Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q1 2024 Earnings Conference Call May 8, 2024 8:30 AM ET Company Participants Austin Murtagh - Director at Stern Investor Relations Gregory Divis - CEO Richard Kim - Chief Commercial Officer Thomas McHugh - CFO Conference Call Participants Andrew Tsai - Jefferies François Brisebois - Oppenheimer Ami Fadia - Needham & Company David Amsellem - Piper Sanger Marc Goodman - Leerink Partners Ashwani Verma - UBS Oren Livnat - H.C. Wainwright Chase Knickerbocker - Craig Hallu ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— Title of each class Trading Symbol(s) Name of each exchange on which registered Ordinary Shares, nominal value $0.01 per share AVDL The Nasdaq Global Market FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period ...

Revenue and Sales Performance - Generated $27.2 million in net revenue from sales of LUMRYZ for the quarter ended March 31, 2024[5] - More than 1,700 patients initiated therapy with LUMRYZ, representing an increase of over 70% from December 31, 2023[3] - Over 2,800 patients enrolled in Avadel's RYZUP patient support services, an increase of approximately 50% since December 31, 2023[3] Expenses and Financial Performance - R&D expenses decreased to $3.1 million for the quarter, down from $3.8 million in the same period in 2023[5] - SG&A expenses increased to $48.6 million, compared to $24.5 million for the same period in 2023, driven by higher commercial launch costs[5] - Net loss for the quarter was $27.3 million, or ($0.30) per diluted share, compared to a net loss of $30.8 million, or ($0.48) per diluted share, for the same period in 2023[6] - Net loss for the three months ended March 31, 2024, was $27,342,000, an improvement from a net loss of $30,784,000 for the same period in 2023, representing a reduction of 7.93%[27] - The company reported a significant increase in share-based compensation expense to $5,389,000 for the three months ended March 31, 2024, compared to $1,522,000 for the same period in 2023[27] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $88.8 million as of March 31, 2024[6] - Cash and cash equivalents rose to $35,794,000 at March 31, 2024, up from $31,167,000 at December 31, 2023, marking an increase of 14.99%[26] - Total current assets increased to $136,035,000 as of March 31, 2024, compared to $134,202,000 at December 31, 2023, reflecting a growth of 1.36%[23] Liabilities and Equity - Total liabilities increased to $89,515,000 as of March 31, 2024, compared to $76,959,000 at December 31, 2023, indicating a rise of 16.31%[24] - Total shareholders' equity decreased to $78,384,000 as of March 31, 2024, down from $87,739,000 at December 31, 2023, reflecting a decline of 10.66%[25] Market and Regulatory Developments - The FDA accepted the sNDA for LUMRYZ for pediatric narcolepsy, with a target action date of September 7, 2024[4] - The company is on track to enroll the first patient in a Phase 3 pivotal trial for idiopathic hypersomnia in the second half of 2024[4] Cash Flow and Financing Activities - Proceeds from sales of marketable securities amounted to $119,066,000 for the three months ended March 31, 2024, significantly higher than $15,295,000 for the same period in 2023[27] - Net cash used in operating activities was $29,704,000 for the three months ended March 31, 2024, slightly better than $30,233,000 for the same period in 2023, showing a decrease of 1.75%[27] - Cash flows from financing activities provided $13,190,000 for the three months ended March 31, 2024, compared to $34,442,000 for the same period in 2023, showing a decrease of 61.73%[27] Operating Lease and Other Liabilities - The current portion of operating lease liability increased to $953,000 as of March 31, 2024, compared to $934,000 at December 31, 2023, indicating a rise of 2.04%[24]

Company Update - Avadel Pharmaceuticals plc will host a conference call and live webcast on May 8, 2024, at 8:30 a.m. ET to provide a corporate update and discuss financial results for Q1 2024 [1] - Investors can access the conference call by dialing +1 (800) 715-9871 for U.S. and Canada or +1 (646) 307-1963 for international calls, using conference ID 2270373 [1] Product Information - Avadel'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 adults with narcolepsy [2]

Core Viewpoint - Avadel (AVDL) shows potential for significant upside based on analysts' price targets, with a mean target of $22.90 indicating a 28.6% upside from the current price of $17.81 [1] Price Target Analysis - The average price target consists of 10 estimates ranging from $19 to $29, with a standard deviation of $3, indicating a relatively high agreement among analysts [1] - The lowest estimate suggests a 6.7% increase, while the highest points to a 62.8% upside [1] Analyst Sentiment - Analysts exhibit strong agreement on AVDL's earnings prospects, with a positive trend in earnings estimate revisions supporting the potential for stock price increases [2][5] - The Zacks Consensus Estimate for the current year has risen by 0.3% over the past month, with one estimate increasing and no negative revisions [5] Zacks Rank - AVDL holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating a strong potential for upside [5]

miniseriesThesis on AVDL: Maintaining a Buy Rating Q4 2023 Earnings and Commercial Performance of Lumryz We update readers based on FY 2023 earnings print and litigation update, where we carefully evaluated our thesis and decided to maintain our buy rating on AVDL (our latest analysis). Avadel Pharmaceuticals reported its Q4 2023 earnings, highlighting the commercial traction of Lumryz, its novel once-nightly formulation of sodium oxybate for narcolepsy. We believe the earnings are positive based on the ...

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 ...