AMryt gave an update of its business, and it included a reflection of the COVID-19 pandemic effect on its projects.
It said that, as at 31 December 2019, Amryt had $65 million unrestricted cash (unaudited), which compares to $57 million cash that was raised (net of fees) when Amryt completed the acquisition of Aegerion on 24 September 2019.
Amryt’s debt maturity profile offers significant flexibility and no debt facilities are due to mature before September 2024 at the earliest with other facilities scheduled to mature in April 2025. The company’s cash balances remain strong in Q1 2020, it said. The integration of Aegerion has gone exceptionally well and will be largely completed by 31 March 2020.
“The primary concern of all the Amryt team is to ensure the safety of our colleagues, their families and our patients and partners at this time. Global healthcare systems are operating at or close to full capacity and the focus within systems now is to treat those patients in need of acute care,” Amryt said in a press release.
Amryt’s business lends itself to remote working and in recent weeks, we have successfully transitioned appropriate functions to remote platforms exclusively without incident, the company has explained.
The impact of COVID-19 to date on Amryt’s business has been minimized and this is a result of deploying contingency plans already in place for a variety of scenarios and challenges which may occur.
Amryt provides therapeutic products to Homozygous Familial Hypercholesterolaemia (“HoFH”) and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) are prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient. As such, the majority of our revenues are recurring in nature and therefore, we do not anticipate significant changes to our existing revenues as a result of COVID-19.
Amryt has in excess of 12 months of labelled and unlabelled finished products on hand for both lomitapide and metreleptin. Our supply chain is robust and we are confident that we can continue to supply patients for the foreseeable future. We are taking additional steps to further strengthen our inventory levels of both metreleptin and lomitapide. To date, we have not experienced any logistical difficulties in delivering product to patients. In major markets such as the USA, the UK and Germany, product has historically been delivered direct to patients’ homes. In other markets, product has typically been delivered to local hospitals/distributors and we are continuing to explore opportunities to expand direct to home delivery in these markets as well.
Clinical Trials Update
Following the positive interim efficacy analysis in the company’s EASE Phase 3 global clinical study of AP101 in Epidermolysis Bullosa (“EB”) (“EASE”), the company has announced its intention to recruit 245 patients into the study as recommended. Final patient recruitment is ongoing and Amryt continues to evaluate the potential impact COVID-19 may have on recruitment timing. Amryt said it is operating EASE trial sites across 55 centres in 27 countries and in the current circumstances, we may focus our resources on those geographies less impacted by COVID-19 than others.
As part of its post-approval commitments in the EU, the company has also recently initiated a Phase 3, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH. On successful completion, the Amryt said it would submit the data to both the EMA and the US Food and Drug Administration (“FDA”) to potentially expand the label for lomitapide to include pediatric patients.
Dr Joe Wiley, CEO of Amryt Pharma, said: “Amryt is a well-capitalised resilient business with recurring revenues, a strong balance sheet and a robust supply of product to meet patient needs. Our primary focus remains the safety and welfare of our colleagues, their families and our patients and partners. Despite the very significant challenges that COVID-19 presents, how we act now both as a company and as citizens will determine how we perform through these difficult times. The Amryt team are operating well in this environment and should it be necessary, we have further contingency plans in place to ensure we are able to adapt to additional challenges that may arise.