MediWound Q1 2024 Financial Results and Company Update

7 June 2024

YAVNE, Israel, May 29, 2024 — MediWound (Nasdaq: MDWD), a global leader in enzymatic therapeutics for tissue repair, has announced its financial results for Q1 2024. The company highlighted substantial strides in revenue growth and strategic objectives.

Performance Overview:

NexoBrid® Progress:
- The U.S. launch through Vericel is advancing well, with over 60 burn centers submitting to Pharmacy and Therapeutics (P&T) committees. Approximately 40 centers have gained approval, and over 30 have placed their first orders.
- NexoBrid has seen a significant increase in patient treatments and orders from burn centers and hospitals.
- The new Good Manufacturing Practice (GMP)-compliant facility is on track to be completed by mid-2024, with commissioning expected by Q3 2024 and full operational status by 2025. This expansion will enhance manufacturing capacity sixfold.
- A supplemental Biologic License Application (BLA) for pediatric use has been accepted by the U.S. FDA, with a decision anticipated in the latter half of 2024.
- Development of a temperature-stable NexoBrid formulation for non-surgical field-care burn treatment, aimed at the U.S. Army, is progressing as planned with FDA feedback expected in the second half of 2024.
- Concluded enrollment and 12-month follow-up for the Expanded Access Treatment Protocol (NEXT) with 239 patients treated across 29 U.S. centers. Data readout is anticipated in the second half of 2024.

EscharEx® Developments:
- Phase III trial remains on course for protocol submission in the first half of 2024. The global study plans to enroll 216 patients across 40 sites, treated with EscharEx or a placebo gel. An interim assessment will occur once 67% of participants complete the trial, expected to begin in the latter half of 2024.
- Phase II data indicated EscharEx’s superiority over SANTYL®, presented at three major wound care conferences.

Corporate Highlights:
- MediWound is set to join the Russell 3000® Index as part of the 2024 annual reconstitution.

Financial Performance:
- Q1 2024 revenue was $5.0 million, up from $3.8 million in Q1 2023, driven primarily by Vericel and U.S. Department of Defense contracts.
- Gross profit for Q1 2024 was $0.6 million, or 12.2% of total revenue, down from $0.8 million (21.7%) in Q1 2023, due to changes in the revenue mix.
- Research and development (R&D) expenses decreased to $1.5 million from $2.1 million in Q1 2023, attributed to the completion of the EscharEx Phase II study.
- Selling, General, and Administrative (SG&A) expenses fell to $2.9 million from $3.1 million in Q1 2023.
- Operating loss narrowed to $3.7 million from $4.4 million in Q1 2023.
- Net loss widened to $9.7 million, or $1.05 per share, from $3.7 million, or $0.44 per share, in Q1 2023, due to financial expenses from warrant revaluation driven by a 40% share price increase.
- Adjusted EBITDA loss improved to $2.9 million from $3.4 million in Q1 2023.

Balance Sheet:
- As of March 31, 2024, cash and cash equivalents, restricted cash, and deposits totaled $36.0 million, down from $42.1 million as of December 31, 2023.
- The company raised $0.5 million from Series A warrant exercises and invested $2.7 million into CAPEX for facility scale-up.

Conference Call Information:
MediWound’s management will host a conference call on May 29, 2024, at 8:30 a.m. Eastern Time to discuss these results. The call will be available via webcast on the company’s website.

About MediWound:
MediWound Ltd. specializes in non-surgical tissue repair through enzymatic therapeutics. Its flagship product, NexoBrid®, is FDA-approved for severe burn eschar removal and can minimize surgical interventions. EscharEx®, in Phase III for chronic wound debridement, aims to surpass current market leaders. 

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