Biofrontera Inc 2026年季度报告

FORM 10-Q (Mark One) For the quarterly period ended June 30, 2026 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number 001-40943 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware47-3765675(State or other jurisdiction ofincorporation or organization)(IRS EmployerIdentification No.) 660 Main Street, 1stFloor, 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☒Emerging growth 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 August 11, 2026, there were 14,852,359 shares outstanding of the registrant’s common stock, par value $0.001 per share. TABLE OF CONTENTS PART I. FINANCIAL INFORMATION ITEM 1.Financial Statements3Condensed Consolidated Balance Sheets as of June 30, 2026 (unaudited) and December 31, 20253Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026(unaudited) and 2025 (unaudited)4Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2026(unaudited) and 2025 (unaudited)5Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 (unaudited) and2025 (unaudited)6Notes to Condensed Consolidated Financial Statements7ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations23ITEM 3.Quantitative and Qualitative Disclosures About Market Risk35ITEM 4.Controls and Procedures35 PART II. OTHER INFORMATION ITEM 1.Legal Proceedings36ITEM 1A.Risk Factors36ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds36ITEM 3.Defaults Upon Senior Securities36ITEM 4.Mine Safety Disclosures36ITEM 5.Other Information36ITEM 6.Exhibits36Signatures37 BIOFRONTERA INC.CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except par value and share amounts) BIOFRONTERA INC.CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY(In thousands, except number of shares)(Unaudited) BIOFRONTERA INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited) 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 engaging in the development, manufacturing, and commercialization of pharmaceutical products for thetreatment of dermatological conditions with a focus on photodynamic therapy (“PDT”). The Company’s products, which includeAmeluz®as well as the BF-RhodoLED®and RhodoLED®XL lamp series (together, the “RhodoLED®Lamps”), are used for thetreatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous skin lesions (or “AKs”).With our national commercial team, we generate revenue by selling our products directly to dermatology offices and groups. We conduct all clinical trials relating to Ameluz®in the United States through Biofrontera Discovery GmbH (“Discovery”), ourwholly owned subsidiary organized under the laws of Germany and formed in February 2022. Our research and development (“R&D”)programs are focused on label expansion for Ameluz®as well as supporting PDT growth by improving the capabilities of theRhodoLED®Lam