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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 20, 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 3.01 Notice
of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On May 20,
2024, Eagle Pharmaceuticals, Inc. (the “Company”) received a notice (the “Notice”)
from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) advising the
Company that it has initiated a process to delist the Company’s securities from Nasdaq because the Company had not filed
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 (the “2023 Form 10-K”) by May 13, 2024. The Notice further advises the Company that, pursuant to Nasdaq Listing Rule
5810(d)(2), the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (the “Q1
2024 Form 10-Q”) serves as an additional and separate basis for delisting.
Unless the
Company requests a hearing to appeal the delisting process by May 28, 2024, trading of the Company’s common stock will be suspended
from The Nasdaq Capital Market at the opening of business on May 30, 2024, and will subsequently be removed from listing. Accordingly,
the Company intends to timely request a hearing before a Nasdaq Hearings Panel (the “Panel”). The hearing request will automatically stay the suspension of
the Company’s common stock for 15 calendar days from the date of the request, or 22 calendar days from the date of the Notice if
the request is filed on May 28, 2024. In connection with the hearing request, the Company intends to request that the stay be extended
through the conclusion of the hearings process and the expiration of any additional extension period 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, 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.
As previously disclosed, on November 27, 2023, the Company received a delinquency notification from the Staff advising the Company that
due to the failure to timely file its Q3 2023 Form 10-Q, the Company is not in compliance with Nasdaq’s continued listing requirements
under Nasdaq Listing Rule 5250(c)(1) (the “Rule”). In accordance with Nasdaq rules, following timely submission by the Company
of a compliance plan, Nasdaq granted the Company until May 13, 2024, to regain compliance with the Rule. On April 8, 2024, the Company
received an additional notice from Nasdaq advising the Company that due to the Company’s failure to timely file its 2023 Form 10-K, the
Company is not in compliance with the Rule. On May 10, 2024, the Company filed a Notification of Late Filing on Form 12b-25 with respect
to its Q1 2024 Form 10-Q.
Item 7.01 Regulation FD Disclosure.
On May 22, 2024, the Company issued a press
release announcing the Company’s receipt of the Notice. A copy of the press release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K.
The information
furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of
the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any
of the Company’s filings under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made
before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth
by specific reference in such filing.
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,”
“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, any requests
or communications the Company may submit to Nasdaq for a hearing, appeal, stay or otherwise, the potential to obtain any additional extensions
or stays from Nasdaq, 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 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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 22, 2024 |
| |
EAGLE PHARMACEUTICALS, INC. |
| |
|
| |
By: |
/s/ Michael Graves |
| |
|
Michael Graves |
| |
|
Interim Principal Executive Officer |
Exhibit 99.1
Eagle
Pharmaceuticals Announces Receipt of Delisting Notification from Nasdaq
WOODCLIFF LAKE, N.J. — May 22, 2024 —
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (the “Company” or “Eagle”) today announced that it received a notice
(the “Notice”) on May 20, 2024, from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market
LLC (“Nasdaq”) advising the Company that it has initiated a process to delist the Company’s securities from Nasdaq because
the Company had not filed 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 (the “2023 Form 10-K”) by May 13, 2024. The Notice further advises the Company that,
pursuant to Nasdaq Listing Rule 5810(d)(2), the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter
ended March 31, 2024 (the “Q1 2024 Form 10-Q”) serves as an additional and separate basis for delisting.
Unless the Company requests a hearing to appeal
the delisting process by May 28, 2024, trading of the Company’s common stock will be suspended from The Nasdaq Capital Market at the
opening of business on May 30, 2024, and will subsequently be removed from listing. Accordingly, the Company intends to timely request
a hearing before a Nasdaq Hearings Panel (the “Panel”). The hearing request will automatically stay the suspension of the Company’s common stock for 15 calendar
days from the date of the request, or 22 calendar days from the date of the Notice if the request is filed on May 28, 2024. In connection
with the hearing request, the Company intends to request that the stay be extended through the conclusion of the hearings process and
the expiration of any additional extension period 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,
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.
As previously disclosed, on November 27, 2023, the Company received a delinquency notification from the Staff advising the Company that
due to the failure to timely file its Q3 2023 Form 10-Q, the Company is not in compliance with Nasdaq’s continued listing requirements
under Nasdaq Listing Rule 5250(c)(1) (the “Rule”). In accordance with Nasdaq rules, following timely submission by the Company
of a compliance plan, Nasdaq granted the Company until May 13, 2024, to regain compliance with the Rule. On April 8, 2024, the Company
received an additional notice from Nasdaq advising the Company that due to the Company’s failure to timely file its 2023 Form 10-K, the
Company is not in compliance with the Rule. On May 10, 2024, the Company filed a Notification of Late Filing on Form 12b-25 with respect
to its Q1 2024 Form 10-Q.
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 PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS®
through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product
candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on
developing medicines with the potential to become part of the personalized medicine paradigm in cancer care. Additional information is
available on Eagle’s website at www.eagleus.com.
Forward-Looking
Statements Disclaimer
This press release
contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
and other securities law. Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,”
“forward,” “will,” “would,” “could,” “may,” “intend,” “remain,”
“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, any requests
or communications the Company may submit to Nasdaq for a hearing, appeal, stay or otherwise, the potential to obtain any additional extensions
or stays from Nasdaq, 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 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 press release speak only as
of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements
to reflect events that occur or circumstances that exist after the date on which they were made.
Investor
Relations Contact
Timothy
McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com
# # #
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Eagle Pharmaceuticals (NASDAQ:EGRX)
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From Oct 2024 to Nov 2024
Eagle Pharmaceuticals (NASDAQ:EGRX)
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From Nov 2023 to Nov 2024
