MediWound (NASDAQ: MDWD) reported Q4 EPS of ($0.06), $0.05 better than the analyst estimate of ($0.11). Revenue for the quarter came in at $6.67 million versus the consensus estimate of $5.59 million.

Fourth Quarter and Full-Year 2020 Business Highlights:

• U.S. Food and Drug Administration (FDA) accepted for review the Company’s Biologics License Application (BLA) for NexoBrid® and assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.
• BARDA initiated the procurement of NexoBrid for emergency stockpile, valued at $16.5 million, with first deliveries accepted by BARDA in the third and fourth quarters of 2020, with additional deliveries planned through end of 2021.
• Completed enrollment in the company’s NexoBrid pivotal Phase 3 (CIDS) study; top-line data, including twelve-month follow-up safety data, are anticipated in the second half of 2021.
• Completed U.S Phase 3 (DETECT) study, including patient long-term safety follow-up; the twenty-four-month safety data of cosmesis and function was comparable across all study arms with no new safety signals observed.
• Continued NexoBrid global expansion with additional distribution agreements in France, Switzerland and other EU countries; entered the Middle Eastern market with the signing of a distribution agreement in the United Arab Emirates.
• Adjusted the U.S. phase 2 adaptive design study of EscharEx® for the treatment of venous leg ulcers (VLUs) enrollment target to 120 patients down from the 174 originally planned; interim assessment is expected in mid-2021 and completion of enrollment by year-end 2021.
• Launched a new clinical development program to evaluate its product candidate MWPC005 in patients with non-melanoma skin cancers; a U.S. phase I/II clinical study for the treatment of basal cell carcinoma (BCC) is scheduled to begin in the second quarter of 2021.

“I am very proud of our team’s perseverance and resilience in delivering positive results in our clinical programs and financial performance despite the enormous COVID-19 challenges that we all face globally. We look forward to 2021 as a pivotal year of important catalysts for MediWound,” said Sharon Malka, Chief Executive Officer of MediWound. “We remain focused on our continued growth with the advancement of our EscharEx clinical program with a U.S phase 2 study interim assessment later this year. NexoBrid’s global expansion continues as we look forward to NexoBrid's BLA approval in 2021. Finally, we are excited to initiate the clinical development program of MWPC005 as a treatment for BCC, leveraging our platform technology to enhance our diverse and innovative portfolio.”

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