Biofrontera (BFRI) investor relations material

Executive summary

• Product revenues reached $10.1 million in Q1 2026, up 17%–17.4% year-over-year, driven by higher Ameluz sales, a price increase, and strong commercial execution under a new cost structure post-strategic transaction.

• Gross margin expanded to 80%, up from 62% in Q1 2025, reflecting a shift to a lower earnout-based cost structure.

• Cash used in operations was minimal at $70,000, a dramatic improvement from $4.1 million in Q1 2025, with cash and equivalents at $6.3 million at quarter-end.

• Clinical pipeline advanced with FDA acceptance of sNDA for superficial basal cell carcinoma (SBCC), positive Phase III results for actinic keratosis (AK) on new body areas, and promising Phase II/2b acne data.

• Regained Nasdaq compliance for minimum bid price in May 2026.

Financial highlights

• Revenues increased to $10.1 million from $8.6 million year-over-year, driven by 16% Ameluz unit volume growth and a price increase.

• Cost of revenues dropped 40%–40.5% to $1.8 million, reflecting the new earnout agreement.

• Operating expenses rose to $14.4 million from $13.1 million, mainly due to higher SG&A and legal costs.

• Net loss was $4.8 million ($0.41/share) versus $4.2 million ($0.47/share) in Q1 2025, impacted by non-recurring patent remediation and warrant liability changes.

• Adjusted EBITDA improved to -$3.6 million from -$4.4 million, with margin improving to -35.3% from -51.0%.

Outlook and guidance

• Targeting cash flow breakeven in 2026, supported by higher revenues, lower cost structure, and disciplined expense management.

• Expecting to maintain gross margin in the 80%-85% range for the year, with some variability based on product mix and discounting.

• Preparing for potential SBCC label expansion with a PDUFA date of September 28, 2026, and planning for immediate launch upon approval.

• sNDA filing for AK on neck, trunk, and extremities planned for Q3 2026.

• Phase III acne program design to be discussed with FDA in H2 2026.