AVDL Avadel Pharmaceuticals plc

5.04
-0.1  -2%
Previous Close 5.14
Open 5.14
52 Week Low 3.25
52 Week High 13.49
Market Cap $293,431,995
Shares 58,220,634
Float 56,798,806
Enterprise Value $195,220,534
Volume 648,317
Av. Daily Volume 945,586
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Drug Pipeline

Drug Stage Notes
FT 218
Excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy
Phase 3
Phase 3
Phase 3 trial met co-primary endpoints - April 27, 2020.
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.
Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved Jun 3 2013
Akovaz
Hypotension
Approved
Approved
Announced approval May 2 2016
Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved June 3, 2013.

Latest News

  1. 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:

     

    Primary Logo

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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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  2. 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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  3. 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:

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