Biofrontera (BFRI) investor relations material

Executive summary

• Achieved record Q2 and H1 2026 performance as a standalone U.S. business, with net product revenue up 32.9% year-over-year to $12.0 million in Q2 2026, driven by higher Ameluz sales and accelerated order timing due to anticipated ITC supply restrictions.

• Gross margin expanded to 80% from 71% a year ago, and Adjusted EBITDA improved to near breakeven at $(0.2) million, a significant improvement from a $5.1 million loss in Q2 2025.

• Strategic transaction in October 2025 with Biofrontera Group granted full U.S. rights to Ameluz and RhodoLED, reducing transfer pricing costs and improving profitability.

• Operating loss narrowed to $0.5 million from $5.1 million in Q2 2025, reflecting improved gross profit and lower operating expenses.

• Accelerated reorder pace and strong demand for Ameluz, with pipeline progress in new indications including sBCC and acne.

Financial highlights

• Q2 2026 net product revenue was $12.0 million, up 32.9% from $9.0 million in Q2 2025; H1 2026 revenue was $22.1 million, up 25.4% year-over-year.

• Gross profit margin for Q2 was 80%, up from 71% in Q2 2025; H1 gross margin was 80% versus 67% in H1 2025.

• Net loss for Q2 was $0.6 million ($0.05/share), a sharp improvement from $5.3 million ($0.57/share) in Q2 2025; H1 net loss was $5.4 million, improved from $9.5 million year-over-year.

• Adjusted EBITDA for Q2 was $(0.2) million, up from $(5.1) million in Q2 2025; H1 Adjusted EBITDA was $(3.7) million versus $(9.5) million last year.

• Cash and equivalents at June 30, 2026, were $4.7 million, down from $6.4 million at year-end 2025.

Outlook and guidance

• Expectation to achieve cash flow breakeven in 2026, supported by strong commercial execution, cost discipline, and margin improvements.

• Anticipate full launch of Ameluz for superficial basal cell carcinoma in Q1 2027, pending FDA approval (PDUFA date: September 28, 2026).

• Plan to file for label expansion for actinic keratosis on extremities, neck, and trunk by end of Q3 2026, with FDA approval expected in Q3 2027.

• Advancing acne program toward phase III, with future growth expected through expanded indications.

• No formal quantitative guidance provided.