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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities Exchange
Act of 1934
Date of Report (Date of earliest event reported): May 28, 2024
Eagle
Pharmaceuticals, Inc.
(Exact Name of Registrant
as Specified in its Charter)
Delaware |
001-36306 |
20-8179278 |
(State
or Other Jurisdiction |
(Commission |
(IRS Employer |
of Incorporation) |
File Number) |
Identification No.) |
50
Tice Boulevard, Suite 315
Woodcliff Lake, NJ |
|
07677 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone
number, including area code: (201) 326-5300
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
EGRX |
|
The
Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events.
On May 28, 2024, Eagle
Pharmaceuticals, Inc. (the “Company”) requested a hearing before a hearings panel (the “Panel”) of The
Nasdaq Stock Market LLC (“Nasdaq”) following the Company’s previously disclosed receipt of a
notice from Nasdaq advising the Company that Nasdaq has initiated a process to delist the Company’s securities from
Nasdaq because the Company had not filed with the Securities and Exchange Commission (the “SEC”) its Form 10-Q for
the quarter ended September 30, 2023 (the “Q3 2023 Form 10-Q”) and its Form 10-K for the year ended
December 31, 2023 by May 13, 2024, and advising that the Company’s failure to timely file its Form 10-Q
for the quarter ended March 31, 2024 serves as an additional and separate basis for delisting. On May 28, 2024, in response to
its request, the Company was notified by Nasdaq that an oral hearing has been scheduled for July 11, 2024. The hearing request
automatically stayed the suspension of the Company’s common stock for 15 days from the date of the request. In connection with
the hearing request, the Company also requested that the stay be extended through the conclusion of the hearing process and the
expiration of any additional extension period that may be potentially granted by the Panel following the hearing. In that regard,
pursuant to the Nasdaq Listing Rules, the Panel may grant an additional extension period not to exceed 360 days from the initial due
date of the Q3 2023 Form 10-Q.
There can be no assurance that any hearing before
the Panel would be successful, that an extended stay or additional extension would be granted or, if granted, the duration thereof, that
the Company will be able to regain compliance with the Rule or maintain compliance with the other continued listing requirements
set forth in the Nasdaq Listing Rules or that the Company will be able to continue its listing on Nasdaq. In the event an extended
stay is not granted, the Company's securities would be immediately suspended as soon as following 15 days from the date of the Company’s
hearing request and would remain suspended unless the Panel determines to reinstate the securities following the hearing. See the Company’s
Current Report on Form 8-K filed on May 22, 2024, incorporated herein by reference, for further information regarding the notice
from Nasdaq.
Forward-Looking Statements
This current report on Form 8-K contains
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other
securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,”
“forward,” “will,” “would,” “could,” “may,” “intend,” “remain,”
“regain,” “maintain,” “potential,” “prepare,” “expected,” “believe,”
“plan,” “seek,” “continue,” “estimate,” “and similar expressions are intended to
identify forward-looking statements. These statements include, but are not limited to, statements with respect to: the Company’s
SEC filings and the timing thereof, the potential hearing process and the potential to obtain any additional extensions or stays from
Nasdaq and, if obtained, the duration thereof, and the Company’s ability to regain or maintain compliance with the Nasdaq Listing
Rules or continue its listing on Nasdaq, and the outcome of any hearing process, the Company’s internal control over financial
reporting and disclosure controls and procedures and related remediation, the expected restatement of financial statements, the time and
effort required to complete the Company’s financial statements, expectations with respect to filings with the SEC and the timing
and content thereof, and the Company’s expectations regarding its financial results. 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 completion of the review and preparation of the Company’s financial
statements and internal control over financial reporting and disclosure controls and procedures and the timing thereof; the discovery
of additional information; further delays in the Company’s financial reporting, including as a result of unanticipated factors;
the Company’s ability to comply with its obligations under its credit agreement; the possibility that the Company will be unable
to regain compliance with, or thereafter continue to comply with, the Nasdaq Listing Rules, or experience violations of additional Nasdaq
Listing Rules; the possibility that Nasdaq may suspend and delist the Company’s securities; the Company’s ability to remediate
material weaknesses in its internal control over financial reporting; the Company’s ability to recruit and hire a new Chief Executive
Officer and new Chief Financial Officer; the ability of the Company to realize the anticipated benefits of its plan designed to improve
operational efficiencies and realign its sales and marketing expenditures and the potential impacts thereof; the impacts of the post-
COVID-19 environment and geopolitical factors such as the conflicts between Russia and Ukraine and Hamas and Israel; delay in or failure
to obtain regulatory approval of the Company’s or its partners’ product candidates and successful compliance with Federal
Drug Administration, European Medicines Agency and other governmental regulations applicable to product approvals; changes in the regulatory
environment; the uncertainties and timing of the regulatory approval process; whether the Company can successfully market and commercialize
its products; the success of the Company's relationships with its partners; the outcome of litigation; 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 competition from generic entrants into the market; unexpected safety or efficacy data observed during clinical trials; clinical
trial site activation or enrollment rates that are lower than expected; the risks inherent in drug development and in conducting clinical
trials; risks inherent in estimates or judgments relating to the Company’s critical accounting policies, or any of the Company’s
estimates or projections, which may prove to be inaccurate; unanticipated factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance and may cause the Company’s actual results and outcomes to materially differ from
its estimates, projections and guidance; and those risks and uncertainties identified in the “Risk Factors” sections of the
Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 23, 2023,
the Company’s Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023,
and for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023, and its subsequent filings with the SEC. Readers
are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements contained in this current
report on Form 8-K speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes
no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Date: May 29, 2024 |
|
|
|
EAGLE PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/
Michael Graves |
|
|
Michael Graves |
|
|
Interim Principal Executive
Officer |
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