Investing in equities is an emotional roller-coaster. So it proved again today, with news that the FDA had extended its review of Amryt Pharma plc
(AMYT ) break-through Epidermolysis Bullosa (EB) skin treatment, Oleogel-10, by 3 months to 28th February.
In turn, pushing the shares in one of my largest positions, down another -10% after yesterday’s -5% fall (re AIM delisting).
Big picture though, I suspect this is a just another bump in the road, which should hopefully be ironed-out by 31st Mar’22.
Indeed it appears neither Oleogel-10’s safety or efficacy is in question, having already met its primary end-point goals in Phase 3 trials. Nor does the delay affect #AMYT’s FY21 revenue guidance of $220m-$225m, or impact the drug’s priority status.
More likely I guess, the deferral simply reflects the FDA needing a little more time/info to decide for which patients & conditions the cream should be authorised (ie its label).
Encouragingly too, the FDA did reach out to AMYT 7 days before the old date (30th Nov) expired. Suggesting that the relationship remains strong.
Elsewhere, the European Medicines Agency's authorisation process is on track and scheduled for completion by 31st January.
CEO Joseph Wiley adding: “We are well positioned to address these regulatory requests from our existing data within the time periods required, and we look forward to our continued productive discussions as the regulatory agencies complete their review”.
Wrt the numbers, I reckon FY23 sales could hit $300m, even without Oleogel approval. Which assuming a 25% EBITDA margin (excluding new R&D investment) & a 15x multiple - would generate a theoretical ('back of the envelope') $1.1bn valuation on its own, or worth >200p/share (post Est $120m net debt).
Meaning both Oleogel & the pipeline are effectively in the price for free. And despite the last 2 days' news, the stock has actually been remarkably resilient.
Time to be patient.