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United States securities and exchange commission logo
May 30, 2024
Cecilia Jones
Chief Financial Officer
AGIOS PHARMACEUTICALS, INC.
88 Sidney Street
Cambridge, MA 02139
Re: AGIOS
PHARMACEUTICALS, INC.
Form 10-K for
Fiscal Year Ended December 31, 2023
Filed February 15,
2024
File No. 001-36014
Dear Cecilia Jones:
We have reviewed your
filing and have the following comment(s).
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 Fiscal Year Ended December 31, 2023
Item 7. Management's Discussion and Analysis of Financial Condition and
Results of Operations
Financial Operations Overview
Cost of Sales, page 70
1. You disclose that it is
your policy to expense costs associated with the manufacturing of
your products prior to
regulatory approval and, therefore, they are not included in costs of
sales. With regards to
PYRUKYND , please tell us, and provide proposed disclosure to
be included in future
periodic reports, the following:
The cost of the
inventory build-up prior to regulatory approval that had been
expensed in prior
periods as research and development expenses (i.e. zero cost
inventories)
The estimated
selling value of zero cost inventory on hand at December 31, 2023 and
when you expect,
based on your current sales trends, the zero cost inventories to be
depleted
The shelf life of
your inventory and your consideration of whether or not your
inventory will be
determined to be obsolete in future periods.
Cecilia Jones
AGIOS PHARMACEUTICALS, INC.
May 30, 2024
Page 2
Research and Development Expenses
PYRUKYND (mitapivat): First-in-Class PK Activator, page 71
2. You note that in connection with your regulatory approvals in the EU
and Great Britain,
you are currently providing access to PYRUKYND free of charge for
eligible patients in
those jurisdictions through a global managed access program and that
you may provide
access to PYRUKYND for adult patients with PK deficiency in other
jurisdictions upon
request through the global managed access program. Please tell us, and
provide proposed
disclosure to be included in future periodic reports, the following:
A robust description of the global managed access program and
how your product is
process through this program
Your accounting policy for the free products provided through
the global managed
access program
The expense incurred in each jurisdiction for the product
provided free of charge
through the global managed access program or a statement, if
true, that the
aggregated expense is not considered by management to be material
A discussion regarding your future plans and/or obstacles you
have
encountered to commercialize PYRUKYND in the EU and Great
Britain.
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 Sasha Parikh at 202-551-3627 or Tracie Mariner at
202-551-3744 if you
have questions regarding comments on the financial statements and related
matters.
FirstName LastNameCecilia Jones Sincerely,
Comapany NameAGIOS PHARMACEUTICALS, INC.
Division of
Corporation Finance
May 30, 2024 Page 2 Office of Life
Sciences
FirstName LastName