What Biofrontera does

Biofrontera Inc. is a US-headquartered, commercial-stage biopharmaceutical company specializing in photodynamic therapy (PDT) for dermatological conditions. The company commercializes Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, an FDA-approved photosensitizer applied to affected skin and activated by red light from the company's BF-RhodoLED lamp series to produce reactive oxygen species that destroy abnormal cells. Following the October 2025 strategic acquisition of all US rights from German parent Biofrontera AG for $11 million, Biofrontera Inc. now holds independent control of the NDA, IND, patents, trademarks, and manufacturing rights for Ameluz and RhodoLED in the United States, eliminating a prior earnout structure and improving gross margins by approximately 2,400 basis points.

The company serves two primary customer segments: dermatologists and healthcare providers who prescribe and administer PDT, and the patient populations they treat, including those with actinic keratosis (58 million Americans), basal cell carcinoma (3.6 million annual US diagnoses), and acne vulgaris (50 million Americans). Biofrontera generates revenue through direct product sales of Ameluz and RhodoLED via a US-focused sales organization led by a Chief Commercial Officer and Senior Vice President of Sales & Strategic Accounts, with additional contribution from the November 2025 divestiture of Xepi (ozenoxacin cream) to Pelthos Therapeutics for $3 million at closing plus up to $6 million in milestones. The company reported record full-year 2025 revenue of $41.7 million with Q4 2025 revenue of $17.1 million (36% year-over-year growth) and Q1 2026 revenue of $10.1 million (17% year-over-year growth).

The business model is a single-platform, indication-expansion model centered on Ameluz. Beyond the current face and scalp actinic keratosis indication, Biofrontera is pursuing three near-term growth vectors: an FDA-accepted supplemental NDA for superficial basal cell carcinoma with a September 28, 2026 PDUFA date; a planned Q3 2026 sNDA submission based on positive Phase 3 results in AK on extremities, neck, and trunk (45.6% complete clearance); and an FDA meeting planned for Q3 2026 following positive Phase 2b results in acne vulgaris (57.97% reduction in inflammatory lesions). Biofrontera is publicly traded on NASDAQ under ticker BFRI, with German parent Biofrontera AG remaining a significant shareholder.

Name

Biofrontera

Legal name

Biofrontera Inc.

Website

https://biofrontera-us.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

Biofrontera Inc. is a US biopharmaceutical company that commercializes Ameluz (an FDA-approved topical photosensitizer) combined with its BF-RhodoLED red-light lamp for photodynamic therapy of actinic keratosis, targeting dermatologists treating skin conditions including actinic keratosis, basal cell carcinoma, and acne.

Ownership category

akta.pro rank

Product category

Dermatology Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (32541), Medical Equipment and Supplies Manufacturing (3391)

SIC

Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Dermatology Specialty Pharmaceuticals (HLAIACAL)

akta.pro secondary industry

Dermatology & Aesthetics Pharmaceuticals (HLAIAAAK)

Keywords

• Photodynamic therapy
• Dermatology pharmaceuticals
• Actinic keratosis treatment
• Topical photosensitizers
• FDA-approved drug-device combination

Headquarters

HQ city

Woburn

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Marketing or Sales, Technology or R&D, Operations

Revenue model

1. Product Sales - Ameluz: Revenue from sales of FDA-approved Ameluz (aminolevulinic acid hydrochloride) topical gel for photodynamic therapy treatments in dermatology.
2. Licensing and Milestone Payments - Xepi Divestiture: Biofrontera sold its US license for Xepi antibiotic cream to Pelthos Therapeutics for $3 million at closing plus up to $6 million in milestone payments.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Biofrontera commercializes a proprietary photodynamic therapy (PDT) drug-device combination consisting of Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, and the BF-RhodoLED red-light lamp, sold to dermatologists for the in-office treatment of actinic keratoses and related dermatological conditions. The company also pursues label expansion into superficial basal cell carcinoma and acne vulgaris and supplies the German parent Biofrontera AG's legacy products under transfer arrangements.

Differentiator

Problem solved

Functional benefit

Brands

• Ameluz: Aminolevulinic acid hydrochloride topical gel, 10% - FDA-approved flagship drug for photodynamic therapy treatment of actinic keratoses
• RhodoLED
• Xepi

Products and services

• Ameluz (aminolevulinic acid hydrochloride) topical gel, 10% FDA-approved topical photosensitizer drug applied to skin lesions and activated by the BF-RhodoLED red-light lamp during in-office photodynamic therapy; sold to dermatologists for treatment of actinic keratoses.
• BF-RhodoLED lamp series Medical device that emits red light at specific wavelengths to activate aminolevulinic acid in Ameluz gel during photodynamic therapy; sold to dermatology practices as the device component of the Ameluz PDT drug-device combination.

Quantifiable outcome

• 45.6% complete clearance for actinic keratosis vs 16.7% for vehicle PDT in Phase 3 trial
• +6 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered minor and core.

• Pelthos Therapeutics Inc.minorOEM/ Whitelabel/ Licensing Partner · 7 November 2025Biofrontera sold its US license for Xepi antibiotic cream to Pelthos Therapeutics for $3 million at closing plus up to $6 million in potential milestone payments. The divestiture allows Biofrontera to focus on its photodynamic therapy platform.
• Biofrontera AGcoreStrategic or Co-development Partner · 23 October 2025Biofrontera Inc. completed acquisition of all US rights to Ameluz and RhodoLED from Biofrontera AG, including drug applications, patents, trademarks, and manufacturing rights. The $11 million investment was led by existing investors and enables the company to independently manage US clinical development, manufacturing, and marketing.

Scale indicators16 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Sun Pharmaceutical Industries: Sun Pharma is a direct competitor through its dermatology franchise (including the former DUSA Pharmaceuticals Levulan PDT franchise) and is also a known IP adversary to Biofrontera, having filed patent infringement claims against Ameluz. Both compete in dermatology with branded therapies sold through US dermatology channels.

Broad incumbents

• Galderma: Galderma is one of the largest pure-play dermatology companies globally, offering prescription and aesthetic dermatology products sold through the same dermatologist prescriber base Biofrontera targets. Its scale and broad portfolio make it a key incumbent competitor.
• Almirall: Almirall is a dermatology-focused European pharma company with US commercial operations in dermatology (including the legacy Aqua Pharmaceuticals portfolio). It directly competes in the AK and medical dermatology space through overlapping US specialty sales channels.
• LEO Pharma: LEO Pharma is a global dermatology-focused pharmaceutical company with a strong presence in actinic keratosis (e.g., Picato) and other skin conditions. It serves the same dermatology specialty channel as Biofrontera with branded prescription therapies.
• Bausch Health (Ortho Dermatologics): Ortho Dermatologics, the dermatology division of Bausch Health, markets prescription dermatology products (e.g., Solodyn, Retin-A Micro, Onexton) directly to US dermatologists. It is one of the largest established players competing for the same prescriber relationships and treatment slots.

Emerging players

• Dermavant Sciences: Dermavant is a late-stage dermatology company focused on inflammatory skin conditions (Vtama for psoriasis/atopic dermatitis). It targets the same US dermatology specialty channel and represents an emerging competitor with novel topical therapies.
• Aclaris Therapeutics: Aclaris is a clinical-stage dermatology company developing novel immuno-inflammatory and oncologic dermatology therapies. It operates in the same dermatology specialty category with overlapping R&D focus on skin conditions.
• Verrica Pharmaceuticals: Verrica is a dermatology therapeutics company developing topical treatments for skin diseases including molluscum contagiosum and actinic keratoses (its investigational VP-315). It overlaps with Biofrontera in the AK treatment space as an emerging PDT-adjacent competitor.
• Sol-Gel Technologies: Sol-Gel is a dermatology company developing topical branded generics and innovative therapies for skin conditions including acne vulgaris. It directly overlaps with Biofrontera's acne indication expansion plans.

Others

• Pelthos Therapeutics: Pelthos is a specialty pharmaceutical company that acquired Biofrontera's Xepi (ozenoxacin) antibiotic cream asset in November 2025. It is a transactional counterparty rather than a direct competitor but reflects overlap in the dermatology commercial ecosystem.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biofrontera-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biofrontera