1. DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program. Clinical Therapeutics is a leading, peer-reviewed journal publishing recent developments in drug therapy for an international audience of scientists and clinicians.

    Sodium oxybate is recognized as standard of care by the American Academy of Sleep Medicine for patients living with narcolepsy, a chronic neurological condition that impacts…

    DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program. Clinical Therapeutics is a leading, peer-reviewed journal publishing recent developments in drug therapy for an international audience of scientists and clinicians.

    Sodium oxybate is recognized as standard of care by the American Academy of Sleep Medicine for patients living with narcolepsy, a chronic neurological condition that impacts about 1 in 2,000 Americans.1 Due to its short half-life, conventional sodium oxybate treatment has required patients to wake up in the middle of the night, two and a half to four hours after their first dose, to take their second dose to maintain therapeutic concentrations. Once-nightly FT218 utilizes Avadel's proprietary, controlled-release technology platform to optimize the pharmacokinetic profile of sodium oxybate by providing a blend of immediate-release and controlled-release microparticles.

    Key findings from the paper, titled "Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults," include bioequivalent systemic drug exposure, as measured by area-under-the-curve (AUC), for the FT218 6-gram dose compared to immediate-release sodium oxybate given as two, separate 3-gram doses.2 Furthermore, FT218 demonstrated a dose-proportional increase in Cmax and a slightly more than dose-proportional increase in AUC. In all Phase 1 studies, FT218 exhibited a pharmacokinetic profile that supported once-nightly dosing with adequate concentrations maintained throughout the night, and gradual decline to lowest levels by 8-10 hours after dosing (i.e., the time when most patients wake up in the morning).

    "These data should instill confidence in clinicians and patients regarding the robust Phase 1 development program for FT218, with the demonstration of predictable blood levels of the active ingredient with a single dose, and a low residual amount of active drug remaining when a patient would awaken," said David Seiden, M.D., lead author and senior medical director of clinical development and medical affairs at Avadel Pharmaceuticals. "As a sleep medicine physician and researcher, I am pleased that we have leveraged our proven technology to move toward the goal of patients potentially having access to a once-nightly sodium oxybate treatment."

    Results from these four Phase 1 studies have been previously presented at the 15th World Sleep Congress in Vancouver, Canada.3

    For all studies, adverse events with FT218 were mostly mild or moderate in severity, nonserious and known to be associated with sodium oxybate. Most common adverse events included somnolence, dizziness and nausea.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. On February 26, 2021, the NDA for FT218 was formally accepted for filing by the FDA and issued a target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the pharmacokinetic profile of FT218, the bioequivalence of FT218 to twice-nightly sodium oxybate, and the potential benefits of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    References:

    1. Morgenthaler, T. I., Kapur, V. K., Brown, T., Swick, T. J., Alessi, C., Aurora, R. N., Boehlecke, B., Chesson, A. L., Jr, Friedman, L., Maganti, R., Owens, J., Pancer, J., Zak, R., & Standards of Practice Committee of the American Academy of Sleep Medicine (2007). Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep, 30(12), 1705–1711. https://doi.org/10.1093/sleep/30.12.1705.
    2. Seiden D, Tyler C, Dubrow J. Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. Clinical Therapeutics. Online publication ahead of print: https://pubmed.ncbi.nlm.nih.gov/33632533/
    3. Thorpy M., Dubow J., Monteith D., Grassot J., Roth T., Winkelman J., Corser B. The pharmacokinetics of once-nightly controlled- release sodium oxybate (FT218): overview of results from four phase 1 studies. Sleep Medicine. 2019;64(Suppl 1):S385.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email: el.com

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  2. DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.

    "The FDA's acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we…

    DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.

    "The FDA's acceptance of our NDA for once-nightly FT218 and assignment of a PDUFA target action date of October 15th represents another important milestone on the path towards receiving approval. We are confident in our regulatory filing strategy and we look forward to working with the Agency in our pursuit of bringing this important treatment to patients," said Greg Divis, Chief Executive Officer of Avadel. "If approved, FT218 will be the first and only once-nightly oxybate medication, a significant advancement to the twice-nightly regimen that has been required for nearly 20 years."

    "It's important to remember that FT218 was granted Orphan Drug Designation by the FDA based on the plausible hypothesis that it may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the Agency for the same indication. If the FDA approves FT218 and grants Orphan Drug Exclusivity, then we would be awarded a seven-year period of market exclusivity in the U.S.," concluded Mr. Divis.

    The NDA submission is supported by positive data from the pivotal Phase 3 REST-ON study, which was completed under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans on presenting data from the study for the three primary endpoints, as well as a number of secondary endpoints and post-hoc analyses at upcoming conferences in the first half of 2021.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the FDA's review of the NDA for FT218, the benefits of Orphan Drug Exclusivity for FT218, if granted by the FDA, commercial launch of FT218, if approved, and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  3. DUBLIN, Ireland, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in fireside chats at the H.C. Wainwright Global Life Sciences Conference and Oppenheimer 31st Annual Healthcare Conference which are being held in March 2021.

    Fireside Chat Details:
    Event:H.C. Wainwright Global Life Sciences Conference
    Date:March 9th
    Webcast:A webcast of this event will be available starting at 7 a.m. ET on Tuesday, March 9th, at (click here), as well as on Avadel's website, www.avadel.com

    DUBLIN, Ireland, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in fireside chats at the H.C. Wainwright Global Life Sciences Conference and Oppenheimer 31st Annual Healthcare Conference which are being held in March 2021.

    Fireside Chat Details:
    Event:H.C. Wainwright Global Life Sciences Conference
    Date:March 9th
    Webcast:A webcast of this event will be available starting at 7 a.m. ET on Tuesday, March 9th, at (click here), as well as on Avadel's website, www.avadel.com, with an archive available for 90 days.
      
    Event:Oppenheimer 31st Annual Healthcare Conference
    Time and Date:3:10 p.m. ET on Wednesday, March 17th  
    Webcast:A live webcast of this event, as well as an archived recording, will be available at (click here), as well as on Avadel's website, www.avadel.com, for 90 days from being made available.

    Contacts:

     Tom McHugh
     Chief Financial Officer
     Phone: (636) 449-1843
     Email:
      
     Tim McCarthy
     LifeSci Advisors, LLC
     Phone: (212) 915-2564
     Email:


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  4. DUBLIN, Ireland, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Tuesday, March 9, 2021, to provide a company update and discuss the Company's financial results for the fourth quarter and full year ended December 31, 2020.

    To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13716363. A live audio webcast can be accessed by visiting the…

    DUBLIN, Ireland, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Tuesday, March 9, 2021, to provide a company update and discuss the Company's financial results for the fourth quarter and full year ended December 31, 2020.

    To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13716363. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:



    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  5. DUBLIN, Ireland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company's lead program, once-nightly FT218, pending regulatory approval.

    "Richard joins our team at an important point in the company's history," said Greg Divis, Chief Executive Officer of Avadel. "Richard has over 25 years of biopharmaceutical commercial experience…

    DUBLIN, Ireland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company's lead program, once-nightly FT218, pending regulatory approval.

    "Richard joins our team at an important point in the company's history," said Greg Divis, Chief Executive Officer of Avadel. "Richard has over 25 years of biopharmaceutical commercial experience with direct leadership of successful product launches in the U.S. and around the world to treat specialty and orphan diseases. His hands-on experience in building world-class teams, capabilities and infrastructure to support the commercial launches of those innovative new drugs will play a critical role at Avadel as we accelerate our commercialization strategy for once-nightly FT218, in preparation for the highly anticipated U.S. regulatory approval."

    "I was drawn to Avadel because of the potential its investigational, once-nightly FT218 product offers as a game changing therapy for patients living with narcolepsy," said Mr. Kim. "I am excited to have the opportunity to work alongside the amazing Avadel team and build upon the positive momentum they have already established for the once-nightly FT218 program, including completion of the pivotal phase 3 study, submission of the NDA to the FDA at the end of last year, and the ongoing preparation for a successful commercial launch."

    "It isn't often that a new product has the potential to offer such a significant advancement in patient care for an established multi-billion dollar market. If approved, I believe FT218 will be the preferred choice for sodium oxybate drug therapy and provide a potentially life-changing option for narcolepsy patients, while creating value for our shareholders," concluded Mr. Kim.

    Mr. Kim has over 25 years of commercialization, marketing, development and managerial experience in the biopharmaceutical industry in the U.S. and abroad. Prior to joining Avadel, he was at Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), where he most recently served as the President of U.S. Commercial & Strategic Marketing. During his time there he helped to successfully launch OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years in an orphan disease, Primary Billiary Cholangitis, and led the launch strategy for obeticholic acid for the treatment of NASH. Prior to joining Intercept, Mr. Kim worked at Bristol-Myers Squibb, where he served as General Manager, Hepatitis C Worldwide Commercialization where he led the successful worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. Prior to this, Mr. Kim held a number of roles of increasing responsibility leading sales, operational and strategic marketing teams at Bristol-Myers Squibb, including Vice President, SPRYCEL™ Brand Lead, Oncology Global Marketing; Vice President, U.S. In-Line Oncology and Global Marketing; and Vice President, East Area Sales, Cardiovascular and Metabolics. Prior to his time at Bristol-Myers Squibb, Mr. Kim held a range of senior positions in the U.S., Canada and Australia at Schering-Plough, which was acquired by Merck & Co., Inc.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the FDA's review of the NDA for FT218, the benefits of Orphan Drug Exclusivity for FT218, if granted by the FDA, the commercial launch of FT218, if approved, and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  6. DUBLIN, Ireland, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at the 10th Annual SVB Leerink Global Healthcare Conference, which is being held February 24th to 26th.

    Fireside Chat Details:
    Event:SVB Leerink 10th Annual Global Healthcare Conference
    Time and Date:3:40 p.m. ET on Wednesday, February 24th
    Webcast:A live webcast of this event, as well as an archived recording, will be available at (click here), as well as on Avadel's website,

    DUBLIN, Ireland, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at the 10th Annual SVB Leerink Global Healthcare Conference, which is being held February 24th to 26th.

    Fireside Chat Details:

    Event:SVB Leerink 10th Annual Global Healthcare Conference
    Time and Date:3:40 p.m. ET on Wednesday, February 24th
    Webcast:A live webcast of this event, as well as an archived recording, will be available at (click here), as well as on Avadel's website, www.avadel.com, for 90 days from being made available.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Contacts:
     
     Tom McHugh
     Chief Financial Officer
     Phone: (636) 449-1843
     Email:
      
     Tim McCarthy
     LifeSci Advisors, LLC
     Phone: (212) 915-2564
     Email:



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  7. DUBLIN, Ireland, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    "The submission of our NDA represents a significant milestone for the Company. We look forward to working with the FDA during the NDA review process in order to get once-nightly FT218 approved and commercially available to patients with narcolepsy who suffer from excessive daytime sleepiness and cataplexy," said Greg Divis, Chief Executive Officer of Avadel. "If approved, we believe…

    DUBLIN, Ireland, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.

    "The submission of our NDA represents a significant milestone for the Company. We look forward to working with the FDA during the NDA review process in order to get once-nightly FT218 approved and commercially available to patients with narcolepsy who suffer from excessive daytime sleepiness and cataplexy," said Greg Divis, Chief Executive Officer of Avadel. "If approved, we believe once-nightly FT218 has the potential to provide a valuable treatment option for sodium oxybate eligible narcolepsy patients, including those who are not satisfied with the current twice-nightly treatment, which requires waking up in the middle of the night to take a second dose."

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the FDA's review of the NDA for FT218 and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not accept the NDA submission for FT218, the risk that such NDA is not approved by the FDA or such approval is delayed, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  8. DUBLIN, Ireland, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI), effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is re-ranked annually…

    DUBLIN, Ireland, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI), effective prior to market open on Monday, December 21, 2020.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (NASDAQ®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is re-ranked annually. All securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements, among other criteria. More information about the Index can be found at https://indexes.nasdaqomx.com/Index/Overview/NBI.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the filing of the NDA for FT218 is delayed, the risk that the FDA does not accept the NDA submission for FT218, the risk that such NDA is not approved by the FDA or such approval is delayed, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915-2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  9. DUBLIN, Ireland, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced the appointment of Dr. Jennifer Gudeman to the newly formed role of Vice President, Medical and Clinical Affairs, effective immediately. In this role her responsibilities will include overseeing all medical and clinical affairs activities, including the company's lead program, once-nightly FT218.

    "We are pleased to further strengthen our team with the appointment of Dr. Gudeman. Her broad medical affairs experience will be especially valuable…

    DUBLIN, Ireland, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced the appointment of Dr. Jennifer Gudeman to the newly formed role of Vice President, Medical and Clinical Affairs, effective immediately. In this role her responsibilities will include overseeing all medical and clinical affairs activities, including the company's lead program, once-nightly FT218.

    "We are pleased to further strengthen our team with the appointment of Dr. Gudeman. Her broad medical affairs experience will be especially valuable as we continue to establish and communicate the scientific body of evidence in support of our investigational once-nightly FT218. Jennifer is an accomplished medical leader and is joining Avadel at a critical juncture as we expand Avadel's focus to include the scientific, clinical and market preparation activities for FT218," said Greg Divis, Chief Executive Officer of Avadel.

    "It is a pleasure to join Avadel at this exciting time in the Company's history, with the pending submission of the FT218 NDA to the FDA planned for this month," said Dr. Gudeman. "I am proud to be part of a team that is working towards bringing an innovative once-nightly therapy to an underserved patient population. The need for such a therapy is highlighted by recent research that shows a majority of sodium oxybate-eligible patients are not going on currently available therapies, with twice-nightly dosing being the primary reason cited."

    Dr. Gudeman brings approximately 20 years of pharmaceutical industry-specific, medical and clinical affairs experience to Avadel. During this time, she has led or contributed to six commercial product launches and three clinical development programs. Dr. Gudeman has also led interactions with medical societies and patient advocacy organizations to help ensure that commercial medications fulfill their clinically proven therapeutic benefits to patients and providers. Prior to joining Avadel, Dr. Gudeman was Vice President, Medical Affairs at AMAG Pharmaceuticals, overseeing a team of medical science liaisons and scientific communications. Prior to her time at AMAG Pharmaceuticals, she was Director of Medical Affairs at Lumara Health. Additionally, she began her industry career at Mallinckrodt Pharmaceuticals. Dr. Gudeman has published numerous peer-reviewed papers and provided domestic and international presentations on partnership with industry for drug development in high-risk pregnancies. In 2017, Dr. Gudeman received the Healthcare Businesswomen's "Rising Star" award. Dr. Gudeman graduated summa cum laude with a bachelor's degree in pharmacy and magna cum laude with a doctorate in pharmacy from St. Louis College of Pharmacy in 1999 and 2000, respectively.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Footnote: 1. Annualized Xyrem revenues from the Jazz Pharmaceuticals third quarter and year to date results reported in their press release dated November 2, 2020.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA, the risk that such NDA is not approved by the FDA or such approval is delayed, the risk that the RESTORE study, the open-label extension/switch study of FT218, may be delayed or may not be completed at all, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  10. DUBLIN, Ireland, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that members of the Avadel management team will present at both the 32nd Annual Piper Sandler Virtual Healthcare Conference and the 3rd Annual Evercore ISI HealthCONx Conference that are being held in December 2020.

    Event:32nd Annual Piper Sandler Virtual Healthcare Conference
    Date:December 1st - 3rd  
    Webcast:A webcast presentation will be available via the Piper Sandler conference site (click here) from November 23rd to December 3rd. In addition, the

    DUBLIN, Ireland, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that members of the Avadel management team will present at both the 32nd Annual Piper Sandler Virtual Healthcare Conference and the 3rd Annual Evercore ISI HealthCONx Conference that are being held in December 2020.

    Event:32nd Annual Piper Sandler Virtual Healthcare Conference
    Date:December 1st - 3rd  
    Webcast:A webcast presentation will be available via the Piper Sandler conference site (click here) from November 23rd to December 3rd. In addition, the webcast will be posted on Avadel's website, www.avadel.com, for 90 days from being made available.
      
    Event:3rd Annual Evercore ISI HealthCONx Conference
    Date:Thursday, December 3rd  
    Time:9:15 a.m. ET
    Webcast:A webcast will be available at (click here), as well as on the "Investors" section of the Company's website at www.avadel.com. A replay of the webcast will be available on Avadel's website for 90 days following the presentation.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Contacts:

     Tom McHugh
     Chief Financial Officer
     Phone: (636) 449-1843
     Email:
      
     Tim McCarthy
     LifeSci Advisors, LLC
     Phone: (212) 915-2564
     Email:

     



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  11. DUBLIN, Ireland, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that members of the Avadel management team will present at both the Stifel Virtual Healthcare Conference and the Jefferies Virtual London Healthcare Conference that are being held in November 2020.

      
    Event:Stifel 2020 Virtual Healthcare Conference 
    Date: Monday, November 16
    Time: 9:20 a.m. ET
    Webcast: A webcast will be available at the "Investors" section of the Company's website at www.avadel.com. A replay of the webcasts will be available on Avadel's

    DUBLIN, Ireland, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that members of the Avadel management team will present at both the Stifel Virtual Healthcare Conference and the Jefferies Virtual London Healthcare Conference that are being held in November 2020.

      
    Event:Stifel 2020 Virtual Healthcare Conference 
    Date: Monday, November 16
    Time: 9:20 a.m. ET
    Webcast: A webcast will be available at the "Investors" section of the Company's website at www.avadel.com. A replay of the webcasts will be available on Avadel's website for 90 days following the presentation.
      
    Event:Jefferies Virtual London Healthcare Conference
    Date:Wednesday, Nov. 18th 
    Time: 6:45 p.m. GMT (1:45 p.m. ET)
    Webcast:A webcast will be available at the "Investors" section of the Company's website at www.avadel.com. A replay of the webcasts will be available on Avadel's website for 90 days following the presentation.
      

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Contacts:

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

            

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Primary Logo

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    • NDA for once-nightly FT218 is on track for FDA submission by end of December 2020
    • New market assessment data identifies a significant potential market expansion opportunity for once-nightly FT218 beyond existing twice-nightly sodium oxybate patients
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

    "Over the past several months, the…

    • NDA for once-nightly FT218 is on track for FDA submission by end of December 2020
    • New market assessment data identifies a significant potential market expansion opportunity for once-nightly FT218 beyond existing twice-nightly sodium oxybate patients
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.

    "Over the past several months, the Avadel clinical and regulatory teams have made substantial progress in advancing FT218 toward its anticipated FDA approval for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The Company remains on track to submit the filing to the FDA by the end of December. We are pleased with the progress we have made despite the challenges of a global pandemic and look forward to updating our shareholders on this upcoming regulatory milestone for the FT218 program," said Greg Divis, Chief Executive Officer of Avadel.

    "We recently gained even greater insight into this evolving therapeutic area including the significant and growing opportunity for FT218. Specifically, we completed a comprehensive market assessment, which provided current and critical prescriber and patient insights. A key finding is that six out of ten sodium oxybate-eligible patients are not going on therapy today, with twice-nightly dosing being the primary reason cited. This finding suggests there could be a significantly larger potential sodium oxybate-eligible market beyond those currently being treated with twice-nightly therapy. These insights, coupled with patient discontinuation rates of nearly 50% within the first 12 months of initiating twice-nightly therapy, underscore the unmet patient need and opportunity once-nightly FT218 may have in addition to the nearly $1.8 billion1 twice-nightly sodium oxybate market. Based on our extensive research, we believe once-nightly FT218 has the potential, if approved, to offer a meaningful treatment option for patients switching from twice-nightly sodium oxybate, as well as those patients who previously refused or discontinued twice-nightly therapy," concluded Mr. Divis.

    Third quarter and recent company highlights

    • FT218 NDA is on track and expected to be filed with the FDA by the end of December.



    • Completed a new comprehensive market assessment that included a review of over five years of twice-nightly sodium oxybate utilization and interviews with over 500 critical stakeholders. Key findings from the market assessment include:

    • Insights from over 150 sodium oxybate prescribing physicians show that 60% of sodium oxybate-eligible patients are not receiving sodium oxybate treatment today, with the primary reason being twice-nightly dosing-related challenges.
    • In a survey of current sodium oxybate-treated patients, once-nightly dosing ranked as the most important driver of their treatment preference, placing it higher in importance than efficacy and side effect profile.
    • Analysis of longitudinal patient claims analysis demonstrates nearly 50% of all newly treated twice-nightly sodium oxybate patients discontinued their treatment within 12 months of initiation, including about half of that group discontinuing within the first 30 days.

    • Supported a recently published article in the peer-reviewed journal Sleep Medicine highlighting the lack of evidence linking the sodium content of sodium oxybate with increased cardiovascular risk in patients with narcolepsy. (https://doi.org/10.1016/j.sleep.2020.09.017)



    • Additional subgroup analysis of the REST-ON study demonstrated comparable, robust results for FT218 in narcolepsy patients both with and without cataplexy as well as those on concomitant wake-promoting agents compared to those not on wake-promoting agents. In addition, results of responder analyses for the Maintenance of Wakefulness Test and mean weekly cataplexy attacks further supported the potential clinical benefits of FT218.



    • Continued progress of the RESTORE trial, an open-label extension/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy.

    • 29 patients have been enrolled and initiated treatment or are pending treatment initiation.
    • The majority of these patients switched from twice-nightly sodium oxybate, many of which also completed the REST-ON study, and nearly all are on the same or lower stable dose of FT218 compared to their prior twice-nightly treatment.

    • U.S. Patent & Trademark Office issued the second U.S. patent covering once-nightly gamma- hydroxybutyrate formulations, including FT218, with an expiration date of mid-2037. In addition, Avadel has several patent applications pending at the USPTO, which the Company expects to result in additional issued patents in the future.

    Overview of Third Quarter Results

    As a result of the sale of the sterile injectable products to Exela Sterile Medicines LLC, which closed on June 30, 2020, the Company did not report any revenue for the third quarter of 2020, compared to $14.2 million in the third quarter of 2019.

    R&D expenses were $5.6 million in the third quarter of 2020, compared to $7.5 million in the third quarter of 2019. The decrease on a year-over-year basis was primarily attributed to the completion of the FT218 clinical study during the first quarter of 2020, as well as lower headcount due to the restructuring activities initiated during 2019.



    SG&A expenses were $8.4 million in the third quarter of 2020, compared to $5.3 million in the third quarter of 2019. The year-over-year increase is primarily the result of higher stock-based compensation, professional fees and market preparation costs related to FT218.

    Net loss for the third quarter of 2020 was $11.7 million, or ($0.20) per diluted share, compared to a net loss of $8.9 million, or ($0.24) per diluted share, for the same period in 2019. The increase in net loss is primarily the result of the year-over-year decline in revenue due to the sale of the sterile injectable products to Exela Sterile Medicines LLC on June 30, 2020. The decrease in diluted loss per share is due to a higher number of shares outstanding resulting from equity issuances completed during the first half of the year.

    Cash, cash equivalents and marketable securities were $231.6 million as of September 30, 2020. The Company has convertible debt of $143.8 million due in February 2023.

    Conference Call:

    A conference call to discuss these results has been scheduled for Monday, November 9, 2020 at 8:30 a.m. ET. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13712485. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Footnote: 1. Annualized Xyrem revenues from the Jazz Pharmaceuticals third quarter and year to date results reported in their press release dated November 2, 2020.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA, the risk that such NDA is not approved by the FDA or such approval is delayed, the risk that the RESTORE study may be delayed or may not be completed at all, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email: el.com

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email: m

    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME

    (In thousands, except per share data)

    (Unaudited)

      Three Months Ended September 30, Nine Months Ended September 30,
      2020 2019 2020 2019
             
    Product sales $  $14,229  $22,334  $48,220 
    Operating expenses:        
    Cost of products   2,823  5,742  9,711 
    Research and development expenses 5,569  7,539  15,156  25,160 
    Selling, general and administrative expenses 8,423  5,316  23,431  22,520 
    Intangible asset amortization   205  406  610 
    Changes in fair value of contingent consideration (69) 627  3,327  2,384 
    Gain on sale of Hospital Products     (45,760)  
    Restructuring (income) costs (226) 1,866  (43) 4,600 
    Total operating expense 13,697  18,376  2,259  64,985 
    Operating (loss) income (13,697) (4,147) 20,075  (16,765)
    Investment and other income (expense), net 213  781  (906) 2,548 
    Interest expense (3,259) (3,125) (9,686) (9,293)
    Loss on deconsolidation of subsidiary       (2,840)
    Other expense - changes in fair value of contingent consideration payable   (139) (435) (496)
    (Loss) income before income taxes (16,743) (6,630) 9,048  (26,846)
    Income tax (benefit) provision (5,040) 2,234  (9,258) 3,641 
    Net (loss) income $(11,703) $(8,864) $18,306  $(30,487)
             
    Net (loss) income per share - basic $(0.20) $(0.24) $0.36  $(0.82)
    Net (loss) income per share - diluted (0.20) (0.24) 0.35  (0.82)
             
    Weighted average number of shares outstanding - basic 58,213  37,436  51,206  37,382 
    Weighted average number of shares outstanding - diluted 58,213  37,436  52,849  37,382 



    AVADEL PHARMACEUTICALS PLC


    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

      September 30, 2020 December 31, 2019
      (unaudited)  
    ASSETS    
    Current assets:    
    Cash and cash equivalents $83,109  $9,774 
    Marketable securities 148,467  54,384 
    Accounts receivable   8,281 
    Inventories   3,570 
    Research and development tax credit receivable 3,058  2,107 
    Prepaid expenses and other current assets 47,054  4,264 
    Total current assets 281,688  82,380 
    Property and equipment, net 373  544 
    Operating lease right-of-use assets 2,866  3,612 
    Goodwill 16,836  18,491 
    Intangible assets, net   813 
    Research and development tax credit receivable 3,608  6,322 
    Other non-current assets 22,264  39,274 
    Total assets $327,635  $151,436 
         
    LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)    
    Current liabilities:    
    Current portion of long-term contingent consideration payable $  $5,554 
    Current portion of operating lease liability 520  645 
    Accounts payable 2,660  6,100 
    Accrued expenses 16,398  19,810 
    Other current liabilities 3,431  3,875 
    Total current liabilities 23,009  35,984 
         
    Long-term debt 126,520  121,686 
    Long-term contingent consideration payable, less current portion   11,773 
    Long-term operating lease liability 1,968  2,319 
    Other non-current liabilities 4,938  8,873 
    Total liabilities 156,435  180,635 
         
    Shareholders' equity (deficit):    
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at September 30, 2020 and none issued and outstanding at December 31, 2019, respectively 5   
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 58,243 issued and outstanding at September 30, 2020 and 42,927 issued and 37,520 outstanding at December 31, 2019 582  429 
    Treasury shares, at cost, 0 and 5,407 shares held at September 30, 2020 and December 31, 2019, respectively   (49,998)
    Additional paid-in capital 565,440  434,391 
    Accumulated deficit (372,909) (391,215)
    Accumulated other comprehensive loss (21,918) (22,806)
    Total shareholders' equity (deficit) 171,200  (29,199)
    Total liabilities and shareholders' equity (deficit) $327,635  $151,436 

    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)

      Nine Months Ended September 30,
      2020 2019
         
    Cash flows from operating activities:    
    Net income (loss) $18,306  $(30,487)
    Adjustments to reconcile net income (loss) to net cash provided by operating activities:    
    Depreciation and amortization 1,297  1,690 
    Loss on disposal of property and equipment   478 
    Remeasurement of acquisition-related contingent consideration 3,327  2,384 
    Remeasurement of financing-related contingent consideration 435  496 
    Amortization of debt discount and debt issuance costs 4,835  4,424 
    Change in deferred tax and income tax deferred charge (4,582) 1,333 
    Stock-based compensation expense 1,705  177 
    Gain on the disposition of the hospital products (45,760)  
    Loss on deconsolidation of subsidiary   1,750 
    Other adjustments 306  (667)
    Net changes in assets and liabilities    
    Accounts receivable 8,281  2,026 
    Inventories (1,352) 2,465 
    Prepaid expenses and other current assets 1,759  (1,859)
    Research and development tax credit receivable 2,036  (749)
    Accounts payable & other current liabilities (4,051) 259 
    Accrued expenses (6,625) (2,379)
    Earn-out payments for contingent consideration in excess of acquisition-date fair value (5,323) (8,640)
    Royalty payments for contingent consideration payable in excess of original fair value (866) (1,374)
    Other assets and liabilities (3,337) (1,399)
    Net cash used in operating activities 29,609  (30,072)
         
    Cash flows from investing activities:    
    Purchases of property and equipment (33) (29)
    Proceeds from the disposal of property and equipment   154 
    Proceeds from the disposition of the hospital products 17,250   
    Proceeds from sales of marketable securities 30,075  57,242 
    Purchases of marketable securities (124,254) (23,814)
    Net cash (used in) provided by investing activities (76,962) 33,553 
         
    Cash flows from financing activities:    
    Proceeds from the February 2020 private placement 60,570   
    Proceeds from the May 2020 public offering 116,924   
    Proceeds from stock option exercises and ESPP 2,006  123 
    Other financing activities, net   (109)
    Net cash provided by financing activities 179,500  14 
         
    Effect of foreign currency exchange rate changes on cash and cash equivalents 406  47 
         
    Net change in cash and cash equivalents 73,335  3,542 
    Cash and cash equivalents at January 1, 9,774  9,325 
    Cash and cash equivalents at September 30, $83,109  $12,867 

    AVADEL PHARMACEUTICALS PLC

    UNAUDITED SUPPLEMENTAL INFORMATION

    (In thousands, except per share data)

    (Unaudited)

      Three Months Ended September 30, Nine Months Ended September 30,
    Revenues by Product: 2020 2019 2020 2019
             
    Bloxiverz $  $1,466  $2,201  $6,392 
    Vazculep   8,786  10,429  27,669 
    Akovaz   4,208  9,545  13,946 
    Other   (231) 159  213 
    Total product sales $  $14,229  $22,334  $48,220 

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  12. DUBLIN, Ireland, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, November 9, 2020, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13712485. A live audio webcast can be accessed by visiting the investor relations…

    DUBLIN, Ireland, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, November 9, 2020, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13712485. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results (including, without limitation, the continued advancement and development of FT218 and potential benefits and cost savings from the sale of our sterile injectible products) and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA or does not approve FT218, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:          

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:

    Primary Logo

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  13. DUBLIN, Ireland, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that its executive team will be presenting at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit taking place September 21 – 23, 2020.

    Presentation details:
    Date:Tuesday, September 22, 2020
    Time:10:50 a.m. – 11:30 a.m. ET
    Webcast:A live and archived webcast of the presentation will be available at (click here) or on the Company's website (click here)

    In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals…

    DUBLIN, Ireland, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that its executive team will be presenting at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit taking place September 21 – 23, 2020.

    Presentation details:
    Date:Tuesday, September 22, 2020
    Time:10:50 a.m. – 11:30 a.m. ET
    Webcast:A live and archived webcast of the presentation will be available at (click here) or on the Company's website (click here)

    In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    Contacts:

    Investor Contacts
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
     
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915-2564
    Email:
     
    Media Contact
    Patrick Bursey
    LifeSci Communications, LLC
    Phone: (646) 970-4688
    Email:

     

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    • Jordan Dubow, M.D. stepping down as CMO and will continue as a consultant to the Company through the FT218 NDA submission and review
    • Seasoned industry veteran and Avadel Board member, Mark McCamish, M.D., Ph.D., to work with management and provide direct leadership of the FT218 program

    DUBLIN, Ireland, Sept. 14, 2020 (GLOBE NEWSWIRE) --  Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that Jordan Dubow, M.D. will be stepping down as Chief Medical Officer to pursue another opportunity. He will continue in a consultancy role in order to support…

    • Jordan Dubow, M.D. stepping down as CMO and will continue as a consultant to the Company through the FT218 NDA submission and review

    • Seasoned industry veteran and Avadel Board member, Mark McCamish, M.D., Ph.D., to work with management and provide direct leadership of the FT218 program

    DUBLIN, Ireland, Sept. 14, 2020 (GLOBE NEWSWIRE) --  Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that Jordan Dubow, M.D. will be stepping down as Chief Medical Officer to pursue another opportunity. He will continue in a consultancy role in order to support the Company through the filing, review and anticipated approval of the new drug application (NDA) for FT218 with the FDA. Mark McCamish, M.D., Ph.D., an Independent Director on Avadel's Board of Directors and an accomplished industry executive with over 30 years of drug development experience, will assume a direct leadership role for the FT218 filing working with Avadel CEO Greg Divis, Dr. Dubow and the rest of the team to ensure continuity of the FT218 program, including the completeness and timeliness of the NDA submission.

    "We thank Jordan for his hard work and dedication as our Chief Medical Officer, including the important role he played in the acceleration of and reporting the data from our pivotal Phase 3 REST-ON study that produced robust and statistically significant results across all primary endpoints. With that phase complete, we believe the addition of Mark's extensive experience and direct leadership of the FT218 filing serves to strengthen our internal and external teams, which include world class capabilities in the fields of clinical development, regulatory affairs and CMC. As a result, I have the utmost confidence in our team and I am confident this change will not impact the timing of our planned NDA filing," said Mr. Divis. "We continue to be excited by the market potential for FT218, if approved. As we execute our market preparation activities, we will continue to evaluate all strategic options, including sale, merger, out-licensing or commercialization to maximize shareholder value."

    "I want to thank Greg, the Avadel team, and the Board for their support of my personal decision to take a new role outside of Avadel that is focused on developing gene therapies," stated Dr. Dubow. "I am excited by and proud of the progress we made in advancing the development program for FT218 and the potential for this once-nightly formulation of sodium oxybate to have a positive impact on the lives of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. I look forward to continuing to support the program and the Avadel team in my new capacity and remain highly confident in the clinical data for FT218, the timing of the NDA filing and its commercial potential."

    "The Board and I are committed to supporting the Avadel team through the NDA preparation and review process for FT218. Since joining the Board, I have been actively overseeing the development and regulatory plan of FT218. I remain confident that the team is well positioned to finish the filing without delay," stated Dr. McCamish. "If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy. As a result, the Avadel Board remains confident in the potential for FT218 to be an important treatment option for narcolepsy patients, and disrupt the estimated $1.7 billion1 twice-nightly sodium oxybate market."  

    Dr. McCamish, who joined the Avadel Board of Directors in December 2019, is an internationally recognized expert in drug development, regulatory affairs and manufacturing. Most recently, he was the President and Chief Executive Officer of Forty Seven, Inc., moving magrolimab through early development into registration trials, which led to Gilead's acquisition of the company for $5 billion in April 2020. Prior to Forty Seven, Inc., Dr. McCamish was the Global Head of Biopharmaceutical Development at Sandoz International, a Novartis company where he led the filing of ten BLAs in the last three years of his tenure.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Footnote: 1. Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release, February 25, 2020

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results (including, without limitation, the continued advancement and development of FT218 and benefits and cost savings from the sale of our hospital products) and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA or does not approve FT218, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:

    Primary Logo

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  14. DUBLIN, Ireland, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that its executive team will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference taking place September 14 – 16, 2020.

    Presentation details:
    Date:   Wednesday, September 16, 2020
    Time: 10:30 a.m. – 10:50 a.m. ET
    Webcast: A live and archived webcast of the presentation will be available at (click here) or on the Company's website (click here)
       

    In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.

    About Avadel Pharmaceuticals plc:
    Avadel…

    DUBLIN, Ireland, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that its executive team will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference taking place September 14 – 16, 2020.

    Presentation details:
    Date:   Wednesday, September 16, 2020
    Time: 10:30 a.m. – 10:50 a.m. ET
    Webcast: A live and archived webcast of the presentation will be available at (click here) or on the Company's website (click here)
       

    In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The Company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:



    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915-2564

    Email:



    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:
     

    Primary Logo

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    • Presented positive topline data from the pivotal Phase 3 REST-ON study
    • Announced today that results of the data analyses for the secondary endpoints of the REST-ON study were consistent with the primary analyses and further demonstrated the overall statistical significance of FT218 compared to placebo
    • Completed the pre-NDA meeting for FT218 with the Food and Drug Administration
    • First patient dosed in the open-label extension/switch study of investigational once-nightly FT218
    • Strengthened balance sheet through completion of $125 million public equity offering to support the company's strategic priorities
    • Completed sale of the sterile injectable drug portfolio for $42.0 million
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland…

    • Presented positive topline data from the pivotal Phase 3 REST-ON study

    • Announced today that results of the data analyses for the secondary endpoints of the REST-ON study were consistent with the primary analyses and further demonstrated the overall statistical significance of FT218 compared to placebo
    • Completed the pre-NDA meeting for FT218 with the Food and Drug Administration
    • First patient dosed in the open-label extension/switch study of investigational once-nightly FT218
    • Strengthened balance sheet through completion of $125 million public equity offering to support the company's strategic priorities
    • Completed sale of the sterile injectable drug portfolio for $42.0 million
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the second quarter ended June 30, 2020 and provided a company update.

    "We are at a pivotal point in Avadel's transformation, as we recently completed our pre-NDA meeting with the FDA and are currently focused on completing our NDA submission and filing for FT218. A key component of the planned NDA for FT218 is the positive data from the Phase 3 REST-ON study of FT218, which was first announced in April. These data show that the three dose levels of FT218 that were tested demonstrated statistically significant (p<0.001) and clinically meaningful improvement for all three co-primary endpoints. In addition, FT218 was highly significant for the secondary endpoints that tested additional measures of daytime sleepiness, sleep architecture, and other narcolepsy symptoms compared to placebo at all three doses and all sensitivity analyses of the primary endpoint. If approved, FT218 could be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy," said Greg Divis, Chief Executive Officer of Avadel.

    "In May, we strengthened our balance sheet with the completion of a public equity offering for gross proceeds of $125.0 million that will be used to support the development and plan for the go-to-market strategy of FT218. In June, we further bolstered our cash position with the sale of our legacy portfolio of sterile injectable drugs for $42.0 million. Divesting this product portfolio is in line with our overall strategy to focus the Company's resources on FT218, thus streamlining and focusing Avadel while enabling the company to maintain optionality for creating shareholder value."

    "As we move forward for the balance of 2020, our highest priority remains the completion and filing of our once-nightly FT218 NDA.  In addition, we are in the process of compiling additional supporting scientific data to position FT218 in the market which includes the ongoing open-label extension (OLE)/switch study of FT218," concluded Mr. Divis.

    Second quarter and recent company highlights

    • Presented an update on the development of FT218 and positive results from the Phase 3 Rest-On clinical trial for excessive daytime sleepiness and cataplexy in patients with narcolepsy, which were previously announced in April 2020:

    ° FT218 at the 9 g dose demonstrated highly statistically significant (p<0.001) and clinically meaningful improvement across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and Mean Weekly Cataplexy Attacks) compared to placebo.

    ° FT218 at the 9 g dose was generally well-tolerated, with commonly known sodium oxybate adverse reactions occurring at low rates (nausea 1.3%, vomiting 5.2%, decreased appetite 2.6%, dizziness 5.2%, somnolence 3.9%, tremor 1.3%, enuresis 9%; discontinuation rate due to adverse reactions 3.9%).

    ° FT218 at the 7.5 g and 6 g dose levels also achieved highly statistically significant (p<0.001), clinically meaningful improvements across all three co-primary endpoints compared to placebo, as soon as 3 weeks after initiating FT218.

    • Announced today additional data from the REST-ON study:

    ° All three doses of FT218 studied were highly significant compared to placebo on secondary endpoints evaluating daytime sleepiness, sleep architecture, and other narcolepsy symptoms

    ° FT218 was also significant compared to placebo for all sensitivity analyses of the three co-primary endpoints at all three doses

    ° Detailed data for the secondary endpoints and sensitivity analyses will be presented at a scientific conference or in a peer-reviewed scientific publication

    • Held a successful pre-NDA meeting with the FDA and are on track to move forward with filing our NDA for FT218
    • First patient dosed in an OLE/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
    • Completed a public equity offering with gross proceeds of $125.0 million to strengthen the Company's balance sheet and provide capital to support its strategic priorities.   
    • Completed the sale of the legacy portfolio of sterile injectable drugs used in the hospital setting to Exela Sterile Medicines LLC for a total of $42.0 million.

    Overview of Second Quarter Results

    Revenues for the second quarter of 2020 were $10.1 million, compared to $17.6 million in the second quarter of 2019. The decline on a year-over-year basis was primarily attributed to lower overall sales volume across the Company's hospital products as a result of increased market competition.

    R&D expenses were $4.1 million in the second quarter of 2020, compared to $10.3 million in the second quarter of 2019. The decrease on a year-over-year basis was primarily attributed to the completion of the FT218 clinical study during the first quarter of 2020, as well as lower headcount due to the restructuring activities initiated during 2019.

    SG&A expenses were $7.1 million in the second quarter of 2020, compared to $6.8 million in the second quarter of 2019. The year-over-year increase is primarily the result of higher professional fees and market research costs related to FT218.

    A $45.8 million pre-tax gain from the sale of the portfolio of sterile injectable drugs was recorded in the second quarter of 2020.  The gain reflects the $42.0 million transaction price adjusted for the net liabilities that were transferred to Exela Sterile Medicines LLC and transaction costs incurred by the company.

    Income tax provision was $5.3 million in the second quarter of 2020, compared to $1.8 million in the second quarter of 2019. 

    Net income for the second quarter of 2020 was $30.9 million, or $0.49 per diluted share, compared to a net loss of $8.6 million, or ($0.23) per diluted share, for the same period in 2019. 

    Cash, cash equivalents and marketable securities were $238.6 million as of June 30, 2020. The Company has convertible debt of $143.8 million due in February 2023.

    Conference Call:

    A conference call to discuss these results has been scheduled for Monday, August 10, 2020 at 8:30 a.m. ET. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13707645. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results (including, without limitation, the continued advancement and development of FT218 and benefits and cost savings from the sale of our hospital products) and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)

    (In thousands, except per share data)

    (Unaudited)

      Three Months Ended June 30, Six Months Ended June 30,
      2020 2019 2020 2019
             
    Product sales $10,091  $17,554  $22,334  $33,991 
    Operating expenses:        
    Cost of products 3,285  3,622  5,742  6,888 
    Research and development expenses 4,057  10,292  9,587  17,621 
    Selling, general and administrative expenses 7,095  6,758  15,008  17,204 
    Intangible asset amortization 203  204  406  405 
    Changes in fair value of contingent consideration 918  (377) 3,396  1,757 
    Gain on sale of hospital business (45,760)   (45,760)  
    Restructuring costs 24  1,506  183  2,734 
    Total operating (income) expense (30,178) 22,005  (11,438) 46,609 
    Operating income (loss) 40,269  (4,451) 33,772  (12,618)
    Investment and other (expense) income, net (741) 950  (1,119) 1,767 
    Interest expense (3,237) (3,106) (6,427) (6,168)
    Loss on deconsolidation of subsidiary   (167)   (2,840)
    Other expense - changes in fair value of contingent consideration payable (125) (50) (435) (357)
    Income (loss) before income taxes 36,166  (6,824) 25,791  (20,216)
    Income tax provision (benefit) 5,292  1,781  (4,218) 1,407 
    Net income (loss) $30,874  $(8,605) $30,009  $(21,623)
             
    Net income (loss) per share - basic $0.57  $(0.23) $0.63  $(0.58)
    Net income (loss) per share - diluted 0.49  (0.23) 0.58  (0.58)
             
    Weighted average number of shares outstanding - basic 54,272  37,356  47,665  37,355 
    Weighted average number of shares outstanding - diluted 69,942  37,356  63,083  37,355 





    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

      June 30, 2020 December 31, 2019
      (unaudited)  
    ASSETS    
    Current assets:    
    Cash and cash equivalents $102,174  $9,774 
    Marketable securities 136,380  54,384 
    Accounts receivable 5,692  8,281 
    Inventories   3,570 
    Research and development tax credit receivable   2,107 
    Prepaid expenses and other current assets 32,773  4,264 
    Total current assets 277,019  82,380 
    Property and equipment, net 407  544 
    Operating lease right-of-use assets 3,117  3,612 
    Goodwill 16,836  18,491 
    Intangible assets, net   813 
    Research and development tax credit receivable 6,407  6,322 
    Other non-current assets 37,615  39,274 
    Total assets $341,401  $151,436 
         
    LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)    
    Current liabilities:    
    Current portion of long-term contingent consideration payable $1,914  $5,554 
    Current portion of operating lease liability 563  645 
    Accounts payable 4,879  6,100 
    Accrued expenses 15,820  19,810 
    Income taxes 354  43 
    Other current liabilities 3,488  3,832 
    Total current liabilities 27,018  35,984 
    Long-term debt 124,879  121,686 
    Long-term contingent consideration payable, less current portion   11,773 
    Long-term operating lease liability 2,087  2,319 
    Other non-current liabilities 5,292  8,873 
    Total liabilities 159,276  180,635 
         
    Shareholders' equity (deficit):    
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at June 30, 2020 and none issued and outstanding at December 31, 2019, respectively 5   
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 63,536 issued and 58,129 outstanding at June 30, 2020 and 42,927 issued and 37,520 outstanding at December 31, 2019 635  429 
    Treasury shares, at cost, 5,407 shares held at June 30, 2020 and December 31, 2019, respectively (49,998) (49,998)
    Additional paid-in capital 615,207  434,391 
    Accumulated deficit (361,206) (391,215)
    Accumulated other comprehensive loss (22,518) (22,806)
    Total shareholders' equity (deficit) 182,125  (29,199)
    Total liabilities and shareholders' equity (deficit) $341,401  $151,436 





    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)

      Six Months Ended June 30,
      2020 2019
         
    Cash flows from operating activities:    
    Net income (loss) $30,009  $(21,623)
    Adjustments to reconcile net income (loss) to net cash provided by operating activities:    
    Depreciation and amortization 975  1,064 
    Loss on disposal of property and equipment   478 
    Remeasurement of acquisition-related contingent consideration 3,396  1,757 
    Remeasurement of financing-related contingent consideration 435  357 
    Amortization of debt discount and debt issuance costs 3,193  2,918 
    Change in deferred tax and income tax deferred charge 161  1,900 
    Stock-based compensation expense 1,511  406 
    Gain on the disposition of the hospital business (45,760)  
    Loss on deconsolidation of subsidiary   1,750 
    Other adjustments 477  (995)
    Net changes in assets and liabilities    
    Accounts receivable 2,589  579 
    Inventories (1,353) 2,124 
    Prepaid expenses and other current assets (1,149) (1,829)
    Research and development tax credit receivable 2,036  (593)
    Accounts payable & other current liabilities (1,550) 3,127 
    Accrued expenses (6,906) (3,737)
    Accrued income taxes 321  (71)
    Earn-out payments for contingent consideration in excess of acquisition-date fair value (3,736) (5,790)
    Royalty payments for contingent consideration payable in excess of original fair value (608) (917)
    Other assets and liabilities (3,458) (3,558)
    Net cash used in operating activities (19,417) (22,653)
         
    Cash flows from investing activities:    
    Purchases of property and equipment   (29)
    Proceeds from the disposal of property and equipment   154 
    Proceeds from the disposition of the hospital business 14,500   
    Proceeds from sales of marketable securities 15,716  52,202 
    Purchases of marketable securities (97,878) (21,991)
    Net cash (used in) provided by investing activities (67,662) 30,336 
         
    Cash flows from financing activities:    
    Proceeds from the February 2020 private placement 60,639   
    Proceeds from the May 2020 public offering 116,974   
    Proceeds from stock option exercises and ESPP 1,903  92 
    Other financing activities, net   (37)
    Net cash provided by financing activities 179,516  55 
         
    Effect of foreign currency exchange rate changes on cash and cash equivalents (37) 48 
         
    Net change in cash and cash equivalents 92,400  7,786 
    Cash and cash equivalents at January 1, 9,774  9,325 
    Cash and cash equivalents at June 30, $102,174  $17,111 





    AVADEL PHARMACEUTICALS PLC

    UNAUDITED SUPPLEMENTAL INFORMATION

    (In thousands, except per share data)

    (Unaudited)

      Three Months Ended June 30, Six Months Ended June 30,
    Revenues by Product: 2020 2019 2020 2019
             
    Bloxiverz $800  $2,358  $2,201  $4,926 
    Vazculep 4,915  9,410  10,429  18,883 
    Akovaz 4,196  5,946  9,545  9,738 
    Other 180  (160) 159  444 
    Total product sales $10,091  $17,554  $22,334  $33,991 

     

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  15. DUBLIN, Ireland, July 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 10, 2020, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13707645. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals…

    DUBLIN, Ireland, July 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 10, 2020, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13707645. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. For more information, please visit www.avadel.com.

    Contacts:

          Investor Contacts

          Tom McHugh

          Chief Financial Officer

          Phone: (636) 449-1843

          Email:

          Tim McCarthy

          LifeSci Advisors, LLC

          Phone: (212) 915.2564

          Email:

          Media Contact

          Patrick Bursey

          LifeSci Communications, LLC

          Phone: (646) 970-4688

          Email:

    Primary Logo

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    • Clinical study to enroll 250 patients from sites that participated in the REST-ON study
    • Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218

    DUBLIN, Ireland, July 13, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that the first patient has been dosed at a Florida Research Institute initiating an open-label extension (OLE)/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy.

    "Narcolepsy is a rare…

    • Clinical study to enroll 250 patients from sites that participated in the REST-ON study

    • Study to examine the long-term safety and maintenance of efficacy in patients, and evaluate dosing and preference for patients switching from twice-nightly sodium oxybate to once-nightly FT218

    DUBLIN, Ireland, July 13, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, today announced that the first patient has been dosed at a Florida Research Institute initiating an open-label extension (OLE)/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy.

    "Narcolepsy is a rare neurological sleep disorder with limited treatment options. We were encouraged by the positive Phase 3 data from the REST-ON study that evaluated FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy, so we are enrolling our patients in the open-label extension/switch study. We are pleased to be the first site participating in the study advancing clinical research on narcolepsy to potentially provide our patients more treatment options," said Akinyemi Ajayi, M.D., principal investigator and Sleep Disorder Specialist.

    Jordan Dubow, M.D., Chief Medical Officer of Avadel, added, "The initiation of the OLE/switch study of FT218 underscores the need for more treatment options for people living with narcolepsy. This is an important milestone for FT218, as we start to generate dosing and preference data for narcolepsy patients switching from twice-nightly sodium oxybate to once-nightly FT218. If approved, FT218 could potentially address the key symptoms of narcolepsy, excessive daytime sleepiness and cataplexy, in one nightly dose."

    The OLE/switch study will examine the long-term safety and maintenance of efficacy of FT218 in patients with narcolepsy who participated in the REST-ON study, as well as dosing and preference data for patients switching from twice-nightly sodium oxybate to once-nightly FT218 regardless if they participated in REST-ON or not. The study will enroll about 250 patients at most of the North American clinical trial sites that participated in the REST-ON study.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. For more information, please visit www.avadel.com.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The Company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to i) the potential benefits of FT218 including the long-term safety and maintenance of efficacy of FT218, and ii) the anticipated enrollment for the OLE/switch study. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:

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  16. DUBLIN, Ireland, July 01, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz®, Vazculep®, and Akovaz®, as well as Nouress™, which is approved by the U.S. Food and Drug Administration, to Exela Sterile Medicines LLC for a total of $42.0 million.

    "The sale of the sterile injectable drug portfolio is a significant milestone for the Company, as it further reflects our commitment to strategically focus…

    DUBLIN, Ireland, July 01, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz®, Vazculep®, and Akovaz®, as well as Nouress™, which is approved by the U.S. Food and Drug Administration, to Exela Sterile Medicines LLC for a total of $42.0 million.

    "The sale of the sterile injectable drug portfolio is a significant milestone for the Company, as it further reflects our commitment to strategically focus on advancing FT218 through the regulatory review process and, if approved, bringing our once-nightly formulation of sodium oxybate to patients," said Greg Divis, Chief Executive Officer of Avadel. "By divesting our portfolio of sterile injectable drugs, we are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for FT218."

    Under the terms of the agreement, Avadel will receive $14.5 million upfront and the remaining $27.5 million will be paid out to Avadel over the next 13 months. The transaction closed on June 30, 2020.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. For more information, please visit www.avadel.com.

    About FT218

    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The Company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "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 are not limited to, the anticipated benefits of the sale of the Company's sterile injectable drug portfolio, the planned submission of the FT218 NDA to the FDA and the commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:
    Investor Contacts
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
     
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:
     
    Media Contact
    Patrick Bursey
    LifeSci Communications, LLC
    Phone: (646) 970-4688
    Email:  

    Primary Logo

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  17. DUBLIN, Ireland, June 08, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that Greg Divis, Chief Executive Officer of Avadel, and Jordan Dubow, M.D., Chief Medical Officer of Avadel, will present a corporate overview at BIO Digital from June 8-12, 2020.

    The presentation will focus on the development of once-nightly FT218 and positive results from the Phase 3 Rest-On clinical trial. The presentation will be available on-demand during the conference via https://www.bio.org/events/bio-digital/sessions/693802.

    About Avadel

    DUBLIN, Ireland, June 08, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that Greg Divis, Chief Executive Officer of Avadel, and Jordan Dubow, M.D., Chief Medical Officer of Avadel, will present a corporate overview at BIO Digital from June 8-12, 2020.

    The presentation will focus on the development of once-nightly FT218 and positive results from the Phase 3 Rest-On clinical trial. The presentation will be available on-demand during the conference via https://www.bio.org/events/bio-digital/sessions/693802.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com

    Contacts:
     Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:  
      
     Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:  
      
     Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:  

    Primary Logo

    View Full Article Hide Full Article
  18. DUBLIN, Ireland, June 01, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that members of the Avadel management team will participate in a virtual fireside chat at the Jefferies Healthcare Conference at 10:00 a.m. ET on Thursday, June 4, 2020.

    A live webcast of the event will be available at the "Investors" section of the Company's website at www.avadel.com. A replay of the webcast will be available on Avadel's website for 90 days following the presentation.

    Date: Thursday, June 4, 2020
    Time: 10:00 a.m. ET
    Presenters:

    • Greg…

    DUBLIN, Ireland, June 01, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced that members of the Avadel management team will participate in a virtual fireside chat at the Jefferies Healthcare Conference at 10:00 a.m. ET on Thursday, June 4, 2020.

    A live webcast of the event will be available at the "Investors" section of the Company's website at www.avadel.com. A replay of the webcast will be available on Avadel's website for 90 days following the presentation.

    Date: Thursday, June 4, 2020
    Time: 10:00 a.m. ET
    Presenters:

    • Greg Divis, Chief Executive Officer
    • Jordan Dubow, M.D., Chief Medical Officer
    • Thomas McHugh, Chief Financial Officer   

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Contacts:

    Investor Contacts
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
                 
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:

    Media Contact
    Patrick Bursey
    LifeSci Communications, LLC
    Phone: (646) 970-4688
    Email:

    Primary Logo

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    • Reported positive topline data from the pivotal Phase 3 REST-ON study

    • Strengthened balance sheet with $190 million in gross proceeds from a private placement in February 2020 and public equity offering in May 2020
       
    • Reported revenue of $12.2 million for the first quarter of 2020
       
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, May 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the first quarter ended March 31, 2020 and provided a company update.

    "During the first…

    • Reported positive topline data from the pivotal Phase 3 REST-ON study

    • Strengthened balance sheet with $190 million in gross proceeds from a private placement in February 2020 and public equity offering in May 2020
       
    • Reported revenue of $12.2 million for the first quarter of 2020
       
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, May 11, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the first quarter ended March 31, 2020 and provided a company update.

    "During the first quarter of 2020, we made significant progress advancing the development program for once-nightly FT218 with the completion of the pivotal Phase 3 REST-ON study. In April, we delivered positive topline data from the study, which showed that all three dose levels of once-nightly FT218 demonstrated statistically significant (p<0.001) and clinically meaningful improvement for all three co-primary endpoints compared to placebo," said Greg Divis, Chief Executive Officer of Avadel.

    "Looking ahead, we have a multi-pronged strategy to continue advancing towards achieving our objective of bringing once-nightly FT218, if approved, to patients.  Our strategic priorities include finalizing the New Drug Application (NDA), compiling additional supporting scientific data to position FT218 in the market and expanding our capabilities to prepare for product launch. We look forward to keeping patients, healthcare providers, and shareholders updated on our progress.  If approved, FT218 could be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy. As such, we believe once-nightly FT218 could offer a meaningful alternative for patients in the approximate $1.7 billion twice-nightly sodium oxybate market.1"

    First quarter and recent company highlights

    • Announced positive topline data for the pivotal Phase 3 REST-ON trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy:

    ° Once-nightly FT218 at the 9 g dose demonstrated highly statistically significant (p<0.001) and clinically meaningful improvement across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and Mean Weekly Cataplexy Attacks) compared to placebo.
    ° Once-nightly FT218 at the 9 g dose was generally well-tolerated, with commonly known sodium oxybate adverse reactions occurring at low rates (nausea 1.3%, vomiting 5.2%, decreased appetite 2.6%, dizziness 5.2%, somnolence 3.9%, tremor 1.3%, enuresis 9%; discontinuation rate due to adverse reactions 3.9%).
    ° Once-nightly FT218 at the 7.5 g and 6 g dose levels also achieved highly statistically significant (p<0.001), clinically meaningful improvements across all three co-primary endpoints compared to placebo, as soon as 3 weeks after initiating FT218. 

    • Raised $190 million of gross proceeds to strengthen the Company's balance sheet and provide the capital to support its strategic priorities to bring FT218 to market:

    ° Completed a private placement in February 2020 with gross proceeds of $65 million.
    ° Completed a public equity offering in May 2020 with gross proceeds of $125 million. 

    • Reported revenues of $12.2 million for the first quarter of 2020.

    Overview of first quarter 2020 financial results

    Revenues for the first quarter of 2020 were $12.2 million, compared to $16.4 million in the first quarter of 2019. The decline on a year-over-year basis was primarily attributed to lower overall sales volume across the Company's hospital products as a result of increased market competition.

    R&D expenses were $5.5 million in the first quarter of 2020, compared to $7.3 million in the first quarter of 2019. The decrease on a year-over-year basis was primarily attributed to lower headcount due to the restructuring activities completed during 2019.

    SG&A expenses were $7.9 million in the first quarter of 2020, compared to $10.4 million in the first quarter of 2019. The year-over-year decline is primarily the result of realized cost reductions and restructuring actions completed during 2019.

    Income tax benefit was $9.5 million in the first quarter of 2020, compared to $0.4 million in the first quarter of 2019.  The year-over-year increase is primarily the result of the passage of H.R. 748, the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act"), enacted on March 27, 2020, which allows the company to carry back Net Operating Losses (NOLs) incurred to periods when the statutory tax rate was 35% versus our current tax rate of 21%.

    Net loss for the first quarter of 2020 was $0.9 million, or $0.02 per share, compared to a net loss of $13.0 million, or $0.35 per share, for the same period in 2019. 

    Cash, cash equivalents and marketable securities were $113.5 million as of March 31, 2020.  Subsequent to the end of the quarter, in May 2020, the Company completed a public offering and received net proceeds of approximately $117 million after deducting estimated offering expenses. The Company has convertible debt of $143.8 million due in February 2023.

    Conference Call:
    A conference call to discuss these results has been scheduled for Monday, May 11, 2020 at 8:30 a.m. ET. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13703221. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    Footnote:
    1. Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release dated February 25, 2020 and press release dated May 5, 2020 announcing First Quarter 2020 Financial Results.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The Company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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 are not limited to, the planned submission of the FT218 NDA to the FDA and commercial launch of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
                 
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (In thousands, except per share data)
    (Unaudited)

        Three Months Ended March 31,
        2020   2019
             
    Product sales   $ 12,243     $ 16,437  
    Operating expenses:        
    Cost of products   2,457     3,266  
    Research and development expenses   5,530     7,329  
    Selling, general and administrative expenses   7,913     10,446  
    Intangible asset amortization   203     201  
    Changes in fair value of contingent consideration   2,478     2,134  
    Restructuring costs   159     1,228  
    Total operating expenses   18,740     24,604  
    Operating loss   (6,497 )   (8,167 )
    Investment and other income, net   (378 )   817  
    Interest expense   (3,190 )   (3,062 )
    Loss on deconsolidation of subsidiary       (2,673 )
    Other expense - changes in fair value of contingent consideration payable   (310 )   (307 )
    Loss before income taxes   (10,375 )   (13,392 )
    Income tax benefit   (9,510 )   (374 )
    Net loss   $ (865 )   $ (13,018 )
             
    Net loss per share - basic   $ (0.02 )   $ (0.35 )
    Net loss per share - diluted   (0.02 )   (0.35 )
             
    Weighted average number of shares outstanding - basic   41,057     37,354  
    Weighted average number of shares outstanding - diluted   41,057     37,354  
                 



    AVADEL PHARMACEUTICALS PLC

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except per share data)

        March 31, 2020   December 31, 2019
        (unaudited)    
    ASSETS        
    Current assets:        
    Cash and cash equivalents   $ 73,506     $ 9,774  
    Marketable securities   39,977     54,384  
    Accounts receivable   8,797     8,281  
    Inventories   3,523     3,570  
    Research and development tax credit receivable   1,835     2,107  
    Prepaid expenses and other current assets   3,337     4,264  
    Total current assets   130,975     82,380  
    Property and equipment, net   472     544  
    Operating lease right-of-use assets   3,365     3,612  
    Goodwill   18,491     18,491  
    Intangible assets, net   610     813  
    Research and development tax credit receivable   6,288     6,322  
    Other non-current assets   47,524     39,274  
    Total assets   $ 207,725     $ 151,436  
             
    LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)        
    Current liabilities:        
    Current portion of long-term contingent consideration payable   $ 5,855     $ 5,554  
    Current portion of operating lease liability   604     645  
    Accounts payable   6,790     6,100  
    Accrued expenses   14,858     19,810  
    Income taxes   2,297     43  
    Other current liabilities   1,932     3,832  
    Total current liabilities   32,336     35,984  
    Long-term debt   123,258     121,686  
    Long-term contingent consideration payable, less current portion   12,195     11,773  
    Long-term operating lease liability   2,205     2,319  
    Other non-current liabilities   5,664     8,873  
    Total liabilities   175,658     180,635  
             
    Shareholders' equity (deficit):        
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at March 31, 2020 and none issued and outstanding at December 31, 2019, respectively   5      
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 51,812 issued and 46,404 outstanding at March 31, 2020 and 42,927 issued and 37,520 outstanding at December 31, 2019   518     429  
    Treasury shares, at cost, 5,407 shares held at March 31, 2020 and December 31, 2019, respectively   (49,998 )   (49,998 )
    Additional paid-in capital   497,249     434,391  
    Accumulated deficit   (392,080 )   (391,215 )
    Accumulated other comprehensive loss   (23,627 )   (22,806 )
    Total shareholders' equity (deficit)   32,067     (29,199 )
    Total liabilities and shareholders' equity (deficit)   $ 207,725     $ 151,436  
                     


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (In thousands)
    (Unaudited)

        Three Months Ended March 31,
        2020   2019
             
    Cash flows from operating activities:        
    Net loss   $ (865 )   $ (13,018 )
    Adjustments to reconcile net loss to net cash provided by operating activities:        
    Depreciation and amortization   456     369  
    Remeasurement of acquisition-related contingent consideration   2,478     2,134  
    Remeasurement of financing-related contingent consideration   310     307  
    Amortization of debt discount and debt issuance costs   1,573     1,445  
    Change in deferred tax and income tax deferred charge   (8,440 )   (222 )
    Stock-based compensation expense   742     351  
    Loss on deconsolidation of subsidiary       1,750  
    Other adjustments   573     (541 )
    Net changes in assets and liabilities        
    Accounts receivable   (517 )   (1,021 )
    Inventories   47     467  
    Prepaid expenses and other current assets   899     (3,228 )
    Research and development tax credit receivable   160     (449 )
    Accounts payable & other current liabilities   (1,187 )   752  
    Accrued expenses   (4,905 )   (4,750 )
    Accrued income taxes   2,253     (46 )
    Earn-out payments for contingent consideration in excess of acquisition-date fair value   (1,774 )   (3,181 )
    Royalty payments for contingent consideration payable in excess of original fair value   (291 )   (507 )
    Other assets and liabilities   (3,148 )   (1,818 )
    Net cash used in operating activities   (11,636 )   (21,206 )
             
    Cash flows from investing activities:        
    Purchases of property and equipment       (30 )
    Proceeds from sales of marketable securities   14,788     34,864  
    Purchases of marketable securities   (1,562 )   (13,444 )
    Net cash provided by investing activities   13,226     21,390  
             
    Cash flows from financing activities:        
    Proceeds from February 2020 private placement   60,733      
    Proceeds from stock option exercises and ESPP   1,477     92  
    Net cash provided by financing activities   62,210     92  
             
    Effect of foreign currency exchange rate changes on cash and cash equivalents   (68 )   29  
             
    Net change in cash and cash equivalents   63,732     305  
    Cash and cash equivalents at January 1,   9,774     9,325  
    Cash and cash equivalents at March 31,   $ 73,506     $ 9,630  
                     


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED SUPPLEMENTAL INFORMATION
    (In thousands, except per share data)
    (Unaudited)

        Three Months Ended March 31,
    Revenues by Product:   2020   2019
             
    Bloxiverz   $ 1,401     $ 2,568  
    Vazculep   5,514     9,473  
    Akovaz   5,349     3,792  
    Other   (21 )   604  
    Total product sales   $ 12,243     $ 16,437  

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  19. DUBLIN, Ireland, May 04, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 11, 2020, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13703221. A live audio webcast can be accessed by visiting the investor relations section…

    DUBLIN, Ireland, May 04, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 11, 2020, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2020.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13703221. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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 are not limited to, those regarding the anticipated closing of the public offering and Avadel's expectation with respect to granting a 30-day option to purchase additional ADSs. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission on March 16, 2020, the preliminary prospectus supplement related to this offering and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

                Tom McHugh
                Chief Financial Officer
                Phone: (636) 449-1843
                Email:
                 
                Tim McCarthy
                LifeSci Advisors, LLC
                Phone: (212) 915.2564
                Email:

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  20. DUBLIN, Ireland, April 28, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today the pricing of an underwritten public offering of 11,630,000 ordinary shares, in the form of American Depositary Shares ("ADSs") at a price to the public of $10.75 per ADS. Each ADS represents the right to receive one ordinary share. All of the ADSs are being offered by Avadel. The gross proceeds to Avadel from the offering are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and estimated offering…

    DUBLIN, Ireland, April 28, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today the pricing of an underwritten public offering of 11,630,000 ordinary shares, in the form of American Depositary Shares ("ADSs") at a price to the public of $10.75 per ADS. Each ADS represents the right to receive one ordinary share. All of the ADSs are being offered by Avadel. The gross proceeds to Avadel from the offering are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.

    In connection with the public offering, Avadel has granted the underwriters a 30-day option to purchase up to an additional 1,744,500 ADSs at the public offering price less the underwriting discounts and commissions. The closing of the offering is expected to occur on May 1, 2020, subject to customary closing conditions.

    Jefferies LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated are acting as the joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as the lead manager and Ladenburg Thalmann & Co. Inc. and Craig-Hallum Capital Group LLC are acting as co-managers for the offering.

    The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission ("SEC") (File No. 333-236258). A preliminary prospectus supplement dated April 27, 2020 relating to and describing the terms of the offering was filed with the SEC. The final prospectus supplement relating to the offering will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus and the final prospectus supplement, when available, can also be obtained for free from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; by phone at 877-821-7388; or by email at , Piper Sandler & Co., Attention Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402; by phone at 800-747-3924; or by email at , or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at .

    This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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 are not limited to, those regarding the anticipated closing of the public offering and Avadel's expectation with respect to granting a 30-day option to purchase additional ADSs. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission on March 16, 2020, the preliminary prospectus supplement related to this offering and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email: 

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  21. DUBLIN, Ireland, April 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it is commencing an underwritten public offering of $100 million in ordinary shares, in the form of American Depositary Shares ("ADSs"). Each ADS represents the right to receive one ordinary share. All of the ADSs are being offered by Avadel. In connection with the offering, Avadel intends to grant the underwriters a 30-day option to purchase up to an additional $15 million in ADSs at the public offering price less the underwriting discounts and…

    DUBLIN, Ireland, April 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it is commencing an underwritten public offering of $100 million in ordinary shares, in the form of American Depositary Shares ("ADSs"). Each ADS represents the right to receive one ordinary share. All of the ADSs are being offered by Avadel. In connection with the offering, Avadel intends to grant the underwriters a 30-day option to purchase up to an additional $15 million in 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.

    The closing of the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. The size of the offering and the price per share of the ADSs placed in the offering will be determined following the bookbuilding process.

    Jefferies LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated are acting as the joint book-running managers for the offering.

    The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission ("SEC") (File No. 333-236258). A preliminary prospectus supplement and accompanying prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, can also be obtained for free from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; by phone at 877-821-7388; or by email at , Piper Sandler & Co., Attention Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402; by phone at 800-747-3924; or by email at , or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at .

    This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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 are not limited to, those regarding the completion and size of the proposed public offering and Avadel's expectation with respect to granting a 30-day option to purchase additional ADSs. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission on March 16, 2020, the preliminary prospectus supplement related to this offering and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email: 

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  22. Once-nightly FT218 at 9 g was generally well-tolerated with commonly known sodium oxybate adverse reactions occurring at low rates



    Management is scheduled to host a conference call at 8:30 a.m. EDT today to present the topline data

    DUBLIN, Ireland, April 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced…

    The primary analysis of investigational, once-nightly FT218 at 9 g demonstrated highly statistically significant (p<0.001), and clinically meaningful improvement across all three co-primary endpoints compared to placebo

    Once-nightly FT218 at 9 g was generally well-tolerated with commonly known sodium oxybate adverse reactions occurring at low rates

    Once-nightly FT218 at the 7.5 g and 6 g dose levels achieved highly statistically significant (p<0.001), clinically meaningful improvements across all three co-primary endpoints compared to placebo

    Management is scheduled to host a conference call at 8:30 a.m. EDT today to present the topline data

    DUBLIN, Ireland, April 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced today positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. The REST-ON trial, under a Special Protocol Assessment agreement with the FDA, met its three co-primary efficacy endpoints at all three doses (9 g, 7.5 g, and 6 g) demonstrating highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) and mean weekly cataplexy attacks.

    "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo," said Jordan Dubow, M.D., Chief Medical Officer of Avadel. "Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period. Commonly known sodium oxybate adverse reactions occurred at low rates at the highest dose level. We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care. We look forward to presenting more detailed data from the REST-ON study in publications and at upcoming medical conferences."

    Greg Divis, Chief Executive Officer of Avadel, added, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market.1 Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy. We extend our appreciation to the patients, investigators, study staff, and advocacy groups who contributed to the REST-ON Phase 3 study and supported the development of this potentially life-changing treatment."

    Summary of Topline Results

    Results from the 212 patient, double-blind, randomized, placebo-controlled study showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints.

      Change from Baseline (Week 13)² FT218 Difference from Placebo p-value
      Once-nightly FT218 (9 g) Placebo
    MWT (minutes) 10.82 4.69 LS Mean 6.13 <0.001
    CGI-I
    (% of patients much/very much improved)
    72.0 31.6 Odds ratio 5.56 <0.001
    Mean Weekly Cataplexy Attacks -11.51 -4.86 LS Mean -6.65 <0.001

    Overall, the 9 g dose of once-nightly FT218 was generally well-tolerated with the most commonly known adverse reactions for sodium oxybate occurring at low frequencies (nausea 1.3%, vomiting 5.2%, decreased appetite 2.6%, dizziness 5.2%, somnolence 3.9%, tremor 1.3%, enuresis 9%). The discontinuation rate due to adverse reactions at the 9 g dose of once-nightly FT218 was 3.9%.

    Following the achievement of statistical significance on the three co-primary endpoints by patients on the 9 g dose, the same analyses were conducted comparing the 7.5 g dose.  Following the achievement of statistical significance on the three co-primary endpoints by patients on the 7.5 g dose, the same analyses were conducted comparing the 6 g dose of once-nightly FT218 to placebo. The 7.5 g and 6 g doses also demonstrated highly statistically significant (p<0.001), clinically meaningful improvements compared to placebo across the three co-primary endpoints. Safety data for these doses and additional secondary endpoint data for all doses will be presented at future scientific meetings after the data becomes available.

    Conference Call Details
    Avadel Pharmaceuticals management will hold a conference call to discuss the positive results from the REST-ON study on Monday, April 27, 2020 at 8:30 a.m. EDT.

    Dial-in Number: (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International)
    Conference ID number: 13702937

    A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company conducted the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is the subject of a recently completed Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. In addition, Avadel markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "could," "would," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. Actual results (including, without limitation, announcement of additional data from our Phase 3 REST-ON study or any other FT218-related study, timing of filing the NDA for FT218, our ability to achieve FDA approval for FT218, and our ability to successfully commercialize FT218) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involved certain risks and uncertainties that are subject to change based on various factors (many of which are beyond our control) including those set forth in our 2019 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:

    Investor Contacts
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
                 
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:

    Media Contact
    Patrick Bursey
    LifeSci Communications, LLC
    Phone: (646) 970-4688
    Email:  

    Footnote:

    1. Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release, February 25, 2020
    2. CGI-I does not have a baseline endpoint

     

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  23. DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.

    "We're excited to complete our pivotal Phase 3 REST-ON study of FT218 and look forward to announcing the topline data from the study as we move closer toward potentially…

    DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.

    "We're excited to complete our pivotal Phase 3 REST-ON study of FT218 and look forward to announcing the topline data from the study as we move closer toward potentially bringing this new drug to narcolepsy patients. I want to thank our investigators, study staff and patients for their participation in this study, as well as the Avadel team for their continued dedication," stated Dr. Jordan Dubow, Chief Medical Officer of Avadel.

    The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of FT218, a once-nightly formulation of sodium oxybate using Avadel's proprietary Micropump™ technology for extended-release oral suspension, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.

    Based on the Company's industry research, it believes FT218, if approved by the FDA, has the potential to provide a valuable advancement in the treatment of both excessive daytime sleepiness and cataplexy for patients with narcolepsy. Currently, the twice-nightly sodium oxybate market is valued at an estimated annualized rate of $1.7 billion1.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. In addition, Avadel markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Footnote:
          1.    Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release, February 25, 2020

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "could," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. Actual results (including, without limitation, the timely announcement of topline data and success of our Phase 3 REST-ON study and our ability to achieve FDA approval for FT218) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involved certain risks and uncertainties that are subject to change based on various factors (many of which are beyond our control) including those set forth in our 2019 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:

                Tom McHugh
                Chief Financial Officer
                Phone: (636) 449-1843
                Email:
                 
                Tim McCarthy
                LifeSci Advisors, LLC
                Phone: (212) 915.2564
                Email:

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    • Completed enrollment for the pivotal REST-ON Phase 3 study in Q4 2019; data readout expected in Q2 2020

    • Raised $65 million in gross proceeds from private placement with leading biotech investment funds in February 2020

    • Realized over $80 million in cost savings from restructuring and other cost reduction actions

    • Reported revenue at the high end of the annual guidance at $59.2 million for full year 2019

    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, March 12, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy…

    • Completed enrollment for the pivotal REST-ON Phase 3 study in Q4 2019; data readout expected in Q2 2020

    • Raised $65 million in gross proceeds from private placement with leading biotech investment funds in February 2020

    • Realized over $80 million in cost savings from restructuring and other cost reduction actions

    • Reported revenue at the high end of the annual guidance at $59.2 million for full year 2019

    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, March 12, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, today announced its financial results for the fourth quarter and year ended December 31, 2019, and provided a company update.

    "Throughout the past year we have successfully executed on our focused development strategy for FT218 and completed a corporate restructuring program that resulted in $82 million of cost savings year-over-year. We believe these activities have changed the course of the company and created a significant opportunity to drive long-term shareholder value," said Greg Divis, Chief Executive Officer of Avadel. "The opportunity presented by the development of FT218 is increasingly being recognized by the investment community, as we completed in February 2020 a $65 million private placement priced at-the-market with leading biotech investors, Vivo Capital, Avoro Capital Advisors, RTW Investments, Venrock Healthcare Capital Partners, Acuta Capital, and KVP Capital."

    "Looking ahead, we have several near-term clinical milestones, including the last patient last visit for the pivotal Phase 3 REST-ON trial for FT218 scheduled to occur in the next two weeks, which will be followed by topline data from the study in the second quarter of 2020. In addition, we've announced plans to enhance the FT218 program by including an open-label extension study for REST-ON, and a switch study to evaluate patients switching from twice-nightly sodium oxybate to once-nightly FT218, which we plan to start by the end of the first quarter of 2020. This is an exciting time in Avadel's history, as we believe that FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market, which we estimated to be approximately $1.7 billion1 in 2019," concluded Mr. Divis.

    Fourth quarter and recent company highlights

    • Completed enrollment for the REST-ON Phase 3 pivotal trial of FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy for a total Phase 3 trial size of 212 patients, which exceeded the trial's enrollment target of 205 patients;
      • Last patient last visit for the REST-ON Phase 3 trial is expected to occur in the next two weeks, with topline data expected in the second quarter of 2020;
         
    • Completed a $65 million private placement with leading biotech investment funds in February 2020;
       
    • Strengthened the management team's financial and operational capabilities with the appointments of Thomas McHugh as Chief Financial Officer and Dr. Jason Vaughn to the newly created role of Senior Vice President of Technical Operations
       
    • Appointed Dr. Mark McCamish, an internationally recognized expert in drug development and manufacturing, to the Board of Directors
       
    • Achieved approximately $82 million of lower operating expenses for the full year 2019 compared to 2018 due to cost reductions and restructuring actions;
       
    • Received U.S. FDA approval for Nouress™, a cysteine hydrochloride injection for treating neonate patients requiring total parental nutrition, and the USPTO issued an Orange Book-listed patent for Nouress; and
       
    • Reported revenues of $11.0 million for the fourth quarter of 2019.

    Overview of fourth quarter 2019 financial results

    Revenues for the fourth quarter of 2019 were $11.0 million, compared to $20.9 million in the fourth quarter of 2018. The decline on a year-over-year basis was primarily attributed to lower overall sales volume across the Company's hospital products as a result of increased market competition.

    R&D expenses were $7.8 million in the fourth quarter of 2019, compared to $6.1 million in the fourth quarter of 2018. The increase on a year-over-year basis was primarily attributed to the Company's investment in R&D spend in its FT218 development program.

    SG&A expenses were $7.7 million in the fourth quarter of 2019, compared to $23.2 million in the fourth quarter of 2018. The year-over-year decline is primarily the result of realized cost reductions resulting from the exit of Noctiva™ and the Company's cost reduction and restructuring actions.

    Net loss for the fourth quarter of 2019 was $2.7 million, or $0.07 per share, compared to a net loss of $63.9 million or $1.72 per share for the same period in 2018. 

    Cash, cash equivalents and marketable securities were $64.2 million as of December 31, 2019. In February 2020, the Company completed a private placement with leading biotech investment funds receiving net proceeds of approximately $61.1 million. The Company has convertible debt of $143.8 million due in February 2023.

    Based on recent hospital products sales performance, increased competition from additional products launched in 2019, and recent market price actions, revenue for the first quarter of 2020 is expected to be at or above $10 million.

    Conference Call:
    A conference call to discuss these results has been scheduled for Tuesday, March 12, 2020 at 8:30 a.m. EST. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13699575. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    Footnote:
    1. Annualized Xyrem revenues from the Jazz Pharmaceuticals Full Year and Fourth Quarter 2019 Financial Results press release, February 25, 2020

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "could," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. Actual results (including, without limitation, the timely completion and success of our Phase 3 REST-ON study and our ability to achieve FDA approval for FT218, our ability to achieve sales of our current marketed hospital products consistent with our current expectations, our ability to launch and commercialize Nouress, our ability to continue to service our Exchangeable Senior Notes due in 2023 and our ability to achieve continued cost savings from our restructuring plan) may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involved certain risks and uncertainties that are subject to change based on various factors (many of which are beyond our control) including those set forth in our 2018 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:

    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (In thousands, except per share data)
    (Unaudited)

        Three Months Ended December 31,   Twelve Months Ended December 31,
        2019   2018   2019   2018
                     
    Revenues:                
    Product sales   $ 10,995     $ 19,320     $ 59,215     $ 101,423  
    License revenue       1,600         1,846  
    Total revenues   10,995     20,920     59,215     103,269  
    Operating expenses:                
    Cost of products   2,414     4,292     12,125     17,516  
    Research and development expenses   7,757     6,086     32,917     39,329  
    Selling, general and administrative expenses   7,663     23,200     30,183     100,359  
    Intangible asset amortization   206     1,623     816     6,619  
    Changes in fair value of related party contingent consideration   (1,539 )   (5,695 )   845     (22,731 )
    Impairment of intangible asset       66,087         66,087  
    Restructuring costs   1,841     748     6,441     1,016  
    Total operating expenses   18,342     96,341     83,327     208,195  
    Operating loss   (7,347 )   (75,421 )   (24,112 )   (104,926 )
    Investment and other income, net   (1,479 )   (393 )   1,069     452  
    Interest expense   (3,190 )   (3,045 )   (12,483 )   (10,622 )
    Gain (loss) on deconsolidation of subsidiary   162         (2,678 )    
    Other income (expense) - changes in fair value of related party payable   118     467     (378 )   1,899  
    Loss before income taxes   (11,736 )   (78,392 )   (38,582 )   (113,197 )
    Income tax benefit   (8,997 )   (14,533 )   (5,356 )   (17,893 )
    Net loss   $ (2,739 )   $ (63,859 )   $ (33,226 )   $ (95,304 )
                     
    Net loss per share - basic   $ (0.07 )   $ (1.72 )   $ (0.89 )   $ (2.55 )
    Net loss per share - diluted   (0.07 )   (1.72 )   (0.89 )   (2.55 )
                     
    Weighted average number of shares outstanding - basic   37,465     37,073     37,403     37,325  
    Weighted average number of shares outstanding - diluted   37,465     37,073     37,403     37,325  



    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except per share data)

        December 31, 2019   December 31, 2018
        (unaudited)    
    ASSETS        
    Current assets:        
    Cash and cash equivalents   $ 9,774     $ 9,325  
    Marketable securities   54,384     90,590  
    Accounts receivable   8,281     11,330  
    Inventories, net   3,570     4,770  
    Research and development tax credit receivable   2,107     283  
    Prepaid expenses and other current assets   4,264     8,553  
    Total current assets   82,380     124,851  
    Property and equipment, net   544     1,911  
    Operating lease right-of-use assets   3,612      
    Goodwill   18,491     18,491  
    Intangible assets, net   813     1,629  
    Research and development tax credit receivable   6,322     7,272  
    Other non-current assets   39,274     36,146  
    Total assets   $ 151,436     $ 190,300  
             
    LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY        
    Current liabilities:        
    Current portion of long-term debt   $     $ 106  
    Current portion of long-term related party payable   5,554     9,439  
    Current portion of operating lease liability   645      
    Accounts payable   6,100     3,503  
    Accrued expenses   19,810     21,695  
    Other current liabilities   3,875     3,640  
    Total current liabilities   35,984     38,383  
    Long-term debt, less current portion   121,686     115,734  
    Long-term related party payable, less current portion   11,773     19,401  
    Long-term operating lease liability   2,319      
    Other non-current liabilities   8,873     14,002  
    Total liabilities   180,635     187,520  
             
    Shareholders' (deficit) equity:        
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; none issued or outstanding at December 31, 2019 and December 31, 2018, respectively        
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 42,927 issued and 37,520 outstanding at December 31, 2019, and 42,720 issued and 37,313 outstanding at December 31, 2018   429     427  
    Treasury shares, at cost, 5,407 shares held at December 31, 2019 and December 31, 2018, respectively   (49,998 )   (49,998 )
    Additional paid-in capital   434,391     433,756  
    Accumulated deficit   (391,215 )   (357,989 )
    Accumulated other comprehensive loss   (22,806 )   (23,416 )
    Total shareholders' (deficit) equity   (29,199 )   2,780  
    Total liabilities and shareholders' (deficit) equity   $ 151,436     $ 190,300  


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (In thousands)
    (Unaudited)

        Twelve Months Ended December 31,
        2019   2018
             
    Net loss   $ (33,226 )   $ (95,304 )
    Adjustments to reconcile net loss to net cash provided by operating activities:        
    Depreciation and amortization   2,486     7,430  
    Impairment of intangible asset       66,087  
    Amortization of premiums on marketable securities   41     2,823  
    Remeasurement of related party acquisition-related contingent consideration   845     (22,731 )
    Remeasurement of related party financing-related contingent consideration   378     (1,899 )
    Amortization of debt discount and debt issuance costs   5,995     4,830  
    Changes in deferred tax   (6,334 )   (19,152 )
    Stock-based compensation expense   519     7,852  
    Loss on deconsolidation of subsidiary   1,750      
    Other adjustments   (295 )   1,365  
    Net changes in assets and liabilities        
    Accounts receivable   2,471     3,452  
    Inventories, net   1,155     711  
    Prepaid expenses and other current assets   (1,187 )   3,577  
    Research and development tax credit receivable   (1,014 )   (2,545 )
    Accounts payable & other current liabilities   4,641     (2,032 )
    Deferred revenue   (114 )   (1,892 )
    Accrued expenses   357     (10,640 )
    Accrued income taxes   (30 )   (341 )
    Earn-out payments for related party contingent consideration in excess of acquisition-date fair value   (10,988 )   (19,468 )
    Royalty payments for related party payable in excess of original fair value   (1,748 )   (2,838 )
    Other assets and liabilities   (4,027 )   (2,001 )
    Net cash used in operating activities   (38,325 )   (82,716 )
             
    Cash flows from investing activities:        
    Purchases of property and equipment   (29 )   (178 )
    Proceeds from disposal of property and equipment   154      
    Purchase of intangible assets       (20,000 )
    Proceeds from sales of marketable securities   63,246     359,507  
    Purchases of marketable securities   (24,648 )   (376,310 )
    Net cash provided by (used in) investing activities   38,723     (36,981 )
             
    Cash flows from financing activities:        
    Proceeds from debt issuance       143,750  
    Payments for debt issuance costs       (6,190 )
    Earn-out payments for related party contingent consideration       (645 )
    Exercise of warrants       2,911  
    Proceeds from issuance of ordinary shares   118     577  
    Share repurchases       (27,637 )
    Other financing activities, net   (145 )   (107 )
    Net cash (used in) provided by financing activities   (27 )   112,659  
    Effect of foreign currency exchange rate changes on cash and cash equivalents   78     (201 )
    Net change in cash and cash equivalents   449     (7,239 )
    Cash and cash equivalents at January 1   9,325     16,564  
    Cash and cash equivalents at December 31   $ 9,774     $ 9,325  


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED SUPPLEMENTAL INFORMATION
    (In thousands, except per share data)
    (Unaudited)

        Three Months Ended December 31,   Twelve Months Ended December 31,
    Revenues by Product:   2019   2018   2019   2018
                     
    Bloxiverz   $ 1,087     $ 4,159     $ 7,479     $ 20,850  
    Vazculep   5,483     9,819     33,152     42,916  
    Akovaz   4,696     5,676     18,642     33,759  
    Other   (271 )   (334 )   (58 )   3,898  
    Total product sales   10,995     19,320     59,215     101,423  
    License revenue       1,600         1,846  
    Total revenues   $ 10,995     $ 20,920     $ 59,215     $ 103,269  

    Primary Logo

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  24. DUBLIN, Ireland, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, March 12, 2020, to provide a corporate update and discuss the Company's financial results for the fourth quarter and year ended December 31, 2019.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13699575. A live audio webcast can be accessed by visiting the investor…

    DUBLIN, Ireland, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, March 12, 2020, to provide a corporate update and discuss the Company's financial results for the fourth quarter and year ended December 31, 2019.

    To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (international). The conference ID number is 13699575. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019 and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:

    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:

    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:  

    Primary Logo

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  25. DUBLIN, Ireland, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it entered into a definitive agreement for the sale of its American Depositary Shares (ADSs) and Series A Non-Voting Convertible Preferred Shares (Series A Preferred) in a private placement to a group of institutional accredited investors led by Vivo Capital, Avoro Capital Advisors, RTW Investments, Venrock Healthcare Capital Partners, Acuta Capital, and KVP Capital. The private placement is expected to result in gross proceeds to the Company of…

    DUBLIN, Ireland, Feb. 21, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it entered into a definitive agreement for the sale of its American Depositary Shares (ADSs) and Series A Non-Voting Convertible Preferred Shares (Series A Preferred) in a private placement to a group of institutional accredited investors led by Vivo Capital, Avoro Capital Advisors, RTW Investments, Venrock Healthcare Capital Partners, Acuta Capital, and KVP Capital. The private placement is expected to result in gross proceeds to the Company of approximately $65 million before deducting placement agent and other offering expenses.

    Pursuant to the terms of the private placement, the Company will issue 8,680,225 ADSs and 487,614 shares of Series A Preferred at a price of $7.09 per share, priced at-the-market under Nasdaq rules. Each share of non-voting Series A Preferred is convertible into one ADS, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of Avadel ADSs outstanding. The closing of the private placement is subject to certain conditions and is expected to occur on February 25, 2020. Proceeds from the private placement will be used to fund continued clinical and program development of FT218, including an open-label extension study for REST-ON, a switch study to evaluate patients switching from twice-nightly sodium oxybate to once-nightly FT218, as well as for general corporate purposes.

    Jefferies, Piper Sandler, and Stifel are acting as lead placement agents for the private placement. Ladenburg Thalmann and LifeSci Capital LLC are acting as co-placement agents for the private placement. Craig-Hallum Capital Group is serving as financial advisor to the Company in connection with the private placement.

    The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Section 4(a)(2) and/or Regulation D of the Securities Act. The ADSs and Series A Preferred may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to file a registration statement covering the resale of the ADSs acquired by the investors in the private placement or upon conversion of the Series A Preferred.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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 are not limited to, those regarding:  the anticipated closing of the private placement; the use of proceeds from the private placement; and the filing of a registration statement to register the resale of the securities to be issued and sold in the private placement. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019 and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:

    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:
                 
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:

    Primary Logo

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  26. NEW ORLEANS, Jan. 10, 2020 /PRNewswire/ -- LongueVue Capital Partners ("LVC"), a partnership-driven, operator-centric private equity firm based in New Orleans with approximately $500 million of assets under management, announced today that Geoff Glass and Pete Allen have joined the firm as healthcare Operating Partners. Geoff, a seasoned pharma services executive, will focus on the life science space. Pete, a healthcare executive with broad reaching experience, will focus on medical devices and related contract services as well as healthcare supply chain services. The additions of both Pete and Geoff reiterate LVC's commitment to the healthcare industry, which is one of the firm's largest investment verticals.

    Geoff brings a wealth of experience…

    NEW ORLEANS, Jan. 10, 2020 /PRNewswire/ -- LongueVue Capital Partners ("LVC"), a partnership-driven, operator-centric private equity firm based in New Orleans with approximately $500 million of assets under management, announced today that Geoff Glass and Pete Allen have joined the firm as healthcare Operating Partners. Geoff, a seasoned pharma services executive, will focus on the life science space. Pete, a healthcare executive with broad reaching experience, will focus on medical devices and related contract services as well as healthcare supply chain services. The additions of both Pete and Geoff reiterate LVC's commitment to the healthcare industry, which is one of the firm's largest investment verticals.

    Geoff brings a wealth of experience in the life science and pharmaceutical space. Geoff began his career in life science consulting at Ernst & Young before jumping into the industry at ICN Pharmaceuticals, which eventually became Valeant Pharmaceuticals. Since then, Geoff has held senior executive roles at Valeant Pharmaceuticals and Patheon across both sales and operations functions. Before becoming President of Patheon's Banner Life Sciences business unit, Geoff served as the Executive Vice President of Global Sales and Marketing. More recently, Geoff was CEO of Sancilio Pharmaceuticals and has served on a number of life science boards, including Locus Biosciences. Geoff is currently Chairman of the Board of Avadel Pharmaceuticals (NASDAQ:AVDL). Across all his roles, Geoff has been instrumental in developing and growing companies with differentiated service and/or product offerings. 

    Pete has an impressive background as a senior healthcare executive across a variety of healthcare verticals with specific expertise in P&L management, business development, sales, marketing, distribution management, regulatory affairs, political lobbying, group purchasing, research and development, manufacturing, M&A integration, and new product/business launches. Most recently, Pete was the Executive Vice President of sourcing operations at Vizient (from 2010 to 2019), the largest group purchasing organization in the United States with over 3,500 employees. Prior to Vizient, Pete served as Vice President and General Manager of the infusion therapy division at Becton Dickinson (NYSE:BDX), a $650 million business unit. Pete also held numerous sales positions at Kimberly-Clark Healthcare, ultimately serving as Director of Global Strategic Marketing. Through his entire career, Pete has led growth transformations and built established, defendable market-leading healthcare companies.

    Ryan Nagim, LVC Partner who helps lead the firm's healthcare investment strategy, commented, "Both Geoff and Pete have deep operating experience that will serve as a tremendous resource to our firm and expand LVC's ability to create meaningful value within our healthcare portfolio. Specifically, Geoff and Pete will work with LVC and our management team partners to enhance each company's value proposition through operational improvement, technological enhancement, customer and service-line expansion, synergistic add-on acquisitions, and prudent deployment of financial and human capital. We are incredibly excited to launch these partnerships."

    Rick Rees, LVC's Co-Founder and Managing Partner, added, "In working with Pete and Geoff, it is clear that both place the same value in partnerships as we do. Both are tremendous cultural fits with LVC, making them ideal partners to help guide our healthcare investments through the next phase of growth."

    Within life sciences, LVC will focus on companies that have differentiated capabilities in contract development, manufacturing and lab services; ingredient or equipment suppliers essential to drug manufacturing or delivery; and value-added service providers or suppliers to the cell and gene therapy market, including cold chain logistics. LVC will also target businesses with niche product or service offerings within the pharmaceutical, biopharma, nutritional, and/or consumer health sectors as well as mission-critical software and quality and compliance offerings serving the life science sector.

    Geoff noted, "Over the past three years, I've developed a deep relationship with the LVC team. I'm thrilled to formally join the team in a position where I can add value to scalable companies in a highly dynamic and rapidly changing sector. While I've had the pleasure of working with many private equity firms over the years, I remain extremely impressed with LVC's culture, and their unique operator-centric and partnership-driven approach to investing."

    Pete will support expanding LVC's healthcare portfolio in the packaging and supply chain segments, low- to mid-tech medical device segments, and medical equipment capital management and disposal segments. Pete will also focus on opportunities that reduce costs to the provider community.

    Pete commented, "I've developed a strong relationship with the LVC team over the past few years and have worked with a number of their portfolio companies. I am impressed by the LVC team's partnership approach and their ability to drive sustainable growth within their healthcare portfolio. I am extremely excited to partner with LVC and leverage my multi-disciplinary healthcare expertise to expand the firm's presence across multiple healthcare sectors."

    About LongueVue Capital Partners

    Founded in 2001, LongueVue Capital is a New Orleans-based private equity firm that focuses on providing human capital, financial capital, and a skill set built upon a successful 19-year track record of partnering with entrepreneurs and management teams to drive value creation in middle market companies. Having managed over $500 million of capital spanning three funds coupled with 150 years of combined operating and investing experience, our team is the ideal partner for middle market companies at inflection points and seeking to maximize value.

    Our opportunistic investment strategy provides the flexibility to partner with attractive businesses across a variety of industries and situations, and we tailor transaction structures to meet company and stakeholders' objectives. While we are selective with our investment strategy, we target growth-oriented companies with scalable, sustainable business models and exceptional leadership teams.

    Our proactive, hands-on approach enables us to be thoughtful stewards of our portfolio companies and trusted and dependable strategic partners to all stakeholders. Together with our entrepreneur and management team partners, we help create superior value for our portfolio companies and investors.

    To learn more about LongueVue Capital, please visit our website at www.lvcpartners.com, and to learn more about our healthcare portfolio and investment approach, please visit our healthcare themes and portfolio page at www.lvcpartners.com/portfolio/healthcare. For inquiries, please contact Ryan Nagim, Partner, at or call 504.293.3600.

    Cision View original content:http://www.prnewswire.com/news-releases/longuevue-capital-adds-experienced-healthcare-operating-partners-to-support-new--existing-investments-300984194.html

    SOURCE LongueVue Capital Partners

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  27. - - -
    A total of 212 patients enrolled in the REST-ON study exceeds the trial's enrollment target of 205
    - - -
    Topline data from the REST-ON study expected in Q2 2020

    DUBLIN, Ireland, Dec. 17, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed patient enrollment in the REST-ON Phase 3 clinical trial for FT218. The REST-ON study has enrolled a total of 212 patients, which includes additional patients who were in the screening process when the study achieved its enrollment target of 205 patients. The last patient…

    - - -
    A total of 212 patients enrolled in the REST-ON study exceeds the trial's enrollment target of 205
    - - -
    Topline data from the REST-ON study expected in Q2 2020

    DUBLIN, Ireland, Dec. 17, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed patient enrollment in the REST-ON Phase 3 clinical trial for FT218. The REST-ON study has enrolled a total of 212 patients, which includes additional patients who were in the screening process when the study achieved its enrollment target of 205 patients. The last patient last visit (LPLV) is expected to occur by the end of the first quarter of 2020, with topline data expected in the second quarter of 2020.

    "We're excited to complete enrollment in our pivotal Phase 3 REST-ON study and move towards completing the study in the next three months.  As a result, the study is on schedule to allow us to announce topline data in the second quarter of 2020," stated Dr. Jordan Dubow, Chief Medical Officer. "We've experienced strong interest in FT218 and the REST-ON study from across the narcolepsy community, which we believe is mostly centered around the once-nightly dosing formulation of FT218. FT218's once-nightly dosing may be safer in treating patients with narcolepsy than the previously-approved sodium oxybate product due to that product's twice-nightly dosing regimen."

    Based on the Company's industry research, it believes FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market. Currently, this market is valued at an estimated annualized rate of $1.7 billion1.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Footnote:
    1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q3 2019 earnings press release, November 5, 2019

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019 and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
       
      Tom McHugh
      Chief Financial Officer
      Phone: (636) 449-1843
      Email:
       
      Tim McCarthy
      LifeSci Advisors, LLC
      Phone: (212) 915.2564
      Email:

     

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  28. DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).

    In addition, Avadel announced today that the United States Patent and Trademark Office (USPTO) recently issued United States Patent No. 10,493,051 covering cysteine solutions, including the approved Nouress product. This patent is listed in the Orange Book for Nouress and is set to expire in March of 2039…

    DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).

    In addition, Avadel announced today that the United States Patent and Trademark Office (USPTO) recently issued United States Patent No. 10,493,051 covering cysteine solutions, including the approved Nouress product. This patent is listed in the Orange Book for Nouress and is set to expire in March of 2039. Avadel has additional U.S. patent applications pending for Nouress.

    "We are pleased to receive FDA approval for Nouress, which validates our strategy of developing innovative medicines for patients," said Greg Divis, Chief Executive Officer of Avadel. "Nouress is the fourth FDA approved product in our sterile injectable hospital business. The cash flow generated by this legacy business is supporting the clinical development costs from our lead program, FT218, which is currently expected to announce topline data from the pivotal Phase 3 REST-ON trial in the second quarter of 2020. We believe that as a once-nightly formulated sodium oxybate, FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market, which is currently valued at an estimated annualized rate of $1.7 billion1."

    Avadel is currently evaluating the timing and process for a commercial launch of Nouress in the United States. In this regard, a competitor received FDA approval earlier this year for its cysteine hydrochloride injection and more recently was granted a U.S. patent, which Avadel is assessing along with other market factors. 

    Due to a historical lack of reliable supply, U.S. markets previously imported cysteine hydrochloride injection from Canada under special FDA rules allowing shortage drugs to be sourced abroad if no domestic supplies are available. With FDA approvals of Nouress and another U.S. company's cysteine hydrochloride injection earlier this year, Avadel expects domestic supply of cysteine hydrochloride injection will be sufficient to support the entire U.S. market, which, under FDA regulations, should preclude further import or U.S. marketing of unapproved cysteine hydrochloride injection products.  Under these potential market conditions, the U.S. annual market for cysteine hydrochloride could be greater than $50 million. 

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Footnote:
    1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q3 2019 earnings press release, November 5, 2019

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, including the risk that Nouress is not launched in 2020 or at all and the risk that a third party claims Nouress infringes its patent(s), and, as a result, there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019 and subsequent filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:

                Tom McHugh
                Chief Financial Officer
                Phone: (636) 449-1843
                Email:
                 
                Tim McCarthy
                LifeSci Advisors, LLC
                Phone: (212) 915.2564
                Email:

    Primary Logo

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  29. DUBLIN, Ireland, Dec. 10, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Mark McCamish, MD, Ph.D. to its board of directors, effective immediately.

    "We are pleased to have Dr. McCamish join our board of directors. He brings Avadel tremendous experience as a senior executive overseeing research and development at several leading global companies, including Abbott, Amgen, and Sandoz," stated Mr. Geoffrey Glass, Chairman of the Board. "Dr. McCamish has demonstrated a commercial mindset in establishing novel research, development, and regulatory strategies that led…

    DUBLIN, Ireland, Dec. 10, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Mark McCamish, MD, Ph.D. to its board of directors, effective immediately.

    "We are pleased to have Dr. McCamish join our board of directors. He brings Avadel tremendous experience as a senior executive overseeing research and development at several leading global companies, including Abbott, Amgen, and Sandoz," stated Mr. Geoffrey Glass, Chairman of the Board. "Dr. McCamish has demonstrated a commercial mindset in establishing novel research, development, and regulatory strategies that led to approvals and commercial successes in multiple therapeutic areas and various dosage forms. This deep domain expertise, coupled with his leadership experience as CEO of Forty Seven, Inc., make him a great addition to the Avadel board of directors."

    Dr. McCamish is an internationally recognized expert in drug development and manufacturing. He is currently the President and Chief Executive Officer of Forty Seven, Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer. Prior to Forty Seven, Inc., Dr. McCamish was the Global Head of Biopharmaceutical Development at Sandoz International, a Novartis company. Dr. McCamish was acknowledged by Novartis with a Chairman award for 2010, 2011, 2012, 2013, 2014, and 2015, and the European Antibody Congress named Dr. McCamish one of the top 50 global antibody industry influencers. Prior to Sandoz, Dr. McCamish served as a member of the executive team of PDL Biopharma, Inc. across several roles, including SVP and Chief Medical Officer. He helped lead the spin out of PDL's R&D business, which was named Facet Biotech. Due to clinical advances made in both multiple sclerosis with daclizumab and multiple myeloma with elotuzumab, Facet Biotech was acquired by Abbott Labs. Dr. McCamish has also held senior R&D roles at Perlegen Sciences, Amgen, Inc., and Abbott Laboratories.

    After earning a Ph.D. in Human Nutrition from Penn State and MD from UCLA, he completed his residency and fellowship training at the University of California, Davis (UC Davis). He has also held professorships at UC Davis and Ohio State University.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
     
    Tom McHugh
    Chief Financial Officer
    Phone: (636) 449-1843
    Email:

    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:

    Primary Logo

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  30. - - -
    Thomas S. McHugh appointed as Chief Financial Officer
    - - -
    Dr. Jason Vaughn appointed Senior Vice President of Technical Operations

    DUBLIN, Ireland, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Thomas S. McHugh as its new Chief Financial Officer, replacing Michael Kanan, effective immediately. In addition, the Company has appointed Dr. Jason M. Vaughn to the newly formed role of Senior Vice President of Technical Operations, where his responsibilities will include overseeing the analytical, process development, technical transfer and commercial scale…

    - - -
    Thomas S. McHugh appointed as Chief Financial Officer
    - - -
    Dr. Jason Vaughn appointed Senior Vice President of Technical Operations

    DUBLIN, Ireland, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today the appointment of Thomas S. McHugh as its new Chief Financial Officer, replacing Michael Kanan, effective immediately. In addition, the Company has appointed Dr. Jason M. Vaughn to the newly formed role of Senior Vice President of Technical Operations, where his responsibilities will include overseeing the analytical, process development, technical transfer and commercial scale up of the company's lead clinical program, FT218. These two appointments bring significant financial and operational experience in the biopharmaceutical industry to Avadel. Mr. McHugh and Dr. Vaughn will report to Avadel's Chief Executive Officer, Greg Divis.

    "We are excited to welcome Tom and Jason to the Avadel team. They both bring tremendous experience to the company that will elevate their respective roles and support our planned scaling of operations and future growth. These appointments are part of a broader strategy and restructuring implemented throughout most of 2019, during which we've strengthened the team across all operations in order to positively advance our FT218," commented Mr. Divis. "We recently completed patient enrollment for the Phase 3 REST-ON study of FT218, and expect to announce the data readout in the second quarter of 2020."

    "I want to thank Mike for his role in the company's successful restructuring and cost cutting initiative implemented earlier this year. The Board and I appreciate his service over the past several years and wish him the best on his future endeavors," concluded Mr. Divis.

    Mr. McHugh most recently served as Senior Vice President of Finance of Ironshore Pharmaceuticals Inc. where he built and led the U.S. Finance, Accounting and Treasury functions and supported Ironshore's new product launch.  Prior to his time at Ironshore, McHugh was the Chief Financial Officer and Treasurer at Lumara Health, a specialty pharmaceutical company that focused on maternal fetal medicine and obstetrics/gynecology.  While at Lumara he supported a number of key strategic initiatives, including a new product launch, a restructuring and a sale of the company.  Prior to joining Lumara, Tom was a Managing Director and Global Controller at BearingPoint, a global consultancy. Before joining BearingPoint, he was the Chief Financial Officer at Huttig Building Products, Inc.  Tom began his career in public accounting at PricewaterhouseCoopers. Tom earned his bachelor's degree in finance from Bentley University and a master's degree in accounting from Northeastern University.

    Dr. Vaughn has held several executive and managerial roles throughout his career. Before joining Avadel, Dr. Vaughn was Principal at Wyatt Pharma Consulting, LLC where he led several development programs for client companies, including Avadel. Prior to this, he was Senior Director and Vice President, Process Technology Development for the North American region of Patheon Pharmaceuticals, a ThermoFisher Scientific company. In this role, he was responsible for assisting client companies in the development, scale-up and commercialization of their products. Additionally, Dr. Vaughn led teams to solve challenging technical problems involving formulation and manufacturing of oral pharmaceuticals and controlled release technologies. He also served as Vice President, Pharmaceutical Development for Banner Life Sciences, a specialty pharmaceutical company focused on developing products using the 505(b)2 pathway. He led technical teams developing a number of oral, modified release products for IND enabled clinical studies, registration, scale-up, NDA regulatory submission and commercialization readiness for products, including Bafiertam™, which has received tentative FDA approval. Prior to Joining Banner, Jason served as Director, Formulation Development for Patheon Pharmaceuticals in Cincinnati, OH, leading teams focused on development, scale-up, registration and commercialization of oral modified release dosage. He received a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
                     
    Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:

     

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  31. 205 patients enrolled; additional patients currently in screening will be allowed to enroll if eligible

    Topline data from the REST-ON study expected in Q2 2020

    DUBLIN, Ireland, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly sodium oxybate, FT218. Additional patients currently in the screening process will also be allowed to enroll in the study if they meet eligibility criteria. The…

    205 patients enrolled; additional patients currently in screening will be allowed to enroll if eligible

    Topline data from the REST-ON study expected in Q2 2020

    DUBLIN, Ireland, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly sodium oxybate, FT218. Additional patients currently in the screening process will also be allowed to enroll in the study if they meet eligibility criteria. The last patient's last visit is expected to occur by the end of the first quarter of 2020, with topline data expected in the second quarter of 2020.

    "Achieving the patient enrollment target in the pivotal REST-ON study marks an important milestone in our development efforts for our lead asset, FT218. We expect to announce topline data from the study in the second quarter of 2020, as we continue to advance this program towards submission for regulatory approval," stated Dr. Jordan Dubow, Chief Medical Officer. "Being able to accelerate this achievement by up to 12 months is a testament to the hard work of the study investigators, staff, and patients, as well as the Avadel team."

    Based on the Company's industry research, it believes FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market. Currently, this market is valued at an estimated annualized rate of $1.7 billion1.

    The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump™ technology for extended-release oral suspension, in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to a twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

    Footnote:
    1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q3 2019 earnings press release, November 5, 2019

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
                    Michael F. Kanan
                    Chief Financial Officer
                    Phone: (636) 449-1844
                    Email:
                     
                    Tim McCarthy
                    LifeSci Advisors, LLC
                    Phone: (212) 915.2564
                    Email:

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  32. DUBLIN, Ireland, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that its Chief Executive Officer, Greg Divis, will present at two upcoming investor conferences.

    Evercore ISI HealthCONx Conference 2019
    Date: Wednesday, December 4, 2019 
    Time:  3:30 p.m. Eastern Time
    Location: Four Seasons Hotel, Boston, Massachusetts

    A live audio webcast of the fireside chat can be accessed at the Investor section of the Company's website, www.avadel.com. A replay of the webcast will be available on the Company's website for 90 days following the event.

    Piper Jaffray 31st Annual Healthcare

    DUBLIN, Ireland, Nov. 21, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that its Chief Executive Officer, Greg Divis, will present at two upcoming investor conferences.

    Evercore ISI HealthCONx Conference 2019
    Date: Wednesday, December 4, 2019 
    Time:  3:30 p.m. Eastern Time
    Location: Four Seasons Hotel, Boston, Massachusetts

    A live audio webcast of the fireside chat can be accessed at the Investor section of the Company's website, www.avadel.com. A replay of the webcast will be available on the Company's website for 90 days following the event.

    Piper Jaffray 31st Annual Healthcare Conference
    Date: Thursday, December 5, 2019 
    Time: 10:50 a.m. Eastern Time
    Location:  Lotte New York Palace, New York

    A live audio webcast of the presentation can be accessed at the Investor section of the Company's website, www.avadel.com. A replay of the webcast will be available on the Company's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
      Michael F. Kanan
    Chief Financial Officer
    Phone: (636) 449-1844
    Email:  
       
      Tim McCarthy
    LifeSci Advisors, LLC
    Phone: (212) 915.2564
    Email:  

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    • Enrollment currently at 200 patients for the pivotal REST-ON Phase 3 study (97.5% complete); the Company currently expects to complete patient enrollment by end of 2019, with data readout expected in Q2 2020
       
    • Revenue of $48.2 million for first nine months of 2019; increasing revenue guidance to be at or above $55 million for full year 2019
       
    • Restructuring and other cost reduction actions on track to realize $80 to $90 million in annualized cost savings
       
    • Cash, cash equivalents and marketable securities as of September 30, 2019 totaled $72.5 million
       
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an…

    • Enrollment currently at 200 patients for the pivotal REST-ON Phase 3 study (97.5% complete); the Company currently expects to complete patient enrollment by end of 2019, with data readout expected in Q2 2020
       
    • Revenue of $48.2 million for first nine months of 2019; increasing revenue guidance to be at or above $55 million for full year 2019
       
    • Restructuring and other cost reduction actions on track to realize $80 to $90 million in annualized cost savings
       
    • Cash, cash equivalents and marketable securities as of September 30, 2019 totaled $72.5 million
       
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 12, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, today announced its financial results for the third quarter of 2019 and provided a company update.

    "In the third quarter of 2019, Avadel achieved several milestones that were established as part of our focused business strategy announced earlier this year," said Greg Divis, Chief Executive Officer of Avadel. "Appointments to the clinical and medical teams during the second and third quarters of 2019 strengthened our R&D focus and quickly made meaningful contributions to the clinical development of our lead asset, FT218. The team's most important recent activities include amendments to the statistical analysis plan for our pivotal Phase 3 REST-ON trial for FT218 that were accepted by the FDA in September. As a result of these amendments, the study is now targeting the enrollment of 205 patients, reducing the estimated time for completion by up to 12 months, with enrollment expected to be completed by the end of 2019 and topline data available in the second quarter of 2020."

    "Our sterile injectable hospital business has continued to outperform our expectations in the third quarter of 2019, and we have raised our annual revenue guidance for 2019 to be at or above $55 million. We look forward to the potential launch of AV001, our fourth hospital product, pending the outcome of the FDA's Prescription Drug User Fee Act (PDUFA) target action date of December 15, 2019. If approved, AV001 is expected to contribute to our 2020 revenue and support the development of FT218," stated Mr. Divis.

    "We have made significant progress over the first nine months of 2019 in strengthening the company financially, while primarily focusing on the clinical development of FT218. We believe these actions have put the company on a path toward long-term success and re-building shareholder value," concluded Mr. Divis.  

    Third quarter and recent company highlights

    • The FDA agreed to the Company's amendments to the statistical analysis plan, ultimately resulting in a reduced sample size for the ongoing pivotal Phase 3 study for once-nightly FT218 while retaining our Special Protocol Assessment (SPA) agreement; full enrollment now expected by end of 2019 and top-line data on track to be announced in the second quarter of 2020;
       
    • Announced pharmacokinetic (PK) data for once-nightly FT218 from four Phase 1 studies in an oral presentation at the World Sleep 2019 Congress;
       
    • Data presented at the World Sleep 2019 Congress from four Phase 1 studies demonstrate that FT218 exhibits a pharmacokinetic profile desirable for once-nightly dosing with equivalent exposure to twice-nightly sodium oxybate at the 4.5 g and 6 g dosing levels;
       
    • Received a new Prescription Drug User Fee Act (PDUFA) target action date of December 15, 2019 for AV001 from the U.S. Food and Drug Administration;
       
    • Cost reductions and restructuring actions have resulted in approximately $63 million of lower SG&A and R&D spending; the Company is on track to realize $80 to $90 million of cost reductions in 2019 compared to 2018, as previously announced;
       
    • Cash, cash equivalents and marketable securities as of September 30, 2019 totaled $72.5 million, compared to $79.3 million as of June 30, 2019 and $99.9 million as of December 31, 2018; and
       
    • Reported revenues of $14.2 million in the third quarter of 2019; annual revenue is now expected to be at or above $55 million for 2019.

    Overview of third quarter 2019 financial results

    Revenues for the third quarter of 2019 were $14.2 million, compared to $19.8 million in the third quarter of 2018. The decline on a year-over-year basis was primarily attributed to lower net selling prices across the Company's hospital products as a result of increased market competition.

    In thousands (Unaudited)   Three Months Ended September 30,   Nine Months Ended September 30,
    Revenues by Product:   2019   2018   2019   2018
                     
    Bloxiverz   $ 1,466     $ 3,656     $ 6,392     $ 16,691  
    Vazculep   8,786     8,759     27,669     33,097  
    Akovaz   4,208     5,991     13,946     28,083  
    Other   (231 )   1,420     213     4,232  
    Total product sales   14,229     19,826     48,220     82,103  
    License revenue               246  
    Total revenues   $ 14,229     $ 19,826     $ 48,220     $ 82,349  

    Research and development (R&D) expenses were $7.5 million in the third quarter of 2019, compared to $11.4 million in the third quarter of 2018. The Company continues to invest a substantial portion of R&D spend in its FT218 development program.

    Selling, general and administrative (SG&A) expenses were $5.3 million in the third quarter of 2019, compared to $24.8 million in the third quarter of 2018 and $6.8 million in the second quarter of 2019. The year-over-year and sequential quarterly declines are primarily the result of realized cost reductions resulting from the exit of Noctiva™ and the Company's cost reduction and restructuring actions.

    Net loss for the third quarter of 2019 was $8.9 million, or $0.24 per share, compared to a net loss of $15.8 million or $0.43 per share for the same period in 2018. 

    Cash, cash equivalents and marketable securities were $72.5 million as of September 30, 2019, compared to $79.3 million as of June 30, 2019 and $99.9 million as of December 31, 2018.  Based on Avadel's current FT218 clinical development plan, anticipated cost structure improvements and hospital products revenue projections, the Company expects its cash to be sufficient to fund operations well into 2021. The Company believes that the commercial launch of AV001, pending regulatory approval, could further fund operations and support the development of FT218. The Company has convertible debt of $144 million due in 2023.

    2019 Guidance:
    Based on recent hospital products sales performance, increased competition from additional products launched in 2019, and recent market price actions, annual revenue for 2019 is now expected to be at or above $55 million.

    The U.S. Food and Drug Administration (FDA) is reviewing an NDA for a fourth hospital product, AV001, with a PDUFA target action date of December 15, 2019. If approved, AV001 is expected to contribute to revenues in 2020 and beyond.

    Conference Call:
    A conference call to discuss these results has been scheduled for Tuesday, November 12, 2019 at 8:30 a.m. EST. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13696031. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is an emerging biopharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release includes "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. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "believe," "expect," "look forward," "on track," "could," "guidance," "anticipate," "estimate," "project" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include:

    (a) risks relating to our recent net losses and restructuring plan, including risks relating to the following:
    due to a decrease in our available liquid assets, our business strategy has been refocused and is now substantially directed to development of a single product, FT218; our recent restructuring plan may not be as effective as we anticipate and may have unintended negative impacts; further restructuring actions, if needed, may require third-party consents (including consents under the indenture governing our convertible debt), and such consents may not be granted; and the Chapter 11 bankruptcy filing by our subsidiary Avadel Specialty Pharmaceuticals, LLC may have unexpected adverse results. While our financial resources are currently anticipated to be sufficient to finance our operations well into 2021, it may be necessary for us to seek additional financial resources to continue our operations, and such financial resources may not be available to us on reasonable terms or at all.

    b) risks relating to the following: our three products Bloxiverz®, Vazculep® and Akovaz®, which are not patent protected and have a small number of customers, currently produce substantially all of our revenues and could face further competition resulting in a further loss of market share and/or forcing us to further reduce our prices for those products; our current "unapproved marketed drug" (UMD) product candidate, AV001, could fail to achieve FDA approval; we could fail to develop future potential UMD product candidates, or competitors could develop such products and market such products with FDA approval before us; we could experience failure or further delay in completing the Phase III clinical trial for FT218, and if the FDA ultimately approves such product, the approval may not include any period of market exclusivity; we may not have sufficient cash or the ability to raise sufficient cash to service our $143.75 million Exchangeable Senior Notes due 2023 ("Notes"), including cash necessary to repay such Notes at maturity, to settle exchanges of such Notes in cash, or to repurchase such Notes as required following a "fundamental change" event described in the indenture governing such Notes; we depend on a limited number of third parties to manufacture certain of our products and to provide certain raw materials used in our products; our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; we may face challenges in obtaining intellectual property protecting our products and drug delivery technologies; and we depend on key personnel to execute our business plan.

    (c) the other risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, which we filed with the Securities and Exchange Commission on March 15, 2019.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

    Contacts:
     
      Michael F. Kanan  
      Chief Financial Officer  
      Phone: (636) 449-1844  
      Email:    
         
      Tim McCarthy  
      LifeSci Advisors, LLC  
      Phone: (212) 915.2564  
      Email:  



    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (In thousands, except per share data)
    (Unaudited)

        Three Months Ended September 30,   Nine Months Ended September 30,
        2019   2018   2019   2018
                     
    Revenues:                
    Product sales   $ 14,229     $ 19,826     $ 48,220     $ 82,103  
    License revenue               246  
    Total revenues   14,229     19,826     48,220     82,349  
    Operating expenses:                
    Cost of products   2,823     3,120     9,711     13,224  
    Research and development expenses   7,539     11,402     25,160     33,243  
    Selling, general and administrative expenses   5,316     24,829     22,520     77,159  
    Intangible asset amortization   205     1,620     610     4,996  
    Changes in fair value of related party contingent consideration   627     (7,115 )   2,384     (17,036 )
    Restructuring costs   1,866     65     4,600     268  
    Total operating expenses   18,376     33,921     64,985     111,854  
    Operating loss   (4,147 )   (14,095 )   (16,765 )   (29,505 )
    Investment and other income, net   781     208     2,548     845  
    Interest expense   (3,125 )   (3,000 )   (9,293 )   (7,577 )
    Loss on deconsolidation of subsidiary           (2,840 )    
    Other (expense) income - changes in fair value of related party payable   (139 )   425     (496 )   1,432  
    Loss before income taxes   (6,630 )   (16,462 )   (26,846 )   (34,805 )
    Income tax provision (benefit)   2,234     (691 )   3,641     (3,360 )
    Net loss   $ (8,864 )   $ (15,771 )   $ (30,487 )   $ (31,445 )
                     
    Net loss per share - basic   $ (0.24 )   $ (0.43 )   $ (0.82 )   $ (0.84 )
    Net loss per share - diluted   (0.24 )   (0.43 )   (0.82 )   (0.84 )
                     
    Weighted average number of shares outstanding - basic   37,436     36,904     37,382     37,410  
    Weighted average number of shares outstanding - diluted   37,436     36,904     37,382     37,410  



    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except per share data)

        September 30, 2019   December 31, 2018
        (unaudited)    
    ASSETS        
    Current assets:        
    Cash and cash equivalents   $ 12,867     $ 9,325  
    Marketable securities   59,587     90,590  
    Accounts receivable   8,725     11,330  
    Inventories   2,260     4,770  
    Prepaid expenses and other current assets   5,163     8,836  
    Total current assets   88,602     124,851  
    Property and equipment, net   770     1,911  
    Operating lease right-of-use assets   4,385      
    Goodwill   18,491     18,491  
    Intangible assets, net   1,019     1,629  
    Research and development tax credit receivable   7,694     7,272  
    Other non-current assets   34,927     36,146  
    Total assets   $ 155,888     $ 190,300  
             
    LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY        
    Current liabilities:        
    Current portion of long-term debt   $ 35     $ 106  
    Current portion of long-term related party payable   7,588     9,439  
    Current portion of operating lease liability   1,596      
    Accounts payable   3,538     3,503  
    Accrued expenses   17,017     21,695  
    Other current liabilities   1,989     3,640  
    Total current liabilities   31,763     38,383  
    Long-term debt, less current portion   120,132     115,734  
    Long-term related party payable, less current portion   14,118     19,401  
    Long-term operating lease liability   2,866      
    Other non-current liabilities   13,972     14,002  
    Total liabilities   182,851     187,520  
             
    Shareholders' (deficit) equity:        
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; none issued or outstanding at September 30, 2019 and December 31, 2018, respectively        
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 42,857 issued and 37,450 outstanding at September 30, 2019 and 42,720 issued and 37,313 outstanding at December 31, 2018   428     427  
    Treasury shares, at cost, 5,407 shares held at September 30, 2019 and December 31, 2018, respectively   (49,998 )   (49,998 )
    Additional paid-in capital   434,055     433,756  
    Accumulated deficit   (388,476 )   (357,989 )
    Accumulated other comprehensive loss   (22,972 )   (23,416 )
    Total shareholders' (deficit) equity   (26,963 )   2,780  
    Total liabilities and shareholders' (deficit) equity   $ 155,888     $ 190,300  


    AVADEL PHARMACEUTICALS PLC
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (In thousands)
    (Unaudited)

        Nine Months Ended September 30,
        2019   2018
             
    Cash flows from operating activities:        
    Net loss   $ (30,487 )   $ (31,445 )
    Adjustments to reconcile net loss to net cash provided by operating activities:        
    Depreciation and amortization   1,690     5,625  
    Loss on disposal of property and equipment   478      
    Amortization of premiums on marketable securities   (275 )   2,889  
    Remeasurement of related party acquisition-related contingent consideration   2,384     (17,036 )
    Remeasurement of related party financing-related contingent consideration   496     (1,432 )
    Amortization of debt discount and debt issuance costs   4,424     3,402  
    Change in deferred tax and income tax deferred charge   1,333     (4,675 )
    Stock-based compensation expense   177     7,190  
    Loss on deconsolidation of subsidiary   1,750      
    Other adjustments   (392 )   117  
    Net changes in assets and liabilities        
    Accounts receivable   2,026     5,059  
    Inventories   2,465     (548 )
    Prepaid expenses and other current assets   (1,859 )   2,194  
    Research and development tax credit receivable   (749 )   (1,350 )
    Accounts payable & other current liabilities   259     4,312  
    Accrued expenses   (2,379 )   (11,660 )
    Earn-out payments for related party contingent consideration in excess of acquisition-date fair value   (8,640 )   (16,254 )
    Royalty payments for related party payable in excess of original fair value   (1,374 )   (2,362 )
    Other assets and liabilities   (1,399 )   (2,216 )
    Net cash used in operating activities   (30,072 )   (58,190 )
             
    Cash flows from investing activities:        
    Purchases of property and equipment   (29 )   (167 )
    Proceeds from the disposal of property and equipment   154      
    Purchase of intangible asset       (20,000 )
    Proceeds from sales of marketable securities   57,242     308,015  
    Purchases of marketable securities   (23,814 )   (341,036 )
    Net cash provided by (used in) investing activities   33,553     (53,188 )
             
    Cash flows from financing activities:        
    Earn-out payments for related party contingent consideration       (645 )
    Proceeds from debt issuance       143,750  
    Payments for debt issuance costs       (6,190 )
    Share repurchases       (27,637 )
    Proceeds from issuance of ordinary shares and warrants   123     3,488  
    Other financing activities, net   (109 )   (31 )
    Net cash provided by financing activities   14     112,735  
             
    Effect of foreign currency exchange rate changes on cash and cash equivalents   47     (84 )
             
    Net change in cash and cash equivalents   3,542     1,273  
    Cash and cash equivalents at January 1,   9,325     16,564  
    Cash and cash equivalents at September 30,   $ 12,867     $ 17,837  

     

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  33. DUBLIN, Ireland, Oct. 04, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, a once-nightly formulation of sodium oxybate, for narcolepsy, today announced that Kevin Kotler, the Managing Member of Broadfin Capital, LLC, has resigned from the Board of Directors.

    "On behalf of the Avadel Board of Directors I would like to thank Kevin for his service. He joined our board at an important time in the company's history and catalyzed actions that have helped put the company in the best possible position to capitalize on the value of FT218," said Geoffrey Glass, Chairman of Avadel's Board of Directors.

    "After many months of working closely with my fellow directors and the new management team to…

    DUBLIN, Ireland, Oct. 04, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, a once-nightly formulation of sodium oxybate, for narcolepsy, today announced that Kevin Kotler, the Managing Member of Broadfin Capital, LLC, has resigned from the Board of Directors.

    "On behalf of the Avadel Board of Directors I would like to thank Kevin for his service. He joined our board at an important time in the company's history and catalyzed actions that have helped put the company in the best possible position to capitalize on the value of FT218," said Geoffrey Glass, Chairman of Avadel's Board of Directors.

    "After many months of working closely with my fellow directors and the new management team to put Avadel on the path towards value creation, I am pleased to have helped bring meaningful change to Avadel for the benefit of the company and its shareholders. The company has made significant progress with a focus on building long term shareholder value. I believe strongly in the future of Avadel and am proud of the progress that's been made in such a short period of time, and now is the right time for me to leave the Board to increase my focus on other investment opportunities," said Kevin Kotler, the Managing Member of Broadfin Capital, LLC.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a branded specialty pharmaceutical company. The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release contains "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements (which may be identified by words and phrases such as "to capitalize," "on the path towards" and "focus on building") are not statements of historical facts regarding Avadel, FT218, the FDA review process relating to FT218 including the expected timing of that process, and the possible commercial launch of FT218. All forward-looking statements involve risks and uncertainties, including, without limitation, the risks that i) the Company may encounter challenges in the remaining development efforts for FT218, ii) the FDA may determine there are deficiencies in the new drug application (NDA) for FT218 or may never approve the NDA for FT218, iii) FT218 may not have the therapeutic benefits the Company anticipates, iv) the commercial launch of FT218 could be delayed, v) FT218 may not achieve commercial acceptance, vi) other companies may develop competing products that may receive FDA approval before FT218, and vii) the other risks detailed in Avadel's filings with the SEC, including, without limitation, its Form 10-K, Forms 10-Q and other reports on Forms 8-K, all of which can be obtained on the SEC website at www.sec.gov. Avadel assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

    Contacts: Michael F. Kanan
      Chief Financial Officer
      Phone: (636) 449-1844
      Email:
       
      Tim McCarthy
      LifeSci Advisors, LLC
      Phone: (212) 915.2564
      Email:

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  34. DUBLIN, Ireland, Sept. 24, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, for narcolepsy, today announced pharmacokinetic (PK) data for FT218 from four Phase 1 studies comparing 4.5g and 6g of once-nightly FT218 to 4.5g and 6g of twice-nightly sodium oxybate, evaluating the food effect of FT218, as well as determining the dose proportionality of FT218. The data will be included in an oral presentation by leading sleep expert, Dr. Michael Thorpy, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, which is titled, "The Pharmacokinetics of once-nightly controlled-release sodium oxybate (FT218…

    DUBLIN, Ireland, Sept. 24, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate, for narcolepsy, today announced pharmacokinetic (PK) data for FT218 from four Phase 1 studies comparing 4.5g and 6g of once-nightly FT218 to 4.5g and 6g of twice-nightly sodium oxybate, evaluating the food effect of FT218, as well as determining the dose proportionality of FT218. The data will be included in an oral presentation by leading sleep expert, Dr. Michael Thorpy, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, which is titled, "The Pharmacokinetics of once-nightly controlled-release sodium oxybate (FT218): Overview of results from four Phase 1 Studies," at the World Sleep 2019 Congress on Thursday, September 25th, in Vancouver, Canada.

    The key PK data points from these four studies demonstrated:

    • Once-nightly FT218 at 4.5g and 6g demonstrated lower overall maximum plasma concentrations (Cmax) and equivalent exposure (AUC) to twice-nightly sodium oxybate, as well as similar morning plasma levels (C8h) and variability to twice-nightly sodium oxybate.
    • The Cmax of FT218 was dose proportional and AUC was slightly higher than dose proportional, which demonstrates the predictability of FT218 as dosing increases.
    • Consistent with the expectations of a sodium oxybate product, FT218 has lower exposure and lower maximum plasma concentration in the Fed versus the Fasted State.
    • FT218 up to the 9g dose level was generally well-tolerated.  Further, observed Adverse Events for the 4.5 and 6g doses of FT218 were consistent with those known for sodium oxybate and appeared comparable to the Adverse Effects for corresponding strengths of twice-nightly sodium oxybate in the study.

    According to Dr. Thorpy, "The totality of the pharmacokinetic data from these four Phase 1 studies demonstrates that Avadel has developed a formulation of sodium oxybate that exhibits a pharmacokinetic profile desirable for once-nightly dosing."  

    "Based on the results of these four studies, we are confident that the ongoing Phase 3 REST-ON study of FT218 will demonstrate efficacy in the treatment of both excessive daytime sleepiness and cataplexy in patients with narcolepsy.  We currently expect to complete enrollment of the Phase 3 trial by the end of this year, with top line data estimated to be available in the second quarter of 2020," said Jordan Dubow, MD, Chief Medical Officer of Avadel.

    In addition to previously published pharmacokinetic data, information on the ongoing Phase 3 REST-ON study of FT218 will be available at Avadel's Booth #113 in the Exhibit Hall during the World SLEEP 2019 Congress.

    The four Phase 1 studies include:
    A comparative, open-label, randomized, 2-period, 2-sequence, crossover study to assess the bioavailability of FT218 6g compared to twice-nightly sodium oxybate 6g (2 divided doses of 3g) in 28 healthy volunteers. Subjects were randomized to receive either FT218 6g followed by twice-nightly sodium oxybate 6g or twice-nightly sodium oxybate followed by FT218 6g with a minimum of a 3-day washout between doses.

    An open-label, randomized, single-dose, two treatment (Fed vs. Fasted), two-period, two-sequence crossover study to assess the effect of food on the pharmacokinetics of FT218 in 16 healthy volunteers. Subjects were randomized to receive either FT218 6g in the Fed (30-minutes after a standardized high-fat breakfast) followed by FT218 in the Fasted (10-hours after an overnight fast) or FT218 6g in the Fasted state followed by FT218 6g in the Fed state with a minimum of a 3-day washout between doses.

    A pharmacokinetics and formulation selection pilot study that was designed as a four-way crossover study in 16 healthy volunteers, evaluating three proprietary once-nightly formulations of Micropump™ controlled-release (CR) sodium oxybate (FT218) versus twice-nightly immediate-release (IR) sodium oxybate at a nightly dose of 4.5g (two doses of 2.25g for IR sodium oxybate). Each subject consumed a standard meal two hours prior to dosing. Subjects receiving the twice-nightly sodium oxybate were administered the second dose 4 hours after the first dose.

    A dose proportionality study that was an open-label, single ascending dose, three-sequential-period study in 20 healthy volunteers. Subjects received three separate single-dose administrations of FT218 at bedtime, two hours post-evening meal, in a sequential order of 4.5g, 7.5g and 9g with a minimum 7-day washout between doses.

    About FT218
    FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to a twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

    About Avadel Pharmaceuticals plc
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a branded specialty pharmaceutical company.  The Company's primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy.  In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release contains "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements (which may be identified by words such as "will," "look forward," "should," "planned" and "anticipate") are not statements of historical facts regarding FT218, the FDA review process relating thereto including the expected timing of that process, and the possible commercial launch of FT218. All forward-looking statements involve risks and uncertainties, including, without limitation, the risks that i) the Company may encounter challenges in the remaining development efforts for FT218, ii) the FDA may determine there are deficiencies in the NDA for FT218 or may never approve the NDA for FT218, iii) FT218 may not have the therapeutic benefits the Company anticipates, iv) the commercial launch of FT218 could be delayed, v) FT218 may not achieve commercial acceptance, vi) other companies may develop competing products that may receive FDA approval before FT218, and vii) the other risks detailed in Avadel's filings with the SEC, including, without limitation, its Form 10-K, Forms 10-Q and other reports on Forms 8-K, all of which can be obtained on the SEC website at www.sec.gov. Avadel assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

    Contacts: Michael F. Kanan
      Chief Financial Officer
      Phone: (636) 449-1844
      Email:
       
      Tim McCarthy
      LifeSci Advisors, LLC
      Phone: (212) 915.2564
      Email:

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    • FDA agrees with Company's proposed changes to the statistical analysis plan for the REST-ON Phase 3 study for once-nightly sodium oxybate, FT218
    • Reduces estimated time to completion by up to 12 months; now expected to complete patient enrollment by end of 2019, with pivotal data readout now expected in 2Q 2020
    • Enrollment currently at 193 patients for the REST-ON Phase 3 study (94% complete)
    • Management to hold conference call today at 9:00 a.m. ET

    DUBLIN, Ireland, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, today announced that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendments to the…

    • FDA agrees with Company's proposed changes to the statistical analysis plan for the REST-ON Phase 3 study for once-nightly sodium oxybate, FT218
    • Reduces estimated time to completion by up to 12 months; now expected to complete patient enrollment by end of 2019, with pivotal data readout now expected in 2Q 2020
    • Enrollment currently at 193 patients for the REST-ON Phase 3 study (94% complete)
    • Management to hold conference call today at 9:00 a.m. ET

    DUBLIN, Ireland, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing once-nightly sodium oxybate, FT218, for narcolepsy, today announced that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendments to the statistical analysis plan and protocol under its special protocol assessment agreement (SPA), resulting in a lower sample size needed to demonstrate significance for both excessive daytime sleepiness and cataplexy in narcolepsy patients.  No modifications were made to the fundamental design of the study, including the primary or secondary endpoints, dosing scheme or duration of the study, and the SPA remains intact.

    The REST-ON study will now target enrolling 205 patients.  Based on this updated target sample size and enrollment currently at 193 patients, the company now expects to complete enrollment by the end of 2019 and have topline data in the second quarter of 2020. This is up to a year ahead of expectations to complete enrollment for the previous target of 264 patients for the study.  Even with this change, the REST-ON clinical trial remains one of the largest studies conducted, to date, for this indication.

    "This REST-ON clinical trial update is a direct result of an overall strategic review of the entire FT218 program.  The addition of our recently appointed medical and clinical team members was instrumental in this important development and their contributions have put us on track to save significant time, resources and capital in the completion of the REST-ON clinical trial," said Greg Divis, Chief Executive Officer of Avadel.

    The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump™ technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.

    Once-nightly FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that once-nightly FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication. In particular, once-nightly FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product. The twice-nightly sodium oxybate market is currently valued at an estimated annualized rate of $1.6 billion1. Avadel's market research leads it to believe that FT218, if approved by the FDA, has the potential to take a significant share of this market. 

    Conference Call:
    A conference call to discuss these results has been scheduled for Monday, September 23, 2019 at 9:00 a.m. EDT. To access the conference call, investors are invited to dial 877-407-9716 (U.S. and Canada) or 201-493-6779 (International). The conference ID number is 13694841. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com, or clicking http://public.viavid.com/index.php?id=136221.  A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About Avadel Pharmaceuticals plc:
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a branded specialty pharmaceutical company.  The Company's primary focus is on the development and potential FDA approval for FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy.  In addition, Avadel develops and markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

    Footnote:
    1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q2 2019 earnings press release, August 6, 2019

    Cautionary Disclosure Regarding Forward-Looking Statements
    This press release contains "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements (which may be iden