Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that it has raised its Adjusted non-GAAP
earnings per share and Adjusted non-GAAP EBITDA guidance for the
2023 fiscal year. Full-year 2023 Adjusted non-GAAP earnings per
share is now expected to range from $4.40 to $4.70, up from the
previously disclosed estimated range of $4.20 to $4.53. Full-year
2023 Adjusted non-GAAP EBITDA is now expected to range from $78.0
to $84.0 million, up from the previously disclosed estimated range
of $74.0 to $80.0 million. Full-year 2023 Adjusted non-GAAP
research and development and Adjusted non-GAAP SG&A continue to
be expected to range from $41.0-$45.0 million and $86.0-$90.0
million, respectively.
“Due to the strength and momentum of our business, we are
raising our full year Adjusted non-GAAP EPS and Adjusted non-GAAP
EBITDA guidance. Our previously disclosed Adjusted non-GAAP
research and development and Adjusted non-GAAP SG&A expense
ranges remain the same as we continue to invest in our robust
pipeline of products. We look forward to sharing additional details
during our second quarter earnings call on August 8th,” 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
expectations for the design and timing of the planned Phase 2
study, including with respect to enrollment and site selection and
the timing thereof; statements regarding the potential of CAL02 to
be a medical breakthrough and offer unique or meaningful
therapeutic benefits to seriously ill patients, potentially
improving the treatment regimen for patients with severe
community-acquired pneumonia, shortening the duration of illness
and improving patient outcomes; statements regarding potential
regulatory exclusivity, CAL02’s potential eligibility for fast
track and breakthrough therapy designations and the potential for a
CAL02 new drug application for the treatment of SCABP to qualify
for priority review; statements regarding the Company’s expectation
to strengthen the patent portfolio for CAL02; 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
ongoing COVID-19 pandemic, including interruptions or other adverse
effects on clinical trials and delays in regulatory review or
further disruption or delay of any pending or future litigation;
delay in or failure to obtain regulatory approval of the Company's
product candidates and successful compliance with FDA, European
Medicines Agency and other governmental regulations applicable to
product approvals; 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; the risks inherent in drug
development and in conducting clinical trials; 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 quarters ended March 31, 2023, filed with the SEC on
May 9, 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,
adjusted non-GAAP earnings per share, adjusted non-GAAP R&D
expense and adjusted non-GAAP SG&A expense. 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.
Adjusted non-GAAP R&D expense excludes stock-based
compensation expense, depreciation expense and severance
expense.
Adjusted non-GAAP SG&A expense excludes stock-based
compensation expense, depreciation expense, 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, adjusted non-GAAP R&D expenses, and
adjusted non-GAAP earning per share to their most comparable GAAP
financial measures are not provided because the quantification of
projected GAAP R&D expenses, net income and earnings per share
and the reconciling items between projected GAAP to adjusted
non-GAAP EBITDA, adjusted non-GAAP R&D expenses, 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 and R&D Expense, 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, R&D expenses, and earnings per share would vary
significantly from projected GAAP and adjusted non-GAAP EBITDA,
adjusted non-GAAP R&D expenses, 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 non-GAAP EBITDA, adjusted non-GAAP earnings per
share, adjusted non-GAAP R&D expense and adjusted non-GAAP
SG&A expense are non-GAAP financial measures. For descriptions
of these non-GAAP financial measures, please see below.
Eagle Pharmaceuticals (NASDAQ:EGRX)
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