Core Insights - Avadel Pharmaceuticals reported approximately $50.0 million in net revenue from LUMRYZ sales for Q4 2024, representing a greater than 150% increase compared to $19.5 million in Q4 2023 [1][5] - The company anticipates LUMRYZ net product revenue to be between $240 million and $260 million in 2025, indicating a 50% year-over-year growth at the midpoint [1][10] - As of December 31, 2024, there were 2,500 patients on LUMRYZ, a more than 275% increase from 900 patients on the same date in 2023 [1][5] Financial Highlights - Full year net product revenue for 2024 is approximately $169.0 million, up from $28.0 million in 2023 [5] - The company ended Q4 2024 with approximately $73.0 million in cash, cash equivalents, and marketable securities [5] - The fourth quarter revenue was impacted by an estimated $6.0 million due to approximately 1.5 fewer weeks of inventory in the channel compared to the previous quarter [5] Patient Adoption and Market Strategy - In Q4 2024, 600 patients initiated therapy with LUMRYZ, contributing to consistent demand across three patient segments: 38% switched from first-generation oxybates, 34% were new to oxybate, and 28% had previously tried and discontinued oxybates [1][5] - Approximately 74% of patients on therapy were reimbursed as of December 31, 2024 [5] - The company has expanded its field sales team by nearly 15% and doubled its field reimbursement team to enhance physician reach and patient fulfillment [5][10] Future Guidance - The company projects a net product revenue range of $240 million to $260 million for 2025, with cash flow expected between $20 million and $40 million [10] - The anticipated number of patients initiating therapy in 2025 is between 2,800 and 3,000, with total patients on therapy expected to reach between 3,300 and 3,500 by December 31, 2025 [10] - Ongoing patient enrollment in the REVITALYZ pivotal study, a Phase 3 trial for idiopathic hypersomnia, is expected to complete in the second half of 2025 [10]

Group 1 - Avadel Pharmaceuticals plc has granted non-statutory options to twelve new employees to purchase a total of 131,700 ordinary shares under its 2021 Inducement Plan [1] - The options have a ten-year term and will vest over four years, with 25% vesting on the one-year anniversary of each employee's start date and 25% vesting on the second, third, and fourth anniversaries thereafter [1] - The grants were made as an inducement material to the employees' acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4) [1] Group 2 - Avadel Pharmaceuticals is focused on transforming medicines to improve patients' lives, applying innovative solutions to medication development [2] - The company's commercial product, LUMRYZ™, is the first and only once-at-bedtime oxybate approved by the FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [2]

Company Update - Avadel Pharmaceuticals plc will host a conference call and live webcast on January 8, 2025, at 4:30 p.m. ET to provide a corporate update and discuss preliminary unaudited financial results for Q4 and the full year ended December 31, 2024 [1] - A live audio webcast of the call can be accessed through the investor relations section of the company's website, and a replay will be available for 90 days following the event [2] Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [3] - The company's commercial product, LUMRYZ™, is the first and only once-at-bedtime oxybate approved by the FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [3]

Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [3] - The company has developed LUMRYZTM, the first and only once-at-bedtime oxybate approved by the U.S. FDA for treating cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy [3] Upcoming Events - Members of Avadel's management will participate in a fireside chat at the Jefferies London Healthcare Conference on November 20, 2024, at 7:30 a.m. GMT / 2:30 a.m. ET [1] - A live webcast of the fireside chat will be available on Avadel's Investor Relations website for 90 days following the conference [2]

Financial Data and Key Metrics Changes - For Q3 2024, the company reported net revenue of $50 million and gross profit of $43.9 million, with an estimated inventory level consistent with the previous quarter [33][34] - The operating loss was reported at $327,000 on a GAAP basis, while adjusted EBITDA was positive at $6.1 million [39][40] - Cash, cash equivalents, and marketable securities totaled approximately $66 million as of September 30, down from $71 million at the end of June [38] Business Line Data and Key Metrics Changes - The LUMRYZ launch saw 2,300 active patients on therapy as of September 30, with 700 new patients initiating therapy in Q3, contributing to the $50 million in net revenue [9][22] - The fastest-growing segment of new patients is those new-to-oxybate, indicating a shift in market dynamics [11][22] - The company is making investments to improve patient persistency, including doubling the number of nurse care navigators and increasing patient engagement efforts [26][70] Market Data and Key Metrics Changes - The company reported strong demand for LUMRYZ, with a notable increase in new-to-oxybate prescribers, now totaling around 150 [27][79] - The overall narcolepsy market is expanding, with indications that LUMRYZ is adding new patients who were previously untreated with oxybate [81] Company Strategy and Development Direction - The company is focused on executing the near-term value drivers, including the continued launch of LUMRYZ and lifecycle management efforts [21] - The recent FDA approval for LUMRYZ in pediatric patients and the initiation of the Phase 3 IH trial are key strategic developments [20][17] - The company aims to maximize LUMRYZ's potential as the preferred oxybate treatment among narcolepsy patients and providers [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued strong demand for LUMRYZ despite potential seasonality and higher gross-to-net deductions impacting Q4 [45][54] - The company is optimistic about its growth trajectory, particularly with the expansion into the pediatric market and the ongoing legal matters being resolved favorably [19][56] Other Important Information - The company is in the process of addressing legal matters, including ongoing patent trials and antitrust actions against Jazz, which are expected to progress in the coming months [57][59] - The company has received favorable court rulings affirming the clinical superiority of LUMRYZ, which is crucial for its market position [19][60] Q&A Session Summary Question: Can you talk about the patient trends you're seeing so far, including the month of October and the parts of November? - Management noted strong demand for LUMRYZ continues, with a shorter quarter affecting selling days but overall interest remains high [46] Question: Can you help us understand the role of AGs and how you're expanding your sales force? - The company has achieved 85% commercial coverage, making AGs rarely a step for LUMRYZ, and plans to increase the sales force by over 10% to reach moderate and low oxybate prescribers [49][51] Question: Can you provide an update on revenue expectations and litigation? - Management is pleased with progress and expects continued patient demand, while legal matters include ongoing patent trials and an antitrust action against Jazz [54][56] Question: Can you discuss the reasons for higher discontinuation rates among new patients? - Higher discontinuation rates are attributed to new patients not knowing what to expect, necessitating more frequent support and expectation management [64][68] Question: What is the current mix of NT1 and NT2 patients for LUMRYZ? - The prevalence is approximately 30% NT1 and 70% NT2, with LUMRYZ usage consistent with these proportions [83]

PART I – FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2024, including statements of loss, balance sheets, cash flows, and notes on accounting policies, revenue, and legal matters [Note 1: Summary of Significant Accounting Policies](index=11&type=section&id=Note%201%3A%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's operations, focusing on its sole commercial product LUMRYZ, its FDA approvals, Orphan Drug Exclusivity, and recent corporate actions including direct Nasdaq listing and an ATM offering program - The company's only commercialized product is **LUMRYZ**, an extended-release sodium oxybate for treating cataplexy or excessive daytime sleepiness (EDS) in adults and children (7+) with narcolepsy[26](index=26&type=chunk)[29](index=29&type=chunk) - **LUMRYZ** received FDA approval for adults on **May 1, 2023**, with **Orphan Drug Exclusivity (ODE)** until **May 1, 2030**. The pediatric indication was approved on **October 16, 2024**, with **ODE** through **October 16, 2031**[27](index=27&type=chunk) - Effective **April 15, 2024**, the company's ordinary shares were directly listed on **Nasdaq**, following a mandatory exchange of its American Depositary Shares (ADSs) A new At-the-Market (ATM) offering program for up to **$100 million** was established on **May 8, 2024**[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk) [Note 2: Revenue Recognition](index=13&type=section&id=Note%202%3A%20Revenue%20Recognition) This note details that all net product revenue is from U.S. LUMRYZ sales, with **100%** of gross sales concentrated among three key customers: Caremark, Accredo, and Optum Gross Sales by Customer Concentration | Customer | Three Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2024 | | :--- | :--- | :--- | | **Caremark** | 43% | 46% | | **Accredo** | 39% | 37% | | **Optum** | 18% | 17% | [Note 6: Royalty Financing Obligation](index=17&type=section&id=Note%206%3A%20Royalty%20Financing%20Obligation) This note details the royalty financing obligation with RTW, including the **$30 million** first tranche, **3.75%** quarterly royalty payments up to **$75 million**, a **$2 million** expiration fee, and an effective interest rate of **30.4%** - The company has a royalty financing obligation with RTW, requiring quarterly payments of **3.75%** of LUMRYZ worldwide net revenue until a total of **$75 million** is paid back[58](index=58&type=chunk) - The company received the first tranche of **$30 million** but allowed the second tranche to expire on August 31, 2024, incurring a one-time commitment fee of **$2 million**[57](index=57&type=chunk) Royalty Financing Obligation Activity (Nine Months Ended Sep 30, 2024) | Description | Amount (in K) | | :--- | :--- | | **Beginning Balance (Dec 31, 2023)** | $32,760 | | **Accretion of imputed interest** | $8,128 | | **Royalty payments made** | ($3,305) | | **One-time expiration payment** | ($2,000) | | **Ending Balance (non-current)** | $34,437 | [Note 11: Commitments and Contingencies](index=20&type=section&id=Note%2011%3A%20Commitments%20and%20Contingencies) This note details the company's complex legal proceedings, primarily with Jazz Pharmaceuticals, involving patent infringement lawsuits, Avadel's antitrust counterclaims, trade secret misappropriation claims, and Jazz's unsuccessful challenge to LUMRYZ's FDA approval - In the patent trial with Jazz, a jury found infringement of one patent (U.S. Patent No. 11147782) with damages of **$234** The court issued an injunction but excluded Avadel's ability to continue selling LUMRYZ for narcolepsy An ongoing royalty rate is pending, and Avadel is appealing the decision[87](index=87&type=chunk)[88](index=88&type=chunk) - Avadel has filed **antitrust counterclaims** against Jazz, alleging monopolization under the **Sherman Act** related to the improper listing of a patent in the FDA's Orange Book The court denied Jazz's motion to dismiss these claims[96](index=96&type=chunk)[97](index=97&type=chunk) - On **October 30, 2024**, the D.C. District Court ruled in favor of the **FDA and Avadel**, denying Jazz's motion for summary judgment that sought to overturn the FDA's approval of LUMRYZ[108](index=108&type=chunk) [Note 12: Subsequent Events](index=28&type=section&id=Note%2012%3A%20Subsequent%20Events) This note reports a significant post-period event: LUMRYZ received FDA approval on **October 16, 2024**, for pediatric narcolepsy (ages seven and older), with Orphan Drug Exclusivity granted until **October 16, 2031** - On **October 16, 2024**, LUMRYZ was approved by the FDA for pediatric narcolepsy patients aged seven and older, receiving **Orphan Drug Exclusivity** until **October 16, 2031**[110](index=110&type=chunk) Condensed Consolidated Statements of Loss (Unaudited) | Metric | Three Months Ended Sep 30, 2024 | Three Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Net product revenue** | $50,025 K | $7,014 K | $118,707 K | $8,510 K | | **Gross profit** | $43,870 K | $6,897 K | $108,242 K | $8,357 K | | **Operating loss** | ($327) K | ($35,110) K | ($39,102) K | ($112,949) K | | **Net loss** | ($2,625) K | ($36,274) K | ($43,789) K | ($131,490) K | | **Net loss per share - diluted** | ($0.03) | ($0.41) | ($0.46) | ($1.71) | Condensed Consolidated Balance Sheets (Unaudited) | Metric | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | $127,258 K | $134,202 K | | **Total assets** | $158,253 K | $164,698 K | | **Total current liabilities** | $42,783 K | $36,855 K | | **Total liabilities** | $83,590 K | $76,959 K | | **Total shareholders' equity** | $74,663 K | $87,739 K | Condensed Consolidated Statements of Cash Flows (Unaudited) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($54,780) K | ($100,482) K | | **Net cash provided by (used in) investing activities** | $36,867 K | ($78,021) K | | **Net cash provided by financing activities** | $15,090 K | $156,446 K | | **Net change in cash and cash equivalents** | ($2,585) K | ($22,170) K | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, emphasizing significant revenue growth from LUMRYZ's commercial launch, increased operating expenses due to commercialization and clinical trials, and confirms sufficient liquidity for the next twelve months - **LUMRYZ** is the company's only commercial product It received FDA approval for adults in **May 2023** and for pediatrics in **October 2024**, with **Orphan Drug Exclusivity** through **2030** and **2031**, respectively[114](index=114&type=chunk)[115](index=115&type=chunk) - The company has initiated **REVITALYZ**, a **Phase 3** pivotal trial to evaluate LUMRYZ for the treatment of **Idiopathic Hypersomnia (IH)**, with the first patient dosed on **July 31, 2024**[124](index=124&type=chunk) Financial Performance Summary (Q3 2024 vs Q3 2023) | Metric | Q3 2024 | Q3 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Net product revenue** | $50,025 K | $7,014 K | +$43,011 K | +613.2% | | **Gross profit** | $43,870 K | $6,897 K | +$36,973 K | +536.1% | | **Operating loss** | ($327) K | ($35,110) K | +$34,783 K | -99.1% | | **Net loss per share** | ($0.03) | ($0.41) | +$0.38 | -92.7% | - Management believes existing cash, cash equivalents, marketable securities, and anticipated cash from LUMRYZ sales provide **sufficient capital** to meet requirements for the **next twelve months**[155](index=155&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section addresses the company's exposure to various market risks, concluding that interest rate risk from short-term investments and foreign exchange risk from a euro-denominated subsidiary are immaterial, while acknowledging potential future impacts of inflation on operational costs - Interest rate risk is considered **low**, as a hypothetical **50 basis point** change in interest rates would not materially impact the fair value of the company's short-term investment portfolio[157](index=157&type=chunk) - Foreign exchange risk is primarily related to a subsidiary with a euro functional currency, but the potential impact of a **10%** currency fluctuation on net loss is considered **immaterial**[158](index=158&type=chunk) - Inflation has **not had a material effect** on operations, but the company acknowledges it could increase future costs for clinical trials, commercial launch, and labor[160](index=160&type=chunk)[161](index=161&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirms the effectiveness of disclosure controls and procedures as of September 30, 2024, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of **September 30, 2024**[162](index=162&type=chunk) - There were **no changes** in internal control over financial reporting during the third quarter of 2024 that have **materially affected**, or are reasonably likely to materially affect, these controls[163](index=163&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 11 of the financial statements in Part I for detailed information on the company's legal matters, primarily ongoing litigation with Jazz Pharmaceuticals - Information regarding legal proceedings is incorporated by reference from **Note 11**: Commitments and Contingencies - Litigation in **Part I, Item 1** of this report[164](index=164&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 - There have been **no material changes** in risk factors from those disclosed in the **Annual Report on Form 10-K** filed on February 29, 2024[165](index=165&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the reporting period - The company reported **no unregistered sales** of equity securities for the period[165](index=165&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) This section discloses that no directors or officers adopted, terminated, or modified Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the third quarter of 2024 - During the three months ended September 30, 2024, **no directors or officers** adopted, terminated, or modified a **Rule 10b5-1** or non-Rule 10b5-1 trading arrangement[166](index=166&type=chunk)

[Avadel Pharmaceuticals Corporate Update and Third Quarter 2024 Financial Results](index=1&type=section&id=Avadel%20Pharmaceuticals%20Corporate%20Update%20and%20Third%20Quarter%202024%20Financial%20Results) Avadel Pharmaceuticals reports strong Q3 2024 financial and operational results, driven by LUMRYZ™ and key milestones [Third Quarter 2024 Highlights](index=1&type=section&id=Third%20Quarter%202024%20Highlights) Avadel Pharmaceuticals reported strong Q3 2024 with **$50.0 million** LUMRYZ™ revenue, 2,300 patients, and key regulatory and legal milestones | Metric | Value | | :--- | :--- | | Net Revenue (LUMRYZ™) | **$50.0 million** | | Total Patients on LUMRYZ | **2,300** (as of Sept 30) | | New Patients in Q3 | **700** | - Received FDA approval for LUMRYZ to treat cataplexy or EDS in narcolepsy patients aged **7** and older, with **Orphan Drug Exclusivity (ODE)** granted through October **16**, **2031**[1](index=1&type=chunk)[6](index=6&type=chunk) - A U.S. District Court upheld the FDA's determination that LUMRYZ is **clinically superior** to twice-nightly oxybate products, mitigating a significant legal and business risk from a suit brought by Jazz Pharmaceuticals[1](index=1&type=chunk)[2](index=2&type=chunk)[5](index=5&type=chunk) - The company is advancing its Phase **3** REVITALYZ™ study to evaluate LUMRYZ for treating idiopathic hypersomnia (IH)[1](index=1&type=chunk)[6](index=6&type=chunk) [Business and Operational Updates](index=1&type=section&id=Business%20and%20Operational%20Updates) Avadel achieved significant LUMRYZ™ commercial milestones, including **$50.0 million** Q3 net revenue and patient growth, with key legal and FDA approvals [LUMRYZ Commercial Updates](index=1&type=section&id=LUMRYZ%20Commercial%20Updates) LUMRYZ achieved **$50.0 million** in Q3 net product revenue and expanded its patient base, especially among new oxybate users | Metric | Q3 2024 | | :--- | :--- | | Net Product Revenue | **$50.0 million** | | Total Patients on Therapy | **2,300** | | New Patients Initiating Therapy | **700** | - The fastest-growing patient segment for LUMRYZ consists of individuals who are new to oxybate therapy, indicating market expansion[4](index=4&type=chunk) [Corporate and Pipeline Updates](index=2&type=section&id=Corporate%20and%20Pipeline%20Updates) Key corporate updates include a favorable court ruling, FDA pediatric approval for LUMRYZ, and ongoing Phase **3** REVITALYZ study enrollment - On October **30**, **2024**, a U.S. District Court ruled in favor of the FDA, upholding LUMRYZ's approval and its **clinical superiority** over Jazz Pharmaceuticals' twice-nightly oxybate products[5](index=5&type=chunk) - On October **16**, **2024**, the FDA approved LUMRYZ for patients **7** years or older with narcolepsy and granted **Orphan Drug Exclusivity (ODE)** through October **16**, **2031**[6](index=6&type=chunk) - Patient enrollment is ongoing for the pivotal Phase **3** REVITALYZ study, evaluating LUMRYZ's efficacy and safety in idiopathic hypersomnia (IH)[6](index=6&type=chunk) - Recent publications highlighted LUMRYZ's efficacy with alerting agents, high patient preference (**94%**) for the once-nightly regimen, and an association with weight loss[7](index=7&type=chunk)[8](index=8&type=chunk) [Third Quarter 2024 Financial Performance](index=2&type=section&id=Third%20Quarter%202024%20Financial%20Performance) Avadel reported a dramatic increase in Q3 2024 net product revenue to **$50.0 million**, significantly narrowing its operating and net losses year-over-year | Financial Metric | Q3 2024 | Q3 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Net Product Revenue | **$50.0M** | **$7.0M** | **+614%** | | Gross Profit | **$43.9M** | **$6.9M** | **+536%** | | Total Operating Expenses | **$44.2M** | **$42.0M** | **+5.2%** | | Operating Loss | (**$0.3M**) | (**$35.1M**) | **+99.1%** | | Net Loss | (**$2.6M**) | (**$36.3M**) | **+92.8%** | | Net Loss per Share | (**$0.03**) | (**$0.41**) | **+92.7%** | - Operating expenses included **$6.4 million** in non-cash charges, comprising **$5.4 million** in stock-based compensation and **$1.0 million** in depreciation and amortization[10](index=10&type=chunk) - Cash, cash equivalents, and marketable securities stood at **$65.8 million** as of September **30**, **2024**[13](index=13&type=chunk) - Cash usage in the quarter included a **$2.0 million** commitment fee payment related to a decision not to draw on a second financing tranche[13](index=13&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The financial statements detail Avadel's Q3 2024 performance, showing significant revenue growth, reduced net loss, and improved cash flow from operations [Condensed Consolidated Statements of Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss) The statements detail Avadel's Q3 2024 financial performance, showing significant revenue growth and reduced net loss year-over-year Three Months Ended September 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Net product revenue | **$50,025** | **$7,014** | | Gross profit | **$43,870** | **$6,897** | | Total operating expense | **$44,197** | **$42,007** | | Operating loss | (**$327**) | (**$35,110**) | | Net loss | (**$2,625**) | (**$36,274**) | | Net loss per share - diluted | (**$0.03**) | (**$0.41**) | Nine Months Ended September 30 (in thousands) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Net product revenue | **$118,707** | **$8,510** | | Gross profit | **$108,242** | **$8,357** | | Total operating expense | **$147,344** | **$121,306** | | Operating loss | (**$39,102**) | (**$112,949**) | | Net loss | (**$43,789**) | (**$131,490**) | | Net loss per share - diluted | (**$0.46**) | (**$1.71**) | [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets present Avadel's financial position, detailing assets, liabilities, and shareholders' equity as of September **30**, **2024** Assets (in thousands) | Account | Sept 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | **$28,582** | **$31,167** | | Marketable securities | **$37,225** | **$73,944** | | Total current assets | **$127,258** | **$134,202** | | Total assets | **$158,253** | **$164,698** | Liabilities and Shareholders' Equity (in thousands) | Account | Sept 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total current liabilities | **$42,783** | **$36,855** | | Total liabilities | **$83,590** | **$76,959** | | Total shareholders' equity | **$74,663** | **$87,739** | | Total liabilities and shareholders' equity | **$158,253** | **$164,698** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statement highlights improved net cash usage in operating activities for the nine months ended September **30**, **2024** Nine Months Ended September 30 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (**$54,780**) | (**$100,482**) | | Net cash provided by (used in) investing activities | **$36,867** | (**$78,021**) | | Net cash provided by financing activities | **$15,090** | **$156,446** | | Net change in cash and cash equivalents | (**$2,585**) | (**$22,170**) | | Cash and cash equivalents at end of period | **$28,582** | **$51,811** | [Product and Company Information](index=3&type=section&id=Product%20and%20Company%20Information) Avadel Pharmaceuticals focuses on innovative medication development, with LUMRYZ™ as its FDA-approved, once-at-bedtime sodium oxybate treatment for narcolepsy - LUMRYZ™ is the first and only once-at-bedtime treatment for cataplexy or EDS in adults and children (**7** years and older) with narcolepsy[15](index=15&type=chunk) - The FDA granted LUMRYZ **7** years of **Orphan Drug Exclusivity**, finding it **clinically superior** to twice-nightly oxybate treatments because its once-nightly dosing avoids nocturnal arousal[17](index=17&type=chunk) - Avadel Pharmaceuticals focuses on applying innovative solutions to develop medications that address challenges with current treatment options[18](index=18&type=chunk) [Important Safety Information and Forward-Looking Statements](index=4&type=section&id=Important%20Safety%20Information%20and%20Forward-Looking%20Statements) The report includes important safety information for LUMRYZ™ regarding **CNS** depressant risks and abuse potential, alongside standard forward-looking statement disclosures - LUMRYZ has a **BOXED Warning** regarding risks of co-administration with other **CNS** depressants (like alcohol or sedatives), which can cause respiratory depression, hypotension, and death[19](index=19&type=chunk) - Due to its active ingredient (a form of **GHB**), LUMRYZ is a **controlled substance** available only through a **restricted Risk Evaluation and Mitigation Strategy (REMS) program** to prevent abuse[19](index=19&type=chunk) - Common side effects in adults include nausea, dizziness, and headache, while in children they include nausea, bedwetting, and vomiting[26](index=26&type=chunk) - The press release contains forward-looking statements concerning the commercialization of LUMRYZ, market demand, and clinical studies, which are subject to significant risks and uncertainties[28](index=28&type=chunk)[29](index=29&type=chunk)

Core Viewpoint - The U.S. District Court for the District of Columbia ruled in favor of the FDA regarding the approval of LUMRYZ, affirming its clinical superiority over Jazz Pharmaceuticals' products for treating narcolepsy [1][2][3] Group 1: Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patient lives [7] - LUMRYZ is the first and only once-at-bedtime oxybate treatment approved for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [4][7] Group 2: FDA Approval and Legal Context - The FDA granted final approval and Orphan Drug Exclusivity to LUMRYZ in May 2023, which was challenged by Jazz Pharmaceuticals [2][6] - The court ruling upheld the FDA's determination that LUMRYZ is clinically superior, allowing it to remain available to the narcolepsy community [1][3] Group 3: Clinical Evidence - LUMRYZ's approval was supported by the REST-ON trial, which showed significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [5][6] - The FDA found that LUMRYZ's once-nightly dosing regimen significantly contributes to patient care by minimizing sleep disruption [6]

Core Viewpoint - Avadel Pharmaceuticals has received FDA approval for the label expansion of Lumryz, allowing its use in pediatric patients aged seven years and older with narcolepsy, which is expected to enhance sales and market presence [1][2]. Group 1: Drug Approval and Market Impact - The FDA approved Lumryz for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged seven and older, expanding its previous approval for adults [1][2]. - Following the announcement, Avadel's shares increased by 5.1%, although the stock has seen a year-to-date decline of 1.4%, compared to a 0.7% decline in the industry [1]. - Lumryz is a once-at-bedtime formulation of extended-release sodium oxybate, first approved for adults on May 1, 2023, and now includes pediatric patients, with orphan drug exclusivity granted until October 16, 2031 [2]. Group 2: Sales Performance and Future Studies - In Q2 2024, Avadel reported $41.5 million in net product revenues from Lumryz, with over 1,900 patients using the drug as of June 30, up from 1,400 patients in March [4]. - Pediatric patients currently make up about 5% of all oxybate-treated narcolepsy patients, indicating potential for increased sales following the label expansion [4]. - A phase III study is underway to evaluate Lumryz's efficacy in idiopathic hypersomnia, with an expected enrollment of approximately 150 adults [4]. Group 3: Competitive Landscape - Avadel holds a Zacks Rank 3 (Hold), while competitors like Catalyst Pharmaceuticals and ANI Pharmaceuticals have higher rankings, indicating a competitive market environment [5]. - Catalyst Pharmaceuticals has seen a significant increase in EPS estimates, with shares rising 25.9% year-to-date, while ANI Pharmaceuticals has also experienced upward revisions in earnings estimates and a 9% increase in share price [5][6].

-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy— -- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 -- DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administrati ...