RE: From today's RNS10 Jun 2020 12:19
US LiquiBand®
We are pleased to report that end market sales data for LiquiBand® show that it has started to recover some momentum which resulted in strong sales volumes for the first quarter of 2020 and market share gains. This strong performance predated the significant reduction in demand seen since the start of the second quarter as a result of the COVID-19 pandemic but did evidence that the sales initiatives implemented in late 2019 and earlier this year have been successful. In addition to this, the launch of LiquiBand® Rapid™ went ahead with one of the Group’s main US partners, albeit at a lower level than originally planned due to COVID-19 restrictions. This partner is now well positioned to compete in the US market when hospitals reopen for elective surgery.
The LiquiBand® XL critical pilot study has been completed with three different formulations successfully meeting our objective of 14-day wear time. However, some of the variants demonstrated extended set time. The lead formulation, which we believe maximises our potential for long term commercial success on all product features, is an accelerated formulation of LiquiBand® that will require additional stability and biocompatibility data along with a repeat of the clinical study as part of the FDA filing. The additional work required on this lead formulation means that we now expect to file for 510K approval in the first quarter of 2021. We expect the financial impact of this delayed approval to be offset by the stronger than anticipated LiquiBand® market share improvement and short term commercial agreements with US hospitals to encourage additional LiquiBand® adoption in the run up to the LiquiBand® XL approval. Once approved, LiquiBand® XL will allow entry into the market for care of larger wounds and unlock further growth potential in the LiquiBand® business with all partners.
Chris Meredith, Chief Executive Officer of AMS, commented: “Our strong balance sheet enables us to weather the disruption of COVID-19 whilst continuing to invest in R&D and regulatory projects, in order to be in the best position to return to strong growth when the Group’s end markets recover to a more normal basis.
Given the strong demand for LiquiBand® in the first quarter, the launch of LiquiBand® Rapid™ and the development plan now in place for LiquiBand® XL that will allow entry into the larger wounds market, we remain confident in the growth potential for the LiquiBand® portfolio.”
The Group expects to release a trading update covering the first six months of the financial year in early July 2020.
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