Avadel Announces Preliminary 2024 Results and 2025 Commercial Priorities to Accelerate the LUMRYZ Launch
Avadel Pharmaceuticals (NASDAQ: AVDL) reported strong preliminary Q4 2024 results for LUMRYZ, their narcolepsy treatment. Q4 net revenue reached approximately $50.0 million, representing a 150% increase from Q4 2023's $19.5 million. Full-year 2024 revenue was approximately $169.0 million, up from $28.0 million in 2023.
The company achieved 2,500 patients on LUMRYZ by December 31, 2024, a 275% increase from 900 patients in 2023, with 600 new patients in Q4. Patient composition included 38% switching from first-generation oxybates, 34% new to oxybate, and 28% previously discontinued oxybate users. About 74% of patients were reimbursed.
For 2025, Avadel projects net product revenue of $240-260 million, a 50% year-over-year growth at midpoint, with expected cash flow of $20-40 million. The company aims to have 3,300-3,500 total patients on therapy by end-2025.
Avadel Pharmaceuticals (NASDAQ: AVDL) ha riportato risultati preliminari solidi per il quarto trimestre 2024 per LUMRYZ, il loro trattamento per la narcolessia. Il fatturato netto del Q4 ha raggiunto circa $50,0 milioni, con un aumento del 150% rispetto ai $19,5 milioni del Q4 2023. Il fatturato totale per l'intero anno 2024 è stato di circa $169,0 milioni, in crescita rispetto ai $28,0 milioni del 2023.
L'azienda ha raggiunto 2.500 pazienti con LUMRYZ entro il 31 dicembre 2024, un aumento del 275% rispetto ai 900 pazienti del 2023, con 600 nuovi pazienti nel Q4. La composizione dei pazienti includeva il 38% che ha switchato da ossibato di prima generazione, il 34% nuovi all'ossibato, e il 28% precedentemente discontinuati nell'uso dell'ossibato. Circa il 74% dei pazienti ha ricevuto rimborso.
Per il 2025, Avadel prevede un fatturato netto da prodotto di $240-260 milioni, con una crescita annua del 50% al punto medio, e un flusso di cassa previsto di $20-40 milioni. L'azienda punta ad avere un totale di 3.300-3.500 pazienti in terapia entro la fine del 2025.
Avadel Pharmaceuticals (NASDAQ: AVDL) informó resultados preliminares sólidos para el cuarto trimestre de 2024 para LUMRYZ, su tratamiento para la narcolepsia. Los ingresos netos del Q4 alcanzaron aproximadamente $50.0 millones, lo que representa un incremento del 150% en comparación con los $19.5 millones del Q4 de 2023. Los ingresos totales del año 2024 fueron de aproximadamente $169.0 millones, en comparación con $28.0 millones en 2023.
La compañía alcanzó 2,500 pacientes con LUMRYZ para el 31 de diciembre de 2024, un aumento del 275% desde los 900 pacientes en 2023, con 600 nuevos pacientes en el Q4. La composición de pacientes incluía un 38% que cambió de oxibato de primera generación, un 34% nuevos al oxibato, y un 28% que anteriormente habían discontinuado el uso de oxibato. Aproximadamente el 74% de los pacientes recibieron reembolso.
Para 2025, Avadel proyecta ingresos netos por producto de $240-260 millones, un crecimiento del 50% interanual en el punto medio, con un flujo de caja esperado de $20-40 millones. La compañía tiene como objetivo tener entre 3,300 y 3,500 pacientes en terapia para finales de 2025.
Avadel Pharmaceuticals (NASDAQ: AVDL)는 기면증 치료제인 LUMRYZ에 대해 2024년 4분기 강력한 Preliminary 결과를 보고했습니다. 4분기 순수익은 약 $50.0 백만에 달하며, 2023년 4분기의 $19.5 백만에서 150% 증가했습니다. 2024년 전체 연간 수익은 약 $169.0 백만으로, 2023년의 $28.0 백만에서 증가했습니다.
회사는 2024년 12월 31일 기준으로 LUMRYZ의 2,500명의 환자를 확보하였으며, 이는 2023년의 900명에서 275% 증가한 수치로, 4분기에 600명의 신규 환자가 포함됩니다. 환자 구성은 38%가 1세대 옥시베이트에서 전환되었고, 34%는 옥시베이트를 처음 접하였으며, 28%는 이전에 옥시베이트 사용을 중단한 환자였습니다. 약 74%의 환자가 보험금을 청구했습니다.
2025년에는 Avadel이 예상하는 순 제품 수익은 $240-260 백만으로, 중간값 기준으로 연간 50% 성장할 것으로 보이며, 예상 현금 흐름은 $20-40 백만에 이를 것입니다. 회사의 목표는 2025년 말까지 총 3,300-3,500명의 환자를 치료하는 것입니다.
Avadel Pharmaceuticals (NASDAQ: AVDL) a rapporté de solides résultats préliminaires pour le quatrième trimestre 2024 de LUMRYZ, leur traitement pour la narcolepsie. Les revenus nets du Q4 ont atteint environ $50,0 millions, représentant une augmentation de 150 % par rapport aux 19,5 millions de dollars du Q4 2023. Les revenus totaux pour l'année 2024 étaient d'environ $169,0 millions, en hausse par rapport aux 28,0 millions de dollars en 2023.
L'entreprise a atteint 2 500 patients sous LUMRYZ d'ici le 31 décembre 2024, soit une augmentation de 275% par rapport à 900 patients en 2023, avec 600 nouveaux patients dans le Q4. La composition des patients comprenait 38% passant des oxybates de première génération, 34% nouveaux aux oxybates, et 28% auparavant arrêtés dans l'utilisation des oxybates. Environ 74% des patients ont bénéficié d'un remboursement.
Pour 2025, Avadel prévoit des revenus nets de produits de $240-260 millions, avec une croissance de 50% d'une année sur l'autre au point médian, et un flux de trésorerie attendu de 20 à 40 millions de dollars. L'entreprise vise à avoir entre 3 300 et 3 500 patients sous traitement d'ici fin 2025.
Avadel Pharmaceuticals (NASDAQ: AVDL) berichtete von starken vorläufigen Q4 2024 Ergebnissen für LUMRYZ, ihr Medikament zur Behandlung von Narkolepsie. Der Nettoumsatz im Q4 lag bei etwa $50,0 Millionen, was einem Anstieg von 150% im Vergleich zu $19,5 Millionen im Q4 2023 entspricht. Der Gesamtumsatz für das Jahr 2024 betrug etwa $169,0 Millionen, ein Anstieg von $28,0 Millionen im Jahr 2023.
Das Unternehmen hatte bis zum 31. Dezember 2024 2.500 Patienten auf LUMRYZ, was einem Anstieg von 275% im Vergleich zu 900 Patienten im Jahr 2023 entspricht, mit 600 neuen Patienten im Q4. Die Patientenaufteilung bestand aus 38%, die von der ersten Generation von Oxybaten gewechselt sind, 34%, die neu zu Oxybat sind, und 28%, die zuvor Oxybat nicht mehr verwendet haben. Etwa 74% der Patienten wurden erstattet.
Für 2025 prognostiziert Avadel einen Nettoumsatz von $240-260 Millionen, was einem jährlichen Wachstum von 50% im Mittelwert entspricht, mit einer erwarteten Cashflow von $20-40 Millionen. Das Unternehmen hat das Ziel, bis Ende 2025 insgesamt 3.300-3.500 Patienten in Therapie zu haben.
- Q4 2024 revenue increased 150% YoY to $50.0 million
- Full-year 2024 revenue grew to $169.0 million from $28.0 million in 2023
- Patient base expanded 275% YoY to 2,500 patients
- Achieved positive cash flow in Q4 2024
- 74% of patients secured reimbursement
- Projected 50% revenue growth for 2025
- Q4 revenue impacted by $6.0 million due to lower channel inventory
Insights
The preliminary Q4 results and 2025 guidance present compelling growth metrics for LUMRYZ. Q4 net product revenue of
The 2025 revenue guidance of
Patient metrics are particularly strong with balanced acquisition across all three target segments - switches (
The commercial execution demonstrates effective market penetration strategy. The
The steady quarterly patient adds of 600 new starts shows consistent demand generation. The balanced mix across patient segments suggests the product is gaining traction in both the treatment-naive and switch populations. The expanded patient ambassador program and enhanced support services should help improve persistence rates, which is important for sustained revenue growth.
The ongoing Phase 3 REVITALYZ study in idiopathic hypersomnia represents a significant potential market expansion opportunity. With study completion expected in H2 2025, positive results could open up an additional therapeutic indication. The development of a low-/no-sodium formulation could further differentiate LUMRYZ in the oxybate market, addressing cardiovascular risk concerns associated with high sodium intake.
The
-- Approximately
--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
-- Management to host a conference call today at 4:30 p.m. ET --
DUBLIN, Ireland, Jan. 08, 2025 (GLOBE NEWSWIRE) -- 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:
- Generated fourth quarter net product revenue of approximately
$50.0 million , a greater than150% increase compared to$19.5 million in the fourth quarter of 2023.- Fourth quarter revenue was impacted by approximately
$6.0 million due to an estimated 1.5 fewer weeks of inventory in the channel at December 31, 2024, compared to September 30, 2024.
- Fourth quarter revenue was impacted by approximately
- Full year net product revenue of approximately
$169.0 million compared to$28.0 million in 2023. - Positive cash flow during the fourth quarter ending with approximately
$73.0 million of cash, cash equivalents and marketable securities at December 31, 2024.
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:
- As of December 31, 2024, there were 2,500 patients on LUMRYZ, a more than
275% increase compared to 900 as of December 31, 2023.- In the fourth quarter, generated consistent patient demand for LUMRYZ with 600 patients initiating therapy.
- Continuing demand from all three patient segments during the fourth quarter, with
38% of patients switching from first generation oxybates,34% who are new to oxybate and28% who have previously tried and discontinued oxybates. - As of December 31, 2024, approximately
74% of patients on therapy were reimbursed.
- The Company recently made the following commercial investments to accelerate LUMRYZ’s reach and improve persistency into 2025:
- Expanded and upgraded field sales team by nearly
15% to gain broader physician reach and impact into the under-penetrated75% prescriber universe; - Doubled field reimbursement team to align with field sales team to accelerate the time and pace of patient fulfillment;
- Expanded patient ambassador direct-to-patient initiatives to better educate and activate oxybate patients to seek LUMRYZ; and
- Progressing field-based patient support services beyond the traditional telephonic and digital interventional tools to a more personal intervention at the patient and physician office level.
- Expanded and upgraded field sales team by nearly
Full Year 2025 Guidance:
- Net product revenue in the range of
$240 – 260 million, representing a50% increase at the midpoint of guidance from 2024. - Cash flow of
$20 –$40 million . - 2,800 – 3,000 patients initiating therapy.
- 3,300 – 3,500 total patients on therapy at December 31, 2025.
Pipeline Updates:
- Patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in IH. Completion of this study is expected during the second half of 2025.
- Preclinical development ongoing for a once-nightly, low-/no-sodium oxybate formulation with a target product profile bioequivalent to LUMRYZ.
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.
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 EDS in both adults and pediatrics 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 of age 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 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 benefit of, and market and prescriber preference for, LUMRYZ; the success of commercialization of LUMRYZ; the anticipated market availability, demand and sales opportunity of LUMRYZ, expectations for the Company to solidify its leadership in the sleep space; expectations regarding the Company’s financial results for the fourth quarter of 2024, including net product revenue and cash as of December 31, 2024; and the Company’s full year 2025 guidance, including net product revenue, cash flow, total patient initiations and total patients as of December 31, 2025. 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 estimate of revenue for the fourth quarter of 2024 and cash as of December 31, 2024 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, 2024, 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, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, 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:
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 was LUMRYZ's Q4 2024 revenue growth compared to Q4 2023?
How many patients were on LUMRYZ treatment by the end of 2024?
What is Avadel's (AVDL) revenue guidance for 2025?
What percentage of LUMRYZ patients were reimbursed as of December 2024?
How many new patients started LUMRYZ treatment in Q4 2024?
