MediWound Ltd. (MDWD) Earnings

Management highlights

- SCRx (Escarex) Clinical Development * The global Phase III Value study for venous leg ulcers (VLU) has 30 active sites across the U.S., Europe, and Israel. Enrollment progress was slower than originally anticipated due to completed European ancillary regulatory adjustments and participation barriers for the older, medically complex VLU patient population. * 10 additional European sites will be activated within weeks; patient assistance programs (transportation, hotel reimbursement, enhanced care access) have been implemented to reduce participation burden. Enrollment completion is now targeted for the end of Q1 2027, a one-quarter shift from the original timeline. * New collaborations, clinical data, and scientific validation have been secured: Medline joined the existing network of top global advanced wound care collaborators, providing Marathon skin protectant for the upcoming Phase II diabetic foot ulcer (DFU) study; a peer-reviewed U.S. expert consensus document supported the need for SCRx's profile of effective, low-invasion debridement; new preclinical and clinical data was presented at three major wound care conferences. * Indication expansion studies (Phase II DFU, investigator-initiated pressure ulcer trial) plus required regulatory studies (PK, human factors) are planned for H2 2026. - NexoBridge (NexoBrid) Commercial and Government Progress * VeriCell reported continued growth in ordering centers and total orders for NexoBridge in the U.S. burn care market, reflecting ongoing commercial adoption. * VeriCell was awarded a 10-year BARDA contract valued at up to $197 million, covering procurement, vendor managed inventory, blast trauma indication development, and next-generation manufacturing/formulation. BARDA-related activity will begin in H2 2026, building on $138 million in prior BARDA/Department of War funding. * New national consensus guidelines from Japan and the UK now recommend NexoBridge, joining existing recommendations from the WHO and multiple European countries. - Manufacturing * The expanded NexoBrit manufacturing facility is being upgraded for commercial readiness. An EMA pre-audit identified operational modifications that are currently being implemented, with completion targeted for H2 2026. No product quality, safety, or comparability issues were identified. EMA approval is required prior to FDA inspection of the facility, which is planned for early 2027.

Guidance

- Management reaffirmed full year 2026 total revenue guidance of $24 million to $26 million, maintaining the original range despite lower Q1 2026 revenue tied to timing issues. - Full year 2026 revenue is expected to be heavily weighted toward the second half of the year, driven primarily by ramp-up of BARDA and other government-related development services and procurement activities. The guidance does not rely on an accelerated timeline for the new manufacturing facility coming online, as the company has flexibility to meet guidance with existing development and product revenue streams. - No changes to long-term strategic or commercial guidance were announced.

Segment performance

MetaWound operates two core product segments: SCRx (Escarex, in clinical development) and NexoBridge (NexoBrid, commercialized). For Q1 2026, total company revenue was $1.5 million (100% of total revenue), down from $4 million in Q1 2025. The year-over-year decrease was driven by timing of BARDA-related NexoBridge revenue and postponed shipments due to regional conflict. SCRx does not generate commercial revenue as it remains in late-stage clinical development; all R&D expenses for SCRx are classified as corporate-level investment. Gross profit for the combined business was $0.3 million (21.9% gross margin) in Q1 2026, compared to $0.7 million (18.7% gross margin) in Q1 2025. Research and development expenses were $5.2 million, 64% of total operating expenses, up from $2.9 million in Q1 2025, primarily for SCRx Phase III study investment. SG&A expenses were $3.6 million, 36% of total operating expenses, compared to $3.1 million in Q1 2025.

Risks & headwinds

- Enrollment for the SCRx Phase III VLU study has proceeded slower than originally anticipated, pushing completion back one quarter to Q1 2027. While management attributes the slowdown to operational issues that have now been resolved, enrollment could face further delays if patient recruitment remains slower than expected. - Postponed NexoBridge shipments in Q1 2026 were caused by ongoing regional conflict, creating near-term revenue volatility. * The expanded manufacturing facility requires EMA-mandated operational modifications, and any delays in completing these modifications or passing subsequent regulatory inspections could delay commercial production and revenue. A regulatory approval from European/Israeli authorities is required prior to FDA inspection and U.S. supply from the new facility, creating a sequential regulatory risk. * A 2025 Medicare physician fee schedule change cut Medicare spending on cellular tissue products (CTP) by an expected 90%, creating near-term market disruption in the U.S. chronic wound care market, though management notes this disruption creates a long-term commercial opportunity for SCRx.

Analyst Q&A

• Q: What additional risks could delay the SCRx Phase III interim analysis and enrollment completion by Q1 2027, and do the implemented fixes give management confidence the new timeline is achievable? /

  A: Management confirmed the slower enrollment is entirely tied to resolved operational issues (European regulatory adjustments for ancillary products) rather than safety, efficacy, or protocol concerns. The remaining 10 inactive sites are all European and will open within weeks. Patient assistance programs have been added to address participation barriers for the target patient population, and management is prioritizing enrollment of correctly qualified patients to ensure study data validity, which adds some time but is on track to meet the Q1 2027 completion target.

• Q: What is the nature of the EMA pre-audit recommendations for the expanded manufacturing facility, do they impact already produced material, and when will the facility be ready for commercial supply? /

  A: The recommendations are only operational modifications, with no concerns over product safety, quality, or comparability. Management is implementing the changes as required and expects to complete all work in H2 2026, consistent with the original timeline, with EMA approval required before FDA inspection in early 2027.

• Q: What is MetaWound's share of the new $197 million BARDA contract awarded to VeriCell? /

  A: The 10-year contract includes five core components: procurement (shared with VeriCell), vendor managed inventory (run by VeriCell), manufacturing development, next-generation formulation, and blast trauma indication development (where MetaWound holds a large share). Management cannot disclose specific revenue split details at this time, but confirms BARDA-related revenues will begin in H2 2026.

• Q: How does the recent Medicare fee schedule change impacting cellular tissue products (CTP) affect SCRx's commercial opportunity? /

  A: The fee schedule change is expected to cut Medicare CTP spending by ~90%, reducing the overall U.S. chronic wound care market from $18 billion to $5.5 billion, and leading to steep year-over-year sales declines for major CTP providers. Management notes this creates a large commercial opportunity for SCRx, as leading wound care companies will shift focus to approved, differentiated products like SCRx that fall outside the impacted CTP category.

• Q: What lessons from SCRx Phase III enrollment challenges will be applied to future indication expansion studies? /

  A: The key lesson learned is that historical enrollment rate estimates (half a patient per site per month) from the COVID period were inflated, as COVID drove higher patient participation that has not persisted. Future trial timelines will use lower enrollment rate assumptions to avoid overestimating progress. Tactical changes, including pre-clearing ancillary product import requirements for Europe and building in patient assistance budgets, will also be applied to future studies.