CONTINUING STRONG PROGRESS
Financial
- mRevenues increased to €12.8m (2016: €1.4m)
– driven by growth of Lojuxta drug sales - Cash balances totalled €20.5m at 31 December 2017 (2016: €8.3m), with €10m undrawn from the European Investment Bank facility
- Successful equity placing raised €15m (gross) in October 2017
- Gross profit margin increased to 58% (2016: 57%)
Operational
- Sales of Lojuxta, a drug which treats a rare, life-threatening cholesterol disease, Homozygous Familial Hypercholesterolaemia (“HoFH”), grew strongly
– first full year’s contribution of €11.9m compared to €0.8m for one month in December 2016
– first distribution agreement signed in November 2017 – covers the Kingdom of Saudi Arabia
– a further four distribution agreements were signed in Q1 2018 - Pivotal Phase III EASE trial commenced in March 2017 – investigating AP101 as a potential treatment for Epidermolysis bullosa (“EB”), a rare skin disorder that can cause skin to blister and tear at the slightest touch
- In response to physician interest, Amryt is also now evaluating other dermatological indications for AP101, where there is high unmet medical need and which relate to the European Medicine Agency’s existing approval for AP101
- Senior Management Team enhanced further by new appointments
Post Period
- Amryt granted access to data from Amicus Therapeutics’s landmark EB trial (ESSENCE) – a remarkable sharing of data. As a result, Amryt is now making modest refinements to its protocol for its Phase III EASE trial, with the aim of increasing the probability of success for the study
– interim analysis is expected to be completed in Q4 2018, with read out of top-line data expected in Q2 2019 - In-licensing agreement for a gene-therapy platform technology signed with University College Dublin in March 2018
– technology uses a novel gene delivery mechanism and the focus of potential application is on patients with a sub-type of EB
– pre-clinical studies are to commence, with initial results planned for Q4 2018
Joe Wiley, CEO of Amryt, said: “Amryt made very strong progress both financially and operationally in 2017. The dramatic increase in revenues to €12.8m reflected a full year’s contribution from sales of Lojuxta, which is used to treat the rare, life-threatening cholesterol disorder, HoFH. We remain in a very good position to expand Lojuxta sales further, having secured a number of distribution agreeements across our licensed territories, including Eastern Europe and the Middle East.
“2017 marked a milestone for our lead development asset, AP101, as we commenced our pivotal Phase III trial, EASE, in March. This study is investigating AP101 as a potential treatment for EB, the rare and distressing genetic skin disorder. We are now refining the study’s protocol after being granted remarkable access to Amicus Therapeutics’s trial data, which read-out in September 2017. This very generous decision by Amicus Therapeutics allows us the opportunity to increase the chances of our study’s success and we now expect interim analysis to be completed in Q4 2018, with read out of top-line data expected in Q2 2019.
“We continue to expand the Company’s growth opportunities, and Amryt remains well positioned to continue to make significant progress in 2018.”
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