Biofrontera Inc 2025年季度报告

FORM10-Q (Mark One) For the quarterly period endedSeptember 30,2025 OR For the transition period from _______________ to _______________ Commission file number001-40943 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware47-3765675(State or other jurisdiction ofincorporation or organization)(IRS EmployerIdentification No.) 120 Presidential Way,Suite 330,Woburn,Massachusetts01801(Address of principal executive offices)(Zip Code) (781)245-1325(Registrant’s telephone number, including area code) Not Applicable(Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: 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 during the preceding 12 months (or for such shorter period that the registrant was required tosubmit 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,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒ 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of November 10, 2025 there were11,648,323shares outstanding of the registrant’s common stock, par value $0.001per share. TABLE OF CONTENTS PART I. FINANCIAL INFORMATION ITEM 1.Financial Statements3Condensed Consolidated Balance Sheets as of September 30, 2025 (unaudited) and December 31, 20243Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2025(unaudited) and 2024 (unaudited)4Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and nine months endedSeptember 30, 2025 (unaudited) and 2024 (unaudited)5Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2025 (unaudited)and 2024 (unaudited)6Notes to Condensed Consolidated Financial Statements7ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations22ITEM 3.Quantitative and Qualitative Disclosures About Market Risk34ITEM 4.Controls and Procedures34 PART II. OTHER INFORMATION ITEM 1.Legal Proceedings35ITEM 1A.Risk Factors35ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds35ITEM 3.Defaults Upon Senior Securities35ITEM 4.Mine Safety Disclosures35ITEM 5.Other Information35ITEM 6.Exhibits36Signatures37 BIOFRONTERA INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except par value and share amounts) The accompanying notes are an integral part of these condensed consolidated financial statements. BIOFRONTERA INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In Thousands)(Unaudited) The accompanying notes are an integral part of these condensed consolidated financial statements. Biofrontera Inc.Notes to Condensed Consolidated Financial Statements(Unaudited) 1.Organization and Business Overview BiofronteraInc.,a Delaware Corporation(the“Company,”“we,”“us,”“our,”or“Biofrontera”),is a United States-basedbiopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditionswith a focus on photodynamic therapy (“PDT”). The Company’s primary licensed products are used for the treatment of actinickeratoses, which are pre-cancerous skin lesions. The Company includes its wholly owned subsidiary Biofrontera Discovery GmbH (“Discovery”), a limited liability companyorganized under the laws of Germany, formed on February 9, 2022, as a German presence to facilitate our relationship withBiofrontera Pharma GmbH (“Biofrontera Pharma”) and Biofrontera Bioscience GmbH (“Biofrontera Bioscience” and together withBiofrontera Pharma, the “Ameluz Licensor”) and manage our clinical trial work. Our principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with the RhodoLED®Lamps, for PDT (when used together, “Ameluz®PDT”). In the United States, the PDT treatment is used for the lesion-directed andfield-