     

    Other assets

     

    15,530

     

     

    3,908

     

    Total assets

    $

    361,944

     

    $

    254,554

     

    LIABILITIES AND STOCKHOLDERS' EQUITY
    Current liabilities:
    Accounts payable

    $

    9,756

     

    $

    5,462

     

    Accrued expenses and other liabilities

     

    20,123

     

     

    28,361

     

    Current portion of long-term debt

     

    116,000

     

     

    5,000

     

    Total current liabilities

     

    145,879

     

     

    38,823

     

    Other long-term liabilities

     

    3,454

     

     

    3,000

     

    Long-term debt, less current portion

     

    30,781

     

     

    33,557

     

    Total liabilities

     

    180,114

     

     

    75,380

     

    Commitments and Contingencies
    Stockholders' equity:
    Preferred stock, 1,500,000 shares authorized and no shares issued or outstanding as of March 31, 2020 and December 31, 2019
    Common stock, $0.001 par value; 50,000,000 shares authorized; 16,597,814 and 16,537,846 shares issued as of March 31, 2020 and December 31, 2019, respectively

     

    17

     

     

    17

     

    Additional paid in capital

     

    285,044

     

     

    278,518

     

    Retained earnings

     

    69,629

     

     

    72,500

     

    Treasury stock, at cost, 2,933,320 and 2,907,687 shares as of March 31, 2020 and December 31, 2019, respectively

     

    (172,860

    )

     

    (171,861

    )

    Total stockholders' equity

     

    181,830

     

     

    179,174

     

    Total liabilities and stockholders' equity

    $

    361,944

     

    $

    254,554

     

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

     

    2020

     

     

    2019

     

     
    Revenue:
    Product sales

    $

    17,694

     

    $

    14,472

     

    Royalty revenue

     

    28,326

     

     

    26,313

     

    License and other revenue

     

    9,000

     

    Total revenue

     

    46,020

     

     

    49,785

     

    Operating expenses:
    Cost of product sales

     

    4,765

     

     

    9,554

     

    Cost of royalty revenue

     

    3,038

     

     

    3,546

     

    Research and development

     

    9,427

     

     

    6,375

     

    Selling, general and administrative

     

    24,755

     

     

    18,141

     

    Total operating expenses

     

    41,985

     

     

    37,616

     

    Income from operations

     

    4,035

     

     

    12,169

     

    Interest income

     

    346

     

     

    494

     

    Interest expense

     

    (889

    )

     

    (686

    )

    Other expense

     

    (6,500

    )

    Total other expense, net

     

    (7,043

    )

     

    (192

    )

    (Loss) Income before income tax benefit (provision)

     

    (3,008

    )

     

    11,977

     

    Income tax benefit (provision)

     

    137

     

     

    (3,004

    )

    Net (Loss) Income

    $

    (2,871

    )

    $

    8,973

     

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

    $

    (0.21

    )

    $

    0.64

     

    Diluted

    $

    (0.21

    )

    $

    0.62

     

    Weighted average number of common shares outstanding:
    Basic

     

    13,667,606

     

     

    13,925,227

     

    Diluted

     

    13,667,606

     

     

    14,418,211

     

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

     

    2020

     

     

    2019

     

    Cash flows from operating activities:
    Net (loss) income

    $

     

    (2,871

    )

    $

     

    8,973

     

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

     

    (90

    )

     

    (287

    )

    Depreciation expense

     

    472

     

     

    503

     

    Amortization expense

     

    666

     

     

    630

     

    Fair value adjustments on equity investment

     

    6,500

     

    Stock-based compensation expense

     

    7,472

     

     

    5,782

     

    Amortization of debt issuance costs

     

    65

     

     

    94

     

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

     

    (6,487

    )

     

    2,556

     

    Inventories

     

    (1,868

    )

     

    (1,961

    )

    Prepaid expenses and other current assets

     

    4,473

     

     

    4,368

     

    Accounts payable

     

    4,294

     

     

    6,869

     

    Accrued expenses and other liabilities

     

    (8,238

    )

     

    (1,083

    )

    Other assets and other long-term liabilities, net

     

    (1,230

    )

     

    (263

    )

    Net cash provided by operating activities

     

    3,158

     

     

    26,181

     

    Cash flows from investing activities:
    Purchase of equity investment security

     

    (17,500

    )

    Purchase of property and equipment

     

    (472

    )

     

    (177

    )

    Net cash used in investing activities

     

    (17,972

    )

     

    (177

    )

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

     

    330

     

     

    42

     

    Employee withholding taxes related to stock-based awards

     

    (1,276

    )

     

    (198

    )

    Proceeds from existing revolving credit facility

     

    110,000

     

    Payment of debt

     

    (1,000

    )

     

    (2,500

    )

    Repurchases of common stock

     

    (999

    )

    Net cash provided by (used in) financing activities

     

    107,055

     

     

    (2,656

    )

    Net increase in cash and cash equivalents

     

    92,241

     

     

    23,348

     

    Cash and cash equivalents at beginning of period

     

    109,775

     

     

    78,791

     

    Cash and cash equivalents at end of period

    $

     

    202,016

     

    $

     

    102,139

     

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

    $

     

    24

     

    $

     

    (6,490

    )

    Interest

     

    576

     

     

    625

     

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

     

    842

     

     

    2,871

     

     
    EAGLE PHARMACEUTICALS, INC.
    RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME AND
    ADJUSTED NON-GAAP EARNINGS PER SHARE
    (In thousands, except share and per share amounts)
    (unaudited)
     
    Three Months Ended March 31,

     

    2020

     

     

    2019

     

    Net (loss) income - GAAP

    $

    (2,871

    )

    $

    8,973

     

     
    Adjustments:
    Cost of product revenues:
    Amortization expense

     

    261

     

     

    225

     

    Research and development:
    Stock-based compensation expense

     

    1,550

     

     

    1,143

     

    Depreciation expense

     

    177

     

     

    69

     

    Selling, general and administrative:
    Stock-based compensation expense

     

    5,922

     

     

    4,639

     

    Expense related to collaboration with Tyme

     

    2,500

     

     

    -

     

    Amortization expense

     

    405

     

     

    405

     

    Depreciation expense

     

    74

     

     

    172

     

    Severance

     

    245

     

     

    -

     

     
    Other:
    Non-cash interest expense

     

    118

     

     

    94

     

    Fair value adjustments on equity investment

     

    6,500

     

     

    -

     

    Tax effect of the non-GAAP adjustments

     

    (3,179

    )

     

    (1,091

    )

     
    Adjusted non-GAAP net income

    $

    11,702

     

    $

    14,629

     

     
    Adjusted non-GAAP earnings per share:
    Basic

    $

    0.86

     

    $

    1.05

     

    Diluted

    $

    0.84

     

    $

    1.01

     

    Weighted number of common shares outstanding:
    Basic

     

    13,667,606

     

     

    13,925,227

     

    Diluted

     

    14,000,932

     

     

    14,418,211

     

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

    Three Months Ended March 31,

     

    Twelve Months

    Ended March 31,

     

    Twelve Months Ended

    December 31,

     

    2020

     

     

     

    2019

     

     

    2020

     

     

    2019

     
    Net (loss) income - GAAP

    $

    (2,871

    )

    $

    8,973

    $

    2,469

    $

    14,313

     
    Add back:
    Interest expense, net of interest income

     

    543

     

     

    192

     

    868

     

    517

    Income tax (benefit) provision

     

    (137

    )

     

    3,004

     

    4,544

     

    7,685

    Depreciation and amortization expense

     

    917

     

     

    871

     

    3,538

     

    3,492

     
    Add back:
    Stock-based compensation expense

     

    7,472

     

     

    5,782

     

    23,688

     

    21,998

    Debt issuance cost

     

    -

     

     

    -

     

    88

     

    88

    Fair value adjustments on equity investment

     

    6,500

     

     

    -

     

    6,500

     

    -

    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

    $

    15,169

     

    $

    18,822

    $

    45,395

    $

    49,048

     

    View Full Article Hide Full Article
  5. Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today provided an update on its pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes.

    "As discussed on our March 2nd earnings call, we have continued to refine our EA-114 program, collected additional pilot data, and are pleased with our progress. We have had two meetings with FDA and will request another meeting to discuss these data. With FDA's guidance, we hope to move ahead with our plans. We look forward to providing additional updates on the progress of this potential drug treatment for hormone-receptor ("HR")-positive…

    Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ:EGRX) today provided an update on its pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes.

    "As discussed on our March 2nd earnings call, we have continued to refine our EA-114 program, collected additional pilot data, and are pleased with our progress. We have had two meetings with FDA and will request another meeting to discuss these data. With FDA's guidance, we hope to move ahead with our plans. We look forward to providing additional updates on the progress of this potential drug treatment for hormone-receptor ("HR")-positive advanced breast cancer," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

    "A substantial number of women with advanced HR-positive breast cancer receiving standard treatment experience early disease progression," said Adrian Hepner, Chief Medical Officer of Eagle Pharmaceuticals. "Low and inconsistent estrogen receptor inhibition often results in suboptimal treatment, which may lead to faster progression of the disease. Our research suggests that we may have a better approach."

    About Fulvestrant

    Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the FDA for the treatment of advanced hormone-related breast cancers. The therapeutic effect of fulvestrant involves its ability to competitively inhibit estrogen-stimulated cell division by binding to the ERs in cancer cells, which may reduce cancer cell proliferation.

    Fulvestrant is indicated as a monotherapy treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy, or as a combination therapy for the treatment of: (1) HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy, or (2) HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with palbociclib or abemaciclib, in women with disease progression after endocrine therapy.

    About Breast Cancer

    Breast cancer is the most commonly diagnosed cancer in women, with approximately 290,000 women diagnosed in the U.S. annually and more than 2.8 million breast cancer survivors in the U.S. today. HR-positive breast cancer is the most common clinical subtype, with the ER being expressed in approximately 75% of those diagnosed.

    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. These statements may be identified by the words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" or other similar terms or expressions. All statements other than statements of historical fact could be deemed forward looking, including, but not limited to, statements regarding Eagle's plans for clinical development of its fulvestrant product candidate, EA-114, including the reporting of results and timing of completion of the pilot study and its communications with the FDA; the potential benefits and efficacy of EA-114, including its ability to achieve a greater level of ER inhibition; and the potential for EA-114 to be a possible therapeutic option for HR-positive advanced breast cancer. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, but are not limited to, the uncertainty related to the impact of the COVID-19 pandemic on Eagle's clinical development plans for its product candidates, including EA-114; delay in or failure to obtain regulatory approval of Eagle's product candidates, including EA-114; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Eagle's product candidate and namely, unexpected concerns that may arise from additional data, analysis or results obtained during the pilot clinical study; that regulatory authorities may require additional information or further studies; as well as those risks and uncertainties described in the section titled "Risk Factors" section of Eagle's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission on March 2, 2020 and its other subsequent filings with the Securities and Exchange Commission. All information in this press release speaks only as of the date of this press release, and Eagle undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    View Full Article Hide Full Article
View All Eagle Pharmaceuticals Inc. News