MediWound Ltd. (MDWD) Earnings

Management highlights

- Pipeline & Clinical Development Progress * Escorex (SCRX) global Phase III Value trial for chronic wounds is actively enrolling patients, targeting 216 patients across ~40 sites in the U.S., Europe, and Israel. The two key upcoming milestones (pre-specified interim sample size reassessment and full enrollment completion) remain on track for the end of Q1 2027. * An updated independent U.S. market assessment for Escorex, which added pressure ulcers to the analysis, estimates annual peak U.S. sales at $1.05 billion, up from the prior $800 million estimate. An investigator-initiated open-label small trial of Escorex in pressure ulcers is expected to start enrollment in Q4 2026, and a randomized Phase 2 trial of Escorex in diabetic foot ulcers (DFUs) is also planned to initiate in Q4 2026. * MediWound has established a collaboration network with all major advanced wound care companies for the Escorex program, positioning the candidate as a leading non-surgical debridement therapy for chronic wounds. - Nexobrid Commercial & Development Updates * Partner VeriCell reported Nexobrid's strongest U.S. quarter since launch, with record quarterly revenue, hospital unit sales, and ordering centers. Approximately 80 U.S. burn centers have ordered Nexobrid to date, reflecting ongoing adoption across the U.S. burn care market. * Following VeriCell's 10-year $197 million BARDA contract, MediWound entered a new master service agreement (MSA) with VeriCell covering Nexobrid and next-generation product development. Revenue recognition from MSA development activities (including a program to expand Nexobrid indication for blast and friction injuries) is expected to begin in H2 2026. * A Department of War (DOW) non-dilutive $18.3 million program is advancing a room-temperature stable formulation of Nexobrid for military battlefield burn care. - Manufacturing Progress * The company is implementing operational modifications requested by the EMA following a pre-audit of the expanded Nexobrid manufacturing facility. All modifications are expected to be completed by Q4 2026. Regulatory approval for commercial supply from the expanded facility is expected in H2 2027. The requested changes are operational only, with no concerns around product quality, safety, or comparability.

Guidance

- Management reaffirmed full-year 2026 total revenue guidance of $24 million to $26 million, consistent with prior guidance. The revenue profile is expected to be heavily weighted toward H2 2026, driven by the expected start of revenue recognition from the VeriCell MSA and other government-funded programs, which was already factored into the existing guidance range. - The expanded Nexobrid manufacturing facility timeline will not have a material impact on 2026 revenue, as most expected H2 2026 revenue comes from development activities and existing product supply agreements, not commercial supply from the new expanded facility. Management also stated the current timeline will not impact expected Nexobrid revenue for 2027 and 2028. - Key milestone guidance: Escorex Phase III interim assessment and full enrollment completion remains set for the end of Q1 2027; investigator-initiated pressure ulcer trial and DFU Phase 2 trial initiation are both expected in Q4 2026; EMA-requested facility modifications are expected to be completed by Q4 2026; regulatory approval for the expanded facility is expected in H2 2027.

Segment performance

MediWound does not break out financial performance across formal product segments in this call. Overall consolidated financial results for Q2 2026 are: total revenue of $3.1 million (down from $5.7 million in Q2 2025, a decrease driven by timing of BARDA-funded development revenue); gross profit of $0.3 million, gross margin of 10.9% (down from $1.3 million gross profit and 23.5% margin in Q2 2025, with lower margin driven by one-time facility scale-up costs); R&D expenses of $5.9 million (up from $3.5 million in Q2 2025, driven by increased investment in the Escorex Phase III Value trial); SG&A expenses of $3.9 million (up from $3.6 million in Q2 2025); operating loss of $9.5 million (wider than $5.7 million operating loss in Q2 2025); net loss of $7.4 million ($0.57 per share, narrower than $13.3 million net loss/$1.23 per share in Q2 2025, driven by non-cash financial income); adjusted EBITDA loss of $8.3 million (wider than $4.5 million adjusted EBITDA loss in Q2 2025). For the first half of 2026, total revenue was $4.6 million (down from $9.7 million H1 2025, again driven by timing of BARDA revenue); gross profit was $0.7 million (14.4% margin, down from $2.1 million gross profit/21.5% margin H1 2025); R&D expenses were $11.1 million (up from $6.4 million H1 2025, driven by Escorex trial investment); SG&A expenses were $7.5 million (up from $6.6 million H1 2025); operating loss was $17.4 million (wider than $10.9 million H1 2025); net loss was $10.3 million ($0.80 per share, narrower than $14 million net loss/$1.30 per share H1 2025, driven by non-cash warrant revaluation income); adjusted EBITDA loss was $15.3 million (wider than $8.5 million H1 2025). As of June 30, 2026, the company held $36 million in cash, cash equivalents and deposits, down from $54 million at year-end 2025, with $20 million in cash burn in H1 2026.

Risks & headwinds

- Forward-looking statements (including clinical trial timelines, regulatory milestones, and revenue projections) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as outlined in the company's SEC filings. MediWound assumes no obligation to update forward-looking statements after the date of the call. - Clinical trial enrollment could proceed slower than expected, potentially delaying key milestones, though management reaffirmed current timelines are achievable. - Regulatory approval for the expanded Nexobrid manufacturing facility is not guaranteed, and any further delays could impact future commercial supply timelines. - Competition in the enzymatic debridement market could emerge, though management notes Escorex holds a substantial clinical lead over potential late-stage pipeline competitors. - Details of the BARDA/VeriCell MSA are subject to confidentiality requirements, and further negotiation of program scope with government stakeholders could impact the timing and amount of future revenue from these agreements.

Analyst Q&A

• Q: The analyst asked if Escorex's Phase III milestones (interim assessment and enrollment completion) remain on track for Q1 2027, and how potential competition from Smith & Nephew's second-generation debridement candidate impacts Escorex's development. /

  A: Management confirmed the milestones remain on track for the end of Q1 2027. They noted that Smith & Nephew's new candidate is being developed because their existing product Santyl is not a fast-acting debridement option, and based on public data, the new candidate has not entered clinical development for chronic wounds. Management stated Escorex's advanced Phase III position gives it a substantial clinical lead over all competitors. This dynamic also confirms the large unmet need in the debridement market that Escorex is positioned to fill. The addition of pressure ulcers to the market analysis brings peak U.S. sales to $1.05 billion, reflecting the expanded opportunity from unmet need.

• Q: The analyst asked for details on the requested EMA modifications to the expanded Nexobrid manufacturing facility, whether the timeline has shifted, and if the CPT code for U.S. reimbursement is still on track for January 2027. /

  A: Management clarified the requested changes are only operational adjustments, with no concerns around product quality, safety or comparability. All modifications will be completed by Q4 2026, with regulatory approval for the facility still expected in H2 2027; there is no delay to this timeline from the original adjusted schedule. Management confirmed there is no new public update on the Category 1 CPT code as of the call.

• Q: The analyst asked for additional details on the VeriCell MSA and revenue recognition for the BARDA-funded programs, and for an update on the DFU development path for Escorex. /

  A: Management stated the 10-year $197 million BARDA contract awarded to VeriCell covers multiple components including procurement, inventory, manufacturing readiness, next-gen formulation development, and blast injury indication expansion. The company cannot share additional details due to confidentiality obligations to VeriCell and the fact that some program elements are still subject to FDA feedback that may change scope. The MSA is signed, the first blast injury development program is underway, and revenue recognition will begin in H2 2026. For DFU, the company has aligned with FDA and EMA on a 50-patient, randomized, one-to-one Phase 2 trial vs. placebo, which will initiate in Q4 2026. After the Escorex Value trial readout, management will work with regulators to define the approval pathway for the DFU indication.

• Q: The analyst asked about enrollment trends for the Escorex Value trial, how many sites are active, what the timeline is for top-line data after enrollment, and what site-of-care distribution is expected for Escorex if approved. /

  A: Management declined to share interim enrollment data to protect trial integrity, but confirmed the trial remains on track to hit the Q1 2027 milestones for interim assessment and full enrollment. The trial targets ~40 total sites, and the company is very close to having all sites open and recruiting. After enrollment completion, top-line data is expected approximately one quarter later, with final results a few months after that. Management noted that current Santyl usage is fairly evenly distributed across acute care, wound clinics, home health, nursing homes and SNFs following recent CMS reimbursement changes, and Escorex is expected to have a similar distribution if approved.