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MediWound Ltd. earnings calls

MDWD · every analyst question and management's answer

Aug 13, 2026 earnings call — EscharEx Phase III progress and NexoBrid expansion

Reaffirmed full year 2026 revenue guidance of $24 million to $26 million.

Revenue $0.0B (est $0.0B) · EPS $-0.77 (est $-0.76) · Next-quarter revenue outlook $0.0B

Key quotes

"Our focus is on execution with enrollment ongoing, targeting the 216 patients across approximately 40 sites in the United States, Europe and Israel."

— Ofer Gonen (CEO) · EscharEx Phase III progress

"Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the U.S. burn care market."

— Ofer Gonen (CEO) · NexoBrid commercial growth

"Cash burn during the first half of 2026 totaled $20 million."

— Hani Luxenburg (CFO) · Cash position and spending

Analyst Q&A 6

VLU study timing and competition

Q (Swayampakula Ramakanth · H.C. Wainwright): He asked if enrollment and the interim assessment for the VLU study will finish in early 2027. He also asked about Smith & Nephew's potential new drug and about the investigator-initiated pressure ulcer study and whether that data will support regulatory filings.

A: They said the company still targets the interim assessment and enrollment completion in the first quarter of 2027. They said the competing SN-514 is not known to be in chronic wound clinical development and that EscharEx already has a Phase III lead. They said the pressure ulcer study is an investigator-initiated, open-label trial of 10 to 15 patients starting in the fourth quarter of 2026, treated for a week or 2 and assessed for debridement, granulation and wound closure.

"Yes, our target of meeting the interim assessment and the enrollment completion is still in the first quarter of 2027." — Ofer Gonen (CEO)

Vericel MSA revenue and DFU plan

Q (Joshua Jennings · TD Cowen): He asked what changed for revenue recognition under the updated MSA with Vericel and whether revenue will come from expanded development work. He also asked for updates on the clinical path and timing for the DFU indication.

A: They said the MSA with Vericel is signed and the first development program for blast and friction injuries is underway, but many details remain confidential and subject to FDA feedback. They said they will begin recognizing revenue from that program in the second half of 2026. They said the DFU Phase II will start in the fourth quarter of 2026, will enroll 50 patients randomized 1:1 versus placebo, with primary endpoint time to complete debridement.

"We are about to begin recognizing revenue from that program in the second half of 2026." — Ofer Gonen (CEO)

BARDA revenue and facility impact on 2026

Q (Jeffrey Jones · Oppenheimer): He asked how Vericel's expected $6 million in BARDA revenue aligns with the company's projected government revenue for 2026. He also asked how the facility delay affects NexoBrid revenue for 2026 and beyond.

A: They said the figure the analyst cited is not exclusively BARDA and includes other government agreements, and that the MSA contains multiple components they cannot yet disclose. They said MediWound expects to benefit from Vericel procurement but transfer prices are not public. They said they do not expect the current facility timeline to have a material impact on their 2026 revenue guidance.

"Yes. Jeff, we do not actually expect the current facility timeline to have material impact on our 2026 revenue guidance." — Hani Luxenburg (CFO)

Enrollment progress and sites of use

Q (Chase Knickerbocker · Craig-Hallum): He asked how enrollment per site has trended, whether all ~40 sites are active and enrolling, and whether the Q1 2027 sample reassessment assumes any enrollment improvement. He also asked how long to top-line data after last patient and where EscharEx would be used compared with SANTYL.

A: They said they will not share enrollment numbers to protect study integrity, but the design is unchanged at 216 patients across roughly 40 sites and they expect the interim assessment and enrollment completion by the end of the first quarter of 2027. They said they are very close to having all sites recruiting, with less than 10% remaining. They said if things go well it may take about a quarter to get top-line data after the interim and then a few months to final results, and that EscharEx usage would be distributed across acute care, clinics, home health, nursing homes and SNFs similar to SANTYL.

2027 sales after manufacturing readiness

Q (Michael Okunewitch · Maxim Group): He asked whether the projected jump in 2027 NexoBrid sales is due to pent-up demand after approval or if product can be shipped and recognized before EMA commissioning. He also asked about timing between EMA and FDA approvals.

A: They said they will start manufacturing NexoBrid at the beginning of 2027 and everything will be ready to ship. They said demand exists and in the second half of 2027 they can sell significantly more because current sales are capped by manufacturing capacity. They said FDA approval could follow EMA by about three months, but the key milestone is the first approval.

"Second half of 2027, we can sell significantly more than we are selling now." — Ofer Gonen (CEO)

Quarterly product capacity and R&D path

Q (Scott Henry · Alliance Global Partners): He asked if current product capacity implies about $1.7–$1.8 million of product sales per quarter or if the $2.6 million quarter could be repeated before capacity expansion. He also asked whether R&D spending will spike in H2 2026.

A: They said they are not providing specific product guidance and that sales are capped by capacity, not demand. They said inventory is effectively zero in most territories and some revenue limits were due to facility inspections, so Q2 is a better indicator of current capacity. They said R&D spending is elevated and driven primarily by the VALUE Phase III trial and will remain elevated while many NexoBrid development activities are supported by nondilutive government funding.

"we are not guiding specifically for product, but I don't think it will be the right thing to do is to think that we sold everything that we could." — Ofer Gonen (CEO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

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