MediWound (NASDAQ:MDWD) executives said 2025 marked a “pivotal year” for the company, highlighting progress in its late-stage EscharEx chronic wound program and the completion of an expanded manufacturing facility for NexoBrid, while also acknowledging revenue headwinds tied to U.S. government disruptions.
EscharEx Phase III program advances, expansion planned into additional indications
Chief Executive Officer Ofer Gonen said MediWound ended 2025 with “two significant growth drivers firmly in place,” led by the ongoing global Phase III VALUE trial for EscharEx in venous leg ulcers (VLUs). Management said enrollment is ongoing, with the majority of sites active and enrolling, and the study is targeting 216 patients across approximately 40 sites in the U.S. and Europe.
MediWound also outlined plans to broaden EscharEx development beyond VLUs. Management said it has aligned with both the FDA and the European Medicines Agency on a Phase II protocol in diabetic foot ulcers (DFUs) and plans to initiate that study in the second half of 2026. In addition, an investigator-initiated prospective study in pressure ulcers is expected to begin in the second half of 2026.
Executives described these steps as expanding EscharEx across “the three major chronic wounds indications.” In the Q&A, EVP of Strategy and Corporate Development Barry Wolfson characterized pressure ulcers as the “third of the big three ulcer types” alongside DFUs and VLUs, adding that there may be more pressure ulcers than the other two categories, though the company plans to study how many require debridement and would be applicable for EscharEx. Management said it will run third-party market research in parallel with the pressure ulcer initiative to quantify the addressable opportunity.
Industry collaborations highlighted; B. Braun joins DFU effort
Management pointed to continued collaboration with advanced wound care companies as validation for EscharEx. Gonen said B. Braun joined the clinical development program through a research collaboration agreement and will participate in the planned Phase II DFU study, adding to existing collaborations with Coloplast, Convatec, Essity, Mölnlycke, Solventum, and MIMEDX.
Wolfson said MediWound now has seven such collaborations spanning the VLU and DFU programs. He added that collaborators supply key products used as part of standard of care in clinical trials, which are used in both study arms, helping keep the only variable between arms as the active treatment versus control. In B. Braun’s case, he said the company is supplying its antimicrobial wound cleanser, Prontosan, for use during dressing changes in the DFU Phase II study.
NexoBrid manufacturing capacity expands; regulatory approvals expected in 2026
On NexoBrid, Gonen said the company’s expanded manufacturing facility is now operational and increases production capacity sixfold. However, commercial availability from the new site remains subject to regulatory approvals that management expects in 2026. In response to an analyst question, management said guidance assumes regulatory clearance in the second half of 2026, and that product manufactured during the validation process could be released once approvals are obtained.
In the U.S., management said adoption continues to expand with utilization across more than 70 burn centers, representing the majority of Vericel’s approximately 90 target accounts. The company also cited a range of military and civilian data points and events it said support demand for NexoBrid, including:
- Real-world data from the Israel Defense Forces covering nearly 5,000 documented combat casualties, which management said showed NexoBrid was clinically applicable in 71% of war-related injuries.
- A 15-year military analysis across multiple conflicts that management said demonstrated a 50% increase in the proportion of severe burns among wounded soldiers.
- Peer-reviewed prospective data that management said showed NexoBrid reduced embedded particles in abrasion and blast injuries by more than 90%.
- Treatment of survivors from a bar fire in Crans-Montana, Switzerland, at medical centers across Switzerland, Italy, and Germany.
Gonen said that once regulatory clearance is obtained for the expanded facility, MediWound intends to prioritize support for national preparedness initiatives, including stockpiling and collaboration with military and emergency response systems.
2025 financial results: revenue decline tied to U.S. shutdown; R&D spending rises
Chief Financial Officer Hani Luxenburg reported fourth-quarter 2025 revenue of $1.9 million, down from $5.8 million in the prior-year period, primarily due to lower development services revenue that he attributed mainly to the U.S. government shutdown, which delayed budget approval and the initiation of new contractual agreements.
Fourth-quarter gross profit was $0.3 million (14.9% margin) versus $0.9 million (15.5% margin) in the prior-year quarter. R&D expenses increased to $4.5 million from $3.0 million, reflecting investment in the EscharEx VALUE Phase III study. SG&A expenses decreased to $3.6 million from $4.0 million, which Luxenburg attributed mainly to lower marketing and share-based compensation. Operating loss widened to $7.8 million from $6.1 million, while net loss was $7.2 million, or $0.56 per share, compared with a net loss of $3.9 million, or $0.36 per share, in the prior-year period. Luxenburg said the increase was primarily attributable to lower non-cash financial income from warrant revaluation. Adjusted EBITDA loss was $6.5 million versus $4.9 million.
For full-year 2025, revenue was $17.0 million versus $20.2 million in 2024. Management said the decline was primarily attributable to the U.S. government shutdown and lower product sales to Vericel. Full-year gross profit was $3.3 million (19.2% margin) compared with $2.6 million (13.0% margin), with margin improvement attributed to a more favorable revenue mix. R&D expenses rose to $14.3 million from $8.9 million, and SG&A increased to $14.2 million from $13.1 million, mainly reflecting higher marketing authorization owner expenses.
Operating loss for the year widened to $25.3 million from $19.4 million, while net loss narrowed to $23.9 million, or $2.10 per share, compared with $30.2 million, or $3.03 per share, in 2024. Luxenburg said the reduction in net loss was primarily driven by $2.2 million of non-cash financial income from warrant revaluation in 2025, compared with $10.7 million of non-cash financial expenses in 2024. Adjusted EBITDA loss was $20.3 million versus $14.8 million.
Cash position increases; multi-year revenue guidance reaffirmed
As of Dec. 31, 2025, MediWound reported $53.6 million in cash, equivalents, and deposits, up from $43.6 million at the end of 2024. The company used $21.4 million in cash to fund operating activities during 2025. Luxenburg said the balance sheet reflects completion of a $30 million registered direct offering and $3.5 million in proceeds from Series A warrant exercises.
Management reaffirmed revenue guidance of $24 million to $26 million for 2026, $32 million to $35 million for 2027, and $50 million to $55 million for 2028. Gonen said the outlook assumes continued support from BARDA and the U.S. Department of War, and that the 2028 outlook includes a potential initial contribution related to EscharEx, subject to regulatory approval.
In the Q&A, management noted that BARDA issued an RFP in August 2025 covering stockpiling, a room-temperature stable formulation, and trauma and blast injury indications, with Vericel leading the process in the U.S. MediWound said it will provide technical and development support. Management also stated that it has been awarded a total of $18.2 million to date in non-dilutive funding from the U.S. Department of War to support development of a room-temperature stable formulation for the U.S. Army. The company declined to break out the expected revenue contributions by source, but said its 2026 guidance assumes initial BARDA-related revenue beginning in the second quarter of 2026 and reiterated expectations for higher revenue in the second half of 2026 versus the first half.
About MediWound (NASDAQ:MDWD)
MediWound Ltd. (NASDAQ: MDWD) is a biopharmaceutical company headquartered in Yavne, Israel, specializing in the development and commercialization of innovative enzymatic therapies for burn and wound management. Since its establishment, the company has focused on advancing proteolytic enzyme technology to address critical needs in debridement and tissue repair. MediWound operates research and development facilities in Israel and maintains commercial offices in the United States to support its global market presence.
The company’s lead product, NexoBrid®, is an enzyme-based debriding agent designed to selectively remove burn eschar without harming viable tissue.
