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, 2021. 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, 2021, 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, 2021. 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, 2021.
Ernst & Young LLP has independently assessed the effectiveness of our internal control over financial reporting as of December 31, 2021 and its report is included below.
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 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors
Omeros Corporation
Opinion on Internal Control Over Financial Reporting
We have audited Omeros Corporation’s internal control over financial reporting as of December 31, 2021, 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, Omeros Corporation (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Omeros Corporation as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, shareholders' equity (deficit) and cash flows for each of the three years in the period ended December 31, 2021, and the related notes and our report dated March 1, 2022 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
Seattle, Washington
March 1, 2022
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ITEM 9B. OTHER INFORMATION
None
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 2022 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 2022 Annual Meeting of Shareholders and is incorporated herein by reference.
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 2022 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, 2021:
Weighted-
Number of Securities
Average
Remaining Available
Number of Securities
Exercise Price
for
to be
of
Future Issuance
Issued Upon Exercise
Outstanding
Under
of
Options,
Equity
Outstanding Options,
Warrants and
Compensation
Warrants and Rights
Rights
Plans
Equity compensation plans approved by security holders:
2017 Omnibus Incentive Compensation Plan (1)
6,766,499
$
9.66
6,046,652
2008 Equity Incentive Plan (2)
5,943,388
$
10.89
—
Total
12,709,887
$
12.61
6,046,652
(1) Our 2017 Omnibus Incentive Compensation Plan (the “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 Omeros Corporation 2008 Equity Incentive Plan (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 remain 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.
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(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 2022 Annual Meeting of Shareholders and is incorporated herein by reference.
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 2022 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
1.1
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
Form of Omeros Corporation May 2016 Common Stock Warrant
8-K
001-34475
10.3
05/19/2016
4.4
Form of Omeros Corporation April 2018 Common Stock Warrant
8-K
001-34475
10.2
4/13/2018
4.5
Indenture, dated as of November 15, 2018, between Omeros Corporation and Wells Fargo Bank, National Association, as trustee (including the form of 6.25% Convertible Senior Notes due 2023).
8-K
001-34475
4.1
11/15/2018
4.6
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
4.7
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 ††
Asset Purchase Agreement, dated as of December 1, 2021 among Omeros Corporation, Rayner Surgical Inc. and Rayner Surgical Group, Limited, as Parent Guarantor
X
10.2*
Form of Indemnification Agreement entered into between Omeros Corporation and its directors and officers
S-1
333-148572
10.1
01/09/2008
10.3*
2008 Equity Incentive Plan (as amended)
10-K
001-34475
10.6
03/16/2017
10.4*
Form of Stock Option Award Agreement under the 2008 Equity Incentive Plan
10-Q
001-34475
10.2
11/07/2013
10.5*
2017 Omnibus Incentive Compensation Plan (as amended and restated effective as of June 11, 2021)
8-K
001-34475
10.1
6/16/2021
10.6*
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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10.7*
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
10.8*
Technology Transfer Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated June 16, 1994
S-1
333-148572
10.14
01/09/2008
10.9*
Second Technology Transfer Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated December 11, 2001
S-1
333-148572
10.16
01/09/2008
10.10*
Omeros Corporation Non-Employee Director Compensation Policy
10-K
001-34475
1.1
03/01/2021
10.11
Lease dated January 27, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
8-K
001-34475
10.1
02/01/2012
10.12
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
10.13
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
10.14
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
10.15
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
10.16
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
10.17
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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10.18
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
10.19
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
10.20
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
10.21
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
10.22
Eleventh Amendment to Lease dated October 23, 2020 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
1.1
03/01/2021
10.23
Twelfth Amendment to Lease dated January 1, 2021 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-K
001-34475
1.1
03/01/2021
10.24
Thirteenth Amendment to Lease dated January 1, 2021 between Omeros Corporation and BMR-201 Elliott Avenue LLC
10-Q
001-34475
1.1
08/06/2021
10.25†
Exclusive License and Sponsored Research Agreement between Omeros Corporation and the University of Leicester dated June 10, 2004
S-1/A
333-148572
10.29
09/16/2009
10.26†
Research and Development Agreement First Amendment between Omeros Corporation and the University of Leicester dated October 1, 2005
S-1
333-148572
10.30
01/09/2008
10.27†
Research and Development Agreement Eighth and Ninth Amendments between Omeros Corporation and the University of Leicester dated March 21, 2012 and September 1, 2013
10-K
001-34475
10.24
03/16/2015
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10.28†
Exclusive License and Sponsored Research Agreement between Omeros Corporation and Medical Research Council dated October 31, 2005
S-1/A
333-148572
10.31
09/16/2009
10.29†
Amendment dated May 8, 2007 to Exclusive License and Sponsored Research Agreement between Omeros Corporation and the Medical Research Council dated October 31, 2005
S-1
333-148572
10.32
01/09/2008
10.30†
Patent Assignment Agreement between Omeros Corporation and Roberto Ciccocioppo, Ph.D. dated February 23, 2009
S-1/A
333-148572
10.47
09/16/2009
10.31†
First Amendment to Patent Assignment Agreement between Omeros Corporation and Roberto Ciccocioppo, Ph.D. effective December 31, 2010
10-K
001-34475
10.28
03/18/2013
10.32†
License Agreement between Omeros Corporation and Daiichi Sankyo Co., Ltd. (successor-in-interest to Asubio Pharma Co., Ltd.) dated March 3, 2010
10-Q
001-34475
10.1
05/12/2010
10.33†
Amendment No. 1 to License Agreement with an effective date of January 5, 2011 between Omeros Corporation and Daiichi Sankyo Co., Ltd .
10-Q
001-34475
10.1
05/10/2011
10.34†
Amendment No. 2 to License Agreement with an effective date of January 25, 2013 between Omeros Corporation and Daiichi Sankyo Co., Ltd.
10-Q
001-34475
10.1
05/09/2013
10.35†
Exclusive License Agreement between Omeros Corporation and Helion Biotech ApS dated April 20, 2010
10-Q
001-34475
10.2
08/10/2010
10.36†
Platform Development Funding Agreement between Omeros Corporation and Vulcan Inc. and its affiliate dated October 21, 2010
10-K
001-34475
10.44
03/15/2011
10.37†
Grant Award Agreement between Omeros Corporation and the Life Sciences Discovery Fund Authority dated October 21, 2010
10-K
001-34475
10.45
03/15/2011
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10.38†
Commercial Supply Agreement among Omeros Corporation, Hospira S.p.A. and Hospira Worldwide, Inc. dated October 3, 2014
10-K
001-34475
10.46
03/16/2015
10.39†
First Amendment to Commercial Supply Agreement dated August 1, 2015 by and between Omeros Corporation and Hospira Worldwide, Inc.
10-Q
001-34475
10.1
11/09/2015
10.40
Form of capped call transaction confirmation, dated as of November 8, 2018, by and between Royal Bank of Canada and Omeros Corporation, in reference to the 6.25% Convertible Senior Notes due 2023
8-K
001-34475
10.2
11/15/2018
10.41
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
10.42
Loan and Security Agreement, dated as of August 2, 2019, by and between Omeros Corporation and Silicon Valley Bank
8-K
001-34475
10.1
08/08/2019
10.43
First Amendment to Loan and Security Agreement, dated as of August 7, 2020, by and between Omeros Corporation and Silicon Valley Bank
10-Q
001-34475
10.1
08/10/2020
10.44
Consent and Second Amendment to Loan and Security Agreement, dated as of December 1, 2021, by and between Omeros Corporation and Silicon Valley Bank
X
10.45††
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
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
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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
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
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.
† Portions of this exhibit are redacted in accordance with a grant of confidential treatment.
††
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 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: March 1, 2022
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)
March 1, 2022
Gregory A. Demopulos, M.D.
/s/ MICHAEL A. JACOBSEN
Vice President, Finance, Chief Accounting Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
March 1, 2022
Michael A. Jacobsen
/s/ THOMAS F. BUMOL, PH.D.
Director
March 1, 2022
Thomas F. Bumol, Ph.D.
/s/ THOMAS J. CABLE
Director
March 1, 2022
Thomas J. Cable
/s/ PETER A. DEMOPULOS, M.D.
Director
March 1, 2022
Peter A. Demopulos, M.D.
/s/ ARNOLD C. HANISH
Director
March 1, 2022
Arnold C. Hanish
/s/ LEROY E. HOOD, M.D., PH.D.
Director
March 1, 2022
Leroy E. Hood, M.D., Ph.D.
/s/ RAJIV SHAH, M.D.
Director
March 1, 2022
Rajiv Shah, M.D.
/s/ KURT ZUMWALT
Director
March 1, 2022
Kurt Zumwalt
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