Full Press Release Details
– Conference Call Today at 4:30 p.m. ET
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2025, which include:
Fourth Quarter and Recent Highlights
“In the fourth quarter of 2025, Omeros delivered transformative achievements for our shareholders,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Following FDA approval of YARTEMLEA with a broad label and no boxed warning, REMS, or required vaccinations, our commercial launch is well underway, and patients who urgently need the drug are now able to access it. Our partnership with Novo Nordisk expands the breadth of indications being pursued for zaltenibart and has provided — and should continue to provide — substantial operating capital while underscoring the value of our science. These successes are expected to fuel the development of a growing portfolio of commercial products from our robust pipeline as we target positive cash flow in 2027.”
Recent Developments
Financial Results
During the fourth quarter, we recognized $237.6 million in net proceeds from the sale of zaltenibart to Novo Nordisk. This represents $240.0 million in upfront cash from Novo Nordisk net of transaction related costs of $2.4 million.
With funds received from Novo Nordisk, we fully repaid $67.1 million in principal outstanding under our senior secured credit agreement in November 2025.
At December 31, 2025, we had $171.8 million of cash and short-term investments. We used available cash on hand to repay the remaining $17.1 million aggregate principal amount outstanding of our 2026 convertible notes at maturity in February 2026.
We had $87.9 million in aggregate principal amount of debt at December 31, 2025, reflecting a decrease of $77.1 million, or 46.7%, compared to $164.9 million in aggregate principal amount of debt at December 31, 2024.
Net income for the fourth quarter of 2025 was $86.5 million, or $1.22 per share, compared to a net loss of $31.4 million, or $0.54 per share for the fourth quarter of 2024. For the year ended December 31, 2025, our net loss was $3.4 million, or $0.05 per share, compared to a net loss of $156.8 million, or $2.70 per share in the prior year.
The change in fair value of financial instruments as shown in our statement of operations and comprehensive loss reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net loss on change in fair value of financial instruments which is non-cash, our non-GAAP adjusted net income for the three months and year ended December 31, 2025 was $222.5 million, or $3.14 per share, and $133.4 million, or $2.10 per share, respectively.
For the fourth quarter of 2025, we earned OMIDRIA royalties of $9.2 million from Rayner Surgical Inc. on U.S. net sales of $30.7 million. This compares to earned OMIDRIA royalties of $10.1 million during the fourth quarter of 2024 on U.S. net sales of $33.6 million. Per the terms of our original 2022 and amended 2024 agreements with DRI Health Acquisition LP, (“DRI”), all U.S.-based royalties through 2031 are remitted from Rayner to DRI through an escrow agent.
Total operating expenses for the year ended December 31, 2025 were $122.8 million compared to $167.0 million for the year ended December 31, 2024. The $44.2 million decrease was primarily due to timing of manufacturing batches, as Omeros released approximately $21.9 million of drug substance in the prior year as well as completed work on the Phase 1 OMS1029 and IgA nephropathy studies. In addition, we reduced expenditures on certain activities in the current year to conserve capital in anticipation of our expected commercial launch of YARTEMLEA.
Interest expense decreased $25.6 million in 2025 compared to 2024. The decrease primarily relates to a $27.8 million change in non-cash remeasurement costs on the OMIDRIA royalty obligation to reflect a change in forecasted OMIDRIA cash flows from Rayner. Excluding any non-cash remeasurement adjustments of the DRI royalty obligation and any amortization of debt discount, premium, or issuance costs, contractual interest expense remained relatively unchanged from the prior year.
Interest and other income was $4.1 million in 2025 compared to $11.3 million in 2024. The difference is primarily due to lower average cash and investments balances available to invest in the current year.
Net income from discontinued operations, net of tax, was $1.5 million, or $0.02 net income per share, in 2025 compared to net income from discontinued operations, net of tax of $25.8 million, or $0.44 net income per share, in 2024.The decrease was primarily attributable to non-cash remeasurements.
Conference Call Details
Omeros’ management will host a conference call and webcast to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time.
For online access to the live webcast of the conference call, please register at the following URLhttps://events.q4inc.com/attendee/106692151or go to Omeros’ website athttps://investor.omeros.com/upcoming-events.
A replay of the call will be made accessible online for 90 days athttps://investor.omeros.com/archived-events.
About Omeros Corporation
Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.
Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visitwww.omeros.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated therapeutic benefits of drug candidates within our development pipeline, expectations regarding our marketing authorization application for YARTEMLEA® in Europe, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in our marketing authorization application or inability to respond satisfactorily to information requests during regulatory review of the thereof, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties, and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Non-GAAP Financial Measures
This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). A non-GAAP financial measure is generally defined as one that purports to measure historical or future financial position, results of operations or cash flows but excludes or includes amounts that would not be included in most GAAP measures. We define and use the non-GAAP financial measure of Adjusted Net Loss which represents net loss adjusted to remove the non-cash remeasurement on the fair value of financial instruments. We believe Adjusted Net Loss and Adjusted Net Loss from Continuing Operations to be a more accurate measure in gauging the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Omeros’ financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting.
| OMEROS CORPORATIONUNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | $ | 19,446 | $ | 23,320 | $ | 81,296 | $ | 119,523 | ||||||||
| Selling, general and administrative | 9,635 | 10,035 | 41,500 | 47,430 | ||||||||||||
| Total costs and expenses | 29,081 | 33,355 | 122,796 | 166,953 | ||||||||||||
| Loss from operations | (29,081 | ) | (33,355 | ) | (122,796 | ) | (166,953 | ) | ||||||||
| Gain on sale of zaltenibart | 237,594 | — | 237,594 | — | ||||||||||||
| Gain on early extinguishment of term debt, net | 17,035 | — | 17,035 | — | ||||||||||||
| Loss on early extinguishment of 2026 Notes | — | — | (2,968 | ) | — | |||||||||||
| Interest and other income | 1,118 | 2,296 | 4,096 | 11,285 | ||||||||||||
| Interest expense, net of remeasurement adjustments and other | (8,726 | ) | (3,177 | ) | 960 | (24,675 | ) | |||||||||
| Gain (loss) on change in fair value of financial instruments, net | (136,038 | ) | — | (136,717 | ) | 19 | ||||||||||
| Loss from continuing operations before income tax expense | 81,902 | (34,236 | ) | (2,796 | ) | (180,324 | ) | |||||||||
| Income tax expense | (2,012 | ) | (2,305 | ) | (2,012 | ) | (2,305 | ) | ||||||||
| Net loss from continuing operations, net of tax | 79,890 | (36,541 | ) | (4,808 | ) | (182,629 | ) | |||||||||
| Net income from discontinued operations, net of tax | 6,561 | 5,183 | 1,458 | 25,814 | ||||||||||||
| Net income (loss) | $ | 86,451 | $ | (31,358 | ) | $ | (3,350 | ) | $ | (156,815 | ) | |||||
| Basic net income (loss) per share: | ||||||||||||||||
| Net income (loss) from continuing operations | $ | 1.13 | $ | (0.63 | ) | $ | (0.08 | ) | $ | (3.14 | ) | |||||
| Net income from discontinued operations | 0.09 | 0.09 | 0.03 | 0.44 | ||||||||||||
| Net income (loss) | $ | 1.22 | $ | (0.54 | ) | $ | (0.05 | ) | $ | (2.70 | ) | |||||
| Diluted net income (loss) per share: | ||||||||||||||||
| Net income (loss) from continuing operations | $ | 0.90 | $ | (0.63 | ) | $ | (0.08 | ) | $ | (3.14 | ) | |||||
| Net income from discontinued operations | 0.08 | 0.09 | 0.03 | 0.44 | ||||||||||||
| Net income (loss) | $ | 0.98 | $ | (0.54 | ) | $ | (0.05 | ) | $ | (2.70 | ) | |||||
| Weighted-average shares used in per share computation: | ||||||||||||||||
| Basic | 70,829,424 | 57,987,961 | 63,510,201 | 58,170,931 | ||||||||||||
| Diluted | 88,475,735 | 57,987,961 | 63,510,201 | 58,170,931 |
| OMEROS CORPORATIONUNAUDITED CONSOLIDATED BALANCE SHEETS(In thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,660 | $ | 3,400 | ||||
| Short-term investments | 162,144 | 86,732 | ||||||
| OMIDRIA contract royalty asset, short-term | 25,351 | 29,083 | ||||||
| Receivables | 10,917 | 7,739 | ||||||
| Prepaid expense and other assets | 7,595 | 7,166 | ||||||
| Total current assets | 215,667 | 134,120 | ||||||
| OMIDRIA contract royalty asset | 96,435 | 124,266 | ||||||
| Right of use assets | 10,708 | 14,961 | ||||||
| Property and equipment, net | 1,768 | 2,678 | ||||||
| Restricted investments | 1,054 | 1,054 | ||||||
| Total assets | $ | 325,632 | $ | 277,079 | ||||
| Liabilities and shareholders’ equity/(deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,764 | $ | 5,905 | ||||
| Accrued expenses | 29,388 | 26,005 | ||||||
| OMIDRIA royalty obligation | 20,547 | 20,645 | ||||||
| 2026 Notes, net | 17,063 | — | ||||||
| Term debt | — | 21,000 | ||||||
| Lease liabilities | 6,300 | 5,971 | ||||||
| Total current liabilities | 78,062 | 79,526 | ||||||
| OMIDRIA royalty obligation, non-current | 147,319 | 195,612 | ||||||
| 2026 and 2029 Notes, non-current, net | 51,364 | 97,178 | ||||||
| 2029 Notes embedded derivative, non-current | 157,171 | — | ||||||
| Term debt, non-current, net | — | 69,640 | ||||||
| Term debt, embedded derivative, non-current | — | (235 | ) | |||||
| Lease liabilities, non-current | 7,245 | 13,466 | ||||||
| Other accrued liabilities, non-current | 5,702 | 4,501 | ||||||
| Shareholders’ equity/(deficit): | ||||||||
| Common stock and additional paid-in capital | 792,464 | 727,736 | ||||||
| Accumulated deficit | (913,695 | ) | (910,345 | ) | ||||
| Total shareholders’ equity (deficit) | (121,231 | ) | (182,609 | ) | ||||
| Total liabilities and shareholders’ equity (deficit) | $ | 325,632 | $ | 277,079 |