UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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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:
(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934: |
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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.
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).
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.
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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
As of May 9, 2025, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was
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,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “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 and short-term investments will fund our anticipated operating expenses, capital expenditures and debt service obligations;
● our ability to raise additional capital through the capital markets or one or more future equity offerings, debt financings, industry collaborations, licensing arrangements, asset sales or other means;
● our ability to comply with the terms of our secured credit facility and our expectations regarding the effect on our operations of compliance with the restrictive covenants and other obligations applicable under our secured credit facility;
● our expectations regarding amounts potentially payable to us based on sales of our former commercial ophthalmology product OMIDRIA®;
● our expectations regarding anticipated or potential paths to regulatory approval of narsoplimab by the U.S. Food and Drug Administration (“FDA”) and/or the European Medicines Agency (“EMA”), including whether FDA will meet the target date for action assigned to the biologics license application (“BLA”) for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”), whether and when a marketing authorization application (“MAA”) may be submitted to the EMA for narsoplimab in any indication, and whether and when FDA, the EMA or any other regulatory authority will grant approval for narsoplimab in TA-TMA or in any other indication;
● our expectation that our contract manufacturer will manufacture narsoplimab when needed to support any regulatory inspection, if required by FDA in connection with or following its review of our BLA for narsoplimab in TA-TMA and, if approved, to support commercial sale of narsoplimab;
● 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 expectations regarding the clinical, therapeutic and competitive benefits and importance of our product candidates, including narsoplimab and zaltenibart;
● our ability to design, initiate and/or successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials;
● our expectations regarding: our ability to recruit and enroll patients in any ongoing or planned clinical trial; 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 utilize the opportunities for expedited development and review that may be provided by fast-track or breakthrough therapy designations granted by FDA;
● our expectations about the commercial competition that our product candidates, if commercialized, face or may face;
● our involvement in existing or 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 product 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 March 31, 2025
PART I — FINANCIAL INFORMATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)
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March 31, |
December 31, |
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2024 |
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Assets |
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Cash and cash equivalents |
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Short-term investments |
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OMIDRIA contract royalty asset |
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Receivables |
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Prepaid expense and other assets |
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Total current assets |
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OMIDRIA contract royalty asset, non-current |
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Right of use assets |
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Property and equipment, net |
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Restricted investments |
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Total assets |
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Accounts payable |
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OMIDRIA royalty obligation |
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Convertible senior notes, net |
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Term debt |
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Lease liabilities |
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Total current liabilities |
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OMIDRIA royalty obligation, non-current |
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Convertible senior notes, non-current, net |
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Lease liabilities, non-current |
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Commitments and contingencies (Note 10) |
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Preferred stock, par value $ |
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Common stock, par value $ |
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Additional paid-in capital |
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Accumulated deficit |
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See accompanying Notes to Condensed Consolidated Financial Statements
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Total costs and expenses |
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Loss from operations |
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Weighted-average shares used to compute basic and diluted net income (loss) per share |
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See accompanying Notes to Condensed Consolidated Financial Statements
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
(unaudited)
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Balance at January 1, 2025 |
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Issuance of common stock upon exercise of stock options |
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Balance at March 31, 2025 |
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Balance at January 1, 2024 |
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Issuance of common stock upon exercise of stock options |
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Net loss |
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Balance at March 31, 2024 |
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See accompanying Notes to Condensed Consolidated Financial Statements
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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(unaudited)
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Three Months Ended March 31, |
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Amortization of discount and issuance costs on convertible notes |
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Non-cash interest remeasurement on the OMIDRIA royalty obligation |
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Non-cash interest on OMIDRIA contract royalty asset |
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Remeasurement of OMIDRIA contract royalty asset |
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Principal payments on OMIDRIA royalty obligation |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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Cash paid for interest |
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See accompanying Notes to Condensed Consolidated Financial Statements
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 diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders.
Our clinical-stage development programs include: narsoplimab, our antibody targeting mannan-binding lectin-associated serine protease 2 (“MASP-2”), the effector enzyme of the lectin pathway of complement; OMS1029, our long-acting antibody targeting MASP-2; zaltenibart, also known as OMS906, our antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”), the key activator of the alternative pathway of complement; and OMS527, our phosphodiesterase 7 (“PDE7”) inhibitor program.
Clinical development of narsoplimab is currently focused primarily on hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). We successfully completed a pivotal clinical trial for narsoplimab in TA-TMA and previously submitted to FDA a biologics license application (“BLA”) seeking marketing approval for narsoplimab in this indication. In October 2021, FDA issued a complete response letter (“CRL”) with respect to the original BLA and 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, including paths based on comparison of survival data from the completed pivotal trial to a historical control group. Based on the recommendations included in the appeal decision and on subsequent interactions with FDA’s review division, we developed a statistical analysis plan to assess data from our pivotal clinical trial, existing data from a historical control population available from an external source and data from the narsoplimab expanded access program.
In March 2025, we resubmitted to FDA the BLA seeking regulatory approval for narsoplimab in TA-TMA. The resubmission was accepted for review by FDA as a class 2 resubmission and, pursuant to the Prescription Drug User Fee Act (“PDUFA”), has been assigned a target action date for the FDA decision of September 25, 2025. As with any BLA or new drug application, there can be no guarantee that FDA will complete its review within a given timeframe, or that our BLA will ultimately be approved.
Our lectin pathway program also includes OMS1029, our long-acting antibody targeting MASP-2. We have completed Phase 1 clinical trials evaluating both single-ascending and multiple ascending doses of OMS1029. Results of these studies support once-quarterly dosing administered either intravenously or subcutaneously. OMS1029 has been well tolerated to date with no safety concerns identified. Several indications for potential Phase 2 clinical development of OMS1029 have been evaluated/selected and may be pursued pending the availability and allocation of capital.
Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes zaltenibart, a proprietary, patented monoclonal antibody targeting MASP-3, the key and most proximal activator of the alternative pathway of complement. We have substantially completed two Phase 2 clinical trials evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (“PNH”) and have an ongoing open label extension study to assess the long-term efficacy and safety of zaltenibart in PNH patients who have completed either of the two Phase 2 clinical trials. We also have a small, ongoing Phase 2 study evaluating zaltenibart in complement 3 glomerulopathy (“C3G”), a rare and debilitating renal disease driven by complement dysregulation.
We began initiating clinical trial sites in our Phase 3 program for zaltenibart in PNH during the first quarter of 2025; however, based on considerations of capital availability and the anticipated ramp up in spending on those trials, we have determined temporarily to pause our Phase 3 clinical development program for zaltenibart in this indication in order to prioritize the use of our available capital to other programs. We are working with our vendors and investigators to ensure that these studies can be restarted with as little disruption to the timeline as possible after securing capital and allocating it to the program.
Our phosphodiesterase 7 (“PDE7”) inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders. In April 2023, we were awarded a grant from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health, to develop, at NIDA’s request, our lead orally administered PDE7 inhibitor compound for the treatment of cocaine use disorder (“CUD”). NIDA awarded the grant to us for a total of $
We also have various programs in preclinical research and development.
OMIDRIA Sale and Royalty Monetization Transactions
On December 23, 2021, we closed an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Rayner Surgical Inc. (“Rayner”) for the sale of our commercial product OMIDRIA which we recorded as an OMIDRIA contract asset on our condensed consolidated balance sheet. As a result of the divestiture, the results of OMIDRIA activities are classified as discontinued operations in our condensed consolidated statements of operations and comprehensive loss and excluded from continuing operations for all periods presented (See “Note 7 — Discontinued Operations – Sale of OMIDRIA”).
On September 30, 2022, we sold an interest in a portion of our future OMIDRIA royalty receipts to DRI Healthcare Acquisition LP (“DRI”) and received $
On February 1, 2024, we sold an expanded interest in our OMIDRIA royalties to DRI and received $
2024 Term Loan and Repurchase of 2026 Notes
On June 3, 2024, we, with certain subsidiaries, as guarantors, entered into a Credit and Guaranty Agreement (the “Credit Agreement”) with funds managed by Athyrium Capital Management LP (collectively, “Athyrium”) and funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) as Lenders (the “Lenders”). The Credit Agreement provides for a senior secured term loan facility of up to $
Also, we used the Term Loan proceeds along with $
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 reflect all adjustments, consisting of normal recurring adjustments and non-recurring adjustments, considered necessary for the fair presentation of such information. Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”).
These financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, from which the December 31, 2024, condensed consolidated balance sheet has been derived.
Liquidity and Capital Resources
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $
In recent years, Omeros has incurred net losses from continuing operations and negative cash flows from operations. The recurring losses, in combination with our cash and investment balances as of March 31, 2025, along with the maturity of the 2026 Notes on February 15, 2026, raises substantial doubt about our ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern.
As we currently do not have an ongoing source of revenue sufficient to cover our operating costs, we will need to raise additional capital to accomplish our business plan.
On May 14, 2025, we completed the exchange (the “Convertible Note Exchange”) of $
On May 12, 2025, the Company entered into note conversion agreements (each, a “Note Conversion Agreement”) with two affiliated holders of the 2026 Notes to convert $
The Convertible Note Exchange reduced the aggregate principal balance of our 2026 Notes from $
To raise capital for our operations, we may also pursue public and private offerings of our equity securities, additional debt transactions or restructuring, future royalty sales, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies. However, pursuing debt financings, certain equity offerings or other strategic transactions may result in mandatory prepayments of the Term Loan to the Credit Agreement. (See “Note 6 — Debt” for further details).
In addition, we have a sales agreement pursuant to an at the market (“ATM”) equity offering facility through which we may, from time to time, offer and sell shares of our common stock equaling an aggregate amount of up to $
If these capital resources, for any reason, are needed but inaccessible, it would have a significant negative impact on our financial condition. For purposes of determining available capital resources, any future royalty and/or milestone receipts are excluded. We have taken steps to manage our operating expenses and reduce our projected cash requirements by delaying clinical trials and reducing selected research and development efforts. Should it be necessary, we may determine to further reduce or delay these or other aspects of our operations and/or implement other restructuring activities.
The conditions described above, including the need to raise additional capital, when evaluated in accordance with the relevant accounting literature, raise substantial doubt with respect to our ability to meet our obligations through one year from the issuance of the Company's condensed consolidated financial statements.
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 the OMIDRIA contract royalty asset valuation and the OMIDRIA royalty obligation valuation. 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
Segment Reporting
We operate in business segment focusing on the research, discovery, development and commercialization of small-molecule and protein therapeutics targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders. The Company defines its operating segment based on internally reported financial information that is regularly used by the Chief Operating Decision Maker (“CODM”) to analyze performance, make decisions and allocate resources. The Company's CODM is our Chief Executive Officer. For the three months ended March 31, 2025, the Company has identified operating and reportable segment. The CODM reviews net loss and expenses reported on the condensed consolidated statement of operations and comprehensive income (loss). The measurement of segment assets is reported on the balance sheet as total consolidated assets. All long-lived assets are held in the U.S. Our segment net income (loss) aligns with our condensed consolidated statement of operations and comprehensive income (loss).
Discontinued Operations
We review the presentation of planned or completed business dispositions in the condensed consolidated financial statements based on the available information and events that have occurred. The review consists of evaluating whether the business meets the definition of a component for which the operations and cash flows are clearly distinguishable from the other components of the business and, if so, whether it is anticipated that, after the disposal, the cash flows of the component would be eliminated from continuing operations and whether the disposition represents a strategic shift that has a major effect on operations and financial results.
Planned or completed business dispositions are presented as discontinued operations when all the criteria described above are met. For those divestitures that qualify as discontinued operations, all comparative periods presented are reclassified in the condensed consolidated balance sheets. Additionally, the results of operations of a discontinued operation are reclassified to income from discontinued operations, net of tax, for all periods presented in the condensed consolidated statements of operations and comprehensive income (loss). Results of discontinued operations include all revenues and expenses directly derived from such businesses. General corporate overhead is not allocated to discontinued operations. The OMIDRIA asset sale to Rayner qualifies as a discontinued operation and has been presented as such for all reporting periods presented. The Company included information regarding cash flow from discontinued operations (See “Note 7 — Discontinued Operations – Sale of OMIDRIA”).
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 use the expected value approach which is the sum of the discounted probability-weighted royalty payments 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.
The royalty rate applicable to U.S. net sales of OMIDRIA is
OMIDRIA Royalty Obligation
On September 30, 2022, we sold to DRI an interest in a portion of our future OMIDRIA royalty receipts for a purchase price of $
To the extent our estimates of future royalties differ materially from previous estimates, we will adjust the carrying amount of the OMIDRIA royalty obligation to reflect the present value of the revised estimated cash flows, discounted at the implied effective interest rate of
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.
2024 Term Loan and Repurchase of 2026 Notes
In June 2024, we performed an assessment of the Credit Agreement which was entered into with Highbridge and Athyrium and determined that it met the criteria to be accounted for as a troubled debt restructuring. As a result, the $
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 basis. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination by the relevant taxing authority. A valuation allowance is established when it is more likely than not that the deferred tax assets will not be realized.
Financial Instruments and Concentrations of Credit Risk
Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of short-term investments is based on quoted market prices. Financial instruments that potentially subject to concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. At times, our cash and cash equivalents balance held at financial institutions may exceed the federally insured limits. To limit the credit risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and U.S. treasury bills.
Recent Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09, Income Taxes - Improvements to Income Tax Disclosure (Topic 740), to enhance the transparency of income tax disclosures. ASU 2023-09 provides enhancements to the income tax disclosures related to the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for annual years beginning after December 15, 2024 and applied prospectively. The Company is evaluating the impact of this pronouncement on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expense, requiring public entities to disclose additional information about specific expense categories in the notes to the financial statements on an interim and annual basis. ASU 2024-03 is effective for annual years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact on its financial statement disclosures.
In November 2024, the FASB issued ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, which provides clarification on the accounting treatment of convertible debt settlements that occur under terms differing from those of the original instrument. The amendments specify that if the settlement is considered an induced conversion, an entity must recognize an inducement expense at the offer acceptance date. Conversely, if the settlement is treated as a debt extinguishment, an entity must recognize a gain or loss at the extinguishment date. This ASU is effective for all entities for annual years beginning after December 15, 2025, including interim periods within those years, with early adoption permitted. The Company is in the process of assessing the potential impact of this ASU on its debt accounting policies.
Note 3—Net Loss Per Share
Basic net income (loss) per share (“Basic EPS”) is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share (“Diluted EPS”) is computed by dividing net income (loss) by the weighted average number of common shares and potentially dilutive common shares outstanding during the period. Our potential dilutive securities include common shares related to our stock options and convertible senior notes calculated using the treasury stock method. In periods where we have a net loss from continuing operations but overall net income, we do not compute Diluted EPS because the effect would be anti-dilutive. Potentially dilutive securities excluded from Diluted EPS are as follows:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
2026 Notes convertible to common stock (1)(2) |
||||||||
|
Outstanding options to purchase common stock |
||||||||
|
Total potentially dilutive shares excluded from net loss per share |
||||||||
|
(1) |
|
|
| (2) |
|
Note 4—Investments and Fair-Value Measurements
All of our investments are short-term and held in our name. Money market funds are classified as available-for-sale on the accompanying condensed consolidated balance sheets. Interest income is included as a component of interest and other income on our condensed consolidated statement of operations and comprehensive loss. Interest and other income for the three months ended March 31, 2025 and March 31, 2024 consists primarily of interest earned of $
The following tables summarize our investments:
|
|
March 31, 2025 |
|||||||||||
|
|
Gross Unrealized |
|||||||||||
|
Amortized Cost |
Gains/(Losses) |
Estimated Fair Value |
||||||||||
|
|
(In thousands) |
|||||||||||
|
Assets: |
| | | |||||||||
|
Money-market funds classified as short-term investments |
$ | $ | $ | |||||||||
|
Certificate of deposit classified as non-current restricted investments |
||||||||||||
|
Total investments |
$ | $ | $ | |||||||||
|
|
December 31, 2024 |
|||||||||||
|
|
Gross Unrealized |
|||||||||||
|
Amortized Cost |
Gains/(Losses) |
Estimated Fair Value |
||||||||||
|
|
(In thousands) |
|||||||||||
|
Assets: |
| | | |||||||||
|
Money-market funds classified as short-term investments |
$ | $ | $ | |||||||||
|
Certificate of deposit classified as non-current restricted investments |
||||||||||||
|
Total investments |
$ | $ | $ | |||||||||
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:
|
|
March 31, 2025 |
|||||||||||||||
|
|
Level 1 |
Level 2 |
Level 3 |
Total |
||||||||||||
|
|
(In thousands) |
|||||||||||||||
|
Assets: |
|
|
|
|
||||||||||||
|
Money-market funds classified as short-term investments |
$ | $ | $ | $ | ||||||||||||
|
Certificate of deposit classified as non-current restricted investments |
||||||||||||||||
|
Total investments |
$ | $ | $ | $ | ||||||||||||
|
|
December 31, 2024 |
|||||||||||||||
|
|
Level 1 |
Level 2 |
Level 3 |
Total |
||||||||||||
|
|
(In thousands) |
|||||||||||||||
|
Assets: |
|
|
|
|
||||||||||||
|
Money-market funds classified as short-term investments |
$ | $ | $ | $ | ||||||||||||
|
Certificate of deposit classified as non-current restricted investments |
||||||||||||||||
|
Total investments |
$ | $ | $ | $ | ||||||||||||
Cash held in demand deposit accounts of $
See “Note 6 — Debt” and “Note 8 — OMIDRIA Royalty Obligation” for the carrying amount and estimated fair value of our outstanding term loan, convertible senior notes and the OMIDRIA royalty obligation.
Note 5 — Certain Balance Sheet Accounts
OMIDRIA Contract Royalty Asset
The OMIDRIA contract royalty asset consists of the following:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Short-term contract royalty asset |
$ | $ | ||||||
|
Long-term contract royalty asset |
||||||||
|
Total OMIDRIA contract royalty asset |
$ | $ | ||||||
See “Note 7 — Discontinued Operations – Sale of OMIDRIA” for discussion regarding the estimated fair value of our OMIDRIA contract royalty asset.
Receivables
Receivables consist of the following:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
OMIDRIA royalty receivables |
$ | $ | ||||||
|
Other receivables |
||||||||
|
Total receivables |
$ | $ | ||||||
Other receivables of $
Property and Equipment, Net
Property and equipment, net consists of the following:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Equipment under finance lease obligations |
$ | $ | ||||||
|
Laboratory equipment |
||||||||
|
Computer equipment |
||||||||
|
Office equipment and furniture |
||||||||
|
Total cost |
||||||||
|
Less accumulated depreciation and amortization |
( |
) | ( |
) | ||||
|
Total property and equipment, net |
$ | $ | ||||||
For the three months ended March 31, 2025 and 2024, depreciation and amortization expense was $
Accrued Expenses
Accrued expenses consist of the following:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Employee compensation |
$ | $ | ||||||
|
Clinical trials |
||||||||
|
Contract research and development |
||||||||
|
Consulting and professional fees |
||||||||
|
Interest payable |
||||||||
|
Other accrued expenses |
||||||||
|
Total accrued expenses |
$ | $ | ||||||
Note 6—Debt
2024 Secured Term Loan
On June 3, 2024, we entered into a Credit Agreement with the Lenders, pursuant to which we have a Term Loan of $
In connection with our entry into the Credit Agreement, we used the Term Loan along with $
The amount outstanding on the Term Loan is as follows:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Principal amount |
$ | $ | ||||||
|
Unamortized debt premium, net of issuance costs and other |
||||||||
|
Total term debt, net |
$ | $ | ||||||
The Loans have a stated maturity date of June 3, 2028 and bear interest at an adjusted (“adjusted SOFR”), subject to a
The following table sets forth interest expense recognized related to the Term Loan:
|
March 31, |
||||
|
2025 |
||||
|
(In thousands) |
||||
|
Contractual interest expense |
$ | |||
|
Amortization of debt issuance costs |
( |
) | ||
|
Total interest expense |
$ | |||
We may elect to prepay the Loans, in whole or in part, in cash, plus an applicable prepayment and/or make-whole premium. Under certain circumstances, we are required to prepay all or a portion of the outstanding Loans, plus an applicable prepayment and/or make-whole premium, as described below.
(1) If, on November 1, 2025, (i) the aggregate outstanding principal amount of the outstanding 2026 Notes that is not held by the Lenders equals or exceeds $
(2) Upon the occurrence of a change in control, we must prepay the entire outstanding amount of the Loans, plus the applicable make-whole or prepayment premium.
(3) We must prepay the Loans in an amount equal to: (i)
Voluntary and mandatory prepayments of the Loans are subject to payment of the following premiums: (i) during the first year of such Loans, a make-whole premium plus
The Credit Agreement contains certain customary default provisions, representations and warranties and affirmative and negative covenants. These include a covenant requiring us to maintain at all times unrestricted cash, cash equivalents and short-term investments of at least $
The fair value of the Loans is classified as a Level 3 liability. As of March 31, 2025 and December 31, 2024, the approximate fair value of our Loan obligations was $
2026 Unsecured Convertible Senior Notes
We have outstanding unsecured convertible senior notes which accrue interest at an annual rate of
In 2024, we repurchased $
On May 14, 2025, we completed the Convertible Note Exchange in which we exchanged $
Amounts outstanding on our 2026 Notes as of March 31, 2025 and December 31, 2024 are as follows:
|
|
March 31, |
December 31, |
||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Principal amount not subject to the Convertible Note Exchange |
$ | $ | ||||||
|
Unamortized debt issuance costs |
( |
) | ( |
) | ||||
|
Total 2026 Notes, net, classified as current |
||||||||
|
Principal amount subject to the Convertible Note Exchange |
||||||||
|
Unamortized debt issuance costs |
( |
) | ||||||
|
Total 2026 Notes, net, classified as noncurrent |
||||||||
|
Total unsecured convertible senior notes, net |
$ | $ | ||||||
|
Fair value of outstanding unsecured convertible senior notes (1) |
$ | $ | ||||||
|
(1) |
|
Unamortized debt issuance costs represent an allocation of the $
The following table sets forth interest expense recognized related to the 2026 Notes:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Contractual interest expense |
$ | $ | ||||||
|
Amortization of debt issuance costs |
||||||||
|
Total interest expense |
$ | $ | ||||||
The conversion rate is
The 2026 Notes are convertible at the option of the holders on or after November 15, 2025 at any time prior to the close of business on February 12, 2026, the second scheduled trading day immediately before the stated maturity date of February 15, 2026. Additionally, holders may convert their 2026 Notes at their option at specified times prior to the maturity date only if:
(1) during any calendar quarter, the last reported sale price per share of our common stock exceeds
(2) during the consecutive business days immediately after any -consecutive-trading-day period (such -consecutive-trading-day period, the “measurement period”) in which the trading price per $
(3) there is an occurrence of one or more certain corporate events or distributions of our common stock; or
(4) we call the 2026 Notes for redemption.
We will settle any conversions by paying or delivering, as applicable, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election, based on the applicable conversion rate(s).
Subject to the satisfaction of certain conditions, we may redeem in whole or in part the 2026 Notes at our option beginning August 15, 2023 through the
In order to reduce the dilutive impact or potential cash expenditure associated with the conversion of the 2026 Notes, we entered into capped call transactions in connection with the issuances of the 2026 Notes (the “2026 Capped Call”). The 2026 Capped Call will cover, subject to anti-dilution adjustments substantially similar to those applicable to the 2026 Notes, the number of shares of common stock underlying the 2026 Notes when our common stock is trading within the range of approximately $
Further, we concluded the 2026 Capped Call qualifies for a derivative scope exception for instruments that are both indexed to an entity’s own stock and classified in stockholders’ equity in its balance sheet. Consequently, the fair value of the 2026 Capped Call of $
Minimum Commitments
As of March 31, 2025, the most probable principal payments on our convertible notes and the Term Loan are as follows and reflects the impact of refinancing our 2026 Notes from short-term to long-term:
|
2026 Notes |
Term Loan |
Total |
||||||||||
|
(In thousands) |
||||||||||||
|
2025 |
$ | $ | $ | |||||||||
|
2026 |
||||||||||||
|
2027 |
||||||||||||
|
2028 |
||||||||||||
|
2029 and thereafter |
||||||||||||
|
Total principal payments |
||||||||||||
|
Unamortized premiums, discounts, issuance costs and other |
( |
) | ||||||||||
|
Carrying value of debt |
$ | $ | $ | |||||||||
Note 7—Discontinued Operations - Sale of OMIDRIA
On December 23, 2021, we sold the rights to OMIDRIA and related assets to Rayner, which is reported as discontinued operations in our condensed consolidated statements of operations and comprehensive loss and excluded from continuing operations for all periods presented.
The results of operations for OMIDRIA are recorded as income from discontinued operations for all periods presented in the condensed consolidated statements of operations and comprehensive loss are as follows:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Interest earned on OMIDRIA contract royalty asset |
$ | $ | ||||||
|
Remeasurement adjustments |
||||||||
|
Other loss, net |
( |
) | ( |
) | ||||
|
Net income from discontinued operations, net of tax |
$ | $ | ||||||
The following is a roll forward of the OMIDRIA contract royalty asset (in thousands):
|
OMIDRIA contract royalty asset at December 31, 2024 |
$ | |||
|
Royalties earned |
( |
) | ||
|
Interest earned on OMIDRIA contract royalty asset |
||||
|
Remeasurement adjustments |
||||
|
OMIDRIA contract royalty asset at March 31, 2025 |
$ |
We remeasure the OMIDRIA contract royalty asset on a quarterly basis using the expected value approach, which incorporates actual results and future expectations.
Cash flow from discontinued operations is as follows:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Net cash provided by discontinued operations from operating activities |
$ | $ | ||||||
Net cash provided by discontinued operations primarily represents royalties received from Rayner. All royalties earned on OMIDRIA sales within the U.S. through December 31, 2031 are remitted by Rayner to an escrow account established by Omeros, from which payments are made to DRI.
Note 8—OMIDRIA Royalty Obligation
In September 2022, we sold to DRI an interest in our future OMIDRIA royalty receipts and received $
In February 2024, Omeros and DRI expanded their royalty purchase agreement under the Amendment, resulting the elimination of previously existing annual caps on royalty payments and Omeros receiving an additional $
We retain the right to receive all royalties payable by Rayner on any U.S. net sales of OMIDRIA after December 31, 2031 and all royalties on global net sales of OMIDRIA from and after December 31, 2031. To date, international royalties have not been significant. DRI has no recourse to our assets other than its interest in OMIDRIA royalties.
We are also entitled to receive a milestone payment ranging between $
The changes in the OMIDRIA royalty obligation during the three months ended March 31, 2025 are as follows (in thousands):
|
Balance at December 31, 2024 |
$ | |||
|
Non-cash interest |
( |
) | ||
|
Principal payments |
( |
) | ||
|
Balance at March 31, 2025 |
$ |
The OMIDRIA royalty obligation is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. The fair value of the OMIDRIA royalty obligation is determined by calculating the net present value of our estimated future OMIDRIA cash flows using the interest rate at inception of our royalty purchase agreement with DRI, adjusted for the change in the prime rate through the measurement date. As of March 31, 2025 and December 31, 2024, the approximate fair value of our obligation was $
For the three months ended March 31, 2025 and 2024, we incurred interest expense of $
As of March 31, 2025, the expected scheduled principal and interest payments (based on an implied effective interest rate of
|
|
|
|
||||||||||
|
|
Principal |
Interest |
Total |
|||||||||
|
|
(In thousands) |
|||||||||||
|
2025 |
$ | $ | $ | |||||||||
|
2026 |
||||||||||||
|
2027 |
||||||||||||
|
2028 |
||||||||||||
|
2029 |
||||||||||||
|
Thereafter |
||||||||||||
|
Total scheduled payments |
$ | $ | $ | |||||||||
Note 9—Lease Liabilities
We have an operating lease for our office and laboratory facilities with an initial term that ends in November 2027 and options to extend the lease term by an additional years each. Restricted investments of $
Supplemental lease information is as follows:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Lease cost |
||||||||
|
Operating lease cost |
$ | $ | ||||||
|
Finance lease cost: |
| |||||||
|
Amortization |
||||||||
|
Interest |
||||||||
|
Variable lease cost |
||||||||
|
Sublease income |
( |
) | ( |
) | ||||
|
Net lease cost |
$ | $ | ||||||
The supplemental cash flow information related to leases is as follows:
|
|
Three Months Ended |
|||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Cash paid for amounts included in the measurement of lease liabilities |
|
|
||||||
|
Cash payments for operating leases |
$ | $ | ||||||
|
Cash payments for financing leases |
||||||||
Note 10—Commitments and Contingencies
Good and Service Contracts
We have various agreements with third parties that collectively require payment of termination fees totaling $
Development Milestones and Product Royalties
We have entered a variety of development, collaboration, licensing or similar agreements with third parties under which we have accessed technology or services in connection with our development assets and programs. Some of these agreements require milestone payments based on achievements of development, regulatory or sales milestones, and/or low-single to low-double digit royalties on net income or net sales of the relevant product. For the three months ended March 31, 2025 and 2024, development milestone expenses were not significant.
Note 11—Shareholders’ Deficit
Common Stock
At the Market Sales Agreement - We have a sales agreement to sell shares of our common stock having an aggregate offering price of up to $
Share Repurchase Program - On November 9, 2023, the Board of Directors approved a share repurchase program under which we were permitted to repurchase from time to time up to $
Note 12—Stock-Based Compensation
Our stock option plans provide for the grant of incentive and non-qualified stock options, restricted stock awards, restricted stock units, and other stock awards to employees, non-employee directors and consultants.
Stock-based compensation is as follows:
|
Three Months Ended |
||||||||
|
|
March 31, |
|||||||
|
|
2025 |
2024 |
||||||
|
|
(In thousands) |
|||||||
|
Continuing operations |
|
|
||||||
|
Research and development |
$ | $ | ||||||
|
Selling, general and administrative |
||||||||
|
Total stock-based compensation |
$ | $ | ||||||
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 |
|||
|
|
March 31, 2025 |
|||
|
Estimated weighted-average fair value |
$ | |||
|
Weighted-average assumptions: |
|
|||
|
Expected volatility |
% | |||
|
Expected life, in years |
||||
|
Risk-free interest rate |
% | |||
|
Expected dividend yield |
% | |||
Expected volatility is based on the historical volatility of our stock price weighted by grant issuances over the reporting period. We estimated the expected life of the stock options granted using the historical exercise behavior of option holders. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant. Forfeiture expense is estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates.
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, 2024 |
$ | |||||||||||||||
|
Granted |
||||||||||||||||
|
Exercised |
( |
) | ||||||||||||||
|
Forfeited |
( |
) | ||||||||||||||
|
Balance at March 31, 2025 |
$ | $ | ||||||||||||||
|
Vested and expected to vest at March 31, 2025 |
$ | $ | ||||||||||||||
|
Exercisable at March 31, 2025 |
$ | $ | ||||||||||||||
Of the
As of March 31, 2025, there were
As of March 31, 2025, the total number of shares of common stock available for grant was
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, 2024, which was filed with the SEC on March 31, 2025. 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, 2024, 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
We are a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing first-in-class 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 Inhibitor Programs
The complement system plays a role in the body’s inflammatory response and becomes activated as a result of tissue damage or trauma or microbial pathogen invasion. Inappropriate or uncontrolled activation of the complement system can cause diseases characterized by serious tissue injury. Three main pathways can activate the complement system: classical, lectin, and alternative. We are focused on development of therapeutics to treat diseases associated with the lectin and/or alternative pathways of complement. We are developing antibodies as well as small-molecule inhibitors of key enzymes known to be centrally involved in the in activation of the targeted pathway of complement.
Lectin Pathway / MASP 2
MASP-2 is a novel pro-inflammatory protein target that is the effector enzyme of the lectin pathway and is required for the function of this pathway. We are developing antibodies and small-molecule inhibitors of MASP-2 as potential therapeutics for diseases in which the lectin pathway has been shown to contribute to significant tissue injury and pathology. When not treated, these diseases are typically characterized by significant end-organ damage, such as kidney or central nervous system injury. Importantly, inhibition of MASP-2 has been demonstrated not to interfere with the antibody-dependent classical complement activation pathway, a critical component of the acquired immune response to infection.
The lead product candidate in our pipeline of complement-targeted therapeutics is narsoplimab (OMS721), a proprietary, patented human monoclonal antibody targeting MASP-2, the key activator of the lectin pathway of complement. In March 2025, we resubmitted to FDA a BLA seeking regulatory approval for narsoplimab in TA-TMA. The resubmission was accepted for review by FDA as a class 2 resubmission and, pursuant to the Prescription Drug User Fee Act (“PDUFA”), has been assigned a target action date for the FDA decision of September 25, 2025. As with any BLA or new drug application, there can be no guarantee that FDA will complete its review within a given timeframe, or that our BLA will ultimately be approved. We also preparing a European marketing authorization application (MAA) for narsoplimab in TA-TMA, which is targeted for submission to the European Medicines Agency during the second quarter of 2025. Development efforts in our narsoplimab program have also been directed to COVID-19, acute respiratory distress syndrome and post-acute sequelae SARS-CoV-2, commonly known as long COVID.
Our pipeline also includes OMS1029, our long-acting antibody targeting MASP-2 which we expect will be well-suited to indications requiring long-term, chronic administration. In addition, we have a program focused on development of an orally administered small-molecule MASP-2 inhibitor. In the first quarter of 2025 we determined to pause most development activities in our OMS1029 and MASP-2 small-molecule development programs to preserve available capital for narsoplimab and other prioritized programs.
Alternative Pathway / MASP-3
Our pipeline of clinical-stage complement-targeted therapeutic candidates also includes zaltenibart (OMS906), a proprietary, patented monoclonal antibody targeting MASP-3, the key activator of the alternative pathway of complement. We believe zaltenibart has the potential to treat a wide range of alternative pathway-related diseases and that its attributes favorably differentiate zaltenibart from other marketed and in-development alternative pathway inhibitors.
Clinical development of zaltenibart is currently focused on PNH and C3G. We have substantially completed two Phase 2 clinical trials evaluating zaltenibart and have an ongoing open label extension study to assess the long-term efficacy and safety of zaltenibart in PNH patients who have completed either of the two Phase 2 clinical trials. We also have a small, ongoing Phase 2 study evaluating zaltenibart in C3G.
We began initiating clinical trial sites in our Phase 3 program for zaltenibart in PNH during the first quarter of 2025; however, based on considerations of capital availability and the anticipated ramp up in spending on those trials, we have determined temporarily to pause our Phase 3 clinical development program for zaltenibart in this indication to prioritize the use of our available capital to other programs. We are working with our vendors and investigators to ensure that these studies can be restarted after securing capital and allocating it to the program with as little disruption to the timeline as possible.
PDE7 Inhibitor Programs
Our PDE7 inhibitor program, which we refer to as OMS527, comprises multiple PDE7 inhibitor compounds and is based on our discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder, and between PDE7 and any 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”). With NIDA funding, we successfully completed preclinical cocaine interaction/toxicology studies to assess safety of the OMS527 compound when co-administered with cocaine. Based on the successful outcome of the preclinical studies, we have initiated, and NIDA has confirmed availability of grant funding for, an in-patient, placebo-controlled clinical study evaluating the safety and effectiveness of OMS527 in adults with CUD who receive concurrent intravenous cocaine. Organizational and regulatory activities necessary to begin the study evaluating OMS527 in adult patients with CUD is in progress with enrollment expected to begin in 2025 and data anticipated to become available late this year or early 2026.
Preclinical Programs - Oncology Platform
We are developing a portfolio of signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator that, unlike other cellular therapy approaches requires no cellular engineering, may reduce manufacturing costs and timelines, and may maintain an enhanced anti-cancer immune response through subsequent repetitive and simple therapeutic administrations.
We continue on a limited basis to progress pre-clinical studies within our novel oncology program, including IND-enabling studies in our program to develop novel, proprietary large molecule therapeutics designed to target and kill only dividing cancer cells. Acute myeloid leukemia (“AML”) is the lead indication for development in this program, which we refer to as OncotoX-AML. In preclinical models both in vivo and in vitro, our potential AML therapeutic has consistently demonstrated superior efficacy to current AML standard of care treatments and has been well-tolerated in preliminary, preclinical tolerability studies. Our OncotoX-AML therapeutic also shows broad potential application across AML regardless of genetic mutation, including TP53, NPM1, KMT2a and FLT3.
In April 2025, we established the Omeros Oncology Clinical Steering Committee to help advance our OncotoX-AML program. The clinical steering committee is composed of leaders in AML treatment and research at the premier cancer centers across the United States. These experts in the treatment of AML are expected to help guide clinical development of our potential AML therapeutic. IND-enabling work is ongoing with an estimated timeline to clinical entry of 18-24 months.
We continue to confirm our results and to generate new data which we expect will contribute to our intellectual property position.
OMIDRIA Sale and Royalty Monetization Transactions
We previously developed and commercialized OMIDRIA® (phenylephrine and ketorolac intraocular solutions) 1%/0.3%, which is approved by FDA for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. We marketed OMIDRIA in the U.S. from the time of its commercial launch in 2015 until December 2021.
On December 23, 2021, we closed an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Rayner Surgical Inc. (“Rayner”) for the sale of OMIDRIA and related business assets. As contemplated by the Asset Purchase Agreement, in December 2022, we achieved a milestone event upon the establishment of separate payment for OMIDRIA for a continuous period of at least four years when furnished in the ambulatory surgery center setting. The achievement of this milestone event resulted in a reduction of our royalty rate applicable to U.S. net sales of OMIDRIA from 50% to 30%. The 30% royalty rate continues until the expiration or termination of the last issued and unexpired U.S. patent, which we expect to occur no earlier than 2035.
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., becomes included in the packaged payment rate for the surgical procedure) under Medicare Part B, or in certain circumstances involving entry of generic competition for OMIDRIA, 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.
As a result of the OMIDRIA divestiture, we recorded an OMIDRIA contract royalty asset on our balance sheet. The results of OMIDRIA activities are classified as discontinued operations in our condensed consolidated statements of operations and comprehensive income (loss) and excluded from continuing operations for all periods presented. See “Note 8 — OMIDRIA Royalty Obligation” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
On September 30, 2022, we sold to DRI Healthcare Acquisition LP (“DRI”) an interest in a portion of our future OMIDRIA royalty receipts for $125.0 million which we recorded as an OMIDRIA royalty obligation in our condensed consolidated balance sheet. DRI was entitled under that arrangement to receive royalties on OMIDRIA net sales between September 1, 2022 and December 31, 2030, subject to certain annual caps.
On February 1, 2024, we sold an expanded interest in our future OMIDRIA royalties to DRI and received $115.5 million in cash consideration, which we recorded as an addition to the OMIDRIA royalty obligation. The amended and restated royalty purchase agreement with DRI (the “Amendment”) eliminated the previously existing annual caps on royalty payments after January 1, 2024, and provides that DRI receives all royalties on U.S. net sales of OMIDRIA payable between January 1, 2024 and December 31, 2031. In addition to the cash consideration received at closing, the Amendment also entitles us to receive two milestone payments of up to $27.5 million each, payable in January 2026 and January 2028, respectively, based on achievement of certain thresholds for U.S. net sales of OMIDRIA. All royalties earned on OMIDRIA sales within the U.S. through December 31, 2031 are remitted by Rayner to an escrow account established by Omeros, from which payments are made to DRI. We retain the rights to receive all royalties payable by Rayner on any net sales of OMIDRIA outside the U.S. as well as royalties on global net sales of OMIDRIA payable from and after December 31, 2031, including royalties on U.S. OMIDRIA net sales. To date, international royalties have not been significant. DRI has no recourse to our assets other than its interest in OMIDRIA royalties. Interest expense on the OMIDRIA royalty obligation is recorded as a component of continuing operations. See “Note 8 — OMIDRIA Royalty Obligation” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
2024 Term Loan and Repurchase of 2026 Notes
On June 3, 2024 (the “Closing Date”), we, with certain subsidiaries, as guarantors, entered into the Credit and Guaranty Agreement (the “Credit Agreement”) with Athyrium Capital Management, LP (collectively, “Athyrium”) and certain funds managed by Highbridge Capital Management, LLC (collectively, “Highbridge”) as lenders (together with additional lenders from time to time, the “Lenders”) and Wilmington Savings Fund Society, FSB, as administrative agent and collateral agent. The Credit Agreement provides for a senior secured term loan facility initially of up to $92.1 million consisting of (i) the term loan of $67.1 million (the “Term Loan”), which was fully funded on the Closing Date, and (ii) a $25.0 million delayed draw term loan (the “Delayed Draw Term Loan”), which may be drawn once in full upon notice delivered on or prior to June 3, 2025, conditioned on receipt of FDA approval of narsoplimab in TA-TMA within 30 days of the notice. We do not expect to meet the conditions required to access the Delayed Draw Term Loan based on the September 25, 2025 target date for FDA action assigned to the BLA for narsoplimab.
In 2024, we used the $67.1 million Term Loan, along with $21.7 million of cash on hand to repurchase from the Lenders $118.1 million aggregate principal amount of the Company's existing 5.25% convertible senior notes due on February 15, 2026 (the “2026 Notes”, and such repurchase the “2026 Note Repurchase Transaction”). The principal amount retired in the 2026 Note Repurchase Transaction represented a 55% reduction of the outstanding principal balance of the 2026 Notes at a purchase price of approximately 75% of par value.
We are permitted under the Credit Agreement to repurchase additional outstanding 2026 Notes for cash in open market or privately negotiated transactions, subject to certain limitations described below. Additionally, until November 1, 2025, we may at our sole discretion exchange up to $14.9 million aggregate principal amount of outstanding 2026 Notes for cash and additional term loan amounts, with the holders of such notes becoming Lenders under the Credit Agreement (any such additional term loans, together with the Term Loan and the Delayed Draw Term Loan, the “Loans”). We also retain all potential future value of the capped call purchased in connection with the issuance of the 2026 Notes covering all shares underlying the original 2026 Notes.
All indebtedness outstanding under the Credit Agreement is guaranteed by certain of our direct and indirect subsidiaries, other than certain foreign subsidiaries that are not material (we and the guarantors, collectively, the “Credit Parties”). Pursuant to a Pledge and Security Agreement, dated June 3, 2024, the indebtedness under the Credit Agreement is secured by a first-priority security interest in and lien on substantially all tangible and intangible property of the Credit Parties, subject to customary exceptions, and excluding royalty interests in OMIDRIA and certain related rights.
The Credit Agreement contains certain customary default provisions, representations and warranties and affirmative and negative covenants, including a covenant for the Credit Parties to maintain at all times unrestricted cash, cash equivalents and short-term investments of at least $25.0 million in accounts subject to control agreements, and a covenant limiting the use of cash for open market or privately negotiated repurchases of any outstanding 2026 Notes to: (i) an initial amount not exceeding $25.0 million, which may be increased by up to an additional $10.0 million subject to the satisfaction of certain conditions; (ii) an unlimited amount, if the amount of Loans outstanding at the time of repurchase does not exceed $38.5 million; and (iii) an additional amount not to exceed 50% of the net cash proceeds from an equity offering, provided that we offer to prepay an equal amount of Loans with the net cash proceeds of such offering.
The Loans accrue interest at an adjusted term secured overnight financing rate, (“adjusted term SOFR”) (with a 3.00% floor) plus 8.75% per annum, payable quarterly. As of March 31, 2025, the contractual interest rate on the Term Loan was 13.17%. We may choose to pay up to 50% of any quarterly interest payment in kind by adding the portion of such interest payment to the outstanding principal amount of Loans using a quarterly interest rate of adjusted term SOFR (with a 3.00% floor) plus 10.25% per annum. A default interest rate of an additional 3.00% per annum would apply on all outstanding obligations after the occurrence and during the continuance of certain specified events of default.
The Credit Agreement has a scheduled maturity date of June 3, 2028.
We may elect to prepay Loans, in whole or in part, in cash, subject to (i) during the first year of such Loans, a make-whole premium plus 5.00% of the aggregate principal amount of Loans subject to prepayment (unless the prepayment is made in contemplation of a change of control, in which case only the make-whole premium would be payable); (ii) during the second year, a 5.00% prepayment premium; and (iii) during the third year, a 3.00% prepayment premium. The Credit Agreement requires mandatory prepayments of Loans in an amount equal to 60% of the net cash proceeds (excluding research and development and certain other milestone payments) received by the Credit Parties from asset sales and licenses. Mandatory prepayments are also required: (i) from insurance recoveries on loss of property that are not otherwise reinvested in other assets of the Credit Parties; (ii) from indebtedness incurred by any of the Credit Parties other than as permitted by the Credit Agreement; (iii) in the event of a change of control and (iv) in respect of 25% of the amount of any Milestone Payment received from DRI its affiliates on the basis of net sales of OMIDRIA. See “Note 6 — Debt” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
Convertible Note Exchange and Equitization Transaction
In May 2025, we completed the exchange of $70.8 million of our 2026 Notes on a one-for-one basis for newly issued convertible senior notes maturing on June 15, 2029 (the “Convertible Note Exchange”). In addition, the Company entered into note conversion agreements (each, a “Note Conversion Agreement”) with two affiliated holders of the 2026 Notes to convert $10.0 million aggregate principal amount of 2026 Notes into shares of the Company’s common stock (the “Equitization Transaction”). Under the terms of the Note Conversion Agreements, the holders will convert the principal amount of the 2026 Notes in three equal tranches for a number of shares of common stock to be determined based in part on the closing price of the Company’s common stock on May 9, 2025 and in part based on the 20-day volume-weighted average price applicable to each tranche conversion date, subject to a floor conversion price. The Note Conversion Agreements provide that conversion of the entire $10.0 million principal amount of 2026 Notes will be completed no later than September 15, 2025.
The Convertible Note Exchange reduced the aggregate principal balance of our 2026 Notes from $97.9 million to $27.1 million. Upon completion of the Equitization Transaction, the aggregate principal balance of our 2026 Notes will have been further reduced from $27.1 million to $17.1 million. As a result of the reduced principal balance of the 2026 Notes, the Company will no longer be required to make a $20.0 million prepayment of the Term Loan outstanding under the Credit Agreement. The prepayment otherwise would have been required to be paid in November 2025 to avoid accelerated maturity of the entire Term Loan balance.
See “Note 6 — Debt” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for further details.
Financial Summary
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $52.4 million available to fund operations and to service debt. Our loss for the three months ended March 31, 2025 and 2024 was $33.5 million and $37.2 million, respectively. For the three months ended March 31, 2025, our cash used in operations was $35.8 million and included a net loss for the year of $33.5 million.
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 product candidate, contract research organizations, clinical trial sites, collaborators, licensors and consultants. Preclinical 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. Our accounting policy is to expense all manufacturing costs related to product candidates until regulatory approval is reasonably assured in either the U.S. or European Union.
The following table illustrates our expenses associated with these activities:
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Three Months Ended |
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March 31, |
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2025 |
2024 |
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(In thousands) |
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Research and development expenses: |
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Direct external expenses: |
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Clinical research and development: |
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MASP-3 program - OMS906 (zaltenibart) |
$ | 7,030 | $ | 5,253 | ||||
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MASP-2 program - OMS721 (narsoplimab) |
2,631 | 6,685 | ||||||
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MASP-2 program - OMS1029 and other |
364 | 1,126 | ||||||
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Total clinical research and development |
10,025 | 13,064 | ||||||
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Preclinical research and development |
1,383 | 1,580 | ||||||
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Total direct external expenses |
11,408 | 14,644 | ||||||
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Internal overhead and other expenses |
11,402 | 11,112 | ||||||
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Stock-based compensation expenses |
1,036 | 1,014 | ||||||
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Total research and development expenses |
$ | 23,846 | $ | 26,770 | ||||
For the three months ended March 31, 2025, clinical research and development expenses decreased $3.0 million compared to the prior year quarter primarily due to the winding down of our IgA nephropathy program following analysis of our Phase 3 clinical trial results and reduction in spend on our OMS1029 program. These costs were offset by increased PNH clinical development costs.
We expect research and development expenses, exclusive of any one-time restructuring expenses, in the second quarter of 2025 to be lower than those in the first quarter of this year due to a pause in our two Phase 3 clinical trials for zaltenibart and reductions in development activities across certain other programs.
At this time, we are unable to estimate with certainty the longer-term costs we will incur in the continued development of our product 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 differ 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 product candidate as well as ongoing assessments of each program’s commercial potential. In addition, we cannot forecast with precision which product 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 product 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
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Three Months Ended |
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March 31, |
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2025 |
2024 |
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(In thousands) |
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Selling, general and administrative expenses: |
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Selling, general and administrative expenses, excluding stock-based compensation expense |
$ | 9,706 | $ | 10,620 | ||||
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Stock-based compensation expense |
1,417 | 1,644 | ||||||
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Total selling, general and administrative expenses |
$ | 11,123 | $ | 12,264 | ||||
We expect selling, general and administrative expenses, exclusive of any one-time restructuring expenses, in the second quarter of 2025 to be comparable to those in the first quarter of this year.
Interest Expense
Interest expense is comprised of contractual cash and accrued interest on our 2026 Notes and Term Loan. In addition, we record pass through interest on the OMIDRIA royalty obligation, non-cash interest comprised of remeasurement adjustments taken on our OMIDRIA royalty obligation and amortization of debt discount or premiums on our notes and term debt.
Interest expense, net of premiums, discounts, issuance costs and remeasurement adjustments is shown below:
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Three Months Ended |
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March 31, |
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2025 |
2024 |
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(In thousands) |
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2026 Notes |
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Contractual interest expense |
$ | 1,284 | $ | 2,834 | ||||
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Amortization of debt discount and issuance costs |
148 | 308 | ||||||
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Interest expense on 2026 Notes |
1,432 | 3,142 | ||||||
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OMIDRIA royalty obligation |
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Pass through interest remitted to administrative agent |
5,217 | 3,944 | ||||||
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Non-cash remeasurement adjustment |
(3,372 | ) | 1,079 | |||||
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Interest expense on OMIDRIA royalty obligation |
1,845 | 5,023 | ||||||
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2024 Term Loan |
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Contractual interest expense |
2,381 | — | ||||||
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Amortization of debt premium and issuance costs |
(2,056 | ) | — | |||||
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Interest expense on 2024 Term Loan |
325 | — | ||||||
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Finance leases and other |
52 | 66 | ||||||
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Total interest expense |
$ | 3,654 | $ | 8,231 | ||||
Contractual interest expense is comprised of cash interest paid during the year and the net change in accrued interest. Interest on our OMIDRIA royalty obligation is calculated under the effective interest method and represents a portion of the royalties remitted by Rayner to our administrative agent, Wilmington Savings Fund Society, FSB, along with principal. Pass through interest paid to DRI is offset by non-cash remeasurement adjustments taken to properly reflect the OMIDRIA royalty obligation for changes in probable cash flows on our future expected Rayner royalties. Debt discounts on the 2026 Notes are accretive whereas the unrealized gain on the 2026 Note Repurchase Transaction is treated as a premium on the Term Loan and deducted from contractual interest expense.
For the three months ended March 31, 2025, interest expense decreased $4.6 million compared to the same period in 2024. This decrease was primarily due to (i) non-cash remeasurement costs of our OMIDRIA royalty obligation to reflect the change in the future expected OMIDRIA cash flows from Rayner and (ii) decreased contractual interest expense on our 2026 Notes due to repurchasing $118.1 million of principal amount outstanding (approximately 75% of par value) in the 2026 Note Repurchase Transaction. These expenses were offset by an increase in pass through interest remitted to DRI through our administrative agent, resulting from DRI purchasing an expanded interest in all U.S. OMIDRIA royalties through 2031 for $115.5 million in February 2024, which consequentially increased the OMIDRIA royalty obligation by the same amount in the prior year.
For further information see “Note 6 — Debt” and “Note 8 – OMIDRIA Royalty Obligation” in the Notes to Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
We expect that interest expense for the second quarter of 2025 will be higher compared to the first quarter, under the assumption that there is no remeasurement adjustment to the OMIDRIA royalty obligation.
Interest and Other Income
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Three Months Ended |
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March 31, |
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2025 |
2024 |
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Interest and other income |
$ | 1,058 | $ | 3,415 | ||||
Interest and other income decreased $2.4 million for the three months ended March 31, 2025 as compared to the same period in 2024 primarily due to holding a lower average cash and investment balance than in the prior year period.
We expect interest and other income for the second quarter of 2025 to be lower compared to those in the first quarter of this year due to lower average cash and investment balances.
Discontinued operations and the OMIDRIA contract royalty asset
Net income from OMIDRIA discontinued operations, net of tax is shown below:
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Three Months Ended |
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March 31, |
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2025 |
2024 |
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(In thousands) |
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Interest earned on OMIDRIA contract royalty asset |
$ | 3,954 | $ | 4,343 | ||||
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Remeasurement adjustments |
166 | 2,339 | ||||||
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Other loss, net |
(15 | ) | (16 | ) | ||||
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Net income from discontinued operations, net of tax |
$ | 4,105 | $ | 6,666 | ||||
Interest is earned on the OMIDRIA contract royalty asset at an implied effective interest rate of 11.0%. The $2.6 million decrease in net income from discontinued operations is primarily due to lower royalties earned in the first quarter of 2025 compared to the first quarter of 2024, which resulted in a lower remeasurement adjustment.
The following schedule presents a roll forward of the OMIDRIA contract royalty asset (in thousands):
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OMIDRIA contract royalty asset at December 31, 2024 |
$ | 153,349 | ||
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Royalties earned |
(6,682 | ) | ||
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Interest earned on OMIDRIA contract royalty asset |
3,954 | |||
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Remeasurement adjustments |
166 | |||
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OMIDRIA contract royalty asset at March 31, 2025 |
$ | 150,787 |
Financial Condition – Liquidity and Capital Resources
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $52.4 million. For the three months ended March 31, 2025, our cash used in operations was $35.8 million and included a net loss for the quarter of $33.5 million. Pursuant to a covenant in the Credit Agreement entered on June 3, 2024, we must maintain $25.0 million of unrestricted cash, cash equivalents and short-term investments at all times.
In recent years, Omeros has incurred net losses from continuing operations and negative cash flows from operations. The recurring losses, in combination with our cash and investment balances as of March 31, 2025, along with the maturity of our remaining 2026 Notes on February 15, 2026, raise substantial doubt about our ability to continue as a going concern through one year from the issuance of the Company's condensed consolidated financial statements.
As we currently do not have an ongoing source of revenue sufficient to cover our operating costs, we will need to raise additional capital to accomplish our business plan.
To raise capital for our operations, we may pursue public and private offerings of our equity securities, additional debt transactions or restructurings, future royalty sales, or other strategic transactions, which may include licensing or selling a portion or all of one or more of our existing technologies. However, pursuing debt financings, certain equity offerings or other strategic transactions may result in mandatory prepayments of the Term Loan to the Credit Agreement. See “Note 6 — Debt” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for further details.
We also have a sales agreement pursuant to an at the market (“ATM”) equity offering facility through which we may, from time to time, offer and sell shares of our common stock equaling an aggregate amount of up to $150.0 million. Subsequent to March 31, 2025, we received $3.5 million in net proceeds from sale of our common stock through the ATM facility.
If these capital resources, for any reason, are needed but inaccessible, it would have a significant negative impact on our financial condition. For purposes of determining available capital resources, any future royalty and/or milestone receipts are excluded. We have taken steps to manage our operating expenses and reduce our projected cash requirements by delaying clinical trials and reducing selected research and development efforts. Should it be necessary, we may determine to further reduce or delay these or other aspects of our operations and/or implement other restructuring activities.
Cash Flow Data
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Three Months Ended |
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March 31, |
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2024 |
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Selected cash flow data |
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Cash provided by (used in): |
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Operating activities |
$ | (35,841 | ) | $ | (41,780 | ) | ||
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Investing activities |
$ | 38,541 | $ | (61,925 | ) | |||
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Financing activities |
$ | (1,839 | ) | $ | 98,431 | |||
Operating Activities. Net cash used in operating activities for the three months ended March 31, 2025 decreased by $5.9 million compared to the same period in 2024. This decrease was primarily due to a $4.6 million reduction in prepayments during the quarter as compared to the same period in the prior year.
Investing Activities. Cash flows provided by investing activities primarily reflects cash used to purchase short-term investments and proceeds from the sale of those investments. This frequently causes a shift between our cash, cash equivalents and short-term investment balances. As we manage our usage with respect to 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 provided by investing activities during the three months ended March 31, 2025 changed by $100.5 million as compared to the same period in 2024 as cash and investments were used to fund operations.
Financing Activities. Net cash used by financing activities decreased $100.3 million for the three months ended March 31, 2025 as compared to the same period in the prior year. The decrease was primarily due to prior year activities related to (i) receiving $115.5 million in cash from DRI related to the sale of expanded OMIDRIA royalties in February 2024, (ii) repurchases of $11.9 million in common stock and (iii) payments to DRI of $3.4 million in royalties.
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, 2024. Other than the following, our future minimum contractual obligations and commitments have not changed materially from the amounts previously reported. See “Note 10 — Commitments and Contingencies” in the Notes to the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
Operating Leases
Our lease for our office and laboratory space ends in November 2027. We have two options to extend the lease term by five years each. In addition, we carry various finance lease obligations for laboratory and office equipment. As of March 31, 2025, the remaining aggregate non-cancelable rent payable under the initial term of the lease, excluding common area maintenance and related operating expenses, is $18.5 million.
Convertible Senior Notes and Long-Term Debt
See “Note 6 — Debt” in the Notes to the 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 the 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 the Condensed Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q.
Critical Accounting Policies and Significant Judgments and Estimates
There have not been any material changes in our critical 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, 2024, which was filed with the SEC on March 31, 2025.
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 March 31, 2025, we had cash, cash equivalents and short-term investments of $52.4 million. In accordance with our investment policy, we invest funds in highly liquid, investment-grade securities. The money market funds 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 March 31, 2025. 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 March 31, 2025, 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.
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.
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, 2024, as filed with the SEC on March 31, 2025. In assessing the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, 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.
(a) .
(b) .
(c) During the three months ended March 31, 2025, none of our directors or Section 16 reporting officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act or any “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K).
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Exhibit Number |
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Description |
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31.1 |
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31.2 |
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32.1 |
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32.2 |
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101.INS |
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Inline XBRL Instance Document |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Link base Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104.1 |
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Cover Page Interactive Data File, formatted in Inline XBRL (included in Exhibit 101) |
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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. |
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.
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OMEROS CORPORATION |
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Dated: May 15, 2025 |
/s/ Gregory A. Demopulos |
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Gregory A. Demopulos, M.D. |
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President, Chief Executive Officer and Chairman of the Board of Directors |
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Dated: May 15, 2025 |
/s/ David J. Borges |
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David J. Borges |
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Vice President, Finance, Chief Accounting Officer and Treasurer |