 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 extensionswitch study of investigational once-nightly FT218 Strengthened balance sheet through completion of 125 million public equity offering to support the companys 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. ETDUBLIN, 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 Avadels 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 p0.001 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 Companys 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 OLEswitch 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 p0.001 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 p0.001, 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 OLEswitch 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 Companys 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 Companys hospital products as a result of increased market competition.RD 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. SGA 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 Companys website, A replay of the webcast will be archived on Avadels website for 90 days following the event.About FT218 FT218 is an investigational, once-nightly formulation of MicropumpTM 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 Companys 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 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. 