Amryt Pharma: Interim results for the six months ended 30 June 2019

30 September 2019
AIM: AMYT
Euronext Growth: AYP

Interim results for the six months ended 30 June 2019

Amryt, a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, today announces interim results for the six months ended 30 June 2019.

Financial Highlights

• Revenue growth of 15.9% to €8.1m (H1 2018: €7.0m)
• Revenues from Lojuxta (lomitapide) increased to €7.9m, which represents a growth rate of 19.5% compared to H1 2018 (€6.6m)
• Acquisition related expenses relating to work completed in H1 amounted to €2.3m
• Cash balance at 30 June 2019 of €4.8m (31 December 2018: €9.8m)

Operational Highlights

Lead Commercial Asset - Lojuxta

• Initial orders received for patients in France in Q1 2019
• Positive momentum building in the UK and Saudi Arabian markets, following first orders received for patients in Q4 2018

Lead Development Asset - AP101

• Significant continued progress made in the EASE Phase 3 clinical trial supporting the development of AP101, a potential treatment for Epidermolysis Bullosa (“EB”) with final patient enrolment expected by the end of 2019
• Following an assessment of the results of an unblinded interim efficacy analysis of its pivotal Phase 3 EASE trial for AP101 as a potential treatment for EB, the IDMC recommended that the trial should continue with an increase of 48 patients in the study to a total of 230 evaluable patients, in order to maintain 80% statistical power
• Following an assessment in February by the EASE trial’s IDMC of pharmacokinetic (“PK”) data received from patients already enrolled in the trial (aged four years and older), Amryt can now enrol infants and children with EB between the ages of 21 days to 4 years of age into the trial

Gene Therapy Platform - AP103

• Data from two preclinical studies showed that topical application of AP103 restored production of collagen VII in pre-clinical models of EB to levels exceeding those produced by healthy human keratinocytes and to levels similar to those observed following delivery with a viral vector
• In addition, AP103 exhibited no evidence of cellular toxicity after repeated administration

Post-Period End Events

• In August/September 2019, Amryt raised gross proceeds of $8.0 million by way of an interim placing
• Scheme of arrangement completed to create new English group holding company (“New Amryt”)
• Acquisition of Aegerion completed on 24 September 2019
• Admission of the enlarged share capital of New Amryt to trading on AIM and Euronext Growth
• $60 million equity raise completed in conjunction with the acquisition of Aegerion on 24 September 2019
• Re-financing of existing Aegerion debt and additional debt introduced to repay the existing Amryt EIB debt facility resulting in a new 5-year term loan facility of $81 million and a new 5.5-year convertible loan facility of $125 million
• New board structure announced for the Enlarged Group

Dr Joe Wiley, CEO of Amryt Pharma, commented: “We are pleased to report solid growth in our commercial business in the first half driven by continued positive momentum from Lojuxta. We also achieved a significant milestone in Q1 with our lead development asset - AP101 - with the successful completion of an unblinded interim efficacy analysis for our EASE Phase 3 trial. EASE is progressing well and we expect the study to be fully enrolled by the end of the year. We continued to make good progress advancing AP103 and in H1 announced the results of two preclinical studies which further support the potential of our novel gene therapy platform as a potentially transformative treatment for patients with Recessive Dystrophic EB, which is a particularly severe form of EB. If successful, this platform has potential in other genetic skin conditions and beyond.

“2019 to date has been transformational for Amryt and we are extremely well positioned to develop and grow our commercial business whilst also progressing our very exciting development pipeline. Amryt today has two substantial revenue-generating products with built in 2018 revenues of $136.5m, a ready-made international commercial business in the USA, Europe, the Middle East and Latin America, a strong development pipeline and the financial flexibility to fully execute on our growth plans. We are very confident in the opportunities the deal will deliver for all of our stakeholders, and that the transaction will drive future shareholder value as we seek to deliver innovative treatments and improve the lives of patients with rare and orphan diseases.”

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