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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): November 9, 2023
Eagle Pharmaceuticals, Inc.
(Exact name of registrant
as specified in its charter)
Delaware |
001-36306 |
20-8179278 |
(State
or other jurisdiction of |
(Commission File Number) |
(IRS Employer Identification No.) |
incorporation) |
|
|
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 obligations 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 |
|
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 2.02 | Results of Operations and Financial Condition. |
On November 9, 2023, Eagle
Pharmaceuticals, Inc., or the Company, issued a press release, or the Press Release, announcing, among other things, that it will be
delaying the release of its third quarter 2023 results and related investor conference call as the Company will need more time to
review potential adjustments relating to the reporting of sales of PEMFEXY®. The Company anticipates filing a Form 12b-25,
Notification of Late Filing, with the Securities and Exchange Commission no later than one business day after the due date of its
Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 (“Form 10-Q”), and expects to file its Form 10-Q
by November 14, 2023, prior to the expiration of the extension period provided by Rule 12b-25 under the Securities Exchange Act of
1934, as amended, or the Exchange Act. The Press Release also provided that the Company expects to revise its 2023 guidance
downward. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by
reference.
The information furnished under this Item
2.02, 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.
|
Item 9.01 |
Financial Statements and 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.
Dated: November 9, 2023 |
EAGLE PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Scott Tarriff |
|
|
Scott Tarriff |
|
|
Chief Executive Officer |
Exhibit 99.1
Eagle Delays Third Quarter 2023 Results and
Conference Call
WOODCLIFF
LAKE, NJ—November 9, 2023—Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that it will be delaying the release of its third quarter 2023 results and investor
conference call, previously scheduled for today, Thursday, November 9, 2023. The Company currently anticipates filing
a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission no later than one
business day after the due date of its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2023 (the “Form
10-Q”), and expects to file its Form 10-Q by November 14, 2023, prior to the expiration of the extension period
provided by Rule 12b-25 under the Securities Exchange Act of 1934.
The Company
requires more time to review potential adjustments relating to the reporting of sales of PEMFEXY® prior to filing its Form 10-Q.
In addition, the Company expects to revise its previously disclosed 2023 full year guidance downward.
“We remain confident in the strength of our business and our
outlook for 2024, and we look forward to reporting on our commercial portfolio, progress on our pipeline and other initiatives,”
stated Scott Tarriff, President and CEO of Eagle.
Third Quarter Fiscal Year 2023 Earnings Conference Call
The Company will reschedule its third quarter 2023 financial results
call at a time to be announced.
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
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,” “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, the Company’s expectations
with respect to the timing of its SEC filings, including the Form 12b-25 and the Form 10-Q, and the anticipated release of
financial results for the third quarter ended September 30, 2023, expectations with respect to the anticipated reporting of financial
and business results, including potential adjustments related to the reporting of sales for PEMFEXY®, and statements
and expectations regarding the Company’s financial projections and guidance, including anticipated financial performance for 2023,
the strength of the Company’s business, pipeline and other initiatives and the potential of the Company’s pipeline and product
candidates to address underserved therapeutic areas across multiple disease states. 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 post- COVID-19 environment and geopolitical factors such as the
conflicts between Russia and Ukraine and Gaza and Israel; delay in or failure to obtain regulatory approval of the Company's or its partners’
product candidates and successful compliance with FDA, 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 product candidates; the success of the Company's relationships with its partners; the outcome
of litigation involving any of its products or that may have an impact on any of its products; the strength and enforceability of the
Company’s intellectual property rights or the rights of third parties; competition from other pharmaceutical and biotechnology
companies and the potential for 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 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 Securities
and Exchange Commission (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 other 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 for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Public
Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward
T: 817-807-8044
E: faith@eagleus.com
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