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Globe and Mail
3 days ago
- Business
- Globe and Mail
Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update
Woburn, MA, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy in dermatology, today reported financial results for the three and six months ended June 30, 2025 and provided a business update. Highlights from the first six months of 2025 included the following: Total revenues for the second quarter of 2025 were $9.0 million, a 15% increase from the same period of the prior year For the first six months of 2025, revenue was $17.7 million, a 12% increase from the comparable period in 2024 Cash and cash equivalents were $7.2 million as of June 30, 2025, compared with $5.9 million at December 31, 2024 Agreed to major restructuring of relationship with Biofrontera AG, including acquisition of United States Intellectual Property (IP) and New Drug Applications (NDA) and control of manufacturing, supported by an addition $11 million in funding for the company US patent on revised formulation of Ameluz® granted, extending patent protection through to December 2043 Announced last patient completing 1 year follow-up in superficial basal cell carcinoma (sBCC) Phase 3 study Completed patient enrollment in Phase 3 study with Ameluz® for mild to moderate actinic keratosis (AK) on the entire body and in Phase 2b study for the treatment of moderate to severe acne vulgaris Hermann Luebbert, Chief Executive Officer and Chairman of the Company, stated, "We have changed our approach to our business in 2025 by transforming our customer segmentation, focusing our strategy and using extended data analysis to support our sales team effectiveness. This led to two very gratifying quarters for us driven by customer growth and disciplined execution resulting in increased sales volume and higher revenues. In addition to Ameluz® treating pre-cancerous skin lesions on the face and scalp, we are very encouraged about the potential for Ameluz® to be used more broadly to treat AK on the entire body, and the potential label extension to basal cell carcinoma and acne vulgaris.' 'In addition, we recently announced a fundamental change in our agreement with Biofrontera AG which includes acquiring all the rights, approvals and patents to Ameluz® and RhodoLED® in the United States. This has been a long process that began June 1, 2024 when we assumed control of all clinical studies relating to Ameluz® in the United States, a move that has given us direct oversight of trial efficiency and more effective cost management. We are now in the process of transferring the US IP, NDA, and manufacturing capabilities for Ameluz® and the RhodoLED® lamps. We will pay a monthly Ameluz® royalty of 12% in years where Ameluz® revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The royalty replaces the former transfer pricing model — which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. This will give us further savings on our cost of goods above those already generated by the earlier renegotiation of the transfer pricing model.' Prof. Luebbert concluded by saying 'The $11 million investment we secured, the fundamental restructuring in our agreement with Biofrontera AG and the improvements we have made this year in our promotional strategy and sales effectiveness have led to significant increases in volume and revenue in the first half of 2025 and have positioned us strongly for the rest of the year and beyond'. Second Quarter Financial Results Total revenues for the second quarter of 2025 were $9.0 million compared with $7.8 million for the second quarter of 2024. This increase was driven by both a 5% higher unit sales price and a 9.5% increase in sales volume of Ameluz® in the second quarter of 2025. The higher sales volume of Ameluz® was due to improvements in direct sales team effectiveness. Total operating expenses were $14.1 million for the second quarter of 2025 compared with $12.9 million for the second quarter of 2024. Cost of revenues decreased by $1.7 million, or 41.8% as compared to the three months ended June 30, 2024. This was primarily due to the reduced Ameluz® cost agreed upon with Biofrontera AG in relation to taking over clinical trial costs. Selling, general and administrative expenses were $10.5 million for the second quarter of 2025 compared with $7.9 million for the second quarter of 2024. The increase was primarily driven by a $3.4 million increase in legal costs, partially offset by $0.5 million in personnel savings within both the direct sales team and general and administrative staff and a $0.3 million decrease in miscellaneous general and administrative expenses. The net loss for the second quarter of 2025 was $5.3 million, compared with a net loss of $0.3 million for the prior-year quarter. The increase in the net loss is attributed to the $5.4 million non-cash fluctuation in the change in fair value of warrants of in 2024. Adjusted EBITDA for the second quarter of 2025 was negative $5.1 million compared with negative $4.7 million for the second quarter of 2024, driven by higher legal costs offset by lower cost of goods sold. We look at Adjusted EBITDA, a non-GAAP financial measure, as a better indication of ongoing operations and this measurement is defined as net income or loss excluding interest income and expense, income taxes, depreciation and amortization, and certain other non-recurring or non-cash items. Please refer to the table below which presents a GAAP to non- GAAP reconciliation of Adjusted EBITDA for the second quarters of 2025 and 2024. Six Month Financial Results Total revenues were $17.6 million for the first half of 2025 compared with $15.8 million for the first half of 2024. This 12% increase was driven by a higher unit sales price contributing $0.6 million and increased sales volume of Ameluz ® contributing $1.0 million, as well as a $0.3 million increase in sales of the RhodoLED ® Lamps. The higher sales volume of Ameluz ® was due to improvements in direct sales team effectiveness. Total operating expenses were $27.2 million for the first half of 2025 compared with $26.3 million for the first half of 2024. Increased legal expense was offset by reduced operational cost. Cost of revenues decreased from the prior year to $5.5 million for the first six months of 2025 compared to $8.0 million for the first half of 2024 due to the reduced transfer price agreed upon with Biofrontera AG in February 2024 in relation to taking over clinical development costs. Selling, general and administrative expenses increased to $19.2 million compared to $17.2 million in the prior year. The increase was primarily attributable to a $4.4 million increase in legal expenses. The increased legal expenses were partially offset by savings in personnel expenses of $0.9 million due to headcount fluctuations in our direct sales and administrative teams, as well as a decrease of $0.5 million in expenses relating to sales support functions and a decrease of $0.4 million in issuance costs. Adjusted EBITDA was negative $9.5 million for the first half of 2024 compared with negative $9.3 million for the first half of 2024. Conference Call Details Conference call: Thursday, August 14, 2025 at 10:00 AM ET Toll Free: 1-877-877-1275 (U.S. toll-free) International: 1-412-858-5202 Webcast: About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company's licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions.. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Contacts Investor Relations Andrew Barwicki 1-516-662-9461 ir@ 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. These statements include, but are not limited to, statements relating to the Company's revenue guidance, business and marketing strategy, revenue growth, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, and other statements that are not historical facts. The words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential", "target", "goal", "assume", "would", "could" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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, our reliance on sales of products we currently license from other companies as our sole source of revenue; the success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; the success of our principal licensed product, Ameluz®; the ability of the Company's licensors to establish and maintain relationships with contract manufacturers that are able to supply the Company with enough of our products to meet our demand; the ability of our licensors or their manufacturing partners to supply the licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; the ability of our licensors to successfully defend or enforce patents related to our licensed products; the availability of insurance coverage and medical expense reimbursement for our licensed products; the impact of legislative and regulatory changes; competition from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; the Company's ability to achieve and sustain profitability; the Company's ability to obtain additional financing as needed to implement its growth strategy; the Company's ability to retain and hire key personnel; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC 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 undertake 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. (Tables follow) June 30, 2025 December 31, 2024 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 7,239 $ 5,905 Investment, related party 9 7 Accounts receivable, net 3,955 5,315 Inventories, net 4,028 6,646 Prepaid expenses and other current assets 331 527 Asset held for sale 2,300 2,300 Other assets, related party 953 - Total current assets 18,815 20,700 Property and equipment, net 37 80 Operating lease right-of-use assets 729 903 Intangible assets, net 26 35 Other assets 535 383 Total assets $ 20,142 $ 22,101 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable 4,268 1,856 Accounts payable, related parties, net 670 5,344 Operating lease liabilities 443 548 Advance from Stockholders 8,500 - Accrued expenses and other current liabilities 5,806 4,273 Total current liabilities 19,687 12,021 Long-term liabilities: Convertible notes payable, net 4,338 4,098 Warrant liabilities 548 1,250 Operating lease liabilities, non-current 223 276 Other liabilities 14 23 Total liabilities 24,810 17,668 Commitments and contingencies Stockholders' (deficit) equity: Preferred Stock $0.001 par value; 20,000,000 shares authorized; no Series B-1 issued; 2,641 and 3,366 Series B-2; 6,593 and 6,763 Series B-3 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively - - Common Stock $0.001 par value; 70,000,000 shares authorized; 10,138,567 and 8,873,932 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 9 9 Additional paid-in capital 122,259 121,833 Accumulated deficit (126,936) (117,409) Total stockholders' (deficit) equity (4,668) 4,433 Total liabilities and stockholders' equity $ 20,142 $ 22,101 BIOFRONTERA INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts and number of shares) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Product revenues, net $ 9,030 $ 7,831 $ 17,617 $ 15,732 Revenues, related party - 8 - 18 Total revenues, net 9,030 7,839 17,617 15,750 Operating expenses Cost of revenues, related party 2,380 4,092 5,455 8,038 Cost of revenues, other 262 250 455 421 Selling, general and administrative 10,528 7,915 19,183 17,163 Selling, general and administrative, related party 69 32 76 29 Research and development 870 621 2,077 637 Total operating expenses 14,109 12,910 27,246 26,288 Loss from operations (5,079) (5,071) (9,629) (10,538) Other income (expense) Change in fair value of warrants 153 5,438 702 2,009 Change in fair value of investment, related party 2 (14) 2 (11) Loss on debt extinguishment - - - (316) Interest expense, net (115) (596) (220) (2,003) Other income, net (264) 6 (363) 186 Total other income (expense) (224) 4,834 121 (135) Loss before income taxes (5,303) (237) (9,508) (10,673) Income tax expense 21 20 19 21 Net loss $ (5,324) $ (257) $ (9,527) $ (10,694) Loss per common share: Basic and diluted $ (0.57) $ (0.05) $ (1.05) $ (2.45) Weighted-average common shares outstanding: Basic and diluted 9,351,557 5,091,353 9,108,091 4,357,474 BIOFRONTERA INC. GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION (In thousands, except per share amounts and number of shares) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net loss $ (5,324) $ (257) $ (9,527) $ (10,694) Interest expense, net 115 596 220 2,003 Income tax expenses 21 20 19 21 Depreciation and amortization 22 130 46 258 EBITDA (5,166) 489 (9,242) (8,412) Loss on debt extinguishment - - - 316 Change in fair value of warrant liabilities (153) (5,438) (702) (2,009) Change in fair value of investment, related party (2) 14 (2) 11 Stock based compensation 187 204 426 432 Expensed issuance costs - - - 354 Adjusted EBITDA $ (5,135) $ (4,731) $ (9,520) $ (9,308) Adjusted EBITDA margin -56.9 % -60.3 % -54.0 % -59.1 %
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
Yahoo
22-03-2025
- Business
- Yahoo
Lennar Corp (LEN) Q1 2025 Earnings Call Highlights: Navigating Market Challenges with Strategic ...
Average Sales Price: Declined to $408,000, 1% lower than last year. Homes Started: 17,651 homes. Homes Delivered: 17,834 homes. Homes Sold: 18,355 homes. Sales Incentives: Increased to approximately 13%. Gross Margin: Reduced to 18.7%. SG&A: Came in at 8.5%. Net Margin: 10.2%. Community Count: Increased from 1,447 to 1,584 communities. Cash on Book: $2.3 billion. Debt-to-Total Capital Ratio: 8.9%. Share Repurchase: 5.2 million shares for $703 million. Liquidity: Approximately $5.3 billion. Homesites Owned: 13,000 homesites. Homesites Controlled: 533,000 homesites. Inventory Turn: 1.7 times. Return on Inventory: Almost 30%. Book Value Per Share: About $86. Q2 New Orders Guidance: 22,500 to 23,500 homes. Q2 Deliveries Guidance: 19,500 to 20,500 homes. Q2 Average Sales Price Guidance: $390,000 to $400,000. Q2 Gross Margin Guidance: Approximately 18%. Q2 SG&A Guidance: 8% to 8.2%. Q2 EPS Guidance: Approximately $1.80 to $2 per share. Warning! GuruFocus has detected 2 Warning Signs with BFRI. Release Date: March 21, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lennar Corp (NYSE:LEN) successfully completed the Moro spin-off and Rausch Coleman acquisition, supporting their transition to an asset-light land-light model. The company maintained a strong balance sheet with $2.3 billion in cash and an 8.9% debt-to-total capital ratio. Lennar Corp (NYSE:LEN) achieved a sales pace of 4.1 homes per community per month, aligning with their target and demonstrating operational efficiency. Construction costs decreased by 2.5% year-over-year, reaching the lowest level since Q3 2021, indicating effective cost management. The company repurchased 5.2 million shares for $703 million, demonstrating a commitment to returning capital to shareholders. The macroeconomic environment remains challenging with high mortgage interest rates, impacting housing market demand. Lennar Corp (NYSE:LEN) experienced a decline in average sales price to $408,000, 1% lower than the previous year. Sales incentives rose to approximately 13%, significantly impacting gross margins, which fell to 18.7%. The company faces ongoing pressure on margins due to the need for incentives to maintain sales volume. Consumer confidence and affordability issues continue to limit actionable demand in the housing market. Q: What is Lennar's view on the normalized operating margin and the path to achieve it? A: Stuart Miller, Executive Chairman and Co-CEO, explained that Lennar is focused on improving efficiencies across all business elements, especially after the Millrose spin-off. The current high level of incentives is temporary, and the company expects to achieve a significantly higher operating margin once these incentives normalize. Diane Bessette, CFO, added that historically, SG&A was around 7% and corporate G&A around 1.5%, suggesting room for improvement from current levels. Q: How does Lennar determine its sales pace, and what if current demand levels are the new normal? A: Stuart Miller stated that Lennar assesses demand at the community level and believes the current market is undersupplied due to years of underproduction. The company is prepared to adjust its production levels quickly if necessary, typically within a quarter or two, as market conditions evolve. Q: Is Lennar underwriting new land acquisitions to current incentive levels, and can margins improve without incentives returning to historical levels? A: Stuart Miller confirmed that Lennar is strategically turning over land inventory to align with current market conditions. Fred Rothman, COO, added that the company is patient and strategic in land acquisitions, underwriting them to current incentive levels while aiming for higher margins as land costs adjust. Q: How does Lennar respond to concerns about increased cyclicality in margins due to its even flow strategy? A: Stuart Miller emphasized that Lennar's strategy is to work through assets at lower margins rather than walking away from deposits. The company believes that maintaining production levels and turning land into cash is more beneficial in the long run, even in a challenging market. Q: What is the impact of the Millrose transaction on Lennar's cash flow and leverage strategy? A: Stuart Miller noted that the Millrose transaction is part of Lennar's transition to an asset-light model, which will eventually lead to cash generation approximately equal to earnings. Diane Bessette highlighted that 2025 is a transition year, but the asset-light model is expected to enhance shareholder returns through increased cash flow and stock buybacks. 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
