AMYT.L Regulatory News (AMYT)

19 July 2018

AIM: AMYTESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Trading Update

SALES ON TRACK AND SIGNIFICANT MOMENTUM BUILDING IN H2

Amryt, a biopharmaceutical company focused on rare and orphan diseases, is today pleased to provide an update on trading for the half-year period ended 30 June 2018.

Amryt has had a strong H1 2018 with progress across all three pillars of its growth strategy: namely, continued revenue growth and territory expansion for its lead commercial asset Lojuxta™▼ (lomitapide), development of its late stage pipeline and acquiring new products to leverage its established commercial, medical and regulatory infrastructure in rare diseases.

Revenues (unaudited) for the first half were €7.0 million, representing 14% growth versus H1 2017. Cash Balance (unaudited) at 30 June 2018 was €12.2 million (30 June 2017, €10.9 million). Amryt is well positioned to continue to grow revenues in 2018 and the Board expects full year results to be in line with current market expectations.

This anticipated full year growth is underpinned by (i) the recent successful reimbursement decision by NHS England for Lojuxta in patients with Homozygous Familial Hypercholesterolaemia ("HoFH") and (ii) the success of Amryt's strategy to appoint local distribution partners for new territories, which is already resulting in new prescriptions. For example, in November 2017, Amryt signed a distribution agreement for the key territory of Saudi Arabia and since then has identified 100 patients diagnosed with HoFH, of the estimated 150 patients in the country. In addition, Amryt's distributor for Central and Eastern Europe is seeing good revenue momentum in Austria and Lithuania where the first patients have been initiated. 

Moving to Amryt's late stage development pipeline, the investigational global Phase III ('EASE') clinical trial with AP101 for Epidermolysis bullosa ("EB") is progressing well with a pre-planned interim efficacy analysis expected to be completed in Q4 2018, and top-line data expected in Q2 2019. It is estimated that the market potential for AP101 is more than €1 billion.

During H1, Amryt further delivered on the third pillar of its growth strategy to acquire new products by expanding its EB franchise with the in-licencing of a non-viral gene therapy platform with preliminary data in EB. Results from pre-clinical studies are expected in Q4 2018. Amryt is also actively seeking to acquire new commercial stage assets that can further leverage its established commercial, medical and regulatory infrastructure.

Joe Wiley, CEO of Amryt Pharma, commented: "We are pleased with the progress that we have made in the first half of 2018 across all aspects of our business and growth strategy. Our focus on adoption of and access to Lojuxta in new and existing territories is already delivering significant returns and we are confident that this positive momentum will continue in 2018 and beyond. We are particularly pleased by the recent funding approval of this medicine by NHS England and also with progress to date in markets such as Saudi Arabia, Austria and Lithuania. With the first indication of efficacy from our Phase III study of AP101 in EB due to be reported in Q4 and our continuing efforts to create future commercial opportunities for this drug, we are very well positioned to continue to build and scale Amryt into a world leader in rare and orphan diseases."

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About Amryt

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases.

Lojuxta is an approved treatment for adult patients with the rare cholesterol disorder - Homozygous Familial Hypercholesterolaemia ("HoFH"). This disorder impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature narrowing and blocking of blood vessels, heart attacks and strokes, even at a very young age if not properly diagnosed or receiving adequate treatment. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis in adult patients with HoFH.

Amryt holds an exclusive licence to sell Lojuxta (lomitapide) across the European Economic Area, Middle East and North Africa, Switzerland, Turkey, Israel, Russia, the Commonwealth of Independent States and the non-EU Balkan states.

Amryt's lead drug candidate, AP101, is a potential treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children for which there is currently no treatment. It is currently in Phase III clinical trials. The European and US market opportunity for EB is estimated to be in excess of €1 billion.

Amryt's earlier stage product, AP102, is focused on developing novel, next generation somatostatin analogue ("SSA") peptide medicines for patients with rare neuroendocrine diseases, where there is a high unmet medical need, including Acromegaly and Cushing's disease. 

In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.

For more information on Amryt, please visit amrytpharma.com