Amryt Pharma reveals record results
Amryt Pharma () has released ‘record’ results for FY20 which it said are demonstrative of ‘the very positive performance and growth’ that its commercial products are delivering.
The commercial-stage biopharmaceutical company focused on rare diseases reported 18.5% growth in revenues for the full year ended 31 December 2020 to $182.6m (FY19: $154.1m),well ahead of market expectations.
The Group also returned a positive adjusted EBITDA result over the period of US$30.4m, excluding non-cash items and share based compensation expenses as EBIT loss reduced to 46.5m (FY19: $50.5M).
Amryt said the strong trading performance is has translated into a significant increase in its cash balances with $26.9m of cash generated from operating activities in FY20, of which $5.8m was generated in 4Q20, its 4th consecutive quarter of positive cashflow.
As at 31 December 2020, total cash was $118.8m, nearly doubling from $67.2m in FY19.
Wiley attributes the strength of the Group’s FY20 results to the ‘significant operational progress’ it has achieved in an ‘exciting development pipeline’ of new therapeutic drug candidates.
The Group’s two commercial products metreleptin and lomitapide secured a string of regulatory approvals and distribution agreements over the period. Metreleptin revenues rose by 25% to $106.9m in FY20 (FY19: $85.4m) while lomitapide revenues rose to $74.8m.
In particular, it hailed the success of its EASE trial which was the first ever Phase 3 study to demonstrate positive results for the medical condition epidermolysis bullosa. The Group is now progressing regulatory submissions with the relevant authorities in the US and Europe.
The primary endpoint of the trial was achieved and demonstrated a statistically significant acceleration of target wound healing by day 45 in patients treated with the Group’s Oleogel-S10 product demonstrating a 44% increase in target wound closure vs control gel.
“Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY21 of $200-$205m which demonstrates our confidence in our prospects,” Wiley noted.
The Group said both metreleptin and lomitapide continue to deliver growth ‘across a host of metrics’ including revenue and EBITDA growth, cash generation and market expansion.
Amryt said it has infrastructure in place to continue to grow its existing commercial products, adding that it will be able to leverage these capabilities to launch Oleogel-S10, if approved.
“2020 was a challenging year for us all as a result of the global pandemic but our business model proved resilient and capable of overcoming the challenges the pandemic presented.” he added.
Investors will be pleased with these record results in general and the +10% performance in the shares since the beginning of 2021 in particular.
Looking forward into FY21 and beyond, double digit revenue growth following distribution agreements in Canada and Israel and positive cashflow generation (by excluding the legacy Aegerion fines, total FY20 cash generation was $42.6m) offer investors further positive newsflow opportunities and a possible re-rating of the shares over the next 12 months. The stock was trading 2p higher at 213p on Thursday afternoon following the results announcement.
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Leading Intellectual Portfolio
AMYT’s portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.
The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.
Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.
In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.
Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.
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®.
Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.
The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.
In recent weeks, Amryt received approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales, to treat partial and generalised lipodystrophy in adults and children 12+ years of age.
Amryt is well positioned in the novel therapeutics market and strong momentum achieved in the year to date has prompted management to upgrade its guidance for FY20 by around 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m.
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