MediWound (NASDAQ: MDWD) reported Q4 EPS of ($0.13), $0.03 worse than the analyst estimate of ($0.10). Revenue for the quarter came in at $5.4 million versus the consensus estimate of $4.08 million.

Fourth Quarter and Full-Year 2019 Financial Highlights:

• Total revenues of $31.8 million for the full-year 2019.
• Total revenues of $5.4 million for the fourth quarter of 2019, an increase of $4.4 million from the $1.0 million of fourth quarter of 2018, driven primarily by revenues from development services.
• The Company had $29.5 million in cash and short-term investments as of December 31, 2019.

Fourth Quarter and Full-Year 2019 Business Highlights:

• Announced positive top-line results from the pivotal U.S. Phase 3 DETECT study in NexoBrid for eschar removal of severe thermal burns. The safety data of cosmesis and function collected in the twelve-month patient follow-up period, was comparable across all study arms, and no new safety signals were observed.
• Entered into exclusive license and supply agreements with Vericel Corporation in May to commercialize NexoBrid in North America for an upfront payment of $17.5 million, sales royalties, and up to $132.5 million in potential milestones.
• Initiated the NexoBrid Expanded Access Treatment protocol (NEXT) to treat burn patients with deep partial and full-thickness burns in the U.S. during the ongoing preparation and review of the NexoBrid Biologics License Application (BLA).
• Initiated a U.S. Phase 2 adaptive design clinical study of EscharEx, the Company’s topical biologic drug candidate designed to enzymatically debride chronic wounds, for the treatment of venous leg ulcers (VLUs).
• The U.S. Biomedical Advanced Research and Development Authority (BARDA) initiated the procurement of NexoBrid for emergency response, valued at $16.5 million.
• Continued global expansion of NexoBrid through new distribution agreement in Australia, Ukraine and additional EU countries.

“2019 was a transformational year for MediWound, and we have continued building on this momentum in what we believe will be a meaningful 2020,” said Sharon Malka, Chief Executive Officer of MediWound. “We are very pleased to have our U.S. Phase 2 adaptive design study for EscharEx up and running. This study is designed to assess the efficacy and safety of our advanced once-a-day topical treatment in the debridement of venous leg ulcers. The study enables the comparison of EscharEx to placebo control, as well as a head-to-head comparison with the current non-surgical standard of care in the U.S. We believe EscharEx can be a game-changer, addressing a significant unmet medical need, and we anticipate having an interim assessment for this study by the end of the year.”

Mr. Malka continued, “With regard to NexoBrid, we announced in early 2019 the results of the U.S. phase 3 DETECT study, which were robust across all endpoints, and subsequently reported the long-term follow-up safety data, which was comparable across all study arms. We are currently targeting the NexoBrid BLA submission for midyear 2020 and are actively preparing for commercial launch in the U.S. with our partner, Vericel. In addition, the NEXT program is up and running, allowing for the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. Finally, the initiation of the NexoBrid procurement by BARDA prior to BLA submission is a significant milestone in our partnership with BARDA, which we believe will significantly increase U.S. readiness for burn mass casualty incidents.”

“Our solid balance sheet and near-term cash inflows will continue to support our development plans and we look forward to several meaningful upcoming milestones in each of our programs,” concluded Mr. Malka.

For earnings history and earnings-related data on MediWound (MDWD) click here.