UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 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) Delaware 47-3765675 (State or other ...

Core Insights - Biofrontera Inc. achieved record annual revenues of $41.7 million in fiscal year 2025, marking a 12% increase from the previous year, with Q4 revenues reaching $17.1 million, a 36% year-over-year growth, indicating strong commercial execution and adoption of Ameluz PDT in dermatology [1][5][21] Financial Performance - The adjusted EBITDA for Q4 2025 was $4.9 million, with a net income of $5.6 million, a significant improvement from a net loss of $1.4 million in Q4 2024 [5][20] - For the full year 2025, total GAAP net revenues were $41.7 million, up from $37.3 million in 2024, driven by organic growth in Ameluz sales [21][22] - The cost of goods sold decreased by 43% to $10.1 million, leading to a gross profit margin improvement from 50% to 74% for the year [22][23] Strategic Developments - Biofrontera completed a significant asset purchase agreement with its former parent company, Biofrontera AG, gaining full U.S. rights and regulatory control over Ameluz and RhodoLED, which is expected to enhance financial performance [5][6][34] - The new royalty structure is set at 12% for annual U.S. Ameluz net sales up to $65 million and 15% for sales exceeding that threshold, replacing a previous model that ranged from 25% to 35% [6][7] Clinical Advancements - The company submitted a supplemental New Drug Application for superficial basal cell carcinoma (sBCC) based on positive Phase III data, with a PDUFA target action date of September 28, 2026 [9][10] - Positive Phase III results were announced for actinic keratosis (AK) on extremities, and Phase II results for moderate to severe acne vulgaris showed a 58% reduction in inflammatory lesions [11][12] Commercial Strategy - Biofrontera's commercial strategy has been refined, leading to a 10% increase in Ameluz unit volumes, with approximately 121,000 tubes sold in 2025 [13][14] - The company placed approximately 85 RhodoLED lamps in dermatology practices, increasing its installed base to about 745 lamps [14][15] Future Outlook - The company anticipates that the full benefits of the new cost structure will be realized in 2026, with expected gross profit margins ranging between 80% and 85% [30][34] - Biofrontera is positioned for continued growth with multiple clinical studies planned and a strengthened patent portfolio extending protection through 2043 [34][35]

Financial Data and Key Metrics Changes - Biofrontera achieved record annual revenues of $41.7 million in 2025, representing approximately 12% growth over the prior year [5][22] - Fourth quarter revenues reached $17.1 million, marking a 36% year-over-year increase and the highest quarterly revenue in the company's history [5][17] - Adjusted EBITDA for Q4 2025 was $4.9 million, a significant improvement from negative $1.4 million in Q4 2024 [21][27] - Net income for Q4 2025 was $5.6 million, compared to a net loss of $1.4 million in the same quarter of 2024 [21][26] Business Line Data and Key Metrics Changes - Ameluz unit volumes increased to approximately 121,000 tubes for the full year 2025, reflecting about 10% growth over 2024 [13] - Fourth quarter unit volumes were approximately 49,840 tubes, contributing to the strong revenue performance [13] - The installed base of RhodoLED lamps grew to approximately 745 across 686 dermatology offices by the end of 2025 [14] Market Data and Key Metrics Changes - The FDA accepted a supplemental new drug application for Ameluz in treating superficial basal cell carcinoma, with a PDUFA target action date of September 28, 2026 [9] - Positive phase 3 results were reported for actinic keratosis on the extremities, with plans to file a supplemental NDA in Q3 2026 [10] - The company anticipates a significant addressable market for treating extensive fields of actinic keratosis, affecting approximately 58 million American adults [10] Company Strategy and Development Direction - The completion of a strategic transaction with Biofrontera AG has fundamentally changed the business model, granting full control over U.S. assets and improving cost structure [7][40] - The new earn-out structure is expected to enhance gross margins, with projections of 80%-85% in 2026 [7][40] - The company is focused on expanding its clinical pipeline, with planned studies in squamous cell carcinoma and reduced pain PDT [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's trajectory, citing improved commercial execution and a strong pipeline of clinical developments [16][40] - The strategic transaction is expected to reduce cash consumption and advance towards cash flow breakeven [30][41] - Management highlighted the importance of institutional investors in supporting the company's strategic initiatives [30] Other Important Information - The company secured $11 million in funding through a private placement of Series C preferred stock [8] - A successful divestiture of the Xepi antibiotic cream license generated initial proceeds of $3 million, with potential additional milestone payments [8] Q&A Session Summary Question: Discussion on gross margin improvement for 2026 - Management expects gross profit margins to be between 80%-85%, starting from January 1, 2026, with potential fluctuations based on product mix [34][35]

Financial Data and Key Metrics Changes - Biofrontera achieved record annual revenues of $41.7 million in 2025, representing a 12% growth over the prior year, with Q4 revenues of $17.1 million, a 36% year-over-year increase [5][18] - Adjusted EBITDA for Q4 2025 was $4.9 million, a significant improvement from negative $1.4 million in Q4 2024, reflecting a margin improvement to 29% from negative 11% [21][28] - The net income for Q4 2025 was $5.6 million, compared to a net loss of $1.4 million in Q4 2024, driven by higher revenues and lower costs [21][27] Business Line Data and Key Metrics Changes - Ameluz unit volumes increased significantly, with Q4 2025 unit volumes at approximately 49,840 tubes, bringing the full year total to about 121,000 tubes, a 10% increase over 2024 [14] - The installed base of RhodoLED lamps grew to approximately 745 across 686 dermatology offices by the end of 2025, with 85 new lamps placed during the year [15] Market Data and Key Metrics Changes - The new royalty structure for Ameluz is set at 12% for annual U.S. net sales at or below $65 million and 15% for sales exceeding that threshold, improving gross margins significantly [8][19] - The FDA accepted a supplemental new drug application for Ameluz to treat superficial basal cell carcinoma, with a target action date of September 28, 2026, representing a new commercial opportunity [10] Company Strategy and Development Direction - The completion of the strategic transaction with Biofrontera AG has fundamentally changed the business model, allowing full control over U.S. assets, intellectual property, and regulatory approvals [41] - The company plans to expand its clinical pipeline, with studies in squamous cell carcinoma in situ and reduced pain PDT, while patent protection extends through 2043 [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving gross profit margins between 80%-85% in 2026, driven by the new cost structure and improved operational efficiencies [35] - The company anticipates that the full annualized benefit of the new cost structure will be realized in 2026, contributing to a stronger financial trajectory [41] Other Important Information - Biofrontera secured $11 million in funding through a private placement of Series C preferred stock to support growth and the strategic transaction [9] - The company reported a significant reduction in related party cost of goods sold by 45% year-over-year, improving gross profit margins from 50% to 74% for the full year [24] Q&A Session Summary Question: Discussion on gross margin improvement for 2026 - Management expects gross profit margins to be between 80%-85% throughout 2026, starting at an 82% level [35] Question: Variability of gross margins over the year - Management indicated that while margins may fluctuate slightly based on product mix, they expect to maintain the target range consistently [36]

Conference call will be held today, Thursday, March 19 at 10:00 am ET Woburn, MA, March 19, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and twelve months ended December 31, 2025 and provided a business update. Fourth Quarter Financial Highlights Revenues for 4Q25 were a record $17.1 million, a 36% increase ...

Company Performance - Align Technology (ALGN) has outperformed the Medical sector with a year-to-date return of approximately 8.5%, while the average return for Medical companies is -1.4% [4] - The Zacks Consensus Estimate for ALGN's full-year earnings has increased by 3.7% over the past quarter, indicating stronger analyst sentiment and an improving earnings outlook [4] - Biofrontera Inc. (BFRI) has also shown strong performance, with a year-to-date return of 45.6% and a 300% increase in the consensus estimate for its current year EPS over the past three months [5] Industry Ranking - Align Technology is part of the Medical - Dental Supplies industry, which consists of 15 stocks and currently ranks 50 in the Zacks Industry Rank, with this group gaining about 1% year-to-date [6] - The Medical - Biomedical and Genetics industry, which includes Biofrontera Inc., has 444 stocks and is currently ranked 144, with a year-to-date increase of 6.4% [6] Sector Overview - The Medical sector includes 925 companies and is currently ranked 10 in the Zacks Sector Rank, which evaluates the average Zacks Rank of individual stocks within the sector [2] - The Zacks Rank system identifies stocks with characteristics likely to outperform the market in the short term, with Align Technology holding a Zacks Rank of 2 (Buy) [3]

Core Viewpoint - Biofrontera Inc. will report its financial results for Q4 and the full year of 2025 on March 19, 2026, and will host a conference call to discuss these results and provide a business update [1]. Group 1: Financial Reporting - The financial results for the three months and full year ended December 31, 2025, will be reported after the close of U.S. financial markets on March 19, 2026 [1]. - A conference call is scheduled for March 19, 2026, at 10:00 a.m. Eastern Time to discuss the financial results and answer questions [2]. Group 2: Company Overview - Biofrontera is a U.S.-based biopharmaceutical company that specializes in the treatment of dermatological conditions, focusing on photodynamic therapy (PDT) [3]. - The company commercializes Ameluz, a drug-device combination used for PDT of Actinic Keratosis, which are pre-cancerous skin lesions [3]. - Biofrontera is conducting clinical trials to expand the use of its products for treating non-melanoma skin cancers and moderate-to-severe acne [3].

Biofrontera Inc. (BFRI) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a changing e ...

Core Insights - Biofrontera Inc. announced positive results from its Phase 2b clinical trial for Ameluz PDT in treating moderate to severe acne vulgaris, indicating a significant reduction in inflammatory lesions compared to the vehicle group [1][4][5] Clinical Study Details - The Phase 2b study was a multicenter, randomized, double-blind trial comparing Ameluz with a vehicle gel, utilizing two incubation times (1 hour and 3 hours) before treatment with the BF-RhodoLED lamp [2] - The study's co-primary endpoints included the relative reduction in inflammatory lesion counts and an improvement of at least two grades on a modified Investigator Global Assessment (mIGA) scale [3] Clinical Results - The 3-hour incubation regimen showed a 57.97% reduction in inflammatory lesions for the Ameluz group, compared to a 36.51% reduction in the vehicle group [5] - For the mIGA analysis, 25% of Ameluz-treated patients met the co-primary endpoint, while 21.4% of vehicle patients achieved the same outcome [5] - Absolute lesion count reductions were also significant, with Ameluz showing reductions of 19.7, 23.1, and 42.7 for inflammatory, non-inflammatory, and total lesions, respectively, compared to 15.4, 16.5, and 31.9 for the vehicle [6] Safety and Patient Satisfaction - Ameluz PDT demonstrated a favorable safety profile, with mild to moderate treatment-related adverse events such as burning sensation and pruritus [7] - Average pain scores during the 3-hour incubation were modest, ranging from 3.4 to 3.8 for Ameluz and 2.0 to 2.1 for the vehicle on an 11-point scale [8] - High patient satisfaction was reported, with 85.7% of patients stating they would choose PDT again and 71.4% rating their esthetic outcome as "good" or "very good" [8] Market Opportunity - Acne vulgaris is a prevalent dermatologic condition in the US, affecting millions and representing a significant treatment market, with potential for permanent scarring and psychosocial impacts [9] - Current treatment options often involve long-term daily therapies or systemic treatments with safety concerns, driving interest in alternative approaches like photodynamic therapy [10][11] Future Plans - The company plans to present the Phase 2b data to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss next steps for developing Ameluz PDT for acne vulgaris [13]

Core Viewpoint - Biofrontera Inc. has successfully challenged the validity of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028, leading to a decision by the U.S. Patent Trial and Appeal Board that all challenged claims of the patent are unpatentable [1][2]. Group 1: Legal Proceedings - In June 2024, Sun Pharma initiated legal proceedings against Biofrontera for alleged infringement of the '028 Patent and U.S. Patent No. 11,446,512 [2]. - Biofrontera responded by filing petitions for Inter Partes Review with the Board, which has now ruled in favor of Biofrontera regarding the '028 Patent [2][3]. - Sun Pharma retains the right to appeal the Board's decision to the United States Court of Appeals for the Federal Circuit [3]. Group 2: Company Focus and Products - Biofrontera specializes in photodynamic therapy (PDT) for dermatological conditions, particularly through its drug-device combination Ameluz and the RhodoLED lamp series [4]. - The company aims to expand its clinical research and development efforts to treat non-melanoma skin cancers and moderate-to-severe acne [4].