AVDL Avadel Pharmaceuticals plc

9.61
-0.33  -3%
Previous Close 9.94
Open 9.66
52 Week Low 6.03
52 Week High 11.5899
Market Cap $563,339,046
Shares 58,620,088
Float 57,195,860
Enterprise Value $545,645,674
Volume 129,973
Av. Daily Volume 835,548
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Upcoming Catalysts

Drug Stage Catalyst Date
FT 218
Excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
BLOXIVERZ (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved Jun 3 2013
BLOXIVERZ (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved June 3, 2013.
NOURESS (AV001)
Neonate Patients Requiring Total Parental Nutrition (TPN)
Approved
Approved
FDA Approval announced December 16, 2019.
VAZCULEP (phenylephrine hydrochloride)
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
Approved
Approved
Approved June 30 2014.
Akovaz
Hypotension
Approved
Approved
Announced approval May 2 2016

Latest News

  1. DUBLIN, Ireland, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences:

    • Piper Sandler 33rd Annual Virtual Healthcare Conference: Participation starting on Monday, November 29 with a Fireside chat available for on-demand viewing starting today, Monday, November 22 at 10:00 a.m. ET.
    • Evercore ISI 4th Annual HealthCONx Conference: Fireside chat on Wednesday, December 1 at 2:00 p.m. E.T.

    A webcast of these events, as well as archived recordings, will be available on Avadel's Investor Relations website, investors.avadel.com, for…

    DUBLIN, Ireland, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences:

    • Piper Sandler 33rd Annual Virtual Healthcare Conference: Participation starting on Monday, November 29 with a Fireside chat available for on-demand viewing starting today, Monday, November 22 at 10:00 a.m. ET.
    • Evercore ISI 4th Annual HealthCONx Conference: Fireside chat on Wednesday, December 1 at 2:00 p.m. E.T.

    A webcast of these events, as well as archived recordings, will be available on Avadel's Investor Relations website, investors.avadel.com, for 90 days following each conference.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.

     

    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry

     

    (408) 568-4292



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  2. DUBLIN, Ireland, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences in November:

    • Stifel's 2021 Virtual Healthcare Conference: Fireside chat on Tuesday, November 16 at 8:00 a.m. E.T.
    • Jefferies London Healthcare Conference: Fireside chat available for on demand viewing starting on Thursday, November 18 at 3:00 a.m. E.T.

    A webcast of these events, as well as archived recordings, will be available on Avadel's Investor Relations website, investors.avadel.com, for 90 days following each conference.

    About Avadel Pharmaceuticals

    DUBLIN, Ireland, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that Greg Divis, Chief Executive Officer of Avadel, will participate in the following upcoming investor conferences in November:

    • Stifel's 2021 Virtual Healthcare Conference: Fireside chat on Tuesday, November 16 at 8:00 a.m. E.T.
    • Jefferies London Healthcare Conference: Fireside chat available for on demand viewing starting on Thursday, November 18 at 3:00 a.m. E.T.

    A webcast of these events, as well as archived recordings, will be available on Avadel's Investor Relations website, investors.avadel.com, for 90 days following each conference.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



    Primary Logo

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    • FDA review of NDA for FT218 ongoing; commercial and launch preparations progressing
    • Presentation of new data from pivotal REST-ON clinical trial at CHEST 2021 demonstrating that treatment with FT218 causes meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.

    "The need for patients living with the chronic, debilitating…

    • FDA review of NDA for FT218 ongoing; commercial and launch preparations progressing
    • Presentation of new data from pivotal REST-ON clinical trial at CHEST 2021 demonstrating that treatment with FT218 causes meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.

    "The need for patients living with the chronic, debilitating condition of narcolepsy to have a single bedtime dose of sodium oxybate is clear. We are confident in the strength of our data and our regulatory filing strategy for FT218, as the FDA continues their review of our NDA. Importantly, there are no outstanding requests from the FDA at this time, and questions previously received have been addressed. We remain committed to patients and sleep specialists, demonstrated by the significant advances we made during 2021 to support a successful launch of FT218, if approved," said Greg Divis, Chief Executive Officer of Avadel. "This quarter, we published the primary REST-ON results in the SLEEP journal and continued to externalize the robust dataset supporting the potential of FT218 in various scientific congresses. Additionally, payor discussions continue to advance, and we are growing our commercial team, all with the vision of disrupting the narcolepsy market and fulfilling our promise to the narcolepsy community by bring FT218 to patients."

    Third Quarter and Recent Company Highlights

    • In October 2021, the U.S. Food and Drug Administration (FDA) informed the company that the review of its New Drug Application (NDA) for FT218 was ongoing beyond its previously assigned target action date.
    • Continued preparations and launch readiness activities for the potential commercialization of FT218 as the first and only once-at-bedtime option for managing excessive daytime sleepiness (EDS) and cataplexy in narcolepsy
    • Multiple presentations and publications in peer-reviewed forums of data from the pivotal Phase 3 REST-ON study of FT218 throughout the quarter, including:
      • Published the previously announced primary results in SLEEP, the journal of the Sleep Research Society
      • Presented new data at the American College of Chest Physicians (CHEST) annual meeting supporting the clinical benefit of once-at-bedtime FT218 and patient preference for once-nightly dosing:
        • New post-hoc responder analyses demonstrated FT218 treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes and statistically significant improvements compared to placebo on mean sleep latency
        • Discrete choice experiment demonstrated that the strongest driver of patient preference for sodium oxybate was dosing frequency with once-nightly dosing preferred
      • Presented encore posters featuring post hoc analyses from the REST-ON study at the meeting of the American Neurological Association
    • Progressed the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly oxybates and patient preference
      • Avadel plans to present data from RESTORE study on patient preference to once-nightly or twice-nightly dosing regimens, as well as nocturnal experiences when using twice-nightly sodium, at future medical congresses

    Overview of Third Quarter Results

    R&D expenses were $4.4 million in the quarter ended September 30, 2021, compared to $5.6 million for the same period in 2020. The decrease on a period-over-period basis was primarily attributed to lower clinical studies expenses and purchases of active pharmaceutical ingredients used in the research and development of FT218 during the current period.

    SG&A expenses were $21.3 million in the quarter ended September 30, 2021, compared to $8.4 million for the same period in 2020. The period-over-period increase is the result of a number of factors including commercial launch planning costs related to FT218, higher legal and professional fees, and higher compensation costs associated with higher headcount, primarily in the areas of commercial and medical affairs.

    Income tax benefit was $5.1 million in the quarter ended September 30, 2021, compared to income tax benefit of $5.0 million for the same period in 2020.

    Net loss for the quarter ended September 30, 2021 was $22.0 million, or ($0.38) per diluted share, compared to net loss of $11.7 million, or ($0.20) per diluted share, for the same period in 2020.

    Cash, cash equivalents and marketable securities were $181.1 million as September 30, 2021. The Company has convertible debt of $143.8 million due in February 2023.

    Conference Call

    To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 6187211. 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 formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

    In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in patients with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinician's overall assessment of the patient's functioning, and reduction in cataplexy attacks, for all three evaluated does when compared to placebo.

    In January 2018, the U.S. Food and Drug Administration (FDA) granted FT218 Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that FT218 may be safer than the twice-nightly formulation of sodium oxybate already approved by the FDA due to the ramifications associated with dosing regimen of that product. FT218 is currently under review by the FDA.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or 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, expectations regarding the FDA's review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the commercial launch of FT218 (if approved), the market acceptance of FT218 (if approved), and the advancement and expected timing of the RESTORE study to generate long-term safety, tolerability, and efficacy data for FT218, and the publication of data from the RESTORE 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).

    The Company's 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, the Company's business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company's 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 the Company's forward-looking statements include the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on March 9, 2021 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. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292

    AVADEL PHARMACEUTICALS PLC

    CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME

    (In thousands, except per share data)

    (Unaudited)

      Three Months Ended September 30, Nine Months Ended September 30,
      2021 2020 2021 2020
             
    Product sales $   $   $   $22,334  
    Operating expenses:        
    Cost of products          5,742  
    Research and development expenses 4,380   5,569   14,994   15,156  
    Selling, general and administrative expenses 21,283   8,423   47,469   23,431  
    Intangible asset amortization          406  
    Changes in fair value of contingent consideration    (69)     3,327  
    Gain on sale of Hospital Products          (45,760) 
    Restructuring income    (226)  (53)  (43) 
    Total operating expense 25,663   13,697   62,410   2,259  
    Operating (loss) income (25,663)  (13,697)  (62,410)  20,075  
    Investment and other income (expense), net 489   213   1,531   (906) 
    Interest expense (1,929)  (3,259)  (5,788)  (9,686) 
    Gain from release of certain liabilities       166     
    Other expense - changes in fair value of contingent consideration payable          (435) 
    (Loss) income before income taxes (27,103)  (16,743)  (66,501)  9,048  
    Income tax benefit (5,101)  (5,040)  (11,473)  (9,258) 
    Net (loss) income $(22,002)  $(11,703)  $(55,028)  $18,306  
             
    Net (loss) income per share - basic $(0.38)  $(0.20)  $(0.94)  $0.36  
    Net (loss) income per share - diluted (0.38)  (0.20)  (0.94)  0.35  
             
    Weighted average number of shares outstanding - basic 58,585   58,213   58,506   51,206  
    Weighted average number of shares outstanding - diluted 58,585   58,213   58,506   52,849  

    AVADEL PHARMACEUTICALS PLC

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

      September 30, 2021 December 31, 2020
      (unaudited)  
    ASSETS    
    Current assets:    
    Cash and cash equivalents $58,169   $71,722  
    Marketable securities 122,924   149,680  
    Research and development tax credit receivable 2,493   3,326  
    Prepaid expenses and other current assets 22,234   38,726  
    Total current assets 205,820   263,454  
    Property and equipment, net 304   359  
    Operating lease right-of-use assets 2,070   2,604  
    Goodwill 16,836   16,836  
    Research and development tax credit receivable 961   3,445  
    Other non-current assets 38,098   24,939  
    Total assets $264,089   $311,637  
         
    LIABILITIES AND SHAREHOLDERS' EQUITY     
    Current liabilities:    
    Current portion of operating lease liability $504   $474  
    Accounts payable 6,874   2,934  
    Accrued expenses 8,738   6,501  
    Other current liabilities 1,471   5,200  
    Total current liabilities 17,587   15,109  
    Long-term debt 142,086   128,210  
    Long-term operating lease liability 1,460   1,840  
    Other non-current liabilities 3,999   4,212  
    Total liabilities 165,132   149,371  
         
    Shareholders' equity:    
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at September 30, 2021 and 488 issued and outstanding at December 31, 2020, respectively 5   5  
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 58,616 issued and outstanding at September 30, 2021 and 58,396 issued and outstanding at December 31, 2020 586   583  
    Additional paid-in capital 546,565   566,916  
    Accumulated deficit (425,455)  (384,187) 
    Accumulated other comprehensive loss (22,744)  (21,051) 
    Total shareholders' equity 98,957   162,266  
    Total liabilities and shareholders' equity $264,089   $311,637  
         

    AVADEL PHARMACEUTICALS PLC

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

    (Unaudited)

      Nine Months Ended September 30,
      2021 2020
         
    Cash flows from operating activities:    
    Net (loss) income $(55,028)  $18,306  
    Adjustments to reconcile net (loss) income to net cash used in operating activities:    
    Depreciation and amortization 614   1,297  
    Remeasurement of acquisition-related contingent consideration    3,327  
    Remeasurement of financing-related contingent consideration    435  
    Amortization of debt discount and debt issuance costs 937   4,835  
    Change in deferred taxes (11,322)  (4,582) 
    Stock-based compensation expense 6,088   1,705  
    Gain on the disposition of the hospital products    (45,760) 
    Gain from the release of certain liabilities (166)    
    Other adjustments 1,056   306  
    Net changes in assets and liabilities    
    Accounts receivable    8,281  
    Inventories    (1,352) 
    Prepaid expenses and other current assets (54)  1,759  
    Research and development tax credit receivable 3,079   2,036  
    Accounts payable & other current liabilities (201)  (4,051) 
    Accrued expenses 2,421   (6,625) 
    Earn-out payments for contingent consideration in excess of acquisition-date fair value    (5,323) 
    Royalty payments for contingent consideration payable in excess of original fair value    (866) 
    Other assets and liabilities (2,228)  (3,337) 
    Net cash used in operating activities (54,804)  (29,609) 
         
    Cash flows from investing activities:    
    Purchases of property and equipment (26)  (33) 
    Proceeds from the disposition of the hospital products 16,500   17,250  
    Proceeds from sales of marketable securities 83,726   30,075  
    Purchases of marketable securities (58,591)  (124,254) 
    Net cash provided by (used in) investing activities 41,609   (76,962) 
         
    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 employee stock purchase plan 263   2,006  
    Net cash provided by financing activities 263   179,500  
         
    Effect of foreign currency exchange rate changes on cash and cash equivalents (621)  406  
         
    Net change in cash and cash equivalents (13,553)  73,335  
    Cash and cash equivalents at January 1, 71,722   9,774  
    Cash and cash equivalents at September 30, $58,169   $83,109  
               



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  3. DUBLIN, Ireland, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, November 8, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.

    To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 6187211. 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…

    DUBLIN, Ireland, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, November 8, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021.

    To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 6187211. 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 a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



    Primary Logo

    View Full Article Hide Full Article
  4. - Post-hoc responder analyses demonstrated a significantly greater proportion of patients receiving FT218 experienced reductions in weekly cataplexy attacks and improvement in mean sleep latency compared to placebo -

    - Discrete choice experiment demonstrated that the strongest relative driver of overall product choice was number of doses with once-nightly preferred versus twice-nightly dosing regimen between sodium oxybate -

    DUBLIN, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, today announced new data from the completed pivotal Phase 3 REST-ON clinical trial of FT218, also known as ON-SXB. The post-hoc data are being presented in as two separate…

    - Post-hoc responder analyses demonstrated a significantly greater proportion of patients receiving FT218 experienced reductions in weekly cataplexy attacks and improvement in mean sleep latency compared to placebo -

    - Discrete choice experiment demonstrated that the strongest relative driver of overall product choice was number of doses with once-nightly preferred versus twice-nightly dosing regimen between sodium oxybate -

    DUBLIN, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, today announced new data from the completed pivotal Phase 3 REST-ON clinical trial of FT218, also known as ON-SXB. The post-hoc data are being presented in as two separate posters at the American College of Chest Physicians (CHEST) annual meeting, taking place virtually October 17 – 20, 2021, along with the results of a discrete choice experiment (DCE) to understand patient preference. FT218 is the Company's lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration.

    "The new post-hoc responder analyses demonstrating that ON-SXB improved EDS provide further confidence in ON-SXB for people with narcolepsy. We believe this is critical for a patient population whose quality of life is severely impacted by EDS," said John Winkelman, M.D., Ph.D., presenting author, professor of Psychiatry at Harvard Medical School and chief of the Sleep Disorders Clinical Research Program in the Department of Psychiatry at Massachusetts General Hospital. "These ON-SXB data represent a compelling way to set expectations for patients receiving therapy. I believe that ON-SXB, a once-nightly treatment option that has demonstrated clinical benefit in a randomized controlled trial, is a meaningful advance in treatment and, if approved, will be a welcome option for patients and physicians alike."

    Highlights from the poster presentations are outlined below.

    Sleep Latency Response with FT218, a Once-Nightly Sodium Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial

    • ON-SXB (FT218) treatment was associated with statistically significant improvements compared to placebo on mean sleep latency, as shown by the results of the Maintenance of Wakefulness Test, a measure of EDS, in the pivotal Phase 3 REST-ON clinical trial:
      • A significantly greater proportion of participants who received ON-SXB compared to placebo experienced increased mean sleep latency change from baseline ranging from ≥5 minutes to 30 minutes
      • Improvement was evident as early as week 3 at the 6-g dose and increased with the 7.5-g dose at week 8 and the 9-g dose at week 13
      • The most common adverse drug reactions (≥5%) with ON-SXB 9 g were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)

    Cataplexy Response with FT218, a Once-Nightly Sodium Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial

    • ON-SXB (FT218) treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes, as shown by the results of the pivotal Phase 3 REST-ON clinical trial:
      • A significantly greater proportion of participants treated with ON-SXB compared to placebo experienced 25%, 50% and 75% reductions in the number of weekly cataplexy episodes with once-at-bedtime doses of 6, 7.5, and 9 g
      • Of participants taking the two highest doses (7.5 and 9 g) of ON-SXB, approximately 10% had complete elimination of their cataplexy, while approximately half had a 50% reduction and one-third had a 75% reduction in their weekly cataplexy episodes
      • The most common adverse drug reactions (≥5%) with ON-SXB 9 g were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)

    The Utility of Discrete Choice Experiment in Evaluating Treatment Preferences Among Patients with Narcolepsy

    • A discrete choice experiment evaluated drivers of patient preference for sodium oxybate and demonstrated that dosing frequency was the single most important attribute of a narcolepsy treatment, with once-nightly dosing significantly more preferred than twice-nightly dosing (P<0.001).
    • The number of nightly doses was also the most important driver observed of "taking the medication exactly as directed" and "reduced anxiety/stress", with once-nightly dosing preferred over twice-nightly dosing.

    "Avadel is focused on transforming medicines to transform lives, and FT218, if approved, has the potential to be an innovative solution for patients living with the chronic condition of narcolepsy," said Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel. "FT218 has demonstrated meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients. We believe in listening to patients to deliver solutions that improve their symptoms and look forward to our ongoing partnership with the narcolepsy community as we strive to make FT218 available to patients and prescribers."

    Avadel also presented encore posters featuring post hoc analyses from the REST-ON trial at the annual meeting of the American Neurological Association, taking place virtually October 17 – 19, 2021, which affirmed the clinical benefit of FT218 on EDS, regardless of narcolepsy subtype (NT1, with cataplexy and NT2, without cataplexy) and with or without concomitant stimulant use, while also demonstrating a modest reduction in weight and body mass index over the 13-week trial.

    About FT218

    FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

    In March 2020, Avadel completed the REST-ON study, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of FT218 in adults with narcolepsy. Among the three co-primary endpoints, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinician's overall assessment of the patient's functioning, and reduction in cataplexy attacks, for all three evaluated does when compared to placebo.

    In January 2018, the U.S. Food and Drug Administration (FDA) granted FT218 Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for those with narcolepsy due to the consequences of middle-of-the-night dosing of the approved product. FT218 is currently under review by the FDA.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of 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, our expectations of the therapeutic benefits of FT218, the timing of the FDA's review of our NDA for FT218, the sufficiency of data supporting our NDA for FT218, the commercial launch of FT218 (if approved), and the 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 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, 2020, which we filed with the Securities and Exchange Commission on March 9, 2021 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 Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292 



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