CorMedix (CRMD) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We have a history of operating losses, may incur additional operating losses in the future and may never achieve sustained profitability

Risks Related to the Commercialization of DefenCath

1. 02We are highly dependent on the continued successful commercialization of our only approved product, DefenCath
2. 03The continued successful commercialization of DefenCath will depend on maintaining coverage and reimbursement for use of DefenCath from third-party payors
3. 04We have significant customer concentration, with a limited number of customers accounting for a large portion of our revenues

Risks Related to the Development and Commercialization of our Other Products

1. 05Successful development and commercialization of new product lines is uncertain
2. 06Final approval by regulatory authorities of our product lines for commercial use may be delayed, limited or denied, any of which could adversely affect our ability to generate operating revenues

Risks Related to Healthcare Regulatory and Legal Compliance Matters

1. 07Our approved product, DefenCath, is, and our other product lines (if approved) will be, subject to extensive post-approval regulation
2. 08Healthcare policy changes, including reimbursement policies for drugs and medical devices, may have an adverse effect on our business, financial condition and results of operations

Risks relating to data privacy could create additional liabilities for us

1. 09New legislation may be enacted in other states. The effects on our business of this growing body of privacy and data protection laws are potentially significant, and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply
2. 10Clinical trials required for our product lines, including, but not limited to, new uses or formulations of DefenCath and the required DefenCath PREA study, may be expensive and time-consuming, and their outcome is uncertain
3. 11Changes in funding for the FDA and other government agencies or future government shutdowns or disruptions could cause delays in the submission and regulatory review of marketing applications, including supplements, which could negatively impact our business or prospects

Risks Related to Our Business and Industry

1. 12Healthcare institutions, physicians and patients may not accept and use our products
2. 13Competition and technological change may make DefenCath, as well as our other product lines or indications, less attractive or obsolete
3. 14If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in compensation costs, our business may materially suffer
4. 15We may not successfully manage our growth
5. 16If we are unable to effectively recruit, train, retain and equip our sales force, our ability to continue successfully commercialize DefenCath will be harmed
6. 17We face the risk of product liability claims and the amount of insurance coverage we hold now or in the future may not be adequate to cover all liabilities we might incur
7. 18We may be exposed to liability claims associated with the use of hazardous materials and chemicals

Risks Related to Our Intellectual Property

1. 19If we and our licensors do not obtain protection for and successfully defend our respective intellectual property rights, competitors may be able to take advantage of our research and development efforts to develop competing products
2. 20Intellectual property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights

Risks Related to Dependence on Third Parties

1. 21We depend on third-party suppliers and contract manufacturers for the supply and manufacture of DefenCath and our product lines, as well as our APIs, which subjects us to potential cost increases and manufacturing delays that are not within our control
2. 22We rely on third parties to conduct our clinical trials and pre-clinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, our product lines may not advance in a timely manner or at all

Risks Related to our Common Stock

1. 23Our executive officers and directors may exercise stock options and sell shares of their stock, and these events could adversely affect our stock price
2. 24The market price of our common stock has fluctuated considerably and may continue to fluctuate significantly in response to a number of factors, some of which are beyond our control
3. 25A significant number of additional shares of our common stock may be issued at a later date, and their sale could depress the market price of our common stock
4. 26Additionally, there are 4,756,909 shares of common stock available for grants under the Amended and Restated 2019 Omnibus Stock Plan (adopted on October 13, 2022 and amended on November 21, 2024)
5. 27Our internal control over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur
6. 28We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to such companies could make our common stock less attractive to investors