United States securities and exchange commission logo
August 16, 2023
Barry Shin
Chief Financial Officer
TREVENA INC
955 Chesterbrook Blvd
Suite 110
Chesterbrook, PA 19087
Re: TREVENA INC
Form 10-K for the
Year Ended December 31, 2022
File No. 001-36193
Dear Barry Shin:
We have reviewed your July 28, 2023 response to our comment
letter and have the
following comment. In our comment, we may ask you to provide us with
information so we may
better understand your disclosure.
Please respond to this comment 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
comment applies to your facts and circumstances, please tell us why in
your response.
After reviewing your response to this comment, we may have
additional
comments. Unless we note otherwise, our references to prior comments are
to comments in our
July 14, 2023 letter.
Form 10-K for the Year Ended December 31, 2022
Notes to the Consolidated Financial Statements
10. Product Revenue
Variable Consideration, page 114
1. Please address the
following regarding your response to comment one of our letter dated
July 14, 2023:
Regarding your
response to the second bullet of prior comment one, clarify in your
response as well as
in your future filings the extent you continue to use industry data
to estimate returns
for OLINVYK given the disconnect you experienced between the
actual returns and
expected returns based on industry data. If you do continue to use
industry data,
explain how you determined that was appropriate and the extent to
which you now
adjust such data for the higher actual returns experienced in the
Barry Shin
TREVENA INC
August 16, 2023
Page 2
fourth quarter of 2022 when developing your return estimates for
the most recent
quarters.
Regarding the third and fourth bullets to prior comment one,
please explain how you
determined whether, based on your actual return experience
beginning in November
2022, sales of OLINVYK should be constrained for subsequent
interim periods.
Revise your future filings to provide a tabular breakdown of
your gross sales as
reduced by various adjustments, including reductions for future
estimated returns, to
reconcile to net revenue as presented on your Statement of
Operations for all periods
presented. In your response, provide us with sample disclosure
for the first and
second quarters of 2023.
As noted in your response to the sixth bullet of prior comment
one, you disclose in
your Form 10-Q for the period ended June 30, 2023 that sales from
wholesalers to
hospitals and ambulatory surgical centers have occurred, at a low
level, every quarter
since your commercial launch of OLINVYK. Please tell us the
amount of quarterly
sales by the wholesalers to end customers for each of the
quarters since its
commercial launch, and revise your future filings to provide
quantified disclosure for
the periods presented. As part of such disclosure, discuss the
trends in sales levels to
the end user and how you considered such trends in determining
the amount of
reduction of revenue for future returns.
In response to the seventh bullet of prior comment one, as well
as the
related disclosure added in your Form 10-Q for the period ended
June 30, 2023, you
list multiple positive factors that might affect or have affected
sales of OLINVYK.
To the extent you are aware of negative data, perceptions of your
product, or other
information that may be negatively affecting the level of sales
to end customer
hospitals, revise your future filings to clearly disclose such
information. Provide us
with your proposed revised disclosure as part of your response.
You may contact Christine Torney at 202-551-3652 or Kevin Vaughn at
202-551-3494 if
you have questions regarding our comment.
FirstName LastNameBarry Shin Sincerely,
Comapany NameTREVENA INC
Division of
Corporation Finance
August 16, 2023 Page 2 Office of Life
Sciences
FirstName LastName