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 (AVDL) Update / Briefing June 29, 2023 09:00 AM ET Speaker0 First of all, thank you for everyone here in person and those on the webcast for joining us today for our Loomrise commercial day. We really appreciate you taking a few hours out of your Thursday morning to come and listen to a lot of the insights that we've we've gathered and garnered over the last couple of years as we frame out the early launch period and how we think about this unique opportunity. So before we get started ...

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 ...

Financial Data and Key Metrics Changes - As of June 30, 2022, the company reported $104.1 million in cash, cash equivalents, and market securities, with an additional $17 million in pending tax refunds [23][26] - R&D expenses decreased to $4.5 million in Q2 2022 from $6.8 million in Q2 2021, primarily due to lower purchases of active pharmaceutical ingredients [23][24] - SG&A expenses were $2.8 million in Q2 2022, down from $15.2 million in the same period in 2021, mainly due to fees associated with the exchange of convertible notes [24] - The net loss for Q2 2022 was approximately $63.4 million, or $1.07 per diluted share, compared to a net loss of $19.6 million, or $0.33 per diluted share, in Q2 2021 [25] Business Line Data and Key Metrics Changes - The company is focused on the launch of LUMRYZ, a once-at-bedtime oxybate therapy for narcolepsy, which received tentative FDA approval [7][8] - The clinical profile of LUMRYZ is strong, with a preferred dosing regimen that aligns with patient and clinician preferences [9][14] - The company presented data at SLEEP 2022, highlighting the ease of switching to LUMRYZ from twice-nightly oxybate formulations [13][14] Market Data and Key Metrics Changes - The market opportunity for LUMRYZ is estimated to exceed $3 billion, with over 30,000 potential eligible narcolepsy patients [22] - The total narcolepsy patient population consists of three segments: approximately 16,000 actively treated patients, 10,000 to 15,000 previously treated patients who discontinued therapy, and roughly 3,000 new patient starts [22] Company Strategy and Development Direction - The company aims to accelerate the final approval process for LUMRYZ through legal and regulatory strategies, including a motion to delist the REMS patent [10][11] - The company is preparing for a commercial launch of LUMRYZ, focusing on manufacturing, packaging, and operationalizing the REMS program [12][19] - The company is engaging with payers to establish the clinical value proposition of LUMRYZ and ensure access post-approval [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for LUMRYZ to transform treatment for narcolepsy patients by providing uninterrupted sleep and managing daytime symptoms [27] - The company is committed to keeping stakeholders informed about progress towards final approval and launch readiness [27] Other Important Information - The company recorded a restructuring charge of $3.6 million in Q2 2022 due to workforce reduction, which is expected to reduce quarterly cash operating expenses to $12 million to $14 million [24][25] - The company has established a Patient Services Center to facilitate patient access to LUMRYZ upon approval [34] Q&A Session Summary Question: Timeline for potential earlier approval decision - Management clarified that the timeline for a final approval decision could potentially occur before June 2023, depending on the outcomes of ongoing legal actions [29][30][32] Question: Payer strategy and patient access - Management discussed the importance of ensuring patients can access LUMRYZ quickly post-approval, including potential quick start programs [33][34] Question: Orphan exclusivity for LUMRYZ - Management indicated that while a formal decision on orphan exclusivity has not been made, discussions with the FDA suggest a favorable outlook [36][38] Question: Early adoption and commercialization strategy - Management expects early adoption to come from experienced oxybate prescribers and believes there is a significant opportunity among patients currently on or previously treated with oxybate [56][58] Question: Pricing strategy in light of authorized generics - Management stated that the pricing strategy for LUMRYZ aims to be competitive with existing oxybate therapies, and they do not anticipate significant price erosion due to authorized generics [49][50]