Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Avadel Pharmaceuticals reported strong Q3 2024 results with $50.0 million in net revenue from LUMRYZ sales. The company reached 2,300 patients on LUMRYZ by September 30th, adding 700 new patients in Q3. Key developments include FDA approval for LUMRYZ in patients 7 years and older with narcolepsy, granted Orphan Drug Exclusivity through October 2031. The company reported a minimal operating loss of $0.3 million and a net loss of $2.6 million ($0.03 per share). Cash position stood at $65.8 million as of September 30, 2024.
Avadel Pharmaceuticals ha riportato risultati forti per il terzo trimestre del 2024, con 50,0 milioni di dollari di fatturato netto dalle vendite di LUMRYZ. L'azienda ha raggiunto 2.300 pazienti in terapia con LUMRYZ entro il 30 settembre, aggiungendo 700 nuovi pazienti nel terzo trimestre. Tra i principali sviluppi, c'è stata l'approvazione della FDA per LUMRYZ nei pazienti di 7 anni e più affetti da narcolessia, con concessione di esclusiva come farmaco orfano fino a ottobre 2031. L'azienda ha registrato una perdita operativa minima di 0,3 milioni di dollari e una perdita netta di 2,6 milioni di dollari (0,03 dollari per azione). La posizione di cassa era di 65,8 milioni di dollari al 30 settembre 2024.
Avadel Pharmaceuticals reportó resultados sólidos en el tercer trimestre de 2024, con 50.0 millones de dólares en ingresos netos por ventas de LUMRYZ. La compañía alcanzó 2,300 pacientes en tratamiento con LUMRYZ hasta el 30 de septiembre, añadiendo 700 nuevos pacientes en el tercer trimestre. Entre los desarrollos clave se encuentra la aprobación de la FDA para LUMRYZ en pacientes de 7 años en adelante con narcolepsia, otorgando exclusividad de medicamento huérfano hasta octubre de 2031. La empresa reportó una pérdida operativa mínima de 0.3 millones de dólares y una pérdida neta de 2.6 millones de dólares (0.03 dólares por acción). La posición de efectivo se situaba en 65.8 millones de dólares a 30 de septiembre de 2024.
아바델 제약(Avadel Pharmaceuticals)은 LUMRYZ 판매를 통해 5천만 달러의 순 수익을 기록하며 2024년 3분기에 강력한 실적을 발표했습니다. 이 회사는 9월 30일 기준으로 LUMRYZ을 사용하는 2,300명의 환자에 도달했으며, 3분기 동안 700명의 신규 환자를 추가했습니다. 주요 발전 사항으로는 7세 이상의 기면증 환자에 대한 LUMRYZ의 FDA 승인이 있으며, 2031년 10월까지 희귀의약품 독점권이 부여되었습니다. 이 회사는 30만 달러의 최소 운영 손실과 260만 달러의 순손실(주당 0.03 달러)을 보고했습니다. 2024년 9월 30일 기준 현금 보유액은 6,580만 달러였습니다.
Avadel Pharmaceuticals a annoncé des résultats solides pour le troisième trimestre 2024 avec 50,0 millions de dollars de revenus nets issus des ventes de LUMRYZ. L'entreprise a atteint 2 300 patients sous LUMRYZ au 30 septembre, ajoutant 700 nouveaux patients au cours du troisième trimestre. Parmi les développements clés, on note l'approbation par la FDA de LUMRYZ pour les patients âgés de 7 ans et plus atteints de narcolepsie, bénéficiant d'une exclusivité de médicament orphelin jusqu'en octobre 2031. L'entreprise a rapporté une perte d'exploitation minimale de 0,3 million de dollars et une perte nette de 2,6 millions de dollars (0,03 dollar par action). La position de trésorerie s'élevait à 65,8 millions de dollars au 30 septembre 2024.
Avadel Pharmaceuticals meldete starke Ergebnisse für das dritte Quartal 2024 mit 50,0 Millionen Dollar Nettoerlös aus dem Verkauf von LUMRYZ. Das Unternehmen erreichte bis zum 30. September 2.300 Patienten mit LUMRYZ und fügte im dritten Quartal 700 neue Patienten hinzu. Zu den wichtigsten Entwicklungen gehört die FDA-Zulassung für LUMRYZ bei Patienten ab 7 Jahren mit Narkolepsie, die bis Oktober 2031 eine Orphan Drug Exclusivity erhielt. Das Unternehmen berichtete von einem minimalen operativen Verlust von 0,3 Millionen Dollar und einem Nettoverlust von 2,6 Millionen Dollar (0,03 Dollar pro Aktie). Die Liquiditätsposition betrug am 30. September 2024 65,8 Millionen Dollar.
- Generated $50.0 million in net revenue, up from $7.0 million in Q3 2023
- Significant patient growth to 2,300 users, adding 700 new patients in Q3
- Gross profit increased to $43.9 million from $6.9 million YoY
- Operating loss improved to $0.3 million from $35.1 million YoY
- FDA approval expanded to pediatric patients with Orphan Drug Exclusivity through 2031
- Favorable court ruling upholding LUMRYZ approval and clinical superiority
- Net loss of $2.6 million in Q3 2024
- Operating expenses increased to $44.2 million from $42.0 million YoY
- $2.0 million commitment fee paid for unused financing tranche
Insights
The Q3 2024 results demonstrate strong commercial momentum for LUMRYZ with
The operating loss narrowed substantially to just
The clinical data is compelling, with post-hoc analyses revealing key benefits: 94% of patients preferred once-nightly dosing over twice-nightly alternatives and 93% would recommend LUMRYZ to others. The demonstrated efficacy both as monotherapy and in combination with alerting agents provides flexibility in treatment approaches. The additional finding of weight loss benefits, with patients moving to lower BMI categories, adds another valuable therapeutic advantage.
The expansion into pediatric narcolepsy (ages 7+) and ongoing Phase 3 REVITALYZ study in idiopathic hypersomnia show promising pipeline development that could substantially expand the addressable market. The clinical superiority determination over twice-nightly oxybates validates LUMRYZ's therapeutic advantages.
-- Generated
--2,300 patients on LUMRYZ as of September 30th, including 700 patients that initiated therapy in the quarter --
-- Received FDA approval for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, granted ODE through October 16, 2031 --
-- LUMRYZ approval upheld by court in suit brought by Jazz regarding FDA’s determination that LUMRYZ is clinically superior to twice-nightly oxybate products --
-- Progressed Phase 3 REVITALYZ™ study evaluating efficacy and safety of LUMRYZ in IH --
-- Management to host a conference call today at 8:30 a.m. ET --
DUBLIN, Ireland, Nov. 12, 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 September 30, 2024.
“Over a year ago, we set out on our mission to transform the lives of those living with narcolepsy, including expanding the oxybate market through the introduction of LUMRYZ. This quarter, we are proud to see that expansion come to fruition and continue to be encouraged by patient uptake and quarter-over-quarter growth of LUMRYZ. In parallel to our launch in adults with narcolepsy, we are expanding into additional patient populations, starting with the recent FDA approval of LUMRYZ for the treatment of cataplexy or EDS in patients 7 years and older with narcolepsy, significantly alleviating the burden on patients and their caregivers of waking up in the middle of the night to administer treatment,” stated Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We are also pleased with the recent court ruling affirming FDA’s determination that LUMRYZ, dosed once at bedtime, demonstrates clinical superiority to twice-nightly oxybates, which mitigates an important legal and business risk for the company. With our Phase 3 pivotal trial in IH ongoing, our continued execution of the LUMRYZ launch including our expansion of LUMRYZ into pediatric narcolepsy, we are closing in our business objectives of being a leader in the sleep field and fulfilling the promise of LUMRYZ for all stakeholders.”
Third Quarter and Recent Company Highlights
LUMRYZ Commercial Updates:
- Generated
$50.0 million of net product revenue from sales of LUMRYZ in the third quarter of 2024. - As of September 30, there were 2,300 patients on LUMRYZ compared to 1,900 patients on LUMRYZ at June 30.
- In the third quarter, generated consistent patient demand for LUMRYZ with 700 patients initiating therapy.
- Observed continuing growth in demand from patients who are new to oxybate – these patients represent the fastest growing patient segment for LUMRYZ.
Corporate and Pipeline Updates:
- On October 30, 2024, the U.S. District Court for the District of Columbia ruled in favor of the U.S. Food and Drug Administration (FDA) in a suit brought by Jazz Pharmaceuticals Inc. under the Administrative Procedure Act regarding the FDA’s approval of LUMRYZ.
- With this ruling, the approval of LUMRYZ is upheld based on the FDA’s determination that LUMRYZ is clinically superior to Jazz’s twice-nightly oxybate products.
- On October 16, 2024, the FDA approved LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years or older with narcolepsy.
- LUMRYZ was granted Orphan Drug Exclusivity (ODE) for this patient population through October 16, 2031.
- 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 idiopathic hypersomnia (IH).
- During the quarter ended September 30, 2024, announced publication of results of:
- A post-hoc analysis showing consistent efficacy in participants currently taking alerting agents, highlighting the benefit of LUMRYZ to augment response, as well as the
37% who responded positively based upon LUMRYZ monotherapy. - Data from the RESTORE open-label study, based upon the largest cohort of switch patients, in which
94% preferred the once-nightly dosing regimen and93% who would recommend LUMRYZ to a friend or family member with narcolepsy. - A post-hoc analysis demonstrating weight loss associated with LUMRYZ compared to placebo, and shifting from obese category into overweight and overweight into normal BMI categories.
- A post-hoc analysis showing consistent efficacy in participants currently taking alerting agents, highlighting the benefit of LUMRYZ to augment response, as well as the
Overview of Third Quarter Financial Results
Recognized
Gross profit for the third quarter 2024 was
Total operating expenses were
Selling, general and administrative (SG&A) expenses were
Research and development (R&D) expenses were
Operating loss was
Net loss for the quarter ended September 30, 2024, was
Cash, cash equivalents and marketable securities were
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. To access the conference call, investors are invited to dial (800) 579-2543 (U.S. and International) and reference the conference ID AVADEL.
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 patients 7 years 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 approval in May 2023 and in 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 pediatric patients 7 years 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 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; the potential for the Company to be a leader in the market; 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net product revenue | $ | 50,025 | $ | 7,014 | $ | 118,707 | $ | 8,510 | ||||||||
| Cost of products sold | 6,155 | 117 | 10,465 | 153 | ||||||||||||
| Gross profit | 43,870 | 6,897 | 108,242 | 8,357 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 3,803 | 2,849 | 10,922 | 10,902 | ||||||||||||
| Selling, general and administrative expenses | 40,394 | 39,158 | 136,422 | 110,404 | ||||||||||||
| Total operating expense | 44,197 | 42,007 | 147,344 | 121,306 | ||||||||||||
| Operating loss | (327 | ) | (35,110 | ) | (39,102 | ) | (112,949 | ) | ||||||||
| Investment and other income, net | 610 | 903 | 3,114 | 1,719 | ||||||||||||
| Interest expense | (2,820 | ) | (1,978 | ) | (8,128 | ) | (7,532 | ) | ||||||||
| Loss on extinguishment of debt | — | — | — | (13,129 | ) | |||||||||||
| Loss before income taxes | (2,537 | ) | (36,185 | ) | (44,116 | ) | (131,891 | ) | ||||||||
| Income tax provision (benefit) | 88 | 89 | (327 | ) | (401 | ) | ||||||||||
| Net loss | $ | (2,625 | ) | $ | (36,274 | ) | $ | (43,789 | ) | $ | (131,490 | ) | ||||
| Net loss per share - basic | $ | (0.03 | ) | $ | (0.41 | ) | $ | (0.46 | ) | $ | (1.71 | ) | ||||
| Net loss per share - diluted | $ | (0.03 | ) | $ | (0.41 | ) | $ | (0.46 | ) | $ | (1.71 | ) | ||||
| Weighted average number of shares outstanding - basic | 96,300 | 89,380 | 94,720 | 76,931 | ||||||||||||
| Weighted average number of shares outstanding - diluted | 96,300 | 89,380 | 94,720 | 76,931 | ||||||||||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share data) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,582 | $ | 31,167 | ||||
| Marketable securities | 37,225 | 73,944 | ||||||
| Accounts receivable, net | 37,102 | 12,103 | ||||||
| Inventories | 16,097 | 10,380 | ||||||
| Prepaid expenses and other current assets | 8,252 | 6,608 | ||||||
| Total current assets | 127,258 | 134,202 | ||||||
| Property and equipment, net | 469 | 585 | ||||||
| Operating lease right-of-use assets | 1,930 | 2,591 | ||||||
| Goodwill | 16,836 | 16,836 | ||||||
| Other non-current assets | 11,760 | 10,484 | ||||||
| Total assets | $ | 158,253 | $ | 164,698 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Current portion of operating lease liability | $ | 725 | $ | 934 | ||||
| Accounts payable | 7,917 | 11,433 | ||||||
| Accrued expenses | 33,907 | 24,227 | ||||||
| Other current liabilities | 234 | 261 | ||||||
| Total current liabilities | 42,783 | 36,855 | ||||||
| Long-term operating lease liability | 1,216 | 1,690 | ||||||
| Royalty financing obligation | 34,437 | 32,760 | ||||||
| Other non-current liabilities | 5,154 | 5,654 | ||||||
| Total liabilities | 83,590 | 76,959 | ||||||
| Shareholders’ equity: | ||||||||
| Preferred shares, nominal value of | — | 52 | ||||||
| Ordinary shares, nominal value of | 963 | 898 | ||||||
| Additional paid-in capital | 886,787 | 855,452 | ||||||
| Accumulated deficit | (789,285 | ) | (745,496 | ) | ||||
| Accumulated other comprehensive loss | (23,802 | ) | (23,167 | ) | ||||
| Total shareholders’ equity | 74,663 | 87,739 | ||||||
| Total liabilities and shareholders’ equity | $ | 158,253 | $ | 164,698 | ||||
| AVADEL PHARMACEUTICALS PLC CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) | ||||||||
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (43,789 | ) | $ | (131,490 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 2,013 | 1,784 | ||||||
| Amortization of debt discount and debt issuance costs | — | 2,796 | ||||||
| Share-based compensation expense | 16,261 | 12,293 | ||||||
| Loss on extinguishment of debt | — | 13,129 | ||||||
| Other adjustments | (1,052 | ) | (349 | ) | ||||
| Net changes in assets and liabilities | ||||||||
| Accounts receivable | (24,999 | ) | (6,239 | ) | ||||
| Inventories | (5,255 | ) | (5,286 | ) | ||||
| Prepaid expenses and other current assets | (1,615 | ) | (3,203 | ) | ||||
| Accounts payable & other current liabilities | (3,516 | ) | 3,837 | |||||
| Accrued expenses | 9,680 | 10,621 | ||||||
| Other assets and liabilities | (2,508 | ) | 1,625 | |||||
| Net cash used in operating activities | (54,780 | ) | (100,482 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Proceeds from sales of marketable securities | 298,829 | 125,498 | ||||||
| Purchases of marketable securities | (261,962 | ) | (203,519 | ) | ||||
| Net cash provided by (used in) investing activities | 36,867 | (78,021 | ) | |||||
| Cash flows from financing activities: | ||||||||
| Proceeds from April 2023 public offering, net of issuance costs | — | 134,149 | ||||||
| Payments for February 2023 Notes | — | (17,500 | ) | |||||
| Payments for debt issuance costs | — | (4,357 | ) | |||||
| Proceeds from royalty purchase agreement | — | 30,000 | ||||||
| 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 | 5,840 | 2,241 | ||||||
| Net cash provided by financing activities | 15,090 | 156,446 | ||||||
| Effect of foreign currency exchange rate changes on cash and cash equivalents | 238 | (113 | ) | |||||
| Net change in cash and cash equivalents | (2,585 | ) | (22,170 | ) | ||||
| Cash and cash equivalents at January 1, | 31,167 | 73,981 | ||||||
| Cash and cash equivalents at September 30, | $ | 28,582 | $ | 51,811 | ||||
FAQ
What was Avadel Pharmaceuticals (AVDL) revenue in Q3 2024?
How many patients were using LUMRYZ as of September 30, 2024?
What was AVDL's net loss per share in Q3 2024?
When does LUMRYZ's Orphan Drug Exclusivity expire?
