TIDMAMYT
RNS Number : 1222H
Amryt Pharma PLC
23 March 2020
23 March 2020
AIM: AMYT
Euronext Growth: AYP
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(R)/ Lojuxta(R) (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(R) / Myalepta(R) (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(R) 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 :
Amryt Pharma plc +353 (1) 518 0200
Joe Wiley, CEO
Rory Nealon, CFO/COO
Shore Capital +44 (0) 20 7408 4090
NOMAD and Joint Broker
Edward Mansfield, Mark Percy, Daniel Bush,
John More
Stifel +44 (0) 20 7710 7600
Joint Broker
Jonathan Senior, Ben Maddison
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Daragh O'Reilly
Consilium Strategic Communications +44 (0) 20 3709 5700
Amber Fennell, Matthew Neal, Nicholas
Brown
LifeSci Advisors, LLC +1 (212) 915 2564
Tim McCarthy
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(R)/ Lojuxta(R) (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(R)) and in the
EU (under the trade name, Lojuxta(R)). 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(R) / Myalepta(R) (metreleptin) is approved in the US
(under the trade name, Myalept(R)) 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(R)) 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.
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END
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