10q10k10q10k.net

What changed in Biofrontera Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Biofrontera Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+354 added−516 removedSource: 10-K (2026-03-19) vs 10-K (2025-03-20)

Top changes in Biofrontera Inc.'s 2025 10-K

354 paragraphs added · 516 removed · 261 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

52 edited+24 added−29 removed61 unchanged
Biggest changeBiofrontera must also carry out all mandatory reporting responsibilities under federal and state law with respect to compliance with the Prescription Drug Marketing Act, the Sunshine Act, or any other similar laws and regulations. Biofrontera is also responsible for all activities related to reimbursement and pricing of the products within the United States.
Biggest changeBiofrontera was required to provide reasonable support relating to any regulatory issues relating to pharmacovigilance and/or product recalls, obtaining all state licenses or any other similar approvals required to market Ameluz and/or the RhodoLED Lamps in the United States, and carrying out all mandatory reporting responsibilities under federal and state law with respect to compliance with the Prescription Drug Marketing Act, the Sunshine Act, or any other similar laws and regulations.
In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented and development of and submission of data to support the change.
In addition, changes to the manufacturing process are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented and the development and submission of data to support the change.
Any of our licensed drug products that require FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
Any of our drug products that require FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are not described in the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific and educational activities, and requirements for promotional activities involving the internet.
DOI 10.1111/bjd. 14498 5 https://www.skincancer.org/skin-cancer-information/skin-cancer-facts 6 Market data accessible from CMS and IQVIA, 2020 5 Sales, marketing and distribution We are currently selling our licensed products in the United States through the use of our own commercial organization. We have a single sales force who markets all our licensed products across the dermatology space.
DOI 10.1111/bjd. 14498 5 https://www.skincancer.org/skin-cancer-information/skin-cancer-facts 6 Market data accessible from CMS and IQVIA, 2020 5 Sales, marketing and distribution We are currently selling our products in the United States through the use of our own commercial organization. We have a single sales force who markets all our products across the dermatology space.
We make available, free of charge, on our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such with, or furnish it to, the SEC. 12
We make available, free of charge, on our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such with, or furnish it to, the SEC.
During this process, energy from the light activates the photosensitizer. In PDT, the activated photosensitizer transfers energy to oxygen molecules found in cells, converting the oxygen into a highly reactive oxygen species (“ROS”), which destroys or alters the sensitized cells. PDT can be a highly selective treatment that targets specific cells while minimizing damage to normal surrounding tissues.
During this process, energy from the light activates the photosensitizer. In PDT, the activated photosensitizer transfers energy to oxygen molecules found in cells, converting the oxygen into a highly reactive oxygen species, which destroys or alters the sensitized cells. PDT can be a highly selective treatment that targets specific cells while minimizing damage to normal surrounding tissues.
The following general comments about the drug approval process are relevant to the development activities related to our products. 8 Investigational New Drug Application (“IND”): After certain pre-clinical studies are completed, an IND application is submitted to the FDA to request the ability to begin human testing of the drug or biologic.
The following general comments about the drug approval process are relevant to the development activities related to our products. Investigational New Drug Application (“IND”): After certain pre-clinical studies are completed, an IND application is submitted to the FDA to request the ability to begin human testing of the drug or biologic.
Manufacturers are required to submit baseline reports and reports of deaths, serious injuries, and malfunctions associated with the device to the FDA. Fraud and Abuse Laws We are subject to healthcare anti-fraud and abuse regulations that are enforced by the United States federal government and the states in which we conduct our business.
Manufacturers are required to submit baseline reports and reports of deaths, serious injuries, and malfunctions associated with the device to the FDA. 10 Fraud and Abuse Laws We are subject to healthcare anti-fraud and abuse regulations that are enforced by the United States federal government and the states in which we conduct our business.
Clinical trials may experience delays or fail to demonstrate the safety and efficacy, which could prevent or significantly delay obtaining regulatory approval. 9 Clinical trials require the investment of substantial financial and personnel resources.
Clinical trials may experience delays or fail to demonstrate safety and efficacy, which could prevent or significantly delay obtaining regulatory approval. Clinical trials require the investment of substantial financial and personnel resources.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our product label extensions or products under development. 10 FDA Regulation for Medical Devices After a device is placed on the market, regardless of its classification or premarket pathway, numerous regulatory requirements apply.
Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our product label extensions or products under development. 9 FDA Regulation for Medical Devices After a device is placed on the market, regardless of its classification or premarket pathway, numerous regulatory requirements apply.
These include, but are not limited to: ● establishing establishment registration and device listings with the FDA; ● Quality System Regulation, or QSR, which requires manufacturers, including third party manufacturers and certain other parties, to follow stringent design, testing, process control, documentation, corrective action/preventive action, complaint handling and other quality assurance procedures, as applicable; ● labeling statutes and regulations, which prohibit the promotion of products for uncleared or unapproved, or off-label uses and impose other restrictions on labeling; ● clearance or approval of product modifications that could affect (or for 510(k) devices, significantly affect) safety or effectiveness or that would constitute a change (or for 510(k) devices, a major change) in intended use; ● medical device reporting regulations, which require that manufacturers report to the FDA if an event reasonably suggests that their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the same or a similar device of the manufacturer were to recur; ● corrections and removals reporting regulations, which require that manufacturers report to the FDA field corrections and product removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA, that may present a risk to health.
These include, but are not limited to: ● creating and maintaining registration and device listings with the FDA; ● Quality System Regulation (“QSR”) which requires manufacturers, including third party manufacturers and certain other parties, to follow stringent design, testing, process control, documentation, corrective action/preventive action, complaint handling and other quality assurance procedures, as applicable; ● labeling statutes and regulations, which prohibit the promotion of products for uncleared or unapproved, or off-label uses and impose other restrictions on labeling; ● clearance or approval of product modifications that could affect (or for 510(k) devices, significantly affect) safety or effectiveness or that would constitute a change (or for 510(k) devices, a major change) in intended use; ● medical device reporting regulations, which require that manufacturers report to the FDA if an event reasonably suggests that their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the same or a similar device of the manufacturer were to recur; ● corrections and removals reporting regulations, which require that manufacturers report to the FDA field corrections and product removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA, that may present a risk to health.
Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others.
Detection of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others.
The key elements of our strategy include the following: ● expand our sales in the United States of Ameluz ® in combination with the RhodoLED ® Lamps for the treatment of minimally to moderately thick AKs of the face and scalp and positioning Ameluz ® to be the standard of care in the United States by leveraging new label indications and focusing on acquisition of new customers and growth of the therapy in our current customer base; 4 ● leverage the potential for future approvals and label extensions of our licensed portfolio products that are in the pipeline for the United States market with respect to Ameluz and furthering the clinical development of Ameluz ® after taking over responsibility for certain ongoing clinical trials since June 1, 2024, pursuant to the Second A&R Ameluz LSA; and ● strategically manage our licensed portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring or licensing intellectual property to further leverage our commercial infrastructure and customer relationships.
The key elements of our strategy include the following: ● expand our sales in the United States of Ameluz in combination with the RhodoLED Lamps for the treatment of minimally to moderately thick AKs of the face and scalp and positioning Ameluz to be the standard of care in the United States by leveraging new label indications and focusing on acquisition of new customers and growth of the therapy in our current customer base; 4 ● leverage the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the United States market with respect to Ameluz and furthering the clinical development of Ameluz after taking over responsibility for certain ongoing clinical trials since June 1, 2024; and ● strategically manage our portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring or licensing intellectual property to further leverage our commercial infrastructure and customer relationships.
We launched the commercialization of Ameluz ® in combination with the RhodoLED ® lamp for the treatment of actinic keratosis in the United States in October 2016. Ameluz ® PDT is an in-office procedure. Ameluz ® is distributed as a “buy-and-bill” drug that is purchased by the dermatologist, rather than distribution through pharmacies.
We launched the commercialization of Ameluz in combination with the RhodoLED lamp for the treatment of AK in the United States in October 2016. Ameluz PDT is an in-office procedure. Ameluz is distributed as a “buy-and-bill” drug that is purchased by the dermatologist, rather than distribution through pharmacies.
Our Licensors are subject to announced and unannounced device inspections by FDA and other regulatory agencies overseeing the implementation and adherence of applicable local, state and federal statutes and regulations.
We are subject to announced and unannounced device inspections by FDA and other regulatory agencies overseeing the implementation and adherence of applicable local, state and federal statutes and regulations.
We were formed in March 2015 as Biofrontera Inc., a Delaware corporation, and a wholly owned subsidiary of Biofrontera AG, a stock corporation organized under the laws of Germany. We consummated our initial public offering in November 2021.
We were formed in 2015 as Biofrontera Inc., a Delaware corporation, and a wholly owned subsidiary of Biofrontera AG, a stock corporation organized under the laws of Germany. In 2021, we completed our initial public offering.
It provides that FDA with two additional post-market activities including monitoring of products after market clearance and device tracking for maintaining traceability of certain devices to the user level. The SMDA makes it mandatory for facilities, manufacturers, and importers to submit medical device reporting forms to the FDA after becoming aware of a serious event associated with a device.
It also imposes two additional post-market requirements on manufacturers, including monitoring of products after market clearance and device tracking for maintaining traceability of certain devices to the user level. The SMDA makes it mandatory for facilities, manufacturers, and importers to submit medical device reporting forms to the FDA after becoming aware of a serious event associated with a device.
We are relying exclusively on our licensors’ or their manufacturing partner’s facilities for the production of clinical and commercial quantities of our products in accordance with Current Good Manufacturing Practices (“cGMP”) regulations. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.
We rely, in part, on our manufacturing partner’s facilities for the production of clinical and commercial quantities of our products in accordance with Current Good Manufacturing Practices (“cGMP”) regulations. cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.
The kinetics of skin cancer: Progression of actinic keratosis to squamous cell carcinoma. Dermatologic Surgery . 2007 Sep; 33(9):1099-101 2 Werner RN, Stockfleth E, Connolly SM, et al. Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version.
Dermatologic Surgery . 2007 Sep; 33(9):1099-101 2 Werner RN, Stockfleth E, Connolly SM, et al. Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version.
In general, PDT is a two-step process: ● the first step is the application of a drug known as a “photosensitizer,” or a pre-cursor of this type of drug, which tends to accumulate in cancerous cells; and ● the second step is activation of the photosensitizer by controlled exposure to a selective light source in the presence of oxygen.
In general, PDT is a two-step process: ● the first step is the application of a drug known as a “photosensitizer,” or a pre-cursor of this type of drug, which tends to accumulate in fast growing cells at a faster rate compared to healthy cells; and ● the second step is activation of the photosensitizer by controlled exposure to a selective light source in the presence of oxygen to selectively destroy the fast growing cells.
Our customers will purchase our device and Ameluz ® which will be held in inventory. When a dermatologist uses our product in a treatment, a payor will be billed, and the provider will be paid for both the product and light treatment. There are well established PDT CPT Codes.
Our customers will purchase our device and Ameluz which will be held in inventory. When a dermatologist uses our product in a treatment, a payor will be billed, and the provider will be paid for both the product and light treatment.
Effective June 1, 2024, in accordance with the Second A&R Ameluz LSA, the Company assumed control of all clinical trials relating to Ameluz ® in the US, allowing for more effective cost management and direct oversight of trial efficiency.
Our R&D programs Effective June 1, 2024, the Company assumed control of all clinical trials relating to Ameluz in the US, allowing for more effective cost management and direct oversight of trial efficiency.
Item 1. Business Overview We are a United States based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”).
Item 1. Business Overview We are a United States based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”).
The Company’s primary licensed products, which include Ameluz ® as well as the BF-RhodoLED ® and RhodoLED ® XL lamps (together, the “RhodoLED ® Lamps”), are used for the treatment of actinic keratoses (“AKs”), which are pre-cancerous skin lesions. With our national commercial team, we generate revenue by selling our licensed products directly to dermatology offices and groups.
The Company’s products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamp series (together, the “RhodoLED Lamps”), are used for the treatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous lesions (or “AKs”). With our national commercial team, we generate revenue by selling our products directly to dermatology offices and groups.
We launched the RhodoLED ® XL in June 2024. The new PDT-lamp enables the illumination of larger areas, thus allowing the simultaneous treatment of several actinic keratoses distant from each other. The smaller BF-RhodoLED ® model will continue to be offered in the United States market.
The RhodoLED XL enables the illumination of larger areas, thus allowing the simultaneous treatment of several AKs distant from each other. The smaller BF-RhodoLED model will continue to be offered in the United States market.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. 12 Available Information We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Effective June 1, 2024, we assumed control of all clinical trials relating to Ameluz ® in the United States, allowing for more effective cost management and direct oversight of trial efficiency.
Effective June 1, 2024, we assumed control of all clinical trials relating to Ameluz in the United States, allowing for more effective cost management and direct oversight of trial efficiency through Discovery, our wholly owned subsidiary that was formed in Germany in 2022.
This will allow the Company to finance such R&D activities and continue our commercial growth trajectory. Our R&D programs are focused on label expansion for Ameluz ® as well as supporting PDT growth by improving the capabilities of our RhodoLED ® Lamps to better fulfill the needs of dermatologists.
Our R&D programs are focused on label expansion for Ameluz as well as supporting PDT growth by improving the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists.
AKs, the number one indication at a dermatologist visit for those 40 and older, are superficial potentially pre-cancerous skin lesions caused by chronic sun exposure that may, if left untreated, develop into a form of potentially life-threatening skin cancer called squamous cell carcinoma.
AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left untreated. 1 International treatment guidelines list PDT as the “gold standard” for treating AK, especially multiple AKs and the surrounding photodamaged skin. 2 AKs, the number one indication at a dermatologist visit for those 40 and older, are superficial potentially pre-cancerous skin lesions caused by chronic sun exposure that may, if left untreated, develop into a form of potentially life-threatening skin cancer called squamous cell carcinoma.
The Information on our website is not incorporated by reference into this Form 10-K and does not constitute a part of this Form 10-K.
We also maintain a website at https://www.biofrontera-us.com . The Information on our website is not incorporated by reference into this Form 10-K and does not constitute a part of this Form 10-K.
By executing these strategic objectives and continually evaluating our product portfolio with strategic options to improve our business, we will fuel growth, deepen our trusted relationships in the dermatology community, and above all, help patients live healthier, more fulfilling lives. Employees As of December 31, 2024, the Company had 93 employees, consisting of 92 full-time employees and one part-time employee.
By executing these strategic objectives and continually evaluating our product portfolio with strategic options to improve our business, we will fuel growth, deepen our trusted relationships in the dermatology community, and above all, help patients live healthier, more fulfilling lives.
The SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. These materials may be obtained electronically by accessing the SEC’s website at http://www.sec.gov . We also maintain a website at https://www.biofrontera-us.com .
The Exchange Act requires us to file periodic reports, proxy statements and other information with the Securities and Exchange Commission (the “SEC”). The SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. These materials may be obtained electronically by accessing the SEC’s website at http://www.sec.gov .
Ameluz ® Actinic keratosis ● Combination daylight and conventional PDT, plan to start enrollment in 2026 Ameluz ® Squamous cell carcinoma in situ ● Plan to start enrollment in 2026 The new, larger RhodoLED ® XL was approved by the FDA in 2021 for use in combination with Ameluz ® for the treatment of mild and moderate actinic keratoses on the face and scalp, which corresponds to the current approval of Ameluz ® .
Ameluz Actinic Keratosis ● AK Pain Reduction; Plan to start enrollment in 2027 The new, larger RhodoLED XL was approved by the FDA in 2021 for use in combination with Ameluz for the treatment of mild and moderate AKs on the face and scalp, which corresponds to the current approval of Ameluz and was launched in June 2024.
Complete histological clearance was seen in 75.9% of these lesions in the Ameluz® arm, compared to 19.0% with placebo. Complete clinical clearance was achieved in 83.4% of patients treated with Ameluz® compared to 21.4% with placebo.
According to the phase III ALA-BCC-CT013 study, Ameluz-PDT achieved 65.5% success in the composite endpoint, compared to 4.8% success achieved with placebo-PDT. Complete histological clearance was seen in 75.9% of these lesions in the Ameluz arm, compared to 19.0% with placebo. Complete clinical clearance was achieved in 83.4% of patients treated with Ameluz compared to 21.4% with placebo.
Federal false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent or not provided as claimed.
Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of such laws. 11 Federal false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services, including drugs, that are false or fraudulent or not provided as claimed.
Likewise, the Ameluz Licensor is responsible to maintain a pharmacovigilance database and to respond appropriately to all relevant queries of any regulatory authority pertaining to pharmacovigilance Biofrontera is required to provide reasonable support relating to any regulatory issues relating to pharmacovigilance and/or product recalls.
Likewise, the Former Ameluz Licensor was responsible to maintain a pharmacovigilance database and to respond appropriately to all relevant queries of any regulatory authority pertaining to pharmacovigilance.
A summary of our clinical trials is below: Clinical Phase Product Indication Pre-clinical I II III Approval Process Status Ameluz ® Superficial basal cell carcinoma ● Last-patient-out for 1 year follow up completed in December 2024; Clinical Study Report (“CSR”) expected Q2 – 2025. Ameluz ® Moderate to severe acne ● Last-patient-out of treatment phase expected Q3 2025.
A summary of our clinical trials is below: Clinical Phase Product Indication / comments Pre-clinical I II III Approval process Status Ameluz Superficial basal cell carcinoma ● Submitted to FDA in Q4 2025. Ameluz Moderate to severe acne ● Last-patient-out of treatment phase in Q3 2025. Phase 2 data obtained in Q1 2026.
CSR for treatment expected in Q2 2026. Ameluz ® Actinic keratosis ● Trunk & extremities applying 1-3 tubes of Ameluz®; last patient-in was March 2025. Last-patient-out of treatment phase expected Q3-2025. CSR expected in Q2-2026.
Ameluz Actinic Keratosis ● Trunk & extremities pharmacokinetics study applying 3 tubes of Ameluz. Last-patient-out in Q4 2025. CSR expected Q2 2026. Reg. filing expected together with trunk and extremities phase 3 study in Q3 2026.
NDA or Biologics License Application (“BLA”): After completion of all three clinical trial Phases, if the data indicates that the drug is safe and effective, an NDA or BLA is filed with the FDA requesting FDA approval to market the new drug as a treatment for the target disease.
New Drug Application (“NDA”) or Biologics License Application (“BLA”): After completion of all three clinical trial Phases, if the data indicates that the drug is safe and effective, an NDA or BLA is filed with the FDA requesting FDA approval to market the new drug as a treatment for the target disease. 8 Risk Evaluation and Mitigation Strategy Authority under the Food and Drug Administration Amendments Act (“FDAAA”): The FDAAA also gave the FDA authority to require the implementation of a Risk Evaluation and Mitigation Strategy (“REMS”) for a product when necessary to minimize known and preventable safety risks associated with the product.
Violations of this law are punishable by up to five years in prison, and can also result in criminal fines, civil monetary penalties, administrative penalties and exclusion from participation in federal health care programs. 11 Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
Any changes to the pricing of supply of Ameluz ® or RhodoLED ® Lamps would require agreement by both contract parties. 7 The Ameluz Licensor is responsible for obtaining and maintaining the rights to all FDA approvals (and any required maintenance thereafter) needed for the Ameluz Licensor to manufacture Ameluz ® and/or the RhodoLED ® Lamps and/or for Biofrontera to sell Ameluz ® and/or the RhodoLED ® Lamps in the United States.
Under the Second A&R Ameluz LSA, the Former Ameluz Licensor was responsible for obtaining and maintaining the rights to all FDA approvals (and any required maintenance thereafter) needed for the Former Ameluz Licensor to manufacture Ameluz and/or the RhodoLED Lamps and/or for Biofrontera to sell Ameluz and/or the RhodoLED Lamps in the United States.
Furthermore, in 2023, the FDA approved a new formulation of Ameluz ® that lacks propylene glycol and reduces the accumulation of certain contaminants over time. The new formulation was implemented in all US productions of Ameluz ® starting in 2024.
F urthermore, the FDA approved a new formulation of Ameluz that lacks propylene glycol and reduces the accumulation of certain contaminants over time. A corresponding patent application was granted by the United States Patent and Trademark Office, (the “USPTO”), extending protection of Ameluz to 2043. The new formulation has been implemented in all US productions of Ameluz since 2024 .
Under the Second A&R Ameluz LSA, these requirements are handled by both us and our Licensor. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses. In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval.
Until June 1, 2025, under the Second A&R Ameluz LSA, these requirements were handled by both us and our licensor. See Part 1, Item 7, “Overview and Recent Developments” for more information concerning the Second A&R Ameluz LSA. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.
Under the Second A&R Ameluz LSA, we hold the exclusive license to sell Ameluz ® and the RhodoLED ® Lamps in the United States for all indications currently approved by the FDA as well as all future FDA-approved indications identified under the Second A&R Ameluz LSA.
Effective October 20, 2025, we acquired all rights in the United States to Ameluz and the RhodoLED Lamps for all indications currently approved by the Food and Drug Administration (the “FDA”) as well as all future FDA-approved indications.
In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratosis (“AK”) of mild-to-moderate severity on the face and scalp.
Ameluz and RhodoLED Lamps Our principal 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 and field-directed treatment of AK of mild-to-moderate severity on the face and scalp.
The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. According to the phase III ALA-BCC-CT013 study, Ameluz®-PDT achieved 65.5% success, compared to 4.8% success achieved with placebo-PDT.
A lso in October 2024, the Company received results in its Phase III trial evaluating Ameluz PDT as a treatment for superficial basal cell carcinoma (“sBCC”). The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle.
Among other things, the Second A&R Ameluz LSA reduced the Transfer Price of Ameluz ® from 50% to 25% for all purchases in 2024 and 2025.
Among other things, the Second A&R Ameluz LSA established the “Transfer Price” of Ameluz at 25% for all purchases in 2024 and 2025. The Transfer Price covered the cost of goods, royalties on sales, and services including all regulatory efforts, agency fees, pharmacovigilance, and patent administration.
Biofrontera Pharma currently manufactures through a single unaffiliated contract manufacturer in Switzerland, Glaropharm AG, and is in the process of qualifying a second unaffiliated contract manufacturer located in Germany, Pharbil Waltrop GmbH, to ensure stability of the supply chain.
Production of Ameluz is carried out by a contract manufacturer, Glaropharm AG in Switzerland, as well as a second contract manufacturer located in Germany, Pharbil Waltrop GmbH, who has recently been qualified for manufacturing of Ameluz to ensure stability of the supply chain and help manage possible tariff impacts.
This targeted market is about 11% or $500 million of the total AK market. 6 Ameluz ® PDT is competitive in the market. We are leveraging medical affairs, advisory boards, reimbursement resources, and key opinion leaders in order to educate the market on the use and benefits of Ameluz ® PDT. 1 Fuchs, A., & Marmur, E.
We are leveraging medical affairs, leading educational, CME- and non-CME programs, participating in thought leader advisory boards and focus groups, and offering reimbursement resources in order to educate the market on the use and benefits of Ameluz PDT. 1 Fuchs, A., & Marmur, E. The kinetics of skin cancer: Progression of actinic keratosis to squamous cell carcinoma.
The related intangible asset is presented as held for sale under current assets in the Consolidated Balance Sheets. See Note 9. Assets Held for Sale , for additional information. Our Strategy Our principal objective is to improve patient outcomes through adoption and use of our licensed products.
Our Strategy Our principal objective is to improve patient outcomes in the non-melanoma space through adoption and use of our products.
Additionally, the change to the label and the RhodoLED ® XL are both foundational to support trunk and extremities which we expect to add to the label in the next couple of years. Also in October 2024, the Company received results in its Phase III trial evaluating Ameluz PDT as a treatment for superficial basal cell carcinoma (“sBCC”).
Additionally, the change to the label and the RhodoLED XL are both foundational to support trunk and extremities which we expect to add to the label in 2027. Regulatory submission for the trunk and extremities label change is planned for the second quarter of 2026.
Our commercial team covers the continental United States, and our headquarters is in Woburn, MA. Significant Customers We have a wide and diverse customer base with no single customer dominating our revenues. At December 31, 2024, no customer represented more than 10% of the net accounts receivable balance.
Employees As of December 31, 2025, the Company had a total of 92 employees comprised of 75 employees (72 full-time and three part-time) in the United Sates and 19 employees located in Germany (12 full-time and seven part-time). Significant Customers We have a wide and diverse customer base with no single customer dominating our revenues.
Removed
Discovery was formed on February 9, 2022, as a German presence that manages our clinical trial work and facilitates our relationship with the Ameluz Licensor. We consider the Biofrontera Group to be a related party.
Added
On October 20, 2025, we entered into i) an Asset Purchase Agreement (the “Transfer Agreement”) and ii) an Earnout Agreement (together with the Transfer Agreement, the “Agreements”), with the Biofrontera Group, pursuant to which the Company acquired all rights in the United States to Ameluz and RhodoLED (the “Strategic Transaction”). See Note 3. Asset Acquisition and Note 16.
Removed
The Biofrontera Group held more than 5% of the outstanding shares of our common stock until December 10, 2024, and we continue to rely on the Biofrontera Group as the sole supplier of Ameluz ® and the RhodoLED ® Lamps.
Added
Related Party Transactions for additional information. On November 6, 2025, the Company completed the sale of the intangible asset relating to its Xepi product line, a long-lived asset previously classified as held for sale. See Note 9. Assets Held for Sale , for additional information.
Removed
In the third quarter of 2024, the Company reached the decision to divest its Xepi product line and the related intangible asset is currently held for sale. Xepi ® (ozenoxacin cream, 1%), is a topical non-fluorinated quinolone that inhibits bacterial growth.
Added
At December 31, 2025, no customer represented more than 10% of the net accounts receivable balance. For the year ended December 31, 2025, no customer represented more than 10% of net revenues.
Removed
Currently, no antibiotic resistance against Xepi ® is known and it has been specifically approved by the Federal Drug Administration (the “FDA”) for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes.
Added
However, many of our existing and potential customers for our products have combined or could choose to combine in the near future to form GPOs in an effort to lower costs. See GPO Risk Factor in Item 1A. Risk Factors- Risks Related to Our Business Strategy .
Removed
The Company did not have any sales of Xepi ® during 2024 and generated limited revenue during 2023 from sales of Xepi due to third-party manufacturing delays that have impacted our commercialization of the product. Ferrer is in the process of qualifying a new contract manufacturer.
Added
This targeted market is about 11% or $500 million of the total AK market. 6 Ameluz PDT is competitive in the market.
Removed
If the new contract manufacturer is qualified, we believe that it will be able to supply enough of the Xepi ® product line to meet market demand for as long as we maintain it. However, the Company is working with a potential purchaser and expects to complete a sale of the asset within the next three to six months.
Added
There are three well established PDT Current Procedural Terminology (“CPT”) Codes related to Ameluz PDT treatments: 1) code number 96567, which has an average reimbursement of $129.26 per light treatment, 2) code number 96573, which has an average reimbursement of $217.44 per light treatment performed by qualified health care professional, or 3) code number 96574 which has an average reimbursement of $266.87 per debridement of a hyperkeratotic AK lesion followed by a light treatment performed by a qualified health care professional.
Removed
For the year ended December 31, 2024, no customer represented more than 10 % of net revenues. Ameluz ® and RhodoLED ® Lamps 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”).
Added
Clinical Study Report (“CSR”) for treatment phase expected Q3 2026. Ameluz Actinic Keratosis ● Trunk & extremities applying 1-3 tubes of Ameluz . Last-patient-out of treatment phase in Q3 2025. CSR for treatment phase expected Q2 2026. Reg. filing for sNDA is expected for Q3 2026 for field treatment of AKs on extremities and neck and trunk.
Removed
AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left untreated. 1 International treatment guidelines list PDT as the “gold standard” for treating AK, especially multiple AKs and the surrounding photodamaged skin. 2 We are currently selling Ameluz ® for this indication in the United States under an exclusive license and supply agreement between Biofrontera Inc. and the Ameluz Licensor, (the “Second A&R Ameluz LSA”).
Added
In November 2025 a Supplemental New Drug Application was submitted to the FDA, applying for the approval of the treatment of sBCC by PDT with Ameluz and the BF-RhodoLED or the RhodoLED XL lamp . The FDA has accepted the filing and set a Prescription Drug User Fee Act date of September 28, 2026.
Removed
Ameluz ® PDT is covered by code number 96574 which has an average reimbursement of $262.68 per light treatment and has to be performed by a qualified healthcare professional. Public information regarding CPT reimbursement is available at https://www.cms.gov/medicare/physician-fee-schedule/search?Y=0&T=4&HT=0&CT=3&H1=96574&M=5. Our R&D programs We are a sales organization with a focus on commercializing our portfolio of licensed products that are already FDA-approved.
Added
Seasonality Traditional PDT treatments using a lamp are usually performed more frequently during the winter.
Removed
The increase to R&D spending will be partially offset by the reduced price we pay per unit for Ameluz ® , based on certain percentages of the anticipated net selling price, (the “Transfer Price”) that covers the cost of goods, royalties on sales, and services including all regulatory efforts, agency fees, pharmacovigilance, and patent administration.
Added
As such, our revenue is subject to some seasonality and has historically been higher during the first and fourth quarters of the year than during the second and third quarters. 6 Principal Suppliers & Manufacturers Historically, we have relied on Biofrontera Pharma (the “Former Ameluz Licensor”) as the principal supplier and manufacturer of our products.
Removed
Additionally, our licensor has been granted a patent for a pain-reduced PDT procedure that combines daylight and conventional PDT and, if the respective Phase III trial leads to inclusion of the procedure into the Ameluz ® label, may provide further patent protection beyond 2040.
Added
However, in conjunction with a Strategic Transaction, the Company assumed full control of the Ameluz New Drug Application and Investigational New Drug, enabling the Company to take full responsibility for all aspects of manufacturing Ameluz and the RhodoLED Lamps in the U.S.
Removed
A corresponding patent application has been filed with the United States Patent and Trademark Office, or USPTO, which, if granted, will extend protection of Ameluz ® to 2043. Principal suppliers Our source for the Ameluz ® and the RhodoLED ® Lamps is our Licensor, Biofrontera Pharma, who is considered the responsible manufacturer for Ameluz ® by the FDA.
Added
Pursuant to the Strategic Transaction, we will temporarily continue to rely on the Former Ameluz Licensor for the manufacturing of Ameluz until we secure all necessary licenses and implement all necessary contracts to fully assume these responsibilities.
Removed
Our Licensor is responsible for all raw materials, product, and shipment of products to our third-party logistics partner (“3PL”), Cardinal Health for warehousing and distribution. We centralize our customer sales support and back-office functions through our headquarters in Woburn, Massachusetts. 6 Intellectual Property We do not own any material patents or trademarks.
Added
In preparation of the same, we have entered into an agreement for the primary procurement of our active pharmaceutical ingredient (“API”) with Midas Pharma GmbH, located in Germany. We have also identified a secondary source of API and anticipate entering into a similar agreement with this supplier.
Removed
We license the rights and trademarks related to the products we sell. Ameluz ® and the RhodoLED ® Lamps are approved by the FDA as a combination product, such that the label requires the use of both products together.
Added
Production of the RhodoLED Lamps is currently carried out by the Former Ameluz Licensor in Leverkusen, Germany, which responsibility will be transferred to Discovery pursuant to the Strategic Transaction. See Part 1, Item 7, “Overview and Recent Developments” for more information concerning the Strategic Transaction. We centralize our customer sales support and back-office functions through our headquarters in Woburn, Massachusetts.

… 25 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

147 edited+33 added−161 removed85 unchanged
Biggest changeOur lack of control could adversely affect our ability to implement our strategy for the commercialization of our licensed products. ● Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, which could make it difficult for us to sell our licensed products. ● Healthcare legislative changes may have a material adverse effect on our business and results of operations. ● To date, we have a relatively short history of sales of our licensed products in the United States. ● Competing products and future emerging products may erode sales of our licensed products. ● We face significant competition, and our operating results will suffer if we fail to compete effectively. ● If we are unable to maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our licensed products, we may be unable to generate revenue growth. ● The United States market size for Ameluz ® for the treatment of AK may be smaller than we have estimated. ● If our Licensors are subjected to sanctions due to noncompliance with law, our licensed products could be subject to restrictions or withdrawal from the market. ● Our licensed products may not gain market acceptance among members of the medical community. ● Our failure to comply with healthcare laws and regulations and could have a material adverse effect on our results of operations and financial condition. ● A recall of our licensed drug or medical products, or the discovery of serious safety issues with our licensed drug or medical products, could have a significant negative impact on us. ● Our products subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer. ● Our actual or perceived failure to comply with data and data security regulations could harm our business. ● We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy. ● Our employees may engage in misconduct or other improper activities. ● We will need to grow our organization and we may experience difficulties in managing this growth. ● Our business and operations would suffer in the event of system failures or, cyber-attacks. ● If product liability lawsuits are brought against us, we may incur substantial liabilities ● Failure to comply with applicable anti-corruption legislation could result in fines and criminal penalties. ● Our licensed products will be subject to ongoing regulatory requirements. ● Generic manufacturers may launch products at risk of patent infringement. ● The results of our R&D efforts are uncertain.
Biggest changeOur failure to comply with those laws and regulations could have a material adverse effect on our results of operations and financial condition. ● A recall of our drug or medical products, or the discovery of serious safety issues with our drug or medical products, could have a significant negative impact on us. ● We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy. ● We will need to grow our organization and we may experience difficulties in managing this growth. ● Our business and operations could suffer in the event of system failures or cyber-attacks. ● If lawsuits are brought against us, we may incur substantial liabilities. ● Our subsidiary and certain third-party employees are subject to foreign laws. ● Third party claims of intellectual property infringement may affect our ability to sell our products and may also prevent or delay our product discovery and development efforts. ● The results of our R&D efforts are uncertain.
Risks Related to Clinical Trials and Regulatory Approvals Regulatory Approvals of Indication Expansion Delay or termination of planned clinical trials for expanding the indications of Ameluz ® would result in unplanned expenses and significantly and adversely impact our remaining developmental activities and potential commercial prospects with respect to, and ability to generate revenues from, such indications.
Risks Related to Clinical Trials and Regulatory Approvals of Indication Expansion Delay or termination of planned clinical trials for expanding the indications of Ameluz would result in unplanned expenses and significantly and adversely impact our remaining developmental activities and potential commercial prospects with respect to, and ability to generate revenues from, such indications.
In addition, if we fail to maintain compliance to be eligible to trade on Nasdaq or obtain listing on another reputable national securities exchange, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock” which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock.
In addition, if we fail to regain and maintain compliance to be eligible to trade on Nasdaq or obtain listing on another reputable national securities exchange, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock” which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock.
Although our Licensors may require their employees to assign their inventions to us to the extent permitted by law, and may require our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
Although we may require our employees to assign their inventions to us to the extent permitted by law, and may require our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques.
Our Licensors’ manufacturing partners must comply with federal, state and foreign regulations, including FDA regulations governing cGMP enforced by the FDA through its facilities inspection program and by similar regulatory authorities in other jurisdictions where we do business. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation.
Our manufacturing partners must comply with federal, state and foreign regulations, including FDA regulations governing cGMP enforced by the FDA through its facilities inspection program and by similar regulatory authorities in other jurisdictions where we do business. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation.
We cannot be certain that additional funding for any purpose will be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts and on terms acceptable to us, we may have to significantly delay, scale back or discontinue the commercialization of our licensed products or other plans for strategic growth.
We cannot be certain that additional funding for any purpose will be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts and on terms acceptable to us, we may have to significantly delay, scale back or discontinue the commercialization of our products or other plans for strategic growth.
Any of the foregoing events could prevent us from obtaining regulatory approval for expanded indications of our licensed products and from achieving or maintaining market acceptance of our licensed products for some or all indications, and may result in the failure to realize significant revenues, which would materially and adversely affect our results of operations and business.
Any of the foregoing events could prevent us from obtaining regulatory approval for expanded indications of our products and from achieving or maintaining market acceptance of our products for some or all indications, and may result in the failure to realize significant revenues, which would materially and adversely affect our results of operations and business.
We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we or our Licensors may need to obtain licenses from third parties to advance their research or allow commercialization of the products we license.
We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance their research or allow commercialization of our products.
Our future financial performance and our ability to commercialize and market our licensed products will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
Our future financial performance and our ability to commercialize and market our products will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.
If they are unable to prevent unauthorized material disclosure of their intellectual property to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.
If we are unable to prevent unauthorized material disclosure of their intellectual property to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.
In February 2024, our Ameluz Licensor initiated a voluntary recall of a limited number of lots of Ameluz® due to a manufacturing defect in the impacted product’s packaging, which is provided by an unaffiliated supplier. The Ameluz Licensor confirmed that the recalled product is not likely to cause adverse health consequences.
In February 2024, our former licensor of Ameluz, initiated a voluntary recall of a limited number of lots of Ameluz due to a manufacturing defect in the impacted product’s packaging, which is provided by an unaffiliated supplier. The licensor confirmed that the recalled product is not likely to cause adverse health consequences.
As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable indication, our financial results and the commercial prospects for our licensed products would be harmed, our costs could increase, and our ability to generate additional revenues could be delayed.
As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable indication, our financial results and the commercial prospects for our products would be harmed, our costs could increase, and our ability to generate additional revenues could be delayed.
Even after cGMP compliance has been achieved, the FDA or similar foreign regulatory authorities at any time may implement new standards or change their interpretation and enforcement of existing standards for manufacture, packaging, testing of or other activities related to our licensed products.
Even after cGMP compliance has been achieved, the FDA or similar foreign regulatory authorities at any time may implement new standards or change their interpretation and enforcement of existing standards for manufacture, packaging, testing of or other activities related to our products.
All of the shares issuable upon exercise of these warrants or the conversion of the Series B Preferred Stock have been registered on effective registration statements and therefore, when issued, will be freely tradable without restriction or further registration required under the Securities Act.
All of the shares issuable upon exercise of these warrants or the conversion of the Series B Preferred Stock and Series C Preferred Stock have been registered on effective registration statements and therefore, when issued, will be freely tradable without restriction or further registration required under the Securities Act.
In addition, in an infringement proceeding, a court may decide that one or more of our Licensors’ patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.
In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.
The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for additional indications of our licensed products on a timely basis or at all, our business could be substantially harmed.
The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for additional indications of our products on a timely basis or at all, our business could be substantially harmed.
For our licensed commercialized medical device product, the FDA audits compliance with the through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. Similar audit rights exist in Europe and other foreign jurisdictions.
For our commercialized medical device product, the FDA audits compliance with the through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. Similar audit rights exist in Europe and other foreign jurisdictions.
Any corrective action, whether voluntary or involuntary, will require the dedication of our Licensors’ time and capital, distract our Licensors’ management from operating their business and may harm our and our Licensors’ reputation and financial results as well as threaten our marketing authority for such products.
Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract our management from operating their business and may harm our reputation and financial results as well as threaten our marketing authority for such products.
In addition, adverse events caused by our licensed products could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approvals by the FDA.
In addition, adverse events caused by our products could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approvals by the FDA.
Any adverse event involving our licensed products could result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.
Any adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action.
Further, the commercial prospects of the expanded indications of our licensed products may be harmed, and our ability to generate product revenues from any of these indications could be delayed or not realized at all.
Further, the commercial prospects of the expanded indications of our products may be harmed, and our ability to generate product revenues from any of these indications could be delayed or not realized at all.
The FDA also may approve a more limited indication than we target, and the FDA may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our licensed products.
The FDA also may approve a more limited indication than we target, and the FDA may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our products.
The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: ● the demand for our licensed products, ● if our Licensors obtain regulatory approvals; ● our ability to set a price or obtain reimbursement that we believe is fair for our licensed products; ● our ability to generate revenues and achieve or maintain profitability; and ● the level of taxes that we are required to pay.
The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: ● the demand for our products, ● if we obtain regulatory approvals; ● our ability to set a price or obtain reimbursement that we believe is fair for our products; ● our ability to generate revenues and achieve or maintain profitability; and ● the level of taxes that we are required to pay.
We rely on medical institutions, independent clinical investigators, contract laboratories and other third parties, such as CROs, to conduct GCP-compliant clinical trials on our licensed products properly and on time.
We rely on medical institutions, independent clinical investigators, contract laboratories and other third parties, such as CROs, to conduct GCP-compliant clinical trials on our products properly and on time.
In addition, several of these companies have significantly greater experience than we or our Licensors do in developing products, conducting preclinical and clinical testing, obtaining regulatory approvals to market products for health care, and marketing healthcare products. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated in our competitors.
In addition, several of these companies have significantly greater experience than we do in developing products, conducting preclinical and clinical testing, obtaining regulatory approvals to market products for health care, and marketing healthcare products. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated in our competitors.
Moreover, because of the numerous risks and uncertainties associated with commercializing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if ever. 32 We will likely engage in additional equity or debt financing in the future, which could dilute the voting rights of stockholders and the value of their shares.
Moreover, because of the numerous risks and uncertainties associated with commercializing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if ever. 26 We will likely engage in additional equity or debt financing in the future, which could dilute the voting rights of stockholders and the value of their shares.
Parties making claims against us or our Licensors may seek and obtain injunctive or other equitable relief, which could effectively block our ability to sell our licensed products and to further commercialize our licensed products. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to sell our products and to further commercialize our products. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
Product malfunctions or other adverse event reports may result in a voluntary or involuntary product recall and other adverse actions, which could divert managerial and financial resources, impair our and our Licensors’ ability to market, sell or manufacture our licensed products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.
Product malfunctions or other adverse event reports may result in a voluntary or involuntary product recall and other adverse actions, which could divert managerial and financial resources, impair our ability to market, sell or manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results.
Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our licensed products or product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our licensed technologies infringes upon such patents.
Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our products or product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringe upon such patents.
In either case, such a license may not be available on commercially reasonable terms or at all. If we or our Licensors are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our licensed products may be impaired or delayed, which could in turn significantly harm our business.
In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our products may be impaired or delayed, which could in turn significantly harm our business.
Our existing and future indebtedness could have significant adverse consequences, including: ● requiring us to dedicate a portion of our cash to the payment of interest and principal, reducing money available for working capital, capital expenditure, product development and other general corporate purposes; ● increasing our vulnerability to adverse changes in general economic, industry and market conditions; ● increasing the risk of dilution to the holders of our shares in the event any of these bonds are exercised for or converted into our ordinary shares; ● limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and ● placing us at a competitive disadvantage to competitors that are better capitalized than we are.
Our existing and future indebtedness could have significant adverse consequences, including: ● requiring us to dedicate a portion of our cash to the payment of interest and principal, reducing money available for working capital, capital expenditure, product development and other general corporate purposes; ● increasing our vulnerability to adverse changes in general economic, industry and market conditions; ● increasing the risk of dilution to the holders of our shares in the event any note(s) are exercised for or converted into our ordinary shares; ● limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and ● placing us at a competitive disadvantage to competitors that are better capitalized than we are.
Recalls of our licensed products would divert managerial and financial resources and have an adverse effect on our and our Licensors’ reputation, financial condition and operating results, which could impair our or our Licensors’ ability to market, sell or produce our licensed products in a cost-effective and timely manner.
Recalls of our products would divert managerial and financial resources and have an adverse effect on our reputation, financial condition and operating results, which could impair our ability to market, sell or produce our products in a cost-effective and timely manner.
Any shares of our common stock issued upon exercise of outstanding warrants or conversion of the Series B convertible preferred stock will result in dilution to the then existing holders of our common stock and increase the number of shares eligible for resale in the public market.
Any shares of our common stock issued upon exercise of outstanding warrants or conversion of the Series B, Series C and Series D convertible preferred stock will result in dilution to the then existing holders of our common stock and increase the number of shares eligible for resale in the public market.
Therefore, some of our estimates and judgments are based on various sources which we have not independently verified and which potentially include outdated information, or information that may not be precise or correct, potentially rendering the United States market size for treatment of actinic keratosis with Ameluz ® smaller than we have estimated, which may reduce our potential and ability to increase sales of Ameluz ® and revenue in the United States.
Therefore, some of our estimates and judgments are based on various sources which we have not independently verified and which potentially include outdated information, or information that may not be precise or correct, potentially rendering the United States market size for treatment of AK with Ameluz smaller than we have estimated, which may reduce our potential and ability to increase sales of Ameluz and revenue in the United States.
Further, under the FDA’s medical device reporting, or MDR, regulations, our Licensors are required to report to the FDA any event which reasonably suggests that our licensed product may have caused or contributed to a death or serious injury or in which our licensed product malfunctioned and, if the malfunction of the same or similar device marketed by us were to recur, would likely cause or contribute to death or serious injury.
Further, under the FDA’s medical device reporting, or MDR, regulations, we are required to report to the FDA any event which reasonably suggests that our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction of the same or similar device marketed by us were to recur, would likely cause or contribute to death or serious injury.
Stockholders’ Equity in our audited financial statements for the fiscal year ended December 31, 2024 and 2023 included in this Form 10-K for more information on the Warrants. Item 1B. Unresolved Staff Comments Not applicable.
Stockholders’ Equity in our audited financial statements for the fiscal year ended December 31, 2025 and 2024 included in this Form 10-K for more information on the Warrants. Item 1B. Unresolved Staff Comments Not applicable.
If our Licensors are required to find a new manufacturer or supplier, the process would likely require prior FDA and/or equivalent foreign regulatory authority approval and would be very time consuming. An inability to continue manufacturing adequate supplies of our licensed products at any contract facilities could result in a disruption in the supply of our licensed products.
If we are required to find a new manufacturer or supplier, the process would likely require prior FDA and/or equivalent foreign regulatory authority approval and would be very time consuming. An inability to continue manufacturing adequate supplies of our products at any contract facilities could result in a disruption in the supply of our products.
Any such delay or rejection could prevent us from commercializing expanded indications of our licensed products.
Any such delay or rejection could prevent us from commercializing expanded indications of our products.
There may be third party patents of which we or our Licensors are currently unaware with claims to materials, formulations, devices, methods of manufacture or methods for treatment related to the use or manufacture of the products we license.
There may be third party patents of which we are currently unaware with claims to materials, formulations, devices, methods of manufacture or methods for treatment related to the use or manufacture of our products.
Reimbursement issues affect the economic competitiveness of our licensed products as compared to other therapies.
Reimbursement issues affect the economic competitiveness of our products as compared to other therapies.
Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to: ● the effects of competing technological and market developments; ● the cost and timing of completion of commercial-scale manufacturing activities; ● the cost of establishing or maintaining sales, marketing and distribution capabilities for Ameluz ® PDT or other licensed products or potential products in the United States ● the timing of regulatory approvals obtained by our Licensors, demand for our licensed products, our ability to market and sell our licensed products and other matters.
Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to: ● the effects of competing technological and market developments; ● the cost and timing of completion of commercial-scale manufacturing activities; ● the cost of establishing or maintaining sales, marketing and distribution capabilities for Ameluz PDT or other products or potential products in the United States ● the timing of regulatory approvals, demand for our products, our ability to market and sell our products and other matters.
Regardless of the merits or eventual outcome, liability claims may result in: ● costs to defend litigation and other proceedings; ● a diversion of management’s time and our resources; ● decreased demand for our licensed products; ● injury to our reputation; ● withdrawal of clinical trial participants; ● decreased enrollment rates of clinical trial participants; ● termination of clinical trial sites or entire trial programs; ● initiation of investigations by regulators; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● substantial monetary awards to trial participants or patients; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize our licensed products; and ● a decline in our share price. 30 We currently maintain product liability insurance.
Regardless of the merits or eventual outcome, liability claims may result in: ● costs to defend litigation and other proceedings; ● a diversion of management’s time and our resources; ● decreased demand for our products; ● injury to our reputation; ● withdrawal of clinical trial participants; ● decreased enrollment rates of clinical trial participants; ● termination of clinical trial sites or entire trial programs; ● initiation of investigations by regulators; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● substantial monetary awards to trial participants or patients; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize our products; and ● a decline in our share price.
Under United States GAAP, we are required to evaluate the outstanding warrants to purchase our common stock to determine whether they should be accounted for as a warrant liability or as equity.
Under GAAP, we are required to evaluate the outstanding warrants to purchase our common stock to determine whether they should be accounted for as a warrant liability or as equity.
Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of the formulations, processes for manufacture or methods of use, including combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to commercialize the product unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.
Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our medical devices, formulations of our pharmaceutical products, processes for manufacture, or methods of use (including combination therapy or patient selection methods), the holders of any such patent may be able to block our ability to commercialize the product unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.
If we or the Ameluz Licensor are unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz ® for existing and additional indications, our business may be materially harmed.
If we are unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz for existing and additional indications, our business may be materially harmed.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require our Licensors to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our licensed products.
Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require that we provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products.
Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States or the EU. As a result, our Licensors may encounter significant problems in protecting and defending their intellectual property in the United States, in the EU and in other countries.
Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States or the EU. As a result, we may encounter significant problems in protecting and defending our intellectual property in the United States, in the EU and in other countries.
Third party claims of intellectual property infringement may affect our ability to sell our licensed products and may also prevent or delay our Licensors’ product discovery and development efforts. Our commercial success depends in part on our Licensors avoiding infringement of the patents and proprietary rights of third parties.
Third party claims of intellectual property infringement may affect our ability to sell our products and may also prevent or delay our product discovery and development efforts. Our commercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties.
Although we have not independently verified the data obtained from these sources, we believe that such data provide the best available information relating to the present market for actinic keratosis treatments in the United States, and we often use such data for our business and planning purposes.
Although we have not independently verified the data obtained from these sources, we believe that such data provide the best available information relating to the present market for AK treatments in the United States, and we often use such data for our business and planning purposes.
In the long term, we anticipate increasing our sales and marketing expense as we attempt to exploit the regulatory approvals to market Ameluz ® in the United States for the PDT treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
In the long term, we anticipate increasing our sales and marketing expense as we attempt to exploit the regulatory approvals to market Ameluz in the United States for the PDT treatment of AKs of mild-to-moderate severity on the face and scalp.
If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our licensed products, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.
If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our pharmaceutical products and medical devices, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize our products unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.
Our Licensors’ trade secrets also could be independently discovered by their competitors, in which case, they would not be able to prevent use of such trade secrets by their competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable.
Our trade secrets also could be independently discovered by our competitors, in which case, we would not be able to prevent use of such trade secrets by our competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable.
Recently, following United States patent reform, new procedures including inter partes review and post grant review have been implemented. This reform includes changes in law and procedures that are untried and untested and will bring uncertainty to the possibility of challenge to our patents in the future.
Recently, following United States patent reform, new procedures including inter partes review and post grant review have been implemented. This reform includes changes in law and procedures that are untried and untested and will bring uncertainty to the possibility of challenge to our patents, as well as our ability to challenge the patents of others, in the future.
We cannot assure you that the Biofrontera Group will develop any new lamps (beyond the BF-RhodoLED ® XL lamp which was approved by the FDA on October 21, 2021) or obtain any such new approval.
We cannot assure that we will develop any new lamps (beyond the BF-RhodoLED XL lamp, which was approved by the FDA on October 21, 2021), or obtain any such new approval.
As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our licensed products may give rise to claims of infringement of the patent rights of others. 19 Third parties may assert that we or our Licensors are employing their proprietary technology without authorization.
As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products may give rise to claims of infringement of the patent rights of others. Third parties may assert that we are employing their proprietary technology without authorization.
Because the Ameluz Licensor received approval from the FDA to market in the United States Ameluz ® in combination with PDT using the BF-RhodoLED ® lamp, any new lamp we may license would require new approval from the FDA.
Because we have received approval from the FDA to market in the United States Ameluz in combination with PDT using the BF-RhodoLED lamp series, any new lamp we may license would require new approval from the FDA.
As of December 31, 2024, we had 93 employees. In the longer term, as our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel.
As of December 31, 2025, we had 92 employees. In the longer term, as our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel.
The resulting warrant liabilities are re-measured at each balance sheet date until their exercise or expiration, and any change in fair value is recognized in the Company’s consolidated statement of operations. Refer to Note 3. Fair Value Measurements. As of the date of this Form 10-K, 2,269,356 liability classified Warrants remain outstanding. See Note 14.
The resulting warrant liabilities are re-measured at each balance sheet date until their exercise or expiration, and any change in fair value is recognized in the Company’s consolidated statement of operations. Refer to Note 3. Fair Value Measurements. As of the date of this Form 10-K, 2,192,736 liability classified Warrants remain outstanding. See Note 17.
The FDA can delay, limit or deny approval of additional indications of our licensed products or require us to conduct costly additional clinical testing or abandon a program for many reasons, including: ● disagreements with regulators as to the design or implementation of our clinical trials; ● unfavorable or ambiguous results from our clinical trials; ● results that may not meet the level of statistical significance required by the FDA for approval; ● serious and unexpected drug-related adverse events experienced by participants in our clinical trials or by individuals using drugs similar to our licensed products; ● our inability to demonstrate to the satisfaction of the FDA that our licensed products are safe and effective for the proposed indication; ● the FDA’s disagreement with the interpretation of data from clinical trials; ● our inability to demonstrate that the clinical and other benefits of our licensed products outweigh any safety or other perceived risks; ● the FDA’s disagreement regarding the formulation, container, dosing delivery device, labeling or the specifications of our licensed products; ● the FDA’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or 35 ● the potential for approval policies or regulations of the FDA to significantly change in a manner rendering our clinical data insufficient for approval.
The FDA can delay, limit or deny approval of additional indications of our products or require us to conduct costly additional clinical testing or abandon a program for many reasons, including: ● disagreements with regulators as to the design or implementation of our clinical trials; ● unfavorable or ambiguous results from our clinical trials; ● results that may not meet the level of statistical significance required by the FDA for approval; ● serious and unexpected drug-related adverse events experienced by participants in our clinical trials or by individuals using drugs similar to our products; ● our inability to demonstrate to the satisfaction of the FDA that our products are safe and effective for the proposed indication; ● the FDA’s disagreement with the interpretation of data from clinical trials; ● our inability to demonstrate that the clinical and other benefits of our products outweigh any safety or other perceived risks; ● the FDA’s disagreement regarding the formulation, container, dosing delivery device, labeling or the specifications of our products; ● the FDA’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or ● the potential for approval policies or regulations of the FDA to significantly change in a manner rendering our clinical data insufficient for approval. 29 Of the large number of drugs in development, only a small percentage successfully complete the FDA approval process and become commercialized.
Although the Ameluz Licensor has received marketing approval in the United States for Ameluz ® for lesion- and field-directed treatment of actinic keratosis in combination with PDT using the BF-RhodoLED ® Lamps, there remains a significant risk that we will fail to generate sufficient revenue or otherwise successfully commercialize the product in the United States.
Although we have received marketing approval in the United States for Ameluz for lesion- and field-directed treatment of AK in combination with PDT using the BF-RhodoLED Lamps, there remains a significant risk that we will fail to generate sufficient revenue or otherwise successfully commercialize the product in the United States.
The market price of our common stock is likely to be volatile and could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: ● the success of existing or new competitive products or technologies; ● regulatory actions with respect to Ameluz ® , the BF-RhodoLED ® lamp (and its successors) or our competitors’ products; ● actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results; ● announcements of innovations by us, our Licensors or our competitors; ● overall conditions in our industry and the markets in which we operate; ● market conditions or trends in the biotechnology industry or in the economy as a whole; ● addition or loss of significant healthcare providers or other developments with respect to significant healthcare providers; ● changes in laws or regulations applicable to Ameluz ® , the BF-RhodoLED ® lamp (and its successors); ● actual or anticipated changes in our growth rate relative to our competitors; 37 ● announcements by us, our Licensors or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; ● additions or departures of key personnel; ● issuance of new or updated research or reports by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● disputes or other developments related to the patents covering our licensed products, and our Licensors’ ability to obtain intellectual property protection for our licensed products; ● security breaches; ● litigation matters; ● announcement or expectation of additional financing efforts; ● sales of our common stock by us or our stockholders; ● share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; ● the expiration of contractual lock-up agreements with our executive officers, directors and stockholders; and ● general economic and market conditions.
Others factors beyond our control that may lead to volatility in our share price include: ● the success of existing or new competitive products or technologies; ● regulatory actions with respect to Ameluz, the BF-RhodoLED lamp (and its successors) or our competitors’ products; ● actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results; ● announcements of innovations by us or our competitors; ● overall conditions in our industry and the markets in which we operate; ● market conditions or trends in the biotechnology industry or in the economy as a whole; ● addition or loss of significant healthcare providers or other developments with respect to significant healthcare providers; ● changes in laws or regulations applicable to Ameluz, the BF-RhodoLED lamp (and its successors); ● actual or anticipated changes in our growth rate relative to our competitors; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; ● additions or departures of key personnel; ● issuance of new or updated research or reports by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● disputes or other developments related to the patents covering our products, and our ability to obtain intellectual property protection for our products; ● security breaches; ● litigation matters; ● announcement or expectation of additional financing efforts; ● sales of our common stock by us or our stockholders; ● share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; ● the expiration of contractual lock-up agreements with our executive officers, directors and stockholders; and ● general economic and market conditions.
All employees of our wholly owned subsidiary, Biofrontera Discovery GmbH, and a majority of the employees of Biofrontera AG, the parent company of the Ameluz Licensor, work in Germany and are subject to German employment law.
All employees of our wholly owned subsidiary, Biofrontera Discovery GmbH, and a majority of the employees and former employees of Biofrontera AG, our former licensor, work in Germany and are subject to German employment law.
In those cases where employees have not assigned their interests to Biofrontera AG, Biofrontera AG may need to pay compensation for the use of those patents. If Biofrontera AG is required to pay additional compensation or face other disputes under the German Act on Employees’ Inventions, the impact on our license could adversely affect our results of operations.
In those cases where employees have not assigned their interests, we may need to pay compensation for the use of those patents. If we are required to pay additional compensation or face other disputes under the German Act on Employees’ Inventions, the impact on us could adversely affect our results of operations.
The success of our product will depend on several factors, including: ● successful completion of further clinical trials; ● receipt of further regulatory approvals, including for the marketing of Ameluz ® for additional indications; ● the contract manufacturing facility maintaining regulatory compliance; ● compliance with applicable law for our sales force and marketing efforts; ● the contract manufacturing facility manufacturing sufficient quantities in acceptable quality; ● the Ameluz Licensor sourcing sufficient quantities of raw materials used to manufacture our licensed products; ● continued acceptable safety and effectiveness profiles for our licensed products; ● the Ameluz Licensor obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and ● the Ameluz Licensor protecting its intellectual property rights. 16 If we or the Ameluz Licensor do not achieve one or more of these factors in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our licensed products, which would materially harm our business and we may not be able to earn sufficient revenue and cash flows to continue our operations.
The success of Ameluz will depend on several factors, including: ● successful completion of further clinical trials; ● receipt of further regulatory approvals, including for the marketing of Ameluz for additional indications; ● any contract manufacturing facilities maintaining regulatory compliance; ● compliance with applicable law for our sales force and marketing efforts; ● any contract manufacturing facility producing sufficient quantities at acceptable quality; ● sourcing sufficient quantities of raw materials used to manufacture our products; ● continued acceptable safety and effectiveness profiles for our products; ● maintaining current reimbursement coverage for our existing indication, and expanding reimbursement to cover future indications; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and ● protecting our intellectual property rights. 15 If we do not achieve one or more of these factors in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our products, which would materially harm our business and we may not be able to earn sufficient revenue and cash flows to continue our operations.
If our Licensor or our Licensors’ manufacturing partners, as applicable, fail to manufacture Ameluz ® , RhodoLED ® Lamps, or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with current good manufacturing practice, or cGMP, or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of the products under license to us or we will be unable to meet market demand, and lose potential revenues.
If we or our manufacturing partners, as applicable, fail to manufacture Ameluz, RhodoLED Lamps, or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with cGMP or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of our products or be unable to meet market demand, and lose potential revenues.
Any of the above events could prevent us from realizing business opportunities or prevent us from growing our business or responding to competitive pressures, which could have a material adverse effect on our business, prospects, financial condition and/or results of operations and could cause the price of our shares to decline. 33 Our existing and any future indebtedness could adversely affect our ability to operate our business.
Any of the above events could prevent us from realizing business opportunities or prevent us from growing our business or responding to competitive pressures, which could have a material adverse effect on our business, prospects, financial condition and/or results of operations and could cause the price of our shares to decline.
The products we are developing and may develop in the future may not be technologically successful. At this time, we have limited internal R&D personnel, which makes us dependent on consulting relationships. In addition, the length of our product development cycle may be greater than we originally expected, and we may experience delays in product development.
At this time, we have limited internal R&D personnel, which makes us dependent on consulting relationships. In addition, the length of our product development cycle may be greater than we originally expected, and we may experience delays in product development.
Any delay in obtaining, or inability to obtain, in whole or in part, applicable regulatory approval for additional indications we are targeting would hinder the commercialization of our licensed products, which would limit our ability to increase our revenues, materially and adversely affecting our results of operations and business.
Any delay in obtaining, or inability to obtain, in whole or in part, applicable regulatory approval for additional indications we are targeting would hinder the commercialization of our products, which would limit our ability to increase our revenues, materially and adversely affecting our results of operations and business. We rely on third parties to conduct some of our clinical trials.
We have issued several warrants, which are exercisable for our common stock, and issued Series B Convertible Preferred Stock, which, if exercised or converted, as applicable, could substantially increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
This may also cause the market price of our common stock to further decline. We have issued several warrants, which are exercisable for our common stock, and issued Convertible Preferred Stock, which, if exercised or converted, as applicable, could substantially increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
Given the volatility of exchange rates, we can give no assurance that we will be able to effectively manage our currency transaction risks or that any volatility in currency exchange rates will not have an adverse effect on our results of operations.
Given the volatility of exchange rates, we can give no assurance that we will be able to effectively manage our currency transaction risks or that any volatility in currency exchange rates will not have an adverse effect on our results of operations. Competing products and future emerging products may erode sales of our products.
Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our licensed products and product candidates. Even a successful defense would require significant financial and management resources.
If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products and product candidates. Even a successful defense would require significant financial and management resources.
Our licensed products may pose safety issues, cause adverse events, have side effects or have other properties that could delay or prevent the regulatory approval of additional indications, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
Any of these occurrences may significantly harm our business, financial condition and prospects. 28 Our products may pose safety issues, cause adverse events, have side effects or have other properties that could delay or prevent the regulatory approval of additional indications, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
The foregoing restrictive covenants are subject to a number of important exceptions and qualifications, as set forth in the Notes. The Notes are secured by substantially all property of the Company, including but not limited to the Company’s assets, inventory, intellectual property and accounts. See Note 11. Debt , for additional information regarding our existing indebtedness .
The foregoing restrictive covenants are subject to a number of important exceptions and qualifications, as set forth in the Notes. The Notes are secured by substantially all property of the Company, including but not limited to the Company’s assets, inventory, intellectual property and accounts. See Note 14.
The impact of changes in fair value on earnings may have an adverse effect on the market price of our common stock. 42 The warrants issued in connection with the private placement offerings (completed on December 1 , 2021, May 16, 2022, July 26, 2022, and November 2, 2023) (collectively, the “PIPE Warrants”) were accounted for as liabilities as these warrants provide for a redemption right in the case of a fundamental transaction which fails the requirement of the indexation guidance under ASC 815-40.
The warrants issued in connection with the private placement offerings (completed on December 1 , 2021, May 16, 2022, July 26, 2022, and November 2, 2023) (collectively, the “PIPE Warrants”) were accounted for as liabilities as these warrants provide for a redemption right in the case of a fundamental transaction which fails the requirement of the indexation guidance under ASC 815-40.
Organization and Business Overview - Liquidity and Going Concern for additional information. We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability. We have incurred losses in each year since inception.
Organization and Business Overview - Liquidity and Going Concern for additional information. We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability. We have incurred losses in each year since inception. As of December 31, 2025, we had an accumulated deficit of $127.9 million.
However, vandalism, terrorism or a natural or other disaster, such as a fire or flood, could damage or destroy manufacturing equipment or the inventory of raw material or finished goods, cause substantial delays in operations, result in the loss of key information, and cause additional expenses.
However, vandalism, terrorism or a natural or other disaster, such as a fire or flood, could damage or destroy manufacturing equipment or the inventory of raw material or finished goods, cause substantial delays in operations, result in the loss of key information, and cause additional expenses. Our insurance may not cover losses related to our products in any particular case.
In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Quality and Security Act and the Drug Supply Chain Security Act in the United States, which require us to develop electronic systems to serialize, track, trace and authenticate units of our licensed products through the supply chain and distribution system.
Delay or disruption in our ability to meet demand may result in the loss of potential revenue. 16 In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Quality and Security Act and the Drug Supply Chain Security Act in the United States, which require us to develop electronic systems to serialize, track, trace and authenticate units of our products through the supply chain and distribution system.
Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our licensed products, including with respect to future indications of our licensed products, which could make it difficult for us to sell our licensed products.
See the section entitled “ Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our products, including with respect to future indications of our products, which could make it difficult for us to sell our products ” included below in this Item 1A.
In the United States and certain other countries, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our licensed products profitably.
Healthcare legislative changes may have a material adverse effect on our business and results of operations. In the United States and certain other countries, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably.
There is a risk that the compensation Biofrontera AG provided to employees who assign patents to them may be deemed to be insufficient and Biofrontera AG may be required under German law to increase the compensation due to such employees for the use of the patents.
There is a risk that the compensation that we or Biofrontera AG provided to employees who assign patents may be deemed to be insufficient. German law may require that the compensation due to such employees for the use of the patents is increased.

… 261 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

2 edited+0 added−1 removed5 unchanged
Biggest changeKey elements of our cybersecurity risk management program include: ● risk assessments designed to help identify material cybersecurity risks to our critical systems, information, and our broader enterprise information technology environment; ● leveraging our external service providers, where appropriate, to assess, test, monitor or otherwise assist with aspects of our security controls ; ● training and awareness programs for employees to drive adoption and awareness of cybersecurity processes and controls; ● a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents.
Biggest changeThis does not imply that we meet any particular technical standards, specifications, or requirements, but rather that we use the NIST CSF as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business. 33 Key elements of our cybersecurity risk management program include: ● risk assessments designed to help identify material cybersecurity risks to our critical systems, information, and our broader enterprise information technology environment; ● leveraging our external service providers, where appropriate, to assess, test, monitor or otherwise assist with aspects of our security controls ; ● training and awareness programs for employees to drive adoption and awareness of cybersecurity processes and controls; ● a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents.
Risk Factors - “Our business and operations would suffer in the event of system failures or, cyber-attacks or a deficiency in our cyber-security,” which is incorporated by reference into this Item 1C.
Risk Factors - “Our business and operations would suffer in the event of system failures or cyber-attacks,” which is incorporated by reference into this Item 1C.
Removed
This does not imply that we meet any particular technical standards, specifications, or requirements, but rather that we use the NIST CSF as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

2 edited+0 added−0 removed0 unchanged
Biggest changeGiven the inherent uncertainties of litigation, the ultimate outcome of any such matters cannot be predicted at this time, nor can the amount of possible loss or range of loss, if any, be reasonably estimated, except in circumstances where an aggregate litigation accrual has been recorded for probable and reasonably estimable loss contingencies.
Biggest changeGiven the inherent uncertainties of litigation, the ultimate outcome of any such matters cannot be predicted at this time, nor can the amount of possible loss or range of loss, if any, be reasonably estimated, except in circumstances where an aggregate litigation accrual has been recorded for probable and reasonably estimable loss contingencies. Item 4. Mine Safety Disclosures Not applicable.
Item 3. Legal Proceedings From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. Information regarding our material legal proceedings is included in Note 19. Commitments and Contingencies , to the consolidated financial statements in Item 8 of this Form 10-K, which is incorporated herein by reference.
Item 3. Legal Proceedings From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. Information regarding our material legal proceedings is included in Note 22. Commitments and Contingencies , to the consolidated financial statements in Item 8 of this Form 10-K, which is incorporated herein by reference.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed3 unchanged
Biggest changeIssuer Purchases of Equity Securities There were no repurchases made by us, or on our behalf, of shares of our common stock during the year ended December 31, 2024. Item 6. [Reserved]
Biggest changeIssuer Purchases of Equity Securities There were no repurchases made by us, or on our behalf, of shares of our common stock during the year ended December 31, 2025. 34 Item 6. [Reserved]
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is traded on the NASDAQ Capital Market, under the symbol “ BFRI ,” and our warrants are traded on the NASDAQ Capital Market, under the symbol “ BFRIW .” As of December 31, 2024, there were three holders of record of our common stock.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is traded on the NASDAQ Capital Market, under the symbol “ BFRI ,” and our warrants are traded on the NASDAQ Capital Market, under the symbol “ BFRIW .” As of December 31, 2025, there were three holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

56 edited+36 added−64 removed25 unchanged
Biggest changeResults of Operations Comparison of the Years Ended December 31, 2024 and December 31, 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and December 31, 2023: ( in thousands) 2024 2023 Change Product revenues, net $ 37,303 $ 34,005 3,298 Revenues, related party 18 66 (48 ) Revenues, net 37,321 34,071 (3,250 ) Operating expenses: Cost of revenues, related party 17,855 16,789 1,066 Cost of revenues, other 752 655 97 Selling, general and administrative 33,793 38,975 (5,182 ) Selling, general and administrative, related party 42 152 (110 ) Research and development 2,089 77 2,012 Change in fair value of contingent consideration - 100 (100 ) Total operating expenses 54,531 56,748 (2,217 ) Loss from operations (17,210 ) (22,677 ) 5,467 Change in fair value of warrant liabilities 1,680 6,456 (4,776 ) Warrant inducement expense - (1,045 ) 1,045 Excess of warrant fair value over offering proceeds - (2,272 ) 2,272 Change in fair value of investment, related party (14 ) (7,421 ) 7,407 Loss on debt extinguishment (316 ) - (316 ) Gain on legal settlement - 7,385 (7,385 ) Interest expense, net (2,035 ) (468 ) (1,567 ) Other income (expense), net 158 (75 ) 233 Loss before income taxes (17,737 ) (20,117 ) 2,380 Income tax expenses 22 14 8 Net loss $ (17,759 ) $ (20,131 ) $ 2,372 50 Product Revenues, net Net product revenue for 2024 increased $3.3 million, or 9.7% compared to 2023.
Biggest changeResults of Operations Comparison of the Years Ended December 31, 2025 and December 31, 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and December 31, 2024: ( in thousands) 2025 2024 Change Product revenues, net $ 41,705 $ 37,303 4,402 Revenues, related party - 18 (18 ) Revenues, net 41,705 37,321 4,384 Operating expenses: Cost of revenues, related party 10,111 17,855 (7,744 ) Cost of revenues, other 853 752 101 Selling, general and administrative 37,751 33,793 3,958 Selling, general and administrative, related party 619 42 577 Research and development 3,719 2,089 1,630 Total operating expenses 53,053 54,531 (1,478 ) Loss from operations (11,348 ) (17,210 ) 5,862 Change in fair value of warrant liabilities 899 1,680 (781 ) Change in fair value of investment, related party 2 (14 ) 16 Loss on debt extinguishment - (316 ) 316 Interest expense, net (452 ) (2,035 ) 1,583 Other income (expense), net 388 158 230 Loss before income taxes (10,511 ) (17,737 ) 7,226 Income tax expenses 25 22 3 Net loss $ (10,536 ) $ (17,759 ) $ 7,223 Product Revenues, net Net product revenue for 2025 increased $4.4 million, or 11.8% compared to 2024.
Financing Activities During the year ended December 31, 2024, net cash provided by financing activities was $14.8 million which consisted of proceeds of $7.7 million, net of capitalized issuance costs, from the issuance of preferred stock and warrants, $7.4 million from the exercise of warrants for preferred stock, plus $4 million, net of issuance costs received from the issuance of convertible notes, offset by repayments of $4.2 million on our short-term debt, and prepayment fees of $0.2 million to extinguish our line of credit.
During the year ended December 31, 2024, net cash provided by financing activities was $14.8 million which consisted of proceeds of $7.7 million, net of capitalized issuance costs, from the issuance of preferred stock and warrants, $7.4 million from the exercise of warrants for preferred stock, plus $4 million, net of issuance costs received from the issuance of convertible notes, offset by repayments of $4.2 million on our short-term debt, and prepayment fees of $0.2 million to extinguish our line of credit.
Non-cash income includes a change in fair value of warrant liabilities of $1.7 million offset by stock-based compensation of $1.0 million, non-cash interest expense of $0.3 million, loss on debt extinguishment of $0.3 million, provision for doubtful accounts of $0.2 million and depreciation and amortization in the aggregate of $1.1 million.
Non-cash expense includes stock-based compensation of $1.0 million, non-cash interest expense of $0.3 million, loss on debt extinguishment of $0.3 million, provision for doubtful accounts of $0.2 million and depreciation and amortization in the aggregate of $1.1 million offset by a change in fair value of warrant liabilities of $1.7 million.
Accordingly, we are focused on licensed product sales expansion to drive revenue growth and improve operating efficiencies, including effective resource utilization, information technology leverage, and overhead cost management. 1 Werner RN, Stockfleth E, Connolly SM, et al.
Accordingly, we are focused on product sales expansion to drive revenue growth and improve operating efficiencies, including effective resource utilization, information technology leverage, and overhead cost management. 1 Werner RN, Stockfleth E, Connolly SM, et al.
Net Income to Adjusted EBITDA Reconciliation for years ended December 31, 2024 and 2023 We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations specifically described below.
Net Income to Adjusted EBITDA Reconciliation for years ended December 31, 2025 and 2024 We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations specifically described below.
If the Company is unable to raise capital when needed, the Company will not have sufficient cash resources and liquidity to fund its business operations and the Company may be forced to delay or reduce continued commercialization efforts or R&D programs which could have a material adverse effect on the Company and its financial statements.
If the Company is unable to raise additional capital when needed, it will not have sufficient cash resources and liquidity to fund its business operations and may be forced to delay or reduce continued commercialization efforts or R&D programs, which could have a material adverse effect on the Company and its financial statements.
By executing these strategic objectives, we will fuel company growth, deepen our trusted relationships in the dermatology community, and above all, help patients live healthier, more fulfilling lives. We devote a substantial portion of our cash resources to the commercialization of our licensed products, Ameluz ® and the BF-RhodoLED ® Lamps.
By executing these strategic objectives, we will fuel company growth, deepen our trusted relationships in the dermatology community, and above all, help patients live healthier, more fulfilling lives. We devote a substantial portion of our cash resources to the commercialization of Ameluz and the BF-RhodoLED Lamps.
Additionally, if the final outcome of such litigation and contingencies differs adversely from that currently expected, it would result in a charge to operating results when determined. See Note 19. Commitments and Contingencies – Legal Claims for more details .
Additionally, if the final outcome of such litigation and contingencies differs adversely from that currently expected, it would result in a charge to operating results when determined. See Note 20. Commitments and Contingencies – Legal Claims for more details .
Due to the uncertainty of litigation and the preliminary stage of the claims, we cannot estimate the possibility of a material loss, nor the potential range of loss that may result from the actions discussed in Note 19. Commitments and Contingencies – Legal Claims .
Due to the uncertainty of litigation and the preliminary stage of the claims, we cannot estimate the possibility of a material loss, nor the potential range of loss that may result from the actions discussed in Note 20. Commitments and Contingencies – Legal Claims .
We have financed our operating and capital expenditures through cash proceeds generated from our product sales, short term debt and proceeds received from convertible notes and equity financings. We believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted EBITDA (a non-GAAP measure as defined below).
We have financed our operating and capital expenditures through cash proceeds generated from our product sales, proceeds received from convertible notes and equity financings. We believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted EBITDA (a non-GAAP measure as defined below).
Our R&D expenses include costs directly attributable to the clinical development of Ameluz ® , including personnel-related expenses, the cost of services provided by outside contractors, including services related to the Company’s clinical trials, facilities, depreciation, and other direct and allocated expenses.
Our R&D expenses include costs directly attributable to the clinical development of Ameluz, including personnel-related expenses, the cost of services provided by outside contractors, including services related to the Company’s clinical trial sites, facilities, depreciation, and other direct and allocated expenses.
An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group were less than its carrying amount and if the carrying value was also determined to be greater than its fair value.
An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount and if the carrying value is also determined to be greater than its fair value.
The key elements of our strategy include the following: ● expanding our sales in the United States of Ameluz ® in combination with the RhodoLED ® Lamps for the treatment of minimally to moderately thick actinic keratoses of the face and scalp and positioning Ameluz ® to be the standard of care in the United States by focusing on acquisition of new customers and growth of the therapy in our current customer base; ● leveraging the potential for future approvals and label extensions of our licensed portfolio products that are in the pipeline for the United States market with respect to Ameluz ® and f urthering the clinical development of this product after taking over responsibility for certain ongoing clinical trials since June 1, 2024, pursuant to the Second A&R Ameluz LSA ; and ● strategically managing our licensed portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring or licensing IP to further leverage our commercial infrastructure and customer relationships.
The key elements of our strategy include the following: ● expanding our sales in the United States of Ameluz in combination with the RhodoLED Lamps for the treatment of minimally to moderately thick AKs of the face and scalp and positioning Ameluz to be the standard of care in the United States by focusing on acquisition of new customers and growth of the therapy in our current customer base; ● leveraging the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the United States market with respect to Ameluz and furthering the clinical development of this product after taking over responsibility for certain ongoing clinical trials since June 1, 2024; and ● strategically managing our portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring or licensing IP to further leverage our commercial infrastructure and customer relationships.
Along with our Ameluz ® clinical trials, our R&D program also aims to improve the capabilities of our RhodoLED ® Lamps to better fulfill the needs of dermatologists and improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them, allowing for easier product demonstrations and evaluations.
Along with our Ameluz clinical trials, our R&D program also aims to improve the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists and improve the effectiveness of our commercial team by letting sales representatives carry approved devices with them, allowing for easier product demonstrations and evaluations. All costs associated with R&D are expensed as incurred.
Interest Income (Expense), net Interest expense, net, primarily consists of interest on our convertible notes, and short-term debt including amortization of deferred costs. 49 Other Income (Expense), net Other income, net primarily includes (i) gain on return of leased assets, and (ii) gain (loss) on foreign currency transactions.
Interest Income (Expense), net Interest expense, net, primarily consists of interest on our convertible notes, and short-term debt including amortization of deferred costs. 38 Other Income (Expense), net Other income, net primarily includes (i) gain on return of leased assets, (ii) gain on sale of asset held for sale, and (iii) gain (loss) on foreign currency transactions.
Additional considerations when assessing impairment included changes in our strategic, operational, and financial decisions, economic conditions, demand for our product, and other corporate initiatives that may have eliminated or significantly decreased the realization of future benefits from our long-lived assets.
Additional considerations when assessing impairment include changes in our strategic, operational, and financial decisions, economic conditions, demand for our product and other corporate initiatives which may eliminate or significantly decrease the realization of future benefits from our long-lived assets.
We exclude the impact of this loss as it is attributed to the prepayment fee, which is considered non-recurring and the write-off of deferred financing costs, which is considered non-cash. Legal settlement expenses : To measure operating performance, we exclude legal settlement expenses.
We exclude the impact of this loss as it is attributed to the prepayment fee, which is considered non-recurring and the write-off of deferred financing costs, which is considered non-cash. Stock Based Compensation : To measure operating performance, we exclude the impact of costs relating to share-based compensation.
As such, our future results of operations will not be impacted by the change in fair value. Change in fair value of warrant liabilities: The Warrants issued in conjunction with our private placement offerings and registered public offering were accounted for as liabilities in accordance with Accounting Standards Codification (“ASC”) 815-40.
Change in fair value of warrant liabilities: The Warrants issued in conjunction with our private placement offerings and registered public offering were accounted for as liabilities in accordance with Accounting Standards Codification (“ASC”) 815-40.
Other selling, general and administrative expenses include marketing, trade, and other commercial costs necessary to support the commercial operation of our licensed products and professional fees for legal, consulting and accounting services. Selling, general and administrative expenses also include the amortization of our intangible assets and our legal settlement expenses.
Other selling, general and administrative expenses include marketing, trade, and other commercial costs necessary to support the commercial operation of our products and professional fees for legal, consulting and accounting services, as well as depreciation and amortization.
(the “Company” or “Biofrontera”) is a United States based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”).
(the “Company” or “Biofrontera”) is a United States based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”).
The Company’s primary licensed products, which include Ameluz ® as well as the BF-RhodoLED ® and RhodoLED ® XL lamps (the “RhodoLED ® Lamps”), are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions. With our national commercial team, we generate revenue by selling our licensed products directly to dermatology offices and groups.
The Company’s products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamp series (together, the “RhodoLED Lamps”), are used for the treatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous skin lesions (“AKs”). With our national commercial team, we generate revenue by selling our products directly to dermatology offices and groups.
They are continuously reviewed but may vary from the actual values. Our significant accounting policies are described in more detail in Note 2 – Summary of Significant Accounting Policies , to our consolidated financial statements. Critical Accounting Estimates We believe that the following are the most critical estimates which required significant judgments in the preparation of our financial statements.
They are continuously reviewed but may vary from the actual values. Our significant accounting policies are described in more detail in Note 2 – Summary of Significant Accounting Policies , to our consolidated financial statements.
However, there can be no assurance that the Company will be successful in executing the aforementioned commercial strategies and/or obtaining sufficient funding on acceptable terms, if at all, and that the substantial doubt will be alleviated.
However, there can be no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all.
Our research and development (“R&D”) program is focused on label expansion for Ameluz ® as well as supporting PDT growth by improving the capabilities of our RhodoLED ® Lamps to better fulfill the needs of dermatologists. The reduced LSA transfer price will allow the Company to finance such R&D activities and continue our commercial growth trajectory.
Our research and development (“R&D”) program is focused on label expansion for Ameluz as well as supporting PDT growth by improving the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists.
Cash Flows The following table summarizes our cash provided by (and used in) operating, investing and financing activities: For the Year Ended December 31, (in thousands) 2024 2023 Net cash used in operating activities $ (10,270 ) $ (24,895 ) Net cash provided by (used in) investing activities (3 ) 619 Net cash provided by financing activities 14,835 8,411 Net increase (decrease) in cash and restricted cash $ 4,562 $ (15,865 ) 53 Operating Activities During the year ended December 31, 2024, operating activities used $10.3 million of cash, primarily resulting from our net loss of $17.8 million, adjusted for the add back of non-cash income of $1.3 million and offset by net cash used by changes in our operating assets and liabilities of $6.2 million.
Cash Flows The following table summarizes our cash provided by (and used in) operating, investing and financing activities: For the Year Ended December 31, (in thousands) 2025 2024 Net cash used in operating activities $ (13,361 ) $ (10,270 ) Net cash provided by (used in) investing activities 2,998 (3 ) Net cash provided by financing activities 10,850 14,835 Net increase in cash and restricted cash $ 487 $ 4,562 Operating Activities During the year ended December 31, 2025, operating activities used $13.4 million of cash, primarily resulting from our net loss of $10.5 million, and net cash used by changes in our operating assets and liabilities of $3.5 million, adjusted for the add back of non-cash expense of $0.7 million.
During the year ended December 31, 2023, operating activities used $24.9 million of cash, primarily resulting from our net loss of $20.1 million, adjusted for the add back of non-cash income of $0.4 million and offset by net cash used by changes in our operating assets and liabilities of $4.4 million.
During the year ended December 31, 2024, operating activities used $10.3 million of cash, primarily resulting from our net loss of $17.8 million, and net cash used by changes in our operating assets and liabilities of $6.2 million, adjusted for the add back of non-cash expense of $1.3 million.
Investing Activities During the year ended December 31, 2024, the Company had minimal investing activities which consisted of proceeds from the sales of equity investments which were partially offset by capitalized software and computer purchases. During the year ended December 31, 2023, investing activities provided $0.6 million, primarily resulting from the sale of shares of Biofrontera AG.
Asset Held for Sale for additional details. 43 During the year ended December 31, 2024, the Company had minimal investing activities which consisted of proceeds from the sales of equity investments which were partially offset by capitalized software and computer purchases.
The primary factors that determine our revenue derived from our licensed products are: ● the level of orders generated by our sales force; ● the level of prescriptions and institutional demand for our licensed products; and ● unit sales prices.
Revenues from product sales are recorded net of trade discounts and allowances and government rebates. The primary factors that determine our revenue derived from our products are: ● the level of orders generated by our sales force; ● the level of prescriptions and institutional demand for our products; and ● unit sales average sales price.
We exclude the impact of the variance between the warrant fair value and the proceeds as this is non-cash. Change in fair value of investment, related party: The Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities (“ASC 321”).
Change in fair value of investment, related party: The Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities (“ASC 321”).
The below table presents a reconciliation from net loss to Adjusted EBITDA for the years ended December 31, 2024 and 2023: Years ended December 31, 2024 2023 Net loss $ (17,759 ) $ (20,131 ) Interest expense, net 2,035 468 Income tax expenses 22 14 Depreciation and amortization 421 504 EBITDA (15,281 ) (19,145 ) Change in fair value of contingent consideration - 100 Change in fair value of warrant liabilities (1,680 ) (6,456 ) Warrant inducement expense - 1,045 Excess of warrant fair value over offering proceeds - 2,272 Change in fair value of investment, related party 14 7,421 Gain on legal settlement - (7,385 ) Loss on debt extinguishment 316 - Legal settlement expenses - 1,225 Stock based compensation 1,019 1,045 Expensed issuance costs 354 422 Adjusted EBITDA $ (15,258 ) $ (19,456 ) Adjusted EBITDA margin -40.9 % -57.1 % Adjusted EBITDA Adjusted EBITDA increased from ($19.5) million for the year ended December 31, 2023 to ($15.3) million for the year ended December 31, 2024.
The below table presents a reconciliation from net loss to Adjusted EBITDA for the years ended December 31, 2025 and 2024: Years ended December 31, 2025 2024 Net loss $ (10,536 ) $ (17,759 ) Interest expense, net 452 2,035 Income tax expenses 25 22 Depreciation and amortization 138 421 EBITDA (9,921 ) (15,281 ) Gain on sale of asset held for sale (700 ) - Change in fair value of warrant liabilities (899 ) (1,680 ) Change in fair value of investment, related party (2 ) 14 Loss on debt extinguishment - 316 Stock based compensation 951 1,019 Expensed issuance costs - 354 Adjusted EBITDA $ (10,571 ) $ (15,258 ) Adjusted EBITDA margin -25.4 % -40.9 % Adjusted EBITDA Adjusted EBITDA increased from ($15.3) million for the year ended December 31, 2024 to ($10.6) million for the year ended December 31, 2025.
Selling, General and Administrative Expenses, Related Party Selling, general and administrative expenses, related party, relate to the services provided by Biofrontera AG, primarily for regulatory support and pharmacovigilance. These expenses are charged to us based on costs incurred plus 6% in accordance with the Amended and Restated Master Contact Services Agreement, (the “2021 Services Agreement”), entered into in December 2021.
These expenses were charged to us based on costs incurred plus 6% in accordance with the Amended and Restated Master Contact Services Agreement, (the “2021 Services Agreement”), entered into in December 2021.
Adjusted EBITDA margin is adjusted EBITDA for a particular period expressed as a percentage of revenues for that period. Our management uses adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors.
Our management uses adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors.
The Company incurred net cash outflows from operations of $10.3 million and $24.9 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company’s accumulated deficit was $117.4 million. The Company’s primary sources of liquidity are its cash collected from the sales of its products and cash flows from financing transactions.
The Company incurred net cash outflows from operations of $13.4 million and $10.3 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the Company’s accumulated deficit was $127.9 million.
In determining future cash flows, various factors were taken into account, including the remaining useful life of each asset group, forecasted growth rates, pricing, working capital, capital expenditures, and other cash needs specific to the asset group.
The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows. 45 In determining future cash flows, we take various factors into account, including the remaining useful life of each asset group, forecasted growth rates, pricing, working capital, capital expenditures, and other cash needs specific to the asset group.
For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations. Under the Release, the Company agreed to transfer 5,451,016 shares of Biofrontera AG to Maruho in exchange for the release of our obligations relating to the Cutanea acquisition.
For the investments held in foreign currencies, the change in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations.
Recently issued accounting pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is included in Note 2, Summary of Significant Accounting Policies—Recently Issued Accounting Pronouncements .
Changes in actual net sales relative to expectations could result in the recognition of material expense in future periods when the contingency is resolved. Recently issued accounting pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is included in Note 2. Summary of Significant Accounting Policies—Recently Issued Accounting Pronouncements .
Our principal objective is to improve patient outcomes through adoption and use of our licensed products in the United States.
This may also cause the market price of our common stock to further decline. 36 Strategy Our principal objective is to improve patient outcomes through adoption and use of our products in the United States.
Our sole source of product revenue is sales of products that we license from certain related and unrelated companies. Our long-term financial objectives include consistent revenue growth and expanding operating margins.
Our sole source of product revenue is sales of Ameluz and the BF-RhodoLED Lamps. Our long-term financial objectives include consistent revenue growth and expanding operating margins.
Effective as of January 4, 2024, we voluntarily terminated the Loan Agreement and recognized a $0.3 million loss on debt extinguishment upon the early termination related to prepayment fees and the write-off of deferred financing costs.
Loss on debt extinguishment : Effective as of January 4, 2024, we voluntarily terminated the Loan and Security Agreement dated May 8, 2023 with MidCap Business Credit LLC and recognized a $0.3 million loss on debt extinguishment upon the early termination of the loan.
Additionally, the current capital resources are not adequate to continue operating and maintaining the business strategy for a period of twelve months from the issuance date of this report.
The Company cannot provide assurance that it will ultimately achieve profitable operations and become operating cash flow positive or raise additional debt or equity capital. Additionally, the current capital resources are not adequate to continue operating and maintaining the business strategy for a period of twelve months from the issuance date of this report.
Research and Development Expense R&D expenses for the year ended December 31, 2024 increased $2.0 million as compared to the year ended December 31, 2023. The increase was attributed to our assumption of all clinical trial activities for Ameluz ® in the United States effective June 1, 2024, allowing for more effective cost management and direct oversight of trial efficiency.
Research and Development Expense R&D expenses for the year ended December 31, 2025 increased $1.6 million as compared to the year ended December 31, 2024. The increase was attributable to our responsibility over clinical trial activities for Ameluz in the United States for the full year 2025, which we assumed control of starting June 1, 2024.
The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above, that might be necessary should the Company be unable to continue as a going concern.
The consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
The following table summarizes the major categories of our R&D expenses for the years ended December 31, 2024 and 2023: 2024 2023 Actinic keratosis $ 682 $ - Moderate to severe acne 267 - Superficial basal cell carcinoma 148 - Portable devices 94 - Personnel-related costs 756 - Other research and development 142 77 $ 2,089 $ 77 Change in Fair Value of Warrant Liabilities The change in fair value of warrant liabilities was driven primarily by a greater decrease in the underlying value of the Company’s common stock during 2023 as compared to 2024. 51 Change in Fair Value of Investment, Related Party As of December 31, 2023, the Company had transferred substantially all of its investment in Biofrontera AG to Maruho in exchange for the release of certain obligations, in accordance with the Release.
The following table summarizes the major categories of our R&D expenses for the years ended December 31, 2025 and 2024: 2025 2024 Actinic keratosis $ 1,486 $ 682 Moderate to severe acne 349 267 Superficial basal cell carcinoma 320 148 Portable devices 22 94 Personnel-related costs 1,527 756 Other research and development 15 142 $ 3,719 $ 2,089 Change in Fair Value of Warrant Liabilities The change in fair value of warrant liabilities was driven primarily by the decrease in the underlying value of the Company’s common stock during 2025 as compared to 2024. 40 Interest Expense, net Interest expense decreased by $1.6 million due to the decrease in the interest rate applicable to the outstanding convertible notes issued in November of 2024 (with an original balance of $4.2 million), as compared to the term loan with a balance of $4.0 million that matured on July 5, 2024.
In connection with this review, assets were grouped at the lowest level at which identifiable cash flows were largely independent of other asset groupings. If indications of impairment existed, projected future undiscounted cash flows associated with the asset grouping were compared to the carrying amount to determine whether the asset’s value was recoverable.
If indications of impairment exist, projected future undiscounted cash flows associated with the asset grouping are compared to the carrying amount to determine whether the asset’s value is recoverable.
Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP. Change in fair value of contingent consideration: Pursuant to the Share Purchase Agreement, the profits from the sale of Cutanea products were to be shared equally between Maruho and Biofrontera until 2030.
Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP.
Non-cash income includes a gain on legal settlement of $7.4 million and a change in fair value of warrant liabilities of $6.5 million offset by a change in fair value of equity securities of $7.4 million, loss on warrant fair value over offering proceeds of $2.3 million, warrant inducement expense of $1.1 million, stock-based compensation of $1.1 million, non-cash interest expense of $0.4 million, change in fair value of contingent consideration of $0.1 million, provision for doubtful accounts of $0.1 million and depreciation and amortization in the aggregate of $1.1 million.
Non-cash expense includes stock-based compensation of $1.0 million, non-cash interest expense of $0.5 million, reduction of right of use assets of $0.7 million and depreciation and amortization in the aggregate of $0.1 million, offset by a change in fair value of warrant liabilities of $0.9 million, gain on asset held for sale of $0.7 million, and allowance for credit losses of $0.1 million.
We discuss many of these risks and uncertainties at the beginning of this Form 10-K and under the sections captioned “Business” and “Risk Factors.” The following discussion should also be read in conjunction with the financial statements and the Notes thereto appearing elsewhere in this Form 10-K.
The following discussion should also be read in conjunction with the financial statements and the Notes thereto appearing elsewhere in this Form 10-K. Overview and Recent Developments Biofrontera Inc.
During the year ended December 31, 2023, net cash provided by financing activities was $8.4 million which consisted of net proceeds received from our loan and line of credit of $3.9 million and net proceeds of $4.5 million from the issuance of common stock and warrants in a public offering. 54 Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or GAAP.
Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States, or GAAP.
J Eur Acad Dermatol Venereol. 2015;29(11):2069-2079. doi:10.1111/jdv.13180. 46 Components of Our Results of Operations Product Revenues, net We generate product revenues through the third-party sales of our licensed products Ameluz ® and RhodoLED ® Lamps . Revenues from product sales are recorded net of trade discounts and allowances and government rebates.
Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version. J Eur Acad Dermatol Venereol. 2015;29(11):2069-2079. doi:10.1111/jdv.13180. 37 Components of Our Results of Operations Product Revenues, net We generate product revenues through the sales of our products Ameluz and RhodoLED Lamps .
Our Adjusted EBITDA margin increased from (57.1%) for the year ended December 31, 2023 to (40.9%) for the year ended December 31, 2024, as the impact of the decrease in cost of revenue and the decrease in selling, general and administrative expenses outweighed the impact of the increase in revenue.
Our Adjusted EBITDA margin increased from (40.9%) for the year ended December 31, 2024 to (25.4%) for the year ended December 31, 2025, as the favorable impact of the higher gross profit and improved operating cost discipline outweighed the effect of the increased legal and research and development expenses.
The increase was primarily driven by organic growth of Ameluz ® sales volume of $0.5 million, a $1.7 million increase due to an increased Ameluz ® unit price, and the launch of our RhodoLED ® XL Lamp, which resulted in sales of RhodoLED ® XL Lamps of $1.1 million.
The increase was primarily driven by organic growth of Ameluz sales volume of $4.1 million and a $0.7 million increase due to an increased Ameluz unit price. We still continued to grow net revenues despite the impact of group purchasing organizations for independent dermatology offices’ efforts to erode prices.
Management believes that these conditions raise substantial doubt about the Company’s ability to continue as a going concern for at least twelve months from the date of this Annual Report on Form 10-K.
Management believes that these conditions raise substantial doubt about the Company’s ability to continue as a going concern for at least twelve months from the date of this Annual Report on Form 10-K. 42 The Company plans to address the conditions that raise substantial doubt regarding its ability to continue as a going concern by, among other things, continuing to expand the commercialization of Ameluz in the United States while controlling expenses, expected realization of an additional $1.0 million in milestone payments from the sale of the Xepi intangible asset, and, if necessary, securing additional capital through equity or debt financings.
Assets Held for Sale. Prior to the classification as held for sale, the Company regularly reviewed the carrying amount of its long-lived assets to determine whether indicators of impairment may have existed that warranted adjustments to carrying values or estimated useful lives.
Intangible Assets and Impairment Assessment The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist that warrant adjustments to carrying values or estimated useful lives. In connection with this review, assets are grouped at the lowest level at which identifiable cash flows are largely independent of other asset groupings.
This decrease was primarily driven by a $3.0 million decrease in general and administrative expenses, primarily attributable to a decrease in external legal expenses and expenses relating to financing activities.
The increase was primarily driven by a $6.6 million rise in general and administrative expenses, largely attributable to higher external legal costs and expenses related to patent claims. See Note 20. Commitments and Contingencies – Legal Proceedings .
A significant change in one or more of the aforementioned inputs used in the calculation of the fair value may cause a significant change to the fair value of our warrant liability which could also result in material non-cash gain or loss being reported in our consolidated statement of operations. 55 Contingencies and Litigation In the ordinary course of our business, we are subject to various legal proceedings, claims and other regulatory matters, the outcomes of which are subject to significant uncertainty.
Critical Accounting Estimates We believe that the following are the most critical estimates which required significant judgments in the preparation of our financial statements. 44 Contingencies and Litigation In the ordinary course of our business, we are subject to various legal proceedings, claims and other regulatory matters, the outcomes of which are subject to significant uncertainty.
Cost of Revenues, Related Party Cost of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz ® and RhodoLED ® Lamps from Biofrontera Pharma GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products. 47 Effective February 12, 2024, the Second A&R Ameluz LSA, among other things, was amended to change the Transfer Price from 50% to 25% of the anticipated net selling price per unit through 2025 and then increasing over time pursuant to the schedule set forth in the Second A&R Ameluz LSA to a maximum of 35% of the anticipated net selling price starting in 2032, subject to a minimum dollar amount per unit.
Cost of Revenues, Related Party Cost of revenues, related party, relating to inventory purchased before the Strategic Transaction, is comprised of purchase costs of our products, Ameluz and RhodoLED Lamps from Biofrontera Pharma GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products.
Removed
These statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievement to differ materially from anticipated results, performance, or achievement, expressed or implied in such forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions, and are subject to risks and uncertainties.
Added
We discuss many of these risks and uncertainties at the beginning of this Form 10-K and under the sections captioned “Business” and “Risk Factors.” For more information on forward-looking statement, see the section titled “Special Note Regarding Forward-Looking Statements” included in Part 1 of this Form 10-K.
Removed
Forward-Looking Statements The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain statements in this Form 10-K constitute “forward-looking statements”.
Added
Strategic Transaction On October 20, 2025, we entered into i) an Asset Purchase Agreement (the “Transfer Agreement”) and ii) an Earnout Agreement (together with the Transfer Agreement, the “Agreements”), with Biofrontera AG and its consolidated subsidiaries (the “Biofrontera Group”), pursuant to which the Company finalized the agreements to acquire all rights in the United States (the “U.S.
Removed
Such statements include statements regarding the timeline for regulatory review and approval of our products, the availability of funding sources for continued development of such products, and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words.
Added
Rights”) to Ameluz and RhodoLED (the “Strategic Transaction”).
Removed
Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements.
Added
Pursuant to the terms of the Agreements, retroactive to June 1, 2025, the Company will pay a monthly earnout of 12% of United States revenues of Ameluz in years when United States net sales are $65.0 million or less and an earnout of 15% on all revenue in years when United States net sales of Ameluz exceed $65.0 million, continuing until the expiration of patent protection on Ameluz allows for generic competition in the United States (if not terminated sooner by agreement of the parties).
Removed
See Part I, Item 1A, “Risk Factors” of this Form 10-K for a discussion of the factors that could cause such differences.
Added
The earnout replaces a transfer pricing model under the Company’s Second A&R Ameluz LSA by and among the Company and the Biofrontera Group, which has now been terminated pursuant to the Agreements. The new structure reduces overall cost for the Company and is expected to accelerate the Company’s timeframe to reach break-even. 35 In exchange for the U.S.
Removed
However, other factors besides those listed in Part I, Item 1A, “Risk Factors” or otherwise discussed in this Annual Report also could adversely affect our results, and you should not consider any such list of factors to be a complete set of all potential risks or uncertainties.
Added
Rights, in addition to the aforementioned earnout and an agreement to transfer all costs associated with the U.S. business, Biofrontera AG received 3,019 shares of Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred Stock”).
Removed
Any forward-looking statements made by us or on our behalf speak only as of the date they are made. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law. 44 Overview Biofrontera Inc.
Added
With the completion of the Strategic Transaction, the Company assumed full control of the Ameluz New Drug Application and Investigational New Drug, enabling the Company to manage ongoing and future clinical development activities independently, and to take full responsibility for all aspects of manufacturing and marketing Ameluz and the RhodoLED lamps in the U.S.
Removed
We are currently selling Ameluz ® in the United States under a n exclusive license and supply agreement, the Second Amended and Restated License and Supply Agreement, effective as of February 13, 2024 with the Ameluz Licensor (the “Second A&R Ameluz LSA”).
Added
The patent and trademark transfers further strengthen the Company’s intellectual property portfolio and market position in the U.S.
Removed
The Second A&R Ameluz LSA reduced the Transfer Price of Ameluz ® from 50% to 25% which covers the cost of goods, royalties on sales, and services including all regulatory efforts, agency fees, pharmacovigilance and patent administration for all purchases in 2024 and 2025.
Added
On November 6, 2025, the Company entered into an Asset Purchase Agreement with an unaffiliated party, providing for the sale of the intangible asset relating to the Company’s product, Xepi, for initial proceeds of $3 million with the potential for up to an additional $7 million in milestone payments.
Removed
Starting on January 1, 2026, until 2032 there will be stepwise increases in the Transfer Price from 25% to 35% for sales related to actinic keratosis and, if approved by the FDA, basal cell carcinoma and squamous cell carcinoma. The transfer price for sales related to acne, another indication currently in development, will remain at 25% indefinitely.
Added
This divestiture does not represent a strategic shift that will have a major effect on our consolidated results of operations. See Note 9. Assets Held for Sale , for additional information.
Removed
In October 2024, the FDA approved the Company’s Supplemental New Drug Application to increase the maximally approved dosage of Ameluz ® from one to three tubes per treatment.
Added
Compliance with Nasdaq Listing Standards On December 31, 2025, the Company received a letter from Nasdaq notifying the Company that the listing of the Common Stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) as the closing bid price of the Common Stock was less than $1.00 per share for the previous 34 consecutive business days.
Removed
This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing PDT for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients. In combination with the RhodoLED ® XL Lamp, providers can now treat a patient’s face more efficiently.
Added
The notice has no present impact on the listing or trading of the Company’s securities on Nasdaq. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until June 30, 2026, to regain compliance with the rule referred to in this paragraph.

… 76 more changes not shown on this page.

Other BFRIW 10-K year-over-year comparisons