MediWound(MDWD -0.96%) reported fiscal second quarter 2025 results on Aug. 14, 2025, with revenue rising 43% quarter over quarter to $5.7 million, driven by higher product sales and a favorable mix. The company advanced its Phase III EscharEx VALUE trial, expanded NexoBrid’s U.S. presence, and continued scaling manufacturing to meet global demand. Key strategic partnerships and operational milestones position MediWound for further growth and regulatory progress.

Strategic partnerships expand EscharEx validation

During the quarter, MediWound established new collaborations with wound care leaders ConvaTec (CTEC -1.29%) and SCT, adding to existing relationships with Solventum (SOLV -1.53%), Mölnlycke, and others. These partnerships now cover all major categories of standard-of-care products integrated into clinical trial protocols, supporting both the ongoing venous leg ulcer (VLU) Phase III trial and the planned diabetic foot ulcer (DFU) trial.

"In the second quarter, we continued to execute across our clinical, commercial, and operational objectives. The EscharEx VALUE Phase III trial is actively enrolling patients, and with new collaboration established with ConvaTec and SCT, all the relevant global wound care leaders are now engaged in our clinical programs."
— Ofer Gonen, Chief Executive Officer

This broad network of industry partners reduces adoption risk and positions EscharEx for widespread real-world use, as clinical protocols now reflect the diversity of standard wound care practices across major markets.

MediWound Q2 results show margin improvement

Gross margin (GAAP) improved to 23.5%, up from 8.8% in the fiscal second quarter ended June 30, 2024, with gross profit at $1.3 million. U.S. partner Vericel (VCEL -5.70%) reported a 52% year-over-year revenue increase for NexoBrid, highlighting sustained commercial traction even as supply remained fully absorbed.

"Gross profit for the quarter was $1.3 million or 23.5% of revenue compared to $400,000 or 8.8% in the prior year period. The margin increase reflects a more favorable revenue mix. Research and development expenses were $3.5 million compared to $1.9 million in 2024, driven by continuing investment in the EscharEx VALUE Phase III study."
— Hani Luxenburg, Chief Financial Officer

Improved gross margin and strong sequential revenue growth demonstrate operating leverage, even as research and development expenses increased to support late-stage clinical programs.

NexoBrid facility timeline drives revenue inflection

The new manufacturing facility remains on track for completion and regulatory submission by year-end 2025, with EMA stability testing taking three months and FDA six months, aligning with anticipated European and U.S. approvals in 2026. MediWound’s guidance for $24 million revenue in 2025 reflects current manufacturing constraints, as all NexoBrid production is sold immediately and inventory remains at zero.

"What we guided that by the end of the year, everything will be completed, and we will start submission to the regulatory authorities. Stability testings in the for Europe is three months, and in the United States, it's six months. So our estimation that in 2026, we will get approval from EMA, and in 2026, we will get approval from the FDA. The guidance of the revenue that we are presenting reflects those estimates."
— Ofer Gonen, Chief Executive Officer

Regulatory approval and ramp-up of the new facility are the key bottlenecks for NexoBrid’s global sales growth, with revenue expansion dependent on successful milestones in both Europe and the U.S.

Looking Ahead

Management reaffirmed the $24 million revenue target for 2025 and confirmed new facility completion, with EMA approval expected by mid-2026 and FDA approval in the second half of 2026. A head-to-head trial of EscharEx versus collagenase is scheduled to begin in 2025, and a DFU Phase III trial is targeted for launch in the second half of next year, pending upcoming FDA protocol feedback. No changes to major strategic milestones or enrollment timelines were announced, barring regulatory or site activation delays.