Biofrontera Inc. Q2 FY2025 earnings call

• Biofrontera achieved record-breaking results in the second quarter and first half of 2025. Over 50,000 tubes of Ameluz were sold in the first half of 2025. - The company transformed customer segmentation, focused its strategy, and adjusted sales team hiring to prioritize attitudinal factors over dermatology experience. - 40 RhodoLED XL lamps were placed in physician offices in the first half of 2025, with over 700 lamps now in doctors' offices. - Biofrontera restructured its relationship with Biofrontera AG, making Biofrontera Inc. independent and transferring U.S. rights for Ameluz and RhodoLED lamps. - CMS listed Ameluz in its MUE files for up to 3 tubes per treatment. - Enrollment was completed in the Phase III study for Ameluz on actinic keratosis of the trunk, neck, and extremities. The Phase III trial for superficial basal cell carcinoma was completed with 1-year follow-up data. Patient enrollment was finished in the Phase II trial for acne vulgaris. - Biofrontera received patent approval for a new improved formulation of Ameluz, extending patent protection to December 2043.

In the second quarter of 2025, total revenues were $9.0 million compared to $7.8 million in the second quarter of 2024. This increase was driven by a 5% higher unit sale price and a 9.5% increase in the sales volume of Ameluz. For the first half of 2025, total revenues amounted to $17.6 million, up from $15.8 million in the first half of 2024. The 12% growth was attributed to a higher unit sales price ($0.6 million contribution), increased Ameluz sales volume ($1 million contribution), and approximately $0.3 million increase in sales of RhodoLED lamps. Cost of revenues decreased in the second quarter and first half of 2025 due to the reduced transfer prices resulting from the restructuring with Biofrontera AG.

• The FDA submission for the superficial basal cell carcinoma indication is expected in the second half of 2025. - Data from the Phase II trial for acne vulgaris is anticipated in the fourth quarter of 2025. - There are no plans to increase prices this year. - The patent extension helps in recovering investment and realizing profits from potential opportunities.

• Legal expenses are uncertain and can be lumpy, with timing being unpredictable. - Potential impacts from tariffs in the future, although the restructuring helps address some of these risks.

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

A: 40 RhodoLED XL lamps were placed in the first half of 2025. For Q2 specifically, 18 XLs were mentioned initially, with further clarification that 40 XL lamps were in the first half of 2025. Details on smaller lamps were to be provided later.

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

A: It is a third quarter '2025 event.

Q: Timing for acne data and peripheral AK data?

A: Both the data from the acne trial and the peripheral AK trial are expected in the fourth quarter of 2025.

Q: Any price hikes soon?

A: There are no plans to increase prices this year.

Q: Conversion of Levulan users to Ameluz?

A: Typically, users initially use both Levulan and Ameluz, and conversion from Levulan users grows over time.

Q: Fraction of Levulan use in approved areas?

A: Roughly 20% on arms for Levulan, and 80% on face and scalp where Ameluz is approved for Levulan users.

Q: Gross margin outlook?

A: Gross margin should increase substantially due to the shift to a royalty model, moving from a 25% transfer price to 12%/15% royalty.

Q: Legal expenses outlook?

A: Legal expenses spiked in Q2 2025 and are expected to come down, with SG&A run rate more in line with historical amounts in Q3 and Q4 2025.

Q: Timing for FDA submission of superficial basal cell carcinoma?

A: The FDA submission for the superficial basal cell carcinoma indication is expected in the second half of 2025.