Q: Can you provide more details on the updated Master Service Agreement (MSA) with Vericel, specifically regarding revenue recognition and the expansion into blast and friction injuries? Also, what is the latest on the DFU clinical development path? A: CEO Ofer Gonen explained that the MSA follows Vericel's 10-year BARDA contract (up to $197 million) and covers NexoBrid procurement, vendor-managed inventory, US-based manufacturing readiness, and next-generation formulation development. While confidentiality limits full disclosure, the first development program for blast and friction injuries is underway, and revenue recognition will begin in H2 2026. Regarding DFU, the company has aligned with the FDA and EMA on a Phase 2 protocol, which will enroll 50 patients in a 1:1 randomized trial versus placebo, with the primary endpoint of time to complete debridement. The study is expected to initiate in Q4 2026.

Q: Regarding the BARDA contract with Vericel, how does the $6 million in BARDA revenue Vericel expects in H2 align with the $14-15 million in BARDA revenue you are projecting for 2026? Also, how should we think about NexoBrid revenue in 2026 and 2027 given the facility delay? A: CEO Ofer Gonen clarified that the $14 million figure is not exclusively from BARDA, as it includes other government agreements like the Department of War. The BARDA MSA includes several components, and the first development program is underway, with additional components under negotiation. CFO Hani Luxenberg added that the facility timeline will not materially impact 2026 revenue guidance, as a significant portion of H2 revenue comes from government-funded development activity and product supply under existing agreements, not commercial supply from the expanded facility. The company expects no impact on 2027-2028 NexoBrid revenue.

Q: Can you provide specifics on the VALUE trial enrollment rate per site and confirm if all 40 sites are actively enrolling? Also, does your expectation for the Q1 resampling assume any improvement in enrollment trends? A: CEO Ofer Gonen stated that to protect the integrity of the study, the company cannot disclose patient enrollment numbers or trends during the conduct of the multinational study. He reiterated that the design remains unchanged (216 patients, ~40 sites) and that the interim assessment and enrollment completion are expected by the end of Q1 2027. He confirmed the company is on track and does not require any improvements in enrollment trends. Regarding sites, he noted they are very close to having all ~40 sites recruiting, with less than 10% remaining to reach the target.

Q: What is the EMA requesting regarding the expanded manufacturing facility, and has the timeline slipped? Does this push product availability to 2028? Also, what is the status of the CPT code, and is January 2027 still realistic? A: CEO Ofer Gonen clarified that the EMA pre-audit recommended operational changes, not related to product quality, safety, or comparability. These modifications will be completed in Q4 2026 (not 2027). After completion, manufacturing will begin, with regulatory approval expected as early as H2 2027. He acknowledged a delay but confirmed the company is on track. EVP Barry Wolfson stated there is no publicly available information regarding an update to a Category 1 CPT code.

Q: Given the strong Q2 product sales of $2.6 million versus $528,000 in Q1, should we think about capacity as roughly $1.7-1.8 million per quarter until the capacity expansion? Can you duplicate the $2.6 million quarter? A: CEO Ofer Gonen explained that the company is capped by capacity, not demand, and inventory is currently zero. He suggested that Q2 is a more accurate reflection of run-rate, but noted that last year's sales plus a ~10% premium for price changes and effectiveness would be a more accurate baseline. He did not provide specific quarterly guidance but indicated the company is selling everything it produces.

Q: Should we expect a significant spike in R&D spending in H2 2026, and how should we model the next couple of quarters? A: CFO Hani Luxenberg stated that the increase in R&D is primarily driven by the VALUE Phase 3 trial, which remains the top strategic priority. While not providing quarterly guidance, he confirmed that R&D spending will remain elevated as the trial progresses. However, a meaningful portion of NexoBrid development activity is supported by non-dilutive government funding through BARDA and the Department of War, allowing the company to be disciplined in deploying its own capital.

Q: Regarding the pressure ulcer study, how is it being conducted, what is MediWound's responsibility, and will the data be available by the time you file with the FDA and EMA? A: CEO Ofer Gonen explained that the pressure ulcer study is an investigator-initiated initiative, not run directly by the company. It is a small, open-label trial of 10-15 patients expected to initiate in Q4 2026. Patients will be treated with EscharEx over one to two weeks, assessing debridement, correlation, and wound closure. Following the VALUE readout, the company plans to approach the FDA to determine requirements for pursuing approvals for DFU and pressure ulcer indications.

Q: Given Smith & Nephew's comments about Santyl's limitations, does this imply the market is larger than currently estimated? Also, where do you see EscharEx being used if approved, and where is Santyl usage concentrated today? A: EVP Barry Wolfson confirmed that the market is indeed larger than

For the complete transcript of the earnings call, please refer to the full earnings call transcript .