What MediWound (MDWD) Said on Its Q3 Earnings Call

Key Points

• EscharEx remains MediWound’s priority: The company expects to finish VALUE trial enrollment and conduct a sample-size reassessment by the end of Q1 2027, with top-line results potentially in mid-2027 if the current design continues. The safety board recommended the trial proceed without changes.
• NexoBrid demand is outpacing supply: MediWound says it is selling all the units it can manufacture and prioritizing U.S. sales and government procurement. Expanded-facility commercial supply is expected in the second half of 2027, subject to regulatory approval.
• Revenue declined as trial spending rose: Q3 revenue fell to $3.6 million from $5.4 million a year earlier, while the net loss widened to $6 million as R&D costs increased for VALUE. The company also cited uncertainty around U.S. funding for its planned manufacturing facility as a risk to its 2026 revenue outlook.

MediWound NASDAQ: MDWD reported lower third-quarter revenue and a wider net loss as it increased spending on its late-stage EscharEx trial, while executives said manufacturing constraints continue to limit sales of its burn treatment NexoBrid.

The company expects to complete enrollment and an interim sample size reassessment for its Phase 3 VALUE trial by the end of the first quarter of 2027. Chief Executive Officer Ofer Gonen said top-line results could follow in mid-2027 if the study continues under its current design.

MediWound also said uncertainty over U.S. government funding for a planned domestic manufacturing facility is affecting its 2026 revenue outlook. A substantial portion of anticipated revenue for the year is tied to development services for that project, Gonen said.

EscharEx Trial Remains the Priority

The VALUE trial is evaluating EscharEx in venous leg ulcers, with a current target of 216 patients across approximately 40 sites in the United States, Europe and Israel. Gonen said 95% of sites were open, but the company is not disclosing enrollment numbers or trends while the study is underway.

An independent data and safety monitoring board recently identified no safety concern and recommended that the trial continue without modifications, according to Gonen. Its next review is scheduled for early January 2027, followed by a meeting at the end of the first quarter that will include the sample size reassessment.

The reassessment will take place after approximately 140 patients have completed treatment and is intended to confirm the trial’s targeted 85% statistical power. The assessment could result in an increased sample size. Under the existing 216-patient design, Gonen said, the company expects about three months of treatment after enrollment ends, followed by a couple of weeks to aggregate data.

MediWound is also preparing EscharEx studies in pressure ulcers and diabetic foot ulcers. Gonen said the pressure ulcer study will be a small, investigator-initiated, open-label trial, while the diabetic foot ulcer study will enroll 50 patients and be double-blinded. He expects at least the first study to begin in the coming weeks.

NexoBrid Demand Exceeds Capacity

Gonen said Vericel reported its strongest NexoBrid quarter since launch, with its highest quarterly revenue and the highest number of ordering burn centers and hospital orders to date. More than 80 U.S. centers have ordered the product, including approximately 70 that have placed repeat orders.

Government procurement under Vericel’s Biomedical Advanced Research and Development Authority, or BARDA, contract began in the third quarter and is expected to continue through the first quarter of 2027, Gonen said.

Demand globally exceeds MediWound’s manufacturing capacity, and the company is prioritizing U.S. commercial supply and government procurement. Chief Financial Officer Hani Luxenburg said the company is selling every unit it can manufacture.

MediWound expects to complete modifications to its expanded NexoBrid facility in the fourth quarter of 2026. Commercial supply from the facility is expected in the second half of 2027, subject to regulatory approval. Gonen said the process will include a submission, review and on-site inspection.

Separately, MediWound received an additional $3.3 million in non-dilutive funding from the Department of War for development of a room-temperature-stable NexoBrid formulation for battlefield burn care. The award brings the program’s total budget to $21.8 million and is intended to support development through submission of an investigational new drug application.

Revenue Falls as Trial Spending Rises

Third-quarter revenue declined to $3.6 million from $5.4 million a year earlier, primarily because of lower revenue from U.S. government development services. Gross margin rose to 28.5% from 16.5%, reflecting a greater contribution from higher-margin royalties.

Research and development expenses increased to $6.2 million from $3.5 million, primarily due to the VALUE trial. Net loss widened to $6 million, or $0.47 per share, from $2.7 million, or $0.24 per share. Luxenburg said the change primarily reflected lower non-cash income from warrant revaluation.

For the first nine months of 2026, revenue fell to $8.1 million from $15.1 million. MediWound held $28.4 million in cash, equivalents and deposits as of September 30, compared with $53.6 million at the end of 2025. The company also said it closed a public offering in November that generated gross proceeds of $17.25 million.

Gonen said the offering provided additional financial flexibility through and beyond the expected VALUE data readout. He added that the timing and availability of funding for the planned U.S. facility remain uncertain.

About MediWound (NASDAQ:MDWD)

MediWound Ltd. NASDAQ: MDWD is a commercial-stage biotechnology company focused on developing and marketing innovative enzymatic therapies for complex wounds. The company's products are designed to support the removal of damaged tissue and improve wound management, with an emphasis on severe burns and hard-to-heal chronic wounds. MediWound's lead product, NexoBrid, is a bromelain-based topical biological product used for the enzymatic removal of eschar, or dead tissue, from deep partial-thickness and full-thickness thermal burns.

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