Biofrontera (BFRI) Company Report

Biofrontera (BFRI) reported $37.3 million in revenues for 2024 and anticipates low- to mid-double-digit revenue growth over the next several years, with gross margins expected to increase to 80%-85% due to the acquisition of full ownership of its Ameluz product.
Biofrontera expects FDA approval for basal cell carcinoma (sBCC) by the end of September 2026 and PDUFA for trunk and extremities in mid-2027, which are projected to support continued revenue growth.
LSL Pharma Group (LSL) projects 2025 top-line revenue to be close to CAD 30 million with approximately CAD 4 million in EBITDA, and targets CAD 65-70 million in top-line revenue for 2026, driven by recent acquisitions and organic growth.
LSL Pharma Group is focusing on its high-margin ophthalmic business, which is expected to contribute over 70% of EBITDA and 50% of top-line revenue in the future, and anticipates U.S. FDA approval for its Steri-Med plant to enter the U.S. market with ophthalmic ointments.

Jan 15, 2026, 1:30 PM

Transcript

Lytham Partners 2026 Investor Healthcare Summit Highlights Biofrontera and LSL Pharma Group

BFRI

Revenue Acceleration/Inflection

New Projects/Investments

M&A

Biofrontera Inc. (BFRI) reported $37.3 million in revenues for 2024 and anticipates low- to mid-double-digit revenue growth over the next several years, with gross margins expected to reach 80%-85% in 2026 following a revised licensing agreement.
Biofrontera is expanding its Ameluz drug label, with FDA approval for basal cell carcinoma anticipated by the end of September 2026 and PDUFA for trunk and extremities in mid-2027, and expects to achieve breakeven in 2026.
LSL Pharma Group projects its top line to exceed CAD 60 million in 2026, a significant increase from less than CAD 10 million two years prior, driven by its Contract Manufacturing (CMO), Eye Care, and recently acquired OTC segments.
LSL Pharma's CMO division is targeting CAD 45 million and its OTC business is targeting CAD 20-25 million in top line for the next year (2027), with an overarching goal to reach $100 million top line within two years through organic growth and acquisitions.

Jan 15, 2026, 1:30 PM

Transcript

Biofrontera Inc. Announces Preliminary Q4 and Full Year 2025 Revenue Results

BFRI

Earnings

Guidance Update

Revenue Acceleration/Inflection

Biofrontera Inc. announced preliminary unaudited revenues for the fourth quarter ended December 31, 2025, are expected to be between $17.0 million and $17.5 million, representing 35% to 39% year-over-year growth.
For the full year 2025, preliminary revenues are anticipated to be in the range of $41.5 million to $42.0 million, reflecting 11% to 13% year-over-year growth.
These preliminary figures are subject to change, with complete financial results for Q4 and full year 2025 expected to be reported in March 2026.

Jan 13, 2026, 1:35 PM

8-K

Biofrontera Inc. Announces Preliminary Record Fourth Quarter and Full Year 2025 Revenues

BFRI

Earnings

Guidance Update

Revenue Acceleration/Inflection

Biofrontera Inc. announced preliminary unaudited fourth quarter 2025 revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history.
This preliminary Q4 2025 revenue indicates a year-over-year growth of 35% to 39%, driven by strong sales execution of Ameluz® and a pricing adjustment.
For the full year 2025, revenues are anticipated to be in the range of $41.5 million to $42.0 million, reflecting an expected year-over-year growth of 11% to 13%.
The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026, noting that these preliminary figures are subject to change.

Jan 13, 2026, 1:30 PM

Press Release

Biofrontera Inc. Announces Database Locks for Clinical Studies

BFRI

New Projects/Investments

Biofrontera Inc. successfully locked the databases on January 5, 2026, for its Phase 3 clinical study evaluating Ameluz® PDT for actinic keratosis (AK) and its Phase 2 clinical study for moderate to severe acne vulgaris.
This achievement marks an important milestone ahead of anticipated data and regulatory events in 2026.
Data for both studies is expected to be available in February 2026.
Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) for AK to the FDA in Summer 2026 and present acne vulgaris study results to the FDA in early Q3 2026.

Jan 8, 2026, 1:45 PM

Press Release

Biofrontera Inc. Completes Transfer of Ameluz® and RhodoLED® FDA Approvals and Intellectual Property

BFRI

New Projects/Investments

M&A

Biofrontera Inc. has completed the transfer of FDA approvals for Ameluz® and the RhodoLED® Lamp Series, including the New Drug Application (NDA) and Investigational New Drug Application (IND), effective December 17, 2025.
The company now assumes full control of the Ameluz® NDA and IND, enabling independent management of clinical development, manufacturing, and marketing of Ameluz® and RhodoLED® lamps in the US.
Biofrontera Inc. also completed filings to transfer associated US and international intellectual property, including 11 granted US patents, 10 US patent applications, and 19 international patent filings or registered designs for RhodoLED® lamps.
These asset transfers were partly secured by an $11.0 million investment.

Dec 18, 2025, 1:45 PM

Press Release

Biofrontera Reports Q3 2025 Results, Strategic Asset Acquisition, and 2026 Breakeven Outlook

BFRI

Earnings

Guidance Update

New Projects/Investments

Biofrontera reported Q3 2025 revenues of $7.0 million, a 22% decrease compared to Q3 2024, primarily due to a temporary comparison effect from advanced purchases in Q3 2024 ahead of a price increase. Year-to-date revenues for the first nine months of 2025 were $24.6 million, approximately flat compared to the same period in 2024.
The company's net loss for Q3 2025 was $6.6 million and Adjusted EBITDA was negative $6.0 million. For the first nine months of 2025, the net loss was $16.2 million and Adjusted EBITDA was negative $15.7 million.
Biofrontera acquired all U.S. rights, approvals, and patents for Ameluz and Rhodoled, establishing a new royalty structure of 12% or 15% based on U.S. Ameluz revenue, replacing a prior 25%-35% transfer pricing model.
The company completed the sale of its Xepi license, receiving $3 million at closing with potential for an additional $7 million, and secured an $11 million investment. These proceeds, combined with commercial execution, are expected to lead to cash flow breakeven for fiscal year 2026.
Biofrontera plans to submit a new FDA application for Ameluz to treat superficial basal cell carcinoma in the coming weeks, with commercialization expected in Q4 2026. They also completed patient enrollment for Phase 3 and Phase 2b trials for other indications.

Nov 13, 2025, 3:00 PM

Transcript

Biofrontera Inc. Reports Third Quarter 2025 Financial Results

BFRI

Earnings

Guidance Update

M&A

Biofrontera Inc. reported total revenues of $7.0 million for the third quarter of 2025 and $24.6 million for the first nine months of 2025. The company experienced a net loss of $6.6 million for Q3 2025 and $16.2 million for the first nine months of 2025.
The company completed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG, which is expected to significantly enhance gross margins and strengthen long-term profitability by reducing the payment rate to 12%-15% of U.S. net sales from 25%-35%.
Biofrontera Inc. announced the divestiture of its Xepi antibiotic cream to Pelthos Pharmaceuticals for $3 million at closing, with potential for up to $7 million in additional payments.
The cash balance as of September 30, 2025, was $3.4 million , and the company received the final $2.5 million of an $11 million financing in October 2025.
Management expects 4Q25 revenues to compensate for the Q3 effect and result in substantial annual year-over-year growth.

Nov 13, 2025, 1:30 PM

8-K

Biofrontera Inc. Reports Q3 2025 Financial Results and Business Update

BFRI

Earnings

Guidance Update

M&A

Biofrontera Inc. reported $24.6 million in revenues for the first nine months of 2025, which was stable compared to the same period in 2024, and $7.0 million for the third quarter of 2025. The company anticipates 4Q25 revenues to compensate for the Q3 lag, leading to substantial annual year-over-year growth and achievement of full-year sales objectives.
The company's net loss for the third quarter of 2025 was $6.6 million, and its cash balance as of September 30, 2025, was $3.4 million.
Biofrontera Inc. completed the purchase of all Ameluz and RhodoLED US Assets, which is expected to significantly enhance gross margins by reducing the payment rate to 12%-15% of U.S. net sales from the previous 25%-35%.
The company also received the final $2.5 million of an $11 million financing in October and announced the divestiture of its Xepi antibiotic cream for $3 million at closing, with potential for up to $6 million in milestone payments.

Nov 13, 2025, 1:15 PM

Press Release

Biofrontera Inc. announces sale of Xepi® license to Pelthos Therapeutics Inc.

BFRI

M&A

New Projects/Investments

Biofrontera Inc. (BFRI) divested its US license for Xepi® (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc. on November 6, 2025.
The transaction is valued at up to $10 million, consisting of $3 million received at closing, an additional $1 million upon commercial product availability, and up to $6 million in sales-related milestone payments.
The company expects these proceeds to bolster its cash position, fund Biofrontera to profitability, and support the growth of its photodynamic therapy (PDT) platform and expansion of Ameluz® into additional indications.