Stifel4 Dec 2016 16:41
Amryt secures €20m funding from EIB
Amryt Pharma has announced it has secured a €20m debt facility from the European Investment Bank (EIB) on
very attractive commercial terms. The facility will not only extend the company's funding until well into 2019,
but also provide funding for development of acromegaly product AP102 and potential launch funding for
Episalvan in partial thickness wounds. Amryt remains on track to initiate Phase III trials of Episalvan in
epidermolysis bullosa (EB) in 1Q17 with results expected in mid-2018 and launch possible in 2019. The EIB
funding is non-dilutive and mitigates funding risk. We reiterate our Buy rating and 49p target price.
EIB funding. Under the terms of the five-year facility, Amryt can draw down €10m immediately and a further €10m in two equal tranches on achievement of certain milestones. The loan pays an interest rate of 3% p.a. over the Euro
LIBOR plus a 10% p.a. interest repayable with the principal. Funded through to 2019. On our revised forecasts, the €20m EIB debt facility will help fund Amryt's operations until well into 2019 by which time Episalvan should have completed Phase III trials in epidermolysis bullosa and be nearing commercialisation. It should also now allow Amryt to launch Episalvan in Europe as a treatment for burns and other partial thickness wounds for which it received EU approval in January 2016. In addition, the debt facility will fund development of orphan drug AP102 in acromegaly, providing funds to complete preclincal development and Phase I trials that are expected to start in 2018.
Episalvan in EB is Amryt's key value driver. The drug is due to enter Phase III trials in EB in 1Q17. Development remains on track with results of the 150 patient EB trial expected by mid-2018 and launch possible in 2019. Amryt is now close to finalising a Phase III trial design that would satisfy both EMA and FDA regulatory requirements. It has also finalised selection of a CRO to conduct the trial. With around 55,000 sufferers in the US and Europe, EB represents a significant orphan drug condition with no current treatment other than regular bandaging. We forecast sales of Episalvan in EB of $258m by 2023E with launch in 2019.
Reiterate Buy. Based on a hybrid of NPV, comparative and discounted revenue multiple methodologies, we value Amryt at 49p per share, implying significant upside potential to the current share price. Published data suggests Episalvan has significant advantages over current treatment and Zorblisa, Amicus’s competing product in development.