View:
United States securities and exchange commission logo
June 12, 2024
Steven Pieper
Chief Financial Officer
Xeris Biopharma Holdings, Inc.
1375 West Fulton Street, Suite 100
Chicago, IL 60607
Re: Xeris Biopharma
Holdings, Inc.
Form 10-K for the
year ended December 31, 2023
Form 10-Q for the
quarterly period ended March 31, 2024
File No. 001-40880
Dear Steven Pieper:
We have limited our review of your filings 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 year ended December 31, 2023
Management's Discussion and Analysis of Financial Condition and Results
of Operations, page
67
1. Revise your future
filings to provide quantification of each of the individual factors you
identified in your
disclosure which led to the changes in each of your line items. As part
of your response,
address the following:
Revise to quantify
the extent to which the changes in revenue from each specific
product is from
volume versus pricing.
Discuss the reasons
for the changes in the amount of cost of goods sold as well as the
changes in cost of
goods sold as a percent of revenues.
Tell us and revise
your future filings to quantify the one-time contract credit received
in first quarter
2023 and explain the nature of this credit.
You disclose on
page 68 that "Manufacturing costs for Gvoke and Recorlev incurred
prior to approval
and initial commercialization were expensed as research and
development
expenses." Tell us and revise your future filings to quantify the impact
Steven Pieper
Xeris Biopharma Holdings, Inc.
June 12, 2024
Page 2
of zero cost inventory for 2022 and 2023, as well as any future
periods impacted.
Form 10-Q for the quarterly period ended March 31, 2024
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Research and development expenses, page 25
2. Please provide quantitative disclosures, to be included in future
filings, for the type of
research and development expenses incurred (i.e. by nature or type of
expense) for each
period presented, which should reconcile to total research and
development expense.
Revise to disclose the extent to which you track certain of your
research and development
costs on a project basis, and if so, disclose the amounts tracked for
projects, where
material. In addition, separately quantify the impact from each factor
that led to the
increase in research and development expense (e.g., investments in
XP-8121, your
emerging technology partnership business, as well as higher personnel
costs).
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 Vanessa Robertson at 202-551-3649 or Kevin Vaughn at
202-551-3494
with any questions.
FirstName LastNameSteven Pieper Sincerely,
Comapany NameXeris Biopharma Holdings, Inc.
Division of
Corporation Finance
June 12, 2024 Page 2 Office of Life
Sciences
FirstName LastName