Amryt Pharma (AMYT ) has reported strong operational results for the third quarter to 30 September 2021 as revenues increased to $56.5m, a year-on-year increase of 14.6% from $49.3m in 3Q20.
In particular, the global biopharmaceutical company said revenue growth from metreleptin, Amryt’s leptin replacement therapy, was strong to deliver 21.5% year-on-year growth in 3Q21 to $36.3m, up from $29.9m in 3Q20, while annual revenues increased by 51.6%, respectively.
The Company reported a $21.4m operating loss before finance expense for 3Q21 (3Q20: $3.6m), resulting in EBITDA before restructuring and acquisition costs of $6.2m for 3Q.
Cash as at 30 September 2021 was $123.2m at (30 June 2021: $142.9m) post repayment of outstanding Chiasma revenue interest financing debt and transaction related costs in 3Q.
Amryt noted that while the reported figures exclude the impact of sporadic LATAM ordering, that the results ‘clearly demonstrate’ the strong performance of metreleptin in all regions.
Commenting on this morning’s set of results, Joe Wiley, Chief Executive of Amryt Pharma said: “Overall, the results also demonstrate the strong growth we are experiencing across our business and represent our seventh consecutive quarter of positive EBITDA generation and this performance has been delivered despite the challenging COVID pandemic.”
Amryt said ‘significant progress’ has been made since acquiring the biotechnology firm Chiasma in August 2021 with mycapssa® delivering revenues of $1.45m in 3Q. It said the integration is now ‘significantly advanced’ and that it continues to extract cost synergies.
While mycapssa® revenues in 3Q were impacted by pre-ordering in 2Q, normalised ordering patterns returned in September with Mycapssa® having delivered $1.14m in the month.
The Company highlighted to investors that it continues to progress the regulatory pathway and filed marketing applications for its Oleogel-S10 product in both the US and Europe and noted that a target PDUFA date for Oleogel-S10 has been set for 30 November 2021.
If approved under priority review by the US FDA, Oleogel-S10 will be eligible for a Priority Review Voucher which would allow for faster review under the FDA’s priority review system.
“If Oleogel-S10 is approved, we will have four commercial products and the team, financial flexibility, systems and global infrastructure in place to bring Oleogel-S10 to market and to execute our significant growth plans,” Wiley highlighted to investors in today’s statement.
Given the continued strong performance of its commercial products, Amryt has reaffirmed its revenue guidance for FY21 in the range of $220 - $225m, a growth of 20% to 23% on FY20.
Back in June 2021, Amryt said the U.S. FDA had granted the company priority review for Amryt’s New Drug Application for Oleogel-S10 for the treatment of Epidermolysis Bullosa.
Priority Review is granted by the US FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The FDA has set a Prescription Drug User Fee Act target action date, the deadline by which the FDA must review the application, for the Oleogel-S10 NDA of 30 November 2021.
Amryt’s lead development candidate, Oleogel-S10, or Filsuvez® is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”).
The anticipated launch of Oleogel-S10 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.
Both the NDA and priority review from the US FDA marks ‘another important milestone’ as Amryt progresses Oleogel-S10 with the regulatory authorities in both Europe and the US.
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