Welcome to our dedicated page for Biofrontera SEC filings (Ticker: BFRI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Biofrontera Inc. (NASDAQ: BFRI) SEC filings page provides access to the company’s official disclosures as filed with the U.S. Securities and Exchange Commission. Biofrontera is a U.S.-based biopharmaceutical company focused on dermatology and photodynamic therapy (PDT), commercializing Ameluz® and the RhodoLED® lamp series for actinic keratoses and developing additional indications such as superficial basal cell carcinoma and acne vulgaris.
Through its current and periodic reports, investors can review how Biofrontera describes its business, risk factors and financial condition. Form 8-K filings document material events, including quarterly financial results, strategic transactions with Biofrontera AG to acquire all U.S. rights to Ameluz® and RhodoLED®, private placements of Series C and Series D convertible preferred stock, and the divestiture of the Xepi® antibiotic cream license. Other 8-Ks detail Nasdaq listing compliance notices and stockholder meeting outcomes.
Annual reports on Form 10-K and quarterly reports on Form 10-Q (when available) typically include information on revenues from dermatology products, operating expenses, liquidity, and discussions of clinical and regulatory progress for Ameluz®-PDT. These filings also outline the company’s reliance on product sales, competition in dermatology, intellectual property matters, and other risks relevant to its PDT-focused business model.
Stock Titan enhances these filings with AI-powered summaries that highlight key points from lengthy documents, helping users quickly understand topics such as revenue trends, changes in earnout structures, capital raises, and outcomes of clinical and regulatory milestones. Investors can also use this page to monitor Form 4 insider transaction reports, as well as proxy and registration statements that discuss governance, capital structure and preferred stock offerings.
By combining real-time EDGAR updates with AI-generated insights, this page offers a structured view of Biofrontera’s regulatory history, financial reporting, and material corporate events tied to its dermatology and photodynamic therapy strategy.
Biofrontera Inc. is a U.S.-based biopharmaceutical company focused on photodynamic therapy for dermatology, led by its Ameluz drug used with RhodoLED lamps to treat actinic keratosis. A key milestone was an October 20, 2025 strategic transaction through which it acquired all U.S. rights to Ameluz and RhodoLED from the Biofrontera Group, shifting control of manufacturing, clinical development and regulatory assets to the company. Biofrontera is pursuing label expansions, including superficial basal cell carcinoma, moderate to severe acne, and actinic keratosis on the trunk and extremities, with an sBCC supplemental NDA accepted by the FDA and a PDUFA date of September 28, 2026. A new Ameluz formulation without propylene glycol, backed by a U.S. patent expiring in 2043, has been implemented in U.S. production. As of December 31, 2025, the company had 92 employees and no single customer represented more than 10% of receivables or revenue. The filing highlights substantial regulatory, reimbursement, manufacturing, intellectual property, financing and going-concern risks.
Biofrontera Inc. reported record fourth quarter 2025 results, highlighted by strong growth and a swing to profitability. Q4 revenues rose 36% to $17.1 million from $12.6 million, with gross margin expanding to 82.4% from 58.0%. Operating income reached $4.6 million and net income was $5.6 million, both reversing prior-year losses.
For full year 2025, revenue increased 12% to $41.7 million, while the net loss narrowed to $10.5 million from $17.7 million. Adjusted EBITDA improved to $4.9 million in Q4 versus a $(1.4) million loss a year earlier, though it remained negative at $(10.6) million for the year. Cash and cash equivalents were $6.4 million as of December 31, 2025.
The company completed the purchase of all U.S. Ameluz and RhodoLED assets, reducing the earnout rate on U.S. net sales from 25%–35% to 12%–15%, and advanced its PDT pipeline with positive Phase 2b and Phase 3 data and an FDA-accepted sBCC sNDA with a PDUFA date in September 2026.
Biofrontera Inc. reported positive Phase 2b clinical results for its Ameluz® photodynamic therapy in moderate to severe acne vulgaris. In the 3-hour incubation per-protocol group, Ameluz achieved a 57.97% reduction in inflammatory lesions versus 36.51% with vehicle, and 25% of Ameluz patients met the mIGA co-primary endpoint compared with 21.4% on vehicle.
The 3-hour regimen also showed larger absolute reductions in inflammatory, non-inflammatory and total lesion counts and a safety profile consistent with prior PDT experience, with mainly mild to moderate burning and itching. Patient satisfaction was high, and the company plans to present these Phase 2b data to the FDA in Q3 2026 to discuss potential next development steps.
Biofrontera Inc. director Kevin Daniel Weber reported receiving an employee stock option grant to acquire 20,000 shares of the company’s stock. The option carries an exercise price of $0.00 per share and represents a new award, bringing his total directly held derivative securities from this grant to 20,000 options.
According to the disclosure, the option vests in twelve equal monthly installments beginning on April 4, 2026, meaning the right to exercise will phase in over one year. The filing notes that other options with different terms are not included in this reported transaction.
Biofrontera Inc. CEO and Chairman Hermann Luebbert reported several equity awards and an option-related share conversion. On March 4, 2026, he received 125,000 restricted stock units and an employee stock option for 125,000 shares, both at a price of $0.00 per unit or option. The restricted stock units vest in two equal yearly installments beginning on March 4, 2027, and may be settled in shares, cash, or a combination within 60 days of each vesting date. The option vests in two equal installments on September 4, 2026 and March 4, 2027. On March 5, 2026, 137,500 restricted stock units were exercised or converted into 137,500 shares of common stock at $0.00 per share, bringing his directly held common stock to 290,211 shares after the transaction.
Biofrontera Inc. Chief Financial Officer Eugene Frederick Leffler reported equity compensation activity, mainly awards and a derivative conversion. On March 4, 2026, he received 62,500 restricted stock units and 62,500 employee stock options, both granted for no cash consideration.
On March 5, 2026, 87,500 restricted stock units were converted into 87,500 shares of common stock at a price of $0.00 per share, leaving him with 175,000 common shares held directly after the transaction.
Lanckriet Heikki reported acquisition or exercise transactions in this Form 4 filing.
Biofrontera Inc. director Heikki Lanckriet received a grant of employee stock options covering 20,000 shares on March 4, 2026. These options were awarded at a stated price of $0.0000 per share and represent a new direct derivative holding of 20,000 options.
The option grant vests in twelve equal monthly installments, beginning on April 4, 2026, spreading the benefit to the director over one year. The disclosure notes that options with different terms are not included in this reported amount.
Hoffman Beth J. reported acquisition or exercise transactions in this Form 4 filing.
Biofrontera Inc. director Beth J. Hoffman reported receiving an award of 20,000 employee stock options on March 4, 2026. The options were granted at a reported price of $0.0000 per share. They vest in twelve equal monthly installments beginning on April 4, 2026. After this grant, she holds 20,000 options directly.
Biofrontera Inc. reported that Chief Commercial Officer George Patrick Jones acquired new equity-based compensation. He received 50,000 restricted stock units, each representing a contingent right to one share of BFRI common stock awarded for no consideration.
He also received an option for 50,000 shares with a grant price of $0.00. The option vests in two equal installments on September 4, 2026 and March 4, 2027. The restricted stock units vest in two equal yearly installments beginning March 4, 2027, and each vested unit will be settled in shares, cash, or a combination within 60 days at the company’s discretion.
Biofrontera Inc. director John J. Borer III received an employee stock option grant on March 4, 2026. The award covers options to purchase 20,000 shares, reported at a price of $0.00 per share as a derivative security grant. According to the terms, the option vests in twelve equal monthly installments beginning on April 4, 2026, so the director earns the right to exercise portions of the option gradually over one year.