MediWound NASDAQ: MDWD reported second-quarter 2026 revenue of $3.1 million, down from $5.7 million a year earlier, as the company continued investing in its Phase III EscharEx chronic-wound program and expanded development work around its NexoBrid burn treatment.
Chief Executive Officer Ofer Gonen said the company’s top priority remains the global Phase III VALUE trial of EscharEx. The study is enrolling patients at sites in the United States, Europe and Israel, with a target of 216 patients across approximately 40 sites. MediWound expects both the trial’s pre-specified interim sample-size reassessment and enrollment completion by the end of the first quarter of 2027.
EscharEx Program Advances as Market Assessment Expands
Gonen said an updated U.S. market assessment conducted by an independent global consulting firm estimated annual peak sales potential for EscharEx at $1.05 billion after adding pressure ulcers to the analysis. MediWound had previously cited an approximately $800 million peak-sales opportunity before including pressure ulcers, according to comments from Executive Vice President of Strategy and Corporate Development Barry Wolfenson during the question-and-answer session.
EscharEx is being developed as a non-surgical debridement therapy for chronic wounds. The company said an investigator-initiated, open-label pressure-ulcer study involving approximately 10 to 15 patients is expected to begin in the fourth quarter of 2026. The study will evaluate measures including debridement, granulation and wound closure.
MediWound also plans to initiate a Phase II diabetic foot ulcer, or DFU, trial in the fourth quarter. Gonen said the company has received feedback from the FDA and European Medicines Agency and is aligned on the protocol. The randomized study is expected to enroll 50 patients and compare EscharEx with placebo, using time to complete debridement as its primary endpoint.
Following the VALUE trial readout, MediWound plans to discuss with regulators what would be needed to pursue approvals for diabetic foot ulcers and pressure ulcers, Gonen said.
Wolfenson addressed comments from Smith & Nephew regarding a potential second-generation SANTYL product. He said MediWound was aware of the remarks and noted that, based on publicly available information, the product under development by Certa Therapeutics, SN514, had not entered clinical development in chronic-wound patients. Wolfenson said EscharEx’s Phase III status in chronic wounds provides what the company believes is a substantial clinical lead.
NexoBrid Commercial Adoption and Government Programs
For NexoBrid, MediWound said U.S. commercial momentum continued to build through its commercial partner, Vericel. Gonen said Vericel reported NexoBrid’s strongest quarter since launch, including record quarterly revenue, hospital unit sales and ordering centers. Approximately 80 burn centers have ordered NexoBrid since its launch, he said.
MediWound and Vericel entered a master service agreement following Vericel’s 10-year BARDA contract, which is valued at up to $197 million. The BARDA framework covers NexoBrid procurement, vendor-managed inventory, U.S.-based manufacturing readiness, next-generation formulation development and potential expansion into blast and trauma-related injuries, Gonen said.
The first development program under the agreement, aimed at supporting potential NexoBrid use in blast and friction injuries, is underway. MediWound expects to begin recognizing revenue from the master service agreement during the second half of 2026. Gonen said Vericel expects approximately $6 million in BARDA procurement revenue in the second half, while declining to provide further details on the broader agreement because of confidentiality obligations and pending regulatory feedback.
The company is also developing a room-temperature stable NexoBrid formulation for battlefield burn care with non-dilutive funding from the Department of War. The total program budget is $18.3 million.
Manufacturing Timeline and Financial Results
MediWound is completing modifications requested by the EMA after a pre-audit of its expanded NexoBrid manufacturing facility. Gonen said the requested changes were operational and were not related to product quality, safety or comparability. The company expects to finish the work in the fourth quarter of 2026, begin manufacturing at the facility in early 2027 and potentially receive regulatory approval for commercial supply in the second half of 2027.
Management said the revised facility timing is not expected to materially affect 2026 guidance or anticipated NexoBrid revenue in 2027 and 2028. The company said current NexoBrid sales are constrained by manufacturing capacity rather than demand.
- Second-quarter revenue was $3.1 million, compared with $5.7 million in the prior-year quarter, primarily due to the timing of BARDA-funded development revenue.
- Gross profit was $0.3 million, with a 10.9% gross margin, compared with $1.3 million and a 23.5% margin a year earlier. The company cited a one-time facility scale-up impact.
- Research and development expense rose to $5.9 million from $3.5 million, reflecting increased investment in the EscharEx VALUE trial.
- Operating loss was $9.5 million, compared with $5.7 million a year earlier.
- Net loss was $7.4 million, or $0.57 per share, compared with net loss of $13.3 million, or $1.23 per share, in the prior-year period. The change reflected non-cash financial income.
For the first half, MediWound reported revenue of $4.6 million, down from $9.7 million a year earlier, and an adjusted EBITDA loss of $15.3 million, compared with an $8.5 million loss in the prior-year period. As of June 30, the company had approximately $36 million in cash, cash equivalents and deposits, down from $54 million at year-end 2025. First-half cash burn totaled $20 million.
MediWound reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million. Gonen said revenue is expected to be weighted toward the second half, supported by product supply, development services under the Vericel agreement, other government-funded programs and ongoing NexoBrid commercial sales.
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.
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