Avadel Pharmaceuticals Provides Update at Needham Virtual Healthcare Conference

Rhea-AI Summary

Avadel Pharmaceuticals (AVDL) provided updates at the Needham Virtual Healthcare Conference, highlighting positive Q1 2025 metrics for LUMRYZ™, their narcolepsy medication with billion-dollar peak sales potential. The company reported improvements in patient enrollments, starts, persistency rates, and net patients on therapy compared to Q4 2024.

Key updates include: The REVITALYZ™ Phase 3 trial for LUMRYZ in Idiopathic Hypersomnia remains on schedule for enrollment completion in H2 2025. Avadel has filed four patent infringement lawsuits against Jazz Pharmaceuticals in 2025 regarding Xywav product usage. The company expects to achieve sustainable positive cash flow in 2025.

Addressing U.S. tariff policy concerns, Avadel detailed its robust supply chain for LUMRYZ, featuring dual FDA-approved U.S.-based manufacturers for the sodium oxybate API, U.S. and European manufacturing capabilities for the finished product, and U.S.-based primary packaging operations.

Positive

• Q1 2025 showed improved patient metrics for LUMRYZ across all categories
• LUMRYZ has potential for billion-dollar peak annual sales
• Company expects sustainable positive cash flow in 2025
• Robust and diversified supply chain with dual manufacturing capabilities
• Strong patent protection strategy with multiple infringement lawsuits filed

Negative

• Ongoing patent litigation with Jazz Pharmaceuticals could involve legal costs
• Dependence on external CDMOs for manufacturing

Insights

Pharmaceutical Market Analyst

Avadel's update reveals encouraging commercial momentum for LUMRYZ, with Q1 2025 showing improvements across all patient metrics versus Q4 2024. While this performance aligns with previous guidance rather than exceeding it, the consistent execution in patient enrollments, starts, persistency rates, and net patients on therapy demonstrates the medication is gaining traction in the narcolepsy market.

The $1 billion peak sales potential mentioned for LUMRYZ represents significant revenue upside compared to Avadel's current market cap of around $648 million. The ongoing REVITALYZ Phase 3 trial for Idiopathic Hypersomnia creates a valuable pipeline opportunity that could substantially expand the drug's approved indications beyond narcolepsy.

From a competitive standpoint, Avadel's aggressive legal strategy against Jazz Pharmaceuticals - launching four patent infringement lawsuits in 2025 alone - signals confidence in their intellectual property portfolio and determination to defend their market position. The outcomes of these lawsuits could significantly impact the competitive landscape.

Most importantly, the projection of sustainable positive cash flow in 2025 marks a critical inflection point in Avadel's financial trajectory. This transition from cash-burning development stage to commercial viability enhances the company's financial stability and potentially reduces future dilution risk for shareholders.

Avadel's proactive supply chain diversification, with redundant manufacturing capabilities in both the US and Europe, demonstrates strategic foresight in navigating potential regulatory challenges from changing tariff policies. This approach provides valuable operational flexibility that many smaller pharmaceutical companies lack.

DUBLIN, April 08, 2025 (GLOBE NEWSWIRE) --  Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today presented at the 24th Annual Needham Virtual Healthcare Conference.

The Company provided an update on patient demand metrics that was in line with guidance from its full-year results announcement on March 3, 2025. It also addressed questions related to the recent developments in United States tariff policy and the potential impact on the biopharmaceutical sector, including Avadel.

Specifically:

• In Q1 2025 patient demand metrics for LUMRYZ™, Avadel’s innovative narcolepsy medication with a market potential of a billion dollars in peak annual sales, all improved versus Q4 2024. These improvements include patient enrollments, patient starts, persistency rates, and net patients on therapy.
• REVITALYZ™, the Company’s Phase 3 pivotal trial studying LUMRYZ in Idiopathic Hypersomnia (IH), is on track to complete enrollment in the second half of 2025.
• Avadel has initiated four patent infringement lawsuits against Jazz Pharmaceuticals since the beginning of 2025, alleging certain uses of Jazz’s Xywav product, according to its corresponding labeling, infringe claims of five different Avadel patents.
• The Company expects to generate sustainable positive cash flow in 2025.

Regarding the potential impact of possible changes in U.S. tariff policies, Avadel has developed a diversified supply chain over the past three years for LUMRYZ.

The active pharmaceutical ingredient (“API”) in LUMRYZ is sodium oxybate, which is manufactured by two contract development and manufacturing organizations (“CDMOs”) located in the U.S. and approved by the U.S. Food and Drug Administration. Accordingly, the U.S. is the country of origin for all the API in LUMRYZ. The finished LUMRYZ commercial product is approved to be manufactured by one outsourced CDMO located in the U.S. and another in Europe. Additionally, all primary packaging of LUMRYZ is conducted in the U.S.

In summary, these efforts have strengthened supply chain security and, if needed, the capability to manufacture LUMRYZ entirely in the U.S.

An archived recording of the fireside chat webcast will be available on Avadel’s Investor Relations  website, investors.avadel.com, for 90 days following the conference.

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. On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in pediatric patients 7 years of age and older 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 (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.  

With its approvals in May 2023 and October 2024, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients 7 years of age and older with narcolepsy (respectively) 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 EDS in patients 7 years of age and older with narcolepsy. For more information, please visit www.avadel.com

Avadel 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.

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.

INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years and older with narcolepsy:

• sudden onset of weak or paralyzed muscles (cataplexy)
• excessive daytime sleepiness (EDS)

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 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 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:

• 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 or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.
• Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking.
  
  

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 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 http://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, including the ability to generate positive cash flow; the anticipated market potential and sales opportunity of LUMRYZ; the Company’s idiopathic hypersomnia clinical study for LUMRYZ, including enrollment and timing related thereto; and the Company’s expectations regarding the strength and diversity of its supply chain and the impact of potential tariffs. In some cases, forward-looking statements can be identified by 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 the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.

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:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionAQ.com   
(212) 698-8696

Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com
(609) 273-3162

FAQ

What are the Q1 2025 performance metrics for Avadel's LUMRYZ?

LUMRYZ showed improvements in patient enrollments, patient starts, persistency rates, and net patients on therapy in Q1 2025 compared to Q4 2024.

When will Avadel's REVITALYZ Phase 3 trial for Idiopathic Hypersomnia complete enrollment?

The REVITALYZ Phase 3 trial is scheduled to complete enrollment in the second half of 2025.

How many patent infringement lawsuits has AVDL filed against Jazz Pharmaceuticals in 2025?

Avadel has initiated four patent infringement lawsuits against Jazz Pharmaceuticals in 2025, involving five different patents related to Xywav usage.

What is the manufacturing setup for AVDL's LUMRYZ supply chain?

LUMRYZ's API is manufactured by two U.S.-based CDMOs, with finished product manufacturing capabilities in both U.S. and Europe, and primary packaging conducted in the U.S.

When does Avadel Pharmaceuticals expect to achieve positive cash flow?

Avadel expects to generate sustainable positive cash flow in 2025.