Biofrontera Inc.: A Compelling Investment in Dermatology

October 28, 2020

Pioneering Photodynamic Therapy for a Healthier Future

Biofrontera Inc. (Nasdaq: BFRI) is redefining Photodynamic Therapy (PDT), an in-office, non-invasive treatment for pre-cancerous skin lesions. Our FDA-approved combination product—AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, and the RhodoLED® lamp portfolio— provides a superior, patient-friendly therapy for actinic keratosis (AK), a condition impacting more than 58 million Americans.

With direct ownership of all AMELUZ® and RhodoLED® assets for the U.S. market following our recent acquisition from Biofrontera AG, Biofrontera Inc. now controls the entire value chain—from manufacturing and regulatory oversight to commercialization—unlocking significant operational flexibility.

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Why Biofrontera?

  • Market Leadership: A proven leader in U.S. PDT and now the exclusive owner of the AMELUZ® and RhodoLED® brands in the U.S. markets, Biofrontera is uniquely positioned to drive innovation and growth in dermatology.
  • Accelerating Revenue Growth: Revenues have nearly doubled from $18.8 million (2020) to $37.3 million (2024), with continued acceleration expected in 2025 as U.S. control allows for better pricing, logistics, and sales reach.
  • Improved Economics: A new agreement has replaced legacy acquisition cost structure of up to 35% with an earnout payment as low as 12%, providing a clear path to higher margins and sustainable cash flow.
  • Strengthened Financial Position: Recently secured $11 million in new funding—led by long-term institutional investors—to fully fund the U.S. asset purchase and support the transition to operational self-reliance.

Company Highlights:

  • Long-Term Product Protection: A new patent extends exclusivity for AMELUZ® through December 2043, providing durable market protection.
  • Expanding Clinical Pipeline: With the Phase 3 study for AMELUZ® in actinic keratosis on the extremities, neck, and trunk now completed (last-patient-out in September 2025), Biofrontera plans a supplemental NDA submission in 2026. This label expansion would significantly broaden the addressable market beyond current indications.
    Beyond AK, ongoing trials explore superficial basal cell carcinoma (BCC) and acne vulgaris, representing multi-billion-dollar potential in dermatologic therapeutics.
  • Dynamic Leadership: Under the guidance of new Chief Commercial Officer George Jones, a 25-year veteran of pharmaceutical commercialization, Biofrontera is accelerating adoption of AMELUZ® PDT across clinics nationwide.

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