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United States securities and exchange commission logo
October 27, 2023
A. Ernest Toth, Jr.
Chief Financial Officer
Aquestive Therapeutics, Inc.
30 Technology Drive
Warren, NJ 07059
Re: Aquestive
Therapeutics, Inc.
Form 10-K for the
fiscal year ended December 31, 2022
Filed March 31,
2023
File No. 001-38599
Dear A. Ernest Toth, Jr. :
We have limited our review of your filing to the financial
statements and related
disclosures and have the following comments.
Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to this letter, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2022
Management's Discussion and Analysis of Financial Condition and Results
of Operations, page
58
Results of Operations, page 61
1. In future filings
beginning with your Form 10-Q for the period ended September 30, 2023,
revise your discussions
of the changes in your various revenue streams to quantify the
impact of the factors
cited as the reason for the changes, including but not limited to the
following:
Manufacturing and
supply revenue accounted for 76% of consolidated revenues for
the year ended
December 31, 2022 and increased 3% during 2022. You disclose
"This increase was
due to increased manufacturing volume of Zuplenz subsequent to
receiving foreign
regulatory approval in February 2022, increased manufacturing
volume of Sympazan
subsequent to the outlicensing agreement with Assertio in
October 2022,
offset by a decline in Suboxone manufacturing volume in 2022."
Revise to quantify
the impact of each of these factors.
A. Ernest Toth, Jr.
Aquestive Therapeutics, Inc.
October 27, 2023
Page 2
You disclose that the decrease in your proprietary product
sales was due to the
execution of the license agreement with Assertio in October 2022,
after which
Sympazan sales were recognized in manufacture and supply revenue.
Revise to
clearly quantify the impact of Sympazan recognized in each
revenue stream for the
periods presented.
2. We note that research and development (R&D) expense increased 3%
during 2022,
decreased 26% during the three months ended March 31, 2023 and
decreased 30% during
the six months ended June 30, 2023. However, the explanation for these
different changes
that R&D is "driven by the timing of clinical trial as well as other
product development
activities associated with the Company's pipeline" is the same found
in each respective
results of operations discussion. Please revise your future
disclosures, beginning with your
Form 10-Q for the period ended September 30, 2023, to address the
following:
For the R&D expense that you track by product candidate, revise to
separately
quantify those amounts by product candidate. If you do not track
any amounts by
product candidate, revise to disclose that fact and identify the
reasons why you do not
track by product candidate.
Revise to provide a reasonably detailed explanation that accounts
for the changes in
the underlying components of R&D for the periods presented.
Provide quantification
where necessary or appropriate.
3. We note that the All Other R&D category of total research and
development (R&D)
expense in each period presented makes up the largest component of
R&D. Please revise
your future disclosures, beginning with your Form 10-Q for the period
ended September
30, 2023, to explain the nature of the costs included in this category
and to provide a
reasonably detailed explanation and quantification of the factors
causing the changes
therein. Consider the extent to which this line item can be further
disaggregated in your
tabular presentation.
In closing, we remind you that the company and its management are
responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review,
comments, action or
absence of action by the staff.
Please contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494
with any
questions.
FirstName LastName A. Ernest Toth, Jr. Sincerely,
Comapany NameAquestive Therapeutics, Inc.
Division of
Corporation Finance
October 27, 2023 Page 2 Office of Life
Sciences
FirstName LastName