SEC Comment Letter 0000000000-23-013232 to Amylyx Pharmaceuticals, Inc. (AMLX)
Amylyx Pharmaceuticals, Inc.
Date: Dec. 5, 2023 · CIK: 0001658551 · Accession: 0000000000-23-013232
AI Filing Summary & Sentiment
File numbers found in text: 001-41199
Letter
United States securities and exchange commission logo December 5, 2023 James Frates Chief Financial Officer Amylyx Pharmaceuticals, Inc. 43 Thorndike St. Cambridge, MA 02141 Re:Amylyx Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2022 Filed March 13, 2023 Form 10-Q for the Quarterly Period Ended September 30, 2023 Filed November 9, 2023 File Number 001-41199 Dear James Frates: 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-Q for the Nine Months Ended September 30, 2023 Notes to Condensed Consolidated Financial Statements 3. Product Revenue, Net, page 10 1.Please tell us your consideration of providing disaggregated revenue disclosure such as product sales for the U.S. and Canada. Refer to ASC 606-10-55-89 through 606-10-55-91 and ASC 280-10-50-41. Notes to the Condensed Consolidated Financial Statements 5. Inventories, page 12 2.Your inventory balance was $56.7 million at September 30, 2023, of which $24.3 million is considered long-term. You state that finished goods have a shelf life of 12 - 18 months from the date of manufacture. Tell us how much of the long-term inventory is
FirstName LastNameJames Frates Comapany NameAmylyx Pharmaceuticals, Inc. December 5, 2023 Page 2 FirstName LastName James Frates Amylyx Pharmaceuticals, Inc. December 5, 2023 Page 2 considered finished goods. In light of the shelf life, the early phase of the company's product sale launch, and a significant portion of inventories being recorded as long-term, tell us why you believe no impairment was required to be recorded at September 30, 2023. 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 Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences
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United States securities and exchange commission logo
December 5, 2023
James Frates
Chief Financial Officer
Amylyx Pharmaceuticals, Inc.
43 Thorndike St.
Cambridge, MA 02141
Re:Amylyx Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed March 13, 2023
Form 10-Q for the Quarterly Period Ended September 30, 2023
Filed November 9, 2023
File Number 001-41199
Dear James Frates:
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-Q for the Nine Months Ended September 30, 2023
Notes to Condensed Consolidated Financial Statements
3. Product Revenue, Net, page 10
1.Please tell us your consideration of providing disaggregated revenue disclosure such as
product sales for the U.S. and Canada. Refer to ASC 606-10-55-89 through 606-10-55-91
and ASC 280-10-50-41.
Notes to the Condensed Consolidated Financial Statements
5. Inventories, page 12
2.Your inventory balance was $56.7 million at September 30, 2023, of which $24.3 million
is considered long-term. You state that finished goods have a shelf life of 12 - 18 months
from the date of manufacture. Tell us how much of the long-term inventory is
FirstName LastNameJames Frates
Comapany NameAmylyx Pharmaceuticals, Inc.
December 5, 2023 Page 2
FirstName LastName
James Frates
Amylyx Pharmaceuticals, Inc.
December 5, 2023
Page 2
considered finished goods. In light of the shelf life, the early phase of the company's
product sale launch, and a significant portion of inventories being recorded as long-term,
tell us why you believe no impairment was required to be recorded at September 30, 2023.
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 Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences