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Amryt Pharma advancing on multiple fronts


What the company does

Amryt Pharma PLC (LON:AMYT) sells and develops orphan drugs used to treat rare diseases with two products on the market.

Last year, Amryt acquired US group Aegerion Pharmaceuticals out of Chapter 11 bankruptcy protection in a transaction backed by convertible bondholders, creditors and Nasdaq-listed Novelion Therapeutics, Aegerion’s parent company.

The complex transaction gave Amryt full control of the Lojuxta cholesterol treatment.

One of its lead candidates is the AP101 cream, branded FILSUVEZ, developed for epidermolysis bullosa (EB), a chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate.

The company is also focusing on a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB. This gene-therapy platform also has potential applicability across a range of other genetic disorders.


How it is doing 

Amryt raised its forecast for revenues in the current year, 2020, after strong third-quarter sales for both its lead drugs.

The group said sales in the three months to end September 2020 were US$49.3mln, an underlying improvement of 19% and that had prompted it to raise revenue expectations for full-year 2020 to US$180mln-£182mln from US$170mln-£175mln.

Amryt’s cash position also improved to US$75.4mln at the end of the period.

In a statement, Joe Wiley, Amryt’s chief executive said: “Our two commercial products, metreleptin and lomitapide, continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion.”

Wiley noted that the group was also looking at a launch of  FILSUVEZ in the US in Q4 2021 and in Europe in Q1 2022 if all approvals come through.

FILSUVEZ is a treatment for Epidermolysis bullosa (EB), a rare inherited skin disorder that causes the skin to become very fragile and most often affects babies and young children.

“EASE is the first-ever Phase 3 study to demonstrate positive data in this devastating disease and we look forward to submitting this data to regulatory authorities in both the US and Europe in early 2021,” said Wiley.


What the boss says: Joe Wiley, chief executive 


What the broker says

House broker Shore Capital said if regulatory submissions are approved for FILSUVEZ, Amryt is also eligible for a priority review voucher (PRV), which could be worth up to US$100mn and is not yet reflected in its forecasts and hence represents potential upside.

“We see this as a transformational milestone for Amryt and its management team, with the positive headline data a hugely de-risking event.” 

The shares trade at a significant discount to fair value, the ShoreCap analysts said, representing less than 2x sales versus global peers on at least five times sales, and with “significant upside from EB and the dual-listing on Nasdaq as key drivers for a re-rating”. 

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