Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today reiterated its previously issued guidance for the
2023 fiscal year. Full-year 2023 Adjusted non-GAAP EBITDA is
expected to range from $78.0 to $84.0 million and Adjusted non-GAAP
earnings per share is expected to range from $4.40 to $4.70.
“Based on the strength of our business and product pipeline, we
are reiterating our recently increased guidance and believe Eagle
is on the path to generating sustained long-term growth,” stated
Scott Tarriff, President and Chief Executive 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 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. 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, statements regarding the Company’s
financial projections and guidance, including anticipated financial
performance for 2023, including expected adjusted EBITDA and
adjusted non-GAAP earnings per share; the Company’s ability to
sustain longterm growthand 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 conflict in Ukraine; 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; 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 Report on Form 10-Q for the quarter ended March 31, 2023,
filed with the SEC on May 9, 2023, the Company’s Quarterly Report
on Form 10-Q 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.
Non-GAAP Financial Performance MeasuresThis
press release contains guidance as to adjusted non-GAAP EBITDA and
adjusted non-GAAP earnings per share. 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 and related earnings per share
information excludes amortization expense, stock-based compensation
expense, depreciation expense, severance expense, non-cash interest
expense, fair value adjustments on equity investment, fair value
adjustments related to derivative instruments, foreign currency
exchange gain or loss, amortization of inventory step-up, and the
tax effect of these adjustments.
Adjusted non-GAAP EBITDA excludes interest expense net of
interest income, income tax provision, depreciation and
amortization expense, stock-based compensation expense, fair value
adjustments on equity investment, fair value adjustments related to
derivative instruments, foreign currency exchange gain or loss, and
severance expense.
The Company believes the use of non-GAAP financial measures
helps 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.
Investors should note that reconciliations of the
forward-looking or projected non-GAAP financial measures included
in this press release to their most comparable GAAP financial
measures cannot be provided because the Company cannot do so
without unreasonable efforts due to the unavailability of
information needed to calculate the reconciling items and the
variability, complexity, and limited visibility of comparable GAAP
measures, and the reconciling items that would be excluded from the
non-GAAP financial measures in the future. Likewise, the Company is
unable to provide projected GAAP financial measures. GAAP
projections and reconciliations of the components of projected
adjusted non-GAAP EBITDA and adjusted non-GAAP earning per share to
their most comparable GAAP financial measures are not provided
because the quantification of projected net income and earnings per
share and the reconciling items between projected GAAP to adjusted
non-GAAP EBITDA and adjusted non-GAAP earnings per share cannot be
reasonably calculated or predicted at this time without
unreasonable efforts. For example, with respect to GAAP net income,
the Company is not able to calculate the favorable or unfavorable
expenses related to the fair value adjustments on equity
investments and derivative instruments primarily due to nature of
these transactions. Such unavailable information could be
significant such that actual GAAP net income and earnings per share
would vary significantly from projected GAAP and adjusted non-GAAP
EBITDA and adjusted non-GAAP earnings per share.
These non-GAAP financial measures should be considered in
addition to, but not as a substitute for, the information prepared
in accordance with U.S. GAAP. In addition, from time to time in the
future there may be other items that the Company may exclude for
purposes of its non-GAAP financial measures; and the Company has
ceased, and may in the future cease, to exclude items that it has
historically excluded for purposes of its non-GAAP financial
measures. For example, commencing in 2023, the Company no longer
excludes expense of acquired in-process research & development
from the Company’s adjusted non-GAAP net income or adjusted
non-GAAP EBITDA, their line item components, and non-GAAP earnings
per share. Likewise, the Company may determine to modify the nature
of its adjustments to arrive at its non-GAAP financial measures.
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 financial
measures used by the Company may differ from similar measures used
by other companies, even when similar terms are used to identify
such measures.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
1 Adjusted EBITDA and adjusted non-GAAP earnings per share are
non-GAAP financial measures. For descriptions of these non-GAAP
financial measures, please see below.
Eagle Pharmaceuticals (NASDAQ:EGRX)
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