Biofrontera Inc. Q3 FY2025 earnings call

• Revenues: Year-to-date revenues were approximately flat to 2024, with Q3 2025 revenues down 22% from Q3 2024 but normalizing. Anticipate strong Q4 2025 and full-year growth. • Clinical Pipeline: Advancing Ameluz PDT with submission planned for superficial basal cell carcinoma in Q2 2026; Phase III trial for AK on extremities data expected in January, submit to FDA by end of February; Phase IIb trial for acne data early next year, plan Phase III after end of Phase II meeting with FDA. • Patent and Agreements: Extended patent life for Ameluz formulation to 2043; transformational agreement with Biofrontera AG gives full control over Ameluz and RhodoLED assets, new royalty structure to enhance margins; divested Xepi antibiotic cream, proceeds to support growth. • Financial Position: Aim for cash flow breakeven in fiscal year 2026, with improved control over manufacturing leading to better inventory and working capital management.

Year-to-date revenues for Biofrontera Inc. were approximately flat compared to the same period in 2024. In the third quarter of 2025, total revenues were $7.0 million, which was 22% lower than Q3 2024 due to the lack of a price increase from October 1, 2024. However, recent weeks have seen normalization, and strong revenue growth is anticipated in Q4 2025 and throughout 2026. For the first 9 months of 2025, total revenues were $24.6 million, flat compared to the first 9 months of 2024. Cost of revenues decreased significantly due to a reduced transfer price agreement with Biofrontera AG and a new royalty structure, which is expected to further impact financials positively.

• Anticipate strong revenue growth in Q4 2025 and throughout 2026. • Contemplating a price increase before year-end. • Plan to submit Ameluz for superficial basal cell carcinoma to the FDA in Q2 2026. • Data from AK extremities trial expected in January, submit to FDA by end of February, submit dossier in Q2. • Data from acne trial expected early next year, plan Phase III after end of Phase II meeting with FDA.

• General risks associated with business operations, including uncertainties in regulatory approvals, market conditions, and potential impacts of tariffs. • Risks related to forward-looking statements where actual results may differ materially from expectations.

Q: Are you contemplating any price increases in the future? And if so, when?

A: Yes, we are contemplating a price increase, and we are planning this before year-end.

Q: When will the data from the AK extremities trial be available and what is the plan for submitting to the FDA?

A: The data will be available probably in January. To submit to the FDA, we are waiting for results of a maximal-use pharmacokinetic study, expected about a month after the pivotal trial results (in February), so by end of February we'll have everything needed, then submit dossier to FDA in Q2.

Q: When will data from the acne trial be available and what's the next regulatory step?

A: Data will be pretty much in parallel with the data in the periphery, so early next year. Next step is an end of Phase II meeting with the FDA, then plan Phase III studies based on that.

Q: Should we think of breaking even similar to seasonality with individual quarters bouncing between losses and gains?

A: Yes, that's exactly right; individual quarters in 2026 might bounce around between losses and gains, with full year aiming for breakeven profit situation.