Biofrontera Inc 2025年度报告

FORM 10-K (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 OR BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (781) 245-1325(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Name of Each Exchange on Which Registered:The Nasdaq Stock Market LLC The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered public accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of theregistrant included in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of June 30, 2025, the last day of the registrant’s most recently completed second fiscal quarter, the aggregate market value ofthe common stock held by non-affiliates of the registrant was $6.9 million, based on the closing price of the registrant’s commonstock. As of March 16, 2026, there were 11,648,323 shares outstanding of the registrant’s common stock, par value $0.001 per share. DOCUMENTS INCORPORATED BY REFERENCE: Portions of the registrant’s Proxy Statement relative to the Annual Meeting of Stockholders for the year ended December 31,2025 are incorporated by reference into Part III of this Form 10-K. TABLE OF CONTENTS PART I.Item 1.Business4Item 1A.Risk Factors13Item 1B.Unresolved Staff Comments33Item 1CCybersecurity33Item 2.Properties34Item 3.Legal Proceedings34Item 4.Mine Safety Disclosures34PART II.Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities34Item 6.Reserved35Item 7.Management’s Discussion and Analysis of Financial Conditions and Results of Operations35Item 7A.Quantitative and Qualitative Disclosures About Market Risk46Item 8.Financial Statements and Supplementary DataF-1Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure47Item 9A.Controls and Procedures47Item 9B.Other Information47Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections47PART III.Item 10.Directors, Executive Officers and Corporate Governance48Item 11.Executive Compensation48Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters48Item 13.Certain Relationships and Related Transaction, and Director Independence48Item 14.Principal Accountant Fees and Services48PART IV.Item 15.Exhibit and Financial Statement Schedules49Item 16.Form 10-K Summary54SIGNATURES552 BASIS OF PRESENTATION As used in this Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the “Form 10-K”),