Correspondence 0001104659-23-104113 from TREVENA INC (TRVN) (CIK 0001429560)
TREVENA INC (TRVN) (CIK 0001429560)
Date: Sept. 27, 2023 · CIK: 0001429560 · Accession: 0001104659-23-104113
AI Filing Summary & Sentiment
File numbers found in text: 001-36193
Referenced dates: July 14, 2023, July 28, 2023
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CORRESP
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Christine Torney and Kevin Vaughn
Division of Corporation Finance
Office of Life Sciences
U.S. Securities & Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Re: Trevena, Inc.
Form 10-K for Fiscal Year Ended December 31,
2022
Filed March 30, 2023
File No. 001-36193
September 27, 2023
Dear Ms. Torney and Mr. Vaughn:
Please allow this letter to serve as Trevena’s
response to the comment of the Staff (the “Staff”) of the Division of Corporation Finance of the U.S. Securities
and Exchange Commission (the “Commission”) contained in its letter, dated August 16, 2023 (the “August Commission
Comment Letter”), as discussed with Mr. Vaughn on September 18, 2023, in connection with the Company’s
Form 10-K for the fiscal year ended December 31, 2022, filed with the Commission on March 30, 2023. When used in this
letter, “Trevena,” the “Company,” “we,” and “our”
refer to Trevena, Inc. The responses from our letter dated July 28, 2023, which addressed the items raised in the Commission’s
letter dated July 14, 2023, are incorporated herein by reference.
The Company’s response to the Commission
Comment Letter is set forth below. For ease of reference, the Staff’s comment is printed in bold, italicized font and followed
by the Company’s response.
Form 10-K for the fiscal year ended December 31, 2022
Notes to 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 fourth quarter of 2022
when developing your return estimates for the most recent quarters.
RESPONSE:
Trevena does not currently use industry data, such as sales of other conventional IV opioids and the performance of broadly comparable
hospital-based analgesic product launches, in its returns estimates. The Company previously used such industry data at the time of the
OLINVYK launch in Q1 2021 and during OLINVYK’s early launch phase. At the time, Trevena believed that industry data was a relevant
consideration in the absence of any history of OLINVYK sales or returns that the Company could use to benchmark returns estimates.
U.S. Securities and Exchange Commission
September 27, 2023
Page 2
Trevena currently estimates returns based on factors including historical
OLINVYK purchasing, projected demand from hospitals and ambulatory surgical centers (“ASCs”), the amount of
OLINVYK held by wholesalers, OLINVYK shelf life, and return patterns and feedback from its wholesalers.
The Company respectfully acknowledges the Staff’s comments and
will clarify in future filings that it does not currently rely on industry data, but rather on the factors listed in the above paragraph
with respect to returns estimates. Sample disclosure is set forth below, marked to show changes from disclosure in the Company’s
quarterly report on Form 10-Q filed with the Commission on August 14, 2023.
Generally, the Company’s customers have the right
to return any unopened product during the eighteen (18) month period beginning six (6) months prior to the labeled
expiration date and ending twelve (12) months after the labeled expiration date. Since the Company did not have a history
of OLINVYK returns when the product was launched, the Company estimated returns based on industry data for comparable products in the
market. The Company does not currently rely on industry data in its analysis of returns reserve. As
the Company sells sold OLINVYK and establishes
established historical sales over a longer period of time, the Company places placed
more reliance on historical purchasing, demand from hospitals and ambulatory surgical centers, return
patterns of its customers and the amount of OLINVYK held by wholesalers, when evaluating reserves for product returns. OLINVYK has a forty-eight (48)
month shelf life.
· 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.
RESPONSE:
As background, in October 2022, for the first time, the Company received feedback from one of its wholesalers (“Wholesaler
#1”) that it intended to return a significant portion of its supply of OLINVYK. As a result, the Company updated its estimates
to reflect this expected return and, in addition, the Company increased the probability of returns from its other two wholesalers at
the time to approximately 50%, resulting in the Company recording an approximately $0.4 million returns reserve adjustment in its quarterly
report on Form 10-Q filed with the Commission on November 9, 2022.
U.S. Securities and Exchange Commission
September 27, 2023
Page 3
In the three months ended December 31, 2022, the Company recorded
no product sales, and therefore no constraints were required. In connection with preparing its financial statements for the year ended
December 31, 2022, the Company reviewed its returns reserve and other gross-to-net (“GTN”) adjustments
and did not identify other factors that would result in a material change.
In the three months ended March 31, 2023, the Company recorded
approximately $7,000 in gross product sales, primarily to a newly contracted wholesaler (“Wholesaler #4). Based on
discussions with Wholesaler #4, the Company understood that these sales were due to demand and orders that Wholesaler #4 had received
for OLINVYK from its customers. As a result, the Company estimated returns of approximately 2% for the $7,000 in gross product sales.
The Company recorded approximately $6,000 in net product sales in the three months ended March 31, 2023. The Company reviewed its
returns reserve and other GTN adjustments in connection with preparing its financial statements for the quarter ended March 31,
2023 and did not identify other factors that would result in a material change.
For the three months ended June 30, 2023, the Company recorded
approximately $25,000 in gross product sales to Wholesaler #1, and approximately $2,000 in gross product sales to Wholesaler #4. Notably,
Wholesaler #1 had previously indicated its intent to return its supply of OLINVYK in October 2022 (at which point the Company recorded
an adjustment to its returns reserve as described above) and in fact carried out the return of substantially all of its supply of OLINVYK
in February 2023.
Based on discussions with Wholesaler #1 and Wholesaler #4, the Company
understood that these sales during the three months ended June 30, 2023 were due to demand and orders that Wholesaler #1 and Wholesaler
#4 had received for OLINVYK from their respective customers. In addition, due to its recent return of OLINVYK in February 2023,
Wholesaler #1 effectively had no other supply of OLINVYK with which to fulfill such demand and orders from its customers.
U.S. Securities and Exchange Commission
September 27, 2023
Page 4
As a result, Trevena estimated returns of approximately 2% for the
gross product sales to Wholesaler #1 and Wholesaler #4. The Company recorded approximately $21,000 in net product sales in the three
months ended June 30, 2023. The Company reviewed its returns reserve and other GTN adjustments in connection with preparing its
financial statements for the quarter ended June 30, 2023 and did not identify other factors that would result in a material change.
· 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.
RESPONSE:
The Company respectfully acknowledges the Staff’s comments and will provide a tabular breakdown of gross sales as reduced by various
adjustments, including reductions for future estimated returns, to reconcile to net revenue for all periods presented. As requested by
the Staff, a sample of such disclosure is provided below.
For the three months ended March 31, 2023, the Company recorded
gross sales of approximately $7,000, and GTN adjustments of $1,000 resulting in net sales of approximately $6,000. The amounts in the
following table are in thousands.
Three
Months Ended
March 31,
2023
2022
Product revenue, gross
$ 7
$ -
GTN adjustments
Chargebacks and cash discounts
(1 )
-
Returns
(0 )
-
Other rebates, discounts and adjustments
(0 )
-
Total GTN adjustments
(1 )
-
Product revenue, net
$ 6
$ -
For the three months ended June 30, 2023, the Company recorded
gross sales of approximately $27,000, and GTN adjustments of approximately $6,000 resulting in net sales of approximately $21,000. For
the six months ended June 30, 2023, the Company recorded gross sales of approximately $34,000, and GTN adjustments of approximately
$7,000 resulting in net sales of approximately $27,000. The amounts in the following table are in thousands.
U.S. Securities and Exchange Commission
September 27, 2023
Page 5
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2023
2022
2023
2022
Product revenue, gross
$ 27
$ -
$ 34
$ -
GTN adjustments
Chargebacks and cash discounts
(2 )
-
(3 )
-
Returns
(1 )
-
(1 )
-
Other rebates, discounts and adjustments
(3 )
-
(4 )
-
Total GTN adjustments
(6 )
-
(7 )
-
Product revenue, net
$ 21
$ -
$ 27
$ -
· 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.
RESPONSE:
Sales from wholesalers to hospitals and ambulatory surgical centers (ASCs) have occurred, at a low level, every quarter since
the commercial launch of OLINVYK. Trevena receives reports on orders that the wholesalers fulfill. Based on these reports, starting from
the first quarter of launch in Q1 2021, commercial sales of OLINVYK to hospitals and ASCs were approximately as follows: $300 (1Q 21),
$9,700 (2Q 21), $3,700 (3Q 21), $8,700 (4Q 21), $12,400 (1Q 22), $4,700 (2Q 22), $7,600 (3Q 22), $11,000 (4Q 22), $14,700 (1Q 23) and
$23,800 (2Q 23). While there is a general quarterly upward trend from 1Q 22 through 2Q 23, the overall level of these sales remains low.
The Company respectfully acknowledges the Staff’s comments and
will provide quantified disclosure for the periods presented. As part of such disclosure, the Company will discuss trends in sales levels
to the end user and how the Company considered such trends in determining the amount of reduction of revenue for future returns.
U.S. Securities and Exchange Commission
September 27, 2023
Page 6
· 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.
RESPONSE:
The Company respectfully acknowledges the Staff’s comments and will revise future filings to clearly disclose negative
data, perceptions of the Company’s product, or other information that may be negatively affecting the level of sales to end customer
hospitals. The proposed revised disclosure is set forth below, which shows the text from our quarterly report on Form 10-Q filed
with the Commission on August 14, 2023, with marked changes to highlight the Company’s proposed revisions.
In our returns reserve analysis, we also consider feedback
from our wholesalers, group purchasing organizations and users of OLINVYK, as well as additional factors such as new safety data, or clinical
or health economic data for OLINVYK that may affect future adoption and sales trends. Examples include OLINVYK data we announced in April 2022
with respect to respiratory physiology, and in July 2022 with respect to cognitive function. More recently in July 2023, we
also announced OLINVYK data with respect to reduced cost per admission for hospitals and reduced average length of hospital stay, for
OLINVYK-treated patients compared to matched patients treated with other IV opioids. We also consider factors
that may negatively affect sales of OLINVYK, such as the price of OLINVYK compared to conventional IV opioids, which are generally generic
and available at a lower initial cost relative to OLINVYK. Other factors may include the public perception of opioids in general, as well
as the FDA’s and HHS’ policy initiatives that may limit the promotion and marketing of opioids.
*****
If you have any questions regarding the information
contained in this letter, or need further information, please do not hesitate to call me at 610-727-0545.
Very truly yours,
/s/ Barry Shin
Barry Shin
CFO
cc:
Joel Solomon, General Counsel and Chief Compliance Officer
Troutman Pepper Hamilton Sanders LLP
Brian M. Katz
Cody Mathis