TIDMAMYT
RNS Number : 4139W
Amryt Pharma PLC
17 April 2019
17 April 2019
AIM: AMYT
Euronext Growth: AYP
Amryt Pharma plc
("Amryt" or the "Company")
PRELIMINARY FY 2018 RESULTS AND
Q1 2019 TRADING UPDATE
EASE study in EB making good progress; recent Lojuxta successes
result in strong Q1 2019 growth with first orders received from
France; early access program in EB initiated in Colombia
Amryt, a revenue-generating orphan drug company focused on
acquiring, developing and commercialising products that help
improve the lives of patients where there is a high unmet medical
need, today announces its preliminary unaudited results for the
year ended 31 December 2018. It also provides a trading update for
Q1 2019. The 2018 Annual Report will be published in May 2019.
Revenues for 2018 amounted to EUR14.5m which represented a 13.3%
increase on 2017 and this positive revenue momentum has continued
into Q1 2019 with Lojuxta revenues growing by 28.1% compared to Q1
2018. This growth has been driven by the recent reimbursement
decisions in the UK and France, with initial orders received from
UK patients in Q4 2018 and from French patients in Q1 2019. Revenue
growth has been further strengthened by a 118% increase in
quarterly revenues from Saudi Arabia from Q4 2018 to Q1 2019.
The Company's lead development asset, AP101, continues to
progress, having recently successfully completed an unblinded
interim efficacy analysis by an Independent Data Monitoring
Committee ("IDMC") of the Phase 3 EASE study in Epidermolysis
Bullosa ("EB"). The Committee recommended that the trial continue
with a modest increase in the number of patients in the study, to
230 evaluable patients, to maintain 80% statistical power. The IDMC
has also recently expanded the eligible patient population to
include infants and children with EB between the ages of 21 days to
4 years of age. The Company is also pleased to announce the
commencement of its AP101 early access program for patients with EB
in Colombia who are not eligible for the EASE study with the first
shipments of product in late Q4 2018.
2018 Financial Highlights:
-- Revenue growth of 13.3% to EUR14.5m (2017: EUR12.8m)
-- Revenues from Lojuxta (lomitapide), which treats HoFH, a
rare, genetic, life-threatening disorder that causes abnormally
high levels of "bad" cholesterol, increased to EUR13.6m, which
represents a growth rate of 14.2% year-on-year
-- Gross profit margin increased to 63% (2017: 58%)
-- Cash balance at 31 December 2018 of EUR9.8m (2017: EUR20.5m)
-- Post period-end : additional EUR5m drawn down from the EIB debt facility in Q1 2019
2018 Operational Highlights:
Lead Commercial Asset - Lojuxta
-- Eight new distribution agreements signed in 2018, now covering 23 countries in total
-- Reimbursement approval received in the UK and France
resulting in first orders for the UK in late 2018
-- Initial orders received for patients in Saudi Arabia in Q4
-- Continued expansion in the licenced territories for Lojuxta,
including Russia, the Commonwealth of Independent States ("CIS"),
and the non-EU Balkan states
Lead Development Asset - AP101
-- Significant continued progress made in the development of
AP101, a potential treatment for EB, a rare life limiting genetic
skin condition
-- An Investigational New Drug ("IND") approval, recently
obtained from the FDA, permits the Group to open clinical trial
sites in the US, which is expected to help enrolment into the EASE
Phase3 study in EB
-- A Paediatric Rare Disease designation was granted by the U.S.
Food and Drug Administration ("FDA") which means if a New Drug
Application ("NDA") for AP101 is approved, Amryt will be eligible
to receive a priority review voucher that can be used, sold or
transferred. Publicly disclosed sale prices for such vouchers have
ranged from US$67.5m to US$350m
-- Early access programme in EB initiated in Colombia with first
AP101 shipments in response to unsolicited requests for named
patient access in Q4 2018
Gene Therapy Platform -AP103
-- Exclusive in-licence agreement signed in March 2018 with
University College Dublin ('UCD') for a novel non-viral gene
therapy platform technology, which offers a potential treatment for
patients with both EB and beyond
-- Preliminary data suggests that the treatment could be
disease-modifying for patients with Recessive Dystrophic
Epidermolysis Bullosa ("RDEB"), a major subset of EB
-- Significant grant funding totalling EUR8.4m awarded by the
Irish Government to develop the AP103 gene therapy platform over
the next three years
Post Period-End - Q1 2019 Highlights
Lead Commercial Asset - Lojuxta
-- Lojuxta unaudited revenues for Q1 2019 of EUR3.9m, which
represents an increase of 28.1% on the same period in 2018,
continuing the momentum generated in 2018
-- Significant expansion in patient numbers in the UK in Q1 2019
following the launch in this new market in Q4 2018
-- First patient order received from France in Q1 2019
-- Sales to Saudi Arabia in Q1 2019 increased by 118% compared to Q4 2018
Lead Development Asset - AP101
-- 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
-- The EASE study is progressing well and it is expected that
the final patient will be enrolled in H2 2019
Gene Therapy Platform - AP103
-- Two pre-clinical 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
Dr Joe Wiley, CEO of Amryt Pharma, commented: "2018 was another
strong year for Amryt as we continued to expand our business and
make progress towards our goal of becoming a global leader in rare
and orphan diseases. We continued to grow Lojuxta sales and we
believe that we now have in place the commercial platform and
critical infrastructure to make this a significant business and
cash generator for Amryt in the future. During the year, we
expanded our Lojuxta licenced territories to 23 countries, and
importantly we were granted approval for funding both as an NHS
treatment in England, and for patients in France. We also received
our first prescriptions for patients in Saudi Arabia in Q4. These
very significant achievements are already having a significant
positive impact on our financial & operational performance in
2019. Lojuxta revenues for Q1 2019 are already 28.1% higher than
the same period in 2018, and we are now able to reach more people
living with the ultra-rare and life-threatening condition HoFH than
ever before. Amryt will continue to actively review further growth
opportunities that could expand the Group's commercial product
portfolio.
"Our lead development asset, AP101, achieved a significant
milestone with the completion of an unblinded interim efficacy
analysis of our EASE Phase 3 trial. This resulted in the IDMC
recommendation that we continue with the trial with only a modest
increase in patient numbers. We are now expanding EASE recruitment
with the opening of a number of new trial sites in the US. The IDMC
has also allowed us to open our study to children with EB between
the ages of 21 days to four years of age.
"In addition, we continued our strategy to acquire new products
with the in-licencing of AP103 in 2018. We are excited by the
potential for this novel gene therapy in EB and beyond. We continue
to evaluate new opportunities and expect to further deliver on our
strategy to acquire, develop and commercialise orphan drugs as we
move through 2019. We expect that this continued progress will
bring us closer to realising our vision of becoming a global leader
in rare and orphan diseases."
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
Stifel +44 (0) 20 7710 7600
Joint Broker
Jonathan Senior, Ben Maddison
Davy +353 (1) 679 6363
ESM Adviser and Joint Broker
John Frain, Anthony Farrell
Consilium Strategic Communications +44 (0) 20 3709 5700
Matthew Neal, David Daley, Nicholas
Brown
About Amryt
Amryt is a biopharmaceutical company focused on developing and
delivering innovative new treatments to help improve the lives of
patients with rare or orphan diseases.
Lojuxta is an approved treatment for adult patients with the
rare cholesterol disorder - Homozygous Familial
Hypercholesterolaemia ("HoFH"). This disorder 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 narrowing and blocking of blood vessels,
heart attacks and strokes, even at a very young age if not properly
diagnosed or receiving adequate treatment. Lojuxta is indicated as
an adjunct to a low-fat diet and other lipid-lowering medicinal
products with or without LDL apheresis in adult patients with
HoFH.
Amryt is the marketing authorisation holder and has an exclusive
licence to sell Lojuxta (lomitapide) across the European Economic
Area, Middle East and North Africa, Switzerland, Turkey, Israel,
Russia, the Commonwealth of Independent States and the non-EU
Balkan states.
Amryt's lead drug candidate, AP101, is a potential treatment for
Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin
disorder affecting young children and adults for which there is
currently no treatment. It is currently in Phase 3 clinical trials.
The European and US market opportunity for EB is estimated to be in
excess of EUR1 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, please visit amrytpharma.com.
This announcement contains inside information for the purposes
of article 7 of the Market Abuse Regulation (EU) 596/2014
Unaudited Consolidated Statement of Comprehensive Income
For the year ended 31 December 2018
Unaudited Audited
31 December 31 December
2018 2017
--------------------------------------------- ------------- ---------------
EUR'000 EUR'000
--------------------------------------------- ------------- -------------
Revenue 14,454 12,778
Cost of sales (5,298) (5,373)
--------------------------------------------- ------------- -------------
Gross profit 9,156 7,405
--------------------------------------------- ------------- -------------
Administrative, selling and marketing
expenses (14,663) (10,483)
Share based payment expenses (694) (565)
--------------------------------------------- ------------- -------------
Total administrative, selling and marketing
expenses (15,357) (11,048)
Research and development expenses (9,049) (10,564)
--------------------------------------------- ------------- -------------
Operating loss before finance expense (15,250) (14,207)
--------------------------------------------- ------------- -------------
Non-cash change in fair value of contingent
consideration (8,934) (11,104)
Finance expense (1,557) (825)
--------------------------------------------- ------------- -------------
Loss on ordinary activities before
taxation (25,741) (26,136)
--------------------------------------------- ------------- -------------
Tax on loss on ordinary activities (36) -
--------------------------------------------- ------------- -------------
Loss for the year attributable to the
equity holders of the Company (25,777) (26,136)
--------------------------------------------- ------------- -------------
Exchange translation differences which
may be reclassified through the profit
or loss (12) 22
--------------------------------------------- ------------- -------------
Total other comprehensive (loss)/ profit (12) 22
--------------------------------------------- ------------- -------------
Total comprehensive loss for the year
attributable to the equity holders
of the Company (25,789) (26,114)
--------------------------------------------- ------------- -------------
Loss per share:
Loss per share - basic and diluted,
attributable to ordinary equity holders
of the parent (cent) (9.38) (11.72)
Unaudited Consolidated Statement of Financial Position
As at 31 December 2018
Unaudited Audited
31 December 31 December
2018 2017
-------------------------------------- ------------- -------------
EUR'000 EUR'000
-------------------------------------- ------------- -------------
Assets
Non-current assets
Intangible assets 52,695 52,606
Property, plant and equipment 960 1,160
Other non-current assets 130 -
Total non-current assets 53,785 53,766
-------------------------------------- ------------- -------------
Current assets
Trade and other receivables 5,179 4,729
Inventories 1,868 1,083
Cash and cash equivalents 9,811 20,512
Total current assets 16,858 26,324
-------------------------------------- ------------- -------------
Total assets 70,643 80,090
-------------------------------------- ------------- -------------
Equity and liabilities
Equity attributable to owners of the
parent
Share capital 21,173 21,173
Share premium 57,334 57,334
Other reserves (20,858) (21,512)
Accumulated deficit (60,880) (35,109)
-------------------------------------- ------------- -------------
Total equity (3,231) 21,886
-------------------------------------- ------------- -------------
Non-current liabilities
Contingent consideration 41,351 32,418
Deferred tax liability 5,384 5,384
Long term loan 16,614 10,603
Total non-current liabilities 63,349 48,405
Current liabilities
Trade and other payables 10,525 9,799
-------------------------------------- ------------- -------------
Total current liabilities 10,525 9,799
-------------------------------------- ------------- -------------
Total liabilities 73,874 58,204
-------------------------------------- ------------- -------------
Total equity and liabilities 70,643 80,090
-------------------------------------- ------------- -------------
Unaudited Consolidated Statement of Cash Flows
For the year ended 31 December 2018
Unaudited Audited
31 December 31 December
2018 2017
--------------------------------------------- -------------- -------------
EUR'000 EUR'000
--------------------------------------------- -------------- -------------
Cash flows from operating activities
Loss on ordinary activities after taxation (25,777) (26,136)
Finance expense 1,557 825
Depreciation and amortisation 310 259
Share based payment expenses 694 565
Non-cash change in fair value of contingent
consideration 8,934 11,104
Movements in working capital and other
adjustments:
Change in trade and other receivables (450) (2,189)
Change in trade and other payables 2,580 6,022
Change in contingent consideration - (2,000)
Change in inventories (785) (313)
Change in non-current assets (130) -
Net cash flow used in operating activities (13,067) (11,863)
--------------------------------------------- -------------- -------------
Cash flow from investing activities
Payments for property, plant and equipment (69) (243)
Payments for intangible assets (131) (87)
Cash inflow on sale of property, plant
and equipment - 9
Bank interest and fees paid (17) -
Deposit interest received 5 5
Net cash flow used in investing activities (212) (316)
--------------------------------------------- -------------- -------------
Cash flow from financing activities
Proceeds from issue of equity instruments
- net of expenses - 14,393
Increase in long term debt 5,000 10,000
Interest paid on long term debt (221) -
Payment of deferred consideration (2,000) -
Repayment of short-term loans - (47)
Net cash flow from financing activities 2,779 24,346
--------------------------------------------- -------------- -------------
Exchange and other movements (201) 74
--------------------------------------------- -------------- -------------
Net change in cash and cash equivalents (10,701) 12,241
Cash and cash equivalents at beginning
of year 20,512 8,271
--------------------------------------------- -------------- -------------
Restricted cash at end of year 1,191 537
--------------------------------------------- -------------- -------------
Cash at bank available on demand at
end of year 8,620 19,975
--------------------------------------------- -------------- -------------
Total cash and cash equivalents at end
of year 9,811 20,512
--------------------------------------------- -------------- -------------
Unaudited Consolidated Statement of Changes in Equity
For the year ended 31 December 2018
Share Reverse Exchange
Share Share based Merger acquisition translation Accumulated
capital premium payment reserve reserve reserve deficit Total
reserve
EUR'000 EUR'000 EUR'000 EUR'000 EUR'000 EUR'000 EUR'000 EUR'000
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Balance at 1
January 2017 20,419 43,695 4,215 35,818 (62,107) (5) (8,998) 33,037
Loss for the
year - - - - - - (26,136) (26,136)
Foreign
exchange
translation
reserve - - - - - 27 - 27
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Total
comprehensive
income - - - - - 27 (26,136) (26,109)
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Issue of
placing
shares -
Gross 754 14,329 - - - - - 15,083
Issue of
placing
shares -
Expenses - (690) - - - - - (690)
Share based
payment
expense - - 565 - - - - 565
Share based
payment
expense
- Lapsed - - (25) - - - 25 -
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Balance at 31
December 2017
- Audited 21,173 57,334 4,755 35,818 (62,107) 22 (35,109) 21,886
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Balance at 1
January 2018 21,173 57,334 4,755 35,818 (62,107) 22 (35,109) 21,886
Loss for the
year - - - - - - (25,777) (25,777)
Foreign
exchange
translation
reserve - - - - - (34) - (34)
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Total
comprehensive
income - - - - - (34) (25,777) (25,811)
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Share based
payments - - 694 - - - - 694
Share based
payments -
lapsed - - (6) - - - 6 -
Balance at 31
December 2018
- Unaudited 21,173 57,334 5,443 35,818 (62,107) (12) (60,880) (3,231)
--------------- --------- ---------- ---------- ---------- ------------- ------------- ------------- ---------
Notes
1. General information
Amryt Pharma plc (the "Company") is a company incorporated in
England and Wales. The Company is listed on the AIM market of the
London Stock Exchange (ticker: AMYT.L) and the Euronext market of
the Irish Stock Exchange (ticker: AYP). Amryt is a development and
commercial stage pharmaceutical Company focused on acquiring,
developing and delivering innovative new treatments to help improve
the lives of patients with rare and orphan diseases.
2. Basis of preparation
The consolidated Financial Statements of the Group and the
individual Financial Statements of the Company have been prepared
in accordance with International Financial Reporting Standards
("IFRS") as adopted by the EU and with those parts of the Companies
Act 2006 applicable to companies reporting under IFRS. The
condensed unaudited financial statements above have been prepared
on a historical cost basis, except for contingent consideration
that have been measured at fair value.
The condensed unaudited financial information in this
announcement for the year ended 31 December 2018 does not
constitute statutory accounts as defined by section 435 of the
Companies Act 2006. The financial information in respect of the
year to 31 December 2017, has been extracted from the consolidated
statutory financial statements for that year which have been
delivered to the registrar of companies. The auditors have reported
on those accounts. Their report was unqualified and did not contain
statements under Section 498 (2) of (3) of the Companies Act 2006.
The statutory accounts for 2018 will be finalised on the basis of
the financial information presented by the directors in this
preliminary announcement and will be delivered to the registrar of
companies in due course.
3. Summary of Significant Accounting policies
The principal accounting policies are summarised below. They
have been consistently applied throughout the period covered by the
Financial Statements.
Research and development expenses
Development costs are capitalised as an intangible asset if all
of the following criteria are met:
1. The technical feasibility of completing the asset so that it
will be available for use or sale;
2. The intention to complete the asset and use or sell it;
3. The ability to use or sell the asset;
4. The asset will generate probable future economic benefits and
demonstrate the existence of a market or the usefulness of the
asset if it is to be used internally;
5. The availability of adequate technical, financial and other
resources to complete the development and to use or sell it;
and
6. The ability to measure reliably the expenditure attributable to the intangible asset.
In process R&D acquired as part of a business combination is
capitalised at the date of acquisition.
Research costs are expensed when they are incurred.
Factors which impact our judgement to capitalise certain
research and development expenditure include the degree of
regulatory approval for products and the results of any market
research to determine the likely future commercial success of
products being developed. We review these factors each year to
determine whether our previous estimates as to feasibility,
viability and recovery should be changed.
The assessment whether development costs can be capitalized
requires management to make significant judgements. Management has
reviewed the facts and circumstances of each project in relation to
the above criteria and in management's opinion, the criteria
prescribed for capitalising development costs as assets have not
yet been met by the Group in relation to AP101 or AP102.
Accordingly, all of the Group's costs related to research and
development projects are recognised as expenses in the Consolidated
Statement of Comprehensive Income in the period in which they are
incurred. Management expects that the above criteria will be met on
filing of a submission to the regulatory authority for final drug
approval or potentially in advance of that on the receipt of
information that strongly indicates that the development will be
successful.
Revenue recognition
Revenue arises from the sale of Lojuxta and Imlan. The Group
sells direct to customers and also uses third parties in the
distribution of the product to customers.
To determine whether to recognise revenue, the company follows a
5-step process, as required by IFRS 15:
1. Identifying the contract with a customer
2. Identifying the performance obligations
3. Determining the transaction price
4. Allocating the transaction price to the performance obligations
5. Recognising revenue when/as performance obligation(s) are satisfied.
Revenue from contracts with customers is recognised when control
of the goods or services are transferred to the customer at an
amount that reflects the consideration to which the Group expects
to be entitled to in exchange for those goods. The Group recognises
contract liabilities for consideration received in respect of
unsatisfied performance obligations and reports these amounts as
liabilities in the statement of financial position. Similarly, if
the Group satisfies a performance obligation before it receives the
consideration, the Group recognises either a contract asset or a
receivable in its statement of financial position, depending on
whether something other than the passage of time is required before
the consideration is due.
Contingent consideration
Contingent consideration arising as a result of business
combinations is initially recognised at fair value using a
probability adjusted present value model. Key inputs in the model
include the probability of success and the expected timing of
potential revenues. The fair value of the contingent consideration
will be updated at each reporting date. Adjustments to contingent
consideration are recognised in the Consolidated Statement of
Comprehensive Income.
Acquired intangible assets
Acquired intangible assets outside business combinations are
stated at the lower of cost less provision for amortisation and
impairment or the recoverable amount. Acquired intangibles assets
are amortised over their expected useful economic life on a
straight line basis. In determining the useful economic life each
acquisition is reviewed separately and consideration given to the
period over which the Group expects to derive economic benefit.
Intangible assets acquired in 2016 as part of the acquisitions
of Amryt AG and SomPharmaceuticals are currently not being
amortised as the assets are still under development.
- Ends
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London Stock Exchange. RNS is approved by the Financial Conduct
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Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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