What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2025-03-17 compared with 2024-03-15 · 55 added, 66 removed, 176 unchanged (41% of the section changed)

Controls and Procedures

(a) Evaluation of Effectiveness of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision of our Chief Executive Officer and our Interim Chief Financial Officer, and evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Annual Report on Form 10-K.

Based on that evaluation, our President and Chief Executive Officer and our Interim Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were, in design and operation, effective.

Evaluation of Effectiveness of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision of our Chief Executive Officer and our Chief Financial Officer, and evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Annual Report on Form 10-K.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer, principal financial officer and principal accounting officer, as appropriate, to allow for timely decisions regarding required disclosure.

1 unchanged sentence

Our goal is to ensure that our management has timely access to material information that could affect our business.

While we believe the present design of our disclosure controls and procedures is effective to achieve our goal, future events affecting our business may cause us to modify our disclosure controls and procedures.

In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

(b) Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f).

Based on this evaluation, and as a result of the material weakness described below, our President and Chief Executive Officer and our Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were not effective at a reasonable assurance level.

Notwithstanding this material weakness, management concluded the consolidated financial statements included in this report present fairly, in all material respects, our financial condition, results of operations and cash flows for the periods covered by this report and our external auditors have issued an unqualified opinion on our consolidated financial statements as of and for the year ended December 31, 2024.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f).

Under the supervision and with the participation of our management, including our principal executive officer, principal financial officer and principal accounting officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework).

Based on our evaluation under the framework in Internal Control—Integrated Framework , our management concluded that our internal control over financial reporting was effective as of December 31, 2023.

Ernst & Young LLP, our independent registered public accounting firm, has attested to and issued a report on the effectiveness of our internal control over financial reporting, which is included herein.

Based on our evaluation under the framework in Internal Control—Integrated Framework , our management concluded that our internal control over financial reporting was not effective as of December 31, 2024 due to the material weakness discussed below.

Material Weakness in Internal Control over Financial Reporting

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be detected or prevented on a timely basis.

Management determined that there was a material weakness in the operating effectiveness of our procedures related to documentation and review of certain inventory account reconciliations.

The lack of sufficient evidence of the review performed over these accounting records did not allow for the testing and validation that the relevant internal controls operated, and thus it resulted in the material weakness.

The material weakness related to documentation and did not result in a misstatement with respect to our financial statements included in this Form 10-K.

The effectiveness of our internal control over financial reporting as of December 31, 2024 has been audited by Ernst & Young LLP, an independent registered public accounting firm, as stated in its report which is included in this Item 9A of this Annual Report on Form 10-K.

Management’s Remediation Measures

We are taking steps to remediate this material weakness and to strengthen our internal control over financial reporting.

The remediation measures include additional training and enhancement of our documentation and retention procedures, particularly as they relate to our inventory account reconciliations.

This remediation is in progress and will require validation and testing of operating effectiveness of internal controls over multiple financial reporting cycles.

Changes in Internal Control over Financial Reporting

Except for the material weakness noted above, there has been no change in the Company's internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) that occurred during the quarter ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Report of Independent Registered Public Accounting Firm

2 unchanged sentences

We have audited Coherus BioSciences, Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Coherus BioSciences, Inc.

(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity (deficit) and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated March 15, 2024 expressed an unqualified opinion thereon.

In our opinion, because of the effect of the material weakness described below on the achievement of the objectives of the control criteria, Coherus BioSciences, Inc.

(the Company) has not maintained effective internal control over financial reporting as of December 31, 2024, based on the COSO criteria.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

The following material weakness has been identified and included in management’s assessment.

Management has identified a material weakness relating to the operating effectiveness of their documentation and review procedures over certain inventory account reconciliations.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income (loss), stockholders' deficit and cash flows for each of the three years in the period ended December 31, 2024, and the related notes.

This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the 2024 consolidated financial statements, and this report does not affect our report dated March 17, 2025, which expressed an unqualified opinion thereon.

Basis for Opinion

20 unchanged sentences

Other Information

Item 1.01 Entry into a Material Definitive Agreement

Amendment No.

2 to Collaboration Agreement

On February 1, 2021, we announced that we had entered into the Collaboration Agreement with Junshi Biosciences for the co-development and commercialization of toripalimab, Junshi Biosciences’ anti-PD-1 antibody in the United States and Canada.

We entered into an amendment and waiver under the Collaboration Agreement on October 25, 2023 (Amendment No.

1 to Collaboration Agreement”).

On March 13, 2024, we and Junshi Biosciences entered into Amendment No.

2 to the Collaboration Agreement (“Amendment No.

2 to Collaboration Agreement”).

Under Amendment No.

2 to Collaboration Agreement, we agreed with Junshi Biosciences to change the $25.0 million milestone payment to Junshi Biosciences that became due in connection with the approval by the FDA of toripalimab for the treatment of patients with NPC in the first quarter of 2024.

We agreed to split the $25.0 million milestone payment into two equal installments of $12.5 million each, one due in the second quarter of 2024 and one due in the first quarter of 2025.

We also agreed to pay approximately $2.5 million in the first quarter of 2024 to Junshi Biosciences for routine expenses incurred pursuant to the Collaboration Agreement.

The foregoing summary of Amendment No.

2 to Collaboration Agreement does not purport to be complete and is qualified in its entirety by the full text of the Amendment No.

2 to Collaboration Agreement, a copy of which will be filed as an exhibit to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024.

Item 2.05 Costs Associated with Exit or Disposal Activities

In addition to our 35 former employees who transferred to Sandoz in connection with the closing of the Sale Transaction, on March 11, 2024 we committed to a plan to reduce our workforce (the “Plan”) by approximately 26 employees effective March 18, 2024 to focus resources on strategic priorities including the research, development and commercialization of innovative cancer treatments and the commercialization of our portfolio of FDA-approved oncology products.

One-time restructuring charges associated with the Plan are expected to be approximately $1.5 million, primarily consisting of personnel expenses such as salaries, one-time severance payments, and other benefits.

Cash payments related to these expenses will be paid out and the Plan is expected to be completed in the first half of 2024.

The estimated costs that we expect to incur in connection with the Plan are subject to a number of assumptions, and actual results may differ significantly from these estimates.

We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the Plan.

(b) During the three months ended December 31, 2024, neither we nor any of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each such term is defined in Item 408(a) of Regulation S-K.

20 unchanged sentences

Exhibit Description

Agreement and Plan of Merger, by and among Coherus BioSciences, Inc., Crimson Merger Sub I, Inc., Crimson Merger Sub II, LLC and Surface Oncology, Inc., dated June 15, 2023 (Form of CVR Agreement included as Exhibit A thereto)

Purchase and Sale Agreement, by and between Coherus BioSciences, Inc.

and Sandoz Inc., dated January 19, 2024

Asset Purchase Agreement, by and between Coherus BioSciences, Inc.

and Hong Kong King-Friend Industrial Company Ltd., dated as of June 26, 2024

Asset Purchase Agreement, by and between Coherus BioSciences, Inc.

and Intas Pharmaceuticals Ltd., dated December 2, 2024.

Amended and Restated Certificate of Incorporation.

14 unchanged sentences

Form of Stock Option Grant Notice and Stock Option Agreement under the 2010 Equity Incentive Plan, as amended.

Coherus BioSciences, Inc.

2014 Equity Incentive Award Plan.

Form of Stock Option Grant Notice and Stock Option Agreement under the 2014 Equity Incentive Award Plan.

Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2014 Equity Incentive Award Plan.

Incorporated by Reference

Exhibit Description

Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2014 Equity Incentive Award Plan.

5 unchanged sentences

and BioGenerics, Inc.

Incorporated by Reference

Exhibit Description

New Office Lease, effective July 6, 2015, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.

16 unchanged sentences

Fourth Amendment, effective September 4, 2019, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.

License Agreement, dated November 4, 2019, by and between Coherus BioSciences, Inc.

and Bioeq IP AG

Form of Confirmation for Base Capped Call Transactions under the Indenture.

1 unchanged sentence

and Shanghai Junshi Biosciences, Co.

Stock Purchase Agreement, dated February 1, 2021, by and between the Coherus Biosciences, Inc.

and Shanghai Junshi Biosciences, Co.

Loan Agreement dated as of January 5, 2022 among Coherus BioSciences, Inc., the Guarantors, the Collateral Agent and the Lenders party thereto.

Letter Agreement, dated February 9, 2022, between Coherus BioSciences, Inc.

and Shanghai Junshi Biosciences, Co., Ltd.

First Amendment to Loan Agreement dated as of April 7, 2022, among Coherus BioSciences, Inc., the Collateral Agent and the Lenders party thereto.

Incorporated by Reference

Exhibit Description

License Agreement, dated June 22, 2022, among Coherus BioSciences, Inc., Bioeq AG and Genentech Inc.

Second Amendment and Waiver to Loan Agreement dated as of February 6, 2023, among Coherus BioSciences, Inc., the Collateral Agent and the Lenders party thereto.

Executive Change in Control and Severance Plan, effective January 1, 2023.

Letter Agreement between Coherus BioSciences, Inc.

and Vladimir Vexler, dated as of March 27, 2023.

Amendment No.

1 unchanged sentence

and Cowen and Company, LLC, dated May 15, 2023.

Settlement and License Agreement among Coherus BioSciences, Inc., AbbVie Inc.

and AbbVie Biotechnology Ltd dated January 24, 2019.

Amendment No.

2 unchanged sentences

First Amended and Restated Development and Option Agreement between Adimab, LLC and Surface Oncology, Inc., dated October 3, 2018.

Collaboration Agreement between Novartis Institutes for BioMedical Research, Inc.

and Surface Oncology, Inc., dated January 9, 2016, as amended on May 6, 2016, as further amended on July 14, 2017, and as further amended on September 18, 2017.

Amendment No.

4 to the Collaboration Agreement between Novartis Institutes for BioMedical Research, Inc.

and Surface Oncology, Inc., dated October 9, 2018.

License Agreement, dated as of December 16, 2020, by and between Surface Oncology, Inc.

6 unchanged sentences

and Shanghai Junshi Biosciences, Co.

Incorporated by Reference

Exhibit Description

Coherus BioSciences, Inc.

Insider Trading Compliance Policy and Procedures, effective February 27, 2023.

Letter Agreement between Coherus BioSciences, Inc.

and McDavid Stilwell, dated as of December 11, 2023.

Exclusive Product License Agreement, dated March 23, 2021, by and between Vaccinex, Inc.

and Surface Oncology, Inc.

Amendment No.

2 to the Exclusive License and Commercialization Agreement, as amended, as of March 13, 2024, by and between Coherus BioSciences, Inc.

and Shanghai Junshi Biosciences Co., Ltd.

Loan Agreement dated as of May 8, 2024 among Coherus BioSciences, Inc., the Guarantors, the Collateral Agent and the Lenders party thereto.

Revenue Participation Right Purchase and Sale Agreement dated as of May 8, 2024 between Coherus BioSciences, Inc.

and Coduet Royalty Holdings, LLC.

Coherus BioSciences, Inc.

Amended and Restated 2014 Equity Incentive Award Plan.

Omnibus Amendment to Transaction Documents dated as of June 25, 2024 among Coherus BioSciences, Inc., Coduet Royalty Holdings, LLC and Ankura Trust Company, LLC.

Exclusive License and Distribution Agreement dated as of June 27, 2024 between Coherus BioSciences, Inc.

and Apotex, Inc.

Coherus BioSciences, Inc.

Insider Trading Compliance Policy and Procedures, effective February 27, 2023.

Subsidiaries of Coherus BioSciences, Inc.

Incorporated by Reference

Exhibit Description

Consent of Independent Registered Public Accounting Firm.

13 unchanged sentences

Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.

Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment or pursuant to Regulation S-K, Item 601(b)(10).

Such omitted information is not material and would likely cause competitive harm to the registrant if publicly disclosed.

Additionally, schedules and attachments to this exhibit have been omitted pursuant to Regulation S-K, Item 601(a)(5).

Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Regulation S-K, Item 601(b)(10), or schedules and attachments to this exhibit have been omitted pursuant to Regulation S-K, Item 601(a)(5).

Information omitted pursuant to Regulation S-K, Item 601(b)(10) is not material and would likely cause competitive harm to the registrant if publicly disclosed.

Indicates management contract or compensatory plan.

16 unchanged sentences

Bryan McMichael

Interim Chief Financial Officer, Executive Vice President, Accounting and Corporate Controller

Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

14 unchanged sentences

March 17, 2025

/s/ Kimberly J.

/s/ Rita Karachun

Rita Karachun

March 17, 2025

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures