Biofrontera Inc. Q3 FY2024 earnings call

• Progress in previous months: Increased Ameluz tube orders, improved FDA label to allow up to 3 tubes per treatment, outstanding clinical results for new indications, launched RhodoLED XL lamp, and transferred Ameluz clinical trials to Biofrontera Inc.
• Third quarter revenue: $9.0 million, up 1.5%; first nine months sales: $24.8 million, up 5.6% (5.6% growth excluding Hurricane Milton impact).
• Clinical trials: Phase 2 for acne has 106 of 126 patients enrolled; Phase 3 for superficial BCC has locked the database; Phase 3 for peripheral AK has 130 of 165 patients enrolled.
• Cost control: SG&A expenses reduced 14% in the first nine months of 2024 compared to the prior year.

In the third quarter of 2024, total revenues were $9.0 million, a 1.5% increase from the prior year. Revenue from Ameluz was affected by a delay in shipping 4,640 tubes valued at $1.5 million due to Hurricane Milton, which would have boosted Q3 growth by 19% if not for the delay. For the first nine months of 2024, sales grew by $1.3 million to $24.8 million, a 5.6% increase. The RhodoLED XL lamp contributed to revenue growth, with 39 XL lamps and 66 BF-RhodoLED lamps installed in the first three quarters of 2024. Ameluz sales saw a net decrease in units due to the hurricane delay, but without the delay, growth would have been stronger.

• Third quarter revenue would have been 19% growth year-over-year without Hurricane Milton delay.
• Expect a strong Q4 due to PDT season and tax-related ordering by customers.
• Cash flow breakeven expected towards the end of 2025 into 2026.
• Revenue growth for the current year is expected to be mid- to high teens.

• Impact of Hurricane Milton on Ameluz shipments, delaying revenue recognition.
• Legal expenses related to ITC complaints from DUSA Pharmaceuticals.
• Uncertainty in insurance reimbursement for Ameluz's new 3-tube labeling until CMS MUE was removed.

Q: When will the cost of revenue start to better reflect the 25% margin?

A: Fred Leffler expects the impact in the fourth quarter as they go through older inventory.

Q: Do you still expect to be cash flow breakeven by end of next year and grow revenue 20% over 2023?

A: Fred Leffler expects revenue growth similar to prior years (mid- to high teens) and cash flow breakeven towards end of 2025 into 2026.

Q: Were orders with shipments in October grandfathered in the older price?

A: Fred Leffler says all orders placed in Q3 were grandfathered in the older price.

Q: Enrollment numbers for acne and peripheral AK trials?

A: Hermann Luebbert states acne Phase 2 has 106 of 126 enrolled; peripheral AK Phase 3 has 130 of 165 enrolled.

Q: How see Q4 revenue development after price increase?

A: Hermann Luebbert and Fred Leffler expect a strong Q4 due to PDT season and tax-related ordering despite price increase.

Q: Customer response to new 3-tube labeling?

A: Hermann Luebbert says they prevented early response to avoid reimbursement issues, but now with CMS MUE removed, expect uptake starting next week.