CorMedix Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>CorMedix Inc. has filed its 2023 annual report (10-K) detailing its financial performance and corporate information.</b>

AI Summary

CorMedix Inc. (CRMD) filed a Annual Report (10-K) with the SEC on March 12, 2024. CorMedix Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The company is incorporated in Delaware and its principal executive offices are located in Berkeley Heights, NJ. CorMedix Inc. is registered with the SEC under file number 001-34673. The company's common stock trades on the Nasdaq Global Market under the symbol CRMD. CorMedix Inc. is classified as a non-accelerated filer and a smaller reporting company.

Why It Matters

For investors and stakeholders tracking CorMedix Inc., this filing contains several important signals. This filing provides a comprehensive overview of CorMedix's financial health and operational status for the past fiscal year, crucial for investors assessing the company's trajectory. As a smaller reporting company and non-accelerated filer, this 10-K offers specific insights into its regulatory compliance and financial disclosures relevant to its current market classification.

Risk Assessment

Risk Level: low — CorMedix Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant financial or operational news that would inherently increase risk.

Analyst Insight

Monitor future filings for updates on product development, regulatory approvals, and financial performance, particularly concerning their lead drug candidate.

Key Numbers

• 2023 — Fiscal Year End (The period covered by the 10-K filing.)
• December 31 — Fiscal Year End Date (Specific date marking the end of the fiscal year.)
• 001-34673 — Commission File Number (SEC registration number for CorMedix Inc.)
• CRMD — Trading Symbol (Symbol for CorMedix Inc. common stock on Nasdaq.)
• 908-517-9500 — Business Phone Number (Contact number for CorMedix Inc. principal executive offices.)

Key Players & Entities

• CorMedix Inc. (company) — Filer name
• CRMD (company) — Trading Symbol
• Nasdaq Global Market (company) — Exchange where CRMD is registered
• Delaware (company) — State of Incorporation
• Berkeley Heights, NJ (company) — Address of Principal Executive Offices
• 2023 (date) — Fiscal year end
• December 31 (date) — Fiscal year end
• 001-34673 (regulator) — Commission file number

FAQ

Industry Context

CorMedix Inc. operates in the pharmaceutical preparations industry, focusing on developing and commercializing medical innovations.

Regulatory Implications

The company is subject to standard SEC reporting requirements for public companies, including the annual filing of a Form 10-K.

What Investors Should Do

1. Review the full 10-K for detailed financial statements and management's discussion and analysis.
2. Analyze any disclosed risk factors and their potential impact on CorMedix's operations.
3. Track future SEC filings for updates on product pipeline progress and commercialization efforts.

Year-Over-Year Comparison

This is the initial 10-K filing analyzed for the fiscal year 2023, providing a baseline for future comparisons.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 Par Value CRMD Nasdaq Global Market S
• $17,111 — osed rule that includes a NTAP of up to $17,111 per hospital stay for DefenCath. This N
• $1,170 — saler acquisition cost ("WAC") price of $1,170 per 3 mL vial, and an average utilizati
• $249.99 — of the DefenCath NDA, an actual WAC of $249.99 per 3ml vial was established, we antici
• $325,000 — we paid NDP an initial licensing fee of $325,000 and granted NDP an equity interest in o
• $3,000,000 — ments upon achievement of milestones is $3,000,000, with $2,000,000 remaining at December
• $2,000,000 — ement of milestones is $3,000,000, with $2,000,000 remaining at December 31, 2023. 2 Dur
• $500,000 — cember 31, 2013, a milestone payment of $500,000 was earned by NDP upon the first issuan
• $7.50 — ur common stock at an exercise price of $7.50 per share. The warrant, which was exerc
• $500,000 m — red in April 2018. In January 2014, the $500,000 milestone payment due to NDP was converte
• $4.50 — ur common stock at an exercise price of $4.50 per share. These warrants expired and w

Filing Documents

• ea0201177-10k_cormedix.htm (10-K) — 1702KB
• ea020117701ex10-17_cormedix.htm (EX-10.17) — 38KB
• ea020117701ex23-1_cormedix.htm (EX-23.1) — 3KB
• ea020117701ex31-1_cormedix.htm (EX-31.1) — 14KB
• ea020117701ex31-2_cormedix.htm (EX-31.2) — 16KB
• ea020117701ex32-1_cormedix.htm (EX-32.1) — 5KB
• ea020117701ex32-2_cormedix.htm (EX-32.2) — 5KB
• ea020117701ex97-1_cormedix.htm (EX-97.1) — 54KB
• 0001213900-24-021585.txt (&nbsp;) — 7103KB
• crmd-20231231.xsd (EX-101.SCH) — 49KB
• crmd-20231231_cal.xml (EX-101.CAL) — 46KB
• crmd-20231231_def.xml (EX-101.DEF) — 271KB
• crmd-20231231_lab.xml (EX-101.LAB) — 502KB
• crmd-20231231_pre.xml (EX-101.PRE) — 266KB
• ea0201177-10k_cormedix_htm.xml (XML) — 889KB

Business

Business 1 Item 1A. Risk Factors 14 Item 1B. Unresolved Staff Comments 34 Item 1C. Cybersecurity 34 Item 2.

Properties

Properties 35 Item 3. Legal Proceedings 35 Item 4. Mine Safety Disclosures 35 PART II 36 Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 36 Item 6. [RESERVED] 36 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 36 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 42 Item 8. Financial 42 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 42 Item 9A. Controls and Procedures 42 Item 9B. Other Information 43 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 43 PART III 44 Item 10. Directors, Executive Officers, and Corporate Governance 44 Item 11. Executive Compensation 49 Item 12. Security 56 Item 13. Certain Relationships and Related Transactions and Director Independence 58 Item 14. Principal Accounting Fees and Services 58 PART IV 59 Item 15. Exhibits, Financial Statement Schedules 59 Item 16. Form 10-K Summary 61

SIGNATURES

SIGNATURES 62 i Forward-Looking This Annual Report on Form 10-K contains "forward-looking statements" that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Annual Report on Form 10-K that are not purely historical are forward-looking of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Forward-looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "will," "plan," "project," "seek," "should," "target," "will," "would," and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management, including, but not limited to, statements regarding our commercial launch efforts, our ability to obtain coverage and reimbursement for use of DefenCath by third party payors, the timing and qualification of our contract manufacturing organization alternative manufacturing site, and our future financial position, financing plans, future revenues, projected costs and sufficiency of our cash and short term investments to fund our operations which should be considered forward-looking. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below i

Business

Item 1. Business Overview We are a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions. Our primary focus is on the commercialization of our lead product, DefenCath in the United States. We have in-licensed the worldwide rights to develop and commercialize DefenCath. The name DefenCath is the U.S. proprietary name approved by the U.S. Food and Drug Administration, or FDA. DefenCath is an antimicrobial catheter lock solution ("CLS") (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections ("CRBSI") in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter ("CVC"). It is indicated for use in a limited and specific population of patients. CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality. We believe DefenCath can address a significant unmet medical need. DefenCath – United States On November 15, 2023, we announced that the FDA approved the new drug application ("NDA") for DefenCath to reduce the incidence of CRBSI in adult patients with kidney failure receiving chronic hemodialysis through a CVC. DefenCath is indicated for use in a limited and specific population of patients. DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a Phase 3 clinical study. As a result of the November 2023 FDA approval, we are currently preparing for the commercial launch of DefenCath. DefenCath is listed in the Orange Book as having New Chemical Entity or NCE exclusivity (5 years) expiring on November 15, 2028, and the Generat

View Full Filing

View this 10-K filing on SEC EDGAR