The biopharma company, which acquires, develops and commercialises novel treatments for rare diseases, generated revenue growth of 18.5% to US$182.6mln for 2020 from its two products on the market, metreleptin as a supplement for people with leptin deficiency and lomitapide, for adults with a rare cholesterol disorder.
These two products came via the acquisition of Aegerion in September 2019, while regulatory submissions for a third, Oleogel-S10 (branded Filsuvez), to treat epidermolysis bullosa, are “on track” for the current quarter.
Underlying earnings (EBITDA) came to US$30.4mln if excluding non-cash items and share based compensation expenses. Operating losses before finance expense were US$46.5mln, compared to US$50.5mln the year before.
Generating US$26.9mln of cash generated from operating activities, which would have been above US$42mln if not for legacy fines inherited from Aegerion, meant that there was US$118.8mln on the balance sheet at the end of December, up from US$67.2mln over the 12 months.
Chief executive Joe Wiley said the results “demonstrate the very positive performance and growth that our commercial products are delivering, coupled with the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates”.
With further regulatory approvals and distribution deals its two commercial products signed in recent months, Willey added: “Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY 2021 of US$200-US$205mln which demonstrates our confidence in Amryt’s prospects.”
Wiley noted that the EASE study investigating Oleogel-S10 was the first ever Phase 3 study to demonstrate positive results in what is a devastating disease and that the company is “currently progressing regulatory submissions” with authorities in both the US and Europe.
Based on last year’s growth, he said the company has “the management team, systems and infrastructure in place to continue to grow our existing commercial products and we will be able to leverage these capabilities to launch Oleogel-S10, if approved”.