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Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2024 Financial Results

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Avadel Pharmaceuticals (AVDL) reported strong Q2 2024 results, with $41.5 million in net revenue from LUMRYZ sales. The company saw significant growth in patient demand, with over 1,900 patients on LUMRYZ as of June 30th. Avadel is expanding its focus, having dosed the first patient in a Phase 3 trial for idiopathic hypersomnia and awaiting an FDA decision on LUMRYZ for pediatric narcolepsy by September 7, 2024.

Financial highlights include a gross profit of $38.7 million and a net loss of $13.8 million ($0.14 per diluted share). The company ended the quarter with $71.4 million in cash and equivalents. Avadel continues to invest in R&D and marketing efforts to support LUMRYZ's growth and potential new indications.

Avadel Pharmaceuticals (AVDL) ha riportato risultati solidi per il secondo trimestre del 2024, con 41,5 milioni di dollari di ricavi netti dalle vendite di LUMRYZ. L'azienda ha visto una crescita significativa nella domanda dei pazienti, con oltre 1.900 pazienti in trattamento con LUMRYZ al 30 giugno. Avadel sta ampliando il suo focus, avendo somministrato il primo trattamento a un paziente in uno studio di Fase 3 per l'ipersonnia idiopatica e in attesa di una decisione della FDA su LUMRYZ per la narcolessia pediatrica entro il 7 settembre 2024.

I punti salienti finanziari includono un utile lordo di 38,7 milioni di dollari e una perdita netta di 13,8 milioni di dollari (0,14 dollari per azione diluita). L'azienda ha chiuso il trimestre con 71,4 milioni di dollari in contante e equivalent. Avadel continua a investire in ricerca e sviluppo e in attività di marketing per sostenere la crescita di LUMRYZ e le potenziali nuove indicazioni.

Avadel Pharmaceuticals (AVDL) reportó resultados sólidos en el segundo trimestre de 2024, con 41.5 millones de dólares en ingresos netos provenientes de las ventas de LUMRYZ. La compañía vio un crecimiento significativo en la demanda de pacientes, con más de 1,900 pacientes usando LUMRYZ al 30 de junio. Avadel está ampliando su enfoque, habiendo administrado la primera dosis a un paciente en un ensayo de Fase 3 para la hipersomnia idiopática y esperando una decisión de la FDA sobre LUMRYZ para la narcolepsia pediátrica para el 7 de septiembre de 2024.

Los aspectos financieros destacados incluyen un beneficio bruto de 38.7 millones de dólares y una pérdida neta de 13.8 millones de dólares (0.14 dólares por acción diluida). La compañía cerró el trimestre con 71.4 millones de dólares en efectivo y equivalentes. Avadel continúa invirtiendo en I+D y esfuerzos de marketing para apoyar el crecimiento de LUMRYZ y posibles nuevas indicaciones.

Avadel Pharmaceuticals (AVDL)는 2024년 2분기 실적을 발표했으며, LUMRYZ 판매로 4,150만 달러의 순수익을 올렸습니다. 환자 수요가 크게 증가하여 6월 30일 기준으로 LUMRYZ를 복용하는 환자가 1,900명 이상에 이릅니다. Avadel은 특발성 과잠증에 대한 3상 시험에서 첫 번째 환자에게 투약을 시작하고 2024년 9월 7일까지 소아 기면증에 대한 LUMRYZ에 대한 FDA의 결정을 기다리고 있습니다.

재무 하이라이트에는 3,870만 달러의 총 이익1,380만 달러의 순손실 (1주당 0.14달러)이 포함됩니다. 회사는 7,140만 달러의 현금 및 현금성 자산으로 분기를 마감했습니다. Avadel은 LUMRYZ의 성장과 잠재적인 새로운 적응증을 지원하기 위해 R&D 및 마케팅에 계속 투자하고 있습니다.

Avadel Pharmaceuticals (AVDL) a annoncé de solides résultats pour le deuxième trimestre 2024, avec 41,5 millions de dollars de revenus nets issus des ventes de LUMRYZ. L'entreprise a constaté une forte demande des patients, avec plus de 1 900 patients sous LUMRYZ au 30 juin. Avadel élargit son champ d'action, ayant administré la première dose à un patient lors d'un essai de Phase 3 pour l'hypersomnie idiopathique et attendant une décision de la FDA concernant LUMRYZ pour la narcolepsie pédiatrique d'ici le 7 septembre 2024.

Les points saillants financiers incluent un bénéfice brut de 38,7 millions de dollars et une perte nette de 13,8 millions de dollars (0,14 dollar par action diluée). L'entreprise a terminé le trimestre avec 71,4 millions de dollars en liquidités et équivalents. Avadel continue d'investir dans la R&D et des efforts de marketing pour soutenir la croissance de LUMRYZ et ses nouvelles indications potentielles.

Avadel Pharmaceuticals (AVDL) hat starke Ergebnisse für das zweite Quartal 2024 berichtet, mit 41,5 Millionen Dollar Nettoumsatz aus den Verkäufen von LUMRYZ. Das Unternehmen verzeichnete ein signifikantes Wachstum der Patientennachfrage, mit über 1.900 Patienten, die LUMRYZ verwenden zum Stand vom 30. Juni. Avadel weitet seinen Fokus aus und hat den ersten Patienten in einer Phase-3-Studie zur idiopathischen Hypersomnie behandelt und wartet auf eine FDA-Entscheidung zu LUMRYZ bei pädiatrischer Narkolepsie bis zum 7. September 2024.

Die finanziellen Highlights umfassen einen Bruttogewinn von 38,7 Millionen Dollar und einen Nettoverlust von 13,8 Millionen Dollar (0,14 Dollar pro verwässerter Aktie). Das Unternehmen schloss das Quartal mit 71,4 Millionen Dollar in Bargeld und Äquivalente. Avadel investiert weiterhin in Forschung und Entwicklung sowie in Marketingmaßnahmen zur Unterstützung des Wachstums von LUMRYZ und möglicher neuer Indikationen.

Positive
  • Net revenue from LUMRYZ sales reached $41.5 million in Q2 2024, up from $1.5 million in Q2 2023
  • Patient base for LUMRYZ increased to over 1,900 as of June 30th, compared to 1,400 in March and 900 in December 2023
  • Gross profit grew to $38.7 million in Q2 2024 from $1.5 million in Q2 2023
  • First patient dosed in Phase 3 trial for LUMRYZ in idiopathic hypersomnia, expanding potential indications
  • FDA decision on LUMRYZ for pediatric narcolepsy expected by September 7, 2024, potentially expanding the patient population
Negative
  • Net loss of $13.8 million in Q2 2024, although improved from $64.4 million loss in Q2 2023
  • SG&A expenses increased to $47.4 million in Q2 2024 from $46.8 million in Q2 2023
  • Cash position decreased to $71.4 million as of June 30, 2024, with $5.0 million used for non-recurring costs

Insights

Avadel Pharmaceuticals' Q2 2024 results show strong momentum for LUMRYZ, their narcolepsy treatment. Net product revenue reached $41.5 million, a significant increase from $1.5 million in Q2 2023. The patient base has grown to over 1,900, up from 1,400 in Q1 2024, indicating robust market penetration.

However, the company still reported a net loss of $13.8 million, albeit improved from $64.4 million in Q2 2023. SG&A expenses remained high at $47.4 million, including $5 million in non-recurring costs. With $71.4 million in cash and equivalents, Avadel's financial position appears stable but will require careful management to reach profitability.

Avadel's pipeline progress is promising. The company has initiated a Phase 3 trial for LUMRYZ in idiopathic hypersomnia (IH), potentially expanding its market. The REVITALYZ study's design, including patients both on and off oxybates, could provide comprehensive efficacy data.

Additionally, the sNDA for pediatric narcolepsy with a September 7, 2024 PDUFA date could open a new market segment. While pediatric patients currently represent only 5% of oxybate-treated narcolepsy patients, approval could significantly improve treatment options for this underserved population and potentially drive further growth for LUMRYZ.

LUMRYZ's market performance is impressive, with 3,800 patients enrolled in support services and 2,400 initiating therapy since launch. The 35.7% quarter-over-quarter increase in patients on LUMRYZ suggests strong market acceptance and effective commercialization strategies.

The potential expansion into idiopathic hypersomnia and pediatric narcolepsy could significantly broaden LUMRYZ's market. However, investors should monitor the competitive landscape and reimbursement environment. The company's ability to maintain this growth trajectory while managing expenses will be important for long-term success in the sleep disorder treatment market.

-- Generated $41.5 million in net revenue from sales of LUMRYZ™ --

-- More than 1,900 patients on LUMRYZ as of June 30th --

-- First patient dosed in Phase 3 trial evaluating LUMRYZ in idiopathic hypersomnia --

-- FDA target action date of September 7, 2024 for sNDA for LUMRYZ in pediatric narcolepsy --

-- Management to host a conference call today at 8:30 a.m. ET --

DUBLIN, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the quarter ended June 30, 2024.

“The continued strong quarter over quarter growth in patient demand is a testimonial to the reception LUMRYZ has received from the narcolepsy community since its launch last year. Alongside our focus on maximizing the launch of LUMRYZ for the treatment of narcolepsy, creating further sustainable value through indication expansion is a priority,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We are driven by our commitment to provide patients suffering from sleep disorders with transformative treatment options, and we are well positioned to continue executing on our mission to transform the sleep disorder treatment landscape. Last week, we dosed the first patient in the Phase 3 trial in idiopathic hypersomnia, and a potential FDA approval for the pediatric narcolepsy population is expected in September. We look forward to potentially extending LUMRYZ as a treatment option to both of these patient populations.”

Second Quarter and Recent Company Highlights

LUMRYZ Commercial Updates:

  • Generated $41.5 million of net product revenue from sales of LUMRYZ in the second quarter of 2024.
  • As of June 30, there were more than 1,900 patients on LUMRYZ compared to more than 1,400 as of March 31 and more than 900 as of December 31, 2023.
    • From launch through June 30, approximately 3,800 patients had enrolled in Avadel’s RYZUP™ patient support services and greater than 2,400 patients had initiated therapy.

Pipeline and Corporate Updates:

  • Dosed the first patient in REVITALYZ™, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in idiopathic hypersomnia (IH). Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study is expected to enroll approximately 150 adults who are diagnosed with IH and includes an open label extension portion.
  • Supplemental New Drug Application (sNDA) for LUMRYZ for treatment of cataplexy or EDS in the pediatric narcolepsy population is under review with the U.S. Food and Drug Administration (FDA), with an assigned target action date of September 7, 2024.
    • With potential approval in the pediatric population, LUMRYZ could alleviate the burden placed on families and caregivers of children with narcolepsy who are responsible for waking up in the middle of the night to administer a second dose.
    • Pediatric patients currently represent approximately 5% of all oxybate treated narcolepsy patients.
  • On July 1, joined the Russell 3000® Index.

Overview of Second Quarter Financial Results

Recognized $41.5 million in net product revenue for the second quarter 2024 compared to $1.5 million in the same period in 2023. Net product revenue consists of LUMRYZ product sales, which was launched in the U.S. on June 5, 2023.

Gross profit for the second quarter 2024 was $38.7 million compared to $1.5 million in the same period in 2023.

Selling, general and administrative (SG&A) expenses were $47.4 million in the quarter ended June 30, 2024, compared to $46.8 million for the same period in 2023. SG&A expenses in the current period include $5.0 million of non-recurring costs related to the mandatory exchange of the Company’s American Depositary Shares (ADSs) for the underlying ordinary shares and the termination of its American Depository Receipt program (ADR Program).

Research and development (R&D) expenses were $4.1 million in the quarter ended June 30, 2024, compared to $4.2 million for the same period in 2023. R&D expenses in the current period include clinical study costs related to the Phase 3 pivotal trial in IH.

Net loss for the quarter ended June 30, 2024, was $13.8 million, or ($0.14) per diluted share, compared to net loss of $64.4 million, or ($0.83) per diluted share, for the same period in 2023.

Cash, cash equivalents and marketable securities were $71.4 million as of June 30, 2024. Cash used during the quarter ended June 30, 2024, included $5.0 million of non-recurring costs related to the mandatory exchange of the Company’s ADSs for the underlying ordinary shares and the termination of its ADR Program.

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 excessive daytime sleepiness (EDS) in adults with narcolepsy. For more information, please visit www.avadel.com

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 adults with narcolepsy:

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

It is not known if LUMRYZ is safe and effective in people less than 18 years of age.

Do not take LUMRYZ if you take 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 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 have or had depression or have tried to harm yourself. Call your doctor right away if you have symptoms of mental health problems or a change in weight or appetite.
  • Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking.

Tell your doctor if you are on a salt-restricted diet or if you 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. 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 potential therapeutic benefit of LUMRYZ; the success of the commercialization of LUMRYZ; the anticipated market demand and sales opportunity of LUMRYZ; the FDA’s review of the sNDA for LUMRYZ in the pediatric narcolepsy population and timing related thereto; the Company’s idiopathic hypersomnia clinical study for LUMRYZ, including enrollment and timing related thereto; 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:
Courtney Mogerley
Precision AQ
Courtney.Mogerley@precisionAQ.com
(212) 698-8687

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 June 30, Six Months Ended June 30,
   2024   2023   2024   2023 
         
Net product revenue $41,504  $1,496  $68,682  $1,496 
Cost of products sold  2,788   36   4,310   36 
Gross profit  38,716   1,460   64,372   1,460 
Operating expenses:        
Research and development expenses  4,051   4,223   7,119   8,053 
Selling, general and administrative expenses  47,406   46,778   96,029   71,246 
Total operating expense  51,457   51,001   103,148   79,299 
Operating loss  (12,741)  (49,541)  (38,776)  (77,839)
Investment and other income, net  1,126   623   2,504   816 
Interest expense  (2,716)  (2,295)  (5,308)  (5,554)
Loss on extinguishment of debt     (13,129)     (13,129)
Loss before income taxes  (14,331)  (64,342)  (41,580)  (95,706)
Income tax (benefit) provision  (509)  90   (416)  (490)
Net loss $(13,822) $(64,432) $(41,164) $(95,216)
         
Net loss per share - basic $(0.14) $(0.83) $(0.44) $(1.35)
Net loss per share - diluted $(0.14) $(0.83) $(0.44) $(1.35)
         
Weighted average number of shares outstanding - basic  96,151   77,246   93,922   70,603 
Weighted average number of shares outstanding - diluted  96,151   77,246   93,922   70,603 
                 


     
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
     
  June 30, 2024 December 31, 2023
  (Unaudited)  
ASSETS    
Current assets:    
Cash and cash equivalents $28,847  $31,167 
Marketable securities  42,535   73,944 
Accounts receivable, net  33,377   12,103 
Inventories  13,313   10,380 
Research and development tax credit receivable  927   1,322 
Prepaid expenses and other current assets  6,781   5,286 
Total current assets  125,780   134,202 
Property and equipment, net  484   585 
Operating lease right-of-use assets  2,154   2,591 
Goodwill  16,836   16,836 
Research and development tax credit receivable  252   332 
Other non-current assets  12,015   10,152 
Total assets $157,521  $164,698 
     
LIABILITIES AND SHAREHOLDERS’ EQUITY    
Current liabilities:    
Current portion of operating lease liability $866  $934 
Accounts payable  9,794   11,433 
Accrued expenses  33,711   24,227 
Other current liabilities  242   261 
Total current liabilities  44,613   36,855 
Long-term operating lease liability  1,308   1,690 
Royalty financing obligation  35,493   32,760 
Other non-current liabilities  5,819   5,654 
Total liabilities  87,233   76,959 
     
Shareholders’ equity:    
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; zero issued and outstanding at June 30, 2024 and 5,194 issued and outstanding at December 31, 2023     52 
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 96,204 issued and outstanding at June 30, 2024 and 89,825 issued and outstanding at December 31, 2023  961   898 
Additional paid-in capital  880,202   855,452 
Accumulated deficit  (786,660)  (745,496)
Accumulated other comprehensive loss  (24,215)  (23,167)
Total shareholders’ equity  70,288   87,739 
Total liabilities and shareholders’ equity $157,521  $164,698 
         


   
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
   
  Six Months Ended June 30,
   2024   2023 
     
Cash flows from operating activities:    
Net loss $(41,164) $(95,216)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization  978   1,189 
Amortization of debt discount and debt issuance costs     2,460 
Share-based compensation expense  10,851   9,166 
Loss on extinguishment of debt     13,129 
Other adjustments  (1,208)  42 
Net changes in assets and liabilities    
Accounts receivable  (21,274)  (1,775)
Inventories  (2,264)  (1,439)
Prepaid expenses and other current assets  (1,557)  (4,400)
Research and development tax credit receivable  451   2,127 
Accounts payable & other current liabilities  (1,638)  2,470 
Accrued expenses  9,484   10,246 
Other assets and liabilities  (549)  (255)
Net cash used in operating activities  (47,890)  (62,256)
     
Cash flows from investing activities:    
Proceeds from sales of marketable securities  207,835   25,618 
Purchases of marketable securities  (175,898)  (113,460)
Net cash provided by (used in) investing activities  31,937   (87,842)
     
Cash flows from financing activities:    
Proceeds from April 2023 public offering, net of issuance costs     134,151 
Payments for February 2023 Notes     (17,500)
Payments for debt issuance costs     (4,357)
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  4,663   1,779 
Net cash provided by financing activities  13,913   125,986 
     
Effect of foreign currency exchange rate changes on cash and cash equivalents  (280)  116 
     
Net change in cash and cash equivalents  (2,320)  (23,996)
Cash and cash equivalents at January 1,  31,167   73,981 
Cash and cash equivalents at June 30, $28,847  $49,985 
         

FAQ

What was Avadel Pharmaceuticals' (AVDL) revenue for Q2 2024?

Avadel Pharmaceuticals (AVDL) reported net revenue of $41.5 million from LUMRYZ sales in Q2 2024.

How many patients were using LUMRYZ as of June 30, 2024?

As of June 30, 2024, there were more than 1,900 patients on LUMRYZ.

What is the status of LUMRYZ for pediatric narcolepsy?

The FDA has a target action date of September 7, 2024, for the supplemental New Drug Application (sNDA) for LUMRYZ in pediatric narcolepsy.

What new clinical trial did Avadel Pharmaceuticals (AVDL) initiate in Q2 2024?

Avadel Pharmaceuticals (AVDL) dosed the first patient in REVITALYZ, a Phase 3 trial evaluating LUMRYZ for idiopathic hypersomnia.

What was Avadel Pharmaceuticals' (AVDL) net loss for Q2 2024?

Avadel Pharmaceuticals (AVDL) reported a net loss of $13.8 million, or $0.14 per diluted share, for Q2 2024.

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9.15%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
Link
United States of America
DUBLIN