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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 June 30, 2023

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) 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)

(206676-5000

(Registrant’s 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 August 7, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 62,855,824.

SPECIAL NOTE REGARDING 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 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 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 JUNE 30, 2023

INDEX

Page

Part I — Financial Information

5

Item 1.

Financial Statements (unaudited)

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

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

30

Part II — Other Information

31

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

31

Item 3.

Default Upon Senior Securities

31

Item 4.

Mine Safety Disclosures

31

Item 5.

Other Information

31

Item 6.

Exhibits

32

Signatures

33

PART I — FINANCIAL INFORMATION

ITEM 1. 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

See accompanying Notes to Condensed Consolidated Financial Statements

-5-

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

See accompanying Notes to Condensed Consolidated Financial Statements

-6-

OMEROS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF 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)

Balance at January 1, 2023

    

  

62,828,765

    

$  

628

    

$

720,773

    

$

(635,717)

    

$

85,684

Stock-based compensation expense

2,953

2,953

Net loss

(33,701)

(33,701)

Balance at March 31, 2023

62,828,765

628

723,726

(669,418)

54,936

Exercise of stock options

19,556

97

97

Stock-based compensation expense

2,771

2,771

Net loss

(37,294)

(37,294)

Balance at June 30, 2023

62,848,321

$

628

$

726,594

$

(706,712)

$

20,510

See accompanying Notes to Condensed Consolidated Financial Statements

-7-

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

See accompanying Notes to Condensed Consolidated Financial Statements

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OMEROS CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

Note 1—Organization 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® (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 assets on December 23, 2021 (see “Sale of OMIDRIA Assets” below for additional information).

The lead drug candidate in our pipeline of complement-targeted therapeutics is narsoplimab, 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. Our pipeline of 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.

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

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provided by operations for the six months ended June 30, 2023 was $142.2 million, which included collection of the $200.0 million Milestone Payment in the first quarter of 2023.

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, therefore, could need 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, 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. 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.

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—Significant 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 payment 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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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-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.

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. 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—Discontinued 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 than 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.

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 rollforward 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

Net income from discontinued operations is as follows:

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

Cash flow from discontinued operations is as follows:

Six Months Ended

June 30,

    

2023

    

2022

(In thousands)

Net cash provided by discontinued operations from operating activities

$

217,688

$

46,038

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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Note 4—Net 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

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

2026 Notes convertible to common stock (1)

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

Outstanding options to purchase common stock

98,920

 

88

42,186

 

1,963

Outstanding restricted stock units

89,750

208,819

89,750

207,736

Total potentially dilutive shares excluded from net loss per share

17,302,417

 

17,322,654

17,245,683

 

17,323,446

(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.

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

(In thousands)

Short-term contract royalty asset

$

29,084

$

28,797

Long-term contract royalty asset

115,802

123,425

Total OMIDRIA contract royalty asset

$

144,886

$

152,222

Receivables

Receivables consist of the following:

June 30, 

December 31, 

    

2023

    

2022

(In thousands)

OMIDRIA royalty

$

11,066

$

12,966

Sublease and other

124

255

OMIDRIA milestone

 

 

200,000

Total receivables

$

11,190

$

213,221

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Property and Equipment, Net

Property and equipment, net consists of the following:

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Equipment under finance lease obligations

$

6,477

$

6,204

Laboratory equipment

 

3,385

 

3,135

Computer equipment

 

1,101

 

1,076

Office equipment and furniture

 

625

 

625

Total cost

 

11,588

 

11,040

Less accumulated depreciation and amortization

 

(9,839)

 

(9,548)

Total property and equipment, net

$

1,749

$

1,492

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

Accrued Expenses

Accrued expenses consists of the following:

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Employee compensation

$

7,342

$

6,665

Clinical trials

7,272

5,536

Interest payable

6,160

5,172

Contract research and development

4,043

3,209

Consulting and professional fees

2,901

4,425

Income taxes payable

1,228

4,871

Other accrued expenses

 

847

 

673

Total accrued expenses

$

29,793

$

30,551

Note 6—Investments 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 other income. Investment income for the three months ended June 30, 2023 and June 30, 2022 consists primarily of interest earned of $4.2 million and $0.2 million, respectively. Investment income for the six months ended June 30, 2023 and June 30, 2022 consists of interest earned of $7.6 million and $0.2 million, respectively.

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The following tables summarize our investments:

    

June 30, 2023

    

Amortized Cost

    

Gross Unrealized Gains/(Losses)

    

Estimated Fair Value

(In thousands)

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

$

225,983

$

(89)

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,680

(89)

334,591

Certificate of deposit classified as non-current restricted investments

1,054

1,054

Total

$

335,734

$

(89)

$

335,645

    

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

(In thousands)

Assets:

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

$

225,894

$

$

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,591

334,591

Certificate of deposit classified as non-current restricted investments

 

1,054

 

 

 

1,054

Total

$

335,645

$

$

$

335,645

    

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 million and $11.0 million is excluded from our fair-value hierarchy disclosure as of June 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.

Note 7—Unsecured Convertible Senior Notes

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

Balance as of June 30, 2023

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized debt issuance costs

 

(270)

 

(3,514)

 

(3,784)

Total unsecured convertible senior notes, net

$

94,730

$

221,516

$

316,246

Fair value of outstanding unsecured convertible senior notes (1)

$

93,575

$

157,359

Balance as of December 31, 2022

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized discount

 

(619)

 

(4,124)

 

(4,743)

Total unsecured convertible senior notes, net

$

94,381

$

220,906

$

315,287

Fair value of outstanding unsecured convertible senior notes (1)

$

92,031

$

118,141

(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 mature on November 15, 2023 unless earlier purchased, redeemed or converted in accordance with their terms.

The unamortized debt issuance costs of $0.3 million as of June 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 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 June 30, 2023, approximately 4.9 million shares remained outstanding on the 2023 Capped Call.

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

(In thousands)

(In thousands)

Contractual interest expense

$

1,484

$

1,484

$

2,969

$

2,969

Amortization of debt issuance costs

 

176

 

164

 

349

 

325

Total

$

1,660

$

1,648

$

3,318

$

3,294

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 million as of June 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 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. 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. As of June 30, 2023, approximately 12.2 million shares remained outstanding on the 2026 Capped Call.

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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

(In thousands)

(In thousands)

Contractual interest expense

$

2,954

$

2,954

$

5,907

$

5,907

Amortization of debt issuance costs

 

307

 

290

610

575

Total

$

3,261

$

3,244

$

6,517

$

6,482

Future Minimum Principal Payments

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

2023

    

$

95,000

2024

 

2025

 

2026

 

225,030

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

 

$

320,030

Note 8—OMIDRIA 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 June 30, 2023, the maximum remaining amount that DRI is entitled to receive through the term of the agreement (December 31, 2030) is $180.3 million, which, if fully paid, would be at an implied effective interest rate of 9.4% over the entire payment period.

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.

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

As of June 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

(In thousands)

2023

$

589

$

5,911

$

6,500

2024

 

8,576

 

11,424

20,000

2025

 

14,641

 

10,359

25,000

2026

 

16,081

 

8,919

25,000

2027

 

17,664

 

7,336

25,000

Thereafter

 

68,164

 

10,586

78,750

Total scheduled payments

$

125,715

$

54,535

$

180,250

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

(In thousands)

(In thousands)

Lease cost

  

    

  

Operating lease cost

$

1,616

$

1,663

$

3,249

$

2,870

Finance lease cost:

 

 

 

 

  

Amortization

 

271

 

122

 

389

 

320

Interest

 

41

 

36

 

92

 

92

Variable lease cost

 

757

 

722

 

1,547

 

1,582

Sublease income

 

(375)

 

(453)

 

(750)

 

(945)

Net lease cost

$

2,310

$

2,090

$

4,527

$

3,919

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

Six Months Ended

June 30, 

    

2023

    

2022

(In thousands)

Cash paid for amounts included in the measurement of lease liabilities

Cash payments for operating leases

$

3,568

$

3,562

Cash payments for financing leases

$

336

 

$

401

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Note 10—Commitments and Contingencies

Goods and Services Contracts

We have various agreements with third parties that collectively require payment of termination fees totaling $21.2 million as of June 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 six months ended June 30, 2023 and June 30, 2022, development milestone expenses were insignificant. Should narsoplimab be approved, we would owe milestone payments to development partners and could 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’ 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 June 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.

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 June 30, 2023 was 10,175,852.

Note 12—Stock-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.

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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

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

June 30, 2023

June 30, 2023

Estimated weighted-average fair value

$

4.66

$

4.21

Weighted-average assumptions:

 

 

Expected volatility

 

92

%  

 

92

%

Expected life, in years

 

7.3

 

7.1

Risk-free interest rate

 

3.74

%  

 

3.74

%

Expected dividend yield

 

%  

 

%

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

    

    

Weighted- 

    

    

Average 

Aggregate 

Exercise 

Remaining 

Intrinsic 

Options 

Price per 

Contractual Life 

Value 

Outstanding

Share

(In years)

(In thousands)

Balance at December 31, 2022

 

13,872,973

$

11.02

 

  

 

  

Granted

 

200,000

 

5.20

 

  

 

  

Exercised

 

(19,556)

 

4.98

 

  

 

  

Forfeited

 

(437,821)

 

10.46

 

  

 

  

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

Of the 13.6 million common stock options outstanding at June 30, 2023, 11.1 million have an exercise price per share above $5.44 which was the closing price of our common stock on the NASDAQ exchange on June 30, 2023.

As of June 30, 2023, there were 3.1 million unvested options outstanding that will vest over a weighted-average period of 1.9 years. The total estimated compensation expense yet to be recognized on outstanding options is $14.5 million.

The Company had 89,750 unvested RSUs outstanding as of June 30, 2023 that vest on December 1, 2023. The weighted average grant date fair value per share was $7.53.

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ITEM 2. MANAGEMENT’S 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-Q 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 SEC on May 1, 2022. In addition, you should read the section entitled “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 licensing 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 response data and/or 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 guidance on our proposal to collect and analyze external survival data for inclusion 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 receiving FDA’s feedback on our detailed plan, we would access the data, conduct the requisite analyses and, together with additional new supportive data, resubmit the BLA. Allowing for the full duration of relevant FDA review periods, we currently estimate that an approval decision on the resubmitted BLA could be rendered by FDA in mid-2024. There can be no guarantee that the specific data and analyses discussed with the FDA review division will be satisfactory, 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.

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

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potentially quarterly intravenous or subcutaneous dosing. Dosing is underway in a Phase 1 multiple-ascending-dose study of OMS1029 in healthy subjects. A Phase 2 program is expected to begin 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 data 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 detailed at the 2023 congress of the European Hematology Association as a “late-breaker” podium presentation. 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 successful Phase 1 single-ascending-dose study of OMS906 in healthy subjects and the interim data from our ongoing 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 enrolled and dosed a substantial number of patients. The second, also underway, is evaluating OMS906 in patients with C3G. Each of these trials were initiated under a Phase 1b clinical protocol. We are currently completing a series 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.

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 at Emory University are also evaluating OMS527 in a clinically predictive primate model of 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 developing novel adoptive T cell/CAR-T therapies and novel immunotherapeutics and cancer vaccines as part of our immuno-oncology platform.

OMIDRIA

We previously developed and commercialized 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 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 established 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 June 30, 2023, the maximum future payout that DRI is entitled to receive through the remaining term of the agreement is $180.3 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 six months ended June 30, 2023 was $37.3 million and $71.0 million, respectively. As of June 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 million and outstanding accounts receivable of $11.2 million available to fund operations and debt service. In November 2023, we have a $95.0 million principal payment due on our 2023 Notes which we expect either to pay from our existing funds or to refinance. Our cash provided by operations for the six months ended June 30, 2023 was $142.2 million, which includes the collection of our $200.0 million Milestone Payment.

-24-

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

Clinical research and development expenses increased $7.4 million and $9.6 million for the three and six months ended June 30, 2023, respectively, as compared to the same periods in the prior year, primarily due to drug manufacturing costs and the initiation 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.

Preclinical research and development expenses decreased $1.0 million and $2.8 million for the three and six months ended June 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 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2022 due to additional employee-related costs. This increase was partially offset by the recognition of an employee retention tax credit from the Internal Revenue Service resulting from the passage and implementation of the Coronavirus Aid, Relief and Economic Security (“CARES”) Act.

The $0.3 million and $0.7 million decreases in stock-based compensation for the three and six months ended June 30, 2023, respectively, compared to the same periods in the prior year was due to the valuation and timing of the vesting of employee stock options.

We expect overall research and development costs will increase in 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.

-25-

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

For the three and six months ended June 30, 2023, selling, general and administrative costs, excluding stock-based compensation, decreased by $2.5 million and $2.0 million, respectively, compared to the corresponding prior year periods. The reductions were due primarily to 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.

The $0.1 million and $0.6 million decreases in stock-based compensation for the three and six months ended June 30, 2023 compared to the same periods in the prior year was due to the valuation and timing of the vesting of employee stock options.

We expect selling, general and administrative expenses in the third quarter of 2023 to be similar to those in the second quarter of this year.

-26-

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

Interest expense is primarily comprised of interest and amortization of debt discount and issuance costs related to our 2023 Notes and 2026 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 million increase in interest expenses between the three and six months ended June 30, 2023 and 2022 was primarily due to interest on our OMIDRIA royalty obligation, which we entered into in September 2022.

We expect that interest expense for the third quarter of 2023 will be similar to that of the second quarter of this year.

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 million and $7.3 million increases in interest and other income for the three and six months ended June 30, 2023 as compared to the same periods in 2022 were due to higher average cash and investment balances available to invest in the current year following the receipt of the $200.0 million Milestone Payment in February 2023 and to higher market interest rates in the current year as compared to the prior year.

We expect interest and other income for the third quarter to be slightly less than the second quarter of this year due to a reduction in our overall cash and investments available to invest.

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

Interest is earned on the OMIDRIA contract royalty asset at at implied effective interest rate of 11.0%. The $0.7 million and $1.6 million reductions in interest earned for the three and six months ended June 30, 2023 as compared to the same periods in 2022 was due to the decrease in the balance of the OMIDRIA contract royalty asset.

The $2.4 million and $2.9 million decreases in the remeasurement adjustment for the three and six months ended June 30, 2023 as compared to the same periods in 2022 reflects the amount of royalties earned in excess of projections for the period and any change in discounted future royalty expectations.

-27-

The following schedule presents a rollforward 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

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 June 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 million and outstanding accounts receivable of $11.2 million. Our losses for the three and six months ended June 30, 2023 were $37.3 million and $71.0 million, respectively, and our cash provided by operations for the six months ended June 30, 2023 was $142.2 million. Cash provided by operations includes collection of the $200.0 million Milestone Payment.

We have $95.0 million in outstanding principal of the 2023 Notes that will mature and become due in November 2023. Unless the debt is repurchased or converted to equity at or prior to maturity, we plan to fund the repayment of the 2023 Notes with our existing funds or proceeds from any refinancing transaction. From time to time, we may repurchase our outstanding notes 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, therefore, we would need to continue to raise additional capital to accomplish our business plan and retire our outstanding convertible senior notes due in 2026. We plan to continue to fund our operations for 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. 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

-28-

Operating Activities. Net cash provided by operating activities for the six months ended June 30, 2023 increased by $176.9 million as compared to the same period in 2022. The increase was primarily due to a $178.4 million decrease in receivables resulting from the collection of our $200.0 million Milestone Payment and an $18.0 million change in accounts payable, accrued expenses and other receivables. This was offset by a $7.1 million increase in net loss, an $11.1 million decrease in cash received from royalty earnings and $1.2 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 during the six months ended June 30, 2023 as compared to the same period in the prior year due to net purchases of short-term investments following the receipt of the $200.0 million Milestone Payment. In the corresponding prior year period, net purchases of short-term investments included investing the proceeds from the sale of OMIDRIA.

Financing Activities. Net cash used in financing activities during the six months ended June 30, 2023 increased $0.7 million compared to the same period in 2022 due to principal payments on our contract royalty obligation, partially offset by decreases in our principal payments on finance lease obligations and by stock option exercises.

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.

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 June 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 $30.3 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 have not been any material changes in our critical

-29-

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.

ITEM 3. 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 June 30, 2023, we had cash, cash equivalents and short-term investments of $341.3 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.

ITEM 4. 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 June 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 June 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.

-30-

PART II — OTHER INFORMATION

ITEM 1. 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.

ITEM 1A. 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.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Not applicable.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION

Not applicable.

-31-

ITEM 6. EXHIBITS

Exhibit

Number

Description

10.1

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, irrespective of any general incorporation language contained in such filing.

-32-

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: August 9, 2023

/s/ Gregory A. Demopulos

Gregory A. Demopulos, M.D.

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

Dated: August 9, 2023

/s/ Michael A. Jacobsen

Michael A. Jacobsen

Vice President, Finance, Chief Accounting Officer and Treasurer

-33-

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO RULE 13a-14(a)/15d-14(a) OF
THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002

I, Gregory A. Demopulos, M.D., certify that:

1.            I have reviewed this quarterly report on Form 10-Q of Omeros Corporation;

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.            The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a.            Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b.            Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c.            Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d.            Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.            The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a.            All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b.           Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Dated: August 9, 2023

 

 

 

/s/ Gregory A. Demopulos

 

Gregory A. Demopulos, M.D.

Principal Executive Officer


Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO RULE 13a-14(a)/15d-14(a) OF THE
SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002

I, Michael A. Jacobsen, certify that:

1.            I have reviewed this quarterly report on Form 10-Q of Omeros Corporation;

2.            Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.            Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.            The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a.            Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b.            Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c.            Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d.            Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.           The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a.            All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b.            Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Gust

Dated: August 9, 2023

/s/ Michael A. Jacobsen

Michael A. Jacobsen

Principal Financial and Accounting Officer


Exhibit 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

In connection with the Quarterly Report on Form 10-Q of Omeros Corporation (the “Company”) for the quarter ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.

Dated: August 9, 2023

/s/ Gregory A. Demopulos

Gregory A. Demopulos, M.D.

Principal Executive Officer


Exhibit 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

In connection with the Quarterly Report on Form 10-Q of Omeros Corporation (the “Company”) for the quarter ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officer of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

This certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.

Dated: August 9, 2023

/s/ Michael A. Jacobsen

Michael A. Jacobsen

Principal Financial and Accounting Officer


v3.23.2
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2023
Aug. 07, 2023
Document and Entity Information    
Document Type 10-Q  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2023  
Entity File Number 001-34475  
Entity Registrant Name OMEROS CORPORATION  
Entity Incorporation, State or Country Code WA  
Entity Tax Identification Number 91-1663741  
Entity Address, Address Line One 201 Elliott Avenue West  
Entity Address, City or Town Seattle  
Entity Address, State or Province WA  
Entity Address, Postal Zip Code 98119  
City Area Code 206  
Local Phone Number 676-5000  
Title of 12(b) Security Common Stock  
Trading Symbol OMER  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   62,855,824
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2023  
Document Fiscal Period Focus Q2  
Entity Central Index Key 0001285819  
Amendment Flag false  
v3.23.2
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
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
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
v3.23.2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
CONDENSED CONSOLIDATED BALANCE SHEETS    
Preferred stock, par value (USD per share) $ 0.01 $ 0.01
Preferred stock, authorized shares 20,000,000 20,000,000
Preferred stock, issued shares 0 0
Preferred stock, outstanding shares 0 0
Common stock, par value (USD per share) $ 0.01 $ 0.01
Common stock, authorized shares 150,000,000 150,000,000
Common stock, issued shares 62,848,321 62,828,765
Common stock, outstanding shares 62,848,321 62,828,765
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 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 net income (loss) per share continuing operations $ (0.70) $ (0.66) $ (1.34) $ (1.30)
Basic net income (loss) per share discontinued operations 0.11 0.17 0.21 0.28
Basic net income (loss) per share (0.59) (0.49) (1.13) (1.02)
Diluted net income (loss) per share continuing operations (0.70) (0.66) (1.34) (1.30)
Diluted net income (loss) per share discontinued operations 0.11 0.17 0.21 0.28
Diluted net income (loss) per share $ (0.59) $ (0.49) $ (1.13) $ (1.02)
Weighted-average shares used to compute basic net income (loss) per share (in shares) 62,837,125 62,730,015 62,832,991 62,727,395
Weighted-average shares used to compute diluted net income (loss) per share (in shares) 62,837,125 62,730,015 62,832,991 62,727,395
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($)
$ in Thousands
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Total
Balance at Dec. 31, 2021 $ 626 $ 706,288 $ (683,134) $ 23,780
Balance (in shares) at Dec. 31, 2021 62,628,855      
Increase (Decrease) in Stockholders' Equity        
Exercise of stock options and warrants $ 1 413   414
Exercise of stock options and warrants (in shares) 101,160      
Stock-based compensation   3,892   3,892
Net loss     (33,011) (33,011)
Balance at Mar. 31, 2022 $ 627 710,593 (716,145) (4,925)
Balance (in shares) at Mar. 31, 2022 62,730,015      
Balance at Dec. 31, 2021 $ 626 706,288 (683,134) 23,780
Balance (in shares) at Dec. 31, 2021 62,628,855      
Increase (Decrease) in Stockholders' Equity        
Net loss       (63,860)
Balance at Jun. 30, 2022 $ 627 713,665 (746,994) (32,702)
Balance (in shares) at Jun. 30, 2022 62,730,015      
Balance at Mar. 31, 2022 $ 627 710,593 (716,145) (4,925)
Balance (in shares) at Mar. 31, 2022 62,730,015      
Increase (Decrease) in Stockholders' Equity        
Stock-based compensation   3,072   3,072
Net loss     (30,849) (30,849)
Balance at Jun. 30, 2022 $ 627 713,665 (746,994) (32,702)
Balance (in shares) at Jun. 30, 2022 62,730,015      
Balance at Dec. 31, 2022 $ 628 720,773 (635,717) 85,684
Balance (in shares) at Dec. 31, 2022 62,828,765      
Increase (Decrease) in Stockholders' Equity        
Stock-based compensation   2,953   2,953
Net loss     (33,701) (33,701)
Balance at Mar. 31, 2023 $ 628 723,726 (669,418) 54,936
Balance (in shares) at Mar. 31, 2023 62,828,765      
Balance at Dec. 31, 2022 $ 628 720,773 (635,717) $ 85,684
Balance (in shares) at Dec. 31, 2022 62,828,765      
Increase (Decrease) in Stockholders' Equity        
Issuance of common stock upon exercise of stock options (in shares)       19,556
Net loss       $ (70,995)
Balance at Jun. 30, 2023 $ 628 726,594 (706,712) 20,510
Balance (in shares) at Jun. 30, 2023 62,848,321      
Balance at Mar. 31, 2023 $ 628 723,726 (669,418) 54,936
Balance (in shares) at Mar. 31, 2023 62,828,765      
Increase (Decrease) in Stockholders' Equity        
Exercise of stock options and warrants   97   97
Exercise of stock options and warrants (in shares) 19,556      
Stock-based compensation   2,771   2,771
Net loss     (37,294) (37,294)
Balance at Jun. 30, 2023 $ 628 $ 726,594 $ (706,712) $ 20,510
Balance (in shares) at Jun. 30, 2023 62,848,321      
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2023
Jun. 30, 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
v3.23.2
Organization and Basis of Presentation
6 Months Ended
Jun. 30, 2023
Organization and Basis of Presentation  
Organization and Basis of Presentation

Note 1—Organization 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® (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 assets on December 23, 2021 (see “Sale of OMIDRIA Assets” below for additional information).

The lead drug candidate in our pipeline of complement-targeted therapeutics is narsoplimab, 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. Our pipeline of 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.

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

provided by operations for the six months ended June 30, 2023 was $142.2 million, which included collection of the $200.0 million Milestone Payment in the first quarter of 2023.

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, therefore, could need 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, 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. 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.

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.

v3.23.2
Significant Accounting Policies
6 Months Ended
Jun. 30, 2023
Significant Accounting Policies  
Significant Accounting Policies

Note 2—Significant 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 payment 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.

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-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.

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. 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.

v3.23.2
Discontinued Operations
6 Months Ended
Jun. 30, 2023
Discontinued Operations  
Discontinued Operations

Note 3—Discontinued 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 than 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

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.

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 rollforward 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

Net income from discontinued operations is as follows:

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

Cash flow from discontinued operations is as follows:

Six Months Ended

June 30,

    

2023

    

2022

(In thousands)

Net cash provided by discontinued operations from operating activities

$

217,688

$

46,038

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.

v3.23.2
Net Loss Per Share
6 Months Ended
Jun. 30, 2023
Net Loss Per Share  
Net Loss Per Share

Note 4—Net 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

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

2026 Notes convertible to common stock (1)

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

Outstanding options to purchase common stock

98,920

 

88

42,186

 

1,963

Outstanding restricted stock units

89,750

208,819

89,750

207,736

Total potentially dilutive shares excluded from net loss per share

17,302,417

 

17,322,654

17,245,683

 

17,323,446

(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.
v3.23.2
Certain Balance Sheet Accounts
6 Months Ended
Jun. 30, 2023
Certain Balance Sheet Accounts  
Certain Balance Sheet Accounts

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

(In thousands)

Short-term contract royalty asset

$

29,084

$

28,797

Long-term contract royalty asset

115,802

123,425

Total OMIDRIA contract royalty asset

$

144,886

$

152,222

Receivables

Receivables consist of the following:

June 30, 

December 31, 

    

2023

    

2022

(In thousands)

OMIDRIA royalty

$

11,066

$

12,966

Sublease and other

124

255

OMIDRIA milestone

 

 

200,000

Total receivables

$

11,190

$

213,221

Property and Equipment, Net

Property and equipment, net consists of the following:

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Equipment under finance lease obligations

$

6,477

$

6,204

Laboratory equipment

 

3,385

 

3,135

Computer equipment

 

1,101

 

1,076

Office equipment and furniture

 

625

 

625

Total cost

 

11,588

 

11,040

Less accumulated depreciation and amortization

 

(9,839)

 

(9,548)

Total property and equipment, net

$

1,749

$

1,492

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

Accrued Expenses

Accrued expenses consists of the following:

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Employee compensation

$

7,342

$

6,665

Clinical trials

7,272

5,536

Interest payable

6,160

5,172

Contract research and development

4,043

3,209

Consulting and professional fees

2,901

4,425

Income taxes payable

1,228

4,871

Other accrued expenses

 

847

 

673

Total accrued expenses

$

29,793

$

30,551

v3.23.2
Investments and Fair-Value Measurements
6 Months Ended
Jun. 30, 2023
Investments and Fair-Value Measurements  
Investments and Fair-Value Measurements

Note 6—Investments 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 other income. Investment income for the three months ended June 30, 2023 and June 30, 2022 consists primarily of interest earned of $4.2 million and $0.2 million, respectively. Investment income for the six months ended June 30, 2023 and June 30, 2022 consists of interest earned of $7.6 million and $0.2 million, respectively.

The following tables summarize our investments:

    

June 30, 2023

    

Amortized Cost

    

Gross Unrealized Gains/(Losses)

    

Estimated Fair Value

(In thousands)

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

$

225,983

$

(89)

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,680

(89)

334,591

Certificate of deposit classified as non-current restricted investments

1,054

1,054

Total

$

335,734

$

(89)

$

335,645

    

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.

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

June 30, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

(In thousands)

Assets:

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

$

225,894

$

$

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,591

334,591

Certificate of deposit classified as non-current restricted investments

 

1,054

 

 

 

1,054

Total

$

335,645

$

$

$

335,645

    

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 million and $11.0 million is excluded from our fair-value hierarchy disclosure as of June 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.

v3.23.2
Unsecured Convertible Senior Notes
6 Months Ended
Jun. 30, 2023
Unsecured Convertible Senior Notes  
Unsecured Convertible Senior Notes

Note 7—Unsecured Convertible Senior Notes

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

Balance as of June 30, 2023

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized debt issuance costs

 

(270)

 

(3,514)

 

(3,784)

Total unsecured convertible senior notes, net

$

94,730

$

221,516

$

316,246

Fair value of outstanding unsecured convertible senior notes (1)

$

93,575

$

157,359

Balance as of December 31, 2022

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized discount

 

(619)

 

(4,124)

 

(4,743)

Total unsecured convertible senior notes, net

$

94,381

$

220,906

$

315,287

Fair value of outstanding unsecured convertible senior notes (1)

$

92,031

$

118,141

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

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 mature on November 15, 2023 unless earlier purchased, redeemed or converted in accordance with their terms.

The unamortized debt issuance costs of $0.3 million as of June 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 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 June 30, 2023, approximately 4.9 million shares remained outstanding on the 2023 Capped Call.

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

(In thousands)

(In thousands)

Contractual interest expense

$

1,484

$

1,484

$

2,969

$

2,969

Amortization of debt issuance costs

 

176

 

164

 

349

 

325

Total

$

1,660

$

1,648

$

3,318

$

3,294

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 million as of June 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 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. 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. As of June 30, 2023, approximately 12.2 million shares remained outstanding on the 2026 Capped Call.

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

(In thousands)

(In thousands)

Contractual interest expense

$

2,954

$

2,954

$

5,907

$

5,907

Amortization of debt issuance costs

 

307

 

290

610

575

Total

$

3,261

$

3,244

$

6,517

$

6,482

Future Minimum Principal Payments

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

2023

    

$

95,000

2024

 

2025

 

2026

 

225,030

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

 

$

320,030

v3.23.2
OMIDRIA Royalty Obligation
6 Months Ended
Jun. 30, 2023
OMIDRIA Royalty Obligation  
OMIDRIA Royalty Obligation

Note 8—OMIDRIA 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 June 30, 2023, the maximum remaining amount that DRI is entitled to receive through the term of the agreement (December 31, 2030) is $180.3 million, which, if fully paid, would be at an implied effective interest rate of 9.4% over the entire payment period.

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.

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

As of June 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

(In thousands)

2023

$

589

$

5,911

$

6,500

2024

 

8,576

 

11,424

20,000

2025

 

14,641

 

10,359

25,000

2026

 

16,081

 

8,919

25,000

2027

 

17,664

 

7,336

25,000

Thereafter

 

68,164

 

10,586

78,750

Total scheduled payments

$

125,715

$

54,535

$

180,250

v3.23.2
Leases
6 Months Ended
Jun. 30, 2023
Leases  
Leases

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

(In thousands)

(In thousands)

Lease cost

  

    

  

Operating lease cost

$

1,616

$

1,663

$

3,249

$

2,870

Finance lease cost:

 

 

 

 

  

Amortization

 

271

 

122

 

389

 

320

Interest

 

41

 

36

 

92

 

92

Variable lease cost

 

757

 

722

 

1,547

 

1,582

Sublease income

 

(375)

 

(453)

 

(750)

 

(945)

Net lease cost

$

2,310

$

2,090

$

4,527

$

3,919

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

Six Months Ended

June 30, 

    

2023

    

2022

(In thousands)

Cash paid for amounts included in the measurement of lease liabilities

Cash payments for operating leases

$

3,568

$

3,562

Cash payments for financing leases

$

336

 

$

401

v3.23.2
Commitments and Contingencies
6 Months Ended
Jun. 30, 2023
Commitments and Contingencies.  
Commitments and Contingencies

Note 10—Commitments and Contingencies

Goods and Services Contracts

We have various agreements with third parties that collectively require payment of termination fees totaling $21.2 million as of June 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 six months ended June 30, 2023 and June 30, 2022, development milestone expenses were insignificant. Should narsoplimab be approved, we would owe milestone payments to development partners and could 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.

v3.23.2
Shareholders' Equity (Deficit)
6 Months Ended
Jun. 30, 2023
Shareholders' Equity (Deficit)  
Shareholders' Equity (Deficit)

Note 11—Shareholders’ 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 June 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.

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 June 30, 2023 was 10,175,852.

v3.23.2
Stock-Based Compensation
6 Months Ended
Jun. 30, 2023
Stock-Based Compensation.  
Stock-Based Compensation

Note 12—Stock-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.

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

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

June 30, 2023

June 30, 2023

Estimated weighted-average fair value

$

4.66

$

4.21

Weighted-average assumptions:

 

 

Expected volatility

 

92

%  

 

92

%

Expected life, in years

 

7.3

 

7.1

Risk-free interest rate

 

3.74

%  

 

3.74

%

Expected dividend yield

 

%  

 

%

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

    

    

Weighted- 

    

    

Average 

Aggregate 

Exercise 

Remaining 

Intrinsic 

Options 

Price per 

Contractual Life 

Value 

Outstanding

Share

(In years)

(In thousands)

Balance at December 31, 2022

 

13,872,973

$

11.02

 

  

 

  

Granted

 

200,000

 

5.20

 

  

 

  

Exercised

 

(19,556)

 

4.98

 

  

 

  

Forfeited

 

(437,821)

 

10.46

 

  

 

  

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

Of the 13.6 million common stock options outstanding at June 30, 2023, 11.1 million have an exercise price per share above $5.44 which was the closing price of our common stock on the NASDAQ exchange on June 30, 2023.

As of June 30, 2023, there were 3.1 million unvested options outstanding that will vest over a weighted-average period of 1.9 years. The total estimated compensation expense yet to be recognized on outstanding options is $14.5 million.

The Company had 89,750 unvested RSUs outstanding as of June 30, 2023 that vest on December 1, 2023. The weighted average grant date fair value per share was $7.53.

v3.23.2
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2023
Significant Accounting Policies  
General

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® (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 assets on December 23, 2021 (see “Sale of OMIDRIA Assets” below for additional information).

The lead drug candidate in our pipeline of complement-targeted therapeutics is narsoplimab, 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. Our pipeline of 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.

Sale of OMIDRIA 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 “Note 3 – Discontinued Operations”).

Basis of Presentation

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

Liquidity and Capital Resources

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

provided by operations for the six months ended June 30, 2023 was $142.2 million, which included collection of the $200.0 million Milestone Payment in the first quarter of 2023.

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, therefore, could need 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, 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. 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.

Use of Estimates

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.

OMIDRIA Royalties, Milestones and OMIDRIA Contract Royalty Assets

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 payment 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

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.

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

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-party manufacturing, transportation and internal labor and overhead, will be capitalized.

Right of Use Assets and Related Lease Liabilities

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.

Stock-Based Compensation

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

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. 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.

v3.23.2
Discontinued Operations (Tables)
6 Months Ended
Jun. 30, 2023
Discontinued Operations  
Schedule of contract royalty asset

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

Schedule of net income from discontinued operation

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

Schedule of cash flow from discontinued operation

Six Months Ended

June 30,

    

2023

    

2022

(In thousands)

Net cash provided by discontinued operations from operating activities

$

217,688

$

46,038

v3.23.2
Net Loss Per Share (Tables)
6 Months Ended
Jun. 30, 2023
Net Loss Per Share  
Schedule of Potentially dilutive securities excluded from Diluted EPS

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2023

    

2022

    

2023

    

2022

2026 Notes convertible to common stock (1)

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

Outstanding options to purchase common stock

98,920

 

88

42,186

 

1,963

Outstanding restricted stock units

89,750

208,819

89,750

207,736

Total potentially dilutive shares excluded from net loss per share

17,302,417

 

17,322,654

17,245,683

 

17,323,446

(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.
v3.23.2
Certain Balance Sheet Accounts (Tables)
6 Months Ended
Jun. 30, 2023
Certain Balance Sheet Accounts  
Schedule of OMIDRIA contact royalty asset

June 30, 

December 31, 

    

2023

    

2022

(In thousands)

Short-term contract royalty asset

$

29,084

$

28,797

Long-term contract royalty asset

115,802

123,425

Total OMIDRIA contract royalty asset

$

144,886

$

152,222

Schedule of accounts receivable

June 30, 

December 31, 

    

2023

    

2022

(In thousands)

OMIDRIA royalty

$

11,066

$

12,966

Sublease and other

124

255

OMIDRIA milestone

 

 

200,000

Total receivables

$

11,190

$

213,221

Property, Plant and Equipment

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Equipment under finance lease obligations

$

6,477

$

6,204

Laboratory equipment

 

3,385

 

3,135

Computer equipment

 

1,101

 

1,076

Office equipment and furniture

 

625

 

625

Total cost

 

11,588

 

11,040

Less accumulated depreciation and amortization

 

(9,839)

 

(9,548)

Total property and equipment, net

$

1,749

$

1,492

Accrued Expenses

    

June 30, 

    

December 31, 

2023

2022

(In thousands)

Employee compensation

$

7,342

$

6,665

Clinical trials

7,272

5,536

Interest payable

6,160

5,172

Contract research and development

4,043

3,209

Consulting and professional fees

2,901

4,425

Income taxes payable

1,228

4,871

Other accrued expenses

 

847

 

673

Total accrued expenses

$

29,793

$

30,551

v3.23.2
Investments and Fair-Value Measurements (Tables)
6 Months Ended
Jun. 30, 2023
Investments and Fair-Value Measurements  
Fair value of investments

    

June 30, 2023

    

Amortized Cost

    

Gross Unrealized Gains/(Losses)

    

Estimated Fair Value

(In thousands)

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

$

225,983

$

(89)

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,680

(89)

334,591

Certificate of deposit classified as non-current restricted investments

1,054

1,054

Total

$

335,734

$

(89)

$

335,645

    

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

Financial Assets and Liabilities Measured at Fair Value on Recurring Basis

June 30, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

(In thousands)

Assets:

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

$

225,894

$

$

$

225,894

Money-market funds classified as short-term investments

108,697

108,697

Total short-term investments

334,591

334,591

Certificate of deposit classified as non-current restricted investments

 

1,054

 

 

 

1,054

Total

$

335,645

$

$

$

335,645

    

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

v3.23.2
Unsecured Convertible Senior Notes (Tables)
6 Months Ended
Jun. 30, 2023
Debt Instrument [Line Items]  
Summary of unsecured convertible senior notes outstanding

Balance as of June 30, 2023

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized debt issuance costs

 

(270)

 

(3,514)

 

(3,784)

Total unsecured convertible senior notes, net

$

94,730

$

221,516

$

316,246

Fair value of outstanding unsecured convertible senior notes (1)

$

93,575

$

157,359

Balance as of December 31, 2022

    

2023 Notes

    

2026 Notes

    

Total

(In thousands)

Principal amount

$

95,000

$

225,030

$

320,030

Unamortized discount

 

(619)

 

(4,124)

 

(4,743)

Total unsecured convertible senior notes, net

$

94,381

$

220,906

$

315,287

Fair value of outstanding unsecured convertible senior notes (1)

$

92,031

$

118,141

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

Schedule of future minimum payments of debt

2023

    

$

95,000

2024

 

2025

 

2026

 

225,030

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

 

$

320,030

2023 Unsecured Convertible Senior Notes  
Debt Instrument [Line Items]  
Schedule of total interest expense recognized

    

Three Months Ended

Six Months Ended

June 30,

June 30,

2023

    

2022

    

2023

    

2022

(In thousands)

(In thousands)

Contractual interest expense

$

1,484

$

1,484

$

2,969

$

2,969

Amortization of debt issuance costs

 

176

 

164

 

349

 

325

Total

$

1,660

$

1,648

$

3,318

$

3,294

2026 Unsecured Convertible Senior Notes  
Debt Instrument [Line Items]  
Schedule of total interest expense recognized

Three Months Ended

Six Months Ended

June 30,

June 30,

    

2023

    

2022

2022

2021

(In thousands)

(In thousands)

Contractual interest expense

$

2,954

$

2,954

$

5,907

$

5,907

Amortization of debt issuance costs

 

307

 

290

610

575

Total

$

3,261

$

3,244

$

6,517

$

6,482

v3.23.2
OMIDRIA Royalty Obligation (Tables)
6 Months Ended
Jun. 30, 2023
OMIDRIA Royalty Obligation  
Schedule of maximum remaining scheduled principal and interest payments

Total

    

Principal

    

Interest

    

Annual Cap

(In thousands)

2023

$

589

$

5,911

$

6,500

2024

 

8,576

 

11,424

20,000

2025

 

14,641

 

10,359

25,000

2026

 

16,081

 

8,919

25,000

2027

 

17,664

 

7,336

25,000

Thereafter

 

68,164

 

10,586

78,750

Total scheduled payments

$

125,715

$

54,535

$

180,250

v3.23.2
Leases (Tables)
6 Months Ended
Jun. 30, 2023
Leases  
Schedule of lease costs

Three Months Ended

Six Months Ended

June 30, 

June 30, 

2023

2022

    

2023

    

2022

(In thousands)

(In thousands)

Lease cost

  

    

  

Operating lease cost

$

1,616

$

1,663

$

3,249

$

2,870

Finance lease cost:

 

 

 

 

  

Amortization

 

271

 

122

 

389

 

320

Interest

 

41

 

36

 

92

 

92

Variable lease cost

 

757

 

722

 

1,547

 

1,582

Sublease income

 

(375)

 

(453)

 

(750)

 

(945)

Net lease cost

$

2,310

$

2,090

$

4,527

$

3,919

Schedule of cash paid for amounts included in the measurement of lease liabilities

Six Months Ended

June 30, 

    

2023

    

2022

(In thousands)

Cash paid for amounts included in the measurement of lease liabilities

Cash payments for operating leases

$

3,568

$

3,562

Cash payments for financing leases

$

336

 

$

401

v3.23.2
Stock-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2023
Stock-Based Compensation.  
Stock-Based Compensation Expense

    

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

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions

    

Three Months Ended

Six Months Ended

June 30, 2023

June 30, 2023

Estimated weighted-average fair value

$

4.66

$

4.21

Weighted-average assumptions:

 

 

Expected volatility

 

92

%  

 

92

%

Expected life, in years

 

7.3

 

7.1

Risk-free interest rate

 

3.74

%  

 

3.74

%

Expected dividend yield

 

%  

 

%

Schedule of Stock Option Activity

    

    

Weighted- 

    

    

Average 

Aggregate 

Exercise 

Remaining 

Intrinsic 

Options 

Price per 

Contractual Life 

Value 

Outstanding

Share

(In years)

(In thousands)

Balance at December 31, 2022

 

13,872,973

$

11.02

 

  

 

  

Granted

 

200,000

 

5.20

 

  

 

  

Exercised

 

(19,556)

 

4.98

 

  

 

  

Forfeited

 

(437,821)

 

10.46

 

  

 

  

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

Of the 13.6 million common stock options outstanding at June 30, 2023, 11.1 million have an exercise price per share above $5.44 which was the closing price of our common stock on the NASDAQ exchange on June 30, 2023.

v3.23.2
Organization and Basis of Presentation (Details) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Dec. 23, 2021
Feb. 28, 2023
Dec. 31, 2022
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2022
Mar. 31, 2022
Jun. 30, 2023
Jun. 30, 2022
Mar. 01, 2021
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]                    
Milestone Payment to be received under the Asset Purchase Agreement $ 200,000                  
Period payment is due after milestone period achieved 30 days                  
Milestone period 4 years                  
Milestone Payment receivable     $ 200,000              
Percentage of royalty receivable 50.00%   30.00%              
Percentage of royalties received outside of U.S.               15.00%    
Cash, cash equivalents and short-term investments       $ 341,300       $ 341,300    
Receivables     $ 213,221 11,190       11,190    
Net loss       37,294 $ 33,701 $ 30,849 $ 33,011 70,995 $ 63,860  
Net cash provided by operating activities               142,198 $ (34,662)  
Cash from collection of the Milestone Payment   $ 200,000     $ 200,000          
Discontinued Operation | Omidria Assets Disposal                    
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]                    
Cash proceeds on sale of OMIDRIA $ 126,000                  
At The Market (ATM) Program                    
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]                    
Maximum aggregate offering price       $ 150,000       $ 150,000   $ 150,000
v3.23.2
Significant Accounting Policies - Discontinued Operations (Details) - USD ($)
$ in Millions
1 Months Ended
Sep. 30, 2022
Dec. 23, 2021
Dec. 31, 2022
Jun. 30, 2023
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
Percentage of royalty receivable   50.00% 30.00%  
Milestone Payment receivable     $ 200.0  
Effective interest rate earned on outstanding contract royalty asset       11.00%
DRI        
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
Proceeds received upon entering into OMIDRIA royalty obligation $ 125.0      
OMIDRIA royalty obligation $ 125.0      
Effective interest rate on royalty obligation       9.40%
v3.23.2
Discontinued Operations - Narrative (Details) - USD ($)
$ in Millions
1 Months Ended
Dec. 23, 2021
Dec. 31, 2022
Discontinued Operations    
Milestone period 4 years  
Milestone Payment to be received under the Asset Purchase Agreement $ 200.0  
Percentage of royalty receivable 50.00% 30.00%
Milestone Payment receivable   $ 200.0
Percent of potential reduction in royalty receivable per Asset Purchase Agreement 10.00%  
v3.23.2
Discontinued Operations - OMIDRIA contract royalty asset (Details) - Discontinued Operation - Omidria Assets Disposal - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
OMIDRIA contract royalty asset, beginning balance     $ 152,222  
Royalties earned     (19,914)  
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
OMIDRIA contract royalty asset, ending balance $ 144,886   $ 144,886  
v3.23.2
Discontinued Operations - Net Income Loss (Details) - Discontinued Operation - Omidria Assets Disposal - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
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
v3.23.2
Discontinued Operations - Cash Flow (Details) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Feb. 28, 2023
Mar. 31, 2023
Jun. 30, 2023
Jun. 30, 2022
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
Cash from collection of the Milestone Payment $ 200,000 $ 200,000    
Discontinued Operation | Omidria Assets Disposal        
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]        
Net cash provided by discontinued operations from operating activities     $ 217,688 $ 46,038
v3.23.2
Net Loss Per Share (Details) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Total potentially dilutive shares excluded from net income (loss) per share 17,302,417 17,322,654 17,245,683 17,323,446
2026 Unsecured Convertible Senior Notes        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Total potentially dilutive shares excluded from net income (loss) per share 12,172,008 12,172,008 12,172,008 12,172,008
2023 Unsecured Convertible Senior Notes        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Total potentially dilutive shares excluded from net income (loss) per share 4,941,739 4,941,739 4,941,739 4,941,739
Outstanding options to purchase common stock        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Total potentially dilutive shares excluded from net income (loss) per share 98,920 88 42,186 1,963
Employee restricted stock units        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Total potentially dilutive shares excluded from net income (loss) per share 89,750 208,819 89,750 207,736
v3.23.2
Certain Balance Sheet Accounts - Contract Royalty Asset (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Certain Balance Sheet Accounts    
Short-term contract royalty asset $ 29,084 $ 28,797
Long-term contract royalty asset 115,802 123,425
Total OMIDRIA contract royalty asset $ 144,886 $ 152,222
v3.23.2
Certain Balance Sheet Accounts - Receivables, Net (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Certain Balance Sheet Accounts    
OMIDRIA royalty $ 11,066 $ 12,966
Sublease and other 124 255
OMIDRIA milestone   200,000
Total receivables $ 11,190 $ 213,221
v3.23.2
Certain Balance Sheet Accounts - Property and Equipment, Net (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Property, Plant and Equipment [Line Items]          
Total cost $ 11,588   $ 11,588   $ 11,040
Less accumulated depreciation and amortization (9,839)   (9,839)   (9,548)
Total property and equipment, net 1,749   1,749   1,492
Depreciation and amortization expense 300 $ 200 518 $ 469  
Equipment under finance lease obligations          
Property, Plant and Equipment [Line Items]          
Total cost 6,477   6,477   6,204
Laboratory equipment          
Property, Plant and Equipment [Line Items]          
Total cost 3,385   3,385   3,135
Computer equipment          
Property, Plant and Equipment [Line Items]          
Total cost 1,101   1,101   1,076
Office equipment and furniture          
Property, Plant and Equipment [Line Items]          
Total cost $ 625   $ 625   $ 625
v3.23.2
Certain Balance Sheet Accounts - Accrued Expenses (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Accrued expenses    
Employee compensation $ 7,342 $ 6,665
Clinical trials 7,272 5,536
Interest payable 6,160 5,172
Contract research and development 4,043 3,209
Consulting and professional fees 2,901 4,425
Income taxes payable 1,228 4,871
Other accrued expenses 847 673
Total accrued expenses $ 29,793 $ 30,551
v3.23.2
Investments and Fair-Value Measurements - Fair value of investments (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Fair Value of investment [Line items]          
Investment income, interest $ 4,200 $ 200 $ 7,600 $ 200  
Amortized cost, current 334,680   334,680   $ 183,909
Amortized cost, total 335,734   335,734   184,963
Gross unrealized gains (losses) (89)   (89)   22
Estimated Fair Value, Current 334,591   334,591   183,931
Estimated Fair Value, total 335,645   335,645   184,985
US Treasury Securities          
Fair Value of investment [Line items]          
Amortized cost, current 225,983   225,983   99,027
Gross unrealized gains (losses) (89)   (89)   22
Estimated Fair Value, Current 225,894   225,894   99,049
Money Market Funds          
Fair Value of investment [Line items]          
Amortized cost, current 108,697   108,697   84,882
Estimated Fair Value, Current 108,697   108,697   84,882
Certificates of Deposit [Member]          
Fair Value of investment [Line items]          
Amortized cost, noncurrent 1,054   1,054   1,054
Estimated Fair Value, Noncurrent $ 1,054   $ 1,054   $ 1,054
v3.23.2
Investments and Fair-Value Measurements - Recurring Basis (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Fair Value, Assets and Liabilities    
Short-term investments $ 334,680 $ 183,909
Certificates of deposit classified as non-current restricted investments 1,054 1,054
Fair Value, Measurements, Recurring    
Fair Value, Assets and Liabilities    
Short-term investments 334,591 183,931
Certificates of deposit classified as non-current restricted investments 1,054 1,054
Total 335,645 184,985
Fair Value, Measurements, Recurring | Money Market Funds    
Fair Value, Assets and Liabilities    
Short-term investments 108,697 84,882
Fair Value, Measurements, Recurring | US Treasury Securities    
Fair Value, Assets and Liabilities    
Short-term investments 225,894 99,049
Fair Value, Measurements, Recurring | Level 1    
Fair Value, Assets and Liabilities    
Short-term investments 334,591 183,931
Certificates of deposit classified as non-current restricted investments 1,054 1,054
Total 335,645 184,985
Fair Value, Measurements, Recurring | Level 1 | Money Market Funds    
Fair Value, Assets and Liabilities    
Short-term investments 108,697 84,882
Fair Value, Measurements, Recurring | Level 1 | US Treasury Securities    
Fair Value, Assets and Liabilities    
Short-term investments $ 225,894 $ 99,049
v3.23.2
Investments and Fair-Value Measurements - Narrative (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Investments and Fair-Value Measurements    
Cash held in demand deposit accounts $ 6,603 $ 11,009
v3.23.2
Unsecured Convertible Senior Notes - Unsecured convertible senior notes outstanding (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Sep. 30, 2020
Nov. 30, 2018
Debt Instrument [Line Items]        
Principal amount $ 320,030 $ 320,030    
Unamortized discount   (4,743)    
Unamortized debt issuance costs (3,784)      
Total unsecured convertible senior notes, net 316,246 315,287    
2023 Unsecured Convertible Senior Notes        
Debt Instrument [Line Items]        
Principal amount $ 95,000 95,000    
Interest rate (as a percent) 6.25%     6.25%
Unamortized discount   (619)    
Unamortized debt issuance costs $ (270)      
Total unsecured convertible senior notes, net 94,730 94,381    
Fair value of outstanding unsecured convertible senior notes (1) 93,575 92,031    
2026 Unsecured Convertible Senior Notes        
Debt Instrument [Line Items]        
Principal amount $ 225,030 225,030    
Interest rate (as a percent) 5.25%   5.25%  
Unamortized discount   (4,124)    
Unamortized debt issuance costs $ (3,514)      
Total unsecured convertible senior notes, net 221,516 220,906    
Fair value of outstanding unsecured convertible senior notes (1) $ 157,359 $ 118,141    
v3.23.2
Unsecured Convertible Senior Notes - 2023 Unsecured Convertible Senior Notes (Details)
$ / shares in Units, shares in Millions
1 Months Ended
Nov. 30, 2018
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
shares
Debt Instrument [Line Items]    
Unamortized debt issuance costs | $   $ 3,784,000
2023 Unsecured Convertible Senior Notes    
Debt Instrument [Line Items]    
Interest rate (as a percent) 6.25% 6.25%
Unamortized debt issuance costs | $   $ 270,000
Conversion rate 0.0520183  
Value used in calculation of conversion rate | $ $ 1,000  
Conversion price | $ / shares $ 19.22  
Shares upon conversion | shares 4.9  
Effective interest rate to determine fair value of liability component (as a percent)   7.00%
Number of shares outstanding on the 2023 Capped Call | shares   4.9
2023 Unsecured Convertible Senior Notes | Minimum    
Debt Instrument [Line Items]    
Conversion price | $ / shares $ 19.22  
2023 Unsecured Convertible Senior Notes | Maximum    
Debt Instrument [Line Items]    
Conversion price | $ / shares $ 28.84  
v3.23.2
Unsecured Convertible Senior Notes - Interest expense recognized (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
2023 Unsecured Convertible Senior Notes        
Interest Expense, Debt [Abstract]        
Contractual interest expense $ 1,484 $ 1,484 $ 2,969 $ 2,969
Amortization of debt issuance costs 176 164 349 325
Total 1,660 1,648 3,318 3,294
2026 Unsecured Convertible Senior Notes        
Interest Expense, Debt [Abstract]        
Contractual interest expense 2,954 2,954 5,907 5,907
Amortization of debt issuance costs 307 290 610 575
Total $ 3,261 $ 3,244 $ 6,517 $ 6,482
v3.23.2
Unsecured Convertible Senior Notes - 2026 Unsecured Convertible Senior Notes (Details)
$ / shares in Units, shares in Millions
2 Months Ended
Sep. 30, 2020
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
shares
Debt Instrument [Line Items]    
Unamortized debt issuance costs | $   $ 3,784,000
2026 Unsecured Convertible Senior Notes    
Debt Instrument [Line Items]    
Interest rate (as a percent) 5.25% 5.25%
Unamortized debt issuance costs | $   $ 3,514,000
Effective interest rate to determine fair value of liability component (as a percent)   5.90%
Conversion rate 0.0540906  
Value used in calculation of conversion rate | $ $ 1,000  
Conversion price | $ / shares $ 18.4875  
Shares upon conversion | shares 12.2  
Number of shares outstanding on the 2026 Capped Call | shares   12.2
2026 Unsecured Convertible Senior Notes | Minimum    
Debt Instrument [Line Items]    
Conversion price | $ / shares $ 18.49  
2026 Unsecured Convertible Senior Notes | Maximum    
Debt Instrument [Line Items]    
Conversion price | $ / shares $ 26.10  
v3.23.2
Unsecured Convertible Senior Notes - Future minimum payments (Details) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Long-term Debt, Fiscal Year Maturity [Abstract]    
Total future minimum principal payments under 2023 Notes and 2026 Notes $ 320,030 $ 320,030
2023 and 2026 Convertible Senior Notes    
Long-term Debt, Fiscal Year Maturity [Abstract]    
2023 95,000  
2026 225,030  
Total future minimum principal payments under 2023 Notes and 2026 Notes $ 320,030  
v3.23.2
OMIDRIA Royalty Obligation - Narrative (Details) - USD ($)
$ in Millions
3 Months Ended 6 Months Ended
Sep. 30, 2022
Jun. 30, 2023
Jun. 30, 2023
Royalty Obligation      
Cash contractual interest expense   $ 3.0 $ 5.9
DRI      
Royalty Obligation      
Proceeds received upon entering into OMIDRIA royalty obligation $ 125.0    
Maximum payout payable   $ 180.3 $ 180.3
Maximum Royalty Payable Percentage   9.40% 9.40%
v3.23.2
OMIDRIA Royalty Obligation - Fair Value (Details)
$ in Millions
Jun. 30, 2023
USD ($)
Royalty Obligation | Level 3  
Fair Value, Assets and Liabilities  
Liabilities, Fair Value Disclosure $ 117.1
v3.23.2
OMIDRIA Royalty Obligation - Schedule of maximum scheduled principal and interest payments (Details)
$ in Thousands
Jun. 30, 2023
USD ($)
Principal  
2023 $ 589
2024 8,576
2025 14,641
2026 16,081
2027 17,664
Thereafter 68,164
Total scheduled payments 125,715
Interest  
2023 5,911
2024 11,424
2025 10,359
2026 8,919
2027 7,336
Thereafter 10,586
Total scheduled payments 54,535
Total Annual Cap  
2023 6,500
2024 20,000
2025 25,000
2026 25,000
2027 25,000
Thereafter 78,750
Total scheduled payments $ 180,250
v3.23.2
Leases (Details)
$ in Thousands
3 Months Ended 6 Months Ended
Jan. 14, 2022
USD ($)
Jun. 30, 2023
USD ($)
item
Jun. 30, 2022
USD ($)
Jun. 30, 2023
USD ($)
item
Jun. 30, 2022
USD ($)
Dec. 31, 2022
USD ($)
Leases            
Number of options to extend lease term | item   2   2    
Restricted investments   $ 1,054   $ 1,054   $ 1,054
Expected lease term   5 years   5 years    
Decrease in right of use asset due to lease termination $ 4,700          
Decrease in lease liability due to lease termination 5,200          
Non-cash gain of termination of lease $ 500       $ 454  
Lease cost            
Operating lease cost   $ 1,616 $ 1,663 $ 3,249 2,870  
Amortization   271 122 389 320  
Interest   41 36 92 92  
Variable lease cost   757 722 1,547 1,582  
Sublease income   (375) (453) (750) (945)  
Net lease cost   $ 2,310 $ 2,090 4,527 3,919  
Cash payments for operating leases       3,568 3,562  
Cash payments for financing leases       $ 336 $ 401  
v3.23.2
Commitment and Contingencies (Details) - USD ($)
$ in Millions
Jul. 31, 2023
Jun. 30, 2023
Other Commitments [Line Items]    
Contract termination fees   $ 21.2
Subsequent Event    
Other Commitments [Line Items]    
Contractual milestone payment payable $ 5.0  
v3.23.2
Shareholders' Equity (Deficit) (Details) - USD ($)
$ / shares in Units, $ in Millions
6 Months Ended
Jun. 23, 2023
Jun. 30, 2023
Apr. 12, 2023
Dec. 31, 2022
Mar. 01, 2021
Class of Stock [Line Items]          
Number of warrants to purchase common stock which expired     200,000    
Warrant exercise price (in USD per share)     $ 23.00    
Warrants outstanding   0      
Common stock, authorized shares   150,000,000   150,000,000  
Exercise price   $ 11.89      
Vest monthly on a straight-line basis   4 years 3 months 18 days      
Shares available for future grants (shares)   10,175,852      
Amended 2017 Omnibus Incentive Compensation Plan          
Class of Stock [Line Items]          
Increase in shares available for grant 5,000,000        
At The Market (ATM) Program          
Class of Stock [Line Items]          
Maximum aggregate offering price   $ 150.0     $ 150.0
v3.23.2
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
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
Research and development        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Total stock-based compensation in continuing operations 1,133 1,389 2,405 3,104
Selling, general and administrative        
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]        
Total stock-based compensation in continuing operations $ 1,680 $ 1,793 $ 3,402 $ 3,970
v3.23.2
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Outstanding options to purchase common stock - $ / shares
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award    
Estimated weighted-average fair value (USD per share) $ 4.66 $ 4.21
Weighted Average    
Weighted-average assumptions:    
Expected volatility 92.00% 92.00%
Expected life, in years 7 years 3 months 18 days 7 years 1 month 6 days
Risk-free interest rate 3.74% 3.74%
Expected dividend yield 0.00% 0.00%
v3.23.2
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details)
$ / shares in Units, $ in Thousands
6 Months Ended
Jun. 30, 2023
USD ($)
$ / shares
shares
Options Outstanding  
Beginning balance (shares) | shares 13,872,973
Granted (shares) | shares 200,000
Exercised (in shares) | shares (19,556)
Forfeited (shares) | shares (437,821)
Ending balance (shares) | shares 13,615,596
Vested and expected to vest (shares) | shares 13,290,618
Exercisable (shares) | shares 10,508,263
Weighted-Average Exercise Price per Share  
Beginning balance (USD per share) | $ / shares $ 11.02
Granted (USD per share) | $ / shares 5.20
Exercised (USD per share) | $ / shares 4.98
Forfeited (USD per share) | $ / shares 10.46
Ending balance (USD per share) | $ / shares 10.96
Vested and expected to vest (USD per share) | $ / shares 11.04
Exercisable (USD per share) | $ / shares $ 11.89
Weighted- Average Remaining Contractual Life  
Balance (in years) 5 years 3 months 18 days
Vested and expected to vest (in years) 5 years 2 months 12 days
Exercisable (in years) 4 years 3 months 18 days
Aggregate Intrinsic Value  
Balance | $ $ 4,095
Vested and expected to vest | $ 3,793
Exercisable | $ $ 1,280
v3.23.2
Stock-Based Compensation - Narrative (Details) - USD ($)
$ / shares in Units, $ in Millions
6 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Share-based Compensation Arrangement by Share-based Payment Award    
Options outstanding 13,615,596 13,872,973
Number of options outstanding with exercise price above the closing stock price on NASDAQ exchange 11,100,000  
Stock price $ 5.44  
Outstanding options to purchase common stock    
Share-based Compensation Arrangement by Share-based Payment Award    
Unvested options outstanding (shares) 3,100,000  
Period for recognition 1 year 10 months 24 days  
Unrecognized compensation expense $ 14.5  
Employee restricted stock units    
Share-based Compensation Arrangement by Share-based Payment Award    
Restricted stock units, unvested 89,750  
Weighted average grant-date fair value (USD per share) $ 7.53  

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