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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.

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Biofrontera has launched its FDA-approved RhodoLED XL lamp, a red light emitting LED device for photodynamic therapy (PDT) of actinic keratoses. Used with the Ameluz topical gel, also FDA-approved, the RhodoLED XL is designed to treat mild-to-moderate actinic keratoses on the face and scalp. The device features an expanded treatment area and advanced positioning sensors to optimize energy delivery. It was first shipped on June 10, 2024, and has received positive feedback from dermatology practices, including Cleaver Dermatology. This launch aligns with Biofrontera's commitment to innovation in dermatologic care.

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Biofrontera has reported its Q1 2024 results, indicating a 9% revenue decline to $7.9M compared to Q1 2023. Contributing factors include reimbursement issues stemming from the Change Healthcare data breach. The company secured $8M through a private placement and an additional $8M via warrant exercises. Operational costs were reduced through a renegotiated Ameluz agreement reducing transfer prices. Despite a net loss of $10.4M, cash reserves increased to $3.8M. Sales of the new RhodoLED XL lamp are expected to begin in Q2 2024. An FDA decision on Ameluz dosage is anticipated by October 2024.

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Biofrontera Inc. (NASDAQ:BFRI) will announce its first quarter 2024 financial results on May 15, 2024. The company specializes in dermatological products and will host a conference call on May 16, 2024, to discuss the results.

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Biofrontera Inc. announced the achievement of two milestones associated with Series B-3 Convertible Preferred Stock Warrants. The Board of Directors certified the fulfillment of criteria related to warrants issued in February 2024, triggering payments totaling $8 million. The milestones included a 5% revenue growth from January to April 2024 compared to the same period in 2023 and successful implementation of a new customer relationship management system with over 95% adoption. The company also received shareholder approval to increase its authorized capital and filed a registration statement with the SEC to register shares underlying the Series B-3 Convertible Preferred Stock.

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Biofrontera, Inc. (BFRI) announces details for its 2024 Annual Meeting of Stockholders, including the record date and deadlines for stockholder proposals. The meeting will be held on June 12, 2024, with April 22, 2024, as the record date. Stockholders have until April 19, 2024, to submit proposals for inclusion in the proxy statement and until April 5, 2024, for proposals not included in the proxy materials.
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Biofrontera, Inc. (BFRI) reported record total revenues of $34.1M for 2023, a 19% increase from 2022. Operating expenses rose to $56.7M with one-time legal expenses. The company achieved a 4% revenue increase in Q4 2023 and restructured to decrease operating expenses by 8%. Strategic initiatives include sNDA submission, Phase 3 clinical studies, FDA approval for an improved formulation, and R&D for a new therapy lamp. The CEO highlighted strong sales growth and partnerships in 2023, with plans for cost management and efficiency improvements in 2024. The CFO emphasized revenue growth, balance sheet improvements, and cost optimization. Q4 2023 saw $10.6M in revenues, a $0.5M increase, and net income improved to $3.5M. Adjusted EBITDA for Q4 2023 was negative $3.2M, showing improved performance. Full-year 2023 revenues were $34.1M, operating expenses were $56.7M, and net income improved significantly.
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Biofrontera, Inc. (BFRI) reports record revenues of $34.1M for 2023, a 19% increase from 2022. Operating expenses were $56.7M, with a 4% revenue increase in Q4 2023. The company restructured to align with business needs, initiated a strategic account strategy, and submitted sNDA for Ameluz®. Positive feedback from FDA, new R&D agreements, and Phase 3 clinical studies were highlighted.
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Biofrontera Inc. (BFRI) will report financial results for the three and 12 months ended December 31, 2023, on March 15, 2024. The company will host a conference call on March 18 to discuss the results.
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Biofrontera Inc. (BFRI) closed an $8.0 million financing deal, with an additional $8.0 million tied to milestones, totaling $16 million. The funding allows the company to assume R&D activities and support commercial growth. The financing includes shares of Series B-1 Convertible Preferred Stock and warrants for Series B-3 Convertible Preferred Stock, with conversion prices and exercise conditions specified. The company received $8.0 million upfront and expects an additional $8.0 million upon meeting criteria associated with the warrants. Roth Capital Partners facilitated the private placement. The funds will be used for general business operations and to expedite the development of additional indications for Ameluz, Biofrontera's lead product approved for treating actinic keratosis. The securities issued are under a private placement and not registered under the Securities Act of 1933, requiring a resale registration statement to be filed with the SEC.
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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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FAQ

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.

Biofrontera Inc.

Nasdaq:BFRI

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5.14M
5.09M
28.29%
43.86%
0.5%
Pharmaceutical Preparation Manufacturing
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United States of America
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