• Q4 2024 Revenue: $5.8 million, up from $5.3 million in Q4 2023.
• Q4 2024 Gross Profit: $0.9 million with a gross margin of 15.5%, up from $0.7 million and a 13.5% margin in Q4 2023.
• Q4 2024 R&D Expenses: $3 million, compared to $1.8 million in Q4 2023.
• Q4 2024 SG&A Expenses: $4 million, compared to $2.8 million in Q4 2023.
• Q4 2024 Operating Loss: $6.1 million, compared to $3.9 million in Q4 2023.
• Q4 2024 Net Loss: $3.9 million or $0.36 per share, compared to $1.7 million or $0.19 per share in Q4 2023.
• Q4 2024 Adjusted EBITDA Loss: $4.9 million, compared to $3.2 million in Q4 2023.
• Full Year 2024 Revenue: $20.2 million, up from $18.7 million in 2023.
• Full Year 2024 Gross Profit: $2.6 million with a gross margin of 13%, down from $3.6 million and a 19.1% margin in 2023.
• Full Year 2024 R&D Expenses: $8.9 million, compared to $7.5 million in 2023.
• Full Year 2024 SG&A Expenses: $13.1 million, compared to $11.6 million in 2023.
• Full Year 2024 Operating Loss: $19.4 million, compared to $15.3 million in 2023.
• Full Year 2024 Net Loss: $30.2 million or $3.03 per share, compared to $6.7 million or $0.75 per share in 2023.
• Full Year 2024 Adjusted EBITDA Loss: $14.8 million, compared to $12.3 million in 2023.
• Cash and Equivalents at Year-End 2024: $43.6 million, compared to $42.1 million at the end of 2023.

• Warning! GuruFocus has detected 7 Warning Signs with MDWD.

Release Date: March 19, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• MediWound Ltd (NASDAQ:MDWD) reported strong execution and significant progress in clinical development, commercial expansion, and strategic partnerships in 2024.
• EscharEx demonstrated superiority over existing products in key clinical endpoints, with a peak sales potential estimated at $725 million.
• The company secured EUR16.5 million in funding from the European Innovation Council to accelerate EscharEx development for diabetic foot ulcers.
• NexoBrid achieved significant commercial reach, generating $20.2 million in revenue, with projected growth to $24 million in 2025.
• MediWound Ltd (NASDAQ:MDWD) strengthened its balance sheet with a $25 million PIPE financing round, providing resources for clinical and commercial growth plans.

Negative Points

• The company reported an operating loss of $19.4 million for the year, an increase from $15.3 million in 2023.
• Net loss for the year was $30.2 million, significantly higher than the $6.7 million loss in the prior year.
• R&D expenses increased to $8.9 million, primarily due to costs related to the EscharEx Phase 3 trial.
• SG&A expenses rose to $13.1 million, reflecting higher share-based compensation costs.
• The company's gross profit margin declined to 13% from 19.1% in the previous year, due to changes in revenue mix and higher fixed costs.

Q & A Highlights

Q: What role do wound care collaborators play in the EscharEx study beyond supplying products? A: Barry Wolfenson, Executive Vice President of Strategy & Corporate Development, explained that collaborators provide standardized products to minimize variability and optimize outcomes. They also offer training for site investigators and ongoing support related to their products.

Q: Can you provide details on the DFU study expected to begin in 2026? A: CEO Ofer Gonen stated that the DFU study will be similar to the VLU study, with plans to approach the FDA and EMA for protocol approval. The study may require an interim assessment before transitioning to Phase 3, depending on agency feedback.

Q: When can regulatory approvals for the new manufacturing facility be expected? A: Ofer Gonen indicated that European approval is expected in early 2026, with FDA approval anticipated by mid-2026. This timeline is based on the stability testing requirements of three months for Europe and six months for the U.S.

Q: How does the new Medicare LCD policy impact MediWound? A: Barry Wolfenson noted that the policy requires complete wound debridement before applying tissue substitutes, aligning with EscharEx's capabilities. This positions EscharEx as an optimal choice when surgery or sharp debridement is not preferred.

Q: How does EscharEx compare to SANTYL in terms of performance? A: Barry Wolfenson highlighted that EscharEx outperformed SANTYL in key endpoints such as time to complete debridement and wound closure. EscharEx can achieve CTP application in a couple of weeks, compared to six to eight weeks for SANTYL.

Q: Is there potential for faster enrollment in the VLU study? A: Ofer Gonen emphasized the focus on recruiting the right patients with chronic wounds, rather than speeding up enrollment. The goal is to ensure high-quality data by selecting patients who truly need treatment.

Q: What is the status of the collaboration with BARDA for a U.S. facility? A: Ofer Gonen stated that the U.S. government has funded the planning of a backup facility in the U.S. The project is in the planning phase, with completion expected in three years, but it will not impact revenue guidance for the next four years.

Q: How is the VLU study enrollment progressing, and are there any challenges? A: Ofer Gonen reported that site activation is proceeding as planned, with no significant delays. The study is well-received in the U.S., and there is enthusiasm among sites to participate.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.