MediWound (MDWD) Q3 2024 earnings summary

Executive summary

• Achieved FDA approval for NexoBrid pediatric use in the U.S., aligning indications with EU and Japan.

• Completed construction of a new GMP manufacturing facility, expected to increase output sixfold by end of 2025, pending regulatory approvals.

• Advanced EscharEx with phase III VLU trial preparations, IND submission planned by year-end, and secured significant EU funding for DFU studies.

• Raised $25 million in PIPE financing led by Mölnlycke Health Care and secured €16.25 million EIC funding, strengthening cash runway.

• NexoBrid commercial revenue met expectations but was limited by capacity constraints.

Financial highlights

• Q3 2024 revenue was $4.4 million, down from $4.8 million in Q3 2023, mainly due to lower BARDA revenue.

• Gross profit for Q3 was $0.7 million (16% margin), down from $0.9 million (19%) year-over-year.

• Year-to-date revenue reached $14.4 million, up from $13.3 million in 2023, driven by Vericel.

• Net loss for the first nine months was $26.3 million ($2.72/share), up from $5.56/share loss in 2023, mainly due to warrant revaluation.

• Adjusted EBITDA loss for nine months was $9.9 million, compared to $9 million loss last year.

Outlook and guidance

• 2024 revenue guidance revised to $20 million from $24 million, reflecting reduced BARDA funding and delayed U.S. Army project.

• Full operational capacity of new facility expected by end of 2025, supporting future revenue growth.

• EscharEx phase III VLU trial IND submission planned by year-end, with enrollment expected to begin 30 days after; DFU program accelerated with EIC funding.