Latest news with #Ameluz
Associated Press
7 days ago
- Business
- Associated Press
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication 'Approved Drug Products with Therapeutic Equivalence Evaluations' (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact: Investor Relations Andrew Barwicki 1-516-662-9461 [email protected]
Yahoo
17-05-2025
- Business
- Yahoo
Biofrontera Inc (BFRI) Q1 2025 Earnings Call Highlights: Revenue Growth and Strategic ...
Total Revenue: $8.6 million for Q1 2025, a 9% increase from the same period in 2024. Ameluz Sales Increase: $0.5 million increase due to higher unit price and RotoLED XL lamp launch. Total Operating Expenses: $13.1 million for Q1 2025, down from $13.4 million in Q1 2024. Cost of Revenues: $3.1 million for Q1 2025, a 22.1% decrease from the prior year. SG&A Expenses: Decreased by $0.6 million or 6.5% compared to Q1 2024. R&D Expenses: Increased by $1.2 million due to assumption of clinical trial activities for Ameluz. Net Loss: $4.2 million or $0.47 per share for Q1 2025, compared to $10.4 million or $2.88 per share in Q1 2024. Adjusted EBITDA: Increased to $4.4 million for Q1 2025 from $4.6 million in Q1 2024. Cash and Cash Equivalents: $1.8 million as of March 31, 2025, down from $5.9 million as of December 31, 2024. Inventory: $6.5 million as of March 31, 2025, compared to $6.6 million as of December 31, 2024. Warning! GuruFocus has detected 5 Warning Signs with BFRI. Release Date: May 16, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Biofrontera Inc (NASDAQ:BFRI) reported a 9% increase in total revenues for the first quarter of 2025, reaching $8.6 million. The company successfully reduced its cost of revenue and operating costs compared to the same period in the previous year. A new formulation of Ameluz, free from the allergen propylene glycol, has been granted a patent, providing protection until December 2043. Biofrontera Inc (NASDAQ:BFRI) achieved key milestones in clinical trials, including the final patient enrollment for a Phase 3 trial of Ameluz for actinic keratosis and completion of a one-year follow-up for basal cell carcinoma treatment. The company increased its EBITDA and gross profit, supporting its goal of reaching breakeven quickly. Biofrontera Inc (NASDAQ:BFRI) reported a net loss of $4.2 million for the first quarter of 2025, although this was an improvement from the previous year's loss. The company experienced a decrease in cash and cash equivalents, dropping to $1.8 million as of March 31, 2025, from $5.9 million at the end of 2024. Research and development expenses increased by $1.2 million compared to the previous year, driven by the assumption of all clinical trial activities for Ameluz in the United States. Legal expenses increased by $1.2 million due to patent claims, partially offsetting savings in other areas. The sales force experienced some turnover, and the company is working on restructuring its commercial team to improve efficiency. Q: Over the first quarter of 2025, how many lamp units did Biofrontera sell, both the original and the XL? A: Herman Louvert, CEO, stated that Biofrontera placed 18 XL lamps during the first quarter. Clyde Lefler, CFO, mentioned that he would need to double-check the number of original lamps sold as he did not have that information readily available. Q: Is there any sales force attrition, and what is the current sales force headcount compared to the end of the year? A: Clyde Lefler, CFO, explained that Biofrontera is restructuring its commercial team, bringing in more junior representatives with lower salaries. There has been some turnover, but the company is committed to reorganizing the team to be as efficient as possible. Q: How will the change in transfer pricing affect gross margins for the rest of the year? A: Clyde Lefler, CFO, noted that all current inventory is at the 25% transfer price, which will be consistent for the rest of the year. However, gross margins may fluctuate based on the number of lamps sold, as the margin on lamps is lower. Q: What is the status of reimbursement for the three-tube indication? A: Herman Louvert, CEO, confirmed that after approval, Biofrontera focused on ensuring Medicare coverage and informed private payers. There have been no reported cases of reimbursement refusal for using more than one tube, indicating the issue is resolved. Q: Can you provide an update on the financial performance and strategic goals for the first quarter of 2025? A: Herman Louvert, CEO, highlighted that Biofrontera achieved a 9% revenue increase to $8.6 million, reduced costs, and improved EBITDA and gross profit. The company aims to reach breakeven quickly and continues to explore new applications for Ameluz, including treatments for superficial basal cell carcinoma and moderate to severe acne. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
