EGRX Eagle Pharmaceuticals Inc.

46.99
+0.33  (+1%)
Previous Close 46.66
Open 45.88
52 Week Low 33.8
52 Week High 62.41
Market Cap $612,285,809
Shares 13,030,130
Float 7,980,956
Enterprise Value $557,805,071
Volume 86,897
Av. Daily Volume 140,237
Stock charts supplied by TradingView

Drug Pipeline

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

Latest News

  1. Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that 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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  2. 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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  3. -- 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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  4. -- 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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  5. 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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