MediWound Reports First Quarter 2025 Financial Results and Provides Corporate Update
- NexoBrid adoption expanding with 207% YoY revenue growth and consistent ordering from nearly 60 burn centers
- Manufacturing facility expansion on track to increase production capacity sixfold by end-2025
- Secured collaborations with major wound care companies for EscharEx clinical trials
- Strong cash position of $38.7M as of Q1 2025
- Secured €2.5M grant from European Innovation Council for EscharEx development
- Q1 2025 revenue declined to $4.0M from $5.0M in Q1 2024
- Operating loss increased to $5.2M from $3.7M in Q1 2024
- Adjusted EBITDA loss widened to $4.0M from $2.9M year-over-year
- €13.75M equity investment component from EIC may not materialize
Insights
MediWound's Q1 shows strategic advancement in pipeline but wider losses as they invest in clinical trials while maintaining revenue guidance.
MediWound's Q1 results reflect a company in transition, balancing revenue of $4 million against increased R&D expenses that widened their operating loss to $5.2 million from $3.7 million year-over-year. The
The company's cash position of
NexoBrid continues to gain market traction with Vericel reporting a
Their reaffirmed full-year 2025 revenue guidance of
The strategic collaborations with leading wound care companies (Solventum, Mölnlycke, MIMEDX, Coloplast/Kerecis) provide strong industry validation for their technology platform while potentially reducing development costs and creating partnership opportunities for eventual commercialization.
MediWound's clinical programs advance with strong industry validation while NexoBrid shows promising real-world application in trauma settings.
MediWound's clinical development strategy demonstrates a methodical approach to maximizing EscharEx's market potential. The VALUE Phase III study in venous leg ulcers (VLUs) is progressing as planned across U.S. and European sites with a well-designed protocol that includes an interim sample size assessment after 65% of patients complete treatment. This adaptive design element provides opportunity for potential protocol optimization while maintaining trial integrity.
The company is simultaneously positioning EscharEx against the current standard of care through a head-to-head Phase II trial versus collagenase ointment (SANTYL◊), building on compelling post-hoc analysis from their ChronEx study that demonstrated superior debridement efficiency and improved wound closure outcomes. This comparative data will be crucial for clinician adoption and payer coverage determinations.
Particularly noteworthy is the strategic collaboration framework MediWound has established, bringing "nearly all leading global wound care companies" into their research programs. This unusual level of industry participation suggests strong confidence in EscharEx's potential from established market participants who recognize its differentiated mechanism of action and clinical profile.
The clinical utility of NexoBrid in mass casualty settings, as demonstrated during the Israel-Hamas conflict, validates its practical application beyond controlled clinical environments. This real-world evidence in complex blast injuries complements the formal clinical data package and may support expanded use cases.
The publication of Phase III pediatric study results in the prestigious Burns journal further strengthens NexoBrid's evidence base for vulnerable populations where surgical intervention carries higher risks, potentially expanding its addressable market while addressing an important unmet need in pediatric burn care.
VALUE Phase III trial of EscharEx® in venous leg ulcers advancing as planned
NexoBrid® manufacturing expansion on track; full operational capacity expected by year-end 2025
First quarter revenue of
Conference call today, May 21 at 8:30am Eastern Time
YAVNE, Israel, May 21, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update.
“We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum established in 2024,” said Ofer Gonen, Chief Executive Officer of MediWound. “The VALUE Phase III study for EscharEx remains on schedule, and our additional collaboration with Kerecis marks a significant milestone—bringing nearly all leading global wound care companies into our clinical research programs. Meanwhile, NexoBrid continues to gain global traction, as we advance strategic manufacturing investments to support sustained, long-term growth.”
First Quarter 2025 Highlights and Recent Developments and Upcoming Milestones:
EscharEx®
- Recruitment is underway in the global VALUE Phase III study evaluating EscharEx for the treatment of venous leg ulcers (VLUs). The trial is designed to enroll 216 patients across 40 clinical sites in the U.S. and Europe. Most U.S. sites are already open, and the majority of European sites are expected to be activated in the third quarter of 2025. An interim sample size assessment will be conducted after
65% of patients complete treatment, with results anticipated in mid-2026. - The clinical trial protocol for a head-to-head Phase II study comparing EscharEx to collagenase in venous leg ulcers (VLUs) has been submitted to the U.S. Food and Drug Administration (FDA). The study is expected to commence in the second half of 2025 and is designed to support a future Biologics License Application (BLA) and enhance the U.S. commercialization strategy.
- Strategic research collaborations—reflecting strong industry validation of EscharEx—now include nearly all leading wound care companies. Solventum, Mölnlycke, and MIMEDX are supporting the VLU trial, while Coloplast/Kerecis is contributing to the planned diabetic foot ulcers (DFUs) trial. Under the agreement signed in the first quarter, Kerecis will provide its MariGen Fish-Skin graft as the designated skin substitute during the wound healing phase of the study.
- The Company has secured the
€2.5 million grant component of the European Innovation Council (EIC) Accelerator funding to support the clinical and regulatory advancement of EscharEx for the treatment of DFUs. Following a successful evaluation process, the Company engaged in discussions for the€13.75 million equity investment component, which may not materialize. This should not have an impact on the planned timeline of the DFU clinical trial. - EscharEx was featured in more than a dozen scientific abstracts presented at major international wound care conferences, including the Wound Healing Society (WHS), Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA). These presentations highlighted new preclinical and clinical findings, emphasizing EscharEx’s multitargeted mechanism of action, its efficacy against biofilm and bacterial burden, and its comparative performance versus collagenase ointment (SANTYL◊).
- Results from a post hoc analysis of the ChronEx Phase II study in venous leg ulcers (VLUs), published in the peer-reviewed journal Wounds, demonstrated that EscharEx was significantly more effective and achieved faster debridement compared to collagenase ointment (SANTYL◊). The analysis also showed enhanced granulation tissue formation and improved wound closure outcomes with EscharEx.
NexoBrid®
- U.S. adoption continues to expand, with consistent ordering from nearly 60 burn centers. Vericel reported a
207% year-over-year increase and a31% sequential increase in NexoBrid revenue for the first quarter of 2025. - Commissioning of MediWound’s new manufacturing facility remains on schedule. Full operational capacity is anticipated by year-end 2025, enabling a sixfold increase in production capacity. Commercial availability will depend on securing the necessary regulatory approvals.
- Initiated a BARDA-funded planning and site selection process for future U.S.-based manufacturing capabilities, aimed at securing long-term domestic production capacity.
- At the 2025 American Burn Association (ABA) Annual Meeting, clinical data were presented on NexoBrid’s use during the Israel–Hamas conflict. Under emergency protocols, NexoBrid was administered to patients with blast injuries and complex burns, demonstrating effective eschar removal and supporting its utility in mass casualty scenarios.
- Results from the Phase III pediatric study were published in Burns, the peer-reviewed journal of the International Society for Burn Injuries (ISBI). Findings reaffirm NexoBrid’s safety and efficacy in pediatric patients, supporting its role as a non-surgical eschar removal therapy.
First Quarter 2025 Financial Highlights
- Revenue: Total revenue for the first quarter of 2025 was
$4.0 million , compared to$5.0 million in the first quarter of 2024. The decrease primarily reflects lower revenue from BARDA-funded development services, as the development of NexoBrid for both adult and pediatric populations has reached its final stages. - Gross Profit: Gross profit for the quarter was
$0.7 million , representing a gross margin of19% , compared to$0.6 million and a gross margin of12% in the prior-year period. The increase in gross margin is primarily due to a change in the revenue mix. - Operating Expenses:
- Research and Development expenses were
$2.9 million , an increase from$1.5 million in the first quarter of 2024. The increase was driven by continued investment in the EscharEx VALUE Phase III trial and related clinical activities. - Selling, General, and administrative expenses totaled
$3.1 million , compared to$2.9 million in the same period last year.
- Research and Development expenses were
- Operating Loss: Operating loss was
$5.2 million , compared to$3.7 million in the first quarter of 2024. - Net Loss: Net loss for the first quarter was
$0.7 million , or$0.07 per share, compared to$9.7 million , or$1.05 per share, in the first quarter of 2024. The year-over-year improvement was primarily due to non-cash financial income associated with the revaluation of warrants. - Non-GAAP Adjusted EBITDA: Adjusted EBITDA loss was
$4.0 million , compared to a loss of$2.9 million in the same period last year.
Balance Sheet Highlights
As of March 31, 2025, the Company had cash and cash equivalents, and deposits totaling
Conference Call
MediWound management will host a conference call for investors on Wednesday, May 21, 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 www.mediwound.com.
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 www.mediwound.com 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 Ferry | |
| Chief Financial Officer | Managing Director | |
| MediWound Ltd. | LifeSci Advisors, LLC | |
| ir@mediwound.com | daniel@lifesciadvisors.com | |
| Media Contact: | ||
| Ellie Hanson | ||
| FINN Partners for MediWound | ||
| ellie.hanson@finnpartners.com | ||
| 929-588-2008 | ||
MediWound, Ltd.
Unaudited Condensed Consolidated Statements of Financial Position
U.S. dollars in thousands
| March 31, | December 31, | |||||
| 2025 | 2024 | 2024 | ||||
| CURRENT ASSTS: | ||||||
| Cash and cash equivalents and short-term deposits | 38,266 | 35,568 | 43,161 | |||
| Trade and other receivable | 5,176 | 5,317 | 6,310 | |||
| Inventories | 3,580 | 3,311 | 2,692 | |||
| Total current assets | 47,022 | 44,196 | 52,163 | |||
| NON-CURRENT ASSETS: | ||||||
| Other receivables and long-term restricted bank deposit | 485 | 684 | 439 | |||
| Property, plant and equipment | 14,743 | 10,422 | 14,132 | |||
| Right of use assets | 6,683 | 6,926 | 6,663 | |||
| Intangible assets | 83 | 149 | 99 | |||
| Total non-current assets | 21,994 | 18,181 | 21,333 | |||
| Total assets | 69,016 | 62,377 | 73,496 | |||
| CURRENT LIABILITIES: | ||||||
| Current maturities of long-term liabilities | 688 | 1,541 | 612 | |||
| Warrants | 12,822 | 13,065 | 17,092 | |||
| Trade payables and accrued expenses | 4,992 | 4,246 | 5,281 | |||
| Other payables | 3,341 | 3,486 | 3,556 | |||
| Total current liabilities | 21,843 | 22,338 | 26,541 | |||
| NON- CURRENT LIABILITIES: | ||||||
| Grants received in advance | 736 | - | 736 | |||
| Liabilities in respect of IIA grants | 8,310 | 7,780 | 8,149 | |||
| Liabilities in respect of TEVA | - | 2,111 | - | |||
| Lease liabilities | 6,424 | 6,467 | 6,513 | |||
| Severance pay liability, net | 431 | 482 | 404 | |||
| Total non-current liabilities | 15,901 | 16,840 | 15,802 | |||
| Total liabilities | 37,744 | 39,178 | 42,343 | |||
| Shareholders' equity | 31,272 | 23,199 | 31,153 | |||
| Total liabilities & equity | 69,016 | 62,377 | 73,496 | |||
MediWound, Ltd.
Unaudited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
U.S. dollars in thousands (except of share and per share data)
| Three months ended March 31, | Year ended December 31, | ||||||||
| 2025 | 2024 | 2024 | |||||||
| Total Revenues | 3,955 | 4,964 | 20,222 | ||||||
| Cost of revenues | 3,217 | 4,357 | 17,588 | ||||||
| Gross profit | 738 | 607 | 2,634 | ||||||
| Research and development | 2,886 | 1,470 | 8,878 | ||||||
| Selling and Marketing | 1,287 | 1,179 | 4,936 | ||||||
| General and administrative | 1,786 | 1,692 | 8,202 | ||||||
| Other expenses | 4 | - | 18 | ||||||
| Operating loss | (5,225 | ) | (3,734 | ) | (19,400 | ) | |||
| Financial income (expenses), net | 4,504 | (5,971 | ) | (10,763 | ) | ||||
| Taxes on income | (5 | ) | (24 | ) | (61 | ) | |||
| Net loss | (726 | ) | (9,729 | ) | (30,224 | ) | |||
| Foreign currency translation adjustments | 1 | 8 | 7 | ||||||
| Total comprehensive loss | (725 | ) | (9,721 | ) | (30,217 | ) | |||
| Basic and diluted net loss per share | (0.07 | ) | (1.05 | ) | (3.03 | ) | |||
| Number of shares used in calculating basic and diluted loss per share | 10,798,318 | 9,234,104 | 9,959,723 | ||||||
MediWound, Ltd.
Unaudited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
| Three months ended | Year Ended | |||||||
| March 31, | December 31, | |||||||
| 2025 | 2024 | 2024 | ||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | (726 | ) | (9,729 | ) | (30,224 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Adjustments to profit and loss items: | ||||||||
| Depreciation and amortization | 358 | 368 | 1,483 | |||||
| Share-based compensation | 844 | 512 | 3,138 | |||||
| Revaluation of warrants accounted at fair value | (4,270 | ) | 6,080 | 10,704 | ||||
| Revaluation of liabilities in respect of IIA grants | 243 | 233 | 752 | |||||
| Revaluation of liabilities in respect of TEVA | - | 107 | 770 | |||||
| Financing income and exchange differences of lease liability | 5 | 28 | 487 | |||||
| Increase (decrease) in severance liability, net | 27 | 35 | (30 | ) | ||||
| Other expenses | 4 | - | 18 | |||||
| Financial income, net | (518 | ) | (513 | ) | (2,039 | ) | ||
| Unrealized foreign currency loss (gain) | (15 | ) | 67 | 47 | ||||
| (3,322 | ) | 6,917 | 15,330 | |||||
| Changes in asset and liability items: | ||||||||
| Decrease (Increase) in trade receivables | 1,454 | (123 | ) | (1,141 | ) | |||
| Decrease (Increase) in inventories | (888 | ) | (448 | ) | 187 | |||
| Decrease (Increase) in other receivables | (378 | ) | (115 | ) | 120 | |||
| Increase (decrease) in trade payables and accrued expenses | (103 | ) | (1,370 | ) | 406 | |||
| Increase in grants received in advance | - | - | 1,181 | |||||
| Increase (decrease) in other payables | (147 | ) | 260 | 517 | ||||
| (62 | ) | (1,796 | ) | 1,270 | ||||
| Net cash used in operating activities | (4,110 | ) | (4,608 | ) | (13,624 | ) | ||
MediWound Ltd.
Unaudited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
Three months ended March 31, | Year Ended December 31, | ||||||||
| 2025 | 2024 | 2024 | |||||||
| Cash Flows from Investment Activities: | |||||||||
| Purchase of property and equipment | (959 | ) | (1,259 | ) | (6,273 | ) | |||
| Interest received | 266 | 605 | 2,252 | ||||||
| Investment in short term bank deposits, net | (2,650 | ) | (1,130 | ) | (4,376 | ) | |||
| Net cash used in investing activities | (3,343 | ) | (1,784 | ) | (8,397 | ) | |||
Cash Flows from Financing Activities: | |||||||||
| Repayment of lease liabilities | (248 | ) | (244 | ) | (928 | ) | |||
| Proceeds from exercise of warrants | - | 499 | 1,210 | ||||||
| Proceeds from issuance of shares, net | - | - | 22,165 | ||||||
| Repayments of IIA grants, net | (114 | ) | (120 | ) | (219 | ) | |||
| Repayment of liabilities in respect of TEVA | - | (834 | ) | (2,834 | ) | ||||
| Net cash provided by (used in) financing activities | (362 | ) | (699 | ) | 19,394 | ||||
| Exchange rate differences on cash and cash equivalent balances | 19 | (89 | ) | (84 | ) | ||||
| Decrease in cash and cash equivalents | (7,796 | ) | (7,180 | ) | (2,711 | ) | |||
| Balance of cash and cash equivalents at the beginning of the period | 9,155 | 11,866 | 11,866 | ||||||
| Balance of cash and cash equivalents at the end of the period | 1,359 | 4,686 | 9,155 | ||||||
MediWound Ltd.
ADJUSTED EBITDA
U.S. dollars in thousands
| Three months ended | Year ended | ||||||||
| March 31, | December 31, | ||||||||
| 2025 | 2024 | 2024 | |||||||
| Net loss | (726 | ) | (9,729 | ) | (30,224 | ) | |||
| Adjustments: | |||||||||
| Financial income (expenses), net | 4,504 | (5,971 | ) | (10,763 | ) | ||||
| Other expenses, net | (4 | ) | - | (18 | ) | ||||
| Taxes on income | (5 | ) | (24 | ) | (61 | ) | |||
| Depreciation and amortization | (358 | ) | (368 | ) | (1,483 | ) | |||
| Share-based compensation expenses | (844 | ) | (512 | ) | (3,138 | ) | |||
| Total adjustments | 3,293 | (6,875 | ) | (15,463 | ) | ||||
| Adjusted EBITDA | (4,019 | ) | (2,854 | ) | (14,761 | ) | |||
FAQ
What were MediWound's (MDWD) Q1 2025 financial results?
What is the status of MediWound's VALUE Phase III trial for EscharEx?
How is NexoBrid performing in the market for MDWD?
What is MediWound's manufacturing expansion plan for NexoBrid?
What is MDWD's revenue guidance for 2025?
