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United States securities and exchange commission logo
October 29, 2020
Thomas McHugh
Senior Vice President and Chief Financial Officer
AVADEL PHARMACEUTICALS PLC
10 Earlsfort Terrace
Dublin 2, Ireland
D02 T380
Re: AVADEL
PHARMACEUTICALS PLC
Form 10-K for the
Year Ended December 31, 2019
Filed March 16,
2020
Form 10-Q for the
Period Ended June 30, 2020
Filed August 10,
2020
File No. 001-37977
Dear Mr. McHugh:
We have reviewed your October 14, 2020 response to our comment
letter and have the
following comments. In some of our comments, we may ask you to provide
us with information
so we may better understand your disclosure.
Please respond to these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your response to these comments, we may have
additional
comments. Unless we note otherwise, our references to prior comments are
to comments in our
September 21, 2020 letter.
Form 10-Q for the Period Ended June 30, 2020
Note 4. Disposition of the Hospital Business, page 13
1. We note your response
to comment 1. You state that the sterile injectable drugs (the
Products ) do not
represent a product line, and therefore are not a distinguishable
component of the
company. Please tell us if you believe that the Products meet the
definition of a
component of an entity as defined in ASC 205-20. If not, please explain.
In your response,
please address your presentation of the unaudited pro forma financial
information you
presented in exhibit 99.2 of Form 8-K dated July 2, 2020, which gives
effect to the sale of
the Products. Based on this presentation, it appears that, at a
Thomas McHugh
AVADEL PHARMACEUTICALS PLC
October 29, 2020
Page 2
minimum, the operations of the Products can be clearly distinguished,
operationally and
for financial reporting purposes, from the rest of the entity.
2. We note from your response to comment 1 that you do not believe the
sale of the sterile
injectable drugs represented a strategic shift as contemplated by ASC
205-20-45. We
continue to believe that the disposal may have represented a strategic
shift. Please help us
better understand your conclusion. In your response, please address
the statements made
in the press release announcing the sale of the Products on July 1,
2020. We note that in
that press release, the company articulated that the sale of the
sterile injectable drug
portfolio was a significant milestone for the company, as it further
reflected your
commitment to strategically focus on advancing FT218 through the
regulatory review
process and, if approved, bringing your formulation of sodium oxybate
to patients. We
also note the statement made by Mr. Greg Divis, your Chief Executive
Officer, in which
he stated, 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. Please also tell us how you considered
the fact that the
Products sold and FT218 are based on different technologies.
You may contact Nudrat Salik at (202) 551-3692 or Ameen Hamady at (202)
551-3891 if
you have any questions.
FirstName LastNameThomas McHugh Sincerely,
Comapany NameAVADEL PHARMACEUTICALS PLC
Division of Corporation Finance
October 29, 2020 Page 2 Office of Life Sciences
FirstName LastName