Rockwell Medical (RMTI) risk factors, FY2024 10-K

RISKS RELATED TO OUR FINANCIAL POSITION

1. 01The loss of our largest customer will negatively impact our revenue, and we may not be able to replace that lost revenue with new business
2. 02We have limited capital resources and will likely need additional funding to operate and expand our business. If we are unable to raise additional capital on attractive terms, or at all, we may be unable to sustain our operations
3. 03Our existing capital resources may not be adequate to finance our operating cash requirements for the length of time that we have estimated and additional capital that we may need to operate or expand our business may not be available
4. 04Our revenue growth and profitability projections are based on various assumptions that may not come to fruition

RISKS RELATED TO OUR BUSINESS

1. 05We face competition in the concentrates market and have large competitors with substantial resources
2. 06A few customers account for a substantial portion of the end user sales of our concentrate products. The loss of any of these customers could materially and adversely affect our business, results of operations, financial position and cash flows
3. 07Market dynamics in our concentrates business have resulted in fluctuating volumes that could lead to the implementation of cost-saving measures that would have a material and adverse effect on our business
4. 08If our customers move back to entering into long-term bundled product contracts with suppliers, our business could suffer
5. 09We have been, and may continue to be, materially and adversely affected by increases in raw material, labor and transportation costs and may be unable to recover certain costs due to provisions in our contracts that limit price increases, and we may lose other customers due to price sensitivity
6. 10We expect that if we continue to be subject to the limitations on price increases in our contracts, increasing costs and decreasing volumes may continue to negatively impact our profit margins and materially and adversely affect our financial position
7. 11Unfavorable weather, economic conditions or supply shortages could materially and adversely affect our business, financial condition or results of operations
8. 12Our production and other processes are somewhat manual, which introduces risk of error and may result in rising production costs
9. 13Our business depends on government funding of health care, and changes could impact our ability to be paid in full for our products, increase prices or cause consolidation in the dialysis provider market
10. 14Our medical device products are life sustaining and any failure to supply them to our customers and resulting scrutiny related to such circumstances could negatively impact our reputation and stock price
11. 15We may not be successful in expanding our business or in our business development efforts related to in-licensing, acquisitions or other business collaborations. Even if we are able to enter into business development arrangements, they could have a negative impact on our business and our profitability
12. 16We have in-licensed rights to certain patents that cover Triferic. If we fail to remain in compliance with these license agreements, we could forfeit the rights to these patents, which could result in our noncompliance with those partnership agreements
13. 17Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure
14. 18Our future success depends on our ability to retain executives and key employees and to attract, retain and motivate qualified personnel in the future
15. 19We use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly

RISKS RELATED TO LEGAL AND REGULATORY

1. 20Our business is highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows
2. 21Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations
3. 22We may become the target of litigation, which is costly and time-consuming to defend
4. 23Our products may have or have had undesirable side effects, and our product liability insurance may not be sufficient to protect us from material liability or harm to our business
5. 24Our business could be impacted as a result of actions by activist stockholders, including as a result of a potential proxy contest for the election of directors at our annual meeting

RISKS RELATED TO OUR COMMON STOCK

1. 25The market price of our common stock has fluctuated in the past, and is likely to continue to be volatile, which could subject us to litigation
2. 26Shares eligible for future sale may affect the market price of our common stock
3. 27We may fail to qualify for continued listing on Nasdaq, which could make it more difficult for our stockholders to sell their shares
4. 28Our ability to use our net operating loss carryforwards to offset potential taxable income and related income taxes that would otherwise be due may be limited
5. 29We do not anticipate paying dividends in the foreseeable future
6. 30If securities analysts do not publish research or reports about our business, or if they publish negative evaluations, the price of our common stock could decline
7. 31Our certificate of incorporation, bylaws and Delaware law could prevent a third party from acquiring us (even if an acquisition would benefit our stockholders), may limit the ability of our stockholders to replace our management and limit the price that investors might be willing to pay for shares of our common stock
8. 32We are not subject to the provisions of Section 203 of the Delaware General Corporation Law, which could negatively affect your investment