Omeros (OMER) FY2025 10-K Risk Factors: 11 New, 3 Dropped

What the changes say

Omeros achieved FDA approval for YARTEMLEA in December 2025, shifting its primary business focus to commercial execution.

What changed since the prior 10-K

New

NewRisks Related to Our Products, Product Candidates, Programs and Operations
Our ability to achieve profitability is highly dependent on the commercial success of YARTEMLEA, and to the extent YARTEMLEA is not successful, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline
Profitability depends heavily on the commercial success of YARTEMLEA, our only commercialized product approved by the FDA in December 2025.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
If YARTEMLEA or any other product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would suffer
Revenue will suffer if YARTEMLEA or other products fail to receive adequate coverage or reimbursement from government and private payers.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
Our ability to realize further value from zaltenibart depends on the development and commercialization efforts of Novo Nordisk
Realizing further value from zaltenibart depends entirely on Novo Nordisk's development and commercialization efforts under our APLA.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
We may face a variety of risks associated with international operations that, if realized, could materially adversely affect our business
International operations for YARTEMLEA or product candidates outside the U.S. expose us to tariffs, trade barriers, and geopolitical risks.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
foreign currency fluctuations and other obligations incident to doing business in another country; and
NewRisks Related to Our Products, Product Candidates, Programs and Operations
Failure to comply with any YARTEMLEA post-marketing requirement or commitment could materially adversely affect the commercial prospects of YARTEMLEA and our business
Failure to comply with YARTEMLEA post-marketing requirements, such as a safety registry and pediatric studies, could lead to FDA penalties or approval suspension.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
We have no internal capacity to manufacture commercial or clinical supplies of YARTEMLEA or our product candidates, intend to continue to rely solely on third-party manufacturers, and thus may be materially harmed by issues impacting our contract manufacturers or our relationship with our contract manufacturers
We rely entirely on third-party manufacturers for commercial and clinical supplies of YARTEMLEA and our product candidates.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
Our obligations under the Transition Services Agreement require us to utilize significant internal resources that could otherwise be used to advance our other programs
Our Transition Services Agreement with Novo Nordisk requires internal resources and management time that could otherwise advance our own drug candidates.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
Our use of artificial intelligence exposes us to deficient outputs, unintentional disclosures, and an evolving regulatory landscape
Using artificial intelligence in our business exposes us to deficient outputs, potential data disclosures, and an evolving regulatory landscape.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
The availability of royalties from Rayner is dependent on Rayner’s net sales of OMIDRIA and may be of lesser magnitude than anticipated or may not become payable at all and we do not expect to receive a sales-based milestone payment from DRI
Royalties from Rayner depend on OMIDRIA net sales, and we do not expect to receive a sales-based milestone payment from DRI.
NewRisks Related to Our Products, Product Candidates, Programs and Operations
Our ability to use our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited
Our ability to use $386.4 million in U.S. federal and $229.8 million in state net operating loss carryforwards may be limited.

Dropped

DroppedRisks Related to Our Product Candidates, Programs and Operations
Management has concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern
Substantial doubt existed regarding our ability to continue as a going concern.
DroppedRisks Related to Our Product Candidates, Programs and Operations
Our Credit Agreement places restrictions on our operating and financial flexibility and could, if we were to default, adversely affect our liquidity and ability to retain title to our assets
DroppedRisks Related to Our Product Candidates, Programs and Operations
The success of any product that we or our third-party business partners commercialize in the future will depend heavily on the pricing, availability and duration of adequate coverage or reimbursement for any such product from government, private and other third-party payers, both in the U.S. and in other countries
Our Credit Agreement restricted operating flexibility and pledged substantially all assets as collateral for $67.1 million borrowed.

Reworded

84% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
We may face difficulties from changes to current regulations as well as future legislation
Updated to include that government regulations and future legislation may affect the pricing and terms for selling approved products.
Was: We may face difficulties from changes to current regulations as well as future legislation, including as a result of the new U.S. administration
79% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
Failure to obtain and maintain regulatory approval in the EU or other foreign jurisdictions would prevent us from commercializing and marketing YARTEMLEA or future commercialized products
Replaced the prior discussion of the narsoplimab CRL with a new focus on obtaining regulatory approvals to market YARTEMLEA outside the U.S.
Was: Failure to obtain and maintain regulatory approval in the U.S. or in foreign jurisdictions would prevent us from commercializing and marketing our product candidates
42% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing shareholders would experience further dilution
Updated share counts, option figures for December 31, 2025, and added dilution risks from the conversion of 2029 Notes.
42% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when needed, we may be unable to complete the development and commercialization of our products and product candidates or to continue our other preclinical development programs
Updated financial figures for December 31, 2025, reporting $171.8 million in cash, $116.1 million cash used in operations, and a $3.4 million net loss.
Was: We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when needed we may be unable to complete the development and commercialization of our product candidates or to continue our other preclinical development programs
41% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
Our indebtedness and liabilities and any future indebtedness could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations
Updated debt figures as of December 31, 2025, noting full repayment of the 2026 Notes, $70.8 million in 2029 Notes, and $1.2 million in leases.
Was: In addition to our Credit Agreement, our other indebtedness and liabilities and any future indebtedness could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations
38% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
Any of these risk factors, should one or more occur, could adversely affect our results of operations and financial condition and cause the trading price of our stock to decline
Updated references to reflect that the current U.S. administration has implemented federal government changes rather than just beginning to do so.
34% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
Our operating results are unpredictable and may fluctuate
Updated operating result fluctuation factors to focus on YARTEMLEA commercial sales, payer reimbursement, chargebacks, and zaltenibart milestones.
33% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
Ingredients, excipients, test kits and other materials necessary to manufacture YARTEMLEA or our product candidates may not be available on commercially reasonable terms, or at all, which may adversely affect sales of YARTEMLEA or development and commercialization of our product candidates
Added YARTEMLEA specifically to the raw material and ingredient supply chain risks alongside our product candidates.
Was: Ingredients, excipients, test kits and other materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may adversely affect the development and commercialization of our product candidates
25% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection
23% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
We have never declared or paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future
21% rewrittenRisks Related to Our Products, Product Candidates, Programs and Operations
We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to maintain our operations or grow effectively

All 35 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Products, Product Candidates, Programs and Operations

01Our ability to achieve profitability is highly dependent on the commercial success of YARTEMLEA, and to the extent YARTEMLEA is not successful, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may declineNew
02If YARTEMLEA or any other product that we develop and commercialize does not receive adequate coverage or reimbursement from governments and/or private payers our prospects for revenue and profitability would sufferNew
03Our ability to realize further value from zaltenibart depends on the development and commercialization efforts of Novo NordiskNew
04We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when needed, we may be unable to complete the development and commercialization of our products and product candidates or to continue our other preclinical development programs42% rewritten
05Our indebtedness and liabilities and any future indebtedness could limit the cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations41% rewritten
06Failure to obtain and maintain regulatory approval in the EU or other foreign jurisdictions would prevent us from commercializing and marketing YARTEMLEA or future commercialized products79% rewritten
07We may face a variety of risks associated with international operations that, if realized, could materially adversely affect our businessNew
08foreign currency fluctuations and other obligations incident to doing business in another country; andNew
09Our operating results are unpredictable and may fluctuate34% rewritten
10Any of these risk factors, should one or more occur, could adversely affect our results of operations and financial condition and cause the trading price of our stock to decline38% rewritten
11We are subject to extensive government regulation and the failure to comply with these regulations may have a material adverse effect on our operations and business
12Failure to comply with any YARTEMLEA post-marketing requirement or commitment could materially adversely affect the commercial prospects of YARTEMLEA and our businessNew
13We may face difficulties from changes to current regulations as well as future legislation84% rewritten
14We have no internal capacity to manufacture commercial or clinical supplies of YARTEMLEA or our product candidates, intend to continue to rely solely on third-party manufacturers, and thus may be materially harmed by issues impacting our contract manufacturers or our relationship with our contract manufacturersNew
15Ingredients, excipients, test kits and other materials necessary to manufacture YARTEMLEA or our product candidates may not be available on commercially reasonable terms, or at all, which may adversely affect sales of YARTEMLEA or development and commercialization of our product candidates33% rewritten
16If our clinical trials or clinical protocols are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of approved products
17Our obligations under the Transition Services Agreement require us to utilize significant internal resources that could otherwise be used to advance our other programsNew
18Our product candidates may not successfully complete clinical development or be suitable for successful commercialization or generation of revenue through partnerships, and our preclinical programs may not produce product candidates that are suitable for clinical trials
19It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection25% rewritten
20Competitors may develop products that are less expensive, safer or more effective, or which may otherwise diminish or eliminate the success of any products that we may commercialize
21The loss of members of our management team could substantially disrupt our business operations
22We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to maintain our operations or grow effectively21% rewritten
23We may encounter difficulties managing our growth, which could delay our business plans or adversely affect our results of operations
24Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm our business
25If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed
26Our use of artificial intelligence exposes us to deficient outputs, unintentional disclosures, and an evolving regulatory landscapeNew
27The availability of royalties from Rayner is dependent on Rayner’s net sales of OMIDRIA and may be of lesser magnitude than anticipated or may not become payable at all and we do not expect to receive a sales-based milestone payment from DRINew
28As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act
29Cyber-attacks or other failures in telecommunications or information technology systems could result in information theft, data corruption and significant disruption of our business operations
30Our stock price has been and may continue to be volatile, and the value of an investment in our common stock may decline
31If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing shareholders would experience further dilution42% rewritten
32If we or the third parties upon whom we rely are adversely affected by natural disasters or other events, our business continuity and disaster recovery plans may not adequately protect us from such interruptions
33Anti-takeover provisions in our charter documents and under Washington law could make an acquisition of us, which may be beneficial to our shareholders, difficult and prevent attempts by our shareholders to replace or remove our current management
34We have never declared or paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future23% rewritten
35Our ability to use our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limitedNew

Other Omeros 10-Ks

FY2024 10-K risk factors
27 risks
Substantial doubt exists regarding the company's ability to continue as a going concern, driven by cumulative losses and high cash burn.
Filed Mar 31, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.