Avadel Pharmaceuticals Reiterates 2025 Guidance as it Reports Fourth Quarter and Full Year 2024 Financial Results
Avadel Pharmaceuticals (NASDAQ: AVDL) reported strong Q4 2024 financial results, with LUMRYZ sales reaching $50.4 million, a 158% year-over-year increase. Full-year LUMRYZ revenue totaled $169.1 million.
The company reiterated its 2025 guidance, projecting net product revenue of $240-260 million and cash flow of $20-40 million. Patient count is expected to grow from 2,500 (as of December 2024) to 3,300-3,500 by end-2025.
Key Q4 metrics include: 74% of patients on therapy were reimbursed, R&D expenses were $4.3 million, and SG&A expenses reached $44.6 million. The company reported a reduced net loss of $5.0 million ($0.05 per share) compared to $28.8 million ($0.32 per share) in Q4 2023.
Notable developments include FDA approval for LUMRYZ in pediatric narcolepsy patients aged 7+ and ongoing enrollment in the Phase 3 REVITALYZ study for Idiopathic Hypersomnia.
Avadel Pharmaceuticals (NASDAQ: AVDL) ha riportato risultati finanziari solidi per il quarto trimestre del 2024, con vendite di LUMRYZ che hanno raggiunto i 50,4 milioni di dollari, un aumento del 158% rispetto all'anno precedente. Il fatturato annuale di LUMRYZ ha totalizzato 169,1 milioni di dollari.
L'azienda ha ribadito le sue previsioni per il 2025, prevedendo ricavi netti da prodotto tra 240 e 260 milioni di dollari e un flusso di cassa tra 20 e 40 milioni di dollari. Si prevede che il numero di pazienti cresca da 2.500 (a dicembre 2024) a 3.300-3.500 entro la fine del 2025.
I principali indicatori del quarto trimestre includono: il 74% dei pazienti in terapia è stato rimborsato, le spese per R&S sono state di 4,3 milioni di dollari e le spese SG&A hanno raggiunto i 44,6 milioni di dollari. L'azienda ha riportato una perdita netta ridotta di 5,0 milioni di dollari (0,05 dollari per azione) rispetto ai 28,8 milioni di dollari (0,32 dollari per azione) del quarto trimestre del 2023.
Sviluppi significativi includono l'approvazione della FDA per LUMRYZ nei pazienti pediatrici affetti da narcolessia di età superiore ai 7 anni e l'iscrizione in corso nello studio di Fase 3 REVITALYZ per l'ipersonnia idiopatica.
Avadel Pharmaceuticals (NASDAQ: AVDL) reportó resultados financieros sólidos para el cuarto trimestre de 2024, con ventas de LUMRYZ alcanzando los 50,4 millones de dólares, un aumento del 158% en comparación con el año anterior. Los ingresos anuales de LUMRYZ totalizaron 169,1 millones de dólares.
La compañía reiteró su guía para 2025, proyectando ingresos netos por producto de 240 a 260 millones de dólares y un flujo de efectivo de 20 a 40 millones de dólares. Se espera que el número de pacientes crezca de 2,500 (a diciembre de 2024) a entre 3,300 y 3,500 para finales de 2025.
Las métricas clave del cuarto trimestre incluyen: el 74% de los pacientes en terapia fueron reembolsados, los gastos de I+D fueron de 4,3 millones de dólares y los gastos SG&A alcanzaron los 44,6 millones de dólares. La compañía reportó una pérdida neta reducida de 5,0 millones de dólares (0,05 dólares por acción) en comparación con 28,8 millones de dólares (0,32 dólares por acción) en el cuarto trimestre de 2023.
Desarrollos notables incluyen la aprobación de la FDA para LUMRYZ en pacientes pediátricos con narcolepsia de 7 años o más y la inscripción en curso en el estudio de Fase 3 REVITALYZ para la hipersomnia idiopática.
Avadel Pharmaceuticals (NASDAQ: AVDL)는 2024년 4분기 강력한 재무 결과를 보고했으며, LUMRYZ 매출은 5040만 달러로 전년 대비 158% 증가했습니다. LUMRYZ의 연간 수익은 1억 6910만 달러에 달했습니다.
회사는 2025년 가이던스를 재확인하며, 제품 순수익을 2억 4000만 달러에서 2억 6000만 달러로, 현금 흐름을 2000만 달러에서 4000만 달러로 예상하고 있습니다. 환자 수는 2024년 12월 기준 2500명에서 2025년 말까지 3300~3500명으로 증가할 것으로 예상됩니다.
4분기 주요 지표에는 치료를 받고 있는 환자의 74%가 환급을 받았고, 연구개발(R&D) 비용은 430만 달러, 판매 및 관리(SG&A) 비용은 4460만 달러에 달했습니다. 회사는 2023년 4분기의 2880만 달러(주당 0.32달러)와 비교하여 500만 달러(주당 0.05달러)의 감소된 순손실을 보고했습니다.
주목할 만한 발전으로는 7세 이상의 소아 나르콜렙시 환자에 대한 LUMRYZ의 FDA 승인과 특발성 과수면증에 대한 3상 REVITALYZ 연구의 지속적인 등록이 포함됩니다.
Avadel Pharmaceuticals (NASDAQ: AVDL) a annoncé de solides résultats financiers pour le quatrième trimestre de 2024, avec des ventes de LUMRYZ atteignant 50,4 millions de dollars, soit une augmentation de 158 % par rapport à l'année précédente. Le chiffre d'affaires annuel de LUMRYZ a totalisé 169,1 millions de dollars.
La société a réaffirmé ses prévisions pour 2025, projetant un chiffre d'affaires net de produit de 240 à 260 millions de dollars et un flux de trésorerie de 20 à 40 millions de dollars. Le nombre de patients devrait passer de 2 500 (en décembre 2024) à 3 300-3 500 d'ici fin 2025.
Les indicateurs clés du quatrième trimestre incluent : 74 % des patients sous traitement ont été remboursés, les dépenses de R&D se sont élevées à 4,3 millions de dollars et les dépenses SG&A ont atteint 44,6 millions de dollars. L'entreprise a signalé une perte nette réduite de 5,0 millions de dollars (0,05 dollar par action) par rapport à 28,8 millions de dollars (0,32 dollar par action) au quatrième trimestre 2023.
Les développements notables incluent l'approbation de la FDA pour LUMRYZ chez les patients pédiatriques souffrant de narcolepsie âgés de 7 ans et plus, ainsi que l'inscription en cours dans l'étude de Phase 3 REVITALYZ pour l'hypersomnie idiopathique.
Avadel Pharmaceuticals (NASDAQ: AVDL) berichtete über starke Finanzresultate im vierten Quartal 2024, wobei die Verkäufe von LUMRYZ 50,4 Millionen Dollar erreichten, was einem Anstieg von 158% im Vergleich zum Vorjahr entspricht. Der Jahresumsatz von LUMRYZ belief sich auf 169,1 Millionen Dollar.
Das Unternehmen bekräftigte seine Prognose für 2025 und erwartet einen Nettoumsatz von 240 bis 260 Millionen Dollar sowie einen Cashflow von 20 bis 40 Millionen Dollar. Die Patientenzahl wird voraussichtlich von 2.500 (Stand Dezember 2024) auf 3.300 bis 3.500 bis Ende 2025 steigen.
Wichtige Kennzahlen für das vierte Quartal umfassen: 74% der Patienten in Therapie wurden erstattet, die F&E-Ausgaben betrugen 4,3 Millionen Dollar und die SG&A-Ausgaben beliefen sich auf 44,6 Millionen Dollar. Das Unternehmen meldete einen reduzierten Nettoverlust von 5,0 Millionen Dollar (0,05 Dollar pro Aktie) im Vergleich zu 28,8 Millionen Dollar (0,32 Dollar pro Aktie) im vierten Quartal 2023.
Bemerkenswerte Entwicklungen umfassen die FDA-Zulassung für LUMRYZ bei pädiatrischen Narcolepsie-Patienten ab 7 Jahren sowie die laufende Rekrutierung für die Phase-3-Studie REVITALYZ zur idiopathischen Hypersomnie.
- 158% YoY revenue growth in Q4 2024
- Positive cash flow in Q4 2024
- 74% reimbursement rate for patients on therapy
- Net loss decreased significantly YoY
- FDA approval for pediatric narcolepsy treatment
- 29 patents listed in FDA Orange Book
- Increased R&D expenses to $4.3M in Q4 2024
- Higher SG&A expenses at $44.6M in Q4
- Still operating at a net loss
- Searching for new commercial organization leader
Insights
Avadel's Q4 results demonstrate accelerating commercial momentum with
While the company still posted a net loss of
The 2025 revenue guidance of
Their investment in commercial infrastructure, while increasing SG&A expenses to
Avadel's IP protection strategy has strengthened significantly with 8 additional patents in Q4, bringing their Orange Book-listed portfolio to 29 patents. Combined with the newly granted Orphan Drug Exclusivity for the pediatric indication through October 2031, this creates a robust competitive moat for LUMRYZ.
The pediatric approval for patients 7 years and older expands LUMRYZ's addressable market while reinforcing Avadel's leadership in narcolepsy treatment. This approval validates their once-nightly sodium oxybate formulation as appropriate for younger patients, potentially establishing treatment patterns that could persist into adulthood.
The ongoing REVITALYZ Phase 3 trial for Idiopathic Hypersomnia remains on track for enrollment completion in H2 2025. This indication represents a significant market expansion opportunity beyond narcolepsy. IH is an underdiagnosed and undertreated sleep disorder with FDA-approved treatment options, making it a logical extension for LUMRYZ's once-nightly dosing advantage.
Avadel's multi-pronged commercial strategy – expanding the sales team, doubling reimbursement specialists, enhancing patient support, and deploying patient ambassadors – addresses key friction points in the specialty medication journey. The reimbursement focus is particularly important given the current
-- LUMRYZ™ generated
-- Reiterates 2025 guidance, with the number of patients on LUMRYZ expected to increase to 3,300-3,500 by year-end, generating
-- Executing multiple initiatives to accelerate patient demand for LUMRYZ
-- Patient enrollment is on track in the Phase 3 REVITALYZ™ study to evaluate efficacy and safety of LUMRYZ in Idiopathic Hypersomnia (IH)
-- Avadel management to host a conference call today at 8:30 a.m. ET
DUBLIN, March 03, 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 fourth quarter and full year ended December 31, 2024. The company has also reiterated the 2025 guidance provided to shareholders on January 8, 2025.
“Building on our progress in 2024, we have launched several initiatives since the start of the year with the primary goal of increasing the number of patients on LUMRYZ,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “Although it is still early in 2025, we are encouraged by the positive trends that are developing and remain laser-focused on making the most of our opportunity in our pursuit of the billion-dollar market potential of LUMRYZ.”
“We started 2025 with 2,500 patients on LUMRYZ and generated positive cash flow in the fourth quarter of 2024. The evidence for LUMRYZ as an innovative sleep medicine capable of transforming patients’ lives continues to grow. We are investing to accelerate the market adoption of LUMRYZ and are progressing the search for a new leader of our commercial organization with the right experience and capabilities to advance the pace and performance of the LUMRYZ launch and to lead the team through the next phase of significant growth.”
Avadel has invested in i) expanding its field sales team to reach more physicians, ii) doubling its field reimbursement team to accelerate the pace of patient fulfilment, iii) providing more direct personal support to patients and physicians via an expansion of its nurse team, and iv) adding patient ambassadors to help educate people with narcolepsy.
Avadel expects to generate
Fourth Quarter Highlights and 2025 Guidance:
- Generated
$50.4 million of net product revenue from sales of LUMRYZ in the fourth quarter of 2024, up from$19.5 million from the same period in the prior year, a158% increase. - As of December 31, 2024, 2,500 patients were on LUMRYZ.
- As of December 31, 2024, approximately
74% of patients on therapy were reimbursed. - Patients on therapy expected to increase to 3,300 - 3,500 by end of 2025, a
40% increase over 2024 at the higher end of the estimate.
- As of December 31, 2024, approximately
- Reiterates 2025 full-year guidance of
$240 -$260 million in net product revenue, cash operating expenses of$180 -$200 million and cash flow of$20 - 40 million.
Corporate and Pipeline Updates:
- Received FDA approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy. Granted Orphan Drug Exclusivity for that patient population through October 16, 2031.
- USPTO granted 8 more patents in Q4 bringing the total number of patents listed for LUMRYZ in the U.S. Food & Drug Administration’s Orange Book to 29 as of December 31, 2024.
- Ongoing patient enrollment 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. Enrollment remains on track to be completed during the second half of 2025.
- Strengthened leadership team with the recent appointments of Sev Melkonian as Vice President of Patient Services, Distribution and Reimbursement, and Kevin Springman as Vice President of Sales.
- Focused on further strengthening management team and making progress in the search for a new commercial organization leader with proven experience in rare diseases.
Overview of Fourth Quarter and Full Year Financial Results
Avadel recognized
R&D expenses for the quarter and year ended December 31, 2024 were
SG&A expenses for the quarter and year ended December 31, 2024 were
Net losses for the quarter and year ended December 31, 2024 decreased to
Cash flow was positive during the quarter ended December 31, 2024, resulting in cash, cash equivalents and marketable securities of
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. 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 and expansion into additional patient populations; the anticipated market demand and sales opportunity of LUMRYZ, including assumptions regarding the number of patients using LUMRYZ; the potential for the Company to solidify its leadership in sleep medicine; the Company’s idiopathic hypersomnia clinical study for LUMRYZ, including enrollment and timing related thereto; the Company’s ability to seek and obtain FDA approval for, as well as, commercially launch LUMRYZ for indications beyond narcolepsy; and the Company’s anticipated financial condition, expenses, uses of capital and other future financial results. 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
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF LOSS (In thousands, except per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net product revenue | $ | 50,410 | $ | 19,453 | $ | 169,117 | $ | 27,963 | ||||||||
| Cost of products sold | 4,812 | 693 | 15,277 | 846 | ||||||||||||
| Gross profit | 45,598 | 18,760 | 153,840 | 27,117 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 4,274 | 2,359 | 15,196 | 13,261 | ||||||||||||
| Selling, general and administrative expenses | 44,621 | 41,301 | 181,043 | 151,705 | ||||||||||||
| Total operating expenses | 48,895 | 43,660 | 196,239 | 164,966 | ||||||||||||
| Operating loss | (3,297 | ) | (24,900 | ) | (42,399 | ) | (137,849 | ) | ||||||||
| Investment and other income (expense), net | 1,036 | (1,632 | ) | 4,150 | 87 | |||||||||||
| Interest expense | (2,702 | ) | (2,354 | ) | (10,830 | ) | (9,886 | ) | ||||||||
| Loss on extinguishment of debt | — | — | — | (13,129 | ) | |||||||||||
| Loss before income taxes | (4,963 | ) | (28,886 | ) | (49,079 | ) | (160,777 | ) | ||||||||
| Income tax provision (benefit) | 80 | (100 | ) | (247 | ) | (501 | ) | |||||||||
| Net loss | $ | (5,043 | ) | $ | (28,786 | ) | $ | (48,832 | ) | $ | (160,276 | ) | ||||
| Net loss per share - basic | $ | (0.05 | ) | $ | (0.32 | ) | $ | (0.51 | ) | $ | (2.00 | ) | ||||
| Net loss per share - diluted | $ | (0.05 | ) | $ | (0.32 | ) | $ | (0.51 | ) | $ | (2.00 | ) | ||||
| Weighted average number of shares outstanding - basic | 96,395 | 89,798 | 95,141 | 80,174 | ||||||||||||
| Weighted average number of shares outstanding - diluted | 96,395 | 89,798 | 95,141 | 80,174 | ||||||||||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share data) | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 51,371 | $ | 31,167 | ||||
| Marketable securities | 22,406 | 73,944 | ||||||
| Accounts receivable, net | 34,097 | 12,103 | ||||||
| Inventories | 20,298 | 10,380 | ||||||
| Prepaid expenses and other current assets | 6,036 | 6,608 | ||||||
| Total current assets | 134,208 | 134,202 | ||||||
| Property and equipment, net | 453 | 585 | ||||||
| Operating lease right-of-use assets | 1,702 | 2,591 | ||||||
| Goodwill | 16,836 | 16,836 | ||||||
| Other non-current assets | 11,037 | 10,484 | ||||||
| Total assets | $ | 164,236 | $ | 164,698 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Current portion of operating lease liability | $ | 582 | $ | 934 | ||||
| Accounts payable | 7,328 | 11,433 | ||||||
| Accrued expenses | 40,651 | 24,227 | ||||||
| Other current liabilities | 273 | 261 | ||||||
| Total current liabilities | 48,834 | 36,855 | ||||||
| Long-term operating lease liability | 1,122 | 1,690 | ||||||
| Royalty financing obligation | 35,249 | 32,760 | ||||||
| Other non-current liabilities | 5,183 | 5,654 | ||||||
| Total liabilities | 90,388 | 76,959 | ||||||
| Shareholders’ equity: | ||||||||
| Preferred shares, nominal value of | — | 52 | ||||||
| Ordinary shares, nominal value of | 965 | 898 | ||||||
| Additional paid-in capital | 891,791 | 855,452 | ||||||
| Accumulated deficit | (794,328 | ) | (745,496 | ) | ||||
| Accumulated other comprehensive loss | (24,580 | ) | (23,167 | ) | ||||
| Total shareholders’ equity | 73,848 | 87,739 | ||||||
| Total liabilities and shareholders’ equity | $ | 164,236 | $ | 164,698 | ||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) | ||||||||
| Twelve Months Ended December 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (48,832 | ) | $ | (160,276 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 2,681 | 1,766 | ||||||
| Amortization of debt discount and debt issuance costs | — | 2,796 | ||||||
| Share-based compensation expense | 20,387 | 15,811 | ||||||
| Loss on extinguishment of debt | — | 13,129 | ||||||
| Other adjustments | (828 | ) | 1,262 | |||||
| Net changes in assets and liabilities | ||||||||
| Accounts receivable | (21,994 | ) | (12,103 | ) | ||||
| Inventories | (9,219 | ) | (9,532 | ) | ||||
| Prepaid expenses and other current assets | 416 | (2,155 | ) | |||||
| Accounts payable & other current liabilities | (4,093 | ) | 1,545 | |||||
| Accrued expenses | 16,424 | 16,892 | ||||||
| Other assets and liabilities | (1,849 | ) | 2,354 | |||||
| Net cash used in operating activities | (46,907 | ) | (128,511 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Proceeds from sales of marketable securities | 327,781 | 187,136 | ||||||
| Purchases of marketable securities | (276,001 | ) | (237,229 | ) | ||||
| Net cash provided by (used in) investing activities | 51,780 | (50,093 | ) | |||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of shares off the at-the-market offering program | 9,250 | 11,913 | ||||||
| Proceeds from stock option exercises and employee share purchase plan | 6,720 | 2,293 | ||||||
| Proceeds from April 2023 public offering, net of issuance costs | — | 134,151 | ||||||
| Payments for February 2023 Notes | — | (17,500 | ) | |||||
| Payments for October 2023 Notes | — | (21,165 | ) | |||||
| Payments for debt issuance costs | — | (4,357 | ) | |||||
| Proceeds from royalty purchase agreement | — | 30,000 | ||||||
| Net cash provided by financing activities | 15,970 | 135,335 | ||||||
| Effect of foreign currency exchange rate changes on cash and cash equivalents | (639 | ) | 455 | |||||
| Net change in cash and cash equivalents | 20,204 | (42,814 | ) | |||||
| Cash and cash equivalents at January 1 | 31,167 | 73,981 | ||||||
| Cash and cash equivalents at December 31 | $ | 51,371 | $ | 31,167 | ||||
FAQ
What were LUMRYZ sales for Q4 2024 and how did they compare to last year?
What is Avadel's (AVDL) revenue guidance for 2025?
How many patients are currently on LUMRYZ and what is the 2025 target?
What new FDA approval did AVDL receive for LUMRYZ?
What was AVDL's net loss in Q4 2024 compared to Q4 2023?
