MediWound (MDWD) Q1 FY26 earnings call: guidance and Q&A

Are there any other risks to getting the interim analysis done by the end of Q1 '27, and what gives confidence in this new timeline?

Enrollment delays were due to operational factors (European regulatory adjustments, patient travel burden) not safety/efficacy. These adjustments are complete, 40 active sites are expected soon, and patient assistance measures have been implemented. Management is confident in the Q1 '27 completion timeline.

“As I said, indeed, the enrollment has progressed more gradually than originally anticipated. But importantly, this is not related to, I don't know, safety, efficacy or protocol concern.”

asked by Josh Jennings · answered by Ofer Gonen

What are the next steps for the FDA inspection of the expanded NexoBrid manufacturing facility, and when should it come online for US supply?

The FDA inspection is planned for early 2027 but requires finalization with the EMA first. An EMA pre-audit identified operational modifications, which are being implemented and expected to be completed in H2 2026. These modifications are operational and not related to product quality or safety.

“Yes. So indeed, the U.S. inspectors are supposed to come very early 2027. But in order to do that, we need to finalize with the EMA first.”

asked by Josh Jennings · answered by Ofer Gonen

Can you comment on the portion of the base BARDA contract that goes to NexoBrid procurement and how it flows to MediWound versus Vericel?

The $197 million BARDA contract is a 10-year agreement with Vericel, containing 5 components including procurement, VMI management, manufacturing readiness, next-generation formulation, and blast trauma indication development. MediWound has a significant share in bringing some of these to market, with revenue expected to kick in during H2 2026, but specific share splits cannot be disclosed at this stage.

“So the only thing that I can share about at this stage at the BARDA contract is that the $197 million is a 10-year contract between BARDA and Vericel. It contains 5 components: procurement, we share it with Vericel, VMI management. Vericel is running that. And manufacturing readiness and next-generation formulation, another indication for blast trauma, we are -- we have a big share in bringing that to the market.”

asked by Unknown Analyst · answered by Ofer Gonen

How are the additional studies for EscharEx, particularly DFU and pressure ulcer IITs, progressing?

The Phase III VALUE study remains the primary focus. In parallel, 40 studies required for regulatory submission (PK and human factor) are about to start in H2 2026. A head-to-head Phase II study versus collagenase (SANTYL) is advancing. A Phase II DFU study and an investigator-initiated pressure ulcer trial are both planned for H2 2026.

“In parallel, we are conducting 40 studies that are required for regulatory submission, which is a PK study and human factor studies that we are about to start in the second half of the year.”

asked by Unknown Analyst · answered by Ofer Gonen

How does the Medline partnership help in the overall development of EscharEx and what do they bring to the table?

Medline's involvement, alongside other major wound care companies, validates the need for an effective nonsurgical debridement solution. Medline will provide its Marathon skin protectant for the DFU study to protect healthy periwound skin, allowing EscharEx to focus on debridement. These collaborations standardize products in studies, minimize variability, and could develop into strategic partnerships.

“Regarding Medline specifically, the product that they're going to provide is, again, for the DFU study, and it's their class-leading cyanoacrylate-based product, Marathon. So its job is to protect the healthy skin that surrounds the wound, which is an important component of standard of wound care, and that allows EscharEx to really just do its job within the wound bed itself.”

asked by Unknown Analyst · answered by Barry Wolfenson

Does the Q1 '27 timeline assume an acceleration in enrollment? Have travel reimbursement changes improved enrollment rates?

The Q1 '27 timeline assumes maintained enrollment per site with more sites opening, without compromising on patient selection to ensure trial success. Travel reimbursement changes have not significantly impacted enrollment, as there is no lack of screened patients. However, recent Medicare Physician Fee Schedule changes, which reduced spending on skin substitutes by 90% (from $14B to $1.4B) and the overall US chronic wound care market from $18B to $5.5B, present a significant commercial opportunity for differentiated products like EscharEx.

“As Medicare closes that loophole, setting aside the clinical trial environment from a commercial opportunity, differentiated products outside this reimbursement construct will definitely stand out.”

asked by Chase Knickerbocker · answered by Ofer Gonen

What is the rationale for the consensus on less aggressive debridement methods, and what does this mean for EscharEx adoption and market expansion?

The consensus reflects a need for broad access to wound care across various settings, favoring easy-to-use modalities. EscharEx, being easy to use and optimally effective with debridement measured in days (versus weeks for current products), is positioned to significantly expand the enzymatic debridement market. Peak sales for EscharEx are estimated at $831 million from VLU and DFU alone, compared to a legacy product generating $400 million annually.

“How EscharEx changes that entire dynamic is by, yes, having a product that's easy to use, yes, having a product that could be used across all settings, but most importantly, is optimally effective where debridement can be measured in days.”

asked by Michael Okunewitch · answered by Barry Wolfenson