Item 9A. Controls and Procedures
Item 9A. 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.
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.
We intend to review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis and to correct any material deficiencies that we may discover. 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). 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.
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Coherus BioSciences, Inc.
Opinion on Internal Control Over Financial Reporting
We have audited Coherus BioSciences, Inc.’s internal control over financial reporting as of December 31, 2023, 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.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
San Mateo, California
March 15, 2024
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Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
(a)
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, 2023, 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.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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PART III
Certain information required by Part III is omitted from this Annual Report on From 10-K because we will file a Definitive Proxy Statement (the “Proxy Statement”) with the Securities and Exchange Commission within 120 days after the end of our fiscal year ended December 31, 2023.
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is included in the Proxy Statement to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2023, and is incorporated herein by reference.
Item 11. Executive Compensation
The information required by this Item is included in the Proxy Statement to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2023, and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this Item is included in the Proxy Statement to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2023, and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item is included in the Proxy Statement to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2023, and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
The information required by this Item is included in the Proxy Statement to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2023, and is incorporated herein by reference.
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PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)
(1)
The financial statements required by Item 15(a) are filed in Item 8 of this Annual Report on Form 10-K.
(2)
The financial statement schedules required by Item 15(a) are omitted because they are not applicable, not required or the required information is included in the financial statements or notes thereto as filed in Item 8 of this Annual Report on Form 10-K.
(3)
We have filed, or incorporated into this report by reference, the exhibits listed on the accompanying Index to Exhibits immediately preceding the signature page of this Annual Report on Form 10-K.
Item 16. Form 10-K Summary
None.
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INDEX TO EXHIBITS
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
3.1
Amended and Restated Certificate of Incorporation.
8-K
11/13/2014
3.1
3.2
Amended and Restated Bylaws.
8-K
11/18/2020
3.1
4.1
Reference is made to Exhibits 3.1 and 3.2.
4.2
Form of Common Stock Certificate.
S-1/A
10/24/2014
4.2
4.3
Description of Coherus’ Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
10-K
2/27/2020
4.3
4.4
Indenture, dated April 17, 2020, by and between Coherus BioSciences, Inc. and U.S. Bank National Association.
8-K
4/17/2020
4.1
4.5
Form of certificate representing the 1.5% Convertible Senior Subordinated Notes due 2026.
8-K
4/17/2020
4.1
4.6
Notice of Successor Trustee to Indenture dated February 7, 2022
10-Q
5/5/2022
4.5
10.1†
Distribution Agreement, effective December 26, 2012, by and between Orox Pharmaceuticals B.V. and Coherus BioSciences, Inc.
S-1
9/25/2014
10.3
10.2(a)
Standard Industrial/Commercial Multi-tenant Lease-Gross, effective December 5, 2011, by and between Howard California Property Camarillo 5 and BioGenerics, Inc.
S-1
9/25/2014
10.9(a)
10.2(b)
First Amendment to Lease, effective December 21, 2013, by and between Howard California Property Camarillo 5 and Coherus BioSciences, Inc.
S-1
9/25/2014
10.9(b)
10.3(a)#
BioGenerics, Inc. 2010 Equity Incentive Plan, as amended.
S-1
9/25/2014
10.10(a)
10.3(b)#
Form of Stock Option Grant Notice and Stock Option Agreement under the 2010 Equity Incentive Plan, as amended.
S-1
9/25/2014
10.10(b)
10.4(a)#
Coherus BioSciences, Inc. 2014 Equity Incentive Award Plan.
S-1/A
10/24/2014
10.11
10.4(b)#
Form of Stock Option Grant Notice and Stock Option Agreement under the 2014 Equity Incentive Award Plan.
S-1/A
11/4/2014
10.11(b)
10.4(c)#
Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2014 Equity Incentive Award Plan.
S-1/A
11/4/2014
10.11(c)
10.4(d)#
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2014 Equity Incentive Award Plan.
S-1/A
11/4/2014
10.11(d)
10.5#
Coherus BioSciences, Inc. 2014 Employee Stock Purchase Plan.
S-1/A
10/24/2014
10.12
10.6#
Form of Indemnification Agreement between Coherus BioSciences, Inc. and each of its directors, officers and certain employees.
S-1/A
10/24/2014
10.13
10.7†
Master Services Agreement, effective January 23, 2012, by and between Medpace, Inc. and BioGenerics, Inc.
S-1
9/25/2014
10.15
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Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.8
New Office Lease, effective July 6, 2015, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
10-Q
8/10/2015
10.3
10.9
First Amendment, effective August 10, 2015, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
10-Q
8/10/2015
10.4
10.10(a)#
Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan.
10-Q
8/9/2016
10.1(a)
10.10(b)#
Form of Stock Option Grant Notice and Stock Option Agreement under the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan.
10-Q
8/9/2016
10.1(b)
10.10(c)#
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan.
10-Q
8/9/2016
10.1(c)
10.10(d)#
Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan.
10-Q
8/9/2016
10.1(d)
10.11
Second Amendment, dated September 21, 2016, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
8-K
9/26/2016
10.1
10.12
Letter Agreement to Master Service Agreement, dated as of September 6, 2017, by and between Medpace, Inc. and Coherus BioSciences, Inc.
10-Q
11/06/2017
10.2
10.13†
Confidential Litigation Settlement Agreement and Release, dated as of April 30, 2019 between Amgen Inc. and Amgen USA Inc. (collectively “Amgen”), and Coherus BioSciences Inc.
10-Q
8/5/2019
10.1
10.14
Third Amendment, effective May 24, 2019, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
10-Q
11/8/2019
10.1
10.15
Fourth Amendment, effective September 4, 2019, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
10-Q
11/8/2019
10.2
10.16††
License Agreement, dated November 4, 2019, by and between Coherus BioSciences, Inc. and Bioeq IP AG
10-K
2/27/2020
10.29
10.17††
Form of Confirmation for Base Capped Call Transactions under the Indenture.
8-K
4/17/2020
10.1
10.18
Exclusive License and Commercialization Agreement, dated February 1, 2021, by and between Coherus Biosciences, Inc. and Shanghai Junshi Biosciences, Co. Ltd.
10-Q
5/6/2021
10.1
10.19
Stock Purchase Agreement, dated February 1, 2021, by and between the Coherus Biosciences, Inc. and Shanghai Junshi Biosciences, Co. Ltd.
10-Q
5/6/2021
10.2
10.20††
Loan Agreement dated as of January 5, 2022 among Coherus BioSciences, Inc., the Guarantors, the Collateral Agent and the Lenders party thereto.
8-K
1/7/2022
10.1
10.21††
Letter Agreement, dated February 9, 2022, between Coherus BioSciences, Inc. and Shanghai Junshi Biosciences, Co., Ltd.
10-Q
5/5/2022
10.1
10.22††
First Amendment to Loan Agreement dated as of April 7, 2022, among Coherus BioSciences, Inc., the Collateral Agent and the Lenders party thereto.
10-Q
8/4/2022
10.1
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Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.23††
License Agreement, dated June 22, 2022, among Coherus BioSciences, Inc., Bioeq AG and Genentech Inc.
10-K
3/6/2023
10.25
10.24††
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.
10-Q
5/8/2023
10.1
10.25#
Executive Change in Control and Severance Plan, effective January 1, 2023.
10-Q
5/8/2023
10.2
10.26#††
Letter Agreement between Coherus BioSciences, Inc. and Vladimir Vexler, dated as of March 27, 2023.
10-Q
5/8/2023
10.3
10.27
Amendment No. 1 to Sales Agreement between Coherus BioSciences, Inc. and Cowen and Company, LLC, dated May 15, 2023.
10-Q
8/2/2023
10.1
10.28††
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)
8-K
6/16/2023
2.1
10.29††
Settlement and License Agreement among Coherus BioSciences, Inc., AbbVie Inc. and AbbVie Biotechnology Ltd dated January 24, 2019.
10-Q
11/6/2023
10.1
10.30
Amendment No. 2 to Sales Agreement between Coherus BioSciences, Inc. and Cowen and Company, LLC dated September 11, 2023.
10-Q
11/6/2023
10.2
10.31††
First Amended and Restated Development and Option Agreement between Adimab, LLC and Surface Oncology, Inc., dated October 3, 2018.
X
10.32††
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.
X
10.33††
Amendment No. 4 to the Collaboration Agreement between Novartis Institutes for BioMedical Research, Inc. and Surface Oncology, Inc., dated October 9, 2018.
X
10.34††
License Agreement, dated as of December 16, 2020, by and between Surface Oncology, Inc. and GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No. 4) LIMITED.
X
10.35††
Amendment No. 1, dated as of August 11, 2021, to License Agreement, dated as of December 16, 2020, by and between Surface Oncology, Inc. and GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No. 4) LIMITED.
X
10.36††
Sixth Amendment, effective October 24, 2023, by and between Hudson 333 Twin Dolphin Plaza, LLC and Coherus BioSciences, Inc.
X
10.37††
Amendment to and Waiver, dated October 25, 2023, under the Exclusive License and Commercialization Agreement, dated February 1, 2021, by and between Coherus Biosciences, Inc. and Shanghai Junshi Biosciences, Co. Ltd.
X
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Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.38
Coherus BioSciences, Inc. Insider Trading Compliance Policy and Procedures, effective February 27, 2023.
X
10.39#††
Letter Agreement between Coherus BioSciences, Inc. and McDavid Stilwell, dated as of December 11, 2023.
X
10.40††
Exclusive Product License Agreement, dated March 23, 2021, by and between Vaccinex, Inc. and Surface Oncology, Inc.
X
21.1
Subsidiaries of Coherus BioSciences, Inc.
X
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (included in the signature page to this Form 10-K).
X
31.1
Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended .
X
31.2
Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
X
32.1
Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350.
X
97.1
Coherus BioSciences, Inc. Clawback Policy, effective December 1, 2023.
X
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
X
†
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).
#
Indicates management contract or compensatory plan.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
COHERUS BIOSCIENCES, INC.
Date: March 15, 2024
By:
/s/ Dennis M. Lanfear
Name:
Dennis M. Lanfear
Title:
President and Chief Executive Officer
(Principal Executive Officer)
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dennis M. Lanfear and Bryan McMichael, his or her attorneys-in-fact, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the U.S. Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or their substitute, may do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
/s/ Dennis M. Lanfear
Dennis M. Lanfear
Chairman, President and Chief Executive Officer
(Principal Executive Officer)
March 15, 2024
/s/ Bryan McMichael
Bryan McMichael
Interim Chief Financial Officer, Executive Vice President, Accounting and Corporate Controller
(Principal Financial Officer and Principal Accounting Officer)
March 15, 2024
/s/ Georgia Erbez
Georgia Erbez
Director
March 15, 2024
/s/ Lee N. Newcomer
Director
March 15, 2024
Lee N. Newcomer
/s/ Charles Newton
Charles Newton
Director
March 15, 2024
/s/ Jill O’Donnell-Tormey
Jill O’Donnell-Tormey
Director
March 15, 2024
/s/ Michael Ryan
Michael Ryan
Director
March 15, 2024
/s/ Ali J. Satvat
Ali J. Satvat
Director
March 15, 2024
/s/ Mark D. Stolper
Mark D. Stolper
Director
March 15, 2024
/s/ Kimberly J. Tzoumakas
Kimberly J. Tzoumakas
Director
March 15, 2024
/s/ Mats Wahlström
Mats Wahlström
Director
March 15, 2024
145