Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on transforming medicines to improve patients' lives [2] - The company has developed LUMRYZ™, the first and only once-at-bedtime oxybate approved by the FDA for treating cataplexy or excessive daytime sleepiness in adults with narcolepsy [2] Upcoming Events - Management will participate in the Leerink Global Biopharma Conference with a fireside chat scheduled for March 11 at 3:20 p.m. ET [1] - The company will also take part in the UBS Virtual CNS Day with a fireside chat on March 18 at 12:30 p.m. ET [1] - Live webcasts and archived recordings of these events will be available on Avadel's Investor Relations website for 90 days following each conference [1]

DUBLIN, Ireland, March 04, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), today issued a statement in response to a jury ruling from the United States District Court for the District of Delaware ("Court") in a patent suit brought by Jazz Pharmaceuticals Inc. regarding LUMRYZ™. Avadel is pleased with the jury's decision ruling in favor of Avadel with respect to one of the contested patents. As it relates to the jury's decision against Avadel regarding the additional contested patent, the ...

Financial Data and Key Metrics Changes - The company reported $19.5 million in net revenue for Q4 2023 and $28 million for the seven months ended December 31, 2023, indicating strong early launch momentum for LUMRYZ [10][21]. - Total GAAP operating expenses for Q4 2023 were $43.7 million, up from $28.3 million in Q4 2022, primarily due to launch-related costs and increased headcount [22]. - The company ended the year with $105 million in cash and cash equivalents, down from $153 million at the end of Q3 2023, largely due to operational cash usage and paying off convertible notes [23]. Business Line Data and Key Metrics Changes - LUMRYZ has seen strong uptake, with over 2,200 patient enrollments in the RYZUP program by the end of January 2024, up from 1,900 at the end of December 2023 [15]. - The number of patients who initiated LUMRYZ treatment increased from 1,000 to over 1,200 during the same period, with the majority being commercially reimbursed [15][19]. - The company has secured coverage for LUMRYZ with over 80% of commercially covered lives, including major contracts with Anthem and United Healthcare [20][35]. Market Data and Key Metrics Changes - The company believes there is a significant opportunity in the pediatric narcolepsy market, with current oxybate utilization among pediatric patients estimated at 3% to 5% of the total market [46]. - For idiopathic hypersomnia (IH), the company estimates over 30,000 uniquely diagnosed patients, with less than 10% currently treated, indicating substantial growth potential [48]. Company Strategy and Development Direction - The company's primary focus remains on executing the launch strategy for LUMRYZ and expanding its market share in the oxybate market, which is valued at over $1 billion [10][13]. - Plans include pursuing FDA approval for LUMRYZ in pediatric patients and initiating a trial for IH in the second half of 2024 [12][49]. - The company is also developing a low sodium formulation of oxybate to cater to patients with sodium sensitivities [73]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the ongoing patent trial will not impact the commercial launch of LUMRYZ, regardless of the jury's decision [8]. - The company anticipates achieving operating breakeven with approximately 1,300 to 1,500 commercially reimbursed patients on therapy during 2024 [24]. - While not providing formal guidance, management is comfortable with sell-side estimates of approximately $155 million in revenue for 2024, with potential for higher results based on patient demand and pricing [25]. Other Important Information - The company has initiated a brand ambassador program to share patient stories about LUMRYZ, aiming to enhance community engagement and awareness [17]. - Management highlighted the importance of peer-to-peer education through KOL-led speaker programs to drive healthcare provider engagement [59]. Q&A Session Summary Question: Insights on top prescribers and their prescription behavior - Management noted that over 70% of the top 500 prescribers have written prescriptions for LUMRYZ, with the majority being repeat writers [30]. Question: Impact of reimbursement on patient access - Reimbursement significantly affects patient access, with faster processing times observed for patients meeting prior authorization criteria [32]. Question: Market share and growth potential in pediatric and IH segments - The pediatric market is estimated to be small, but there is a strong need for effective treatments, while the IH market presents a significant opportunity due to low current treatment rates [46][49]. Question: Conversion and discontinuation rates - The company reported favorable conversion rates, with discontinuation rates below historical benchmarks for existing therapies [41]. Question: Market dynamics and future growth - Management believes the oxybate market can expand significantly, with new prescribers entering the market and existing prescribers increasing their usage [66].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period ____________ to ____________ Commission file number: 001-37977 AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) Registrant's telephone number, inc ...

vlada_maestro/iStock via Getty Images Shares of Avadel Pharmaceuticals (NASDAQ:AVDL) made little progress since the launch of Lumryz in June 2023 despite the product's good commercial uptake. The company announced in early January that approximately 1,900 patients were enrolled in the RYZUP hub at the end of 2023, that over 1,000 are already on Lumryz, and that Q4 net sales were $19 million. These are still the early days of the launch, but the numbers are very encouraging with what looks like good exec ...

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to capitalize on established price movements for profitable trades [1] Company Overview: Avadel (AVDL) - Avadel currently holds a Momentum Style Score of A and a Zacks Rank of 2 (Buy), indicating strong potential for outperformance [2] - The stock has shown significant price appreciation, with a 43.27% increase over the past quarter and a 115.12% rise over the last year, compared to the S&P 500's 10.37% and 21.83% respectively [4] Price Performance - AVDL shares have increased by 5.52% over the past week, while the Zacks Medical - Drugs industry remained flat during the same period [3] - The monthly price change for AVDL is 5.79%, outperforming the industry average of 3.39% [3] Trading Volume - AVDL's average 20-day trading volume is 912,182 shares, which serves as a bullish indicator when combined with rising stock prices [4] Earnings Outlook - Over the past two months, two earnings estimates for AVDL have been revised upwards, leading to an increase in the consensus estimate from -$1.99 to -$1.98 [5] - For the next fiscal year, two estimates have also moved upwards with no downward revisions [5] Conclusion - Given the strong momentum indicators and positive earnings outlook, AVDL is positioned as a promising investment opportunity with a Momentum Score of A [6]

One stock that might be an intriguing choice for investors right now is Avadel Pharmaceuticals plc (AVDL) . This is because this security in the Medical - Drugs space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the ...

Avadel Pharmaceuticals PLC (NASDAQ:AVDL) Q3 2023 Earnings Conference Call November 8, 2023 8:30 AM ET Company Participants Austin Murtagh - Stern Investor Relations Gregory Divis - CEO & Director Richard Kim - Chief Commercial Officer Jennifer Gudeman - SVP, Medical & Clinical Affairs Thomas McHugh - SVP & CFO Conference Call Participants Ami Fadia - Needham & Company Rudy Li - Leerink Partners Matthew Kaplan - Ladenburg Thalmann & Co. Francois Brisebois - Oppenheimer Chase Knickerbocker - Craig-Hallum Davi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 8, 2023 AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) Ireland 001-37977 98-1341933 (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 10 Earlsfort Terrace Dublin 2, Ireland, D02 T380 Not ...

Financial Performance - Net product revenue for the three and nine months ended September 30, 2023, was $7,014,000 and $8,510,000, respectively, following the FDA approval of LUMRYZ on May 1, 2023, and its commercial launch in June 2023[135]. - Operating loss for the three and nine months ended September 30, 2023, was $35,110,000 and $112,949,000, respectively, compared to $16,960,000 and $75,523,000 for the same periods in 2022[136]. - Net loss for the three and nine months ended September 30, 2023, was $36,274,000 and $131,490,000, respectively, compared to $20,146,000 and $110,014,000 in the same periods last year[137]. - Diluted net loss per share for the three and nine months ended September 30, 2023, was $0.41 and $1.71, respectively, compared to $0.33 and $1.85 in the same periods last year[138]. - Total operating expenses for the three months ended September 30, 2023, were $42,007,000, an increase of $25,047,000 or 147.7% from the previous year[149]. - The net loss for the three months ended September 30, 2023, was $36,274,000, compared to a net loss of $20,146,000 in the same period of 2022[148]. Revenue and Profitability - Net product revenue for the three months ended September 30, 2023, was $7,014,000, with a gross profit margin of 98%[151]. - For the nine months ended September 30, 2023, net product revenue was $8,510,000, maintaining a gross profit margin of 98%[152]. Expenses - Research and development expenses decreased by $3,563,000 or 24.6% during the nine months ended September 30, 2023, compared to the prior year[153]. - Selling, general and administrative expenses increased by $25,062,000 or 177.8% for the three months ended September 30, 2023, driven by higher compensation and marketing costs[154]. - For the nine months ended September 30, 2023, selling, general and administrative expenses rose by $52,869,000 or 91.9% compared to the same period in 2022[155]. - Interest expense decreased by $1,586,000 or 44.5% during the three months ended September 30, 2023, due to a reduction in amortization of debt discount[156]. - Interest expense for the nine months ended September 30, 2023, decreased by $1,555,000 or 17.1% compared to the prior year[158]. Cash Flow and Liquidity - Cash, cash equivalents, and marketable securities increased to $153,179,000 at September 30, 2023, from $96,499,000 at December 31, 2022, primarily due to net proceeds from a public offering and other financing activities[138]. - Net cash used in operating activities was $100,482 for the nine months ended September 30, 2023, an increase of 82.9% compared to $54,938 in 2022, driven by a net loss of $131,490[162]. - Net cash used in investing activities was $78,021 for the nine months ended September 30, 2023, compared to net cash provided of $56,823 in 2022, reflecting a change of 237.3%[165]. - Net cash provided by financing activities was $156,446 for the nine months ended September 30, 2023, a substantial increase of 1,875.1% from $7,921 in 2022, primarily due to proceeds from issuing shares[166]. - The company believes its existing cash, cash equivalents, and marketable securities are sufficient to meet operating, debt service, and capital requirements for the next twelve months[168]. Regulatory and Market Position - LUMRYZ received seven years of orphan drug exclusivity from the FDA, which will last until May 1, 2030, due to its clinical superiority over existing treatments[123]. - A Phase 3 clinical trial (REST-ON) for LUMRYZ involved 212 patients and demonstrated positive top-line data, confirming its efficacy in treating cataplexy and excessive daytime sleepiness[124]. - Interim data from the ongoing RESTORE study indicated that 94.0% of patients preferred the once-at-bedtime dosing regimen of LUMRYZ over twice-nightly dosing[126]. - The competitive landscape includes the introduction of authorized generic versions of sodium oxybate, which may impact LUMRYZ's market position[132]. - The company began shipping LUMRYZ to customers in June 2023 following FDA approval on May 1, 2023[151]. Legal and Risk Factors - The company is subject to potential liabilities from lawsuits and claims, but there were no contingent liabilities as of September 30, 2023, that are likely to have a material adverse effect on its financial position[169]. - The company is exposed to interest rate risk, but a hypothetical 50 basis point change in interest rates would not materially affect the fair value of its securities due to the short-term nature of its investment portfolio[171]. - The company does not believe inflation had a material effect on its financial condition or results of operations during the nine months ended September 30, 2023, but acknowledges potential future impacts[174].