Release Date: November 26, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- MediWound Ltd (MDWD, Financial) received FDA approval for NexoBrid's pediatric use in the United States, expanding its label to cover patients from newborn to 18 years old.
- NexoBrid's commercial revenue met expectations, with significant progress in the U.S. market, including submissions to over 70 burn centers.
- The World Health Organization designated enzymatic debridement as an essential treatment for burn injuries, reinforcing NexoBrid's role in emergency response.
- MediWound completed construction of a new GMP-compliant manufacturing facility, expected to increase manufacturing output sixfold by the end of 2025.
- The company secured $25 million through a private investment led by Molnlycke Healthcare, enhancing its strategic funding and commercial expertise.
Negative Points
- Revenue for the third quarter of 2024 decreased to $4.4 million from $4.8 million in the same period of 2023, primarily due to lower revenue from BARDA Development Services.
- Gross profit for the quarter declined to $0.7 million, representing 16% of total revenue, compared to $0.9 million or 90% of total revenue in Q3 2023.
- Operating loss for the first nine months of 2024 was $13.3 million, compared to $11.4 million in the same period of 2023.
- Net loss for the first nine months increased significantly to $26.3 million or $2.72 per share, compared to a net loss of $5 million or $0.56 per share in the same period of 2023.
- The anticipated revenue for 2024 was adjusted down to $20 million from prior guidance of $24 million, due to capacity constraints and reduced BARDA funding.
Q & A Highlights
Q: Can you provide details on the Phase 3 EscharEx IND submission and interactions with the FDA? When should we expect the trial to begin?
A: The IND submission for the Phase 3 EscharEx trial is expected by the end of this year. We have cleared the protocol with both the FDA and EMA, and we anticipate starting patient enrollment 30 days after the submission.
Q: Is the head-to-head Phase 2 study of EscharEx versus collagenase a regulatory requirement, or is it intended to support reimbursement decisions?
A: The study is not a regulatory requirement but aims to bolster EscharEx's commercial potential by providing a robust data set for pricing discussions and demonstrating its advantages over SANTYL. It will also support global approval efforts.
Q: Has there been any change in the timeline for increasing NexoBrid's manufacturing capacity?
A: The construction of the new manufacturing facility was completed as planned, and we are now in the commissioning phase. We are preparing for inspections by the FDA and EMA, which will determine the timeline for increased capacity.
Q: What are the expectations for the Phase 2 head-to-head study versus collagenase in terms of success?
A: The study is designed similarly to the previous successful Phase 2 trial. We expect to see similar effects, with EscharEx showing significant impact in the first two weeks compared to SANTYL, supporting pricing discussions and market positioning.
Q: How does the recent WHO inclusion of enzymatic debridement impact stockpiling efforts?
A: The WHO inclusion is a significant achievement, facilitating discussions with European BARDA for stockpiling. We anticipate being able to sign agreements for stockpiling in Europe by 2026, once manufacturing constraints are resolved.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
