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Avadel Announces Preliminary 2024 Results and 2025 Commercial Priorities to Accelerate the LUMRYZ Launch -- Approximately $50.0 million of net revenue from sales of LUMRYZ estimated for the fourth quarter, a greater than

Key Takeaway: Avadel Announces Preliminary 2024 Results and 2025 Commercial Priorities to Accelerate the LUMRYZ Launch -- Approximately $50.0 million of net revenue from sales of LUMRYZ estimated for the fourth quarter, a greater than 150% increase over $19.5 million for the comparable peri

Full Press Release Details

Avadel Announces Preliminary 2024 Results and
2025 Commercial Priorities to Accelerate the LUMRYZ Launch
-- Approximately $50.0 million of net revenue
from sales of LUMRYZ estimated for the fourth quarter, a greater than 150% increase over $19.5 million for the comparable period
--2,500 patients on LUMRYZ as of December
31, 2024, including 600 patients that initiated therapy in the fourth quarter --
-- LUMRYZ net product revenue of $240 -
$260 million in 2025, representing 50% year-over-year growth at the midpoint --
-- Management to host a conference call
today at 4:30 p.m. ET --
DUBLIN, Ireland, January 8, 2025 - 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 2024 net revenue and cash, cash equivalents and
marketable securities.
"2024 was a pivotal year for Avadel, marked by consistent patient
adoption of LUMRYZ and overwhelmingly positive feedback from both patients and providers about the transformative benefits of once-nightly
dosing," said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. "As we move into 2025, we are building on this
momentum with a refined commercial strategy to increase demand for and persistency on, LUMRYZ, with the primary goal of enhancing the
overall LUMRYZ experience for both patients and providers. We believe the strategic initiatives we're introducing now will drive
uptake among each of the three narcolepsy patient segments - switches, new to oxybates, and previously treated and discontinued
- and allow us to further unlock the market potential of LUMRYZ. With the continued execution of our commercial launch in narcolepsy
and ongoing progress in our Phase 3 trial in idiopathic hypersomnia (IH), we are well positioned to solidify our leadership in the sleep
space and transform care for patients with sleep disorders."
2024 Financial Highlights:
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, 2024. The Company
expects to announce its full results for the twelve months ended December 31, 2024 on or before March 3, 2025.
Launch Progress through December 31, 2024 and 2025 Commercial Initiatives:
Full Year 2025 Guidance:
The Company's full year
2025 guidance is preliminary and based upon the Company's current view of existing market conditions and assumptions for the year
ending December 31, 2025. These statements are forward-looking, and actual results could differ materially depending on market conditions.
Conference Call Details
A live audio webcast of the
call can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay
of the webcast will be archived on Avadel's website for 90 days following the event. Participants
may register for the conference call here and are advised to do so at least
10 minutes prior to joining the call.
(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.
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.
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 EDS in both adults and pediatrics with narcolepsy. For more information, please visit www.avadel.com.
intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure
obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to
following the Company's press releases, SEC filings, public conference calls, presentations, and webcast.
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.
LUMRYZ (sodium oxybate) for extended-release oral suspension
is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy:
Do not take LUMRYZ if you take or your child takes other sleep
medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase
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 or your child 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:
Tell your doctor if you or your child are on a salt-restricted diet
or 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. The most common side effects
in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. 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
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 safety and potential therapeutic
Last updated: Dec 31, 2024