Earnings summaries and quarterly performance for Biofrontera.
Executive leadership at Biofrontera.
Board of directors at Biofrontera.
Research analysts who have asked questions during Biofrontera earnings calls.
Recent press releases and 8-K filings for BFRI.
Biofrontera Reports Positive Phase 2b Results for Ameluz® in Acne Vulgaris
BFRI
New Projects/Investments
- Biofrontera Inc. announced positive Phase 2b clinical trial results for Ameluz® Photodynamic Therapy in treating moderate to severe acne vulgaris on March 9, 2026.
- The study identified a 3-hour incubation regimen as the most promising protocol, achieving a 57.97% reduction in inflammatory lesions in the Ameluz group compared to 36.51% in the vehicle group.
- Ameluz® PDT demonstrated a favorable safety profile and high patient satisfaction, with 85.7% of patients in the 3-hour Ameluz group stating they would choose the treatment again.
- The company plans to present these Phase 2b data to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss potential next steps for developing Ameluz® PDT for this indication.
5 days ago
Biofrontera announces U.S. Patent Office finds Sun Pharma's patent unpatentable
BFRI
Legal Proceedings
- On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 to be unpatentable.
- This decision follows proceedings initiated by Sun Pharma in June 2024 alleging infringement, to which Biofrontera responded by challenging the patent's validity.
- Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit.
- The impact of this decision on the pending proceedings in the U.S. District Court for the District of Massachusetts and the International Trade Commission is not determinable at this time.
Feb 26, 2026, 2:20 PM
Biofrontera Receives Favorable Patent Decision Against Sun Pharma
BFRI
Legal Proceedings
- On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.’s U.S. Patent No. 11,697,028 to be unpatentable.
- This decision follows proceedings initiated by Sun Pharma in June 2024, alleging infringement of the ‘028 Patent and a related patent by Biofrontera.
- Biofrontera had challenged the validity of these claims, and the Board agreed with Biofrontera on all challenged claims of the ‘028 Patent.
- Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit.
Feb 26, 2026, 2:15 PM
Biofrontera Announces Database Lock for Ameluz® Phase 1 PK Study
BFRI
New Projects/Investments
Guidance Update
- Biofrontera Inc. completed the database lock for its Phase 1 maximal-use pharmacokinetics (PK) study of Ameluz® topical gel on February 11, 2026.
- This study assessed systemic exposure to 5-aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz®.
- The PK data, combined with previously announced positive Phase 3 efficacy results, will support a supplemental New Drug Application (sNDA) to the U.S. FDA for label expansion.
- The sNDA submission is expected in Q3 2026 and aims to extend the Ameluz® label to treat mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, expanding the treatment field from 60 cm² to up to 240 cm².
Feb 17, 2026, 2:15 PM
Biofrontera's Ameluz® sNDA Accepted by FDA for sBCC Treatment
BFRI
Product Launch
New Projects/Investments
- Biofrontera Inc. announced the FDA's acceptance of its supplemental New Drug Application (sNDA) for Ameluz® topical gel for the treatment of superficial Basal Cell Carcinoma (sBCC).
- The FDA identified no filing deficiencies and set a Prescription Drug User Fee Act (PDUFA) target action date of September 28, 2026.
- If approved, Ameluz® would be the first and only photodynamic therapy (PDT) photosensitizer indicated for sBCC in the U.S., a condition affecting approximately 3.6 million cases diagnosed annually.
- This potential new indication is expected to meaningfully expand the addressable market for Ameluz® and strengthen Biofrontera's position in medical dermatology.
Feb 11, 2026, 2:15 PM
Biofrontera announces positive Phase 3 study results for Ameluz PDT
BFRI
New Projects/Investments
Product Launch
- Biofrontera Inc. announced positive and statistically significant top-line results from its Phase 3 clinical trial for Ameluz® PDT, which met its primary endpoint.
- The study evaluated Ameluz® PDT for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, demonstrating highly statistically significant superiority over vehicle gel (p<0.0003).
- In the Full Analysis Set (FAS), 45.6% of patients treated with Ameluz® PDT achieved complete clearance of all treated AK lesions, compared to 16.7% for vehicle PDT.
- Based on these results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in the third quarter of 2026, which could expand Ameluz®'s addressable market beyond the face and scalp.
Feb 9, 2026, 2:20 PM
Biofrontera Announces Positive Phase 3 Study Results for Ameluz® PDT
BFRI
Product Launch
New Projects/Investments
- Biofrontera Inc. announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® PDT for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
- The study met its primary endpoint, demonstrating highly statistically significant superiority for Ameluz® compared to vehicle gel (p<0.0003).
- In the Full Analysis Set, 45.6% of patients treated with Ameluz® PDT achieved complete clearance of all treated AK lesions, significantly higher than the 16.7% for vehicle PDT.
- Based on these positive results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026.
- These findings support the potential to expand Ameluz®'s addressable market beyond the face and scalp, providing a meaningful benefit to patients with AKs on other sun-exposed body areas.
Feb 9, 2026, 2:15 PM
Lytham Partners 2026 Investor Healthcare Summit Highlights
BFRI
Revenue Acceleration/Inflection
M&A
New Projects/Investments
- 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
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
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
Quarterly earnings call transcripts for Biofrontera.
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