Avadel Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Avadel Pharmaceuticals (Nasdaq: AVDL) reported third quarter 2025 results and a corporate update on Nov 4, 2025. Key financial and corporate items:
- LUMRYZ net product revenue $77.5M in Q3 2025, up 55% year-over-year.
- Approximately 3,400 patients on LUMRYZ as of Sep 30, 2025, up 48% year-over-year.
- Gross profit $81.6M (105% of revenue), reflecting a $9.5M royalty reversal tied to the Jazz settlement.
- Net income $20,000 (EPS $0.00) and cash, cash equivalents and marketable securities of $91.6M at Sep 30, 2025.
Corporate developments: Avadel entered a definitive agreement to be acquired by Alkermes for up to $20.00 per share (≈$2.1B), expected to close in Q1 2026 subject to shareholder, regulatory and Irish High Court approvals. Avadel also announced a global settlement with Jazz dismissing litigation and obtained expanded commercialization timing and royalty terms. Avadel licensed valiloxybate from XWPharma and paid a $15M upfront in Q3 with an additional $5M due in Q4 2025.
Avadel Pharmaceuticals (Nasdaq: AVDL) ha riportato i risultati del terzo trimestre 2025 e un aggiornamento aziendale il 4 novembre 2025. Punti chiave finanziari e aziendali:
- Ricavi di LUMRYZ netti di prodotto $77,5 milioni nel Q3 2025, in crescita del 55% su base annua.
- Circa 3.400 pazienti su LUMRYZ al 30 settembre 2025, in aumento del 48% rispetto all'anno precedente.
- Utile lordo $81,6 milioni (105% dei ricavi), riflettendo una rettifica di royalty di $9,5 milioni legata all'accordo Jazz.
- Utile netto $20.000 (EPS $0,00) e liquidità, equivalenti di cassa e titoli negoziabili pari a $91,6M al 30 settembre 2025.
Sviluppi aziendali: Avadel ha firmato un accordo definitivo per essere acquisita da Alkermes per un importo fino a $20,00 per azione (circa $2,1 miliardi), previsto per chiudersi nel I trimestre 2026 subordinatamente alle approvazioni degli azionisti, regolatorie e della Corte d'Irlanda. Avadel ha inoltre annunciato una transazione globale con Jazz che desestinò le controversie e ha ottenuto condizioni ampliate di commercializzazione e royalty. Avadel ha licenziato valiloxybate da XWPharma e ha pagato un acconto di $15 milioni nel trimestre Q3 con altri $5 milioni dovuti nel Q4 2025.
Avadel Pharmaceuticals (Nasdaq: AVDL) informó sobre los resultados del tercer trimestre de 2025 y una actualización corporativa el 4 de noviembre de 2025. Elementos clave financieros y corporativos:
- Ingresos netos por producto de LUMRYZ de $77.5 millones en el Q3 2025, aumentando un 55% interanual.
- Aproximadamente 3,400 pacientes en LUMRYZ al 30 de septiembre de 2025, aumentando un 48% interanual.
- Utilidad bruta $81.6M (105% de los ingresos), reflejando una reversión de regalías de $9.5 millones vinculada al acuerdo con Jazz.
- Ingreso neto $20,000 (EPS $0.00) y efectivo y equivalentes de efectivo y valores negociables de $91.6M al 30 de septiembre de 2025.
Desarrollos corporativos: Avadel firmó un acuerdo definitivo para ser adquirida por Alkermes por hasta $20.00 por acción (aprox. $2.1 mil millones), con cierre esperado en el primer trimestre de 2026 sujeto a aprobaciones de accionistas, reguladoras y de la Alta Corte de Irlanda. Avadel también anunció un acuerdo global con Jazz que desestimó litigios y obtuvo términos ampliados de comercialización y regalías. Avadel licenció valiloxybate a XWPharma y pagó un avance de $15 millones en el Q3 con un $5 millones adicional por vencer en el Q4 2025.
Avadel Pharmaceuticals (나스닥: AVDL)은 2025년 3분기 실적과 기업 업데이트를 2025년 11월 4일 발표했습니다. 주요 재무 및 기업 내용:
- LUMRYZ 순제품 매출 $77.5M in Q3 2025, 연간 대비 55% 증가.
- 2025년 9월 30일 기준 약 3,400명의 환자들이 LUMRYZ를 사용 중이며, 연간 대비 48% 증가.
- 총이익 $81.6M (매출의 105%), Jazz 합의와 관련된 로열티 역전 $9.5M 반영.
- 순이익 $20,000 (주당순이익 0.00) 및 2025년 9월 30일 기준 현금 및 현금성 자산 및 시장성 증권 $91.6M.
기업 개발: Avadel은 Alkermes에 주당 최대 $20.00(약 $2.1B)로 인수되기로 하는 확정 계약을 체결했으며, 주주, 규제 및 아일랜드 고등법원의 승인을 조건으로 2026년 1분기에 마감될 예정입니다. 또한 Jazz와의 전 세계 합의로 소송을 종결했고, 확대된 상업화 시기 및 로열티 조건을 얻었습니다. Avadel은 XWPharma로부터 valiloxybate를 라이선스 받았고 3분기에 $15M 선지급을 지급했으며 4분기에 추가로 $5M이 지불될 예정입니다.
Avadel Pharmaceuticals (NYSE: AVDL) a publié les résultats du troisième trimestre 2025 et une mise à jour corporate le 4 novembre 2025. Principales données financières et informations d'entreprise :
- Le chiffre d'affaires net produit de LUMRYZ s’est élevé à 77,5 millions de dollars au T3 2025, en hausse de 55% sur un an.
- Environ 3 400 patients sous LUMRYZ au 30 septembre 2025, en hausse de 48% sur un an.
- Bénéfice brut 81,6 M$ (105% du chiffre d'affaires), reflétant une rétrocession de redevances de 9,5 M$ liée à l'accord Jazz.
- Résultat net 20 000 $ (EPS 0,00 $) et dispositions de trésorerie et titres négociables de 91,6 M$ au 30 septembre 2025.
Évolutions corporatives: Avadel a conclu un accord définitif pour être acquise par Alkermes pour un montant allant jusqu'à 20,00 $ par action (environ 2,1 Md$), prévu de clôturer au premier trimestre 2026 sous réserve des approbations des actionnaires, des autorités réglementaires et de la Haute Cour d'Irlande. Avadel a également annoncé un règlement mondial avec Jazz qui met fin à la contestation et a obtenu des conditions élargies de commercialisation et de redevances. Avadel a licencié valiloxybate à XWPharma et a versé un avance de 15 M$ au T3 avec un autre 5 M$ dû au T4 2025.
Avadel Pharmaceuticals (Nasdaq: AVDL) meldete am 4. November 2025 die Ergebnisse des dritten Quartals 2025 sowie ein Unternehmensupdate. Wichtige finanzielle und unternehmensbezogene Punkte:
- Netto-Umsatz von LUMRYZ als Produkt $77,5 Mio. im 3Q2025, YoY um 55% gestiegen.
- Ungefähr 3.400 Patienten auf LUMRYZ zum 30. September 2025, YoY +48%.
- Bruttogewinn $81,6 Mio. (105% des Umsatzes), was eine $9,5 Mio. Royalty-Rückstellung im Zusammenhang mit dem Jazz-Vergleich widerspiegelt.
- Nettoeinkommen $20.000 (EPS $0,00) und Barmittel, Barmitteläquivalente und marktfähige Wertpapiere von $91,6 Mio. zum 30.09.2025.
Unternehmensentwicklungen: Avadel hat eine definitive Vereinbarung getroffen, von Alkermes für bis zu $20,00 pro Aktie (ca. $2,1 Mrd.) übernommen zu werden, voraussichtlicher Abschluss im 1. Quartal 2026 vorbehaltlich der Zustimmung der Aktionäre, regulatorischer Genehmigungen und des irischen High Court. Avadel gab außerdem eine weltweite Einigung mit Jazz bekannt, die Rechtsstreitigkeiten beendet und erweiterte Vermarktungs- und Lizenzbedingungen ermöglichte. Avadel lizenzierte Valiloxybate von XWPharma und zahlte im Q3 eine Anzahlung von $15 Mio., weitere $5 Mio. sind im Q4 2025 fällig.
شركة Avadel للأدوية (ناسداك: AVDL) أبلغت عن نتائج الربع الثالث من 2025 وتحديثاً للشركة في 4 نوفمبر 2025. العناصر المالية والشرعية الأساسية:
- إيرادات LUMRYZ الصافية من المنتج بلغت 77.5 مليون دولار في الربع الثالث من 2025، بزيادة قدرها 55% على أساس سنوي.
- حوالي 3,400 مريض يستخدمون LUMRYZ حتى 30 سبتمبر 2025، بزيادة 48% سنوياً.
- الربح الإجمالي 81.6 مليون دولار (105% من الإيرادات), يعكس عكس امتياز بقدر 9.5 مليون دولار مرتب بموجب تسوية Jazz.
- صافي الدخل 20,000 دولار (EPS 0.00 دولار) ونقد ونقد مكافئ وأوراق مالية قابلة للتداول بقيمة $91.6M حتى 30 سبتمبر 2025.
التطورات الشركات: دخلت Avadel في اتفاق نهائي بأن تُستحوذ عليها من قبل Alkermes مقابل حتى $20.00 للسهم (حوالي $2.1 مليار)، من المتوقع إغلاقها في الربع الأول من 2026 رهناً بموافقات المساهمين والتنظيمية وللمحكمة العليا في أيرلندا. كما أعلنت Avadel عن تسوية عالمية مع Jazz تؤدي إلى إنهاء الدعاوى وتحصل على توجيهات توسيع التوقيت والتراخيص. قامت Avadel بترخيص Valiloxybate من XWPharma ودفع فريق Q3 مقدم 15 مليون دولار مع استحقاق 5 ملايين دولار إضافية في Q4 2025.
- LUMRYZ revenue of $77.5M in Q3 2025 (+55% YoY)
- Approximately 3,400 patients on LUMRYZ as of Sep 30, 2025 (+48% YoY)
- Acquisition agreement values company at up to $20.00 per share (~$2.1B)
- Gross profit $81.6M (105% of net revenue) including $9.5M royalty reversal
- R&D expense $27.0M in Q3 2025 (includes $20.0M upfront license fee)
- GAAP operating expenses $79.6M in Q3 2025 vs $44.2M prior year
- Commercial costs increased; selling, general & administrative $52.6M in Q3 2025
Insights
Strong commercial momentum, litigation cleared, and a cash exit offer create a largely positive outcome for stakeholders.
Avadel shows clear commercial traction with LUMRYZ generating
The business case rests on delivered sales growth, removal of litigation uncertainty via the global settlement with Jazz, and a near‑term closing conditional on shareholder, regulatory and Irish High Court approvals by
Watch the transaction close and the specified milestones: shareholder approval and regulatory/Irish High Court clearance expected before the close in
– Generated LUMRYZ™ net product revenue of
– Approximately 3,400 patients on LUMRYZ as of September 30, 2025, a
– Announced global settlement of all litigation with Jazz Pharmaceuticals, Inc. (“Jazz”) –
– Acquisition by Alkermes plc (“Alkermes”) expected to close in first quarter 2026 –
DUBLIN, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced its financial results for the third quarter ended September 30, 2025, and provided a corporate update.
Pending Acquisition by Alkermes:
On October 22, 2025, Avadel entered into a definitive agreement under which Alkermes will acquire Avadel for total transaction consideration of up to
Completion of the transaction remains subject to the satisfaction of certain conditions, including approval by Avadel shareholders, certain regulatory approvals and the approval of the Irish High Court. Subject to the satisfaction of these conditions, the transaction is expected to close in the first quarter of 2026.
Further details regarding the transaction with Alkermes can be found in the announcement issued jointly by Avadel and Alkermes pursuant to Rule 2.7 of the Irish Takeover Rules, as filed with the Company’s current report on Form 8-K that was filed with the United States Securities and Exchange Commission (“SEC”) on October 22, 2025.
Third Quarter Highlights:
- Generated
$77.5 million of net product revenue from sales of LUMRYZ, representing55% growth over the third quarter 2024. - Sustained year-over-year patient uptake and growth with approximately 3,400 patients being treated with LUMRYZ as of September 30, 2025, compared to approximately 2,300 patients as of September 30, 2024.
Corporate and Pipeline Updates:
Corporate
- Strengthened sleep medicine portfolio with exclusive license to develop and commercialize valiloxybate, a GABAB receptor agonist, from XWPharma for all indications, including the treatment of sleep disorders, such as narcolepsy and IH.
- XWPharma received an upfront payment of
$15 million during the quarter ended September 30, 2025, and will receive an additional upfront payment of$5 million from Avadel in the fourth quarter of 2025. XWPharma is eligible to receive development and sales milestone payments in addition to royalties on future net sales. - On track to progress valiloxybate into an initial pharmacokinetic (PK) and comparative bioavailability study.
- XWPharma received an upfront payment of
LUMRYZ for IH
- Patient enrollment in REVITALYZ™ is on track to be completed by the end of 2025. REVITALYZ is a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in IH.
LUMRYZ for Narcolepsy
- Presented new REFRESH™ real-world study data supporting LUMRYZ’s use for the treatment of narcolepsy across all three patient segments (i.e., switch patients, naïve to oxybate patients, and return to oxybate patients) at World Sleep 2025. Results showed that participants experienced clinically meaningful improvements in Epworth Sleepiness Scale (ESS) scores, a measure of excessive daytime sleepiness (EDS), to within the normal range.
Global Settlement with Jazz
On October 21, 2025, Avadel entered into a global settlement agreement (“Settlement Agreement”) with Jazz. Pursuant to the terms of the Settlement Agreement, Avadel and Jazz have dismissed their respective lawsuits with prejudice. Furthermore, Jazz agreed to provide Avadel with upfront cash consideration as well as grant Avadel the ability to commercialize LUMRYZ for indications beyond narcolepsy as soon as March 1, 2028, while Jazz received rights to royalties on net sales of LUMRYZ from October 1, 2025, through February 18, 2036. Details regarding the full terms of the Settlement Agreement can be found in the Company’s current report on Form 8-K that was filed with the SEC on October 22, 2025, and the Company’s quarterly report on Form 10-Q for the quarter ended September 30, 2025.
Overview of Third Quarter Financial Results
Avadel recognized
Gross profit for the quarter ended September 30, 2025 was
Research and development expenses for the quarter ended September 30, 2025 were
Selling, general and administrative expenses for the quarter ended September 30, 2025 were
Total GAAP operating expenses in the quarter ended September 30, 2025 were
Net income for the quarter ended September 30, 2025 was
The company generated positive cash flow in the third quarter. Cash, cash equivalents and marketable securities were
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 seven 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 seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy and in pediatric patients seven 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.
LUMRYZ is only currently approved for the treatment of cataplexy or EDS in patients seven years of age and older with narcolepsy, and Avadel does not market, promote or offer patient support services for use of LUMRYZ in any indication beyond narcolepsy.
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients seven years of age and older with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
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. |
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.
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.
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 efficacy and therapeutic benefits of LUMRYZ; the Company and Alkermes’ ability to consummate the pending transaction in a timely manner, or at all, and the satisfaction (or waiver) of conditions to the consummation of the pending transaction, including with respect to the approval of the Company’s shareholders and required regulatory clearances; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the transaction agreement with Alkermes; the effect of the pendency of the transaction with Alkermes on the Company’s business relationships, operating results and business generally; the expected terms and timelines of Alkermes' planned acquisition of the Company; expectations regarding the license agreement with XWPharma; expected timing of studies for valiloxybate; expectations for the REVITALYZ trial, including timing for completion of patient enrollment; and the potential benefits resulting from the settlement with Jazz. 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.
Statements Required by the Irish Takeover Rules
Responsibility Statement Required by the Irish Takeover Rules
The directors of Avadel accept responsibility for the information contained in this communication. To the best of the knowledge and belief of the directors of Avadel (who have taken all reasonable care to ensure such is the case), the information contained in this communication is in accordance with the facts and does not omit anything likely to affect the import of such information.
Publication on Website
In accordance with Rule 26.1 of the Irish Takeover Rules, a copy of this communication will be available on Avadel's website at https://investors.avadel.com/transaction-overview by no later than 12:00 noon (U.S. Eastern Time) on the business day following publication of this communication. Neither the content of any such websites referred to in this communication nor the content of any other websites accessible from hyperlinks on such website is incorporated into, or forms part of, this communication.
No Profit Forecast / Quantified Financial Benefit Statement / Asset Valuations
No statement in this communication is intended to constitute a profit forecast, profit estimate or quantified financial benefit statement for any period, nor should any statements be interpreted to mean that earnings or earnings per share will, for the current or future financial years or other periods, will necessarily be greater or lesser than those for the relevant preceding financial periods for Alkermes or Avadel. Further, no statement in this communication constitutes an asset valuation.
Investor Contact:
Austin Murtagh
Precision AQ
Austin.Murtagh@precisionAQ.com
(212) 698-8696
Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) (In thousands, except per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net product revenue | $ | 77,467 | $ | 50,025 | $ | 198,107 | $ | 118,707 | ||||||||
| Cost of products sold | (4,116 | ) | 6,155 | 7,827 | 10,465 | |||||||||||
| Gross profit | 81,583 | 43,870 | 190,280 | 108,242 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 27,010 | 3,803 | 35,619 | 10,922 | ||||||||||||
| Selling, general and administrative expenses | 52,636 | 40,394 | 146,841 | 136,422 | ||||||||||||
| Total operating expense | 79,646 | 44,197 | 182,460 | 147,344 | ||||||||||||
| Operating income (loss) | 1,937 | (327 | ) | 7,820 | (39,102 | ) | ||||||||||
| Investment and other income, net | 532 | 610 | 895 | 3,114 | ||||||||||||
| Interest expense | (2,415 | ) | (2,820 | ) | (7,008 | ) | (8,128 | ) | ||||||||
| Income (loss) before income taxes | 54 | (2,537 | ) | 1,707 | (44,116 | ) | ||||||||||
| Income tax provision (benefit) | 34 | 88 | (3,058 | ) | (327 | ) | ||||||||||
| Net income (loss) | $ | 20 | $ | (2,625 | ) | $ | 4,765 | $ | (43,789 | ) | ||||||
| Net income (loss) per share - basic | $ | 0.00 | $ | (0.03 | ) | $ | 0.05 | $ | (0.46 | ) | ||||||
| Net income (loss) per share - diluted | $ | 0.00 | $ | (0.03 | ) | $ | 0.05 | $ | (0.46 | ) | ||||||
| Weighted average number of shares outstanding - basic | 97,104 | 96,300 | 96,812 | 94,720 | ||||||||||||
| Weighted average number of shares outstanding - diluted | 101,276 | 96,300 | 99,830 | 94,720 | ||||||||||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share data) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 79,813 | $ | 51,371 | ||||
| Marketable securities | 11,764 | 22,406 | ||||||
| Accounts receivable, net | 42,444 | 34,097 | ||||||
| Inventories | 23,905 | 20,298 | ||||||
| Prepaid expenses and other current assets | 14,300 | 6,036 | ||||||
| Total current assets | 172,226 | 134,208 | ||||||
| Property and equipment, net | 467 | 453 | ||||||
| Operating lease right-of-use assets | 2,544 | 1,702 | ||||||
| Goodwill | 16,836 | 16,836 | ||||||
| Other non-current assets | 7,375 | 11,037 | ||||||
| Total assets | $ | 199,448 | $ | 164,236 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Current portion of operating lease liability | $ | 740 | $ | 582 | ||||
| Accounts payable | 12,581 | 7,328 | ||||||
| Accrued expenses | 44,156 | 40,651 | ||||||
| Other current liabilities | 5,010 | 273 | ||||||
| Total current liabilities | 62,487 | 48,834 | ||||||
| Long-term operating lease liability | 1,810 | 1,122 | ||||||
| Royalty financing obligation | 34,828 | 35,249 | ||||||
| Other non-current liabilities | 2,098 | 5,183 | ||||||
| Total liabilities | 101,223 | 90,388 | ||||||
| Shareholders’ equity: | ||||||||
| Preferred shares, nominal value of | — | — | ||||||
| Ordinary shares, nominal value of | 972 | 965 | ||||||
| Additional paid-in capital | 910,391 | 891,791 | ||||||
| Accumulated deficit | (789,562 | ) | (794,328 | ) | ||||
| Accumulated other comprehensive loss | (23,576 | ) | (24,580 | ) | ||||
| Total shareholders’ equity | 98,225 | 73,848 | ||||||
| Total liabilities and shareholders’ equity | $ | 199,448 | $ | 164,236 | ||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) | ||||||||
| Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income (loss) | $ | 4,765 | $ | (43,789 | ) | |||
| Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||||
| Depreciation and amortization | 3,008 | 2,013 | ||||||
| Share-based compensation expense | 14,429 | 16,261 | ||||||
| Acquired in-process research & development expense | 20,000 | — | ||||||
| Other adjustments | (1,048 | ) | (1,052 | ) | ||||
| Net changes in assets and liabilities | ||||||||
| Accounts receivable | (8,347 | ) | (24,999 | ) | ||||
| Inventories | (4,042 | ) | (5,255 | ) | ||||
| Prepaid expenses and other current assets | (1,562 | ) | (1,615 | ) | ||||
| Accounts payable & other current liabilities | 5,067 | (3,516 | ) | |||||
| Accrued expenses | (1,495 | ) | 9,680 | |||||
| Other assets and liabilities | (4,105 | ) | (2,508 | ) | ||||
| Net cash provided by (used in) operating activities | 26,670 | (54,780 | ) | |||||
| Cash flows from investing activities: | ||||||||
| Purchases of property and equipment | (190 | ) | — | |||||
| Proceeds from sales of marketable securities | 57,738 | 298,829 | ||||||
| Purchases of marketable securities | (46,918 | ) | (261,962 | ) | ||||
| Upfront license payment for acquired in-process research & development | (15,000 | ) | — | |||||
| Net cash (used in) provided by investing activities | (4,370 | ) | 36,867 | |||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of shares off the at-the-market offering program | — | 9,250 | ||||||
| Proceeds from stock option exercises and employee share purchase plan | 4,179 | 5,840 | ||||||
| Net cash provided by financing activities | 4,179 | 15,090 | ||||||
| Effect of foreign currency exchange rate changes on cash and cash equivalents | 1,963 | 238 | ||||||
| Net change in cash and cash equivalents | 28,442 | (2,585 | ) | |||||
| Cash and cash equivalents at January 1, | 51,371 | 31,167 | ||||||
| Cash and cash equivalents at September 30, | $ | 79,813 | $ | 28,582 | ||||