AMYT.L Regulatory News (AMYT)

AMRYT PHARMA PLC

("Amryt" or the "Company")

Business integration and delivery of synergies progressing on track

Cash position of US$60.9m

Amryt, an international biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, today announces a market update regarding the integration of the recent acquisition of Aegerion Pharmaceuticals, Inc ("Aegerion") which completed on September 24, 2019.

Amryt reports that the integration and delivery of synergies are progressing well and ahead of the Company's initial expectations. In line with the Company's integration, role redeployment and synergy plan, 28 new positions have been filled to date with additional roles expected to be filled in the first quarter of 2020.

On 25 September 2019, the Company raised US$57 million (net of expenses) by way of the issue of new ordinary shares. At 16 December 2019 the Company had cash of US$60.9 million (unaudited) which is significantly ahead of the Company's expectations at this point.

The EASE Phase 3 global clinical study of AP101 in Epidermolysis Bullosa ("EB") is progressing well and as at 17 December 2019, there were 236 patients either already enrolled in the EASE study or scheduled to enter the study shortly. Amryt intends to recruit 245 patients to be fully enrolled. Management estimate the EB market opportunity to be in excess of US$1 billion.

Dr Joe Wiley, CEO of Amryt Pharma, commented: "Amryt has evolved from a company with a single asset on the market in the EMEA to become a global biopharmaceutical company with two orphan disease products and a commercial infrastructure across North America, EMEA and LATAM. Our strategy is to become a global leader in rare and orphan diseases and we are committed to delivering new therapies to patients in areas of high unmet need.

"We are pleased with the progress that the business integration has made to date and the delivery of synergies following the completion of this transformational acquisition. The operational synergies delivered so far have resulted in a higher cash balance at this point in time than we initially forecast and we are also making solid progress across a number of other financial metrics. We look forward to another productive and successful year in 2020."

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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 and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt's commercial business comprises two orphan disease products.

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name, Juxtapid®) and in the EU (under the trade name, Lojuxta®). HoFH is a rare genetic disorder which 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 cardiovascular disease.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name, Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name, Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 or over for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Amryt's lead development candidate, AP101 (Oleogel-S10), is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. It is currently being studied in a Phase 3 clinical trial and recently reported that unblinded interim efficacy data supported continuation of the study with a modest increase in sample size and unblinded interim safety data allowed the inclusion of children from as young as 21 days old. AP101 has been granted FDA Pediatric Rare Disease Designation and has also received a Fast Track Designation from the FDA. The European and US market opportunity for EB is estimated by the Directors to be in excess of $1 billion.

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, including products, please visit www.amrytpharma.com

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014