AMYT.L Regulatory News (AMYT)

AMRYT PHARMA PLC

("Amryt" or the "Company")

MARKET UPDATE

Strong cash balances coupled with revenue progression;

Prepared and managing through COVID-19; Aegerion integration on track

Amryt, a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces a market update regarding the following:

· FY 2019 pro-forma revenues (unaudited) and year-end cash balances (unaudited);

· COVID-19 preparedness; and

· Clinical trials update

FY 2019 Revenues & Cash

Our business performance in Q4 2019 was strong and this positive momentum has continued into Q1 2020. For the twelve-month period to 31 December 2019 on a pro forma* basis:

· Combined revenues of $154.1M, compared with $136.3M for the year ended December 31, 2018, representing a growth rate of 13.1%;

· Juxtapid®/ Lojuxta® (lomitapide) generated revenues of $68.0M compared with $64.0M for the year ended December 31, 2018, representing a growth rate of 6.3%;

· Myalept® / Myalepta® (metreleptin) generated revenues of $85.4M, compared with $71.4M for the year ended December 31, 2018, representing an increase of 19.6%; and

· The significant growth in metreleptin was driven by the ongoing rollout of Myalepta® in Europe following the approval of the product by the European Medicines Agency ("EMA") in Q3 2018

As at 31 December 2019, Amryt had $65 million unrestricted cash (unaudited). This compares to $57 million cash that was raised (net of fees) when Amryt completed the acquisition of Aegerion on 24 September 2019. Amryt's debt maturity profile offers significant flexibility and no debt facilities are due to mature before September 2024 at the earliest with other facilities scheduled to mature in April 2025. Amryt's cash balances remain strong in Q1 2020. The integration of Aegerion has gone exceptionally well and will be largely completed by 31 March 2020.

COVID-19 Preparedness

The primary concern of all the Amryt team is to ensure the safety of our colleagues, their families and our patients and partners at this time. Global healthcare systems are operating at or close to full capacity and the focus within systems now is to treat those patients in need of acute care.

Amryt's business lends itself to remote working and in recent weeks, we have successfully transitioned appropriate functions to remote platforms exclusively without incident.

The impact of COVID-19 to date on Amryt's business has been minimized and this is a result of deploying contingency plans already in place for a variety of scenarios and challenges which may occur.

Amryt provides therapeutic products to Homozygous Familial Hypercholesterolaemia ("HoFH") and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) are prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient. As such, the majority of our revenues are recurring in nature and therefore, we do not anticipate significant changes to our existing revenues as a result of COVID-19.

Amryt has in excess of 12 months of labelled and unlabelled finished products on hand for both lomitapide and metreleptin. Our supply chain is robust and we are confident that we can continue to supply patients for the foreseeable future. We are taking additional steps to further strengthen our inventory levels of both metreleptin and lomitapide. To date, we have not experienced any logistical difficulties in delivering product to patients. In major markets such as the USA, the UK and Germany, product has historically been delivered direct to patients' homes. In other markets, product has typically been delivered to local hospitals/distributors and we are continuing to explore opportunities to expand direct to home delivery in these markets as well.

Clinical Trials Update

Following the positive interim efficacy analysis in our EASE Phase 3 global clinical study of AP101 in Epidermolysis Bullosa ("EB") ("EASE"), we announced our intention to recruit 245 patients into the study as recommended. Final patient recruitment is ongoing and we continue to evaluate the potential impact COVID-19 may have on recruitment timing. Amryt is operating EASE trial sites across 55 centres in 27 countries and in the current circumstances, we may focus our resources on those geographies less impacted by COVID-19 than others.

As part of our post-approval commitments in the EU, we have also recently initiated a Phase 3, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH. On successful completion, it is our intention to submit the data to both the EMA and the US Food and Drug Administration ("FDA") to potentially expand the label for lomitapide to include pediatric patients.

Dr Joe Wiley, CEO of Amryt Pharma, commented: "Amryt is a well-capitalised resilient business with recurring revenues, a strong balance sheet and a robust supply of product to meet patient needs. Our primary focus remains the safety and welfare of our colleagues, their families and our patients and partners. Despite the very significant challenges that COVID-19 presents, how we act now both as a company and as citizens will determine how we perform through these difficult times. The Amryt team are operating well in this environment and should it be necessary, we have further contingency plans in place to ensure we are able to adapt to additional challenges that may arise.

On a personal note, I would like to thank all of our staff, patients, clinical partners and shareholders for their support as we navigate through this crisis. I have been truly humbled by the team spirit demonstrated by our team in recent weeks and I look forward to seeing you all when we are able to meet again in person".

Amryt's next scheduled update to the market will be the release of FY 2019 Audited Results in early April.

* Pro-forma revenues for 2018 and 2019 represent the combined unaudited revenues of the Amryt group assuming the acquisition by Amryt of Aegerion happened on 1 January 2018. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2018 as if the Recordati agreement was in place from that date.

Enquiries:

About Amryt

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt's commercial business comprises two orphan disease products.

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan (under the trade name, Juxtapid®) and in the EU (under the trade name, Lojuxta®). HoFH is a rare genetic disorder which impairs the body's ability to remove low density lipoprotein ("LDL") cholesterol ("bad" cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth - often ten times more than people without HoFH - and subsequent aggressive and premature cardiovascular disease.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name, Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name, Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 or over for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

Amryt's lead development candidate, AP101 (Oleogel-S10), is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. It is currently being studied in a Phase 3 clinical trial and recently reported that unblinded interim efficacy data supported continuation of the study with a modest increase in sample size and unblinded interim safety data allowed the inclusion of children from as young as 21 days old. AP101 has been granted FDA Pediatric Rare Disease Designation and has also received a Fast Track Designation from the FDA. The European and US market opportunity for EB is estimated by the Directors to be in excess of $1 billion.

In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders. 

For more information on Amryt, including products, please visit www.amrytpharma.com

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014.

Forward-Looking Statements

Statements in this announcement with respect to Amryt's business, strategies, projected financial figures, synergies, earnings guidance, financial guidance, future dividends and beliefs, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the directors' current beliefs and assumptions and are based on information currently available to management.