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Co. Awaits FDA Approval of Drug, Prepares for Launch

March 22, 2022 ( Newswire) The biopharma’s executive team is managing both time and opex spending well, noted an Oppenheimer report.

The takeaway from Avadel Pharmaceuticals Plc’s (AVDL:NASDAQ) recent Q4/21 earnings report is the biopharma is currently well-positioned financially and operationally, reported analyst Francois Brisebois in a March 18 research note.

Financially, the company beat expectations in Q4/21 with a reported earnings per share (EPS) of ($0.38). Oppenheimer’s EPS estimate was ($0.49) and the Street’s, ($0.41). Brisebois attributed the favorable result to the biopharma exercising “good opex discipline.”

Avadel has a strong balance sheet, having $157 million in cash at year-end. Maturity of the company’s convertible note was extended to 2/01/23, “a real positive,” noted the analyst.

Operationally, Avadel is advancing its lead drug candidate FT218 as a potential treatment of narcolepsy-induced excessive daytime sleepiness and cataplexy. The company expects feedback from the U.S. Food and Drug Administration (FDA) soon pertaining to its review of the biopharma’s new drug application, Brisebois wrote. Management still believes Avadel will not need to obtain ODE to receive full FDA approval.

“We are encouraged to see that there have been no outstanding questions [from the FDA],” wrote Brisebois.

The analyst highlighted that in the meantime Avadel continues to prepare for the commercial launch of FT218 and has made progress in that regard. For instance, the biopharma already conditionally hired 90% of its sales force. The company will likely need another five to six months post approval to get fully ready.

“As [Avadel is] still a development story, we are pleased to see that management is focusing on their launch readiness,” wrote Brisebois.

Also encouraging is interim data from Avadel’s RESTORE study of FT218, Brisebois noted. Results showed that tolerability of the drug over 18 months is consistent with sodium oxybate’s safety profile. Further, patients experienced clinically significant improvements in subjective and objective measurements of narcolepsy symptoms.

Oppenheimer has an Outperform rating and a $16 per share price target on Avadel. Its current share price is around $7.32.


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Disclosures for Oppenheimer & Co. Inc., Avadel Pharmaceuticals, Inc. (AVDL), March 18, 2022

Oppenheimer & Co. Inc. does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report.

Investors should consider this report as only a single factor in making their investment decision.

Analyst Certification – The author certifies that this research report accurately states his/her personal views about the subject securities, which are reflected in the ratings as well as in the substance of this report. The author certifies that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views contained in this research report.

Potential Conflicts of Interest: Equity research analysts employed by Oppenheimer & Co. Inc. are compensated from revenues generated by the firm including the Oppenheimer & Co. Inc. Investment Banking Department. Research analysts do not receive compensation based upon revenues from specific investment banking transactions. Oppenheimer & Co. Inc. generally prohibits any research analyst and any member of his or her household from executing trades in the securities of a company that such research analyst covers. Additionally, Oppenheimer & Co. Inc. generally prohibits any research analyst from serving as an officer, director or advisory board member of a company that such analyst covers. In addition to 1% ownership positions in covered companies that are required to be specifically disclosed in this report, Oppenheimer & Co. Inc. may have a long position of less than 1% or a short position or deal as principal in the securities discussed herein, related securities or in options, futures or other derivative instruments based thereon. Recipients of this report are advised that any or all of the foregoing arrangements, as well as more specific disclosures set forth below, may at times give rise to potential conflicts of interest.

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