Amryt Pharma (AIM:AMYT ) reported record results for 3Q20 demonstrating the positive performance and growth of its commercial products as well as “significant progress” with its drug pipeline. 

The biopharmaceutical group recorded 19% Year-on-Year (“YoY”) growth in Q3 revenues to $49.3m (Q319: $41.4m) with 23% YoY growth in unaudited cumulative year-to-date revenues to $140.1m (nine months FY19: $113.6m).  

The group said ‘positive momentum’ experienced during the first half of the year has continued through Q3, reflected in both revenue growth and positive cash momentum.  

Cash generated from operating activities in Q3 2020 came to $11.4m while as at 30 September 2020, Amryt had cash of $75.4m compared to cash at 20 June 2020 of $67.1m. 

The company also cited its recent positive results from the pivotal Phase 3 EASE trial of FILSUVEZ® (Oleogel-S10) the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), performed across 58 sites in 28 countries.    

The trial, which demonstrated the effectiveness of FILSUVEZ® in accelerating wound healing in people with EB, was described by Amryt as “a very important milestone”. The group is seeking to approve FILSUVEZ® as a treatment for EB, for which there are currently none.   

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®.  

The group said it also intends to pursue an accelerated assessment in the EU. Meanwhile, regulatory submissions in the US and EU are expected to be filed by late Q1 2021.   

Joe Wiley, CEO of Amryt Pharma also noted that the company’s other two commercial products, metreleptin and lomitapide, have continued to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion.  

He said, “We have the management team, systems and infrastructure in place to continue to grow our existing commercial products and also to launch FILSUVEZ® if approved next year.” 

During Q3, metreleptin, which is marketed as Myalept® / Myalepta® saw a 31% growth in revenues to $29.9m (Q319: $22.9m), in part bolstered by a $6.9m order in Latin America.  

Lomitapide, which is marketed as Juxtapid®/Lojuxta® saw a 4% increase in revenues to $19.1m throughout the quarter (Q319: $18.3m). The US accounted for 51% of global revenues and Europe, Middle East and Africa accounted for 28% of global revenues in Q3. 

Outlook 

As a result of the group’s strong performance to date, Amryt has upgraded its guidance for FY20 to be in the range of $180m-$182m compared to prior guidance of $170m -$175m. 

Shares in Amryt Pharma have increased over 25% since early September 2020 to open at 204p prior to the release of 3Q20 results. 

Reasons to Follow Amryt Pharma  

Amryt is a biopharmaceutical group developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases with the company comprising a strong and growing portfolio of commercial and development assets.  

Strong Portfolio 

Its 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.  

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®.  

New Distribution Partner 

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.  

Strong Outlook 

The Company 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 approximately 5% to be in the range of $180m-$182m compared to prior guidance of $170m -$175m. 

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