On May 14, 2026 Biofrontera Inc. (NASDAQ: BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported financial results for the three months ended March 31, 2026 and provided a business update.

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First Quarter Financial Highlights

Revenues for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period in 2025.
Gross margins were about 80%, an 18 percentage points increase compared to approximately 62% in Q1 2025, reflecting the first full quarter under the new earnout structure following the closing of the strategic transaction with Biofrontera AG in October 2025 (the "Strategic Transaction").
Operating loss was $4.3 million in Q1 2026 compared to a loss of $4.5 million in Q1 2025.
Adjusted EBITDA improved to $(3.6) million from $(4.4) million in Q1 2025, an improvement of approximately $0.8 million reflecting expanded gross margins under the new earnout structure.
With $70 thousand used in operations, we largely maintained the operating cash balance we had at the end of Q4 2025, with $6.3 million as of March 31, 2026, compared to $1.8 million in Q1 2025.

Recent Operational Highlights

Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026.
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, meeting the primary endpoint.
Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk with a treatment area of up to 240 cm².
Announced positive results of its Phase 2b clinical trial for the treatment of moderate to severe acne vulgaris (AV), with a 58% reduction in inflammatory lesions in the 3-hour incubation protocol with Ameluz PDT, compared to 37% with vehicle PDT (PPS).
Regained compliance with the Nasdaq Minimum Bid Price Requirement as confirmed by Nasdaq on May 6, 2026.

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated: "The first quarter of 2026 marks the first full quarter under our new cost structure following the Strategic Transaction, and the results speak clearly. Revenue grew 17% year over year, gross margins expanded to approximately 80%, and our cash consumption was near zero—a dramatic improvement from $4.1 million of cash consumption in the prior-year quarter. Our results were further driven by continued commercial momentum leading to significant uptake of the Ameluz PDT platform by dermatologists and their patients.

At the same time, our clinical pipeline continues to advance at an accelerated pace. With a PDUFA date for sBCC in September 2026, positive Phase 3 results in AK on neck/trunk and extremities, and encouraging Phase 2b data in acne, we have multiple near-term catalysts that could meaningfully expand the commercial opportunity for the Ameluz platform.

We remain focused on our goal of reaching sustained profitability and cash-flow breakeven while setting the foundation for medium to long-term growth, and I believe we are well positioned to help our customers and their patients and build long-term value for our shareholders."

(Press release, Biofrontera, MAY 14, 2026, View Source [SID1234669304])