Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today provided a business update and reiterated its 2023
financial guidance.
“As we approach midyear 2023, our business remains strong, and
we are pleased with the positive growth trajectory in our key
commercial products. Through our well-trained and experienced sales
force -- made up of 50 reps on the hospital side of the business
and 25 focused on oncology -- for the quarter to date, Barhemsys®
and Byfavo® have already topped the sales number posted in the
first quarter of 2023, and PEMFEXY® has achieved an 18% market
share in early Q2. We are pleased to see these two assets gaining
uptake in the hospital and reflecting the value we saw when we
originally decided to make the acquisition,” stated Scott Tarriff,
President and Chief Executive Officer of Eagle Pharmaceuticals.
“The team is executing well on our plans to drive adoption of
our products, and as we look to future growth beyond our current
marketed offerings, we anticipate expanding the portfolio through
pipeline success and potential acquisition,” concluded Tarriff.
Company Highlights and Commercial Update
Balance sheet: Eagle’s balance sheet remains
strong in the second quarter of 2023. A substantial number of
receivables have been collected, and the Company paid down a
significant portion of debt.
PEMFEXY: Market share of commercial (non-340B)
pemetrexed usage in community oncology in the U.S. has grown from
6% to 18% early in the second quarter of 2023. Eagle anticipates
continued growth in net sales of PEMFEXY in the remainder of 2023
as compared to 2022. Eagle does not believe that the recently
approved pemetrexed product will have an impact on its expectations
of the market or its anticipated share.
Barhemsys1 and
Byfavo2: Barhemsys and
Byfavo, together, are beginning to reflect the pace of growth
anticipated when Eagle purchased Acacia in mid-2022. In the first
quarter of 2023 -- the first full quarter with a fully staffed and
trained sales team in place -- net sales of the two products were
just below $1 million on a combined basis. Thus far in the second
quarter of 2023, sales have exceeded this figure, and the Company
expects the products to show strong year-over-year and sequential
growth throughout the back half of 2023. Barhemsys is the first and
only antiemetic approved by the U.S. Food and Drug Administration
(FDA) for rescue treatment of postoperative nausea and vomiting
(PONV) despite prophylaxis. It is also indicated for the treatment
of PONV in patients who have not received prophylaxis and for the
prevention of PONV, either alone or in combination with an
antiemetic of a different class. Byfavo is indicated for the
induction and maintenance of procedural sedation in adults
undergoing procedures lasting 30 minutes or less. Based on current
positive feedback from physicians and nurses, Eagle expects this
momentum to continue for the foreseeable future.
Bendamustine franchise: The revenue and royalty
produced across the bendamustine markets has also been strong for
the year to date. The Company continues to expect that it will
maintain approximately 75% of the gross profit for the year as
compared to 2022.
Pipeline Progress and Future Growth
Opportunities:
EA-114 Product Candidate (for the treatment of
HR+/HER- advanced breast cancer, is intended to be
an improved version of Faslodex): The Company had
positive results from its EA-114 study and intends to conduct a
type C meeting with FDA in August. Additional updates are
anticipated in the event FDA and Eagle agree on next steps.
CAL02: The Company’s Phase 2 study is underway.
It is a multi-center adaptive, randomized, double-blind,
placebo-controlled study designed to assess the efficacy and safety
of CAL02, a novel first-in-class anti-toxin drug candidate, being
developed to treat severe community-acquired bacterial pneumonia
(SCABP) as an adjunctive therapy to standard of care. The study
plans to enroll approximately 276 patients with SCABP at more than
100 sites in over 20 countries worldwide.
- On June 14, 2023, FDA granted Qualified Infectious Disease
Product (QIDP) Designation under the Generating Antibiotic
Incentives Now (GAIN) Act and Fast Track Designation for CAL02.
QIDP designation entitles Eagle to an additional five years of
marketing exclusivity upon approval. Moreover, Eagle believes CAL02
is a new chemical entity (NCE), which would result in five years of
marketing exclusivity upon approval or three years without NCE
designation. In total, CAL02 may be eligible for a total of eight
or ten years of exclusivity upon approval.
- Eagle has approved patents for CAL02 running until September
2035, with filed patent applications that would extend into 2037 or
later, and may qualify for up to five additional years of patent
term exclusivity, up to 2040.
Guidance: The Company reaffirms previously
provided 2023 full-year guidance.
- Adjusted EBITDA of $74.0-$80.0 million
- Adjusted non-GAAP earnings per share of $4.20-$4.53
- Adjusted non-GAAP R&D expense of $41.0-$45.0 million
- Adjusted non-GAAP SG&A expense of $86.0-$90.0 million
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 StatementsThis 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
“anticipate,” “forward,” “will,” “would,” ‘could,” “should,” “may,”
“remain,” “maintain,” “opportunity,” “potential,” “prepare,”
“expect,” “believe,” “plan,” “future,” “belief,” “guidance,”
“estimate,” “project,” “forecast” “continue,” “further” and similar
expressions are intended to identify forward-looking statements.
These statements include, but are not limited to, statements with
respect to: Eagle Pharmaceuticals, Inc.’s (“Eagle” or the
“Company”) ability to achieve earnings growth and support research
and development, and its capability for further expansion and
improve margin and contribution of key products; expectations with
respect to the Company’s financial results, including projected
estimated financial information, including projected adjusted
EBITDA, adjusted non-GAAP earnings per share, adjusted non-GAAP
R&D expense and adjusted non-GAAP SG&A expense for fiscal
year 2023 and expectations with respect anticipated future product
revenue and profits for fiscal year 2023, including projected
estimated mix of product revenue and profits; expectations with
respect to potential exit run rates, potential revenues, potential
market share, potential commercial opportunity, expected pricing of
drugs and future royalties; the Company’s development programs,
products and pipeline; the potential for the Company to transition
into a diversified pharmaceutical company with a portfolio of
branded, first-in-class assets and to utilize legacy products; the
Company's clinical development plan for its product candidates,
including the number and timing of development initiatives or new
indications for the Company’s product candidates; the development
of, potential therapeutic and economic benefits of and expected
regulatory activities and matters with respect to the product
candidates of the Company; potential commercial opportunities,
addressable markets, patient populations and settings for the
Company’s products and product candidates; CAL02’s ability to
neutralize virulence factors produced by bacteria that are commonly
associated severe pneumonia; the potential of CAL02 to be a
first-in-class broad-spectrum anti-virulence agent for the
treatment of severe community-acquired bacterial pneumonia; the
Company’s expectations for the design and timing of the CAL02 Phase
2 study, including with respect to enrollment and the timing
thereof; the Company’s marketing, product development, partnering
and growth strategy, including relating to the commercialization of
Barhemsys and Byfavo and its other products; expectations with
respect to the Company’s ability to potentially acquire additional
assets; the timing, scope or likelihood and timing of regulatory
filings and approvals, and the outcome of meetings with the U.S.
Food and Drug Administration (“FDA”) for product candidates and the
ability to maintain regulatory approval of products and product
candidates; clinical development plans for product candidates; the
success of the Company's collaborations with its strategic partners
and the timing and results of these partners’ preclinical studies
and clinical trials, and the Company’s potential earnings potential
through such collaborations; the Company's plans and ability to
advance the product candidate in its pipeline; potential
opportunities for, and the Company’s ability to complete,
acquisitions or business development transactions, in a timely
manner, on favorable terms to the Company, or at all; the
sufficiency of the Company’s cash flows and capital resources and
expectations with respect to deployment of cash resources; and the
Company’s ability to achieve expected future financial performance
and 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 risk
that the anticipated benefits of the Company’s acquisition of
Acacia are not realized; the impacts of the continuing effects of
the COVID-19 pandemic and geopolitical events such as the conflict
in Ukraine, including disruption or impact in the sales of the
Company's marketed products, interruptions or other adverse effects
to clinical trials, delays in regulatory review, manufacturing and
supply chain interruptions, adverse effects on healthcare systems,
disruption in the operations of the Company's third party partners
and disruption of the global economy or other events on the
Company's business, financial condition and results of operations;
macroeconomic conditions, including rising inflation and interest
rates, uncertain credit and financial markets and recent and
potential disruptions in banking systems; whether the Company will
incur unforeseen expenses or liabilities or other market factors;
whether the Company will successfully implement its development
plan for its product candidates; delay in or failure to obtain
regulatory approval of the Company's or its partners’ product
candidates; whether the Company can successfully market and
commercialize its product candidates; the success of the Company's
relationships with its partners; the availability and pricing of
third party sourced products and materials; the outcome of
litigation involving any of its products or that may have an impact
on any of our products; successful compliance with the FDA and
other governmental regulations applicable to product approvals,
manufacturing facilities, products and/or businesses; general
economic conditions, including the potential adverse effects of
public health issues, including the COVID-19 pandemic and
geopolitical events, on economic activity and the performance of
the financial markets generally; 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; the risks inherent in the early stages of drug
development and in conducting clinical trials; any unanticipated
factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance that 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, and its other subsequent filings with the SEC, including
the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023, filed with the SEC on May 9, 2023. 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.
This press release includes statistical and other industry and
market data that the Company obtained from industry publications
and research, surveys and studies conducted by third parties or us.
Industry publications and third-party research, surveys and studies
generally indicate that their information has been obtained from
sources believed to be reliable, although they do not guarantee the
accuracy or completeness of such information. All of the market
data used in this presentation involves a number of assumptions and
limitations, and you are cautioned not to give undue weight to such
estimates. While the Company believes these industry publications
and third-party research, surveys and studies are reliable, the
Company has not independently verified such data. The industry in
which the Company operates is subject to a high degree of
uncertainty, change and risk due to a variety of factors, which
could cause results to differ materially from those expressed in
the estimates made by the independent parties and by the
Company.
Non-GAAP Financial Performance Measures
This press release contains adjusted EBITDA, projected adjusted
non-GAAP EBITDA, projected adjusted non-GAAP earnings per share,
projected adjusted non-GAAP R&D expense and projected 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.
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 EBITDA, adjusted non-GAAP R&D expenses, adjusted
non-GAAP SG&A expense, 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,
adjusted non-GAAP SG&A expense, net income and earnings per
share and the reconciling items between projected GAAP to adjusted
EBITDA, adjusted non-GAAP R&D expenses, adjusted non-GAAP
SG&A expense 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,
R&D expenses and SG&A expenses, 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 items. Such unavailable
information could be significant such that actual GAAP net income,
R&D expenses, SG&A expenses and earnings per share would
vary significantly from projected adjusted EBITDA, adjusted
non-GAAP R&D expenses, adjusted non-GAAP SG&A expense and
adjusted non-GAAP earnings per share.
Important Safety Information
for BYFAVO™ (remimazolam)
Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and
maintenance of procedural sedation in adults undergoing procedures
lasting 30 minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND
RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS
AND OTHER SEDATIVE-HYPNOTICS
Personnel and Equipment for Monitoring and
Resuscitation
- Only personnel trained in the administration of
procedural sedation, and not involved in the conduct of the
diagnostic or therapeutic procedure, should administer
BYFAVO.
- Administering personnel must be trained in the
detection and management of airway obstruction, hypoventilation,
and apnea, including the maintenance of a patent airway, supportive
ventilation, and cardiovascular resuscitation.
- BYFAVO has been associated with hypoxia, bradycardia,
and hypotension. Continuously monitor vital signs during sedation
and during the recovery period.
- Resuscitative drugs, and age- and size-appropriate
equipment for bag-valve-mask–assisted ventilation must be
immediately available during administration of
BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics Concomitant use of benzodiazepines,
including BYFAVO, and opioid analgesics may result in profound
sedation, respiratory depression, coma, and death. The sedative
effect of intravenous BYFAVO can be accentuated by concomitantly
administered CNS depressant medications, including other
benzodiazepines and propofol. Continuously monitor patients for
respiratory depression and depth of sedation.
Contraindication
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Personnel and Equipment for Monitoring and
Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were
observed in Phase 3 studies of BYFAVO. Continuously monitor vital
signs during sedation and through the recovery period. Only
personnel trained in the administration of procedural sedation, and
not involved in the conduct of the diagnostic or therapeutic
procedure, should administer BYFAVO. Administering personnel must
be trained in the detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance of a patent
airway, supportive ventilation, and cardiovascular resuscitation.
Resuscitative drugs, and age- and size-appropriate equipment for
bag-valve-mask–assisted ventilation must be immediately available
during administration of BYFAVO. Consider the potential for
worsened cardiorespiratory depression prior to using BYFAVO
concomitantly with other drugs that have the same potential (e.g.,
opioid analgesics or other sedative-hypnotics). Administer
supplemental oxygen to sedated patients through the recovery
period. A benzodiazepine reversal agent (flumazenil) should be
immediately available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and
Other Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in
profound sedation, respiratory depression, coma, and death. The
sedative effect of IV BYFAVO can be accentuated when administered
with other CNS depressant medications (eg, other benzodiazepines
and propofol). Titrate the dose of BYFAVO when administered with
opioid analgesics and sedative-hypnotics to the desired clinical
response. Continuously monitor sedated patients for hypotension,
airway obstruction, hypoventilation, apnea, and oxygen
desaturation. These cardiorespiratory effects may be more likely to
occur in patients with obstructive sleep apnea, the elderly, and
ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity
reactions, including rash, urticaria, pruritus, and anaphylaxis.
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing
dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can
result in sedation (respiratory depression, lethargy, hypotonia) in
the neonate. Observe newborns for signs of sedation and manage
accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and
sedation drugs that block NMDA receptors and/or potentiate GABA
activity increase neuronal apoptosis in the developing brain and
result in long-term cognitive deficits when used for longer than 3
hours. The clinical significance of this is not clear. However, the
window of vulnerability to these changes is believed to correlate
with exposures in the third trimester of gestation through the
first several months of life but may extend out to approximately 3
years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care
of children needing surgery, other procedures, or tests that cannot
be delayed, and no specific medications have been shown to be safer
than any other. Decisions regarding the timing of any elective
procedures requiring anesthesia should take into consideration the
benefits of the procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of
patients (N=630) receiving BYFAVO 5-30 mg (total dose) and
undergoing colonoscopy (two studies) or bronchoscopy (one study)
were: hypotension, hypertension, diastolic hypertension, systolic
hypertension, hypoxia, and diastolic hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on
pregnancy. Benzodiazepines cross the placenta and may produce
respiratory depression and sedation in neonates. Monitor neonates
exposed to benzodiazepines during pregnancy and labor for signs of
sedation and respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for
sedation, respiratory depression, and feeding problems. A lactating
woman may consider interrupting breastfeeding and pumping and
discarding breast milk during treatment and for 5 hours after
BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established. BYFAVO should not be used in patients less than 18
years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed
between these subjects and younger subjects. However, there is a
potential for greater sensitivity (eg, faster onset, oversedation,
confusion) in some older individuals. Administer supplemental doses
of BYFAVO slowly to achieve the level of sedation required and
monitor all patients closely for cardiorespiratory
complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO
should be carefully titrated to effect. Depending on the overall
status of the patient, lower frequency of supplemental doses may be
needed to achieve the level of sedation required for the procedure.
All patients should be monitored for sedation-related
cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it
contains remimazolam which has the potential for abuse and physical
dependence.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
1
https://bynder.acaciapharma.com/m/5d7c2cd0d58865f7/original/Barhemsys-Prescribing-Information.pdf2
https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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