Avadel Pharma

Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. Its products include Bloxiverz, Vazculep, Nouress, and Akovaz. It focuses on the approval of FT218, a formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The company was founded in 1990 and is headquartered in Dublin, Ireland.

Earnings data Q1 2021

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Avadel Pharma reports robust Q3 revenue, eyes market expansion

Avadel Pharma's Q3 performance showed solid revenue and positive EBITDA, with strong patient demand for LUMRYZ.
Despite legal challenges and competition, opportunities exist in market expansion and new patient segments.
The company's focus on persistency, market growth, and product efficacy positions it for future success.
Maintaining strong payer coverage and cash flow positivity are key priorities for upcoming quarters.

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Avadel Pharmaceuticals Plc engages in the development and commercialization of pharmaceutical products. Its main product is LUMRYZ is an extended-release formulation of sodium oxybate, which used in the treatment of cataplexy or EDS in adults with narcolepsy. The company was founded on July 21, 1990 and is headquartered in Dublin, Ireland.

DUBLIN, Ireland, April 10, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the 22nd Annual Needham Healthcare Conference on Monday, April 17 at 9:30 a.m. ET.

Avadel Pharmaceuticals to Present at the 22nd Annual Needham Healthcare Conference

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 Greetings, and welcome to Avadel Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Call. [Operator Instructions] It is now my pleasure to introduce Austin Murtagh with Stern Investor Relations.

Avadel Pharmaceuticals plc (AVDL) Q4 2022 Earnings Call Transcript

• LUMRYZ™ NDA amendment filed March 1 requesting FDA final approval

Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results

DUBLIN, Ireland, March 29, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, March 30, 2023, to provide a corporate update and discuss the Company's financial results for the fourth quarter and full year ended December 31, 2022.

Avadel Pharmaceuticals to Provide a Corporate Update and Report Fourth Quarter and Full Year 2022 Financial Results on March 30

DUBLIN, Ireland, March 29, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (“Avadel”) (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today the pricing of an underwritten public offering of 10,000,001 of its ordinary shares, nominal value $0.01 per share (“Ordinary Shares”) in the form of American Depositary Shares (“ADSs”) and of 4,705,882 Series B Non-Voting Convertible Preferred Shares, convertible into Ordinary Shares on a one-for-one basis (the “Preferred Shares,” together with the ADSs, the “Shares”). Each ADS represents the right to receive one Ordinary Share. All of the Shares are being offered by Avadel. The public offering price of each ADS is $8.50 and the public offering price of each Preferred Share is $8.50. In connection with the public offering, Avadel has granted the underwriters a 30-day option to purchase up to an additional 2,205,882 ADSs at the public offering price, less the underwriting discounts and commissions. The gross proceeds to Avadel from the offering are expected to be approximately $125 million, before deducting underwriting discounts and commissions and estimated offering expenses.

Avadel Pharmaceuticals Announces Pricing of Public Offering of ADSs and Series B Preferred Shares

DUBLIN, Ireland, March 29, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (“Avadel”) (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it is commencing an underwritten public offering of its ordinary shares, nominal value $0.01 per share (“Ordinary Shares”) in the form of American Depositary Shares (“ADSs”). Each ADS represents the right to receive one Ordinary Share. Avadel may, in lieu of ADSs, offer and sell to certain investors Series B Non-Voting Convertible Preferred Shares, convertible into Ordinary Shares on a one-for-one basis (the “Preferred Shares,” together with the ADSs, the “Shares”). All of the Shares are being offered by Avadel. In connection with the offering, Avadel intends to grant the underwriters a 30-day option to purchase additional ADSs at the public offering price, less the underwriting discounts and commissions. The ADSs are listed under the symbol “AVDL” on the Nasdaq Global Market.

Avadel Pharmaceuticals Announces Proposed Underwritten Public Offering of ADSs and Series B Preferred Shares

– In parallel, extended maturity on $96.2 million of convertible notes to April 1, 2027

Avadel Pharmaceuticals Enters into Royalty Agreement with RTW Investments for up to $75 Million

Importation of LUMRYZ to the U.S. shortens the time to product availability following a final approval decision Importation of LUMRYZ to the U.S. shortens the time to product availability following a final approval decision

Avadel Pharmaceuticals Announces FDA Authorization to Import Tentatively-Approved LUMRYZ™ Ahead of Anticipated Final Approval Decision

Avadel Pharmaceuticals' Lumryz has the potential to transform the narcolepsy treatment market. Avadel estimates that the total potential patient population for Lumryz could be greater than 30,000, with a market opportunity of over $3.0 billion annually.

Avadel Pharmaceuticals: Real-World Data Supports Market Opportunity For Lumryz

DUBLIN, Ireland, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that members of management will participate in a fireside chat at the SVB Securities Global Biopharma Conference on Wednesday, February 15 at 1:00 p.m. ET.

Avadel Pharmaceuticals to Present at the SVB Securities Global Biopharma Conference

- Adverse events were reported in patients who took the second, middle-of-the-night dose of immediate-release oxybate less than 2.5 hours after the first dose -

Avadel Pharmaceuticals Announces Publication of Real-World Data Highlighting the Risk of Accidental Dosing Errors with Immediate-Release Twice-Nightly Oxybates

Lumyrz overhang now removed with competitor ordered to delist patent from FDA's Orange Book. The treatment has potential to create a remedial breakthrough in narcolepsy.

Avadel: Lumryz Overhang Now Removed, Rate Buy

- Delisting of REMS Patent sets path to potentially accelerate final approval by FDA

Avadel Pharmaceuticals Announces Favorable Ruling on Motion to Delist REMS Patent from FDA's Orange Book

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 Thalmann Chase Knickerbocker - Craig Hallum Operator Good morning. My name is Rob and I will be your conference operator today.

Avadel Pharmaceuticals plc (AVDL) Q3 2022 Earnings Call Transcript

DUBLIN, Ireland, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2022.

Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2022 Financial Results

- Results identify mood, sleep and pain disorders as the most common comorbidities in people living with narcolepsy -

Avadel Presents New Real-World Data Describing Demographic Characteristics and Comorbidities of Patients with Narcolepsy at ANA 2022

Avadel Pharmaceuticals' LUMRYZ (FT218), with its essential once daily dosing, has snagged a tentative approval from the FDA. Once finally approved, LUMRYZ has serious prospects for knocking off Jazz's flawed blockbuster XYREM/XYWAV duopoly.

Avadel's LUMRYZ: A Good Night's Sleep For Narcolepsy Patients

Avadel Pharmaceuticals goes into the spotlight today. This small biopharma company recently got 'tentative' FDA approval for its flagship drug but is still waiting on one patent challenge to move forward to commercialization.

Avadel Pharmaceuticals: Navigating Through The Uncertainty

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 Adam Evertts - LifeSci Capital Chase Knickerbocker - Craig Hallum Operator Greetings, and welcome to Avadel Pharmaceuticals' Second Quarter 2020 Earnings Call.

Avadel Pharmaceuticals plc (AVDL) CEO Gregory Divis on Q2 2022 Results - Earnings Call Transcript

DUBLIN, Ireland, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the second quarter ended June 30, 2022.

Avadel Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2022 Financial Results

The average of price targets set by Wall Street analysts indicates a potential upside of 105.6% in Avadel (AVDL). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts Think Avadel (AVDL) Could Surge 106%: Read This Before Placing a Bet

- Validates the safety profile and clinical efficacy of LUMRYZ

Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ™ (sodium oxybate) extended-release oral suspension

Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023.  Avadel has received and agreed upon what is expected to be a final label and is completing.

Avadel Cuts Workforce, Optimizes Cost Structure To Support This

DUBLIN, Ireland, June 29, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the steps it is taking to explore every available pathway to accelerate the decision by the U.S. Food and Drug Administration (FDA) to grant final approval of its lead drug candidate, FT218, prior to June 2023. Concurrent with this strategy, Avadel has received and agreed upon what is expected to be a final label and is completing the last edits of the Risk Evaluation and Mitigation Strategy (“REMS”) with FDA and expects to receive tentative approval of FT218.

Avadel Pharmaceuticals Provides Corporate Update

AVDL's FT218 is going to get delayed further over a patent issue. However, there's a goalpost in sight now, and the date is June 2023.

News for Avadel Pharma Stock (AVDL)