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Avadel Pharmaceuticals to Present at Upcoming Investor Conferences
Globenewswire· 2024-03-05 13:00
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]
Avadel Pharmaceuticals Issues Statement On Patent Litigation
Newsfilter· 2024-03-04 20:37
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 ...
Avadel Pharmaceuticals plc(AVDL) - 2023 Q4 - Earnings Call Transcript
2024-03-04 15:43
Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2023 Earnings Conference Call March 4, 2024 7:30 AM ET Company Participants Austin Murtagh - Stern IR Gregory Divis - CEO Richard Kim - Chief Commercial Officer Thomas McHugh - CFO Conference Call Participants Francois Brisebois - Oppenheimer Ami Fadia - Needham Andrew Tsai - Jefferies David Amsellem - Piper Sandler Ashwani Verma - UBS Myriam Belghiti - LifeSci Capital Chase Knickerbocker - Craig-Hallum Rudy Li - Leerink Matt Kaplan - Ladenburg Thalmann Oren Livna ...
Avadel Pharmaceuticals plc(AVDL) - 2023 Q4 - Annual Report
2024-02-28 16:00
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 ...
Avadel Pharmaceuticals: Strong Launch Of Lumryz With A Legal Risk Backdrop
Seeking Alpha· 2024-01-28 07:56
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 ...
Avadel (AVDL) is a Great Momentum Stock: Should You Buy?
Zacks Investment Research· 2024-01-15 18:32
Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the 'long' context, investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Whil ...
Why Avadel Pharmaceuticals (AVDL) Stock Might be a Great Pick
Zacks Investment Research· 2024-01-12 14:47
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(AVDL) - 2023 Q3 - Earnings Call Transcript
2023-11-08 18:48
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 ...
Avadel Pharmaceuticals plc(AVDL) - 2023 Q3 - Quarterly Report
2023-11-07 16:00
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].
Avadel Pharmaceuticals plc(AVDL) - 2023 Q2 - Earnings Call Transcript
2023-08-09 18:02
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]