Biofrontera Inc. Q2 FY2025 earnings call

• Biofrontera completed restructuring with Biofrontera AG, becoming independent for U.S. market, shifting to a royalty model for Ameluz. - Recorded record-breaking results in Q2 and H1 2025, selling over 50,000 tubes of Ameluz in H1. - Changed sales team hiring to prioritize attitudinal factors. - CMS listed Ameluz in MUE files for up to 3 tubes per treatment. - Completed Phase III study for Ameluz on trunk, neck, extremities; Phase III for superficial basal cell carcinoma with 1-year follow-up data. - Phase II trial for acne vulgaris completed patient enrollment. - Extended patent for Ameluz formulation through 2043.

Ameluz: Second quarter 2025 revenues were $9.0 million, with a 9.5% increase in sales volume due to improved direct sales team efficiency. First half of 2025 revenues were $17.6 million, driven by higher unit sales price and increased Ameluz sales volume. RhodoLED lamps: Second quarter 2025 had 18 XL lamps placed; first half of 2025 had 40 XL lamps placed. Total lamps in doctors' offices exceed 700.

• Gross margins expected to increase substantially due to new royalty model replacing previous transfer price. - Legal expenses anticipated to decrease in Q3 and Q4 after spiking in Q2. - FDA submission for superficial basal cell carcinoma indication expected in second half of 2025. - Acne trial data and peripheral AK data both expected in 4Q 2025.

• Unpredictable legal expenses that were lumpy in Q2. - Potential impacts from tariffs in the future, though restructuring helps address this.

Q: How many of each lamp were placed in 2Q '25?

A: 40 XL lamps in the first half of 2025; 18 XLs in Q2; 9 small lamps year-to-date.

Q: When do you think you'll receive the $2.5 million?

A: Third quarter '2025.

Q: Timing for acne data and peripheral AK data?

A: Acne data in 4Q 2025, peripheral AK data also in 4Q 2025.

Q: Price hikes?

A: No expected this year.

Q: Conversion of Levulan users to Ameluz?

A: Typically use both initially.

Q: Gross margins going forward?

A: Should increase substantially due to new royalty model.

Q: Legal expenses timing?

A: Should come down in Q3 and Q4.

Q: Timing for FDA submission for superficial basal carcinoma?

A: Sometime in second half of 2025.