Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
provided a business update including preliminary estimates of
fourth quarter and full year net revenue and cash, cash equivalents
and marketable securities.
“2023 was transformational for Avadel defined by significant
growth and continued execution of milestones critical to Avadel’s
success, beginning with the FDA approval and receipt of Orphan Drug
Exclusivity for LUMRYZ. The LUMRYZ launch has thus far been marked
by robust demand and overwhelmingly positive feedback from the
narcolepsy community, health care providers and payers. Our team is
proud of the momentum built this year, and looking toward 2024, we
are excited to see LUMRYZ’s continued impact across the narcolepsy
community,” said Greg Divis, Chief Executive Officer of Avadel
Pharmaceuticals.
Launch Progress Through December 31, 2023:
- Greater than 1,900 patients enrolled in Avadel’s RYZUP patient
support services:
- More than 1,000 patients initiated therapy.
- The majority of RYZUP enrollments and patients currently being
treated with LUMRYZ are patients who switched from first generation
oxybates, with the balance made up of patients who previously tried
and discontinued a first generation oxybate and patients who are
new to oxybate treatment.
- Signed contract with Emisar (Optum Rx GPO)
- Contracts now in place with all 3 PBM owned GPOs (Ascent/ESI,
Zinc/CVS and Emisar/Optum).
- LUMRYZ moved to preferred status within the CVS commercial
formularies and Optum Select as of January 1, 2024.
- Nearly 1,800 health care providers have completed the LUMRYZ
REMS certification process, including both experienced oxybate
prescribers as well as providers who have never previously
prescribed an oxybate.
Financial
Highlights:
- Approximately $19 million and $28 million of net product
revenue, respectively, estimated for the quarter and year ended
December 31, 2023. Net product revenue consists of LUMRYZ product
sales, which was launched in the U.S. on June 5,
2023.
- Approximately $105 million of cash, cash equivalents and
marketable securities at December 31, 2023.
Results reported above are
preliminary, unaudited and are subject to change, perhaps
materially, upon the audit of the Company’s financial statements
for the year ended December 31, 2023. The Company expects to
announce its full results for the twelve months ended December 31,
2023 on or before February 29, 2024.
Pipeline Update:
- Supplemental New Drug Application (sNDA) for LUMRYZ in the
pediatric narcolepsy population accepted by FDA:
- LUMRYZ has the potential to significantly alleviate the burden
placed on families and caregivers of children with narcolepsy who
are responsible for waking up in the middle of the night to
administer a second dose of twice-nightly oxybate.
- Pediatric patients currently represent approximately 5% of all
oxybate treated narcolepsy patients.
About
LUMRYZ™ (sodium oxybate) for
extended-release oral suspension
LUMRYZ, is an extended-release sodium
oxybate medication approved by the FDA on May 1, 2023, as the first
and only once-at-bedtime treatment for cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy. The FDA
approval of LUMRYZ was supported by results from REST-ON, a
randomized, double-blind, placebo-controlled, pivotal Phase 3 trial
in adults with narcolepsy. LUMRYZ demonstrated statistically
significant and clinically meaningful improvements in the three
co-primary endpoints: EDS, clinicians’ overall assessment of
patients’ functioning (CGI-I) and cataplexy attacks, for all three
evaluated doses when compared to placebo. With its approval,
the FDA also granted seven years of Orphan Drug Exclusivity to
LUMRYZ for the treatment of cataplexy or EDS in adults with
narcolepsy due to a finding of clinical superiority of LUMRYZ
relative to currently available oxybate treatments. In particular,
the FDA found that LUMRYZ makes a major contribution to patient
care over currently available, twice-nightly oxybate products by
providing a once-nightly dosing regimen that avoids nocturnal
arousal to take a second dose.
About Avadel Pharmaceuticals
plc
Avadel Pharmaceuticals plc (Nasdaq:
AVDL) is a biopharmaceutical company focused on transforming
medicines to transform lives. Our approach includes applying
innovative solutions to the development of medications that address
the challenges patients face with current treatment options.
Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food
& Drug Administration (FDA) as the first and only
once-at-bedtime oxybate for the treatment of cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy. For more
information, please visit www.avadel.com.
IMPORTANT SAFETY INFORMATION
WARNING: Taking LUMRYZ™ (sodium oxybate) with other central
nervous system (CNS) depressants, such as medicines used to make
you fall asleep, including opioid analgesics, benzodiazepines,
sedating antidepressants, antipsychotics, sedating anti-epileptic
medicines, general anesthetics, muscle relaxants, alcohol or street
drugs, may cause serious medical problems, including trouble
breathing (respiratory depression), low blood pressure
(hypotension), changes in alertness (drowsiness), fainting
(syncope) and death.The active ingredient of
LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a
controlled substance. Abuse or misuse of illegal GHB alone or with
other CNS depressants (drugs that cause changes in alertness or
consciousness) have caused serious side effects. These effects
include seizures, trouble breathing (respiratory depression),
changes in alertness (drowsiness), coma and death. Call your doctor
right away if you have any of these serious side
effects.Because of these risks, LUMRYZ is
available only by prescription and filled through certified
pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ
REMS to receive LUMRYZ. Further information is available
at www.LUMRYZREMS.com or by
calling 1-877-453-1029. |
INDICATIONSLUMRYZ (sodium oxybate) for
extended-release oral suspension is a prescription medicine used to
treat the following symptoms in adults with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
It is not known if LUMRYZ is safe and effective in people less
than 18 years of age.
Do not take LUMRYZ if you take other sleep
medicines or sedatives (medicines that cause sleepiness), drink
alcohol or have a rare problem called succinic semialdehyde
dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling
or giving away LUMRYZ may harm others and is against the law. Tell
your doctor if you have ever abused or been dependent on alcohol,
prescription medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires
them to be fully awake or is dangerous, including driving a car,
using heavy machinery or flying an airplane, for at least six (6)
hours after taking LUMRYZ. Those activities should not be done
until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while
getting up from the bed, has led to falls with injuries that have
required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the
following:
- Breathing problems, including slower
breathing, trouble breathing and/or short periods of not breathing
while sleeping (e.g., sleep apnea). People who already have
breathing or lung problems have a higher chance of having breathing
problems when they take LUMRYZ.
- Mental health problems,
including confusion, seeing or hearing things that are not
real (hallucinations), unusual or disturbing thoughts (abnormal
thinking), feeling anxious or upset, depression, thoughts of
killing yourself or trying to kill yourself, increased tiredness,
feelings of guilt or worthlessness and difficulty concentrating.
Tell your doctor if you have or had depression or have tried to
harm yourself. Call your doctor right away if you have
symptoms of mental health problems or a change in weight or
appetite.
- Sleepwalking. Sleepwalking can cause
injuries. Call your doctor if you start sleepwalking.
Tell your doctor if you are on a salt-restricted diet or if you
have high blood pressure, heart failure or kidney problems. LUMRYZ
contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea,
dizziness, bedwetting, headache and vomiting. Your side effects may
increase when you take higher doses of LUMRYZ. LUMRYZ can cause
physical dependence and craving for the medicine when it is not
taken as directed. These are not all the possible side effects of
LUMRYZ.
For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side
effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
Please see full Prescribing
Information, including BOXED Warning.
Cautionary Disclosure Regarding Forward-Looking
Statements
This press release includes
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. These forward-looking statements relate to
our future expectations, beliefs, plans, strategies, objectives,
results, conditions, financial performance, prospects or other
events. Such forward-looking statements include, but are not
limited to, expectations regarding the potential therapeutic
benefit of LUMRYZ; the success of the commercialization of LUMRYZ;
the anticipated market availability, demand and sales opportunity
of LUMRYZ; the potential benefits of payor coverage, including
preferred status; and the Company’s expectations regarding its
financial results for the fourth quarter and full year 2023. In
some cases, forward-looking statements can be identified by the use
of words such as “will,” “may,” “could,” “believe,” “expect,” “look
forward,” “on track,” “guidance,” “anticipate,” “estimate,”
“project,” “next steps” and similar expressions and the negatives
thereof (if applicable).
The Company’s forward-looking
statements are based on estimates and assumptions that are made
within the bounds of our knowledge of our business and operations
and that we consider reasonable. However, the Company’s business
and operations are subject to significant risks, and, as a result,
there can be no assurance that actual results and the results of
the company’s business and operations will not differ materially
from the results contemplated in such forward-looking statements.
Factors that could cause actual results to differ from expectations
in the Company’s forward-looking statements include final audit
adjustments and other developments that may arise that would cause
the Company’s expectations with respect to the fourth quarter and
full year 2023 revenue estimates and cash as of December 31, 2023
to differ, perhaps materially, from the financial results that will
be reflected in the Company’s audited consolidated financial
statements for the fiscal year ended December 31, 2023, and the
risks and uncertainties described in the “Risk Factors” section of
Part I, Item 1A of the Company’s Annual Report on Form 10-K for the
year ended December 31, 2022, which was filed with the Securities
and Exchange Commission (SEC) on March 29, 2023, and subsequent SEC
filings.
Forward-looking statements speak only
as of the date they are made and are not guarantees of future
performance. Accordingly, you should not place undue reliance on
forward-looking statements. The Company does not undertake any
obligation to publicly update or revise our forward-looking
statements, except as required by law.
Investor Contact:Courtney MogerleyStern
Investor Relations, Inc.Courtney.Mogerley@sternir.com (212)
698-8687
Media Contact:Lesley StanleyReal
Chemistrylestanley@realchemistry.com (609) 273-3162
Avadel Pharmaceuticals (NASDAQ:AVDL)
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