.15 Mar 2018 07:22
Bad news? Look at that RNS... not bad imo:
A very strong year and encouraging start to 2018
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Revenues for the year ended 31 December 2017 increased to �12.8m (2016: �1.48m)
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Cash balance (unaudited) at 31 December 2017 was �20.5 million with �10 million undrawn from the EIB facility
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Major in-licence agreement signed on 14 March 2018 with University College Dublin for exciting non-viral gene therapy platform technology, which offers a potential treatment for patients with EB
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Preliminary data suggests that the treatment could be potentially disease-modifying for patients with Recessive Dystrophic Epidermolysis Bullosa ("RDEB"), a subset of EB
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Amryt intends to conduct various pre-clinical studies in the coming months and will report initial results in early Q4 2018. These initial studies will be funded from Amryt's existing cash resources
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Revenues from Lojuxta (lomitapide), which treats a rare life-threatening disorder that causes abnormally high levels of "bad" cholesterol, increased to �11.9m
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This is a growth rate of 65% compared to the annualised sales of Lojuxta for the period prior to its in-licensing by Amryt, in December 2016
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Five new distribution agreements signed since November 2017 - significantly broadening potential sales
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Lead development asset, AP101 (a potential treatment for rare, genetic, skin condition, EB), continues to make significant progress:
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Amicus Therapeutics granted Amryt access to the data from its landmark Phase 3 clinical study in EB
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Insights from these data enable Amryt to refine its ongoing global Phase III EASE study of AP101 in EB - with the potential to increase the probability of success for the study
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As a result, clinical trial interim analysis is now expected to be completed in early Q4 2018, with read out of top-line data in Q2 2019
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Additional market opportunities for AP101 in partial thickness wound indications are under evaluation.
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Opportunities include AP101 as a treatment for Toxic Epidermal Necrolysis Syndrome (TENS)/Stevens-Johnson Syndrome (SJS), Bullous Pemphigoid, Pemphigus Vulgaris and grade III/IV radiotherapy and chemotherapy-induced dermatitis. The scope of the current EMA approval may offer the opportunity to launch in some of these indications in Europe.
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Full year results are expected to be announced in mid-April 2018