Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces unaudited financial results and provides a business update for the third quarter ended September 30, 2020.

• 19% YoY growth in unaudited Q3 revenues to $49.3M (Q3 20191 unaudited combined revenues: $41.4M)
• 23% YoY growth in unaudited cumulative YTD revenues to $140.1M (Nine months 20191 unaudited combined revenues: $113.6M)
• 7% QoQ revenue growth in Q3 versus Q2 ($46.2M)
• Raising FY 2020 revenue guidance from $170M – $175M to $180M – $182M (20191: $154.1m)
• $3.6M operating loss before finance expense in Q3. Excluding non-cash items and share based compensation expenses, this resulted in
• EBITDA of $13.5M in Q3 representing 96% QoQ growth
• Strong cash generation during the nine months to September 2020 with $21.1M of cash generated from operating activities YTD and $11.4M during the quarter
• Increase in cash from $67.1M at June 30, 2020 to $75.4M at September 30, 2020
• Amryt announced positive results from EASE pivotal Phase 3 trial in EB. The primary endpoint of the trial was achieved and demonstrated a statistically significant acceleration of target wound healing by day 45 in patients treated with FILSUVEZ®2 vs control gel (p-value = 0.013) representing a 44% increase in target wound closure with FILSUVEZ® vs the control gel. EASE is the largest ever
• Phase 3 randomized controlled study conducted in EB.
• The RDEB sub-group was observed to experience a greater benefit when treated with FILSUVEZ® than the overall population (nominal p=0.008) representing a 72% increase in target wound closure with FILSUVEZ® vs the control gel
• Favourable trends were evident among secondary endpoints including change in procedural pain, EBDASI score and BSAP
• FILSUVEZ® had an acceptable safety profile and was well tolerated when compared with control gel
• On July 8, Amryt listed on the Nasdaq Global Select Market (“Nasdaq”)

Joe Wiley, CEO of Amryt Pharma, commented:

“I am very pleased with today’s record results which demonstrate the positive performance and growth that our commercial products are delivering alongside the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates. The positive momentum we experienced during the first half of the year has continued through Q3 and I am very pleased with both our revenue growth and positive cash momentum. Furthermore, given the strong performance of the business year to date we are now increasing our revenue guidance for 2020 from $170-$175 million to $180-$182 million.

We are also very pleased with the positive results for FILSUVEZ® from our EASE Phase 3 trial in EB. EASE is the first ever Phase 3 study to demonstrate positive data in this devastating disease and we look forward to submitting this data to regulatory authorities in both the US and Europe in early 2021. If approved, we intend to launch FILSUVEZ® in the US in Q4 2021 and in Europe in Q1 2022.

Our two commercial products, metreleptin and lomitapide continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion. We have the management team, systems and infrastructure in place to continue to grow our existing commercial products and also to launch FILSUVEZ® if approved next year”.

RNS in full