MediWound Q3 2026 Earnings Call - MEDIWOUND LTD

Financial Performance:

• Q3 2026 revenue was $3.6 million, down from $5.4 million in Q3 2025, driven by lower U.S. government development services revenue.
• Year-to-date (9 months) 2026 revenue was $8.1 million, down from $15.1 million in the same period in 2025.
• Gross profit for Q3 2026 was $1.0 million (28.5% margin) compared to $0.9 million (16.5%) in Q3 2025, with margin improvement attributed to higher royalty revenue contribution.
• R&D expenses for Q3 2026 were $6.2 million, up from $3.5 million in Q3 2025, reflecting increased investment in the SCRX Phase III VALUE trial.
• SG&A expenses for Q3 2026 were $3.4 million, down from $4.0 million in Q3 2025, due to lower marketing costs.
• Net loss for Q3 2026 was $6.0 million ($0.47/share), compared to $2.7 million ($0.24/share) in Q3 2025, primarily due to lower non-cash warrant revaluation income.
• Adjusted EBITDA loss for Q3 2026 was $7.4 million, worsening from a $5.4 million loss in Q3 2025.
• Cash and equivalents as of September 30, 2026, stood at $28.4 million, down from $53.6 million at year-end 2025.
• Cash burn for the first nine months of 2026 was $28.3 million, partially offset by $2.0 million from warrant exercises (including board members and CEO) and $1.1 million post-quarter-end exercises.
• A public offering in November 2026 raised gross proceeds of $17.25 million.

Guidance and Future Outlook:

• No specific 2026 or 2027 revenue guidance provided due to uncertainty regarding the funding status of a planned U.S.-based manufacturing facility.
• SCRX VALUE trial enrollment is targeted for completion by the end of Q1 2027.
• Top-line data for the SCRX VALUE trial is expected in mid-2027.
• Expanded manufacturing facility modifications are expected to be completed in Q4 2026.
• Commercial supply from the expanded facility is targeted for the second half of 2027, pending regulatory approval and inspection.
• A new stable formulation for NexoBridge is expected to proceed to IND submission.
• Pressure ulcer trials are expected to initiate in the coming weeks, followed by diabetic foot ulcer trials.

Business Segments and Product Lines:

• SCRX (MediWound): The Phase III VALUE trial for venous leg ulcers is the top priority; 40 sites are open globally, with an enrollment target of 216 patients. The program is also advancing into diabetic foot ulcers (ECI-funded) and pressure ulcers (investigator-initiated).
• NexoBridge: U.S. commercial trajectory strengthened with highest quarterly revenue to date; 80+ centers ordered the product, with ~70 placing repeat orders. Demand exceeds current manufacturing capacity.
• Government Programs: NexoBridge procurement under the BARDA/Vericel contract began in Q3 2026 and is expected to continue through Q1 2027 (text error in transcript: likely "2028" or "2027" depending on context, transcript says "2025" which appears inconsistent with "2026" context, but explicitly stated "continue through the fourth quarter of 2027 and the first quarter of 2025" which is logically flawed; likely 2028 or 2027).
• Department of War: Received an additional $3.3 million to advance room-temperature stable formulation for battlefield burn care, bringing the total program budget to $21.8 million.
• Manufacturing: Current facility received GMP certification from FDA, EMA, and Israeli Ministry of Health; expanded facility modifications are being implemented to address capacity constraints.

Market and Competitive Landscape:

• Global demand for NexoBridge exceeds supply capabilities, making capacity expansion a key priority.
• SCRX is positioned as the only late-stage BLA candidate for chronic wounds following CMS reimbursement changes for traditional agents like Apligraf.
• SCRX demonstrates a significantly faster debridement timeline (4-5 days) compared to historical standards (4-8 weeks).
• Projected peak sales opportunity for SCRX is approximately $1 billion across venous leg, diabetic foot, and pressure ulcers.
• Eight out of the nine largest wound care companies are currently collaborating with MediWound.

Risks and Challenges:

• Revenue volatility is tied to the timing and finalization of U.S. government funding for the new manufacturing facility.
• Supply chain constraints currently limit NexoBridge revenue growth, as the company is selling all units it can manufacture.
• Regulatory risk exists for the expanded facility supply release, contingent on successful inspections and approvals in the second half of 2027.
• Clinical trial risks remain with the SCRX VALUE trial, including the potential for sample size reassessment outcomes in Q1 2027.

Management Commentary and Tone:

• Management expressed strong confidence in completing SCRX VALUE enrollment by Q1 2027 (95% of sites open).
• Tone regarding NexoBridge was positive, highlighting commercial momentum and government contract growth despite supply limits.
• CFO emphasized that revenue is heavily weighted toward development services, while product sales are supply-constrained.
• CEO reiterated that SCRX is a strategic asset with high attractiveness to large wound care companies due to the established reimbursement path and efficacy profile.

Analyst Questions and Answers:

• Enrollment Velocity: Management confirmed comfort with Q1 2027 enrollment completion but declined to share specific patient numbers to protect study integrity.
• DSMB Meetings: An interim sample size reassessment will occur at the Q1 2027 DSMB meeting; the next safety review is scheduled for early January 2027.
• Commercial Strategy: Discussions with partners are ongoing, but management prefers to wait for Phase III data to maximize leverage, citing SCRX's unique BLA status.
• Facility Timeline: The expanded facility timeline includes operational changes (Q4 2026), validation, and inspections, with commercial supply targeted for H2 2027; no significant cushion was indicated for delays.
• Endpoint Power: The trial is 99.9% powered to demonstrate superiority on the time-to-wound-closure endpoint; the debridement endpoint requires significantly fewer patients.

Other Key Points:

• All board members, the founder, and the CEO exercised warrants and agreed to lock-up restrictions.
• The transcript contains a significant error regarding the BARDA contract end date ("first quarter of 2025" following "Q4 2027"), which contradicts the timeline of the call (2026); context suggests the contract extends beyond the immediate fiscal year.
• Two additional NexoBridge programs (trauma indication expansion and stable formulation) are covered under the Vericel-BARDA Master Service Agreement.
• The company plans to provide updates on the initiation of the pressure ulcer and diabetic foot ulcer trials in the next quarter or "next few weeks."