SEC Comment Letter for Coherus Oncology, Inc. (CHRS) (CIK 0001512762) (CHRS) — Oct 24, 2019
Coherus Oncology, Inc. (CHRS) (CIK 0001512762)
Date: Oct. 24, 2019 · CIK: 0001512762 · Accession: 0000000000-19-014825
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 001-36721
Letter
October 24, 2019 Jean-Frédéric Viret Chief Financial Officer Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, California 94065 Re:Coherus BioSciences, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed February 28, 2019 Form 10-Q for the Quarterly Period Ended June 30, 2019 Filed August 5, 2019 File No. 001-36721 Dear Mr. Viret: We have reviewed your October 15, 2019 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 the comment, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our October 3, 2019 letter. Form 10-Q for the Quarterly Period Ended June 30, 2019 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Financial Operations Overview Cost of Goods Sold, page 32 1.We acknowledge your response to our comments. Please revise your future filings to disclose the following and provide us with a draft of your proposed disclosures: •the amount of estimated historical cost of the inventory build-up prior to your regulatory approval that had been expensed as R&D for each period presented, •the effect zero cost inventory had on your historical results of operations, •the expected effect on future results of operations and the assumptions made in this regards,
FirstName LastNameJean-Frédéric Viret Comapany NameCoherus BioSciences, Inc. October 24, 2019 Page 2 FirstName LastName Jean-Frédéric Viret Coherus BioSciences, Inc. October 24, 2019 Page 2 •the estimated selling value as of the balance sheet date and estimated period to sell, and •why you believe the shelf life of 12 months for the bulk drug substance, pegfilgrastim, will not affect your ability to sell the inventory after the shelf life expires. In this respect, tell us why adding the shelf life of the bulk drug substance to the shelf life of the finished drug product is appropriate in determining the shelf life of the inventory. You may contact Ibolya Ignat at (202) 551-3636 or Mary Mast at (202) 551- 3613 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences
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October 24, 2019
Jean-Frédéric Viret
Chief Financial Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, California 94065
Re:Coherus BioSciences, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed February 28, 2019
Form 10-Q for the Quarterly Period Ended June 30, 2019
Filed August 5, 2019
File No. 001-36721
Dear Mr. Viret:
We have reviewed your October 15, 2019 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 the comment, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
October 3, 2019 letter.
Form 10-Q for the Quarterly Period Ended June 30, 2019
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Financial Operations Overview Cost of Goods Sold, page 32
1.We acknowledge your response to our comments. Please revise your future filings to
disclose the following and provide us with a draft of your proposed disclosures:
•the amount of estimated historical cost of the inventory build-up prior to your
regulatory approval that had been expensed as R&D for each period presented,
•the effect zero cost inventory had on your historical results of operations,
•the expected effect on future results of operations and the assumptions made in this
regards,
FirstName LastNameJean-Frédéric Viret
Comapany NameCoherus BioSciences, Inc.
October 24, 2019 Page 2
FirstName LastName
Jean-Frédéric Viret
Coherus BioSciences, Inc.
October 24, 2019
Page 2
•the estimated selling value as of the balance sheet date and estimated period to sell,
and
•why you believe the shelf life of 12 months for the bulk drug substance,
pegfilgrastim, will not affect your ability to sell the inventory after the shelf life
expires. In this respect, tell us why adding the shelf life of the bulk drug substance to
the shelf life of the finished drug product is appropriate in determining the shelf life
of the inventory.
You may contact Ibolya Ignat at (202) 551-3636 or Mary Mast at (202) 551- 3613 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences