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 ...

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 (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 ...