Latest news with #VenousLegUlcers
Yahoo
3 days ago
- Business
- Yahoo
MediWound Reports Second Quarter 2025 Financial Results and Provides Corporate Update
VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Continues to Enroll Patients NexoBrid® Manufacturing Expansion on Track; Full Operational Capacity Expected by Year-End 2025 Additional Strategic Research Collaborations Established with Essity and Convatec Second Quarter 2025 Revenue of $5.7 Million, Up 43% from Prior Quarter Conference Call Today, August 14, 2025, at 8:30am Eastern Time YAVNE, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. 'We continue to execute across our clinical, commercial, and operational objectives,' said Ofer Gonen, Chief Executive Officer of MediWound. 'The VALUE Phase III trial of EscharEx® is actively recruiting patients, and with the addition of Convatec and Essity to our clinical partnerships, we are now collaborating with all relevant leading global wound care companies. In the U.S., NexoBrid® is gaining commercial traction, and our manufacturing expansion remains on track to meet the anticipated growth in demand. The solid progress in the first half of 2025 reinforces our confidence in our long-term strategy and our commitment to value creation. Second Quarter 2025 Highlights, Recent Developments, and Upcoming Milestones: EscharEx® Enrollment in the global VALUE Phase III study for the treatment of venous leg ulcers (VLUs) is ongoing. The trial aims to enroll 216 patients across 40 sites in the U.S. and Europe. Interim sample size assessment is planned for mid-2026, after 65% of patients complete treatment. Established new collaborations with Essity and Convatec to support EscharEx trials. The VALUE Phase III VLU trial now includes JOBST®, a leading medical compression therapy brand, while the planned DFU trial will incorporate AQUACEL®, a market-leading wound dressing. These partnerships complement the existing ones with Solventum, Mölnlycke, Kerecis, and MIMEDX, reflecting strong industry recognition of EscharEx's clinical value and potential. Published a post-hoc analysis of new data from the EscharEx Phase II trial in Advances in Wound Care, a peer-reviewed journal, providing clinical evidence that wound bed preparation is a key predictor of healing in venous leg ulcers. NexoBrid® U.S. adoption continues to grow. Vericel, MediWound's exclusive U.S. commercial partner, reported 52% year-over-year revenue growth for NexoBrid in the second quarter, supported by increases in both hospital unit orders and the number of ordering centers. Commissioning of MediWound's expanded manufacturing facility—engineered to increase NexoBrid production capacity six-fold—remains on track, with full operational readiness anticipated by year-end 2025. Regulatory review will determine commercial availability timelines. As part of a BARDA-funded initiative, planning continues for future U.S.-based manufacturing to support global demand. Received an additional $3.6 million in funding from the U.S. Department of Defense (DoD) to advance development of a room temperature-stable formulation of NexoBrid. The supplemental funding will support expanded CMC activities, enhancement of in-house manufacturing capabilities, and initial preparations for a clinical trial. Second Quarter 2025 Financial Highlights Revenue for the second quarter of 2025 increased to $5.7 million, compared to $5.1 million in the same period of 2024. Gross profit totaled $1.3 million, or 23.5% of total revenue, compared to $0.4 million, or 8.8% of total revenue, in the prior-year period. The margin improvement reflects a more favorable revenue mix. Research and development expenses were $3.5 million, compared to $1.9 million a year ago, driven by increased investment in the EscharEx VALUE Phase III trial and related clinical activities. Selling, general and administrative expenses were $3.6 million, compared to $3.0 million in the second quarter of 2024, primarily due to higher share-based compensation expenses. Operating loss was $5.7 million, compared to $4.5 million in the same period last year. Net loss was $13.3 million, or $1.23 per share, compared to $6.3 million, or $0.68 per share, in the second quarter of 2024. The year-over-year increase was primarily driven by $6.6 million in non-cash financial expenses in the second quarter of 2025, related to the revaluation of warrants. Non-GAAP Adjusted EBITDA loss was $4.5 million, compared to a loss of $3.4 million in the prior-year quarter. Year-to-Date 2025 Financial Highlights Revenue for the first half of 2025 was $9.7 million, compared to $10.0 million in the same period of 2024. The decrease primarily reflects lower BARDA-funded development services revenue as NexoBrid development nears completion. Gross profit totaled $2.1 million, or 21.5% of total revenue, compared to $1.1 million, or 10.5% of total revenue, in the first half of 2024. The margin improvement reflects a more favorable revenue mix. Research and development expenses were $6.4 million, compared to $3.4 million in the same period of 2024, reflecting increased investment in the EscharEx VALUE Phase III trial and related clinical activities. Selling, general and administrative expenses were $6.6 million, compared to $5.9 million in the first half of 2024, primarily due to higher share-based compensation expenses. Operating loss was $10.9 million, compared to $8.2 million in the same period of 2024. Net loss was $14.0 million, or $1.30 per share, compared to $16.0 million, or $1.73 per share, in the first half of 2024. Non-GAAP Adjusted EBITDA loss was $8.5 million, compared to a loss of $6.2 million in the same period of 2024. Balance Sheet Highlights As of June 30, 2025, MediWound had cash, cash equivalents, and short-term deposits of $32.9 million, compared to $43.6 million as of December 31, 2024. During the first half of 2025, the Company used $11.9 million to fund operations, including $2.3 million in capital expenditures primarily related to manufacturing scale-up. MediWound received $0.7 million in proceeds from the exercise of Series A warrants during the quarter, with an additional $1.8 million received after quarter-end. Conference Call and Webcast MediWound management will host a conference call for investors on Thursday, August 14, 2025, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-844-676-8833 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-634-6869 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company's website. A replay of the call will be available on the Company's website at Non-IFRS Financial Measures To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses. Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management. However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below. About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company's FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity. For more information visit and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as 'anticipates,' 'intends,' 'estimates,' 'plans,' 'expects,' 'continues,' 'believe,' 'guidance,' 'outlook,' 'target,' 'future,' 'potential,' 'goals' and similar words or phrases, or future or conditional verbs such as 'will,' 'would,' 'should,' 'could,' 'may,' or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. MediWound Contacts: Media Contact: Hani Luxenburg Daniel Ferry Ellie Hanson Chief Financial Officer Managing Director FINN Partners for MediWound MediWound Ltd. LifeSci Advisors, LLC ir@ daniel@ +1-929-588-2008MediWound, Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands June 30, December 31, 2025 2024 2024 Cash and cash equivalents and short-term deposits 32,436 29,215 43,161 Trade and other receivable 6,800 4,888 6,310 Inventories 3,843 3,210 2,692 Total current assets 43,079 37,313 52,163 Other receivables and long-term restricted bank deposits 490 691 439 Property, plant and equipment 15,724 12,308 14,132 Right of use assets 7,642 6,852 6,663 Intangible assets 66 132 99 Total non-current assets 23,922 19,983 21,333 Total assets 67,001 57,296 73,496 Current maturities of long-term liabilities 822 1,496 612 Warrants 18,992 14,902 17,092 Trade payables and accrued expenses 5,880 2,745 5,281 Other payables 3,377 3,468 3,556 Total current liabilities 29,071 22,611 26,541 Grants received in advance 758 - 736 Liabilities in respect of IIA grants 8,504 8,009 8,149 Liabilities in respect of TEVA - 1,962 - Lease liabilities 8,070 6,355 6,513 Severance pay liability, net 479 490 404 Total non-current liabilities 17,811 16,816 15,802 Total liabilities 46,882 39,427 42,343 Shareholders' equity 20,119 17,869 31,153 Total liabilities and equity 67,001 57,296 73,496MediWound, Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or LossU.S. dollars in thousands (except of share and per share data) Six months ended Three months ended Year ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Total revenues 9,663 10,027 5,708 5,063 20,222 Cost of revenues 7,583 8,973 4,366 4,616 17,588 Gross profit 2,080 1,054 1,342 447 2,634 Research and development 6,377 3,368 3,491 1,898 8,878 Selling and marketing 2,749 2,403 1,462 1,224 4,936 General and administrative 3,891 3,501 2,105 1,809 8,202 Other expenses 4 - - - 18 Operating loss (10,941) (8,218) (5,716) (4,484) (19,400) Financing expenses, net (3,060) (7,794) (7,564) (1,823) (10,763) Taxes on income (43) (22) (38) 2 (61) Net loss (14,044) (16,034) (13,318) (6,305) (30,224) Foreign currency translation adjustments (10) 10 (11) 2 7 Total comprehensive loss (14,054) (16,024) (13,329) (6,303) (30,217) Basic and diluted net loss per share (1.30) (1.73) (1.23) (0.68) (3.03) Number of shares used in calculating basic and diluted loss per share 10,816,990 9,256,862 10,835,251 9,279,370 9,959,723 MediWound Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Cash flows from operating activities: Net loss (14,044 ) (16,034 ) (13,318 ) (6,305 ) (30,224 ) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 752 725 394 357 1,483 Share-based compensation 1,706 1,270 862 758 3,138 Revaluation of warrants accounted at fair value 2,377 8,007 6,647 1,927 10,704 Revaluation of liabilities in respect of IIA grants 446 470 203 237 752 Revaluation of liabilities in respect of TEVA - 206 - 99 770 Financing (income) expenses and exchange differences of lease liability 943 17 938 (11 ) 487 Increase (decrease) in severance pay liability, net 75 48 48 13 (30 ) Other expenses 4 - - - 18 Financial income, net (942 ) (918 ) (424 ) (405 ) (2,039 ) Unrealized foreign currency loss (gain) (21 ) 78 (6 ) 11 47 5,340 9,903 8,662 2,986 15,330 Changes in asset and liability items: Decrease (increase) in trade receivables (217 ) 753 (1,671 ) 876 (1,141 ) Decrease (increase) in inventories (1,151 ) (345 ) (263 ) 103 187 Decrease (increase) in other receivables (341 ) (574 ) 37 (459 ) 120 Increase (decrease) in trade payables and accrued expenses 691 (1,900 ) 794 (530 ) 406 Increase in grants received in advance - - - - 1,181 Increase (decrease) in other payables (144 ) (34 ) 3 (294 ) 517 (1,162 ) (2,100 ) (1,100 ) (304 ) 1,270 Net cash used in operating activities (9,866 ) (8,231 ) (5,756 ) (3,623 ) (13,624 )MediWound Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Cash flows from investing activities: Purchase of property and equipment (2,008 ) (4,275 ) (1,049 ) (3,016 ) (6,273 ) Interest received 585 1,127 319 522 2,252 Proceeds from (investment in) short-term bank deposits, net 2,985 4,209 5,635 5,339 (4,376 ) Net cash provided by (used in) investing activities 1,562 1,061 4,905 2,845 (8,397 ) Cash flows from financing activities: Repayment of leases liabilities (537 ) (458 ) (289 ) (214 ) (928 ) Proceeds from exercise of warrants and share options 838 610 838 111 1,210 Proceeds from issuance of shares - - - - 22,165 Repayment of IIA grants (114 ) (120 ) - - (219 ) Repayment of liabilities in respect of TEVA - (834 ) - - (2,834 ) Net cash provided by (used in) financing activities 187 (802 ) 549 (103 ) 19,394 Exchange rate differences on cash and cash equivalent balances 21 (104 ) 2 (15 ) (84 ) Decrease in cash and cash equivalents (8,096 ) (8,076 ) (300 ) (896 ) (2,711 ) Balance of cash and cash equivalents at the beginning of the period 9,155 11,866 1,359 4,686 11,866 Balance of cash and cash equivalents at the end of the period 1,059 3,790 1,059 3,790 9,155 MediWound EBITDAU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Net loss (14,044 ) (16,034 ) (13,318 ) (6,305 ) (30,224 ) Adjustments: Financing expenses, net (3,060 ) (7,794 ) (7,564 ) (1,823 ) (10,763 ) Other expenses, net (4 ) - - - (18 ) Taxes on income (43 ) (22 ) (38 ) 2 (61 ) Depreciation and amortization (752 ) (725 ) (394 ) (357 ) (1,483 ) Share-based compensation expenses (1,706 ) (1,270 ) (862 ) (758 ) (3,138 ) Total adjustments (5,565 ) (9,811 ) (8,858 ) (2,936 ) (15,463 ) Adjusted EBITDA (8,479 ) (6,223 ) (4,460 ) (3,369 ) (14,761 )Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
4 days ago
- Health
- Business Upturn
MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers
MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers Post hoc analysis published in Advances in Wound Care, provides clinical evidence supporting wound bed preparation as a critical step in the healing process YAVNE, Israel, August 13, 2025 (GLOBE NEWSWIRE) – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of ' The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial ', in Advances in Wound Care , a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. The incidence of wound closure was compared between patients who achieved WBP by day 14 and those who did not, as well as between those who achieved WBP at any time and those who did not. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue. Key Findings: Wounds that failed to achieve WBP had a 90% probability of not healing ( Negative Predictive Value = 90% ) ) Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not ( p = 0.0004 ) ) Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing ( Relative Risk = 2.4, p =0.0005 ) ) Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period ( Hazard Ratio = 12, p < 0.0001 ) These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx's therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers. Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: 'While wound bed preparation has long been accepted as the conceptual foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. In other words, wounds that are not adequately prepared are highly unlikely to proceed to closure, underscoring the essential role of wound bed preparation in the healing process. Without adequate wound bed preparation, chronic wounds rarely heal.' About EscharEx® EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily application, EscharEx has demonstrated a favorable safety profile and effective wound bed preparation in multiple Phase II trials. The therapy has shown the ability to remove non-viable tissue, promote granulation tissue, and reduce bioburden and biofilm. A global Phase III study in venous leg ulcers (VLUs) is currently underway, with a clinical study in diabetic foot ulcers (DFUs) in preparation. EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity. About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company's FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity. For more information visit and follow us on LinkedIn . Cautionary Note Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as 'anticipates,' 'intends,' 'estimates,' 'plans,' 'expects,' 'continues,' 'believe,' 'guidance,' 'outlook,' 'target,' 'future,' 'potential,' 'goals' and similar words or phrases, or future or conditional verbs such as 'will,' 'would,' 'should,' 'could,' 'may,' or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. MediWound Contacts: Hani Luxenburg Daniel FerryChief Financial Officer Managing DirectorMediWound Ltd. LifeSci Advisors, LLC [email protected] [email protected]
