Table of Contents



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q


(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended JuneSeptember 30, 2023

or

TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 001-34475


OMEROS CORPORATION

(Exact name of registrant as specified in its charter)


Washington

91-1663741

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification Number)

201 Elliott Avenue West

Seattle,, Washington

98119

(Address of principal executive offices)

(Zip Code)

((206)206676-5000

(Registrant’sRegistrants telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

(Title of each class)

(Trading symbol)

(Name of each exchange on which registered)

Common Stock,, par value $0.01 per share

OMER

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of AugustNovember 7, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 62,855,824.62,865,491.



SPECIAL NOTEREGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), which are subject to the “safe harbor” created by those sections for such statements. Forward-looking statements are based on our management’s beliefs and assumptions and on currently available information. All statements other than statements of historical fact are “forward-looking statements.” Terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof are intended to identify forward-looking statements, but these terms are not the exclusive means of identifying such statements. Examples of these statements include, but are not limited to, statements regarding:

our estimates of future operating expenses and projections regarding how long our existing cash, cash equivalents, short-term investments, royalty receipts and potential revenues will fund our anticipated operating expenses, capital expenditures and debt service obligations;
our expectations related to future royalties potentially payable to us under the terms of the asset purchase agreement under which we divested our former commercial ophthalmology product OMIDRIA®;

●     our estimates of future operating expenses and projections regarding how long our existing cash, cash equivalents, short-term investments, royalty receipts and potential revenues will fund our anticipated operating expenses, capital expenditures and debt service obligations;

●     our expectations related to future royalties potentially payable to us under the terms of the asset purchase agreement under which we divested our former commercial ophthalmology product OMIDRIA®;

●     our expectations regarding clinical plans and anticipated or potential paths to regulatory approval of narsoplimab by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”), COVID-19 or any other indication;

●     whether and when a marketing authorization application (“MAA”) may be filed with the EMA for narsoplimab in any indication, and whether the EMA will grant approval for narsoplimab in any indication;

●     our plans for the commercial launch of narsoplimab following any regulatory approval and our estimates and expectations regarding coverage and reimbursement for any approved products;

●     our expectation that we will rely on contract manufacturers to manufacture narsoplimab, if approved, for commercial sale and to manufacture our drug candidates for purposes of clinical supply and in anticipation of potential commercialization;

●     our expectations regarding the clinical, therapeutic and competitive benefits and importance of our drug candidates;

●     our ability to design, initiate and/or successfully complete clinical trials and other studies for our drug candidates and our plans and expectations regarding our ongoing or planned clinical trials;

●     our expectations regarding: whether enrollment in any ongoing or planned clinical trial will proceed as expected; whether we can capitalize on the financial and regulatory incentives provided by orphan drug designations granted by FDA, the European Commission (“EC”), or the EMA; and whether we can capitalize on the regulatory incentives provided by fast-track or breakthrough therapy designations granted by FDA;

●     our ability to raise additional capital through the capital markets or through one or more corporate partnerships, equity offerings, debt financings, collaborations, licensing arrangements or asset sales;

●     our expectations about the commercial competition that our drug candidates, if commercialized, face or may face;

 ​

our expectations regarding clinical plans and anticipated or potential paths to regulatory approval of narsoplimab by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”), immunoglobulin A (“IgA”) nephropathy, atypical hemolytic uremic syndrome (“aHUS”) and COVID-19;
whether and when a marketing authorization application (“MAA”) may be filed with the EMA for narsoplimab in any indication, and whether the EMA will grant approval for narsoplimab in any indication;
our plans for the commercial launch of narsoplimab following any regulatory approval and our estimates and expectations regarding coverage and reimbursement for any approved products;
our expectation that we will rely on contract manufacturers to manufacture narsoplimab, if approved, for commercial sale and to manufacture our drug candidates for purposes of clinical supply and in anticipation of potential commercialization;
our expectations regarding the clinical, therapeutic and competitive benefits and importance of our drug candidates;
our ability to design, initiate and/or successfully complete clinical trials and other studies for our drug candidates and our plans and expectations regarding our ongoing or planned clinical trials, including for our lead MASP-2 inhibitor narsoplimab and for our other investigational candidates, including OMS906, OMS1029 and OMS527;
with respect to our narsoplimab clinical programs, our expectations regarding: whether enrollment in any ongoing or planned clinical trial will proceed as expected; whether we can capitalize on the financial and regulatory incentives provided by orphan drug designations granted by FDA, the European Commission (“EC”), or the EMA; and whether we can capitalize on the regulatory incentives provided by fast-track or breakthrough therapy designations granted by FDA;
our ability to raise additional capital through the capital markets or through one or more corporate partnerships, equity offerings, debt financings, collaborations, licensing arrangements or asset sales;
our expectations about the commercial competition that our drug candidates, if commercialized, face or may face;


the expected course and costs of existing claims, legal proceedings and administrative actions, our involvement in potential claims, legal proceedings and administrative actions, and the merits, potential outcomes and effects of both existing and potential claims, legal proceedings and administrative actions, as well as regulatory determinations, on our business, prospects, financial condition and results of operations;
the extent of protection that our patents provide and that our pending patent applications will provide, if patents are issued from such applications, for our technologies, programs, and drug candidates;
the factors on which we base our estimates for accounting purposes and our expectations regarding the effect of changes in accounting guidance or standards on our operating results; and
our expected financial position, performance, revenues, growth, costs and expenses, magnitude of net losses and the availability of resources.

●     our involvement in potential claims, legal proceedings and administrative actions, and the merits, potential outcomes and effects of both existing and potential claims, legal proceedings and administrative actions, as well as regulatory determinations, on our business, prospects, financial condition and results of operations;

●     the extent of protection that our patents provide and that our pending patent applications will provide, if patents are issued from such applications, for our technologies, programs, and drug candidates;

●     the factors on which we base our estimates for accounting purposes and our expectations regarding the effect of changes in accounting guidance or standards on our operating results; and

●     our expected financial position, performance, revenues, growth, costs and expenses, magnitude of net losses and the availability of resources.

Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks, uncertainties and other factors described in this Quarterly Report on Form 10-Q under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our other filings with the U.S. Securities and Exchange Commission (the “SEC”). Given these risks, uncertainties and other factors, actual results or anticipated developments may not be realized or, even if substantially realized, may not have the expected consequences to or effects on our company, business or operations. Accordingly, you should not place undue reliance on these forward-looking statements, which represent our estimates and assumptions only as of the date of the filing of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual results in subsequent periods may differ materially from current expectations. Except as required by applicable law, we assume no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.


OMEROS CORPORATION

FORM 10-Q FOR THE QUARTER ENDED JUNESeptember 30, 2023

INDEX

Page

PartI — Financial Information

5

Item 1.

Financial Statements (unaudited)

Financial Statements (unaudited)5

5

Condensed Consolidated Balance Sheets

5

Condensed Consolidated Statements of Operations and Comprehensive Loss

6

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

7

Condensed Consolidated Statements of Cash Flows

8

Notes to Condensed Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

2221

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3029

Item 4.

Controls and Procedures

Controls and Procedures29

30

PartII — Other Information

3130

Item 1.

Legal Proceedings

Legal Proceedings30

31

Item 1A.

Risk Factors

Risk Factors30

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3130

Item 3.

Default Upon Senior Securities

3130

Item 4.

Mine Safety Disclosures

Mine Safety Disclosures30

31

Item 5.

Other Information

Other Information30

31

Item 6.

Exhibits

Exhibits31

32

Signatures

3332

PARTI — FINANCIAL INFORMATION

ITEM1. FINANCIAL STATEMENTS

OMEROS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

(unaudited)

June 30, 

December 31, 

    

2023

    

2022

Assets

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

6,603

$

11,009

Short-term investments

 

334,680

 

183,909

OMIDRIA contract royalty asset, short-term

29,084

28,797

Receivables

 

11,190

 

213,221

Prepaid expense and other assets

 

7,001

 

6,300

Total current assets

 

388,558

 

443,236

OMIDRIA contract royalty asset

115,802

123,425

Right of use assets

20,258

21,762

Property and equipment, net

 

1,749

 

1,492

Restricted investments

 

1,054

 

1,054

Total assets

$

527,421

$

590,969

Liabilities and shareholders’ equity

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

9,552

$

5,989

Accrued expenses

 

29,793

 

30,551

Current portion of unsecured convertible senior notes, net

94,730

94,381

Current portion of OMIDRIA royalty obligation

4,777

1,152

Current portion of lease liabilities

 

4,686

 

4,310

Total current liabilities

 

143,538

 

136,383

Unsecured convertible senior notes, net

 

221,516

 

220,906

OMIDRIA royalty obligation

120,939

125,126

Lease liabilities, non-current

20,422

22,426

Other accrued liabilities, non-current

 

496

 

444

Commitments and contingencies (Note 10)

 

  

 

  

Shareholders’ equity:

 

  

 

  

Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at June 30, 2023 and December 31, 2022.

 

 

Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2023 and December 31, 2022; 62,848,321 and 62,828,765 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively.

 

628

 

628

Additional paid-in capital

 

726,594

 

720,773

Accumulated deficit

 

(706,712)

 

(635,717)

Total shareholders’ equity

 

20,510

 

85,684

Total liabilities and shareholders’ equity

$

527,421

$

590,969

 

September 30,

  

December 31,

 

 

2023

  

2022

 

Assets

 

  

 

Current assets:

 

  

 

Cash and cash equivalents

 $30,640  $11,009 

Short-term investments

  279,670   183,909 

OMIDRIA contract royalty asset, short-term

  29,228   28,797 

Receivables

  6,878   213,221 

Prepaid expense and other assets

  4,922   6,300 

Total current assets

  351,338   443,236 

OMIDRIA contract royalty asset

  119,502   123,425 

Right of use assets

  19,460   21,762 

Property and equipment, net

  1,717   1,492 

Restricted investments

  1,054   1,054 

Total assets

 $493,071  $590,969 

 

  

 

Liabilities and shareholders’ equity (deficit)

        

Current liabilities:

        

Accounts payable

 $5,866  $5,989 

Accrued expenses

  34,859   30,551 

Current portion of unsecured convertible senior notes, net

  94,909   94,381 

Current portion of OMIDRIA royalty obligation

  6,654   1,152 

Current portion of lease liabilities

  4,888   4,310 

Total current liabilities

  147,176   136,383 

Unsecured convertible senior notes, net

  221,828   220,906 

OMIDRIA royalty obligation

  118,770   125,126 

Lease liabilities, non-current

  19,249   22,426 

Other accrued liabilities, non-current

     444 

Commitments and contingencies (Note 10)

          

Shareholders’ equity (deficit):

        

Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none issued and outstanding at September 30, 2023 and December 31, 2022.

      

Common stock, par value $0.01 per share, 150,000,000 shares authorized at September 30, 2023 and December 31, 2022; 62,865,491 and 62,828,765 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively.

  628   628 

Additional paid-in capital

  729,882   720,773 

Accumulated deficit

  (744,462)  (635,717)

Total shareholders’ equity (deficit)

  (13,952)  85,684 

Total liabilities and shareholders’ equity (deficit)

 $493,071  $590,969 

See accompanying Notes to Condensed Consolidated Financial Statements

OMEROS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(unaudited)

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

Costs and expenses:

 

 

  

 

 

  

Research and development

$

29,639

$

23,516

$

54,249

$

47,603

Selling, general and administrative

 

11,260

 

13,922

 

22,363

 

24,881

Total costs and expenses

 

40,899

 

37,438

 

76,612

 

72,484

Loss from operations

 

(40,899)

 

(37,438)

 

(76,612)

 

(72,484)

Interest expense

 

(7,932)

 

(4,927)

 

(15,865)

 

(9,868)

Interest and other income

 

4,537

 

670

 

8,500

 

1,163

Net loss from continuing operations

(44,294)

(41,695)

(83,977)

(81,189)

Net income from discontinued operations

7,000

10,846

12,982

17,329

Net loss

$

(37,294)

$

(30,849)

$

(70,995)

$

(63,860)

Basic and diluted net income (loss) per share:

Net loss from continuing operations

$

(0.70)

$

(0.66)

$

(1.34)

$

(1.30)

Net income from discontinued operations

0.11

0.17

0.21

0.28

Net loss

$

(0.59)

$

(0.49)

$

(1.13)

$

(1.02)

Weighted-average shares used to compute basic and diluted net income (loss) per share

62,837,125

62,730,015

62,832,991

62,727,395

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

  

  

  

 

Costs and expenses:

 

      

     

Research and development

 $31,731  $38,568  $85,980  $86,172 

Selling, general and administrative

  16,422   12,198   38,785   37,079 

Total costs and expenses

  48,153   50,766   124,765   123,251 

Loss from operations

  (48,153)  (50,766)  (124,765)  (123,251)

Interest expense

  (7,916)  (4,932)  (23,781)  (14,799)

Interest and other income

  4,413   906   12,913   2,069 

Net loss from continuing operations

  (51,656)  (54,792)  (135,633)  (135,981)

Net income from discontinued operations, net of tax

  13,906   37,336   26,888   54,665 

Net loss

 $(37,750) $(17,456) $(108,745) $(81,316)

 

  

  

  

 

Basic and diluted net income (loss) per share:

 

  

  

  

 

Net loss from continuing operations

 $(0.82) $(0.87) $(2.16) $(2.17)

Net income from discontinued operations

  0.22   0.59   0.43   0.87 

Net loss

 $(0.60) $(0.28) $(1.73) $(1.30)

 

  

  

  

 

Weighted-average shares used to compute basic and diluted net income (loss) per share

  62,856,721   62,730,015   62,840,990   62,728,276 

See accompanying Notes to Condensed Consolidated Financial Statements

OMEROS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’STOCKHOLDERS EQUITY (DEFICIT)

(In thousands, except share data)

(unaudited)

Additional

Common Stock

Paid-In

Accumulated

    

  

Shares

    

Amount

    

Capital

    

Deficit

    

Total

Balance at January 1, 2022

62,628,855

$

626

$

706,288

$

(683,134)

$

23,780

Exercise of stock options

101,160

1

413

414

Stock-based compensation expense

3,892

3,892

Net loss

(33,011)

(33,011)

Balance at March 31, 2022

62,730,015

627

710,593

(716,145)

(4,925)

Stock-based compensation expense

3,072

3,072

Net loss

(30,849)

(30,849)

Balance at June 30, 2022

62,730,015

$

627

$

713,665

$

(746,994)

$

(32,702)

(unaudited)

       

Additional

      
 

Common Stock

  

Paid-In

 

Accumulated

   
 

Shares

  

Amount

  

Capital

  

Deficit

  

Total

 

Balance at January 1, 2023

    

  

62,828,765

    

$  

628

    

$

720,773

    

$

(635,717)

    

$

85,684

 62,828,765  $628  $720,773  $(635,717) $85,684 

Stock-based compensation expense

2,953

2,953

     2,953    2,953 

Net loss

(33,701)

(33,701)

           (33,701)  (33,701)

Balance at March 31, 2023

62,828,765

628

723,726

(669,418)

54,936

 62,828,765  628  723,726  (669,418) 54,936 

Exercise of stock options

19,556

97

97

 19,556      97      97 

Stock-based compensation expense

2,771

2,771

     2,771    2,771 

Net loss

(37,294)

(37,294)

           (37,294)  (37,294)

Balance at June 30, 2023

62,848,321

$

628

$

726,594

$

(706,712)

$

20,510

 62,848,321   628   726,594   (706,712)  20,510 

Exercise of stock options

 17,170  53  53 

Stock-based compensation expense

     3,235    3,235 

Net loss

           (37,750)  (37,750)

Balance at September 30, 2023

  62,865,491  $628  $729,882  $(744,462) $(13,952)
           
           

 

 

 

 

 

 

Balance at January 1, 2022

 62,628,855  $626  $706,288  $(683,134) $23,780 

Exercise of stock options

 101,160 1 413  414 

Stock-based compensation expense

     3,892    3,892 

Net loss

           (33,011)  (33,011)

Balance at March 31, 2022

 62,730,015   627   710,593   (716,145)  (4,925)

Stock-based compensation expense

     3,072    3,072 

Net loss

           (30,849)  (30,849)

Balance at June 30, 2022

 62,730,015   627   713,665   (746,994)  (32,702)

Stock-based compensation expense

     3,844    3,844 

Net loss

           (17,456)  (17,456)

Balance at September 30, 2022

  62,730,015  $627  $717,509  $(764,450) $(46,314)

See accompanying Notes to Condensed Consolidated Financial Statements

OMEROS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(unaudited)

Six Months Ended June 30, 

    

2023

    

2022

Operating activities:

Net loss

$

(70,995)

$

(63,860)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

  

Stock-based compensation expense

5,724

6,964

Non-cash interest expense on unsecured convertible debt

959

 

900

Depreciation and amortization

518

 

469

Non-cash interest earned on OMIDRIA contract royalty asset

(7,754)

(9,383)

Remeasurement on OMIDRIA contract royalty asset

(4,824)

(7,716)

Accretion on U.S. government treasury bills, net

(5,090)

Early termination of operating lease

(454)

Changes in operating assets and liabilities:

 

 

  

Receivables

 

202,031

 

23,676

Prepaid expenses and other

 

(1,044)

 

(3,668)

OMIDRIA contract royalty asset

19,914

31,063

Accounts payable and accrued expense

 

2,759

 

(12,653)

Net cash provided by (used in) operating activities

 

142,198

 

(34,662)

Investing activities:

 

  

 

  

Purchases of investments and other

(662,738)

(103,169)

Proceeds from the sale and maturities of investments

517,057

51,200

Purchases of property and equipment

 

(275)

 

(103)

Net cash used in investing activities

 

(145,956)

 

(52,072)

Financing activities:

 

  

 

  

Principal payments on OMIDRIA royalty obligation

 

(467)

 

Principal payments on finance lease obligations

(278)

(352)

Proceeds upon exercise of stock options

 

97

 

414

Net cash provided by (used in) financing activities

 

(648)

 

62

Net decrease in cash and cash equivalents

 

(4,406)

 

(86,672)

Cash and cash equivalents at beginning of period

 

11,009

 

100,808

Cash and cash equivalents at end of period

$

6,603

$

14,136

Supplemental cash flow information

 

  

 

  

Cash paid for interest

$

15,865

$

8,998

Equipment acquired under finance lease

$

500

$

557

 

Nine Months Ended September 30,

 

 

2023

  

2022

 

Operating activities:

 

  

 

Net loss

 $(108,745) $(81,316)

Adjustments to reconcile net loss to net cash used in operating activities:

 

     

Stock-based compensation expense

  8,959   10,808 

Non-cash interest expense on unsecured convertible debt

  1,450   1,361 

Depreciation and amortization

  715   789 

Non-cash interest earned on OMIDRIA contract royalty asset

  (11,484)  (13,739)

Remeasurement on OMIDRIA contract royalty asset

  (14,924)  (40,631)

Accretion on U.S. government treasury bills, net

  (7,280)   

Early termination of operating lease

     (454)

Changes in operating assets and liabilities:

 

     

Receivables

  206,343   24,301 

Prepaid expenses and other

  876   1,769 

OMIDRIA contract royalty asset

  29,900   47,555 

Accounts payable and accrued expense

  3,741   (11,544)

Net cash provided by (used in) operating activities

  109,551   (61,101)

Investing activities:

        

Purchases of investments and other

  (839,595)  (103,573)

Proceeds from the sale and maturities of investments

  751,114   84,600 

Purchases of property and equipment

  (308)  (100)

Net cash used in investing activities

  (88,789)  (19,073)

Financing activities:

        

Proceeds from sale of future royalties

     125,000 

Principal payments on OMIDRIA royalty obligation

  (854)   

Principal payments on finance lease obligations

  (427)  (515)

Proceeds upon exercise of stock options and warrants

  150   414 

Net cash provided by (used in) financing activities

  (1,131)  124,899 

Net increase in cash and cash equivalents

  19,631   44,725 

Cash and cash equivalents at beginning of period

  11,009   100,808 

Cash and cash equivalents at end of period

 $30,640  $145,533 

 

  

 

Supplemental cash flow information

        

Cash paid for interest

 $23,801  $13,437 

Property acquired under finance lease

 $632  $806 

See accompanying Notes to Condensed Consolidated Financial Statements

OMEROS CORPORATION

NOTESTO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

(unaudited)Note

Note 1—1Organization and Basis of Presentation

General

Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic disorders, including complement-mediated diseases, cancers and addictive and compulsive disorders. We marketed our first drug product, OMIDRIA®OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% for use during cataract surgery or intraocular lens replacement in the United States (the “U.S.”) until we sold OMIDRIA and related business assets on December 23, 2021 (see(see “Sale of OMIDRIA Assets” below for additional information).

The lead drug candidate in ourOur pipeline of complement-targeted therapeutics isclinical-stage development programs includes: narsoplimab, a proprietary, patented human monoclonalour antibody targeting mannan-binding lectin-associated serine protease 2 (“MASP-2”MASP-2”), the effector enzyme of the lectin pathway of complement; OMS1029, our long-acting antibody targeting MASP-2;OMS906, our antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”), the key activator of the lectinalternative pathway of complement.complement; and OMS527, our phophodiesterase 7 (“PDE7”) inhibitor.

In October 2023, we announced the results of a pre-specified interim analysis of our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the treatment of immunoglobulin A (“IgA”) nephropathy. Topline results showed that narsoplimab did not reach statistically significant improvement over placebo on the primary endpoint of reduction in proteinuria. Based on this result, we have discontinued the ARTEMIS-IGAN clinical trial. Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”). Our Biologics License Application (“BLA”) for narsoplimab in HSCT-TMA is anticipated to be resubmitted with additional information to support potential approval of narsoplimab in this indication. Phase 1 and immunoglobulin A (“IgA”) nephropathy. Our pipeline ofPhase 2 clinical programs are underway in our other clinical-stage development programs includes: our long-acting MASP-2 inhibitor OMS1029, our inhibitor of mannan-binding lectin-associated serine protease-3 (“MASP-3”) OMS906 and our phophodiesterase 7 (PDE7) inhibitor OMS527.assets.  

Sale of OMIDRIA Assets

On December 23, 2021, we sold our commercial product OMIDRIA and certain related assets including inventory and prepaid expenses to Rayner Surgical Inc. (“Rayner”). Rayner paid us $126.0 million in cash at closing, and we retained all outstanding accounts receivable, accounts payable and accrued expenses as of the closing date.

Under the Asset Purchase Agreement with Rayner (the “Asset Purchase Agreement”), we were entitled to receive a milestone payment of $200.0 million (the “Milestone Payment”) within 30 days following an event (the “Milestone Event”) that establishes separate payment for OMIDRIA for a continuous period of at least four years when furnished in the ambulatory surgery center (“ASC”) setting. In December 2022, the Milestone Event occurred and we recorded a $200.0 million milestone receivable. Upon the achievement of the Milestone Event, our royalties on U.S. net sales were reduced from 50% to 30%, with royalties on any net sales outside the U.S. remaining unchanged at 15%. We received the Milestone Payment together with accrued interest in February 2023.

As a result of the divestiture, the results of OMIDRIA operations (e.g., revenues and operating costs) are included in discontinued operations in our condensed consolidated statements of operations and comprehensive loss and excluded from continuing operations for all periods presented (see(See “Note 3 – Discontinued Operations”).

Basis of Presentation

Our condensed consolidated financial statements include the financial position and results of operations of Omeros and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”).

Liquidity and Capital Resources

As of JuneSeptember 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 million and outstanding accounts receivable of $11.2$310.3 million. Our loss for the quarter ended JuneSeptember 30, 2023 was $37.3$37.8 million and our cash

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Table of Contents

provided by operations for the sixnine months ended JuneSeptember 30, 2023 was $142.2$109.6 million, which included collection of the $200.0 million Milestone Payment in the first quarter of 2023. We have a $95.0 million principal payment due at maturity on our 2023 unsecured convertible senior notes on November 15, 2023, which we expect to pay on the maturity date from our existing cash and investments on hand. 

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Historically, we have incurred net losses from continuing operations and negative operating cash flows. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and,costs; therefore, couldwe would need to continue to raise additional capital to accomplish our business plan and to retire our outstanding convertible senior notes due in 2026. We plan to continue to fund our operations for at least the next twelve months with our existing cash, investments and investments, royalties from Rayner and our outstanding accounts receivable. If FDA approves narsoplimab for treatment of any indication within the next twelve months, then sales of narsoplimab may also provide funds for our operations. Rayner. We have a sales agreement in place for an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $150.0 million. Should it be determined to be strategically advantageous, we could also pursue debt financings as well as public and private offerings of our equity securities, similar to those we have previously completed, or other strategic transactions, which may include licensing a portion of our existing technologies. Should it be necessary to manage our operating expenses, we could also reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include OMIDRIA contract royalty asset valuation, stock-based compensation expense, and accruals for clinical trials and manufacturing of drug product. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates.

Note 2—2Significant Accounting Policies

OMIDRIA Royalties, Milestones and Contract Royalty Assets

We have rights to receive future royalties from Rayner on OMIDRIA net sales at royalty rates that vary based on geography and certain regulatory contingencies. Therefore, future OMIDRIA royalties are treated as variable consideration. The sale of OMIDRIA qualified as an asset sale under GAAP. To measure the OMIDRIA contract royalty asset we used the expected value approach, which is the sum of the discounted probability-weighted royalty paymentpayments we would receive using a range of potential outcomes to the extent that it is probable that a significant reversal in the amount of cumulative income recognized will not occur. As contemplated by the Asset Purchase Agreement, the royalty rate applicable to U.S. net sales of OMIDRIA was reduced from 50% to 30% upon the occurrence, in December 2022, of the event triggering the $200.0 million Milestone Payment. Consequently, in December 2022, we revalued the OMIDRIA contract royalty asset using the 30% royalty rate on U.S. net sales and adjusted the probability-weighted outcomes to reflect the occurrence of the Milestone Event. Royalties earned are recorded as a reduction to the OMIDRIA contract royalty asset. The amount recorded in discontinued operations in future periods will reflect interest earned on the outstanding OMIDRIA contract royalty asset at an effective interest rate of 11.0% and any amounts we receive that are different from the expected royalties. The OMIDRIA contract royalty asset will be re-measured periodically using the expected value approach based on actual results and future expectations. Any required adjustment to the OMIDRIA contract royalty asset will be recorded in discontinued operations.

OMIDRIA Royalty Obligation

On September 30, 2022, we sold to DRI Healthcare Acquisitions LP (“DRI”) an interest in a portion of our future OMIDRIA royalty receipts for a purchase price of $125.0 million in cash (see “Note 8 – OMIDRIA Royalty Obligation”).

The $125.0 million cash consideration obtained is classified as a liability and is recorded as an “OMIDRIA royalty obligation” on our condensed consolidated balance sheet. The liability is being amortized over the term of the arrangement using the implied effective interest rate of 9.4% and interest expense is recorded as a component of continuing operations.

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- 10-

To the extent our estimates of future royalties differ materially from previous estimates, we will adjust the carrying amount of the liability for future OMIDRIA royalties to the present value of the revised estimated cash flows, discounted at the original effective interest rate of 9.4% utilizing the cumulative catch-up method. The offset to the adjustment would be recognized as a component of net income (loss) from continuing operations.

Inventory

We expense inventory costs related to product candidates as research and development expenses until regulatory approval is reasonably assured in the U.S. or the European Union (“EU”). Once approval is reasonably assured, costs, including amounts related to third-partythird-party manufacturing, transportation and internal labor and overhead, will be capitalized.

Right-of-Use Assets and Related Lease Liabilities

We record operating leases as right-of-use assets and recognize the related lease liabilities equal to the fair value of the lease payments using our incremental borrowing rate when the implicit rate in the lease agreement is not readily available. We recognize variable lease payments, when incurred. Costs associated with operating lease assets are recognized on a straight-line basis within operating expenses over the term of the lease.

We record finance lease obligations as a component of property and equipment and amortize these assets within operating expenses on a straight-line basis to their residual values over the shorter of the term of the underlying lease or the estimated useful life of the equipment. The interest component of finance lease obligations is included in interest expense and recognized using the effective interest method over the lease term.

We account for leases with initial terms of 12 months or less as an operating expense.expense.

Stock-Based Compensation

Stock-based compensation expense is recognized for all share-based payments, including grants of stock option awards and restricted stock units (“RSU”) based on estimated fair values. The fair value of our stock is calculated using the Black-Scholes valuation model, which requires judgmental assumptions around volatility, risk-free rates, forfeiture rates and expected option life. Compensation expense is recognized over the requisite service periods, which is generally the vesting period, using the straight-line method. Forfeiture expense is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates.

Income Taxes

Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases.basis. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized.

Note 3—3Discontinued Operations

On December 23, 2021, we sold OMIDRIA and certain related assets including inventory and prepaid expenses to Rayner.

Under the Asset Purchase Agreement, the achievement of the Milestone Event in December 2022 triggered a $200.0 million Milestone Payment from Rayner and a reduction in the U.S. royalty rate from 50% to 30% on OMIDRIA net sales until the expiration or termination of the last issued and unexpired U.S. patent, which we expect to occur no earlier than2033. 2033. The Milestone Event resulted in recognition of the $200.0 million Milestone Payment, which we received in February 2023. Upon the occurrence of certain events described in the Asset Purchase Agreement, including during any

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specific period in which OMIDRIA is no longer eligible for separate payment, the U.S. base royalty rate would be further reduced to 10%. Pursuant to legislation enacted in late 2022, we expect separate payment for OMIDRIA under Medicare Part B to extend until at least January 1, 2028.

- 11-

The sale of OMIDRIA and related assets was recorded as an asset sale. Additionally, the results of operations related to OMIDRIA are recorded as income from discontinued operations for all periods presented in the condensed consolidated statements of operations and comprehensive loss.

The following schedule presents a rollforwardroll forward of the OMIDRIA contract royalty asset (in thousands):

OMIDRIA contract royalty asset at December 31, 2022

$

152,222

 $152,222 

Royalties earned

(19,914)

 (29,900)

Interest earned on OMIDRIA contract royalty asset

7,754

 11,484 

Remeasurement adjustments

4,824

  14,924 

OMIDRIA contract royalty asset at June 30, 2023

$

144,886

OMIDRIA contract royalty asset at September 30, 2023

 $148,730 

Net income from discontinued operations is as follows:

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

2023

    

2022

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Interest earned on OMIDRIA contract royalty asset

$

3,829

$

4,545

$

7,754

$

9,383

 $3,730  $4,356  $11,484  $13,739 

Remeasurement adjustments

3,147

5,557

4,824

7,716

 10,100  32,917  14,924  40,631 

Other income (expense), net

24

744

404

230

Other income, net

  76   63   480   295 

Net income from discontinued operations, net of tax

$

7,000

$

10,846

$

12,982

$

17,329

 $13,906  $37,336  $26,888  $54,665 

Cash flow from discontinued operations is as follows:

Six Months Ended

June 30,

    

2023

    

2022

 

Nine Months Ended

 

 

September 30,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Net cash provided by discontinued operations from operating activities

$

217,688

$

46,038

 $232,081  $60,188 

Net cash provided by discontinued operations primarily represents royalties received and the $200.0 million Milestone Payment that we collected from Rayner in February 2023. ​

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- 12-

Note 4—4Net Loss Per Share

Our potentially dilutive securities include potential common shares related to our stock options, RSUs and unsecured convertible senior notes. Diluted earnings per share (“Diluted EPS”) considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would have an anti-dilutive effect. Diluted EPS excludes the impact of potential common shares related to our stock options in periods in which the option exercise price is greater than the average market price of our common stock for the period.

Potentially dilutive securities excluded from Diluted EPS are as follows:

Three Months Ended

Six Months Ended

 

Three Months Ended

 

Nine Months Ended

 

June 30, 

June 30, 

 

September 30,

  

September 30,

 

    

2023

    

2022

    

2023

    

2022

 

2023

  

2022

  

2023

  

2022

 

2026 Notes convertible to common stock (1)

12,172,008

12,172,008

12,172,008

12,172,008

 12,172,008  12,172,008  12,172,008  12,172,008 

2023 Notes convertible to common stock (1)

4,941,739

4,941,739

4,941,739

4,941,739

 4,941,739  4,941,739  4,941,739  4,941,739 

Outstanding options to purchase common stock

98,920

 

88

42,186

 

1,963

 34,450  19,292  37,394  8,246 

Outstanding restricted stock units

89,750

208,819

89,750

207,736

  70,250   200,000   70,250   200,000 

Total potentially dilutive shares excluded from net loss per share

17,302,417

 

17,322,654

17,245,683

 

17,323,446

  17,218,446   17,333,039   17,221,390   17,321,993 

(1)

The 2023 Notes and 2026 Notes (defined below) are subject to capped call arrangements that potentially reduce the dilutive effect as described in “Note 7 — Unsecured Convertible Senior Notes.” Any potential impact of the capped call arrangements is excluded from this table.

(1)The 2023 Notes and 2026 Notes (defined below) are subject to capped call arrangements that potentially reduce the dilutive effect as described in “Note 7

Note5 Unsecured Convertible Senior Notes.” Any potential impact of the capped call arrangements is excluded from this table.

Note 5—Certain Balance Sheet Accounts

OMIDRIA Contract Royalty Asset

The OMIDRIA contract royalty asset consists of the following:

June 30, 

December 31, 

    

2023

    

2022

 

September 30,

 

December 31,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Short-term contract royalty asset

$

29,084

$

28,797

 $29,228  $28,797 

Long-term contract royalty asset

115,802

123,425

  119,502   123,425 

Total OMIDRIA contract royalty asset

$

144,886

$

152,222

 $148,730  $152,222 

Receivables

Receivables

Receivables consist of the following:

June 30, 

December 31, 

    

2023

    

2022

 

September 30,

 

December 31,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

OMIDRIA royalty

$

11,066

$

12,966

 $6,658  $12,966 

Sublease and other

124

255

 220  255 

OMIDRIA milestone

 

 

200,000

     200,000 

Total receivables

$

11,190

$

213,221

 $6,878  $213,221 

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Property and Equipment, Net

Property and equipment, net consists of the following:

    

June 30, 

    

December 31, 

2023

2022

 

September 30,

 

December 31,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Equipment under finance lease obligations

$

6,477

$

6,204

 $6,608  $6,204 

Laboratory equipment

 

3,385

 

3,135

 3,407  3,135 

Computer equipment

 

1,101

 

1,076

 1,113  1,076 

Office equipment and furniture

 

625

 

625

  625   625 

Total cost

 

11,588

 

11,040

 11,753  11,040 

Less accumulated depreciation and amortization

 

(9,839)

 

(9,548)

  (10,036)  (9,548)

Total property and equipment, net

$

1,749

$

1,492

 $1,717  $1,492 

For the three months ended JuneSeptember 30, 2023 and June 30, 2022, depreciation and amortization expense was $0.3$0.2 million and $0.2$0.3 million, respectively. For the sixnine months ended JuneSeptember 30, 2023 and 2022, depreciation and amortization expense was $0.5$0.7 million for each period.and $0.8 million, respectively.

Accrued Expenses

Accrued expenses consists of the following:

    

June 30, 

    

December 31, 

2023

2022

 

September 30,

 

December 31,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Employee compensation

$

7,342

$

6,665

 $12,556  $6,665 

Clinical trials

7,272

5,536

 9,351  5,536 

Contract research and development

 4,158  3,209 

Interest payable

6,160

5,172

 3,703  5,172 

Contract research and development

4,043

3,209

Consulting and professional fees

2,901

4,425

 3,005  4,425 

Income taxes payable

1,228

4,871

 1,228  4,871 

Other accrued expenses

 

847

 

673

  858   673 

Total accrued expenses

$

29,793

$

30,551

 $34,859  $30,551 

Note 6—6Investments and Fair-Value Measurements

All of our investments are held in our name and are classified as short-term and held-to-maturity on the accompanying condensed consolidated balance sheets. Investment income is included as a component of other income.income on our condensed consolidated statement of operations and comprehensive loss. Investment income for the three months ended JuneSeptember 30, 2023 and June September 30,2022 consists primarily of interest earned of $4.2$4.0 million and $0.2$0.4 million, respectively. Investment income for the sixnine months ended JuneSeptember 30, 2023 and June 30, 2022 consists of interest income earned of $7.6$11.7 million and $0.2$0.6 million, respectively.

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The following tables summarize our investments:

    

June 30, 2023

 

September 30, 2023

 

    

Amortized Cost

    

Gross Unrealized Gains/(Losses)

    

Estimated Fair Value

    

Gross Unrealized

   
 

Amortized Cost

  

Gains/(Losses)

  

Estimated Fair Value

 

(In thousands)

 

(In thousands)

 

 

 

 

 

U.S. government securities classified as short-term investments

$

225,983

$

(89)

$

225,894

 $127,385  $2  $127,387 

Money-market funds classified as short-term investments

108,697

108,697

  152,285      152,285 

Total short-term investments

334,680

(89)

334,591

 279,670  2  279,672 

Certificate of deposit classified as non-current restricted investments

1,054

1,054

  1,054      1,054 

Total

$

335,734

$

(89)

$

335,645

 $280,724  $2  $280,726 

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December 31, 2022

 

     

Gross Unrealized

     
  

Amortized Cost

  

Gains/(Losses)

  

Estimated Fair Value

 

 

(In thousands)

 

 

  

  

 

U.S. government securities classified as short-term investments

 $99,027  $22  $99,049 

Money-market funds classified as short-term investments

  84,882      84,882 

Total short-term investments

  183,909   22   183,931 

Certificate of deposit classified as non-current restricted investments

  1,054      1,054 

Total

 $184,963  $22  $184,985 

    

December 31, 2022

    

Amortized Cost

    

Gross Unrealized Gains/(Losses)

    

Estimated Fair Value

(In thousands)

U.S. government securities classified as short-term investments

$

99,027

$

22

$

99,049

Money-market funds classified as short-term investments

84,882

84,882

Total short-term investments

183,909

22

183,931

Certificate of deposit classified as non-current restricted investments

1,054

1,054

Total

$

184,963

$

22

$

184,985

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required:

Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets;

Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and

Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use.

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Our fair value hierarchy for our financial assets and liabilities are as follows:

June 30, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

 

September 30, 2023

 

 

Level 1

  

Level 2

  

Level 3

  

Total

 

(In thousands)

 

(In thousands)

 

Assets:

 

 

 

 

 

U.S. government securities classified as short-term investments

$

225,894

$

$

$

225,894

 $  $127,387  $  $127,387 

Money-market funds classified as short-term investments

108,697

108,697

  152,285         152,285 

Total short-term investments

334,591

334,591

 152,285  127,387    279,672 

Certificate of deposit classified as non-current restricted investments

 

1,054

 

 

 

1,054

  1,054         1,054 

Total

$

335,645

$

$

$

335,645

 $153,339  $127,387  $  $280,726 

 

December 31, 2022

 

 

Level 1

  

Level 2

  

Level 3

  

Total

 

 

(In thousands)

 

Assets:

 

  

  

  

 

U.S. government securities classified as short-term investments

 $  $99,049  $  $99,049 

Money-market funds classified as short-term investments

  84,882         84,882 

Total short-term investments

  84,882   99,049      183,931 

Certificate of deposit classified as non-current restricted investments

  1,054         1,054 

Total

 $85,936  $99,049  $  $184,985 

    

December 31, 2022

    

Level 1

    

Level 2

    

Level 3

    

Total

(In thousands)

Assets:

U.S. government securities classified as short-term investments

$

99,049

$

$

$

99,049

Money-market funds classified as short-term investments

84,882

84,882

Total short-term investments

183,931

183,931

Certificate of deposit classified as non-current restricted investments

 

1,054

 

 

 

1,054

Total

$

184,985

$

$

$

184,985

Cash held in demand deposit accounts of $6.6$30.6 million and $11.0 million is excluded from our fair-value hierarchy disclosure as of JuneSeptember 30, 2023 and December 31, 2022, respectively. The carrying amounts reported in the accompanying condensed consolidated balance sheets for receivables, accounts payable and other current monetary assets and liabilities approximate fair value.

See “Note 7—Unsecured Convertible Senior Notes” and “Note 8—OMIDRIA Royalty Obligation” for the carrying amount and estimated fair value of our outstanding convertible senior notes and the OMIDRIA royalty obligation.

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Note 7—7Unsecured Convertible Senior Notes

We carry $95.0 million in aggregate principal on our 6.25% Convertible Senior Notes (the “2023“2023 Notes”) and $225.0 million in aggregate principal on our 5.25% Convertible Senior Notes (the “2026“2026 Notes”) as shown below:

Balance as of June 30, 2023

    

2023 Notes

    

2026 Notes

    

Total

 

Balance as of September 30, 2023

 

 

2023 Notes

  

2026 Notes

  

Total

 

(In thousands)

 

(In thousands)

 

Principal amount

$

95,000

$

225,030

$

320,030

 $95,000  $225,030  $320,030 

Unamortized debt issuance costs

 

(270)

 

(3,514)

 

(3,784)

  (91)  (3,202)  (3,293)

Total unsecured convertible senior notes, net

$

94,730

$

221,516

$

316,246

 $94,909  $221,828  $316,737 

 

 

 

 

Fair value of outstanding unsecured convertible senior notes (1)

$

93,575

$

157,359

 $94,822  $136,424  

 

Balance as of December 31, 2022

    

2023 Notes

    

2026 Notes

    

Total

 

Balance as of December 31, 2022

 

 

2023 Notes

  

2026 Notes

  

Total

 

(In thousands)

 

(In thousands)

 

Principal amount

$

95,000

$

225,030

$

320,030

 $95,000  $225,030  $320,030 

Unamortized discount

 

(619)

 

(4,124)

 

(4,743)

  (619)  (4,124)  (4,743)

Total unsecured convertible senior notes, net

$

94,381

$

220,906

$

315,287

 $94,381  $220,906  $315,287 

 

 

 

 

Fair value of outstanding unsecured convertible senior notes (1)

$

92,031

$

118,141

 $92,031  $118,141  

 

(1)

(1)

The fair value is classified as Level 3 due to the limited trading activity for the unsecured convertible senior notes.

-16-

2023 Unsecured Convertible Senior Notes

Our 2023 Notes are unsecured and accrue interest at an annual rate of 6.25% per annum, payable semi-annually in arrears on May 15 and November 15 of each year. The 2023 Notes matureWe expect to pay the $95.0 million principal payment upon maturity on November 15, 2023 unless earlier purchased, redeemed or converted in accordance with their terms.from our existing cash and investments on hand.

The unamortized debt issuance costs of $0.3$0.1 million as of JuneSeptember 30, 2023 will be amortized to interest expense at an effective interest rate of 7.0% over the remaining term.

Subject to the satisfaction of certain conditions, the 2023 Notes are convertible into cash, shares of our common stock or a combination thereof, as we elect at our sole discretion. The initial conversion rate is 52.0183 shares of our common stock per $1,000 of note principal (equivalent to an initial conversion price of approximately $19.22 per share of common stock), which equals approximately 4.9 million shares of common stock issuable upon conversion, subject to adjustment in certain circumstances.

To reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2023 Notes, we entered into a capped call transaction (the “2023“2023 Capped Call”), which covers the number of shares of our common stock underlying the 2023 Notes when our common stock share price is trading between the initial conversion price of $19.22 and $28.84. However, should the market price of our common stock exceed the $28.84 cap, then the conversion of the 2023 notes could have a dilutive impact or may require a cash expenditure to the extent the market price exceeds the cap price. As of JuneSeptember 30, 2023, approximately 4.9 million shares remained outstanding on the 2023 Capped Call.Call and expire upon maturity of our 2023 Notes on November 15, 2023.

- 16-

The following table sets forth total interest expense recognized in connection with the 2023 Notes:

    

Three Months Ended

Six Months Ended

June 30,

June 30,

2023

    

2022

    

2023

    

2022

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

(In thousands)

(In thousands)

 

(In thousands)

 

Contractual interest expense

$

1,484

$

1,484

$

2,969

$

2,969

 $1,484  $1,484  $4,453  $4,453 

Amortization of debt issuance costs

 

176

 

164

 

349

 

325

  179   167   528   492 

Total

$

1,660

$

1,648

$

3,318

$

3,294

 $1,663  $1,651  $4,981  $4,945 

2026 Unsecured Convertible Senior Notes

Our 2026 Notes are unsecured and accrue interest at an annual rate of 5.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year. The 2026 Notes mature on February 15, 2026, unless earlier purchased, redeemed or converted in accordance with their terms.

The unamortized debt issuance costs of $3.5$3.2 million as of JuneSeptember 30, 2023 will be amortized to interest expense at an effective interest rate of 5.9% over the remaining term.

Subject to the satisfaction of certain conditions, the 2026 Notes are convertible into cash, shares of our common stock or a combination thereof, as we elect at our sole discretion. The initial conversion rate is 54.0906 shares of our common stock per $1,000 of note principal (equivalent to an initial conversion price of approximately $18.4875 per share of common stock), which equals approximately 12.2 million shares of common stock issuable upon conversion, subject to adjustment in certain circumstances.

To reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2026 Notes, we entered into capped call transactions (the “2026“2026 Capped Calls”), which cover the number of shares of our common stock underlying the 2026 Notes when our common stock share price is trading between the initial conversion price of $18.49 and $26.10.$26.10. However, should the market price of our common stock exceed the $26.10 cap, then the conversion of the 2026 Notes would have a dilutive impact or may require a cash expenditure to the extent the market price exceeds the cap price. AsAs of JuneSeptember 30, 2023, approximately 12.2million shares remained outstanding on the 2026 Capped Call.

-17-

The following table sets forth interest expense recognized related to the 2026 Notes:

Three Months Ended

Six Months Ended

June 30,

June 30,

    

2023

    

2022

2022

2021

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

(In thousands)

(In thousands)

 

(In thousands)

 

Contractual interest expense

$

2,954

$

2,954

$

5,907

$

5,907

 $2,954  $2,954  $8,861  $8,861 

Amortization of debt issuance costs

 

307

 

290

610

575

  312   294   922   869 

Total

$

3,261

$

3,244

$

6,517

$

6,482

 $3,266  $3,248  $9,783  $9,730 

Future Minimum Principal Payments

Future minimum principal payments for the 2023 Notes and 2026 Notes as of JuneSeptember 30, 2023 are as follows (in thousands):

2023

    

$

95,000

 $95,000 

2024

 

  

2025

 

  

2026

 

225,030

  225,030 

Total future minimum principal payments under the 2023 Notes and 2026 Notes

 

$

320,030

 $320,030 

- 17-

Note 8—8OMIDRIA Royalty Obligation

On September 30, 2022, we sold to DRI an interest in our future OMIDRIA royalty receipts and received $125.0 million in cash consideration which was recorded as an OMIDRIA royalty obligation on our condensed consolidated balance sheet. DRI is entitled to receive royalties on OMIDRIA net sales through December 31, 2030, subject to annual caps. DRI receives their prorated monthly cap amount before we receive any royalty proceeds. DRI is not entitled to carry-forward nor recoup any shortfall if the royalties paid by Rayner for an annual period are less than the cap amount applicable to each discrete calendar year. Additionally, DRI has no recourse to or security interest in our assets other than our OMIDRIA royalty receipts, and we retain all royalty receipts in excess of the respective cap in any given calendar year. At JuneSeptember 30, 2023, the maximum remaining amount that DRI is entitled to receive through the term of the agreement (December( December 31, 2030) is $180.3$177.0 million, which, if fully paid, would be at an implied effective interest rate of 9.4% over the entire payment period.term of the agreement.

For the three months and six months ended June 30, 2023, we incurred $3.0 million and $5.9 million, respectively, of cash interest expense.

-18-

We consider our OMIDRIA royalty obligation to be a Level 3 Held-to-Maturity obligation in the fair value hierarchy as its valuation relies on factors that are not easily observable in the market. As of JuneSeptember 30, 2023, the approximate fair value of our obligation is $117.1was $116.2 million.

 ​

For the three months and nine months ended September 30, 2023, we incurred cash interest expense of $3.0 million and $8.9 million, respectively.

 ​

As of JuneSeptember 30, 2023, the maximum remaining scheduled principal and interest payments (based on an implied effective interest rate of 9.4%) are as follows:

Total

    

Principal

    

Interest

    

Annual Cap

 

 

 

Total

 

 

Principal

  

Interest

  

Annual Cap

 

(In thousands)

 

(In thousands)

 

2023

$

589

$

5,911

$

6,500

 $298  $2,952  $3,250 

2024

 

8,576

 

11,424

20,000

 8,576  11,424  20,000 

2025

 

14,641

 

10,359

25,000

 14,641  10,359  25,000 

2026

 

16,081

 

8,919

25,000

 16,081  8,919  25,000 

2027

 

17,664

 

7,336

25,000

 17,664  7,336  25,000 

Thereafter

 

68,164

 

10,586

78,750

  68,164   10,586   78,750 

Total scheduled payments

$

125,715

$

54,535

$

180,250

 $125,424  $51,576  $177,000 

Note9Leases

Note 9—Leases

We have an operating lease for our office and laboratory facilities with an initial term that ends in November 2027 and two options to extend the lease term by an additional five years each. Restricted investments of $1.1 million represent the security deposit on our office and laboratory facilities. On January 14, 2022, we entered into an agreement with our landlord to early terminate a portion of the rentable square footage of our office and laboratory facilities, which reduced the right of use asset by $4.7 million and related liability by $5.2 million. We recorded a non-cash gain of $0.5 million upon early termination of this portion of the lease. In addition, we carry various finance lease obligations for laboratory equipment.

Supplemental lease information is as follows:

Three Months Ended

Six Months Ended

June 30, 

June 30, 

2023

2022

    

2023

    

2022

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

(In thousands)

(In thousands)

 

(In thousands)

 

Lease cost

  

    

  

 

Operating lease cost

$

1,616

$

1,663

$

3,249

$

2,870

 $1,603  $1,659  $4,852  $4,529 

Finance lease cost:

 

 

 

 

  

 

 

 

Amortization

 

271

 

122

 

389

 

320

 140  250  529  570 

Interest

 

41

 

36

 

92

 

92

 29  32  121  123 

Variable lease cost

 

757

 

722

 

1,547

 

1,582

 807  813  2,354  2,395 

Sublease income

 

(375)

 

(453)

 

(750)

 

(945)

  (375)  (432)  (1,125)  (1,377)

Net lease cost

$

2,310

$

2,090

$

4,527

$

3,919

 $2,204  $2,322  $6,731  $6,240 

- 18-

Cash paid for amounts included in the measurement of lease liabilities is as follows:

Six Months Ended

June 30, 

    

2023

    

2022

 

Nine Months Ended

 

 

September 30,

 

 

2023

  

2022

 

(In thousands)

 

(In thousands)

 

Cash paid for amounts included in the measurement of lease liabilities

 

 

 

Cash payments for operating leases

$

3,568

$

3,562

 $5,356  $5,312 

Cash payments for financing leases

$

336

 

$

401

 $499  $598 

-19-

Note 10—10Commitments and Contingencies

Goods

Good and ServicesService Contracts

We have various agreements with third parties that collectively require payment of termination fees totaling $21.2$27.4 million as of JuneSeptember 30, 2023 if we cancel the work within specific time frames, either prior to commencing or during performance of the contracted services.

Development Milestones and Product Royalties

We have licensed a variety of intellectual property from third parties that we are currently developing or may develop in the future. These licenses may require milestone payments during the clinical development processes or on approval of commercial sale as well as low single- to low double-digit royalties on the net income or net sales of the product. For the three months and sixnine months ended JuneSeptember 30, 2023, and June 30, 2022,we paid $5.0 million associated with development milestone expenses related to the OMS906 program. For the three and nine months ended September 30, 2022, development milestones were insignificant.not significant. Should narsoplimab be approved, we would owe milestone payments to development partners and couldwould be obligated to pay low single-digit royalties on net sales of the product.

In July 2023, we achieved a clinical development milestone in our OMS906 program that triggered a $5.0 million milestone payment obligation to a third-party licensor, which we expect to pay in the third quarter of 2023. This amount is excluded from the commitment amount above.

Note 11—Shareholders’11Shareholders Equity (Deficit)

Common Stock and Warrants

On March 1, 2021, we entered into a sales agreement to sell shares of our common stock having an aggregate offering price of up to $150.0 million, from time to time, through an “at the market” equity offering program. As of JuneSeptember 30, 2023, we have not sold any shares under this program.

On April 12, 2023, warrants to purchase 200,000 shares of our common stock with an exercise price of $23.00 per share expired without being exercised. We have no other warrants outstanding.

On November 9, 2023, the Board of Directors approved an indefinite term share repurchase program under which we may repurchase from time to time up to $50.0 million of our common stock in the open market or through privately negotiated transactions.

Amendment of 2017 Omnibus Incentive Compensation Plan

At our June 23, 2023 annual meeting, our shareholders approved a 5,000,000 share increase in the number of shares of our common stock available for grant under the 2017 Omnibus Incentive Compensation Plan, as amended and restated. The total number of shares of common stock available for grant as of JuneSeptember 30, 2023 was 10,175,852.8,613,348.

Note 12—12Stock-Based Compensation

Our stock option plans provide for the grant of incentive and non-qualified stock options, restricted stock awards, RSUs, and other stock awards to employees, non-employee directors and consultants.

-20-

- 19-

Stock-based compensation is as follows:

    

Three Months Ended

    

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

(In thousands)

Continuing operations

Research and development

$

1,133

$

1,389

$

2,405

$

3,104

Selling, general and administrative

 

1,680

 

1,793

 

3,402

 

3,970

Total stock-based compensation in continuing operations

2,813

3,182

5,807

7,074

Discontinued operations

(42)

(110)

(83)

(110)

Total stock-based compensation

$

2,771

$

3,072

$

5,724

$

6,964

  

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Continuing operations

 

  

  

  

 

Research and development

 $1,305  $1,672  $3,710  $4,777 

Selling, general and administrative

  2,054   2,200   5,456   6,170 

Total stock-based compensation in continuing operations

  3,359   3,872   9,166   10,947 

Discontinued operations

  (124)  (28)  (207)  (139)

Total stock-based compensation

 $3,235  $3,844  $8,959  $10,808 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to all stock option grants:

    

Three Months Ended

Six Months Ended

 

Three Months Ended

 

Nine Months Ended

 

June 30, 2023

June 30, 2023

 

September 30, 2023

  

September 30, 2023

 

Estimated weighted-average fair value

$

4.66

$

4.21

 $2.42  $2.54 

Weighted-average assumptions:

 

 

 

 

 

Expected volatility

 

92

%  

 

92

%

 93% 93%

Expected life, in years

 

7.3

 

7.1

 7.1  7.1 

Risk-free interest rate

 

3.74

%  

 

3.74

%

 3.98% 3.96%

Expected dividend yield

 

%  

 

%

 % %

Stock option activity for all stock plans and related information is as follows:

    

    

Weighted- 

    

    

 

 

Weighted-

 

 

 

Average 

Aggregate 

 

 

Average

 

 

Aggregate

 

Exercise 

Remaining 

Intrinsic 

 

 

Exercise

 

Remaining

 

Intrinsic

 

Options 

Price per 

Contractual Life 

Value 

 

Options

 

Price per

 

Contractual Life

 

Value

 

Outstanding

Share

(In years)

(In thousands)

 

Outstanding

  

Share

  

(In years)

  

(In thousands)

 

Balance at December 31, 2022

 

13,872,973

$

11.02

 

  

 

  

 13,872,973  $11.02      

Granted

 

200,000

 

5.20

 

  

 

  

 2,908,200  3.13      

Exercised

 

(19,556)

 

4.98

 

  

 

  

 (36,726) 4.10      

Forfeited

 

(437,821)

 

10.46

 

  

 

  

  (1,439,517)  10.12      

Balance at June 30, 2023

 

13,615,596

$

10.96

 

5.3

$

4,095

Vested and expected to vest at June 30, 2023

 

13,290,618

$

11.04

 

5.2

$

3,793

Exercisable at June 30, 2023

 

10,508,263

$

11.89

 

4.3

$

1,280

Balance at September 30, 2023

  15,304,930  $9.62   6.3  $80 

Vested and expected to vest at September 30, 2023

  14,760,623  $9.78   6.2  $77 

Exercisable at September 30, 2023

  10,169,314  $11.75   4.8  $44 

Of the 13.615.3 million common stock options outstanding at Juneas of September 30, 2023 11.1, 15.2 million have an exercise price per share above $5.44$ 2.92, which was the closing price of our common stock on the NASDAQNasdaq exchange on JuneSeptember 30, 2023.

As of JuneSeptember 30, 2023, there were 3.15.1 million unvested options outstanding that will vest over a weighted-average period of 1.92.2 years. The total estimated compensation expense yet to be recognized on outstanding options is $14.5$ 17.1 million.

The Company had 89,75070,250 unvested RSUs outstanding as of JuneSeptember 30, 2023 that vest on December 1, 2023. The weighted average grant date fair value per share was $7.53.

-21-

- 20-

ITEM2. MANAGEMENT’SMANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report on Form 10-Q10Q and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 13, 2023 and amended by Amendment No. 1 thereto, which was filed with the SECSecurities and Exchange Commission (the "SEC") on May 1, 2022.2023. In addition, you should read the section entitled “Risk Factors”Risk Factors and the disclaimers regarding forward-looking statements included herein and in our Annual Report on Form 10-K for the year ended December 31, 2022, for a discussion of important factors that could cause our results to differ materially from the results described in or implied by any forward-looking statements contained herein.

Overview

Omeros Corporation (“Omeros,” the “Company” or “we”) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.

Complement Programs: Lectin Pathway / MASP-2

The lead drug candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (“MASP-2”), the key activator of the lectin pathway of complement. Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy (“HSCT-TMA”) and immunoglobulin A (“IgA”) nephropathy.

We expect to read out 36-week proteinuria data from our Phase 3 clinical trial evaluating narsoplimab for the treatment of IgA nephropathy, ARTEMIS-IGAN, in the third quarter of this year.

We successfully completed a pivotal clinical trial for narsoplimab in HSCT-TMA and previously submitted to the U.S. Food and Drug Administration (“FDA”) a biologics licensinglicense application (“BLA”) seeking marketing approval for narsoplimab in this indication. In late 2021, FDA issued a complete response letter (“CRL”) with respect to the BLA in which the agency indicated that additional information would be needed to support regulatory approval. We appealed FDA’s decision to issue the CRL through a formal dispute resolution process that concluded in late 2022. Although our appeal was denied, the decision identified potential paths for resubmission of the BLA based on both response data and/orand survival data from the completed pivotal trial versus a historical control group, with or without an independent literature analysis. In May 2023 we had a Type B meeting at which the Agency reiterated its commitment to work with Omeros toward a resubmission and provided helpful guidancebased on our proposal to collect and analyze external survival data for inclusionalone. Consistent with subsequent interactions with FDA’s review division regarding resubmission of the BLA, we have submitted to FDA a formal analysis plan to assess already existing clinical trial data and certain existing external data, and we plan to include these analyses in a resubmitted BLA. Based on the Agency’s feedback, we expect to submit to FDA early next month a detailed plan of how we intend to analyze those survival data from already-identifed external sources. This proposal would be submitted as a Type B meeting request, with FDA’s response expected within 60 days. After receivingWe are currently awaiting FDA’s feedback on our detailedthe formal analysis plan and, assuming the agency’s feedback is favorable, we would access the data,intend to conduct the requisite analyses and, together with additional new supportive data,if results are positive, resubmit the BLA. AllowingBLA as expeditiously as possible. Assuming we reach agreement with FDA on our formal analysis plan in a single round of discussions then, allowing for the full duration of relevant FDA review periods,time on a resubmitted BLA, we currently estimate that an approval decision on the resubmitted BLAnarsoplimab in HSCT-TMA could be rendered by FDA in mid-2024. There can be no guarantee that the specific data and analyses discussedrequirements for resubmission, when determined through interaction with the FDA review division, will be satisfactory in terms of the time and/or expenditure required, that any new analyses conducted will result in favorable data, or that any resubmission of the BLA will result in approval of narsoplimab for HSCT-TMA.

In October 2023, we announced the result of the pre-specified interim analysis of our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the treatment of immunoglobulin A (“IgA”) nephropathy. The primary endpoint is reduction in proteinuria assessed by 24-hour urine protein excretion ("UPE") at 36 weeks compared to placebo in the intent-to-treat population of 180 IgA nephropathy patients with high baseline proteinuria (24-hour UPE > 2 g/day). Topline results of the interim analysis showed that narsoplimab did not achieve statistically significant improvement over placebo on the proteinuria endpoint. The proteinuria reduction in the placebo group was markedly greater than that reported in Phase 3 clinical trials of other agents in IgA nephropathy. Based on the absence of statistical significance and as previously agreed with FDA, we determined not to submit an application for approval of narsoplimab in this indication and the ARTEMIS-IGAN clinical trial has been discontinued.

We are also developing OMS1029, a long-acting, next-generation antibody targeting MASP-2 and the lectin pathway. Dosing of all cohorts in a single-ascending dose Phase 1 clinical trial of OMS1029 was successfully completed in early 2023. OMS1029 was well tolerated with no safety concerns identified. Preliminary pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data show dose-proportional exposure and sustained lectin pathway inhibition, consistent with

-22-

potentially quarterly intravenous or subcutaneous dosing. Dosing is underwayhas been completed in athe first cohort of our ongoing Phase 1 multiple-ascending-dose study of OMS1029 in healthy subjects. A Phase 2 program is expected to begin in mid-2024.

Complement Programs: Alternative Pathway / MASP-3

Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes OMS906, a proprietary, patented monoclonal antibody targeting mannan-binding lectin-associated serine protease 3 (“MASP-3”), the key activator of the alternative pathway of complement. We believe OMS906 has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate OMS906 from other marketed and in-development alternative pathway inhibitors. Clinical development of OMS906 is currently focused on rapidly obtaining proof-of-concept dataongoing in multiple alternative pathway-related disorders, including complement 3 glomerulopathy (“C3G”), a rare chronic kidney disease, and paroxysmal nocturnal hemoglobinuria (“PNH”), a rare and life-threatening hemolytic blood disorder.

In June 2023, results from a pre-specified interim analysis of our ongoing clinical trial of OMS906 in complement-inhibitor-naïve adults with PNH were detailedpresented at the 2023 congress of the European Hematology Association as a “late-breaker”and updated interim analysis data from this study are scheduled for podium presentation. Statisticallypresentation at the 2023 annual meeting of the American Society of Hematology in December. Both presentations report statistically significant and clinically meaningful improvements were observed in all measured markers of hemolysis, including hemoglobin and lactate dehydrogenase. No patients were reported to have had a clinical breakthrough of PNH or a thrombotic event, and none were reported to require a transfusion while receiving OMS906 treatment. Based on pharmacokinetic data from a successfulEnrollment is now complete and dosing is ongoing in our Phase 1 single-ascending-dose study of OMS906 in healthy subjects and the interim data from our ongoing2 clinical trial in treatment-naïve PNH patients, we are planning and expect that we will be able to achieve a dosing frequency of once quarterly, either intravenously or subcutaneously.

We have two additional clinical programs ongoing. One, evaluating OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab, has enrolledravulizumab. We are initiating an open-label extension study to assess the long-term efficacy and dosedsafety of OMS906 in patients with PNH. In the extension study, patients who have completed a substantial numberprevious PNH study evaluating OMS906 will roll directly into the extension study without a break in OMS906 treatment. Data from this study will contribute to a planned BLA for OMS906 in the treatment of patients. The second, also underway, isPNH. Based on PK data from a successful Phase 1 single-ascending-dose study of OMS906 in healthy subjects and interim data from our ongoing clinical trials in PNH patients, we are expecting a dosing frequency of once quarterly for the Phase 3 studies and commercialization.

Enrollment in our Phase 2 clinical program evaluating OMS906 in patients with C3G. EachC3G is also ongoing. Initiation of these trials were initiated under a Phase 1b3 clinical protocol. Weprograms for OMS906 in PNH and C3G are currently completing a seriestargeted for the third quarter of protocol amendments to re-categorize these studies as Phase 2 trials given the positive data obtained to date and to allow for increasing the number of patients to be enrolled.2024. 

PDE7 Inhibitor Program

Our development pipeline also includes OMS527, our phosphodiesterase 7 (“PDE7”) inhibitor program focused on addiction and movement disorders. In April 2023, we were awarded a grant from the National Institute on Drug Abuse, part of the National Institutes of Health, to develop our lead orally administered PDE7 inhibitor compound, for which we have successfully completed a Phase 1 study, for the treatment of cocaine use disorder (“CUD”). The grant amount, a total of $6.69 million over three years, is intended to support preclinical cocaine interaction/toxicology studies to assess safety of the therapeutic candidate in the presence of concomitant cocaine administration, as well as an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adults with CUD who receive concurrent intravenous cocaine. Investigators We expect the preclinical studies to begin in early 2024. Additionally, with investigators at Emory University, we are also evaluating OMS527 inas a clinically predictive primate model ofpotential treatment for levodopa-induced dyskinesias, a common and debilitating side effect of long-term levodopa dosing in patients with Parkinson’s disease. Data will be publicly disclosed after the filing of patent applications, as appropriate.

Pre-clinical Programs

We also have a diverse group of preclinical programs. These include our proprietary G protein-coupled receptor (“GPCR”) platform through which we control 54 GPCR drug targets and their corresponding compounds. We are also developingprograms, including five immuno-oncology platforms directed to development of novel adoptive T cell/CAR-T therapies and novel immunotherapeutics and cancer vaccines as part of our immuno-oncology platform.vaccines.

OMIDRIA

We previously developed and commercialized OMIDRIA®OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%, which is approved by FDA for use during cataract surgery or intraocular lens (“IOL”) replacement to maintain

-23-

pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. We marketed OMIDRIA in the United States (the “U.S.”) from the time of its commercial launch in 2015 until December 2021.

On December 23, 2021, we sold our commercial product OMIDRIA and certain related assets, including inventory and prepaid expenses to Rayner Surgical Inc. (“Rayner”). Rayner paid us $126.0 million in cash at the closing and we retained all outstanding accounts receivable, accounts payable, and accrued expenses as of the closing date.

Under the Asset Purchase Agreement with Rayner (the “Asset Purchase Agreement”), we were entitled to receive a milestone payment of $200.0 million (the “Milestone Payment”) within 30 days following an event (the “Milestone Event”) that establishedestablishes separate payment for OMIDRIA for a continuous period of at least four years when furnished in the ambulatory surgery center (“ASC”) setting. The Milestone Event occurred in December 2022 and we recorded a $200.0 million milestone receivable. We received the Milestone Payment together with accrued interest in February 2023.

Under the Asset Purchase Agreement, the occurrence of the Milestone Event in December 2022 triggered a reduction in the U.S. royalty rate from 50% to 30% on OMIDRIA net sales until the expiration or termination of the last issued and unexpired U.S. patent, which we expect to occur no earlier than 2033. Upon the occurrence of certain events described in the Asset Purchase Agreement, including during any specific period in which OMIDRIA is no longer eligible for separate payment (i.e., included in the packaged payment rate for the surgical procedure) under Medicare Part B, the U.S. base royalty rate would be reduced to 10%. Pursuant to legislation enacted in late 2022, we expect separate payment for OMIDRIA under Medicare Part B to extend until at least January 1, 2028.

On September 30, 2022, we sold to DRI Healthcare Acquisitions LP (“DRI”) an interest in a portion of our future OMIDRIA royalty receipts and received $125.0 million in cash consideration, which we recorded as a liability on our condensed consolidated balance sheet. The liability is being amortized over the term of the arrangement using the implied effective interest rate of 9.4%. Interest expense is recorded as a component of continuing operations. As of JuneSeptember 30, 2023, the maximum future payout that DRI is entitled to receive through the remaining term of the agreement is $180.3$177.0 million. The term of the agreement with DRI runs through December 31, 2030, and our payments to DRI will not total $125.0 million until August 2028 at the earliest.

Financial Summary

Our loss for the three and sixnine months ended JuneSeptember 30, 2023 was $37.3$37.8 million and $71.0$108.7 million, respectively. As of JuneSeptember 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 million and outstanding accounts receivable of $11.2$310.3 million available to fund operations and debt service. InOn November 15, 2023, we have a $95.0 million principal payment due at maturity on our 2023 Notesunsecured convertible senior notes (the "2023 Notes") which we expect either to pay at maturity from our existing funds or to refinance.cash and investments on hand. Our cash provided by operations for the sixnine months ended JuneSeptember 30, 2023 was $142.2$109.6 million which includes the collection of our $200.0 million Milestone Payment.

Results of Operations

Research and Development Expenses

Our research and development expenses can be divided into three categories: direct external expenses, which include clinical research and development and preclinical research and development activities; internal, overhead and other expenses; and stock-based compensation expense. Direct external expenses consist primarily of expenses incurred pursuant to agreements with third-party manufacturing organizations prior to receiving regulatory approval for a drug candidate, contract research organizations (“CROs”), clinical trial sites, collaborators, and licensors and consultants. Pre-clinical research and development includes costs prior to beginning Phase 1 studies in human subjects.  Internal, overhead and other expenses primarily consist of costs for personnel, overhead, rent, utilities and depreciation. The following table illustrates our expenses associated with these activities:

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

(In thousands)

Research and development expenses:

Direct external expenses:

Clinical research and development:

 

  

 

  

 

  

 

  

MASP-2 program - OMS721 (narsoplimab)

$

9,970

$

8,498

$

18,922

$

17,742

MASP-3 program - OMS906

5,280

680

7,791

1,982

MASP-2 program - OMS1029

 

1,390

 

 

2,710

 

Other

 

33

 

91

 

78

 

218

Total clinical research and development

 

16,673

 

9,269

 

29,501

 

19,942

Preclinical research and development

 

1,533

 

2,505

 

2,442

 

5,249

Total direct external expenses

 

18,206

 

11,774

 

31,943

 

25,191

Internal overhead and other expenses

 

10,300

 

10,353

 

19,901

 

19,308

Stock-based compensation expenses

 

1,133

 

1,389

 

2,405

 

3,104

Total research and development expenses

$

29,639

$

23,516

$

54,249

$

47,603

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Research and development expenses:

 

  

  

  

 

Direct external expenses:

 

  

  

  

 

Clinical research and development:

                

MASP-2 program - OMS721 (narsoplimab)

 $8,643  $23,097  $27,566  $40,839 

MASP-3 program - OMS906

  9,246   2,015   17,037   3,997 

MASP-2 program - OMS1029

  1,108   1,502   3,818   1,502 

Other

  46   171   122   389 

Total clinical research and development

  19,043   26,785   48,543   46,727 

Preclinical research and development

  1,046   1,125   3,488   6,374 

Total direct external expenses

  20,089   27,910   52,031   53,101 

Internal overhead and other expenses

  10,337   8,986   30,239   28,294 

Stock-based compensation expenses

  1,305   1,672   3,710   4,777 

Total research and development expenses

 $31,731  $38,568  $85,980  $86,172 

For the three months ended September 30, 2023, clinical research and development expenses decreased $7.7 million compared to the prior year quarter due primarily to decreased narsoplimab clinical manufacturing in the current year quarter. This decrease was partially offset by a $5.0 million payment made to a third-party licensor in connection with achievement of a development milestone in our OMS906 program, as well as increasing drug manufacturing costs to support our OMS906 clinical trials. 

Clinical research and development expenses increased $7.4 million and $9.6 million for the three and sixnine months ended JuneSeptember 30, 2023 respectively, asincreased $1.8 million compared to the same periodsperiod in the prior year primarily due to drug manufacturing coststhe $5.0 million OMS906 development milestone and the initiationtransition of additional OMS906 clinical trials in the third quarter of 2022. Additionally, during the 2023 periods, we incurred incremental OMS721 clinical trial costs for IgA nephropathy and data analysis from HSCT-TMA. In the third quarter of 2022, we transitioned OMS1029 from preclinical research and development to clinical research and development upon the initiation of human trials. This was partially offset by decreased narsoplimab clinical manufacturing costs during the current year period.

Preclinical research and development expenses decreased $1.0$0.1 million and $2.8$2.9 million for the three and sixnine months ended JuneSeptember 30, 2023, respectively, as compared to the same periods in 2022, due primarily to the transitioning of OMS1029 from preclinical research and development to clinical research and development during the third quarter of 2022.

Internal overhead and other expenses increased $0.6$1.4 million and $1.9 million for the sixthree and nine months ended JuneSeptember 30, 2023, respectively, as compared to the sixthree and nine months ended JuneSeptember 30, 2022, due to additional employee-related costs. ThisThe increase over the nine-month periods was partially offset by the recognition of an employee retention tax credit from the Internal Revenue Service resulting fromin the passage and implementationfirst quarter of the Coronavirus Aid, Relief and Economic Security (“CARES”) Act.2023.

The $0.3$0.4 million and $0.7$1.1 million decreases in stock-based compensation expenses for the three and sixnine months ended JuneSeptember 30, 2023, respectively, as compared to the same periods in the prior year waswere primarily due to the valuation and timing of the vesting of employee stock options.

During the fourth quarter, we will incur various costs associated with the termination of the ARTEMIS-IGAN trial. We expect overall research and development costs will increaseexpenses in the fourth quarter of 2023 to be similar to the third quarter of 2023 compared to the second quarter of 2023 due primarily to a $5.0 million payment owed to a licensor in connection with achievement of a clinical development milestone in our OMS906 program.this year.

 ​

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-24-

At this time, we are unable to estimate with certainty the longer-term costs we will incur in the continued development of our drug candidates due to the inherently unpredictable nature of our preclinical and clinical development activities. Clinical development timelines, the probability of success and development costs can change materially as new data become available and as expectations change. Our future research and development expenses will depend, in part, on the preclinical or clinical success of each drug candidate as well as ongoing assessments of each program’s commercial potential. In addition, we cannot forecast with precision which drug candidates, if any, may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We are required to expend substantial resources in the development of our drug candidates due to the lengthy process of completing clinical trials and seeking regulatory approval. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could delay our generation of product revenue and increase our research and development expenses.

Selling, General and Administrative Expenses

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

(In thousands)

Selling, general and administrative expenses:

Selling, general and administrative expenses, excluding stock-based compensation expense

$

9,580

$

12,129

$

18,961

$

20,911

Stock-based compensation expense

 

1,680

 

1,793

 

3,402

 

3,970

Total selling, general and administrative expenses

$

11,260

$

13,922

$

22,363

$

24,881

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Selling, general and administrative expenses:

 

  

  

  

 

Selling, general and administrative expenses, excluding stock-based compensation expense

 $14,368  $9,998  $33,329  $30,909 

Stock-based compensation expense

  2,054   2,200   5,456   6,170 

Total selling, general and administrative expenses

 $16,422  $12,198  $38,785  $37,079 

For the three and six months ended JuneSeptember 30, 2023, selling, general and administrative costs excluding stock-based compensation decreased by $2.5expense increased $4.4 million and $2.0 million, respectively, compared to the corresponding prior year periods. The reductions werequarter primarily due to a non-recurring employee compensation expense.

For the nine months ended September 30, 2023, selling, general and administrative costs excluding stock-based compensation expense, increased $2.4 million compared to the prior year period due primarily to a non-recurring employee compensation expense, partially offset by both an employee retention tax credit taken in the first quarter related to the CARES Act and decreased legal, patent and marketing costs associated with our narsoplimab program for HSCT-TMA. Employee-related costs were also reduced and we recognized an employee retention tax credit in March 2023 related to the CARES Act.HSCT-TMA program.

The $0.1 million and $0.6$0.7 million decreases in stock-based compensation expense for the three and sixnine months ended JuneSeptember 30, 2023 compared to the same periods in the prior year waswere primarily due to the valuation and timing of the vesting of employee stock options.

We expect selling, general and administrative expenses in the thirdfourth quarter of 2023 to be similarreturn to those in the second quarter of this year.historical levels.

Interest Expense

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

(In thousands)

Interest expense

$

7,932

$

4,927

$

15,865

$

9,868

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Interest expense

 $7,916  $4,932  $23,781  $14,799 

Interest expense is primarily comprised of interest and amortization of debt discount and issuance costs related to our 2023 Notes and 2026 Notesunsecured convertible senior notes and interest on our DRI royalty obligation (see “Note 7 - Unsecured Convertible Senior Notes” and “Note 8 – OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q). The $3.0 million and $6.0$9.0 million increaseincreases in interest expensesexpense between the three and sixnine months ended JuneSeptember 30, 2023 and 2022 waswere primarily due to interest expense on our OMIDRIA royalty obligation, which we entered into in September 2022.

We expect that interest expense for the fourth quarter of 2023 to be lower than the third quarter of this year due to the repayment at maturity of our $95.0 million of outstanding 2023 will be similar to that of the second quarter of this year.Notes on November 15, 2023. 

Interest and Other Income

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

(In thousands)

Interest and other income

$

4,537

$

670

$

8,500

$

1,163

The $3.9

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Interest and other income

 $4,413  $906  $12,913  $2,069 

Interest and other income increased $3.5 million and $7.3$10.8 million increases in interest and other income for the three and sixnine months ended JuneSeptember 30, 2023, respectively, as compared to the same periods in 2022, were due to holding higher average cash and investment balances available to investthan in the currentprior year following the receiptas a result of thereceiving a $200.0 million Milestone Payment from Rayner in February 2023 and to higher market interest rates in the current year as compared to the prior year.2023.

We expect interest and other income for the thirdfourth quarter of 2023 to be slightly less than the secondthird quarter of this year due to a reduction in our overall cash and investments available to invest.invest upon the repayment at maturity of the $95 million outstanding principal on our 2023 Notes.

Discontinued operations and OMIDRIA contract royalty asset

Net income from OMIDRIA discontinued operations, net of tax is shown below:

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

2023

    

2022

(In thousands)

Interest earned on OMIDRIA contract royalty asset

$

3,829

$

4,545

$

7,754

$

9,383

Remeasurement adjustments

3,147

5,557

4,824

7,716

Other income (expense), net

24

744

404

230

Net income from discontinued operations, net of tax

$

7,000

$

10,846

$

12,982

$

17,329

 

Three Months Ended

  

Nine Months Ended

 

 

September 30,

  

September 30,

 

 

2023

  

2022

  

2023

  

2022

 

 

(In thousands)

 

Interest earned on OMIDRIA contract royalty asset

 $3,730  $4,356  $11,484  $13,739 

Remeasurement adjustments

  10,100   32,917   14,924   40,631 

Other income, net

  76   63   480   295 

Net income from discontinued operations, net of tax

 $13,906  $37,336  $26,888  $54,665 

Interest is earned on the OMIDRIA contract royalty asset at atan implied effective interest rate of 11.0%. The $0.7$0.6 million and $1.6$2.3 million reductions in interest earned for the three and sixnine months ended JuneSeptember 30, 2023 as compared to the same periods in 2022 waswere due to thea decrease in the balance of the OMIDRIA contract royalty asset.asset during the respective periods.

The $2.4 million and $2.9 million decreases in the remeasurement adjustmentadjustments for the three and sixnine months ended JuneSeptember 30, 2023 decreased by $22.8 million and $25.7 million, respectively, as compared to the same periods in 2022 reflects the amount of royalties earned in excess of projectionscorresponding prior year periods. The primary reason for the period and any changedecrease was due to adjusting the OMIDRIA contract royalty asset in discountedthe third quarter of 2022 to reflect an increase in expected future royalty expectations.OMIDRIA royalties based on actual sales results.

The following schedule presents a rollforwardroll forward of the OMIDRIA contract royalty asset (in thousands):

OMIDRIA contract royalty asset at December 31, 2022

$

152,222

Royalties earned

(19,914)

Interest earned on OMIDRIA contract royalty asset

7,754

Remeasurement adjustments

4,824

OMIDRIA contract royalty asset at June 30, 2023

$

144,886

OMIDRIA contract royalty asset at December 31, 2022

 $152,222 

Royalties earned

  (29,900)

Interest earned on OMIDRIA contract royalty asset

  11,484 

Remeasurement adjustments

  14,924 

OMIDRIA contract royalty asset at September 30, 2023

 $148,730 

The occurrence of the Milestone Event in December 2022 triggered a reduction in the royalty rate applicable to U.S. net sales of OMIDRIA from 50% to 30%. The royalty rate on any net sales outside the U.S. remains unchanged at 15%.

Financial Condition- Liquidity and Capital Resources

As of JuneSeptember 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 million and outstanding accounts receivable of $11.2$310.3 million. Our lossesloss for the three and sixnine months ended JuneSeptember 30, 2023 were $37.3was $37.8 million and $71.0$108.7 million, respectively, and our cash provided by operations for the sixnine months ended JuneSeptember 30, 2023 was $142.2$109.6 million. Cash provided by operations includes collection of the $200.0 million Milestone Payment.

We have $95.0 million inprincipal outstanding principal ofrelated to the 2023 Notes that willwhich mature and become due inon November 15, 2023. Unless the debt is repurchased or converted to equity at or prior to maturity, weWe plan to fund the repayment ofrepay the 2023 Notes withfrom our existing funds or proceeds from any refinancing transaction. cash and investments on hand. From time to time, we may repurchase our outstanding notes2026 Notes in the open market or through privately-negotiatedprivately negotiated transactions. In addition, on November 9, 2023, the Board of Directors approved an indefinite term share repurchase program under which we may repurchase from time to time up to $50.0 million of our common stock in the open market or through privately negotiated transactions.

Historically, we have incurred net losses from continuing operations and negative operating cash flows. We have not yet established an ongoing source of revenue sufficient to cover our operating costs and,costs; therefore, we would need to continue to raise additional capital to accomplish our business plan and to retire our outstanding convertible senior notes due in 2026. We plan to continue to fund our operations for at least the next twelve months with our existing cash, and investments and our accounts receivable. If FDA approves narsoplimab for treatment of any indication within the next twelve months, then sales of narsoplimab may also provide funds for our operations. royalties from Rayner. We have a sales agreement in place for an “at the market” equity offering facility through which we may offer and sell shares of our common stock equaling an aggregate amount up to $150.0 million. Should it be determined to be strategically advantageous, we could also pursue debt financings as well as public and private offerings of our equity securities, similar to those we have previously completed, or other strategic transactions, which may include licensing a portion of our existing technologies. Should it be necessary to manage our operating expenses, we could also reduce our projected cash requirements by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities.

Cash Flow Data

Six Months Ended

June 30, 

    

2023

    

2022

(In thousands)

Selected cash flow data

Cash provided by (used in):

Operating activities

$

142,198

$

(34,662)

Investing activities

$

(145,956)

$

(52,072)

Financing activities

$

(648)

$

62

 

Nine Months Ended

 

 

September 30,

 

 

2023

  

2022

 

 

(In thousands)

 

Selected cash flow data

 

  

 

Cash provided by (used in):

 

  

 

Operating activities

 $109,551  $(61,101)

Investing activities

 $(88,789) $(19,073)

Financing activities

 $(1,131) $124,899 

Operating Activities. Net cash provided by operating activities for the sixnine months ended JuneSeptember 30, 2023 increased by $176.9$170.7 million as compared to the same period in 2022. The increase was primarily due to a $178.4$182.0 million decrease in receivables resulting fromdue to the collection of our $200.0 million Milestone Payment and an $18.0a $15.3 million change in accounts payable, accrued expenses and other receivables.other. This was offset by a $7.1$27.4 million increase in net loss, an $11.1a $17.7 million decreasechange in cash received from royalty earningsOMIDRIA Rayner royalties receivables and $1.2$19.3 million of non-cash charges.

Investing Activities. Cash flows from investing activities primarily reflect cash used to purchase short-term investments and proceeds from the sale of short-term investments, thus causing a shift between our cash and cash equivalents and short-term investment balances. Because we manage our cash usage with respect to our total cash, cash equivalents and short-term investments, we do not consider fluctuations in cash flows from investing activities to be important to the understanding of our liquidity and capital resources.

Net cash used in investing activities increased $93.9 million duringfor the sixnine months ended JuneSeptember 30, 2023 asincreased $69.7 million compared to the same period in the prior year period, due to net purchases of short-term investments following theoutweighing proceeds from sales and maturities. Investment activities during 2023 included receipt and investing of the $200.0 million Milestone Payment.Payment from Rayner and the $125.0 million we received from DRI related to the sale of a portion of our future OMIDRIA royalties. In the corresponding prior year period, net purchases of short-term investments included investing the proceeds from the sale of OMIDRIA.OMIDRIA to Rayner.

Financing Activities. Net cash used in financing activities during the sixnine months ended JuneSeptember 30, 2023 increased $0.7$126.0 million compared to the same period in 2022 This was primarily due to principal payments onthe $125.0 million we received from DRI related to the sale of a portion of our contract royalty obligation, partially offset by decreasesfuture OMIDRIA royalties in our principal payments on finance lease obligations and by stock option exercises.September 2022.

Contractual Obligations and Commitments

Our future minimum contractual commitments and obligations were reported in our Annual Report on Form 10-K for the year ended December 31, 2022. Other than the following, our future minimum contractual obligations and commitments have not changed materially from the amounts previously reported. See “Note 10 – Commitments and Contingencies” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.

Operating Leases

Our lease for our office and laboratory space ends in November 2027. We have two options to extend the lease term by five years each. In addition, we carry various finance lease obligations for laboratory equipment. As of JuneSeptember 30, 2023, the remaining aggregate non-cancelable rent payable under the initial term of the lease, excluding common area maintenance and related operating expenses, was $30.3is $28.6 million.

Convertible Notes

See “Note 7 – Unsecured Convertible Senior Notes” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.

OMIDRIA Royalty Obligation

See “Note 8 – OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.

Goods and Services Contracts, Development Milestones and Product Royalties

 ​

See “Note 10 – Commitment and Contingencies” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.

Critical Accounting Policies and Significant Judgments and Estimates

Aside from using the catch-up method to account for our OMIDRIA royalty obligation (see “Note 2 – Significant Accounting Policies – OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q), there

There have not been any material changes in our critical

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accounting policies and significant judgments and estimates as disclosed in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 13, 2023.

ITEM3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Our exposure to market risk is primarily confined to our investment securities. The primary objective of our investment activities is to preserve our capital to fund operations, and we do not enter into financial instruments for trading or speculative purposes. We also seek to maximize income from our investments without assuming significant risk. To achieve our objectives, we maintain a portfolio of investments in high-credit-quality securities. As of JuneSeptember 30, 2023, we had cash, cash equivalents and short-term investments of $341.3$310.3 million. In accordance with our investment policy, we invest funds in highly liquid, investment-grade securities. These securities in our investment portfolio are not leveraged and are classified as available-for-sale. We currently do not hedge interest rate exposure. Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have a materially negative impact on the realized value of our investment portfolio. We actively monitor changes in interest rates and, with our current portfolio of short-term investments, we are not exposed to potential loss due to changes in interest rates.

ITEM4. CONTROLS AND PROCEDURES

Evaluation of 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 JuneSeptember 30, 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 JuneSeptember 30, 2023, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) under the Exchange Act that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PARTII — OTHER INFORMATION

ITEM1. LEGAL PROCEEDINGS

From time to time, in the ordinary course of business, we may be involved in various claims, lawsuits and other proceedings. As of the date of filing of this Quarterly Report on Form 10-Q, we were not involved in any material legal proceedings.

ITEM1A. RISK FACTORS

We operate in an environment that involves a number of risks and uncertainties. Before making an investment decision you should carefully consider the risks described in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 13, 2023. In assessing the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2022, you should also refer to the other information included therein and in this Quarterly Report on Form 10-Q. In addition, we may be adversely affected by risks that we currently deem to be immaterial or by other risks that are not currently known to us. Due to these risks and uncertainties, known and unknown, our past financial results may not be a reliable indicator of future performance and historical trends should not be used to anticipate results or trends in future periods. The trading price of our common stock could decline due to any of these risks and you may lose all or part of your investment.

ITEM2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

On November 9. 2023, the Board of Directors approved an indefinite term share repurchase program under which we may repurchase from time to time up to $50.0 million of our common stock in the open market or through privately negotiated transactions.

ITEM3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM5. OTHER INFORMATION

Not applicable.

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ITEM6. EXHIBITS

Exhibit

Number

Description

10.131.1

Omeros Corporation 2017 Omnibus Incentive Compensation Plan, as amended and restated effective as of June 23, 2023 (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed June 28, 2023)

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

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

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

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

101.INS

Inline XBRL Instance Document

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Link base Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104.1

Cover Page Interactive Data File, formatted in Inline XBRL (included in Exhibit 101)


The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the SEC and are not to be incorporated by reference into any filing of Omeros Corporation under the Securities Act or the Exchange Act, whether made before or after the date of this Quarterly Report on Form 10-Q, are not deemed filed with the SEC and are not to be incorporated by reference intoirrespective of any filing of Omeros Corporation under the Securities Act or the Exchange Act, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

SIGNATURES

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

Dated: AugustNovember 9, 2023

/s/ Gregory A. Demopulos

Gregory A. Demopulos, M.D.

President, Chief Executive Officer and Chairman of the Board of Directors

Dated: AugustNovember 9, 2023

/s/ Michael A. Jacobsen

Michael A. Jacobsen

Vice President, Finance, Chief Accounting Officer and Treasurer

Vice President, Finance, Chief Accounting Officer and Treasurer

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