MediWound reports Q2 EPS ex-items (12c), consensus (3c)
Reports Q2 revenue $20.7M, consensus $4.45M. "We are very pleased with the continued progress we have made this quarter following our terrific start to 2019, highlighted by the robust top-line results from our Phase 3 DETECT study of NexoBrid, in which we met primary and all secondary endpoints," said Sharon Malka, MediWound's Chief Executive Officer. "We continued being active in the second quarter and thereafter, with several significant milestones including signing commercial license and supply agreements with Vericel for NexoBrid in North America and confirming with the FDA in a pre-BLA meeting our BLA submission plans, which puts us on track to file a BLA for NexoBrid in the second quarter of 2020 and a clear path to the U.S. commercial market. The continued BARDA support provides us with an additional $21 million to fund the NexoBrid expanded access treatment protocol, which we plan to initiate in the third quarter of 2019. "The NEXT protocol allows U.S. burn centers to treat burn patients with NexoBrid prior to BLA approval and to use NexoBrid in non-declared emergency events. The NEXT protocol will result in an increased number of burn centers trained with the use of NexoBrid across the U.S. and thereby furthering the national preparedness for burn mass casualty incidences. In addition, this quarter NexoBrid received marketing authorization from Peru's Ministry of Health, in line with our global commercial strategy of expanding the use of NexoBrid in international markets through collaborations with local distributors. Following the North American commercial collaboration for NexoBrid, our primary focus turns to EscharEx. We plan to initiate an adequately-controlled, adaptive designed Phase 2 clinical study in the fourth quarter of 2019, with an interim assessment planned by year-end 2020. This study will compare EscharEx to a placebo control arm as well as head-to-head with the current non-surgical standard of care in the U.S, and if successfully completed, we believe it may serve as one of the two pivotal studies required for BLA submission. With adequate financial resources and a solid balance sheet, we are well positioned to support our development plans through our numerous upcoming milestones, and we look forward to making further progress during the second half of the year."