MediWound Ltd. 2026 Q2 Earnings Call

Please go ahead. Thank you, Chloe, and welcome everyone.

Earlier today, pre-market open, MediWound issued a press release announcing financial results for the second quarter ended June 30, 2026. You may access this press release on the company's website under the Investor tab. I would ask you to review the full text of our forward-looking statements within this morning press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC.

In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference call is property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound.

Ofer. Thank you, Gaia, and good morning, everyone.

During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx. Do you hear me? Yes, we can hear you.

Please proceed. Okay. Sorry about that.

Thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and expanding the commercial and the development opportunities for NexoBrid. Specifically, the EscharEx global phase III VALUE trial is actively enrolling patients as our assessment of its addressable market continue to grow. For NexoBrid, Vericel reported its strongest quarter since launch, and we entered into a new master service agreement with Vericel following its BARDA contract. Now let us start with an update on EscharEx. The VALUE study remains our top priority and our key long-term value driver. Our focus is on execution, with enrollment ongoing, targeting the 216 patients across approximately 40 sites in the U.S., Europe, and Israel. As the study progresses, we are approaching two key milestones.

First, the pre-specified interim sample size reassessment, and the second, completion of enrollment, both expected by the end of the first quarter of 2027. At the same time, we continue to build the broader commercial opportunity for EscharEx. During this quarter, an independent global consulting firm completed an updated U.S. market assessment. Following the expansion of the analysis to include pressure ulcer, this updated assessment now estimates the U.S. annual peak sales at $1.05 billion. This analysis further strengthened our view that EscharEx, across multiple chronic wound indications, has the potential to address a substantial market opportunity. An investigator-initiated study evaluating EscharEx in pressure ulcers is expected to begin in the fourth quarter of 2026. Our collaboration network across the program now spans essentially all the major relevant advanced wound care companies, including Coloplast, ConvaTec, Essity, Mölnlycke, Solventum, B. Braun, and MiMedx. Together, with the continued progress of the VALUE and the expanding clinical and commercial opportunity, this positions EscharEx as a non-surgical, optimally effective debridement therapy for chronic wounds.

Turning to NexoBrid. The U.S. commercial trajectory continues to strengthen. Vericel reported NexoBrid's strongest quarter since launch, with record quarterly revenue, hospital unit sales, and ordering centers. Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the U.S. burn care market. Following Vericel's 10-year contract with BARDA, valued at up to $197 million, we entered into a master service agreement with Vericel covering NexoBrid and next-generation product development activities. Under the MSA, we expect to begin recognizing revenue in the second half of 2026 through participation in development initiatives, including a next-generation program launched to support the potential expansion of NexoBrid for use in blast and friction-related injuries, leveraging real-world evidence.

We continue to advance a room-temperature stable formulation of NexoBrid as a non-surgical debridement solution for battlefield burn care, supported by non-dilutive funding from the Department of Defense, with a total program budget of $18.3 million. Together, these programs further expand NexoBrid's role.

Yeah, I'm here back. Okay.