Avadel On A High - Eventful Days Ahead

(RTTNews) - Shares of Avadel Pharmaceuticals plc (AVDL) are up an impressive 129 percent year-to-date.

Dublin, Ireland-based Avadel is a branded specialty pharmaceutical company, generating revenue primarily from the sale of pharmaceutical products, previously sold in the U.S. without FDA approval ("Unapproved Marketed Products" or "UMDs"). Three sterile injectable drugs used in the hospital setting, which were developed under the "unapproved marketed drug" (UMD) program, are currently marketed by the Company.

The Company's fourth UMD product AV001, a sterile injectable product intended for the hospital market, is under FDA review, with a decision expected on December 15, 2019.

Avadel is also developing FT218, an investigational once-nightly formulation of sodium oxybate, for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. FT218 is currently being evaluated in a phase III clinical trial called REST-ON. Patient enrollment in this trial is expected to be completed by the end of 2019, with data readout expected in Q2, 2020.

If approved, FT218 will compete with Jazz Pharma's (JAZZ) Xyrem (sodium oxybate), which has a twice nightly dosing. Xyrem had sales of $1.4 billion in 2018.

In order to restore its financial health to maximize the value of FT218 and create a pathway to enhance shareholder value, the Company implemented restructuring and other cost-saving actions in February of this year. Once fully implemented, these actions are expected to lower the Company's cost structure by $80 to $90 million in 2020 and beyond when compared to 2018.

Avadel ended September 30, 2019, with cash, cash equivalents and marketable securities of $72.5 million.

Looking ahead, Avadel expects annual revenue for 2019 to be at or above $55 million compared to its prior forecast of less than $30 million. The annual revenue in 2018 was $103.3 million.

AVDL has traded in a range of $1.03 to $6.20 in the last 1 year. The stock closed Friday's trading at $5.92, up 2.25%.

Can the upcoming events push the stock further high? Stay tuned...