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Biofrontera Inc. - BFRI STOCK NEWS

Welcome to our dedicated page for Biofrontera news (Ticker: BFRI), a resource for investors and traders seeking the latest updates and insights on Biofrontera stock.

Biofrontera Inc. (Nasdaq: BFRI) is a U.S.-based biopharmaceutical company dedicated to the commercialization of innovative dermatological products. Specializing in the treatment of skin conditions such as actinic keratoses and impetigo, Biofrontera focuses on photodynamic therapy (PDT) and topical antibiotics.

One of the company's flagship products is Ameluz®, a prescription drug used in combination with the BF-RhodoLED® lamp series for PDT. Ameluz is approved for the treatment of actinic keratoses, pre-cancerous skin lesions that can develop into skin cancer if left untreated. Another key product in their portfolio is Xepi®, an antibiotic for treating impetigo, a bacterial skin infection.

In recent news, Biofrontera announced record high revenues for 2023, achieving approximately $34.3 million, up 19% compared to 2022. This growth was driven by increased sales of Ameluz and a stronger financial condition, supported by strategic partnerships and clinical trials. The company also reported a successful securities purchase agreement that raised up to $16 million, aimed at advancing product development and expanding indications for Ameluz.

Biofrontera's forward-looking strategy includes reducing the transfer price of Ameluz from 50% to 25% for 2024 and 2025, taking control of U.S. clinical trials, and making significant strides in regulatory approvals with the FDA. For instance, the FDA has commenced a substantive review of a supplementary New Drug Application to increase the approved dosage of Ameluz, indicating the potential for broader usage.

These developments underscore Biofrontera's commitment to enhancing patient care through advanced dermatological therapies and maintaining a robust growth trajectory in the competitive biopharmaceutical landscape.

News

Biofrontera Inc. Announces Restructuring of Supply Agreement with Biofrontera AG

Rhea-AI Summary
Biofrontera Inc. announces a significant reduction in the transfer price of Ameluz ® from 50% to 25% for purchases in 2024 and 2025, with step-wise increases to 35% from 2026 to 2032 for specific sales. The Company will take control of all US clinical trials of Ameluz ® from June 1, aiming for better cost management and increased revenue. The renegotiated terms, along with capital commitment, could lead to profitability by 2025, supported by potential label changes for Ameluz.
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Biofrontera Inc. Announces Private Placement of Up To $16.0 Million Priced at Market per Nasdaq Rules

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Biofrontera Inc. secures $8.0 million financing with potential $8.0 million second tranche tied to milestones, totaling $16 million. The company restructures supply agreement, enabling R&D activities and commercial growth. Funding from securities purchase agreement with institutional investors led by Rosalind Advisors. Shares of Series B-1 and B-3 Convertible Preferred Stock issued at $1,000 per share, with conversion to common stock at $0.7074. Anticipated aggregate gross proceeds of $16 million if all warrants are exercised.
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Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use

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Biofrontera Inc. (BFRI) has announced that the U.S. Food and Drug Administration (FDA) has issued a 'no filing review issues identified' letter regarding the sNDA submitted by its licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. The FDA has set a target action date of October 4, 2024, for the sNDA, which is supported by two Phase 1 safety studies. The studies showed robust safety parameters for the simultaneous use of three tubes, with systemic and application site adverse events equivalent to those with one tube. The sNDA aims at actinic keratosis (AK) field treatment, with an estimated 13 million treatments given each year for AK in the US. If granted, this approval will lead to increased use of Ameluz in the US, making it more convenient for patients and more efficient for their dermatologists.
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Biofrontera Inc. Announces Preliminary Revenues for the Fourth Quarter and Full Year 2023

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Biofrontera Inc. (Nasdaq:BFRI) announced preliminary, unaudited revenues for the three and twelve months ended December 31, 2023, achieving a record high revenue of approximately $33.8 million to $34.3 million, up approximately 19% compared with 2022. Fourth quarter revenues are anticipated to be in the range of approximately $10.4 million to $10.9 million, an increase of approximately 5% compared with the fourth quarter of 2022. Despite a slow start in the first quarter, Biofrontera experienced strong revenue growth throughout the year, with sales increasing between 34% and 37% in the second half of the year compared to the prior year. The company attributes the very strong growth in the third quarter to a price increase and customer buy-in. While fourth quarter sales grew slightly less than expected, the company maintained a solid growth trajectory in the quarter.
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Biofrontera Inc. Reports Third Quarter 2023 Financial Results and Provides a Business Update

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Biofrontera Inc. (NASDAQ: BFRI) reported Q3 2023 financial results, including a 106% increase in total revenues to $8.9 million, raised $4.5 million in a direct offering, and appointed Heikki Lanckriet, Ph.D. to the Board of Directors. The company also announced positive results from a Phase 1 safety study and FDA approval for a new formulation of Ameluz. Management expects full-year 2023 revenue growth of at least 25% compared with 2022 and anticipates becoming cash flow positive within approximately one and a half years.
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Biofrontera Inc. to Report Third Quarter 2023 Financial Results on November 9 and Hold Conference Call on November 10

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Biofrontera Inc. (NASDAQ:BFRI) will report financial results for the three and nine months ended September 30, 2023, on November 9, 2023. A conference call will be held on November 10, 2023, to discuss the results and provide a business update.
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Biofrontera Inc. Announces $4.5 Million Registered Direct Offering Priced At-the-market Under NASDAQ Rules

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Biofrontera Inc. has entered into a securities purchase agreement with an institutional investor to issue and sell 1,205,000 shares of its common stock and warrants to purchase up to 1,807,000 shares. The exercise price for the warrants is $3.55 per share, and they will expire in five years. The company will also adjust the strike price of 385,236 outstanding warrants held by the investor to $3.55. The offering is expected to close soon.
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Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz(R)

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Biofrontera files patent application to extend Ameluz® protection until 2043
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Biofrontera Inc. to Participate in the Roth MKM 2023 Healthcare Opportunities Conference and the 43rd Annual Fall Clinical Dermatology Conference

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Biofrontera to present at Roth MKM Healthcare Opportunities Conference and exhibit at Fall Clinical Dermatology Conference
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Biofrontera Inc. Announces Preliminary Third Quarter Revenues

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Biofrontera Inc. expects revenues for Q3 2023 to increase by approximately 101% to 108% compared to Q3 2022. Revenues for the first nine months of 2023 are anticipated to grow by approximately 25% to 27% compared to the same period in 2022. The company sold approximately 29,000 tubes of Ameluz® during the quarter, compared to about 13,000 tubes in Q3 2022, with growth benefitting from buy-in ahead of a 5% price increase on October 1st. In addition, Biofrontera shipped a record 101 BF-RhodoLED® lamps during the first nine months of the year, up 180% compared to the first nine months of last year. Biofrontera affirms its expectation for full-year 2023 revenue growth of at least 25% compared to 2022.
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FAQ

What is the current stock price of Biofrontera (BFRI)?

The current stock price of Biofrontera (BFRI) is $1.01 as of December 24, 2024.

What is the market cap of Biofrontera (BFRI)?

The market cap of Biofrontera (BFRI) is approximately 7.8M.

What does Biofrontera Inc. specialize in?

Biofrontera Inc. specializes in the commercialization of dermatological products, focusing on photodynamic therapy (PDT) and topical antibiotics.

What are Biofrontera's main products?

Biofrontera's main products include Ameluz®, used in PDT for treating actinic keratoses, and Xepi®, a topical antibiotic for impetigo.

What recent financial milestones has Biofrontera achieved?

Biofrontera achieved record revenues in 2023, totaling approximately $34.3 million, a 19% increase compared to 2022.

What strategic partnerships has Biofrontera entered into?

Biofrontera recently entered into a securities purchase agreement with healthcare-focused institutional investors, raising up to $16 million for product development.

What is the significance of Ameluz in Biofrontera's portfolio?

Ameluz is a key product used in combination with the BF-RhodoLED® lamp series for PDT, primarily for treating actinic keratoses.

What recent regulatory progress has Biofrontera made?

The FDA has begun a substantive review of a supplementary New Drug Application to increase the approved dosage of Ameluz, showing potential for broader usage.

How is Biofrontera planning to manage its clinical trials?

Starting June 1, 2024, Biofrontera will take control of all U.S. clinical trials for Ameluz, allowing for more effective cost management and trial oversight.

What are Biofrontera's plans for future growth?

Biofrontera plans to lower the transfer price of Ameluz, expand clinical trials, and achieve regulatory milestones to enhance its market position and financial performance.

What is the market focus of Biofrontera?

Biofrontera focuses on treating dermatological conditions such as actinic keratoses and impetigo using advanced therapies like PDT and topical antibiotics.

How does Biofrontera contribute to patient care?

Biofrontera enhances patient care by developing and commercializing innovative treatments for pre-cancerous and bacterial skin conditions.

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Biofrontera Inc.

Nasdaq:BFRI

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BFRI Stock Data

7.83M
5.84M
32.06%
20.68%
8.25%
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