MediWound (MDWD) Q3 2025: NexoBridge Demand Drives 38% U.S. Growth, Manufacturing Expansion Sets Stage for Global Upside
NexoBridge, enzymatic burn debridement therapy, delivered record U.S. growth and global recognition this quarter, while expanded manufacturing capacity promises to unlock pent-up demand in 2026. Escarex, late-stage chronic wound candidate, advanced its pivotal trial and received a commercial model upgrade, but regulatory timing and BARDA contract execution remain key variables. Investors should watch for manufacturing ramp and reimbursement milestones as the company pivots from R&D to commercial scale.
Summary
- Manufacturing Expansion Unlocks Global Supply: Newly commissioned facility increases NexoBridge output sixfold, positioning for broader market access.
- Escarex Price Power and Market Model Upgrade: Peak sales estimate raised to $831 million, driven by payer-validated pricing and health economics data.
- BARDA and Reimbursement Milestones in Focus: U.S. government contract timing and CPT code progress will shape revenue visibility and adoption curves.
Performance Analysis
MediWound’s Q3 performance reflects a decisive pivot toward commercial execution, with revenue reaching $5.4 million, up 23% year over year. Growth was led by development services and record NexoBridge sales in the U.S., where partner Vericel reported a 38% increase and expanded penetration across more than 60 burn centers. Gross margin improved to 16.5%, up from 15.5% a year ago, driven by a more favorable revenue mix and higher-margin product sales.
R&D and SG&A investment accelerated, reflecting ongoing Escarex Phase III trial costs and commercial readiness. Operating loss widened to $6.5 million, but net loss narrowed sharply on warrant revaluation gains. The balance sheet was fortified by a $30 million equity raise, ending the quarter with $60 million in cash and equivalents. Adjusted EBITDA loss increased, underscoring the cost of late-stage clinical advancement and infrastructure buildout.
- Burn Franchise Momentum: NexoBridge delivered its highest-ever U.S. sales, with global approvals now spanning 45 countries.
- Margin Leverage Emerging: Gross margin improvement signals positive product mix shift as manufacturing scales.
- R&D Spend Reflects Pipeline Ambition: Escarex and diabetic foot ulcer (DFU) programs drive elevated R&D, with near-term data and regulatory milestones ahead.
Financial discipline remains critical as the company balances pipeline investment, manufacturing scale-up, and the transition to commercial-stage execution.
Executive Commentary
"Our production capacity is now six times larger, providing a strong foundation for future growth. We expect to reach full operational capacity by year-end 2025, with regulatory review and approval determining the timing of commercial output."
Ofer Gonen, Chief Executive Officer
"We believe our current cash position provides the financial flexibility needed to advance our key program and continue executing on our strategic priorities."
Honey Luxemburg, Chief Financial Officer
Strategic Positioning
1. NexoBridge Capacity and Commercial Traction
NexoBridge, MediWound’s enzymatic burn debridement therapy, is gaining clinical and commercial momentum. With a sixfold manufacturing capacity increase and new approvals (Australia, pediatric), the product is now available in 45 markets. U.S. demand is outpacing supply, as evidenced by record sales and broad adoption among burn centers. The permanent CPT code pursuit, set for 2027, is expected to further accelerate adoption by enhancing reimbursement legitimacy and institutional acceptance.
2. Escarex Peak Sales Model and Market Access
Escarex, late-stage chronic wound candidate, saw its U.S. peak sales estimate upgraded to $831 million. This is based on payer-driven pricing validation and health economic benefits (HEOR, health economics and outcomes research, quantifies cost savings from earlier wound closure). The model now assumes a price premium over legacy Santal, justified by robust clinical data and payer willingness to pay for improved outcomes. The ongoing VALUE Phase III trial continues enrolling, with interim analysis set after 65% of patients complete treatment.
3. BARDA and Government Channel Leverage
BARDA (Biomedical Advanced Research and Development Authority, U.S. government procurement and R&D agency) represents a multi-year, high-visibility opportunity. While the recent government shutdown delayed contract execution, management remains optimistic on resumption. The contract covers stockpiling, trauma/blast indications, and product innovation, and could drive durable U.S. government revenue if awarded.
4. Financial Flexibility and Strategic Investment
The $30 million equity raise and warrant exercises provide a cash runway to fund late-stage trials, manufacturing ramp, and commercial expansion. Management’s ability to secure capital from high-quality healthcare investors signals external confidence in the pipeline and commercial prospects.
Key Considerations
MediWound’s strategic context is defined by an inflection point: the company is shifting from a pipeline-centric R&D model to a commercial-stage, global supply and market access execution phase, while managing late-stage trial risk and government contract dependencies.
Key Considerations:
- Manufacturing Bottleneck Resolution: Expanded facility will ease supply constraints and enable international NexoBridge launches, but regulatory approval timing will dictate pace.
- Reimbursement and Adoption Catalysts: CPT code progression and payer-validated pricing are critical for broad physician and institutional uptake in the U.S.
- BARDA Contract Visibility: Government funding and procurement remain subject to political and administrative timelines, introducing revenue timing uncertainty.
- Escarex Data and Regulatory Milestones: VALUE Phase III trial and DFU program initiation are pivotal for long-term platform validation and commercial leverage.
Risks
Execution risk remains high as MediWound scales manufacturing and navigates regulatory approvals for both its facility and late-stage pipeline. BARDA contract timing is uncertain and subject to U.S. government processes. Adoption in new markets depends on reimbursement wins and competitive response from entrenched products and low-cost alternatives. Investors should monitor regulatory, operational, and capital allocation discipline closely.
Forward Outlook
For Q4 2025, MediWound management signaled:
- Full operational readiness of the new NexoBridge manufacturing facility by year-end, pending regulatory review.
- Continued NexoBridge demand outpacing supply, with U.S. and international expansion contingent on capacity ramp.
For full-year 2025, management maintained its focus on:
- Advancing Escarex VALUE Phase III trial and preparing for DFU study initiation in 2026.
- Securing BARDA contract and progressing toward permanent CPT code for NexoBridge.
Management highlighted:
- Strong commercial validation for NexoBridge and Escarex pricing power.
- Financial flexibility to fund growth and pipeline execution through 2026.
Takeaways
MediWound is entering a pivotal phase, with commercial burn franchise momentum, a validated chronic wound pipeline, and a manufacturing platform finally scaled to meet global demand.
- Manufacturing Expansion Is a Game-Changer: The sixfold capacity increase will unlock previously constrained markets and enable NexoBridge to fulfill growing demand.
- Escarex’s Upgraded Market Model Signals Commercial Potential: Payer-validated pricing and health economic benefits support higher peak sales, but execution on trial endpoints and regulatory milestones remains crucial.
- BARDA and Reimbursement Outcomes Will Set the Revenue Trajectory: U.S. government contracts and permanent CPT code adoption are binary catalysts that could accelerate or delay scale-up and adoption curves.
Conclusion
MediWound’s Q3 marks a transition from promise to potential delivery, with NexoBridge’s commercial growth and Escarex’s upgraded opportunity setting the stage for a transformative 2026. Execution on manufacturing, reimbursement, and government contracts will determine whether the company can realize its expanded market vision.
Industry Read-Through
MediWound’s performance underscores the importance of manufacturing scale and reimbursement legitimacy in specialty pharma, especially for biologics and advanced wound care. Rising payer scrutiny and reimbursement reforms (e.g., Medicare skin substitute cuts) are reshaping competitive dynamics and elevating the value of differentiated, HEOR-validated therapies. BARDA-driven procurement and stockpiling remain a meaningful growth lever for companies with trauma and emergency care applications. Peers in wound care and specialty biologics should monitor supply chain, regulatory, and payer trends as key drivers of commercial success.