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].

Financial Data and Key Metrics Changes - The company reported $1.5 million in net revenue for Q2 2023, marking the first sales of LUMRYZ, which were attributed to initial stocking orders from specialty pharmacies [29] - Total GAAP operating expenses for the quarter were $51 million, consisting of approximately $47 million in SG&A costs and $4 million in R&D costs [29][30] - Cash operating expenses for Q2 2023 were approximately $33 million, with expectations of $35 million to $40 million for the remainder of 2023 [31] Business Line Data and Key Metrics Changes - The launch of LUMRYZ has seen over 1,000 REMS certifications for prescribers, up from 625 previously reported [9] - New patient enrollments into the RYZUP patient services center exceeded 400, an increase from 140 previously reported [9] - LUMRYZ has been added to the Express Scripts National Formulary, and CVS Health has removed the new market block for LUMRYZ, allowing coverage for over 30 million additional commercial lines [10] Market Data and Key Metrics Changes - The oxybate market is segmented into three key groups: 1,600 patients currently treated with twice-nightly oxybate, 16,000 patients who have discontinued it, and 3,000 annual new patient starts [17] - The company has achieved approximately 80% to 90% commercial payor channel mix, with significant coverage from major GPOs [21] Company Strategy and Development Direction - The company aims to expand its patient reach in the rare sleep space, targeting innovative therapies like LUMRYZ for more eligible patients [12] - Plans include submitting a supplemental new drug application for LUMRYZ in the pediatric narcolepsy population by the end of 2023 and initiating a multi-center randomized control trial in idiopathic hypersomnia [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early launch indicators and the potential for LUMRYZ to achieve peak sales greater than $1 billion [13] - The company is focused on executing its commercial launch strategy and is encouraged by the positive feedback from the narcolepsy community [15] Other Important Information - The company completed the exchange of $106.3 million convertible notes for 12.3 million common shares, leaving $21.2 million of convertible notes remaining [31] - The cash position at the end of Q2 2023 was approximately $161 million, supplemented by a $30 million tranche from a royalty financing commitment [32] Q&A Session Summary Question: Understanding RYZUP and its correlation to sales - Management acknowledged the challenge in predicting how many enrolled patients would convert to sales but noted increased success in securing reimbursements [35][36] Question: Metrics on patient conversion and CVS news - Management indicated that while specific metrics on patients on therapy will be reported in future quarters, early conversion rates have been better than expected [38][40] Question: Steps required for RYZUP enrollment and free drug support - The process involves enrollment, benefits investigation, and navigating medical necessity, which can take over a month [49][50] Question: Patient types showing the most demand - The majority of patients enrolling in RYZUP are currently on first-generation oxybate, with some being naive to oxybate [62] Question: Timeline for LUMRYZ in idiopathic hypersomnia - Management indicated that it is too early to provide a precise timeline for clinical trials in this indication [70] Question: Anecdotal feedback from the market - Positive receptivity from healthcare providers has been reported, with many expressing eagerness for the once-at-bedtime therapy [58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— FORM 10-Q ——————— ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37977 ——————— AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) ——————— Ireland 98-1341933 ...

Avadel Pharmaceuticals plc (NASDAQ: AVDL) May 2023 ©2023 Avadel. All rights reserved. Safe Harbor Statements This presentation may include 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 a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ——————— 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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37977 ——————— AVADEL PHARMACEUTICALS PLC (Exact name of registrant as specified in its charter) ——————— Ireland 98-134193 ...

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET Company Participants Austin Murtagh – Stern Investor Relations Greg Divis – Chief Executive Officer Jennifer Gudeman – Senior Vice President-Medical and Clinical Affairs Richard Kim – Chief Commercial Officer Tom McHugh – Chief Financial Officer Conference Call Participants Chris Howerton – Jefferies Adam Evertts – LifeSci Capital David Amsellem – Piper Sandler Matt Kaplan – Ladenburg Thalmann Operator Greeti ...

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, 2022 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) Ireland 98-1341933 Registrant's te ...

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q3 2022 Earnings Conference Call November 9, 2022 8:00 AM ET Company Participants Gregory Divis - Chief Executive Officer Jennifer Gudeman - Vice President of Medical & Clinical Affairs Richard Kim - Chief Commercial Officer Tom McHugh - Senior Vice President & Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer Ami Fadia - Needham Chris Howerton - Jefferies Adam Evertts - LifeSci Capital Marc Goodman - SVB Matt Kaplan - Ladenburg Th ...

Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q2 2022 Earnings Conference Call August 9, 2022 8:00 AM ET Company Participants Brandi Robinson - Senior Vice President of Corporate Affairs Gregory Divis - Chief Executive Officer Jennifer Gudeman - Vice President of Medical & Clinical Affairs Richard Kim - Chief Commercial Officer Tom McHugh - Senior Vice President & Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer Oren Livnat - H.C. Wainwright David Amsellem - Piper Sandler Ada ...