Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, 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 December 31, 2023. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our principal executive and principal financial officers concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management ’ s 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). 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.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Our management, with the participation of our principal executive and principal financial officers, conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 framework). Based on the results of this assessment and on those criteria, our management concluded that our internal control over financial reporting was effective as of December 31, 2023.
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our fourth fiscal quarter of 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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ITEM 9B. OTHER INFORMATION
(a) None .
(b) During the three months ended December 31, 2023, none of our directors or officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5 - 1 (c) under the Exchange Act or any “non-Rule 10b5 - 1 trading arrangement” (as defined in Item 408 (c) of Regulation S-K).
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item will be contained in our definitive proxy statement issued in connection with the 2024 Annual Meeting of Shareholders and is incorporated herein by reference. Certain information required by this item concerning executive officers is set forth in Part I of this Annual Report on Form 10-K under the heading “Business - Information About Our Executive Officers and Significant Employees.”
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be contained in our definitive proxy statement issued in connection with the 2024 Annual Meeting of Shareholders and is incorporated herein by reference.
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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS
Except for the information set forth below, the information required by this item will be contained in our definitive proxy statement issued in connection with the 2024 Annual Meeting of Shareholders and is incorporated herein by reference.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table provides certain information regarding our equity compensation plans in effect as of December 31, 2023:
Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights
Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights
Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans
Equity compensation plans approved by security holders:
2017 Omnibus Incentive Compensation Plan (1)
11,201,040
$
8.82
8,802,249
2008 Equity Incentive Plan (2)
4,054,114
$
11.37
—
Total
15,255,154
$
9.50
8,802,249
(1) Our 2017 Plan provides for the grant of incentive and non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and performance shares to employees, directors and consultants and subsidiary corporations’ employees and consultants. The 2017 Plan replaced the 2008 Plan, and as a result we will not grant any new awards under the 2008 Plan. Any stock option awards granted under the 2008 Plan that were outstanding as of the effective date of the 2017 Plan remained in effect pursuant to their terms and, if the award is canceled or is repurchased, the shares underlying such award become available for grant under the 2017 Plan.
(2) The 2008 Plan provided for the grant of incentive and non-statutory stock options, restricted stock, stock appreciation rights, performance units and performance shares to employees, directors and consultants and subsidiary corporations’ employees and consultants.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item will be contained in our definitive proxy statement issued in connection with the 2024 Annual Meeting of Shareholders and is incorporated herein by reference.
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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item will be contained in our definitive proxy statement issued in connection with the 2024 Annual Meeting of Shareholders and is incorporated herein by reference.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
1. Financial Statements
See the Index to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.
2. Financial Statement Schedules
All schedules have been omitted as the required information is either not required, not applicable or otherwise included in the Financial Statements and notes thereto.
3. Exhibits
The following list of exhibits includes exhibits submitted with this Form 10-K as filed with the SEC and those incorporated by reference to other filings.
EXHIBIT INDEX
Incorporated by Reference
Exhibit
No.
Exhibit Description
Form
File No.
Exhibit
No.
Filing Date
Filed
Herewith
1.1
Sales Agreement, dated March 1, 2021, between Omeros Corporation and Cantor Fitzgerald & Co.
10-K
001-34475
1.1
03/01/2021
3.1
Amended and Restated Articles of Incorporation of Omeros Corporation
10-K
001-34475
3.1
03/31/2010
3.2
Amended and Restated Bylaws of Omeros Corporation
10-K
001-34475
3.2
03/31/2010
4.1
Description of Common Stock
10-K
001-34475
4.1
03/01/2021
4.2
Form of Omeros Corporation common stock certificate
S-1/A
333-148572
4.1
10/02/2009
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4.3
Indenture, dated as of August 14, 2020, between Omeros Corporation and Wells Fargo Bank, National Association, as trustee
8-K
001-34475
4.1
08/14/2020
4.4
First Supplemental Indenture, dated as of August 14, 2020, between Omeros Corporation and Wells Fargo Bank, National Association, as trustee (including the form of 5.25% Convertible Senior Notes due 2026)
8-K
001-34475
4.2
08/14/2020
10.1*
Form of Indemnification Agreement entered into between Omeros Corporation and its directors and officers
S-1
333-148572
10.1
01/09/2008
10.2*
2008 Equity Incentive Plan (as amended)
10-K
001-34475
10.6
03/16/2017
10.3*
Form of Stock Option Award Agreement under the 2008 Equity Incentive Plan
10-Q
001-34475
10.2
11/07/2013
10.4*
2017 Omnibus Incentive Compensation Plan (as amended and restated effective as of June 23, 2023)
8-K
001-34475
10.1
06/28/2023
10.5*
Form of Stock Option Award Agreement under the 2017 Omnibus Incentive Compensation Plan
S-8
333-218882
4.4
06/21/2017
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10.6*
Second Amended and Restated Employment Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated April 7, 2010
8-K
001-34475
10.1
04/12/2010
10.7*
Omeros Corporation Non-Employee Director Compensation Policy
10-K
001-34475
10.11
03/13/2023
10.8
Lease dated January 27, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
8-K
001-34475
10.1
02/01/2012
10.9
First Amendment to Lease dated November 5, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.2
11/09/2012
10.10
Second Amendment to Lease dated November 16, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.18
03/18/2013
10.11
Third Amendment to Lease dated October 16, 2013 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.18
03/13/2014
10.12
Fourth Amendment to Lease dated September 8, 2015 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.3
11/09/2015
10.13
Fifth Amendment to Lease dated September 1, 2016 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
05/10/2017
10.14
Sixth Amendment to Lease dated October 18, 2018 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.19
03/01/2019
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10.15
Seventh Amendment to Lease dated April 15, 2019 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
08/08/2019
10.16
Eighth Amendment to Lease dated October 18, 2019 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.20
03/02/2020
10.17
Ninth Amendment to Lease dated January 15, 2020 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
05/11/2020
10.18
Tenth Amendment to Lease dated September 15, 2020 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
11/09/2020
10.19
Eleventh Amendment to Lease dated October 23, 2020 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.23
03/01/2021
10.20
Twelfth Amendment to Lease dated January 1, 2021 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
10.24
03/01/2021
10.21
Thirteenth Amendment to Lease dated January 1, 2021 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
08/09/2021
10.22
F ourteenth Amendment to Lease dated January 14, 2022 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
10.1
05/10/2022
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10.23†
License Agreement between Omeros Corporation and Daiichi Sankyo Co., Ltd. (successor-in-interest to Asubio Pharma Co., Ltd.) dated March 3, 2010
X
10.24†
Amendment No. 1 to License Agreement with an effective date of January 5, 2011 between Omeros Corporation and Daiichi Sankyo Co., Ltd .
X
10.25†
Amendment No. 2 to License Agreement with an effective date of January 25, 2013 between Omeros Corporation and Daiichi Sankyo Co., Ltd.
X
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10.26
Form of capped call transaction confirmation, in reference to the 5.25% Convertible Senior Notes due 2026
8-K
001-34475
10.1
08/14/2020
10.27†
Master Services Agreement, dated July 28, 2019, between Omeros Corporation and Lonza Biologics Tuas Pte. Ltd.
10-Q
001-34475
10.1
11/12/2019
10.28†
Technology License Agreement, effective August 28, 2020 between Omeros Corporation and Xencor, Inc.
10-K
001-34475
10.1
03/13/2023
10.29†
Asset Purchase Agreement, dated as of December 1, 2021 among Omeros Corporation, Rayner Surgical Inc. and Rayner Surgical Group, Limited, as Parent Guarantor
10-K
001-34475
10.1
03/01/2022
10.30†
Amended and Restated Royalty Purchase Agreement between Omeros Corporation and DRI Healthcare Acquisitions LP dated February 1, 2024
X
23.1
Consent of Independent Registered Public Accounting Firm
X
31.1
Certification of Principal Executive Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2
Certification of Principal Financial Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
97.1
Omeros Corporation Compensation Clawback Policy
X
101.INS
Inline XBRL Instance 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 Labels Linkbase Document
X
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101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104.1
Cover Page Interactive Data File, formatted in Inline XBRL (included in Exhibit 101)
X
*
Indicates management contract or compensatory plan or arrangement.
†
Certain identified information has been excluded from the exhibit because it both (A) is not material and (B) would be competitively harmful if publicly disclosed.
ITEM 16. FORM 10-K SUMMARY
Not included.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of 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.
OMEROS CORPORATION
/s/ GREGORY A. DEMOPULOS, M.D.
Gregory A. Demopulos, M.D.
President, Chief Executive Officer
and Chairman of the Board of Directors
Dated: April 1, 2024
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ GREGORY A. DEMOPULOS, M.D.
President, Chief Executive Officer and Chairman of the Board of Directors (Principal Executive Officer)
April 1, 2024
Gregory A. Demopulos, M.D.
/s/ MICHAEL A. JACOBSEN
Vice President, Finance, Chief Accounting Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
April 1, 2024
Michael A. Jacobsen
/s/ THOMAS F. BUMOL, PH.D.
Director
April 1, 2024
Thomas F. Bumol, Ph.D.
/s/ THOMAS J. CABLE
Director
April 1, 2024
Thomas J. Cable
/s/ PETER A. DEMOPULOS, M.D.
Director
April 1, 2024
Peter A. Demopulos, M.D.
/s/ ARNOLD C. HANISH
Director
April 1, 2024
Arnold C. Hanish
/s/ LEROY E. HOOD, M.D., PH.D.
Director
April 1, 2024
Leroy E. Hood, M.D., Ph.D.
/s/ DIANA PERKINSON, M.D.
Director
April 1, 2024
Diana Perkinson, M.D.
Director
April 1, 2024
Rajiv Shah, M.D.
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