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SEC Comment Letters
Company Responses
Letter Text
Coherus Oncology, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
Coherus Oncology, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2019-10-03
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2019-10-03
Generating summary...
↓
Company responded
2019-10-15
Coherus Oncology, Inc.
References: October 3, 2019
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2019-10-15
Generating summary...
↓
Company responded
2019-11-06
Coherus Oncology, Inc.
References: October 24, 2019
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2019-11-06
Generating summary...
↓
Company responded
2021-12-30
Coherus Oncology, Inc.
References: December 16, 2021
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2021-12-30
Generating summary...
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Company responded
2022-04-20
Coherus Oncology, Inc.
References: April 7, 2022 | December 16, 2021
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2022-04-20
Generating summary...
↓
Company responded
2024-09-06
Coherus Oncology, Inc.
References: August 23, 2024
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2024-09-06
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-08-23
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2024-08-23
Generating summary...
Coherus Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-07-14
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2023-07-14
Generating summary...
↓
Company responded
2023-07-24
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2023-07-24
Generating summary...
Coherus Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-11-14
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2022-11-14
Generating summary...
↓
Company responded
2022-11-15
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2022-11-15
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-04-20
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2022-04-20
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-04-07
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2022-04-07
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-16
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2021-12-16
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2019-11-18
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2019-11-18
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-24
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2019-10-24
Generating summary...
Coherus Oncology, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2018-05-04
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2018-05-04
Generating summary...
Coherus Oncology, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2018-02-01
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2018-02-01
Generating summary...
↓
Company responded
2018-02-14
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2018-02-14
Generating summary...
↓
Company responded
2018-02-16
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2018-02-16
Generating summary...
↓
Company responded
2018-03-22
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2018-03-22
Generating summary...
↓
Company responded
2018-03-27
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2018-03-27
Generating summary...
Coherus Oncology, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-09-28
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2017-09-28
Generating summary...
↓
Company responded
2017-10-11
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2017-10-11
Generating summary...
Coherus Oncology, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-12-22
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2015-12-22
Generating summary...
↓
Company responded
2016-01-19
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2016-01-19
Generating summary...
Coherus Oncology, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2014-09-30
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2014-09-30
Generating summary...
↓
Company responded
2014-10-07
Coherus Oncology, Inc.
References: October 6, 2014 | September 3, 2014
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2014-10-07
Generating summary...
↓
Company responded
2014-11-03
Coherus Oncology, Inc.
Filing - Correspondence from Coherus Oncology, Inc.
CORRESP · 2014-11-03
Generating summary...
Coherus Oncology, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-09-03
Coherus Oncology, Inc.
Filing - SEC Comment Letter to Coherus Oncology, Inc.
UPLOAD · 2014-09-03
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-05 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2024-09-13 | SEC Comment Letter | Coherus Oncology, Inc. | DE | 001-36721 | Read Filing View |
| 2024-09-06 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2024-08-23 | SEC Comment Letter | Coherus Oncology, Inc. | DE | 001-36721 | Read Filing View |
| 2023-07-24 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2023-07-14 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-11-15 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-11-14 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-07 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2021-12-30 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2021-12-16 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-18 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-06 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-24 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-15 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-03 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-05-04 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-03-27 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-03-22 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-16 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-14 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-01 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-10-11 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-09-28 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-01-19 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-12-22 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-11-03 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-10-07 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-09-03 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2024-09-13 | SEC Comment Letter | Coherus Oncology, Inc. | DE | 001-36721 | Read Filing View |
| 2024-08-23 | SEC Comment Letter | Coherus Oncology, Inc. | DE | 001-36721 | Read Filing View |
| 2023-07-14 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-11-14 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-07 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2021-12-16 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-18 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-24 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-03 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-01 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-09-28 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2015-12-22 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-09-30 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-09-03 | SEC Comment Letter | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-05 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2024-09-06 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2023-07-24 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-11-15 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2022-04-20 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2021-12-30 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-11-06 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2019-10-15 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-05-04 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-03-27 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-03-22 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-16 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2018-02-14 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2017-10-11 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2016-01-19 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-11-03 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
| 2014-10-07 | Company Response | Coherus Oncology, Inc. | DE | N/A | Read Filing View |
2025-12-05 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Coherus Oncology, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 December 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Re: Coherus Oncology, Inc. Registration Statement on Form S-3 (File No. 333-291520) Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Coherus Oncology, Inc. (the " Company ") hereby requests acceleration of the effective date of its Registration Statement on Form S-3 initially filed on November 13, 2025 (the " Registration Statement "). The Company respectfully requests that the Registration Statement become effective as of 4:30 p.m., Eastern Time, on December 8, 2025, or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with the Company's counsel, Latham & Watkins LLP, by calling Drew Capurro at (714) 755-8008. Very truly yours, Coherus Oncology, Inc. By: /s/ Bryan McMichael Name: Bryan McMichael Title: Chief Financial Officer cc: Dennis M. Lanfear, Coherus Oncology, Inc. Benjamin A. Potter, Latham & Watkins LLP Drew Capurro, Latham & Watkins LLP
2024-09-13 - UPLOAD - Coherus Oncology, Inc. File: 001-36721
September 13, 2024
Dennis M. Lanfear
President and Chief Executive Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, California 94065
Re:Coherus BioSciences, Inc.
Definitive Proxy Statement on Schedule 14A
Filed April 15, 2024
File No. 001-36721
Dear Dennis M. Lanfear:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:Max Brunner, Esq.
2024-09-06 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Via EDGAR Transmission September 6, 2024 Division of Corporation Finance Disclosure Review Program United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Jennifer Gowetski Daniel Crawford RE: Coherus BioSciences, Inc. Definitive Proxy Statement on Schedule 14A Filed April 15, 2024 File No. 001-36721 Dear Ms. Gowetski and Mr. Crawford, Coherus BioSciences, Inc. (the “Company”, “we”, “our”) is providing this letter in response to the comment received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) by letter dated August 23, 2024. To facilitate your review, we have included in bold italics the Staff’s comment below. Definitive Proxy Statement on Schedule 14A Pay Versus Performance, page 63 1. We note footnotes 4 and 5 to your pay versus performance table calculates total shareholder return and peer group total shareholder return using a measurement point of December 31, 2020. Please note that for calculating total shareholder return and peer group total shareholder return, the “’measurement period’ must be the period beginning at the ‘measurement point’ established by the market close on the last trading day before the registrant's earliest fiscal year in the table.” Please ensure your measurement period uses the correct measurement point for calculating total shareholder return and peer group total shareholder return. Refer to Item 402(v)(2)(iv) of Regulation S-K. Response The Company respectfully acknowledges the Staff’s comment and confirms that footnotes 4 and 5 to the Company’s pay versus performance table in the Company’s Definitive Proxy Statement on Schedule 14A, filed with the Commission on April 15, 2024 (the “2024 Proxy Statement”) each contained a typographical error for the measurement point. Instead of stating “December 31, 2020”, footnotes 4 and 5 should have each stated “December 31, 2019”. Despite the aforementioned measurement point referenced in these two footnotes, the actual calculations of total shareholder return and peer group total shareholder return used in the 2024 Proxy Statement’s pay versus performance table used the correct measurement point of December 31, 2019. The Company will ensure that the pay versus performance disclosures in future proxy statements use a measurement period with the correct measurement point for calculating total shareholder return and peer group total shareholder return and will also ensure that the pay versus performance table is derived from the calculations required by Item 402(v)(2)(iv) of Regulation S-K. * * * * Thank you for your consideration of the Company’s response. Please direct any questions or comments regarding this correspondence to our counsel, Phillip S. Stoup of Latham & Watkins LLP, at (415) 395-8216. Sincerely, /s/ Bryan McMichael Bryan McMichael Chief Financial Officer cc: Dennis M. Lanfear Max Brunner, Esq. Benjamin A. Potter, Esq., Latham & Watkins LLP Phillip S. Stoup, Esq., Latham & Watkins LLP
2024-08-23 - UPLOAD - Coherus Oncology, Inc. File: 001-36721
August 23, 2024
Dennis M. Lanfear
President and Chief Executive Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, California 94065
Re:Coherus BioSciences, Inc.
Definitive Proxy Statement on Schedule 14A
Filed April 15, 2024
File No. 001-36721
Dear Dennis M. Lanfear:
We have limited our review of your most recent definitive proxy statement to those issues
we have addressed in our comment.
Please respond to this letter by providing the requested information and/or confirming that
you will revise your future proxy disclosures in accordance with the topics discussed below. 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.
Definitive Proxy Statement on Schedule 14A
Pay Versus Performance, page 63
1.We note footnotes 4 and 5 to your pay versus performance table calculates total
shareholder return and peer group total shareholder return using a measurement point of
December 31, 2020. Please note that for calculating total shareholder return and peer
group total shareholder return, the “’measurement period’ must be the period beginning at
the ‘measurement point’ established by the market close on the last trading day before the
registrant's earliest fiscal year in the table.” Please ensure your measurement period uses
the correct measurement point for calculating total shareholder return and peer group total
shareholder return. Refer to Item 402(v)(2)(iv) of Regulation S-K.
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.
August 23, 2024
Page 2
Please contact Jennifer Gowetski at 202-551-3401 or Daniel Crawford at 202-551-7767
with any questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
cc:Max Brunner, Esq.
2023-07-24 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 July 24, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Re: Coherus BioSciences, Inc. Registration Statement on Form S-4 (File No. 333-273179) Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Coherus BioSciences, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-4 initially filed on July 7, 2023 and amended on July 24, 2023 (the “Registration Statement”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on July 26, 2023, or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with the Company’s counsel, Latham & Watkins LLP, by calling Benjamin A. Potter at (650) 470-4809. Very truly yours, Coherus BioSciences, Inc. By: /s/ McDavid Stilwell Name: McDavid Stilwell Title: Chief Financial Officer cc: Dennis M. Lanfear, Coherus BioSciences, Inc. Bryan McMichael, Coherus BioSciences, Inc. Benjamin A. Potter, Latham & Watkins LLP Phillip S. Stoup, Latham & Watkins LLP
2023-07-14 - UPLOAD - Coherus Oncology, Inc.
United States securities and exchange commission logo
July 13, 2023
McDavid Stilwell
Chief Financial Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
Re:Coherus BioSciences, Inc.
Registration Statement on Form S-4
Filed July 7, 2023
File No. 333-273179
Dear McDavid Stilwell:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Phillip S. Stoup
2022-11-15 - CORRESP - Coherus Oncology, Inc.
CORRESP
1
filename1.htm
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite
600
Redwood City, CA 94065
November 15, 2022
VIA EDGAR
United States Securities and
Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Re:
Coherus BioSciences, Inc.
Registration Statement on Form S-3
(File No. 333-268252)
Ladies and Gentlemen:
In accordance with Rule 461
of the General Rules and Regulations under the Securities Act of 1933, as amended, Coherus BioSciences, Inc. (the “Company”)
hereby requests acceleration of the effective date of its Registration Statement on Form S-3 initially filed on November 8, 2022 (the
“Registration Statement”). The Company respectfully requests that the Registration Statement become effective as of
4:00 p.m., Eastern Time, on November 17, 2022, or as soon thereafter as practicable. Once the Registration Statement has been declared
effective, please orally confirm that event with the Company’s counsel, Latham & Watkins LLP, by calling Benjamin A. Potter
at (650) 470-4809.
Very truly yours,
Coherus BioSciences, Inc.
By: /s/ McDavid Stilwell
Name: McDavid Stilwell
Title: Chief Financial Officer
cc:
Dennis M. Lanfear, Coherus BioSciences, Inc.
Bryan McMichael, Coherus BioSciences, Inc.
Benjamin A. Potter, Latham & Watkins LLP
Phillip S. Stoup, Latham & Watkins LLP
2022-11-14 - UPLOAD - Coherus Oncology, Inc.
United States securities and exchange commission logo
November 14, 2022
McDavid Stilwell
Chief Financial Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
Re:Coherus BioSciences, Inc.
Registration Statement on Form S-3
Filed November 8, 2022
File No. 333-268252
Dear McDavid Stilwell:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Benjamin A. Potter, Esq.
2022-04-20 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR April 20, 2022 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ibolya Ignat and Angela Connell Division of Corporation Finance Office of Life Sciences RE: Coherus BioSciences, Inc. Form 10-K for Fiscal Year Ended December 31, 2020 Filed February 25, 2021 Form 8-K furnished November 8, 2021 File No. 001-36721 Dear Ms. Ignat and Ms. Connell, Coherus BioSciences, Inc. (the “Company”, “we”, “our”) is providing this letter in response to the comment received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”) by letter dated December 16, 2021, (the “Comment Letter”) and the additional comment received from the Staff by letter dated April 7, 2022 (the “Additional Comment Letter”). To facilitate your review, we have included in bold italics the Staff’s comment from the Additional Comment Letter below. Form 8-K furnished November 8, 2021 Exhibit 99.1 Non-GAAP Financial Measures, page 7 1. We appreciate the information provided to us in your response letter and during our conference call. We believe that your adjustments to exclude the upfront and milestone based license fees from Non-GAAP net (loss) are inconsistent with the guidance in Question 100.01 of the Non-GAAP Financial Measures Compliance and Disclosure Interpretations. Please confirm to us that you will no longer include these adjustments in any non-GAAP financial measure presented in accordance with Item 10(e) of Regulation S-K or Regulation G. Response The Company acknowledges the Staff’s comment and advises the Staff that in our future Form 8-K filings, earnings releases and other presentations that include Non-GAAP financial measures, for all periods presented, we will no longer make adjustments to exclude the upfront and milestone based license fees from Non-GAAP net (loss) and any other non-GAAP financial measures presented in accordance with Item 10(e) of Regulation S-K or Regulation G. We will update prior period information for comparability to current year presentation. In connection with responding to the Additional Comment Letter, the Company acknowledges that it is responsible for the adequacy and accuracy of the disclosures in its filings notwithstanding any Staff comments or changes to disclosure in response to Staff comments. If you have any further questions regarding the matters addressed in this letter, I can be reached at (650) 395-0152, and if I am not available, please contact Bryan McMichael, Coherus’ Senior Vice President, Corporate Controller, at (650) 649-3548. Sincerely, /s/ McDavid Stilwell McDavid Stilwell Chief Financial Officer cc: Bryan McMichael
2022-04-20 - UPLOAD - Coherus Oncology, Inc.
United States securities and exchange commission logo
April 20, 2022
McDavid Stilwell
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, 2020
Filed February 25, 2021
File No. 001-36721
Dear Mr. Stilwell:
We have completed our review of your filings. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-04-07 - UPLOAD - Coherus Oncology, Inc.
United States securities and exchange commission logo
April 7, 2022
McDavid Stilwell
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, 2020
Filed February 25, 2021
Form 8-K furnished November 8, 2021
File No. 001-36721
Dear Mr. Stilwell:
We have reviewed your December 30, 2021 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 this comment, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
December 16, 2021 letter.
Form 8-K furnished November 8, 2021
Exhibit 99.1
Non-GAAP Financial Measures, page 7
1.We appreciate the information provided to us in your response letter and during
our conference call. We believe that your adjustments to exclude the upfront and
milestone based license fees from Non-GAAP net (loss) are inconsistent with the
guidance in Question 100.01 of the Non-GAAP Financial Measures Compliance and
Disclosure Interpretations. Please confirm to us that you will no longer include these
adjustments in any non-GAAP financial measure presented in accordance with Item 10(e)
of Regulation S-K or Regulation G.
FirstName LastNameMcDavid Stilwell
Comapany NameCoherus BioSciences, Inc.
April 7, 2022 Page 2
FirstName LastName
McDavid Stilwell
Coherus BioSciences, Inc.
April 7, 2022
Page 2
Please contact Angela Connell, Accounting Branch Chief, at (202) 551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-12-30 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR December 30, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ibolya Ignat and Angela Connell Division of Corporation Finance Office of Life Sciences RE: Coherus BioSciences, Inc. Form 10-K for Fiscal Year Ended December 31, 2020 Filed February 25, 2021 Form 8-K furnished November 8, 2021 File No. 001-36721 Dear Ms. Ignat and Ms. Connell, Coherus BioSciences, Inc. (the “Company”, “we”, “our”) is providing this letter in response to the comment received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “SEC”) by letter dated December 16, 2021, (the “Comment Letter”). To facilitate your review, we have included in bold italics the Staff’s comment below. Form 8-K furnished November 8, 2021 Exhibit 99.1 Non-GAAP Financial Measures, page 7 1. Your presentation of Non-GAAP net (loss) income includes an adjustment for upfront and milestone based license fees. Please tell us how you determined that these fees do not represent normal, recurring, cash operating expenses necessary to operate your business. In this regard, we note that the related licensing transactions are accounted for as asset acquisitions. However, as a license to certain product candidates appears to be the only asset acquired and as the development of these product candidates is an integral part of your business, it is unclear how this adjustment would not violate Question 100.01 of the Non-GAAP Financial Measures Compliance and Disclosure Interpretations. Response In connection with responding to the Comment Letter, the Company performed a critical reassessment of its approach to presenting adjustments to Non-GAAP net (loss) income for upfront and milestone based license fees. Through its review, the Company confirmed its belief that upfront license and collaboration expenses (“Upfronts”) are fundamentally different from normal, recurring research and development expenses. This determination is based primarily on the considerations discussed below, each of which the Company believes are inconsistent with normal, recurring, cash operating expenses considered necessary to operate its business. To help illustrate this, the Company has included below discussion on how each of these considerations applied to the transaction reflected in the 2021 GAAP to Non-GAAP reconciliation appearing in the Current Report on Form 8-K furnished by the Company on November 8, 2021 (the “November 2021 8-K”). The treatment of milestone based license fees is also discussed below. Strategic Nature Upfront payments generally occur at the inception of a multi-year arrangement that is both individually and strategically significant to the Company. Substantial effort and attention across multiple functions of the Company, including at the most senior levels of the organization, are invested into the decision to enter a licensing transaction that involves any Upfront consideration. In the Company’s experience, each Upfront has coincided with a significant recalibration in the Company’s priorities, capital allocation strategy, assessment of organizational risks and opportunities, and the needs and allocations of resources. Although contractual terms and conditions and the words used to describe agreements may be similar from one licensing arrangement to another, each collaboration is unique. For example, the Company’s collaborations all differ in a number of ways, such as the structure of the relationship with the partner, the degree of influence that the partner possesses over the development activities for product candidates, the Company’s required level of involvement, the day-to-day collaboration activities and the degree to which the collaboration represents a strategic change for the Company. Based on the above and with respect to the transaction and non-GAAP adjustments in the November 2021 8-K referred to in the Comment Letter (the “Junshi Biosciences Transaction”), the Company respectfully advises the Staff: • The $150 million Upfront, inclusive of the $5 million right of first negotiation fee fully credited against the total upfront obligation, paid in the Junshi Biosciences Transaction was the largest single expenditure made by the Company by several orders of magnitude since its inception and equaled 18% and 20% of the Company’s total assets and total current assets, respectively, as of December 31, 2020, which was the last quarterly balance sheet date preceding the close of the Junshi Biosciences Transaction. • Entering into the Junshi Biosciences Transaction, and thus paying the associated Upfront, was the catalyst in the Company’s transformation away from a strategy solely dependent upon the development and sales of biosimilar products to a strategy that leverages cash flows from those products to invest in the immuno-oncology market. Through this transaction, the Company made a major shift in its business model and changed its fundamental business strategy. Regularity and Predictability The Company further advises the Staff that the transactions to which Upfronts relate are generally not forecasted. This is due to several inherent characteristics of licensing transactions, which are generally outside the Company’s control, including: the availability of a partner that is a strategic fit, interested in working with the Company and willing to accept contracts with commercially favorable terms or at all; the timing and frequency of attractive intellectual property becoming available for a licensing transaction; the competitive climate related to other potential competitors for the transaction; how the transaction fits into the Company’s strategy and other commitments at the time the opportunity arises. Based on the Company’s experience, there is no discernable pattern or seasonality and no reliable basis to predict when such opportunities arise. Accordingly, because Upfronts generally occur only in opportunistic situations, the Company does not budget for them. As such, the Company regularly uses its non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. With respect to the Junshi Biosciences Transaction, the Upfront paid was the third such payment made by the Company since it became public in 2014 and its largest paid to date. It took the Company approximately two years of searching the global checkpoint inhibitor landscape and evaluating potential collaboration partners to find a PD-1 inhibitor antibody that met the Company’s scientific and commercial requirements. The Company conducted a rigorous assessment that included reviewing over a dozen PD-1 candidates before the Junshi Biosciences Transaction closed. Pace and Level of Uncertainty The list below represents a summary of total research and development expenses other than Upfronts and milestones the Company generally incurs. The Company respectfully notes that since no Upfront was paid related to the development of either the Company’s only current commercial product, Udenyca®, or for the Company’s biosimilar of Humira®, YUSIMRYTM, which was recently approved by the FDA as announced by the Company on December 20, 2021 and that the Company plans to launch in July 2023, this list represents what the Company believes to be normal, recurring, cash operating expenses related to research and development necessary to operate its business: • expense incurred under agreements with consultants, third-party contract research organizations (“CROs”), and investigative sites where a substantial portion of the Company’s preclinical studies and all of the Company’s clinical trials are conducted; • costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from contract manufacturing organizations (“CMOs”), and related costs associated with release and stability testing; • costs associated with manufacturing process development activities; and • internal costs associated with activities performed by the Company’s research and development organization. Entering a licensing transaction generally allows the Company to forgo the expense and time incurred for a significant portion of the activities related to the costs noted above. Additionally, because the intellectual property being licensed has generally been proven to a certain extent, there is less uncertainty in a successful outcome of further development when compared to beginning such research at earlier stages. Using the Junshi Biosciences Transaction to illustrate the points above, toripalimab, the molecule licensed in the Junshi Biosciences Transaction, had been in development since 2015 and at the time the collaboration was consummated, had already been evaluated in 15 registrational clinical trials across a broad range of rare and highly prevalent tumor types, received regulatory approval outside of the United States and breakthrough therapy designation from the FDA. Entering into the Junshi Biosciences Transaction was a singular event that marked a fundamental change in the Company’s strategy and also gave the Company access to an established molecule, as opposed to normal, recurring cash operating expense related to research and development. Proposed Changes While the Company continues to believe that upfront transactions and milestone payments are fundamentally different from normal, recurring research and development expenses, in response to the Staff’s comment and the Company’s critical reassessment of its approach to Non-GAAP reporting, the Company proposes making the following changes related to future transactions beginning with the Company’s earnings release for the fourth quarter of 2021: • Upfronts that are not considered individually significant will not be adjusted in the Company’s presentation of non-GAAP earnings. For purposes of performing this evaluation, transactions will be screened using both quantitative and qualitative measures. The primary reason for this change will be to restrict adjustments for Upfronts reflected as adjustments in the Company’s non-GAAP reporting to those that directly enhance investors’ abilities to meaningfully compare the Company’s results from period to period, and to identify operating trends in the Company’s business. • Future milestone payments will no longer be presented as adjustments in the Company’s non-GAAP earnings. Although potential payout amounts of milestones are generally set at the same time as Upfronts and serve as contingent consideration in those transactions, once a licensing transaction has been consummated, the related potential milestone payments are generally incorporated into the Company’s planning and forecasting. The primary reason for this change is to more closely align the presentation in the Company’s non-GAAP reporting with the measures of the Company’s business performance used by its management. For the foregoing reasons, the Company respectfully advises the Staff that it believes its historical presentation excluding upfront and milestone payments from its non-GAAP financial measures, has not violated the guidance set forth in Question 100.01. Further, the Company respectfully advises the Staff that it believes that the proposed changes elaborated above will improve the Company’s non-GAAP presentation in the future. In connection with responding to the Comment Letter, the Company acknowledges that: (1) it is responsible for the adequacy and accuracy of the disclosure in the filing; (2) Staff comments or changes to disclosure in response to Staff comments do not foreclose the SEC from taking any action with respect to the filing; and (3) the Company may not assert the Staff comments as a defense in any proceeding initiated by the SEC or any person under the federal securities laws of the United States. Thank you for your consideration of the Company’s responses. If you have any further questions regarding the matters addressed in this letter, I can be reached at (650) 395-0152, and if I am not available, please contact Bryan McMichael, Coherus’ Senior Vice President, Corporate Controller, at (650) 649-3548. Sincerely, /s/ McDavid Stilwell McDavid Stilwell Chief Financial Officer cc: Bryan McMichael
2021-12-16 - UPLOAD - Coherus Oncology, Inc.
United States securities and exchange commission logo
December 16, 2021
McDavid Stilwell
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, 2020
Filed February 25, 2021
Form 8-K furnished November 8, 2021
File No. 001-36721
Dear Mr. Stilwell:
We have limited our review of your filings to the financial statements and related
disclosures 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 the 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.
Form 8-K furnished November 8, 2021
Exhibit 99.1
Non-GAAP Financial Measures, page 7
1.Your presentation of Non-GAAP net (loss) income includes an adjustment for upfront and
milestone based license fees. Please tell us how you determined that these fees do not
represent normal, recurring, cash operating expenses necessary to operate your business.
In this regard, we note that the related licensing transactions are accounted for as asset
acquisitions. However, as a license to certain product candidates appears to be the only
asset acquired and as the development of these product candidates is an integral part of
your business, it is unclear how this adjustment would not violate Question 100.01 of the
Non-GAAP Financial Measures Compliance and Disclosure Interpretations.
FirstName LastNameMcDavid Stilwell
Comapany NameCoherus BioSciences, Inc.
December 16, 2021 Page 2
FirstName LastName
McDavid Stilwell
Coherus BioSciences, Inc.
December 16, 2021
Page 2
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.
You may contact Ibolya Ignat at (202) 551-3636 or Angela Connell at (202) 551-3426
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-11-18 - UPLOAD - Coherus Oncology, Inc.
November 18, 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
Dear Mr. Viret:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-11-06 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, California 94065 November 6, 2019 VIA EDGAR United States Securities and Exchange Commission Washington, D.C. 20549 Attention: Ibolya Ignat Division of Corporation Finance Re: 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 Ms. Ignat, Coherus BioSciences, Inc. (“Coherus”, the “Company” or “we”) is transmitting this letter in response to comments received from the staff of the Securities Exchange Commission (the “Staff”), contained in the Staff’s letter dated October 24, 2019 (“Comment Letter”), with respect to the Company’s Form 10-K for the year ended December 31, 2018 and Form 10-Q for the quarter ended June 30, 2019. For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. 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, • 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. We respectfully acknowledge the Staff’s Comment Letter and the Company proposes to include the following language in its future periodic reports, stated hereunder for the year ended December 31, 2019, as an example: “The cost of goods sold was [$xx.x] million and $0 for the year ended December 31, 2019 and 2018, respectively. Cost of goods sold consists primarily of third-party manufacturing, distribution, overhead costs associated with the sale of UDENYCA® and a mid-single digit royalty cost on net product revenue to Amgen, which began on July 1, 2019 and will continue for five years. A portion of the manufacturing costs for inventory were incurred prior to the regulatory approval of UDENYCA® and therefore were expensed as research and development costs when incurred. The costs associated with this inventory were approximately [$xx.x] and [$xx.x] at December 31, 2019 and 2018, respectively, with estimated associated sales value of approximately [$xx.x] and [$xx.x], respectively, based on our current average net selling price for the year ended December 31, 2019. During the year ended December 31, 2019, the cost basis of product sold that was expensed prior to approval, was approximately [$xx.x]. Had such inventories been valued at acquisition cost, it would have resulted in a corresponding increase in cost of goods sold and a corresponding decrease in gross margin during such period. We expect utilizing the inventory expensed prior to approval by [the x quarter of 20xx]. Subsequent to using our entire zero cost inventory, we estimate cost of goods sold as a percentage of net product revenue will be in the range of [high single digit to low double digit percentage], including the mid-single digit royalty cost on net product revenue.” With respect to your question on the shelf life of our inventory, we manufacture UDENYCA® in three stages: 1) bulk drug substance manufacturing, that yields the active ingredient, pegfilgrastim; 2) drug product filling, that yields syringes containing formulated pegfilgrastim; and 3) labeling, assembling and packaging of syringes, that yields a ready-to-sell finished good. After the first stage of the manufacturing process, the bulk drug substance has a shelf life of up to 12 months as stored. Once we complete the second stage of the production, the naked syringes containing pegfilgrastim have a shelf life of up to 36 months. Therefore, we confirm that UDENYCA®’s shelf life is effectively up to 48 months, because once pegfilgrastim is placed in a syringe, whether it is two months or ten months post the completion of the first stage of production, that syringe has a 36 month shelf life. Thus, we have a 12-month slack to manufacture a final product with a 36-month shelf life. Please do not hesitate to contact the undersigned at (650) 649-3546, if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Jean-Fréderic Viret, Ph.D. Jean-Fréderic Viret, Ph.D. Chief Financial Officer Coherus BioSciences, Inc. cc: Dennis M. Lanfear, Chief Executive Officer, Coherus BioSciences, Inc. Alan Mendelson, Esq., Latham & Watkins LLP
2019-10-24 - UPLOAD - Coherus Oncology, Inc.
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
2019-10-15 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83 Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, California 94065 October 15, 2019 VIA EDGAR United States Securities and Exchange Commission Washington, D.C. 20549 Attention: Ibolya Ignat Division of Corporation Finance Re: 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 Ms. Ignat, Coherus BioSciences, Inc. (“Coherus” or the “Company”) is transmitting this letter in response to comments received from the staff of the Securities Exchange Commission (the “Staff”), contained in the Staff’s letter dated October 3, 2019 (“Comment Letter”), with respect to the Company’s Form 10-K for the year ended December 31, 2018 and Form 10-Q for the quarter ended June 30, 2019. For your convenience, the Staff’s comment is reproduced in bold type below, followed by the Company’s response thereto. 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. It appears your cost of product revenues was only 0.7% and 2.3% of net product revenues for the quarter and six months ended June 30, 2019. You disclose that a portion of the costs of producing UDENYCA sold to date was expensed as research and development prior to FDA approval and therefore is not reflected in the cost of goods sold. You further state on page 14 that cost of goods sold includes a write-off of prepaid manufacturing costs of $1.3 million and $0.4 million due to excess and obsolete inventory. Please tell us the following: • the amount of estimated revenues represented by inventory on hand at June 30, 2019 for which manufacturing costs were expensed in prior periods as research and development expenses (i.e. “zero cost inventories”), As stated in its Form 10-K and Form 10-Q referenced above, the Company expensed all costs related to manufacturing of its product UDENYCA® (including stability costs and manufacturing overhead) as incurred prior to receiving the FDA approval for UDENYCA® on November 2, 2018. UDENYCA®, a biosimilar product of Neulasta®, is manufactured in three stages: 1) bulk drug substance manufacturing, that yields the active ingredient, pegfilgrastim; [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Coherus BioSciences, Inc. with respect to portions of this letter. 2) drug product filling, that yields syringes containing formulated pegfilgrastim; and 3) labeling, assembling and packaging of syringes, that yields a ready-to-sell finished good. Because the Company needed final comments from the FDA on UDENYCA® packaging and package insert, the relatively small costs associated with the third and final stage of labeling, assembling and packaging in the manufacturing process were incurred post FDA approval, and were therefore capitalized as inventory. As of June 30, 2019, the zero cost inventories are primarily in the form of bulk drug substance and secondarily in the form of drug product (i.e., naked syringes). As of June 30, 2019, the amount of future estimated net revenues represented by existing physical zero cost inventories at June 30, 2019 is approximately $[***], which assumes the current gross-to-net discount of 45% from gross sales. However, it is anticipated that the gross-to-net discount will increase resulting in lower net revenues from zero cost inventories due to two factors: 1) the possible future entry of other biosimilar competitor products in the United States, on top of an existing biosimilar competitor product, which launched in July 2018 (Fulphila® manufactured by Mylan N.V.), and the originator product (Neulasta® manufactured by Amgen Inc.); and 2) the Company’s future strategic response to increasing competition and its behavior with respect to discounts and rebates, which would cause a decrease in net revenues per unit sold in future periods. Accordingly, the Company cannot estimate reliably its gross-to-net discount and future net revenues. Please note that US-only net revenues for Neulasta® were $3.9 billion in 2018 (Source: Amgen Inc. – Form 10-K for fiscal year ended December 31, 2018 on page 47). • when you expect to finish selling the zero cost inventories, As of June 30, 2019, the Company estimated the future demand for UDENYCA® based on two assumptions: 1) [***]; and 2) [***]. Based on these assumptions, the Company expected to finish selling zero cost inventories during [***]. • if the non-current inventory relates to inventory that will not be sold due to the zero cost inventory runoff, As of June 30, 2019, the Company anticipates that it will sell the entire non-current inventory starting after June 30, 2020 due to the product long shelf life. • what the shelf life of your inventory is and your consideration of whether or not any additional inventory will be determined to be obsolete in future periods, and The shelf life of bulk drug substance, pegfilgrastim, is 12 months and the shelf life of the finished product, UDENYCA®, is 36 months, thus the combined shelf life of drug substance and drug product can be accommodated to be up to 48 months. The Company does not anticipate that any additional inventory will be determined to be obsolete in future periods. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Coherus BioSciences, Inc. with respect to portions of this letter. • what you estimate your gross margin percentage will be after the zero cost inventories are sold. The Company cannot reliably estimate the gross margin percentage after the zero cost inventories are sold during 2021, because the Company cannot reliably estimate net revenue, since the Company may adjust its pricing strategy based on the competitive landscape and cannot reliably predict both market share and net price per unit sold. As of June 30, 2019, the Company estimates that the gross margin would have been approximately [***]% for both the three- and six-months ended June 30, 2019 based on its current bill of material, its current net revenue amounts, and including the [***]% royalty on net revenues that is due to Amgen Inc. beginning on July 1, 2019. The Company anticipates that the net revenues per unit of UDENYCA® sold will decrease in future reporting periods as the market place for pegfilgrastim products is competitive, and as result, the Company anticipates its gross margin percentage will decline. Please do not hesitate to contact the undersigned at (650) 649-3546, if you have any questions or would like additional information regarding these matters. Sincerely, /s/ Jean-Fréderic Viret, Ph.D. Jean-Fréderic Viret, Ph.D. Chief Financial Officer Coherus BioSciences, Inc. cc: Dennis M. Lanfear, Chief Executive Officer, Coherus BioSciences, Inc. Alan Mendelson, Esq., Latham & Watkins LLP [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Coherus BioSciences, Inc. with respect to portions of this letter.
2019-10-03 - UPLOAD - Coherus Oncology, Inc.
October 3, 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 filing 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 the 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.
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.It appears your cost of product revenues was only 0.7% and 2.3% of net product revenues
for the quarter and six months ended June 30, 2019. You disclose that a portion of the
costs of producing UDENYCA sold to date was expensed as research and development
prior to FDA approval and therefore is not reflected in the cost of good sold. You further
state on page 14 that cost of goods sold includes a write-off of prepaid manufacturing
costs of $1.3 million and $0.4 million due to excess and obsolete inventory. Please tell us
the following:
•the amount of estimated revenues represented by inventory on hand at June 30, 2019
for which manufacturing costs were expensed in prior periods as research and
FirstName LastNameJean-Frédéric Viret
Comapany NameCoherus BioSciences, Inc.
October 3, 2019 Page 2
FirstName LastName
Jean-Frédéric Viret
Coherus BioSciences, Inc.
October 3, 2019
Page 2
development expenses (i.e."zero cost inventories"),
•when you expect to finish selling the zero cost inventories,
•if the non-current inventory relates to inventory that will not be sold due to the zero
cost inventory runoff,
•what the shelf life of your inventory is and your consideration of whether or not any
additional inventory will be determined to be obsolete in future periods, and
•what you estimate your gross margin percentage will be after the zero cost
inventories are sold.
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.
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
2018-05-04 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Company Acceleration Request Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 May 4, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Chris Edwards Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-222698) Initially Filed January 25, 2018 and Amended May 4, 2018 Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of Coherus BioSciences, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on May 7, 2018, or as soon as practicable thereafter. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Jean-Frédéric Viret Jean-Frédéric Viret Chief Financial Officer
2018-03-27 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 March 27, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Chris Edwards Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-222698) Ladies and Gentlemen: On March 22, 2018, Coherus BioSciences, Inc. (the “Company”) submitted a letter requesting that the above-referenced Registration Statement be declared effective on March 27, 2018, at 4:00 p.m., Washington, D.C. time. By this letter the Company hereby withdraws the acceleration request dated March 22, 2018. Please direct any questions or comments regarding this correspondence to our counsel, Benjamin A. Potter of Latham & Watkins LLP, at (650) 470-4809. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Jean-Frédéric Viret Jean-Frédéric Viret Chief Financial Officer cc: Benjamin A. Potter, Latham & Watkins LLP
2018-03-22 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 March 22, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Chris Edwards Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-222698) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of Coherus BioSciences, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on March 27, 2018, or as soon as practicable thereafter. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Jean-Frédéric Viret Jean-Frédéric Viret Chief Financial Officer
2018-02-16 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 February 16, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-4628 Attn: Chris Edwards Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-222698) Ladies and Gentlemen: On February 14, 2018, Coherus BioSciences, Inc. (the “Company”) submitted a letter requesting that the above-referenced Registration Statement be declared effective on February 19, 2018, at 4:00 p.m., Washington, D.C. time. By this letter the Company hereby withdraws the acceleration request dated February 14, 2018. Please direct any questions or comments regarding this correspondence to our counsel, Benjamin A. Potter of Latham & Watkins LLP, at (650) 470-4809. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Jean-Frédéric Viret Jean-Frédéric Viret Chief Financial Officer cc: Benjamin A. Potter, Latham & Watkins LLP
2018-02-14 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm CORRESP Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 February 14, 2018 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Chris Edwards Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-222698) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of Coherus BioSciences, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on February 19, 2018, or as soon as practicable thereafter. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Jean-Frédéric Viret Jean-Frédéric Viret Chief Financial Officer
2018-02-01 - UPLOAD - Coherus Oncology, Inc.
February 1, 2018
Dennis M. Lanfear
President and Chief Executive Officer
Coherus BioSciences, Inc.
333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
Coherus BioSciences, Inc.
Registration Statement on Form S-3
Filed January 25, 2018
File No. 333-222698Re:
Dear Mr. Lanfear:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Chris Edwards at 202-551-6761 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Benjamin A. Potter, Esq.
2017-10-11 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Acceleration Letter Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 October 11, 2017 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Jeffrey Gabor Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-220590) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of Coherus BioSciences, Inc. We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on October 16, 2017, or as soon as practicable thereafter. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Dennis M. Lanfear Dennis M. Lanfear President and Chief Executive Officer
2017-09-28 - UPLOAD - Coherus Oncology, Inc.
September 28, 2017 Dennis Lanfear President and Chief Executive Officer Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 Coherus BioSciences, Inc. Registration Statement on Form S-3 Filed September 22, 2017 File No. 333-220590Re: Dear Mr. Lanfear: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. 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 Jeffrey Gabor at 202-551-2544 with any questions. Division of Corporation Finance Office of Healthcare & Insurance cc: Benjamin Potter
2016-01-19 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Company Acceleration Request Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 January 19, 2016 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Michael Gershon Suzanne Hayes Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 (Registration No. 333-208625) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration by the Securities and Exchange Commission (the “Commission”) of the effective date of the above-referenced Registration Statement on Form S-3 (the “Registration Statement”) of Coherus BioSciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Washington, D.C. time, on January 21, 2016, or as soon as practicable thereafter. The Company acknowledges the following: • should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Thank you for your assistance in this matter. Very truly yours, Coherus BioSciences, Inc. By: /s/ Dennis M. Lanfear Dennis M. Lanfear President and Chief Executive Officer [Signature Page to Coherus BioSciences, Inc. Acceleration Letter]
2015-12-22 - UPLOAD - Coherus Oncology, Inc.
Mail Stop 4720 December 2 2, 2015 Dennis M. Lanfear President and Chief Executive Officer Coherus BioSciences, Inc. 333 Twin Dolphin Drive, Suite 600 Redwood City, CA 94065 Re: Coherus BioSciences, Inc. Registration Statement on Form S-3 Filed December 18, 2015 File No. 333-208625 Dear Mr. Lanfear : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Dennis M. Lanfear Coherus BioSciences, Inc. December 2 2, 2015 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Michael Gershon at (202) 551 -6598 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Alan C. Mendelson, Esq.
2014-11-03 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Prepared by R.R. Donnelley Financial -- Company Acceleration Request November 3, 2014 VIA EDGAR AND E-MAIL United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Jeffrey P. Riedler, Assistant Director Tabatha McCullom James Rosenburg Daniel Greenspan Scot Foley Re: Coherus BioSciences, Inc. Registration Statement on Form S-1 (Registration No. 333-198936) Ladies and Gentlemen: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (File No. 333-198936) (the “Registration Statement”) of Coherus BioSciences, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:30 p.m., Washington, D.C. time, on November 5, 2014, or as soon as practicable thereafter. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Benjamin Potter at (650) 470-4809. The Company acknowledges the following: • should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. 201 Redwood Shores Parkway, Suite 200, Redwood City, CA 94065 Main: 650.649.3530 Page 1 Thank you for your assistance in this matter. Very truly yours, COHERUS BIOSCIENCES, INC. By: /s/ Dennis M. Lanfear Dennis M. Lanfear President and Chief Executive Officer cc: Alan C. Mendelson, Esq., Latham & Watkins LLP Benjamin A. Potter, Esq., Latham & Watkins LLP Alan F. Denenberg, Esq., Davis Polk & Wardwell LLP Stephen Salmon, Esq., Davis Polk & Wardwell LLP 201 Redwood Shores Parkway, Suite 200, Redwood City, CA 94065 Main: 650.649.3530 Page 2
2014-10-07 - CORRESP - Coherus Oncology, Inc.
CORRESP 1 filename1.htm Prepared by R.R. Donnelley Financial -- Letter to the SEC 140 Scott Drive Menlo Park, California 94025 Tel: +1.650.328.4600 Fax: +1.650.463.2600 www.lw.com FIRM / AFFILIATE OFFICES Abu Dhabi Milan Barcelona Moscow Beijing Munich Boston New Jersey Brussels New York Chicago Orange County Doha Paris Dubai Riyadh Düsseldorf Rome Frankfurt San Diego Hamburg San Francisco Hong Kong Shanghai October 7, 2014 Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. File No. 048749-0010 Via EDGAR and Overnight Delivery U.S. Securities and Exchange Commission FOIA Confidential Treatment Request Division of Corporation Finance Under 17 C.F.R §200.83 100 F Street, N.E. Washington, DC 20549-3720 Attention: Jeffrey P. Riedler, Assistant Director Tabatha McCullom James Rosenburg Daniel Greenspan Scot Foley Re: Coherus BioSciences, Inc. Registration Statement on Form S-1 (File No. 333-198936) Ladies and Gentlemen: On behalf of Coherus BioSciences, Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in a letter dated September 3, 2014 (the “Initial Comment Letter”), relating to the draft Registration Statement on Form S-1 confidentially submitted with the Commission on August 4, 2014 (as amended by an exhibit-only draft Amendment No. 1 to the Form S-1 submitted on August 5, 2014, a draft Amendment No. 2 to the Form S-1 submitted on September 15, 2014 and an exhibit-only draft Amendment No. 3 to the Form S-1 submitted on September 24, 2014, the “DRS”), we submit this supplemental letter (this “Letter”) to further address Comment No. 13 of the Initial Comment Letter. The Company notes that in between receipt of the Initial Comment Letter and delivery of this Letter, the Company filed the Registration Statement on Form S-1 (the “Registration Statement”) (File No. 333-198936) on September 25, 2014. In addition, the Company filed Amendment No. 1 to the Registration Statement (“Amendment No. 1”) on October 6, 2014 in connection with the submission of the Company’s response letter dated October 6, 2014. October 7, 2014 Page 2 On behalf of the Company, we are respectfully requesting confidential treatment for specified portions of this letter pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.83. This letter is accompanied by such request for confidential treatment because of the commercially sensitive nature of the information discussed in this letter. A redacted version of this letter will be filed with the Commission on EDGAR, omitting the confidential information. The Company does not intend to commence marketing the proposed offering contemplated by the Registration Statement until the 21-day period provided for in Section 6(e)(1) of the Securities Exchange Act of 1933, as amended, has expired, market conditions permitting. Accordingly, no price range has yet been provided in the preliminary prospectus included in Amendment No. 1. However, the Company has authorized us to inform the Staff of the Commission (the “Staff”) supplementally that, based on consultations with the lead underwriters, if the marketing of the initial public offering were to commence today, the Company’s present view is that the estimated offering range would be $[***] to $[***] per share (the “Preliminary IPO Price Range”), with a midpoint price of $[***] (the “Midpoint Price”). The Preliminary IPO Price Range and Midpoint Price do not reflect any reverse stock split that the Company might give effect prior to the Commission’s declaration of effectiveness of the Registration Statement. The Company anticipates implementing a reverse stock split, which, for purposes of this Letter, the Company currently estimates to be approximately [***] to 1.0. This reverse stock split would result in a post-split Preliminary IPO Price Range of $[***] to $[***] per share, with a midpoint of $[***] per share. The Company’s final post-split Preliminary IPO Price Range remains under discussion between the Company and the lead underwriters, and a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus in connection with the Company’s road show. The Company advises the Staff that the Preliminary IPO Price Range represents the Company’s current belief of what the indicative price range in the preliminary prospectus may be, but that the actual indicative price range in the preliminary prospectus will not be determined until the Company completes a valuation process with the underwriters of the offering, which is expected to occur shortly before the printing of the preliminary prospectus for the offering. Therefore, the preliminary estimated indicative price range is subject to further change as a result of various factors, including market conditions and subsequent development of the Company’s business. Upon completion of this valuation process, the Company will establish a bona fide offering price range not to be greater than $2.00 between the low end of the range and the top end of the range. To assist the Staff in its evaluation of the Company’s stock-based compensation, the Company has provide the analysis as set forth below. GRANTS OF COMMON STOCK OPTIONS AND WARRANTS IN THE PRECEDING 12 MONTHS The following table summarizes by month of grant date the number of shares of common stock underlying stock options and warrants granted during the previous twelve months, as well as the associated per share exercise price, the estimated fair value per share of the Company’s common stock on the grant date and the reassessed fair value per share of the Company’s common stock on the grant date following additional third-party valuations commissioned by the Company in connection with the Company’s initial public offering (the “IPO”). CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY COHERUS BIOSCIENCES, INC. WITH RESPECT TO THIS LETTER. October 7, 2014 Page 3 Grant Date Number of Shares underlying Stock Options Granted Per Share Exercise Price Estimated Fair Value per Share on Date of Grant Reassessed Fair Value per Share on Date of Grant(1) November 22, 2013 1,310,300 $ 0.85 $ 0.85 $ 1.50 March 11, 2014 3,561,675 $ 1.00 $ 1.00 $ 3.44 April 7, 2014 50,000 $ 1.00 $ 1.00 $ 3.44 June 30, 2014 885,000 $ 1.50 $ 1.50 $ 4.86 July 1, 2014 10,000 $ 1.50 $ 1.50 $ 4.86 Grant Date Number of Shares underlying Warrants Granted Per Share Exercise Price Estimated Fair Value per Share on Date of Grant Reassessed Fair Value per Share on Date of Grant(1) March 28, 2014 922,309 $ 1.00 $ 1.00 $ 3.44 (1) Subsequent to each grant date and in connection with the IPO, the Company commissioned additional third-party valuations of the estimated fair values per share of its common stock as of each quarter end. See “Historical Fair Value Determination and Methodology” and “Valuations and Option and Warrant Grants over the Previous 12 Months” below for more information. HISTORICAL FAIR VALUE DETERMINATION AND METHODOLOGY The Company has historically determined the estimated fair value of its common stock using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “AICPA Practice Guide”). In addition, the Company’s Board of Directors (the “Board”) also considered numerous objective and subjective factors, along with input from management and third-party valuations, to determine the fair value of the Company’s common stock as disclosed in the Registration Statement. As described in more detail in this Letter, for the prior 12-month period the Company has utilized the probability-weighted expected return method (“PWERM”) alone or in combination with the option pricing method (“OPM”) as a hybrid method (“Hybrid Method”), each an accepted valuation method under the AICPA Practice Guide, for determining the fair value of its common stock. The PWERM is a scenario-based analysis that estimates the value per share of common stock based on the probability-weighted present value of expected future equity values for the common stock, under various possible future liquidity event scenarios, in light of the rights and preferences of each class of stock, discounted for a lack of marketability. The OPM values each equity class by creating a series of call options on the equity value, with exercise prices based on the liquidation preferences, participation rights and strike prices of derivatives. The Hybrid Method is appropriate for a company expecting a near term liquidity event, but where, due to market or other factors, the likelihood of completing the liquidity event is uncertain. The Hybrid Method considers a company’s going concern nature, stage of development and the company’s ability to forecast near and long-term future liquidity scenarios. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY COHERUS BIOSCIENCES, INC. WITH RESPECT TO THIS LETTER. October 7, 2014 Page 4 At each grant date, the Board evaluated any recent events and their potential impact on the estimated fair value per share of the common stock. The Board ultimately determined the fair value of the common stock on the date of grant taking into consideration the immediately preceding independent third-party valuation report as well as other pertinent information available to it at the time of the grant. In connection with the preparation of the DRS for confidential submission to the Commission, Company management reassessed the fair value of the Company’s common stock as of the date of each option and warrant grant over the previous 12 months. These determinations were based in part on supplemental valuations performed by a third-party independent valuation specialist which indicated the estimated fair value of the Company’s common stock to be $1.50 as of September 30, 2013 (the “Q3’13 Revaluation”), $1.80 as of December 31, 2013 (the “Q4’13 Revaluation”), $3.44 as of March 31, 2014 (the “Q1’14 Revaluation”) and $4.86 as of June 30, 2014 (the “Q2’14 Revaluation,” and together with the Q3’13 Revaluation, the Q4’13 Revaluation and the Q1’14 Revaluation, the “Revaluations”) using the PWERM or the Hybrid Method. As described in further detail in “Valuations and Option and Warrant Grants over the Previous 12 Months” below, Company management reassessed the fair value of the Company’s common stock as of the date of each option and warrant grant using the immediately preceding Revaluation for purposes of certain financial disclosures in the DRS, with the exception of the options granted on March 11, 2014 and the warrants granted on March 28, 2014, in which case Company management used the subsequent Revaluation, the Q1’14 Revaluation. VALUATIONS AND OPTION AND WARRANT GRANTS OVER THE PREVIOUS 12 MONTHS Original October 31, 2013 Valuation, Q3’13 Revaluation and Grants of November 2013 On November 22, 2013, the Board determined the fair value of the Company’s common stock to be $0.85 per share (the “Original November 22 Fair Value Per Share”). This determination was based in part on a valuation performed by a third-party independent valuation specialist which determined the fair value of the Company’s common stock to be between $0.76 and $0.91 per share as of October 31, 2013 (the “Original October 31 Valuation”) using the OPM and the Board’s determination that there were no material changes to the business or required adjustments to the estimated fair value of its common stock since October 9, 2013, the date the Company’s Audit and Finance Committee of the Board indicated its support for a valuation of the common stock of $0.85 per share at its meeting held on October 9, 2013. In connection with the preparation of the DRS for confidential submission to the Commission, Company management reassessed the fair value of the Company’s common stock as of November 22, 2013 and determined it to be $1.50 per share (the “Revised November 22 Fair Value Per Share”). As described above in “Historical Fair Value Determination and Methodology,” this determination was based in part on the Q3’13 Revaluation and management’s determination that there were no material changes to the business or required adjustments to the estimated fair value of its common stock since September 30, 2013, the date of the Q3’13 Revaluation. The increase to $1.50 from the Original October 31 Valuation was primarily due to the assumption of a 65% probability of a potential license transaction scenario. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY COHERUS BIOSCIENCES, INC. WITH RESPECT TO THIS LETTER. October 7, 2014 Page 5 On August 30, 2013, the Company entered into a definitive license agreement with Baxter International, Inc. (“Baxter”) for the development, use and commercialization of the Company’s biosimilar version etanercept biosimilar (the “Baxter Collaboration”), which included a $30.0 million upfront payment to the Company and certain other contingent milestone payments and expense reimbursements. However, the Baxter Collaboration contained a provision that if the pharmacokinetic biosimilarity of CHS-0214 to Enbrel was not demonstrated in the Phase 1 study, Baxter would have been entitled to opt out of the agreement. If Baxter opted out and did not elect to enter into a right-of-first refusal agreement on a second product within a set review period, the full $30 million payment would have been converted into convertible debt of the Company, with a five year maturity date from the date of delivery of the opt-out notice and would not be required to make any further payments to the Company. Further, the Company continued to face significant capital constraints that resulted in the delay of some of its clinical programs. The financial distress of the Company was reflected by the high costs and senior preference of its debt financing of approximately $9.95 million executed during the third quarter of 2013 which included the issuance of convertible promissory notes that carried a 300% warrant coverage to the lenders and were therefore highly dilutive to holders of the Company’s common stock (the “2013 Bridge Financing”). For purposes of the Original October 31 Valuation, the Company anticipated a seventy-five percent (75%) probability of a liquidity event and a twenty-five percent (25%) probability of a liquidation scenario, and a discount for lack of marketability (“DLOM”) of 20.3% for the high value indication and 33.3% for the low value indication was applied to reflect the risk arising from the inability to readily sell the shares (as determined using the Black-Scholes option pricing model). This analysis reflected the Company’s belief that due to the prevalence of significant operational, clinical and financial risks still facing the Company, there existed a reasonable possibility that the Company would face a liquidation scenario, in which case the Company’s common stock would have no value. The original determined fair value of the Company’s common stock as of October 31, 2013 was considered by the Board when determining the fair value of the Company’s common stock for purposes of granting stock options to employees on November 22, 2013. For purposes of the Q3’13 Revaluation, the Company assigned a five percent (5%) probability of a potential new financing scenario, a five percent (5%) probability of a potential IPO scenario, a sixty-five percent (65%) probability of a potential license transaction scenario, a five percent (5%) probability of a potential change of control scenario and a twenty percent (20%) probability of a potential maturity scenario. This analysis reflected the Company’s positive view of the Bax
2014-09-30 - UPLOAD - Coherus Oncology, Inc.
September 29, 2014 Via E -mail Dennis M. Lanfear President and Chief Executive Officer Coherus BioSciences, Inc. 201 Redwood Shores Parkway, Suite 200 Redwood City, CA 94065 Re: Coherus BioSciences, Inc. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted September 15, 2014 CIK No. 0001512762 Dear Mr. Lanfear : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us wit h information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting another amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe a further amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your second a mended draft registration statement or filed registration statement, we may have additional comments. Business Collaboration and License Agreements, page 108 1. We note your response to prior comment 27. In your description of the Genentech agreement on page 110, please state the amount of the milestone payment or, in the alternative, provide your analysis why this specific amount should not be considered material disclosure. Index to Financial Statements Notes to Unaudited Condensed Consolidated Fina ncial Statements 12.Net Loss and Unaudited Pro Forma Net Loss Per Share, F -34 2. Please refer to your response to our comment 33. As previously requested, please include herein and in Note 10 on F -58 to your unaudited condensed consolidated financial Dennis M. Lanfear Coherus BioSciences, Inc. September 29, 2014 Page 2 statem ents reconciliations of the numerators and denominators of your basic and diluted per share computations for each period presented, as required under ASC 260 -10-50-1a. The current disclosure solely contains the pro forma calculation. You may contact Taba tha McCullom at (202) 551 -3658 or James Rosenberg at (202) 551-3679 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, Daniel Greenspan at (202) 551 -3623 or me at (202) 55 1-3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Alan C. Mendelson , Esq. Latham & Watkins LLP 140 Scott Drive Menlo Park, CA 94025
2014-09-03 - UPLOAD - Coherus Oncology, Inc.
September 3 , 2014 Via E -mail Donald M. Lanfear President and Chief Executive Officer Coherus BioSciences, Inc. 201 Redwood Shores Parkway, Suite 200 Redwood City, CA 94065 Re: Coherus BioSciences, Inc. Draft Registration Statement on Form S -1 Confidentially Submitted August 4, 2014 CIK No. 0001512762 Dear Mr. Lanfear : We have reviewed your draft registration statement and have the following co mments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you p rovide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. General 1. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplemental ly provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participat ing or will participate in your offering. Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 2 2. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our review. 3. We note that you have submitted an application for confidential treatment relating to several of your exhibits. Please be advised that we will review this application separately and comments issued as a result of that review, if any, must be resolved prior to your filing a request for acceleration. 4. Please revise to ensure that all graphical info rmation presented in your prospectus, such as the pipeline chart on the first page of your prospectus summary and page 89, and the charts on pages 92, 97 and 98, is sufficiently large to be legible to the average reader. Prospectus Summar y, page 1 5. We note that your Phase 1 study for CHS -1701 “did not meet bioequivalence” and that you are planning an additional PK study comparing CHS -1701 and Neulasta. Moreover, your Phase 3 trials will be initiated , at the earliest , in 2015. A ccordingly, please revise your chart on page 1 and 89 so that the arrow for the CHS -1701 row clearly reflects that this product candidate is still effectively in Phase 1, notwithstanding that you have completed your first Phase 1 trial. 6. We note your statement on page 4 and 96 that “(w)e have successfull y advanced CHS - 1701 through completion of a Phase 1 PK/PD study in healthy volunteers.” Please modify your disclosure as necessary to put this assertion in its proper context with your disclosure on page 9 8 that your Phase 1 study of CHS -1701 “did not mee t bioequivalence due to geometric mean values ranging slightly above the allowed upper confidence interval (125%) on all three variables” and that you will perform additional Phase 1 studies before advancing to Phase 3 . In addition, please explain the sign ificance of failing to meet the study’s three designated bioequivalence endpoints and clarify your ability to rely on the post -hoc bioequivalence analysis performed for purposes of future applications for marketing approval . Risks Associated with Our Business, page 5 7. Please expand the 5th and 7th bullets to provide more specificity with respect to the unique risks posed by the various global regulatory pathways and the Biologics Price Competition Act of 2009, respectively. Corporate Information, page 5 8. On page 6, please state that your election to opt out of the JOBS ACT extended transition periods is irrevocable. Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 3 The Offering, page 7 9. Please break out your anticipated use of proceeds among your product candidates. Risk Factors 10. Please add a stand -alone risk factor that discusses the technical challenges inherent in developing protein therapeutics, including information similar to the di sclosure that appears on page 86 of the Business section. Please also add a related bullet to the list of risk factors on page 5 of your prospectus summary. Risks Rela ted to the Discovery and Development of Our Product Candidates “If we are not able to demonstrate biosimilarity of our biosimilar product candidates to the satisfaction of regulatory authorities . . .,” page 16 11. Please amend this risk factor to note the fa ilure of your Phase 1 study of CHS -1701 to meet the endpoints established for bioequivalence with Neulasta and that additional Phase 1 studies will be conducted before proceeding to Phase 3. “The development, manufacture and commercialization of biosimilar products …,” page 19 12. Please specify when the original BLAs for Enbrel and Humira were approved , and in which geographic markets . Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies Stock -Based Compensation Common Stock Options, page 75 13. Please note we may have additional comments on your accounting for stock compensation once you have disclosed an estimated offering price. Please provide us with a quantitative and qualitative analysis explaining the difference between the estimated offering price and the fair value of eac h equity issuance through the date of effectiveness for the preceding twelve months. Business , page 83 14. To the extent practicable, please minimize the use o f highly technical terminology in this section and elsewhere in the registration statement that may be unfamiliar to lay investors. If the use of such terms is necessary, please give the meaning and significance of such terms in plain language that may be readily understood by a person not acquainted with this industry or scientific field. By way of example only and not as an Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 4 exhaustive list , an exp lanation of the following terms should accompany their first usage in the registration statement. endogenou s (page 83); granulocyte (page 83) ; monoclonal antibodies (page 86) ; post-translational modifications (page 86); cell sub -type selection (page 86); geometric ratio (page 87) ; protein stabilization (page 87); moiety (page 90); cellular receptors (page 90); down -regulating (page 90); lineage -specific (page 95); monocytes, fibroblasts and endothelial cells (page 95); neutrophils (page 95); pegylated (page 96); covalent (page 95); necropsy and gross necropsy (page 97); and lymphocytes, eosinophils and basophi ls (page 97); Our Approach, page 86 15. In the next -to-last bullet that appears on page 87, please briefly explain how your formulation technology will allow you to “innovate around” patent protected formulations. Five Key Steps to Biosimilar Drug Development, page 88 16. Please summarize your meetings with regulators by providing the approximate dates of such meetings, the regulatory body with whom you met and the general nature of discussions. 17. On page 89, please provide a brief but straightforward explanation of the three bioequivalence parameters listed. For example, when you discuss AUC 0t, you should explain the concept of area under t he concentration -time curve and what precisely is measured . Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 5 Development Portfolio , page 89 18. Please indicate for each of your product candidates the location of each of your clinical studies and whether you filed an Inves tigational New Dr ug Application, or equivalent request for approval, covering such studies . If an application was not filed , please explain why. 19. We note that your developmental plans call for you to proceed from Phase 1 trials of your lead candidates directly to Phase 3. In your discussion of the FDA approval process on page 105, however, you talk about the typical progression of three sequential phases of clinical trials used to support BLAs for marketing approval. Please address how development al strategy differs from the typical route for biologics , the basis of your belief that this direct progression to Phase 3 is viable, any risks involved and any specific discussions you have had with regulatory agencies about this. 20. With respect to the graphs that appear on pages 92, 97 and 98 , please provide a brief narrative accompanying the illustrations that explain s the major points the pictures are meant to symbolize. For example, consider adding a legend of some kind to the graphs to help readers interpret the information. CHS -1420 (Our Adalimumab (Humira) Biosimilar Candidate), page 93 21. In your discussion of CHS -1420, please clarify the relationship , in layman’s terms, between Humira’s ability to block s ignaling through the TNF pathway a nd the effect on various inflammatory diseases. Similarly , please explain the significance of Humira’s ability to bind activating Fcﻻ receptors and complement component C1q. CHS -1701 (Our Pegfilgrastim (Neulasta ) Bios imilar Candidate), page 96 22. Please explain, in terms comprehensible to the non -specialist , what a luminescence assay is, how CHS -1701 stimulates the proliferation of NFS -60 leukemia cells and clarify the significance of t his proliferation with respect to the accelerated development of neutrophils that pegfilgrastim is designed to facilitate . 23. In your discussion of your in vivo comparability studies of CHJS -1701 on page 97, the significance of your observations is not sufficiently clea r. Please explain the following in layman’s terms and clarify the significance of each with respect to conclusions about bioequivalence : increases in ANC, monocytes, lymphocytes, eosinophils and basophils ; decrease in red blood cell parameters and pla telet counts; increase in the myleloid:erythroid ratio in bone marrows; increased hematopoiesis at necropsy and the fact that , at necropsy, microscopic findings were observed in multiple marrow -bearing areas; and Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 6 exposure PK parameters Manufacturing , page 99 24. We note your statement here that you have entered into commitments with your contract manufacturers as well as your statement in the first risk factor on page 27 regarding your other arrangements with various suppliers . Please indicat e whether these commitments involve binding contracts between you and these companies and, if so, disclose their material terms here and file such contracts as exhibits. Alternatively, if you believe these agreements are not material to your oper ations, please explain why in your response. Collaboration and License Agreements, page 100 25. Please amend your disclosure concerning each agreement to include a range of the royalty payments that may be made pursuant to that agreem ent, e.g. “(low/high) single - digits,” “t eens,” “twenties,” etc. 26. Please disclose the aggregate amount if milestones, if any, that may be paid to you under the agreement with Daiichi Sankyo. 27. Please amend your disclosure to state the aggregate milestone payments relating to the license agreements with Genentech, Inc. and Selexis SA. Intellectual Property , page 102 28. With respect to the material patents that you have in -licensed From Daiichi Sankyo, Baxter, and any other parties, please provide disclosure about this intellectual property similar to the information you have provided for your owned patents and patent applications. Management Scientific Advisory Board, page 115 29. Please briefly discuss the fun ction of your scientific advisory board and the specific responsibilities of the board members, as well as the frequency of board meetings. Principal Stockholders, page 146 30. To the extent not already disclosed, please revise to state the names of the individuals who have voting and/or dispositive power over the shares held by each of y our 5% and greater stockholders . Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 7 Index to Audited Consolidated Financial Statements Notes to Consolidated Financial Statements 5. Collaboration and License Agreement Daiichi Sankyo, page F -18 31. Please dis close the reasons that the deliverables (i.e. license and the manufacture of the drug materials for clinical development) do not have standalone value. Refer to ASC 605 - 25-50-2f. Index to Financial Statements Unaudited Interim Condensed Consolidated Fin ancial Statements Notes to Unaudited Condensed Consolidated Financial Statements 6. Acquisition of InteKrin Therapeutics, Inc., page F -52 32. Tell us why the $2.29 per share value you determined for the Series B convertible preferred stock is significantly less than the $4.1841 initial closing price for Series B issuances that occurred in 2012. 12.Net Loss and Unaudited Pro Forma Net Loss Per Share, F -34 33. Please include herein and in Note 10 on F -57 to your unaudited condensed consolidated financial statements reconciliations of the numerators and denominators of your basic and diluted per share computations for each period presented, as required under ASC 260 -10- 50-1a. If you are treating the unvested restricted shares as contingently issuable and thus excluding them from the basic and diluted denominator, include as a reconciling item. Refer to Example 3 at ASC 260 -10-55-56. Also provide us your analysis with reference to the authoritative literature supporting your treatment of unvested restricted shares as contingently issuable shares. If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on t he SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/c orpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information i n the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may contact Tabatha McCullom at (202) 551 -3658 or James Rosenberg at (202) 551-3679 if you have questions regarding comments on the financial statements and related Donald M. Lanfear Coherus BioSciences, Inc. September 3 , 2014 Page 8 matters. Please contact Daniel Greenspan at (202) 551 -3623, Scot Foley at (202) 551 -3383 or me at (202) 551 -3715 with any other ques tions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. R iedler Assista nt Direct or cc: Via E -mail Alan C. Mendelson , Esq. Latham & Watkins LLP
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