AVDL Avadel Pharmaceuticals plc

7.97
0  0%
Previous Close 7.97
Open 8.04
52 Week Low 1.82
52 Week High 13.49
Market Cap $463,288,425
Shares 58,129,037
Float 56,778,009
Enterprise Value $475,877,424
Volume 711,196
Av. Daily Volume 996,810
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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, 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:  

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  2. 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

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  3. 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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  4. 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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