Biofrontera Inc. Q3 FY2024 earnings call

• Compared the first nine months of 2024 with 2023, total Ameluz tubes ordered increased slightly while costs were significantly reduced. • Improved the FDA label to allow up to three tubes of Ameluz per treatment, adding value. • Achieved outstanding clinical results for a new indication. • Launched the RhodoLED XL lamp, with 39 installed along with 66 BF-RhodoLED lamps in the first three quarters of 2024. • Transferred all clinical trial activities on Ameluz to Biofrontera Inc. • Controlled SG&A expenses by 14% in the first nine months of 2024. • Phase 2 study in the acne indication has 106 of 126 patients enrolled, Phase 3 superficial BCC study locked the database with encouraging results, and Phase 3 actinic keratosis in the periphery study has 130 of 165 patients enrolled.

In the third quarter of 2024, revenues increased by 1.5% to $9 million. Delivery of 4,640 tubes of Ameluz valued at $1.5 million was delayed to October due to Hurricane Milton, but the delayed product was shipped early in October and will be recognized in the current quarter. For the first nine months of 2024, sales grew by $1.3 million to $24.8 million, an increase of 5.6%. Revenue from devices, specifically the RhodoLED XL lamp, saw an increase in the third quarter due to its launch in June 2024, while Ameluz sales decreased by $0.5 million because of the hurricane-related delay. Cost of revenues in the third quarter was impacted by the rise in RhodoLED product revenue, partially offset by the Ameluz sales delay due to the hurricane.

• Expect revenue growth in the mid- to high teens this year. • Anticipate cash flow breakeven towards the end of 2025 into 2026. • Expect a very strong fourth quarter as it is traditionally the strongest quarter, influenced by factors like winter PDT use and tax reasons, and the delayed Ameluz tubes will contribute to the quarter. • The new 3-tube FDA label will start to be promoted next week, with uptake expected in December after CMS MUE removal.

• Delayed delivery of Ameluz tubes due to Hurricane Milton affected Q3 revenue growth. • Legal expenses related to complaints filed by DUSA Pharmaceuticals with the International Trade Commission (ITC).

Q: When will the cost of revenue start to better reflect the 25% valid through next year?

A: We expect that impact in the fourth quarter.

Q: Were the orders that fell into October grandfathered in the older price?

A: All orders were placed in Q3 and had the price pre-price increase as of October 1, so they were grandfathered.

Q: How do you see the fourth quarter developing in terms of revenue after the price increase?

A: Expect a very strong fourth quarter due to traditional factors like winter PDT use and tax reasons despite the price increase.

Q: Have you seen customer response to the new 3-tube labeling?

A: Not yet as we wanted to avoid reimbursement issues, but now that MUE is removed, promotion will start next week with uptake expected in December.