MediWound NASDAQ: MDWD reported a wider first-quarter loss and lower revenue compared with the prior-year period, while management reaffirmed its 2026 revenue outlook and said it continued to advance its EscharEx and NexoBrid programs.
On the company’s earnings call, Chief Executive Officer Ofer Gonen said MediWound “continued to execute against our key strategic priorities,” including moving EscharEx toward commercialization and expanding the global role of NexoBrid. He said the timeline for the EscharEx Phase III VALUE study has shifted by one quarter, but added that “the underlying momentum behind the program continues to strengthen.”
EscharEx Study Timeline Moves Back
Gonen said enrollment is continuing in the global Phase III VALUE study of EscharEx in venous leg ulcers, with more than 30 sites active across the United States, Europe and Israel. He said recruitment has progressed more slowly than originally expected because of operational issues rather than safety, efficacy or protocol concerns.
The first factor, Gonen said, involved regulatory adjustments at certain European sites related to ancillary products. Those adjustments have been completed, and the company expects to reach its target of about 40 active sites “within weeks.” The second factor involved travel and visit requirements for an older and medically complex venous leg ulcer patient population.
To address those issues, MediWound implemented patient support measures, including hotel reimbursements, transportation services and facilitated access to enhanced care. Gonen said the protocol requires daily wound assessments to determine the exact day complete debridement is achieved, because EscharEx works quickly. While that adds operational complexity, he said it may also reflect a potential clinical and commercial advantage in real-world practice.
The company said it expects the interim sample size reassessment and enrollment completion by the end of the first quarter of 2027.
During the question-and-answer session, Gonen said the company is focused on enrolling the “right patients,” excluding patients whose wounds may be too easy for placebo to heal or too difficult for EscharEx to affect. He said more than 1,000 patients have been screened, adding that “there isn’t a lack of patients.”
Industry Collaborations Expand Around EscharEx
MediWound also highlighted expanded industry engagement around EscharEx. Gonen said Medline joined the company’s chronic wound collaboration network during the quarter. The network also includes Coloplast Kerecis, ConvaTec, Essity, Mölnlycke, Solventum, B. Braun and MiMedx.
As part of the collaboration, Medline will provide its skin protectant Marathon for MediWound’s upcoming Phase II diabetic foot ulcer study. Gonen said the product is intended to protect tissue surrounding the wound while EscharEx performs debridement activity in the wound bed.
Barry Wolfenson, EVP of Strategy and Corporate Development, said the collaborations help standardize key products used in clinical studies, which may reduce variability. He said Medline’s Marathon product will be used in the diabetic foot ulcer study to protect peri-wound tissue, and that Medline will review study data related to the condition of surrounding tissue after the trial.
Gonen said MediWound is also preparing additional EscharEx studies, including a pharmacokinetic study and a human factors study expected to begin in the second half of 2026. He said the company is advancing a head-to-head study against collagenase, or SANTYL, and other nonsurgical standard-of-care modalities. The company also plans a Phase II study in diabetic foot ulcers and an investigator-initiated trial in pressure ulcers in the second half of 2026.
NexoBrid Adoption and BARDA Contract Highlighted
Gonen said MediWound continued to see growing commercial adoption and strategic interest in NexoBrid. He noted that Vericel reported continued growth in ordering centers and total orders across the U.S. burn care market.
Vericel was also awarded a 10-year BARDA contract valued at up to $197 million to support NexoBrid procurement, vendor-managed inventory services, potential blast trauma indication development, and next-generation manufacturing and formulation capabilities. Gonen said MediWound expects BARDA-related procurement and development to begin during the second half of 2026.
Gonen said the new BARDA agreement builds on approximately $138 million already received from BARDA and the Department of Defense over the past decade, reinforcing NexoBrid’s role in mass-casualty burn response and national preparedness.
Asked about how the BARDA contract would flow between Vericel and MediWound, Gonen said the contract includes five components and that MediWound shares in procurement with Vericel and has “a big share” in bringing certain development components to market. He said MediWound could not yet disclose the specific portion attributable to the company.
Manufacturing Facility Progresses Toward Readiness
MediWound is also working to bring an expanded NexoBrid manufacturing facility online. Gonen said the company completed an on-site pre-audit by the European Medicines Agency and is implementing operational modifications identified during that process. He said the company expects to complete those activities during the second half of 2026.
Gonen said the feedback was operational and did not relate to product quality, safety or comparability concerns. He said U.S. inspectors are expected to visit in early 2027, but the company first needs to finalize the EMA-related process because products shipped from Israel to the United States require local agency approval.
First-Quarter Results and 2026 Outlook
Chief Financial Officer Hani Luxenburg said first-quarter revenue was $1.5 million, down from $4 million in the first quarter of 2025. The decline was primarily attributed to the timing of BARDA-related revenue and postponed shipments related to regional conflict. Luxenburg said those postponed shipments have already been completed.
- Gross profit was $0.3 million, with gross margin of 21.9%, compared with $0.7 million and 18.7% a year earlier.
- Research and development expenses rose to $5.2 million from $2.9 million, mainly reflecting continued investment in the EscharEx VALUE Phase III study.
- Selling, general and administrative expenses were $3.6 million, compared with $3.1 million in the prior-year period.
- Operating loss was $8 million, compared with $5.2 million a year earlier.
- Net loss was $3 million, or $0.23 per share, compared with a net loss of $0.7 million, or $0.07 per share.
- Adjusted EBITDA loss was $7 million, compared with a loss of $4 million.
As of March 31, MediWound had $45 million in cash equivalents and deposits, down from $54 million at year-end 2025. Luxenburg said operating cash use in the quarter was $9.6 million, including the impact of foreign exchange movements between the U.S. dollar and the Israeli shekel. The balance sheet also benefited from $1.2 million received under the European Innovation Council Accelerator Grant program and $0.7 million from the exercise of Series A warrants after quarter-end.
MediWound reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million. Gonen said the guidance is supported by expected government-related procurement and development revenue in the second half of the year. Luxenburg said revenue is expected to be weighted toward the second half of 2026, driven primarily by government-related development services and procurement activities.
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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