Biofrontera Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net product revenue for the quarter ended September 30, 2026, was $9.1 million, a 29.8% increase from $7.0 million in the prior-year period.
• Net product revenue for the nine months ended September 30, 2026, was $31.2 million, a 26.6% increase from $24.6 million in the prior-year period.
• Gross margin for the quarter was 74.4%, an improvement from 70.7% in the prior-year period, driven by a lower cost structure following a strategic transaction, partially offset by ITC-related inventory write-downs and higher lamp/device costs.
• Gross margin for the nine months ended September 30, 2026, was 78.0%, compared to 67.7% in the prior-year period.
• Net loss for the quarter was $6.4 million ($0.42 per share), compared to $6.6 million ($0.62 per share) in the prior-year period.
• Net loss for the nine months ended September 30, 2026, was $11.8 million ($0.89 per share), compared to $16.2 million ($1.67 per share) in the prior-year period.
• Adjusted EBITDA for the quarter was $(5.5) million, compared to $(6.0) million in the prior-year period.
• Adjusted EBITDA for the nine months ended September 30, 2026, was $(9.3) million, compared to $(15.5) million in the prior-year period.
• Cash and cash equivalents were $3.2 million as of September 30, 2026, down from $6.4 million as of December 31, 2025.
• Cash used in operating activities for the nine months ended September 30, 2026, was $3.2 million, compared to $11.0 million in the prior-year period.
• Total liabilities were $21.7 million as of September 30, 2026, compared to $18.1 million at December 31, 2025.
• Outstanding indebtedness consisted of $4.7 million of convertible notes, net, maturing in November 2027; the company has no bank or other term debt.

Guidance and Future Outlook:

• The company plans to begin commercializing Ameluz for superficial basal cell carcinoma (sBCC) later in the fourth quarter of 2026 and into the first quarter of 2027.
• In October 2026, the company submitted a supplemental New Drug Application to expand the Ameluz label for actinic keratosis to the extremities, neck, and trunk.
• Management indicated that the accelerated ordering in early July 2026 impacted order timing rather than total demand.

Business Segments and Product Lines:

• Ameluz unit volume increased 23.3% in the third quarter, contributing a $1.6 million increase in revenue.
• Revenue growth was also driven by a $0.3 million increase from price and mix, with the balance attributed to higher device sales.
• The company submitted a supplemental New Drug Application to expand Ameluz indications for actinic keratosis.
• Clinical trials have substantially completed, resulting in a decrease in research and development expenses to $0.5 million for the quarter (from $0.9 million) and $1.8 million for the nine months (from $2.9 million).

Market and Competitive Landscape:

• On September 9, 2026, the FDA approved Ameluz for the treatment of superficial basal cell carcinoma (sBCC), making it the first and only photodynamic therapy (PDT) approved in the U.S. for a cancerous skin tumor.
• U.S. Customs and Border Protection ruled on September 14, 2026, that the redesigned RhodoLED XL-C lamp does not violate the ITC exclusion order, allowing imports for the U.S. market.
• The company focuses on increasing utilization with key accounts and bringing Ameluz to new dermatology customers.

Risks and Challenges:

• The company incurred $0.4 million in ITC Matter-related inventory write-downs during the quarter and $0.7 million in patent remediation expenses related to the ITC Matter for the nine-month period.
• Total charges related to the ITC Matter through September 30, 2026, amounted to $1.1 million, including $0.6 million in accrued remediation costs and $0.5 million in inventory write-downs.
• Legal fees increased by $0.9 million in the quarter and $1.8 million over nine months due to the ITC Matter.
• Forward-looking statements highlight risks including the ability to achieve profitability, competition, manufacturing capacity, intellectual property protection, and regulatory approval timelines.

Management Commentary and Tone:

• CEO Hermann Luebbert described the third quarter as "pivotal," citing the FDA approval and the CBP ruling as key milestones.
• Management stated that with the XL-C lamp cleared, attention is now on execution and commercialization.
• CEO noted that the gross margin improvement reflects the lower cost structure established following the strategic transaction with Biofrontera AG in October 2025.

Other Key Points:

• The company has no bank or other term debt, relying on $4.7 million in convertible notes maturing in November 2027.
• Stock-based compensation for the nine months ended September 30, 2025, was revised from $0.4 million to $0.7 million in the non-GAAP reconciliation.
• The company will host a conference call on November 13, 2026, at 10:00 a.m. Eastern Time.
• The company is preparing to commercialize Ameluz for sBCC using existing lamps and sales force infrastructure.