- Amryt Pharma Plc's (NASDAQ:AMYT) Q4 FY21 sales increased 29% Y/Y to $54.8 million, missing the consensus of $56.81 million.
- The growth was driven by metreleptin revenues that increased 44% to $31.9 million.
- Cash of $113 million at December 31, 2021 (2020: $118.8M)
- The Company reported a wider operating loss of $(50.5) million compared to $(13.9) million a year ago.
- Amryt posted Q4 EPS of $0.07, a shift from an EPS loss of $(0.28), compared to the consensus of $(0.15).
- Last month, the FDA asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in Epidermolysis Bullosa.
- During Q2 2022, Amryt intends to discuss the nature of the data required to address the FDA concerns.
- The EMA review process for Oleogel-S10 in EB is ongoing, and Amryt has responded to outstanding questions.
- The EMA has proposed an Ad-Hoc Expert Group to provide external and independent EB-specific advice. The Ad-Hoc Expert Group is scheduled to meet on March 15, 2022.
- Guidance: Amryt Pharma expects FY 2022 revenue of $260 million - $270 million, up 17% - 21%, lower than the consensus of $341.17 million.
- Price Action: AMYT shares are up 7.21% at $6.99 on the last check Wednesday.
