Biofrontera Inc. Q3 FY2025 earnings call

• Revamped sales approach centered on refined customer segmentation and data-driven sales execution has been effective, with stable revenues without a price increase booster.
• Progress in advancing as a premier dermatology company, with Ameluz PDT's clinical value and efficacy better understood. Installed base of RhodoLED lamps expanding.
• Clinical pipeline advancing: Submitting new FDA application for Ameluz to treat superficial basal cell carcinoma in Q4 2026; completed patient enrollment in Phase III trial for AK on extremities, neck, trunk and Phase IIb trial for acne vulgaris. Patent approval for improved Ameluz formulation extends protection to 2043.
• Transformational agreement with Biofrontera AG: Full control over Ameluz and RhodoLED assets, new royalty structure (12% below $65M revenue, 15% above) replaces prior transfer pricing, enhancing gross margins and profitability. Completed divestment of Xepi license, receiving $3M with potential $7M more on milestones.

For the third quarter of 2025, total revenues were $7.0 million compared to $9.0 million in the third quarter of 2024. Year-to-date revenues for the first 9 months of 2025 were $24.6 million, flat to the $24.8 million in the first 9 months of 2024. Cost of revenues decreased in the third quarter and first 9 months due to reduced transfer prices and the new royalty model. Revenue contribution details aren't explicitly broken down by product segment in terms of percentage, but the focus is on Ameluz PDT and RhodoLED lamps.

• Contemplating a price increase before year-end.
• Anticipate strong revenue growth in Q4 2025 and throughout 2025, remaining on track to achieve full year sales objectives.
• Believe to reach cash flow breakeven for fiscal year 2026, with individual quarters in 2026 potentially bouncing around before full year breakeven.
• Plans to submit Ameluz data for extremities AK to FDA in Q2 2026 after waiting for maximal-use pharmacokinetic study results.

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 trial for AK of the extremities be available and what's the plan for submitting to the FDA?

A: Data will be available probably in January. Waiting for results of a maximal-use pharmacokinetic study, expected about a month later than the pivotal trial (so February). Plan to submit to the FDA in Q2 after putting all data together into the dossier.

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, early next year. Next step is an end of Phase II meeting with the FDA, then plan Phase III studies based on FDA's position.

Q: Should we think of breaking even similar to seasonality with individual quarters in 2026 bouncing around between losses and gains and then the fourth quarter being fairly large resulting in a breakeven profit situation for the full year?

A: Yes, that's exactly right.