TIDMAMYT
Amryt Reports Record Q1 2021 Financial and Operating Results
8.7% YoY revenue growth in the quarter to $48.4M
16.5% YoY underlying revenue growth excluding the impact of a LATAM
periodic order in Q1 2020
5(th) consecutive quarter of positive EBITDA generation
National reimbursement achieved for metreleptin in England, Wales and
France
Regulatory submissions for Oleogel-S10(1) (Filsuvez(R)) made to the FDA
and EMA
Raising FY 2021 revenue guidance to $205M - $210M
Today announced proposed acquisition of Chiasma, Inc. (Nasdaq: CHMA)
Conference call and webcast today at 0830 EDT / 1330 BST
DUBLIN, Ireland, and Boston MA, May 5, 2021, Amryt (Nasdaq: AMYT, AIM:
AMYT), a global, commercial-stage biopharmaceutical company dedicated to
acquiring, developing and commercializing novel treatments for rare
diseases, today provides a business update and announces unaudited
financial results for the first quarter ended March 31, 2021.
Joe Wiley, CEO of Amryt Pharma, commented: "I am very pleased with
today's very strong results for Q1 which represent a 13.9% increase in
revenues on Q4 and which demonstrate the continued positive momentum and
growth we are experiencing in our business across our two commercial
products globally. Q1 was extremely busy and we delivered a number of
commercial and regulatory successes during the quarter. Our two
commercial products, metreleptin and lomitapide, continue to deliver
solid growth across a host of metrics including revenue, EBITDA growth,
cash generation and market expansion. Our EBITDA has increased 115%
compared to the same quarter in 2020.
We also achieved a number of positive reimbursement decisions in the
quarter, notably for metreleptin in England, Wales and France. On the
development front, we made regulatory submissions to both the FDA and
EMA for Oleogel-S10 and we continue to work with the respective agencies
as we progress towards potential approval and prepare for launch. If
approved, we have the commercial team, systems and infrastructure in
place to both grow our existing products and to leverage these
capabilities to launch Oleogel-S10.
Given the strong performance of the business during the quarter, we are
now increasing our revenue guidance for 2021 from $200-$205 million to
$205-$210 million excluding any potential contribution from the proposed
Chiasma transaction, which represents growth of between 12% - 15% on
2020.
Furthermore, we today announced the proposed acquisition of Chiasma,
Inc. (Nasdaq: CHMA). We believe this transformational deal can pave a
path to a combined potential $1BN peak revenue for Amryt."
Q1 2021 & Recent Business Highlights:
-- Submitted a New Drug Application to the FDA for Oleogel-S10
-- Marketing Authorisation Application (MAA) accepted by the EMA for
Oleogel-S10
-- Reimbursement approval for metreleptin in England, Wales and France
-- Positive feedback from the FDA on the path forward for metreleptin
indication in partial lipodystrophy (PL) -- Phase 3 planned for Q4 2021
-- Positive results reported from an investigator sponsored study of
lomitapide in familial chylomicronaemia syndrome (FCS)
-- Multi-regional distribution and product agreements signed with Medison in
Canada and in Israel
-- Announced proposed acquisition of Chiasma, Inc. (Nasdaq: CHMA)
Q1 Commercial Product Performance:
Q1 2021 (unaudited)
-------------- ----------------------------------
US EMEA Other Total
-------------- ------- ------- ------- -------
US$'000 US$'000 US$'000 US$'000
-------------- ------- ------- ------- -------
Metreleptin 16,239 12,971 750 29,960
-------------- ------- ------- ------- -------
Lomitapide 8,324 7,440 2,420 18,184
-------------- ------- ------- ------- -------
Other - 223 65 288
-------------- ------- ------- ------- -------
Total revenue 24,563 20,634 3,235 48,432
-------------- ------- ------- ------- -------
Q1 2020 (unaudited)
-------------- ----------------------------------
US EMEA Other Total
-------------- ------- ------- ------- -------
US$'000 US$'000 US$'000 US$'000
-------------- ------- ------- ------- -------
Metreleptin 14,914 8,628 3,385 26,927
-------------- ------- ------- ------- -------
Lomitapide 9,470 5,233 2,718 17,421
-------------- ------- ------- ------- -------
Other - 226 - 226
-------------- ------- ------- ------- -------
Total revenue 24,384 14,087 6,103 44,574
-------------- ------- ------- ------- -------
-- 8.7% revenue growth in Q1 2021 to $48.4M (Q1 2020: $44.6M)
-- 16.5% underlying YoY revenue growth excluding a periodic LATAM order in
Q1 2020 that did not occur in Q1 2021. A significant order has now been
received and will be booked in Q2 2021.
-- 11.3% increase in metreleptin revenues YoY to $30.0M in Q1 2021 (Q1 2020:
$26.9M). Excluding impact of periodic LATAM ordering, metreleptin
revenues grew 25.3% in Q1.
-- US accounted for 54.2% of global metreleptin revenues and EMEA accounted
for 43.3% in Q1 2021. EMEA metreleptin revenues increased by 50.3% in Q1
2021 versus Q1 2020.
-- 4.4% increase in lomitapide revenues to $18.2M in Q1 (Q1 2020: $17.4M)
-- US accounted for 45.8% of global lomitapide revenues and EMEA accounted
for 40.9% in Q1 2021. EMEA lomitapide revenues increased by 42.2% in Q1
2021 versus Q1 2020.
-- 13.9% QoQ revenue growth in Q1 2021 versus Q4 2020 ($42.5M)
Q1 Financial Highlights:
-- $3.4M operating loss before finance expense for Q1 2021 (Q1 2020:
$17.0M). Excluding non-cash items and share based compensation expenses,
this resulted in EBITDA3 of $9.9M (Q1 2020: $4.6M).
-- Cash of $118.6M at March 31, 2021 (Dec 31, 2020: $118.8M)
-- Legacy fines levied on Aegerion were fully discharged in Q1 2021
(1) For the purposes of this announcement, we use the name
Oleogel-S10. Filsuvez(R) has been selected as the brand name for the
product but please note, Amryt does not, as yet, have regulatory
approval for Filsuvez(R) to treat EB.
IFRS and non-GAAP adjusted Q1 2021 results:
Q1 2021
Q1 2020 Q1 2021 Non-cash Q1 2021 Non-GAAP
US$M (unaudited) (unaudited) adjustments(2) Adjusted
-------------------------- ------------ ------------ --------------- ----------------
Revenue 44.6 48.4 - 48.4
-------------------------- ------------ ------------ --------------- ----------------
Gross profit 12.0 24.9 11.7 36.7
-------------------------- ------------ ------------ --------------- ----------------
R&D expenses (8.9) (8.9) - (8.9)
-------------------------- ------------ ------------ --------------- ----------------
SG&A expenses (18.4) (18.2) 0.3 (17.9)
-------------------------- ------------ ------------ --------------- ----------------
Acquisition & severance
related costs (0.9) - - -
-------------------------- ------------ ------------ --------------- ----------------
Share based compensation
expenses (0.8) (1.3) 1.3 -
-------------------------- ------------ ------------ --------------- ----------------
Operating (loss) / profit
before finance expense (17.0) (3.4) 13.3 9.9(3)
-------------------------- ------------ ------------ --------------- ----------------
The Q1 operating loss of $3.4M includes the impact of non-cash items
including amortisation, depreciation and the impact of share-based
compensation expenses. Adjusting for these non-cash items, the Company
delivered $9.9M of EBITDA(3) for the quarter.
(2) Non-cash items include amortisation of the acquired metreleptin
and lomitapide intangible assets ($10.7M), amortisation of the inventory
fair value step-up that was acquired at the acquisition date ($1.0M),
depreciation and amortisation ($0.3M) and share based compensation
expenses ($1.3M).
(3) EBITDA is earnings before interest, tax, depreciation,
amortisation and share based compensation expenses. To supplement
Amryt's financial results presented in accordance with IFRS generally
accepted accounting principles, the Company uses EBITDA as a key measure
of company performance as the Company believes that this measure is most
reflective of the operational profitability or loss of the Company and
provides management and investors with useful supplementary information
which can enhance their ability to evaluate the operating performance of
the business. EBITDA, as measured by the Company, is not meant to be
considered in isolation or as a substitute to operating profit / loss
attributable to Amryt and should be read in conjunction with the
Company's condensed consolidated financial statements prepared in
accordance with IFRS.
Post-Period End Events:
The company earlier today announced that it has signed a definitive
agreement to acquire Chiasma, Inc. (Nasdaq: CHMA). The combined Company
will be a global leader in rare and orphan diseases with three on-market
commercial products, a global commercial and operational footprint and a
significant development pipeline of therapies with the financial
flexibility to execute its growth plans.
Guidance & Outlook:
Amryt issued FY 2021 revenue guidance on March 4, 2021 indicating that
FY 2021 revenues were expected to be in the range of $200M-$205M. Given
the continued strong performance of the Company's commercial products,
the board is now increasing FY 2021 revenue guidance to a range of
$205M-$210M excluding any potential contribution from the proposed
Chiasma transaction, which represents growth of 12-15% versus FY 2020.
Conference Call & Webcast:
Amryt will host a conference call and webcast for analysts and investors
on May 5 at 0830 EDT/1330 BST. Webcast Player URL:
https://www.globenewswire.com/Tracker?data=Kru6cTzl9vZYOMxqmlcWfqJWv3hgbcmWlvS5NkPd2BttkGiNmfRn2eLqUEbCJ5QTB2Ko25HJryZPKD36eo2LFJUojWqaa69XPmwzJxhsrrOO1V5-u-nEVIcxWU6NqmLsTmYFH8SL1f_32ScVcIGIdLnLlwPUvbD5769X50M20ak=
https://edge.media-server.com/mmc/p/hdecnon9
Telephone Dial in details:
United States +1 646 787 1226
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United Kingdom +44 (0) 203 009 5709
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Ireland +353 (1) 506 0626
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Confirmation Code 8698345
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About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on
acquiring, developing and commercializing innovative 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 --
metreleptin (Myalept(R)/ Myalepta(R)) and lomitapide (Juxtapid(R)/
Lojuxta(R)).
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)) as an adjunct to diet 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 years of age and above for
whom standard treatments have failed to achieve adequate metabolic
control. For additional information, please follow this link
https://www.globenewswire.com/Tracker?data=HFl3SRDSbG-wgwYTVDDAJWoWbZdgZTonpMosKiXaC7qWASj2sU0yJGWacSc84HAFd4uHWliRQTzIHvEz1jr1SQgLDbR5MuZQrhDbpsPrSpJJF8AOw-tM4B7_ZYP0zhvEM_NO54uCFHoMlleVTD4U22UhFdhNIuMplT1u3et3tjc=
.
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, Colombia, Argentina and Japan (under the
trade name Juxtapid(R)) and in the EU, Israel and Brazil (under the
trade name Lojuxta(R)). For additional information, please follow this
link
https://www.globenewswire.com/Tracker?data=HFl3SRDSbG-wgwYTVDDAJcq4wbnJpMyRhyp1u4WqFI-0U-GZkDTghHXo2dYN1sils18ZeZFNyii8vs9N8YKczBhZMDjQ5BOco_HE4iIOsec=
.
Amryt's lead development candidate, Oleogel-S10 (Filsuvez(R)) is a
potential treatment for the cutaneous manifestations of Junctional and
Dystrophic Epidermolysis Bullosa ("EB"), a rare and distressing genetic
skin disorder affecting young children and adults for which there is
currently no approved treatment. Filsuvez(R) has been selected as the
brand name for Oleogel-S10. The product does not currently have
regulatory approval to treat EB.
Amryt's pre-clinical gene therapy platform, AP103, offers a potential
treatment for patients with Dystrophic EB, and is also potentially
relevant to other genetic disorders.
For more information on Amryt, including products, please visit
https://www.globenewswire.com/Tracker?data=uyxlnnc98Ol-0BG1PHilAhxVTw0SoOqp_sI57J6l4xGqgzVq3YuVHKdrUq5OvJjPrCTZRRGZwAibswtWO8S_jM_K5ldOgZ4uIB2G9_4CKYA=
www.amrytpharma.com.
This announcement contains inside information for the purposes of
article 7 of the Market Abuse Regulation (EU) 596/2014. The person
making this notification on behalf of Amryt is Rory Nealon, CFO/COO and
Company Secretary.
Financial Advisors
Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and
Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker
to the company in the UK.
Forward-Looking Statements
This press release may contain forward-looking 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 expects to 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, the course of the COVID-19 pandemic, currency fluctuations,
the behaviour of other market participants, the outcome of clinical
trials, 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 Company's current beliefs and assumptions and are based on
information currently available to management.
Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200,
ir@amrytpharma.com
https://www.globenewswire.com/Tracker?data=hfojS_nb8uW9ydk_rSXlBdCXC2efYCcU6uhyBqiqNxRRw4O1agc7FpF0eCLTEZzlPYMt6FDQFTRqmSpS6P_ANfGbR1lsqGVEUgg-D6G9o4U=
Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906,
edward.mansfield@shorecap.co.uk
Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564,
tim@lifesciadvisors.com
Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700
Amryt Pharma plc
Condensed Consolidated Statement of Comprehensive Loss
Three Months Ended
March 31,
--------------------------
2021 2020
Note (unaudited) (unaudited)
---- ------------ ------------
US$'000 US$'000
Revenue 3 48,432 44,574
Cost of sales (23,489) (32,620)
------------ ------------
Gross profit 24,943 11,954
Research and development expenses (8,916) (8,934)
Selling, general and administrative expenses (18,156) (18,406)
Restructuring and acquisition costs 5 -- (853)
Share based payment expenses 4 (1,263) (745)
Operating loss before finance expense (3,392) (16,984)
============ ============
Non-cash change in fair value of contingent
consideration 5 (2,874) (2,906)
Non-cash contingent value rights finance expense 5 (1,763) (1,448)
Net finance expense - other (7,898) (9,416)
------------ ------------
Loss on ordinary activities before taxation (15,927) (30,754)
------------ ------------
Tax (charge)/credit on loss on ordinary activities (610) 1,857
------------ ------------
Loss for the period attributable to the equity
holders of the Company (16,537) (28,897)
============ ============
Exchange translation differences which may be
reclassified through profit or loss 2,547 (13)
------------ ------------
Total other comprehensive income/(loss) 2,547 (13)
------------ ------------
Total comprehensive loss for the period attributable
to the equity holders of the Company (13,990) (28,910)
============ ============
Loss per share
Loss per share - basic and diluted, attributable
to ordinary equity holders of the parent (US$) 6 (0.09) (0.19)
============ ============
Amryt Pharma plc
Condensed Consolidated Statement of Financial Position
As at,
--------------------------
March 31, December 31,
2021 2020
Note (unaudited) (audited)
------------
US$'000 US$'000
Assets
Non-current assets
Goodwill 7 19,131 19,131
Intangible assets 7 292,315 305,369
Property, plant and equipment 7,156 7,574
Other non-current assets 1,484 1,542
------------ ------------
Total non-current assets 320,086 333,616
------------ ------------
Current assets
Trade and other receivables 8 43,963 43,185
Inventories 39,371 40,992
Cash and cash equivalents, including restricted
cash 9 118,551 118,798
------------ ------------
Total current assets 201,885 202,975
------------ ------------
Total assets 521,971 536,591
============ ============
Equity and liabilities
Equity attributable to owners of the parent
Share capital 10 13,899 13,851
Share premium 10 51,596 51,408
Other reserves 10 241,011 236,488
Accumulated deficit (252,142) (235,605)
------------ ------------
Total equity 54,364 66,142
------------ ------------
Non-current liabilities
Contingent consideration and contingent
value rights 5 149,064 148,323
Deferred tax liability 6,753 6,612
Long term loan 11 88,769 87,302
Convertible notes 12 102,216 101,086
Provisions and other liabilities 13 26,649 25,951
------------ ------------
Total non-current liabilities 373,451 369,274
------------ ------------
Current liabilities
Trade and other payables 87,189 90,236
Provisions and other liabilities 13 6,967 10,939
------------ ------------
Total current liabilities 94,156 101,175
------------ ------------
Total liabilities 467,607 470,449
------------ ------------
Total equity and liabilities 521,971 536,591
============ ============
Amryt Pharma plc
Condensed Consolidated Statement of Cash Flows
Three months ended
March 31,
--------------------------
2021 2020
Note (unaudited) (unaudited)
------------ ------------
US$'000 US$'000
Cash flows from operating activities
Loss on ordinary activities after taxation (16,537) (28,897)
Net finance expense - other 7,898 9,416
Depreciation and amortization 11,058 11,241
Amortization of inventory fair value step-up 951 9,503
Share based payment expenses 4 1,263 745
Non-cash change in fair value of contingent
consideration 5 2,874 2,906
Non-cash contingent value rights finance
expense 5 1,763 1,448
Deferred taxation credit 141 (1,576)
Movements in working capital and other
adjustments:
Change in trade and other receivables 8 (778) (4,792)
Change in trade and other payables (3,483) 9,416
Change in provision and other liabilities 13 (3,138) (3,435)
Change in inventories 670 216
Change in non-current assets 58 (4)
------------ ------------
Net cash flow from operating activities 2,740 6,187
------------ ------------
Cash flow from investing activities
Payments for property, plant and equipment (71) (79)
Payments for intangible assets (416) --
Deposit interest received 1 66
------------ ------------
Net cash flow used in investing activities (486) (13)
Cash flow from financing activities
Net costs from issue of equity instruments (175) --
Interest paid (1,418) (1,506)
Payment of leases (263) --
Net cash flow from financing activities (1,856) (1,506)
------------ ------------
Exchange and other movements (645) (3,830)
------------ ------------
Net change in cash and cash equivalents (247) 838
Cash and cash equivalents at beginning of the
period 118,798 67,229
------------ ------------
Restricted cash at end of the period 9 29 1,093
============ ============
Cash at bank available on demand at end of the
period 9 118,522 66,974
============ ============
Total cash and cash equivalents at end of the
period 9 118,551 68,067
============ ============
Amryt Pharma plc
Condensed Consolidated Statement of Changes in Equity
For the period ended March 31, 2021
(unaudited)
Share based Reverse Equity component Currency
Share Share Warrant Treasury payment Merger acquisition of convertible Other distributable translation Accumulated
Note capital premium reserve shares reserve reserve reserve notes reserves reserve deficit Total
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Balance at January 1, 2021
(audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142
Loss for the period -- -- -- -- -- -- -- -- -- -- (16,537) (16,537)
Foreign exchange translation
reserve -- -- -- -- -- -- -- -- -- 2,547 -- 2,547
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Total comprehensive loss -- -- -- -- -- -- -- -- -- 2,547 (16,537) (13,990)
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Transactions with owners
Issue of treasury shares
in exchange for warrants 10 23 99 -- 439 -- -- -- -- -- -- -- 561
Issue of treasury shares
for share options exercised 10 25 89 -- 465 (191) -- -- -- -- -- -- 388
Share based payment expense 4 -- -- -- -- 1,263 -- -- -- -- -- -- 1,263
Share based payment expense
-- Lapsed -- -- -- -- -- -- -- -- -- -- -- --
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Total transactions with
owners 48 188 -- 904 1,072 -- -- -- -- -- -- 2,212
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Balance at March 31, 2021
(unaudited) 13,899 51,596 14,762 (6,517) 8,932 42,627 (73,914) 29,210 217,634 8,277 (252,142) 54,364
======== ======== ======== ======== =========== ======== ============ ================ =================== ============ =========== ========
For the period ended March 31, 2020
(unaudited)
Share based Reverse Equity component Currency
Share Share Warrant Treasury payment Merger acquisition of convertible Other distributable translation Accumulated
Note capital premium reserve shares reserve reserve reserve notes reserves reserve deficit Total
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Balance at January 1, 2020
(audited) 11,918 2,422 29,523 (7,534) 3,190 42,627 (73,914) 29,210 217,634 7,920 (133,674) 129,322
Loss for the period -- -- -- -- -- -- -- -- -- -- (28,897) (28,897)
Foreign exchange translation
reserve -- -- -- -- -- -- -- -- -- (13) -- (13)
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Total comprehensive loss -- -- -- -- -- -- -- -- -- (13) (28,897) (28,910)
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Transactions with owners
Share based payment expense 4 -- -- -- -- 745 -- -- -- -- -- -- 745
Share based payment expense
-- Lapsed -- -- -- -- (2) -- -- -- -- -- 2 --
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Total transactions with
owners -- -- -- -- 743 -- -- -- -- -- 2 745
-------- -------- -------- -------- ----------- -------- ------------ ---------------- ------------------- ------------ ----------- --------
Balance at March 31, 2020
(unaudited) 11,918 2,422 29,523 (7,534) 3,933 42,627 (73,914) 29,210 217,634 7,907 (162,569) 101,157
======== ======== ======== ======== =========== ======== ============ ================ =================== ============ =========== ========
1. General information
Amryt is a global commercial-stage biopharmaceutical company focused on
acquiring, developing and commercializing innovative 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.
As used herein, references to "we," "us," "Amryt" or the "Group"
in these condensed consolidated interim financial statements shall mean
Amryt Pharma plc and its global subsidiaries, collectively. References
to the "Company" in these condensed consolidated interim financial
statements shall mean Amryt Pharma plc.
Amryt Pharma plc is a company incorporated in England and Wales. The
Company is listed on Nasdaq (ticker: AMYT) and the AIM market of the
London Stock Exchange (ticker: AMYT).
Aegerion Pharmaceuticals, Inc. ("Aegerion"), a former subsidiary of
Novelion Therapeutics Inc., is a rare and orphan disease company with a
diversified offering of multiple commercial and development stage
assets. The acquisition of Aegerion by Amryt in September 2019 has given
Amryt an expanded commercial footprint to market two U.S. and EU
approved products, lomitapide (Juxtapid (U.S.) / Lojuxta (EU)) and
metreleptin (Myalept (U.S.) / Myalepta (EU)).
Amryt's lead development asset, Filsuvez(R)/Oleogel-S10, is a potential
treatment for Epidermolysis Bullosa ("EB"), a rare and distressing
genetic skin disorder for which there is currently no treatment.
Oleogel-S10 is currently an investigational product and has not received
regulatory approval by the FDA or EMA. Filsuvez(R) has been selected as
the brand name for the product. On September 20, 2019, Amryt registered
Filsuvez(R) as the trademark name for Oleogel-S10 in the European Union.
On February 18, 2020, Amryt also registered this trademark name in the
United States and is in the process of registering the trademark in
other key jurisdictions.
On July 8, 2020, Amryt listed on the NASDAQ Global Select Market under
the symbol AMYT. The Ordinary Shares will continue to trade on the AIM
market of the London Stock Exchange.
On August 11, 2020 Amryt announced that the Company gave Euronext Dublin
("Euronext") notice of its intention to cancel the admission of the
Company's Ordinary Shares ('Ordinary Shares") to trading on the Euronext
Growth Market ("Cancellation"). The last day of trading in Ordinary
Shares on the Euronext Growth Market was September 8, 2020. The
Cancellation applies only to the Euronext Growth Market and will have no
effect on the Company's American Depositary Shares ("ADSs") which trade
on the NASDAQ Global Select Market under the symbol AMYT or on Amryt's
Ordinary Shares trading on the AIM market of the London Stock Exchange.
2. Accounting policies
Basis of preparation
The condensed consolidated interim financial statements of the Group
have been prepared in accordance with IAS 34 Interim Financial
Reporting. They do not include all of the information required in annual
financial statements in accordance with International Financial
Reporting Standards ("IFRS") and should be read in conjunction with
the annual consolidated financial statements for the year ended December
31, 2020. Selected explanatory notes are included to explain events and
transactions that are significant to an understanding of the Group's
financial position and performance since the last annual financial
statements. The accounting policies used in the preparation of the
interim financial information are the same as those used in the Group's
audited financial statements for the year ended December 31, 2020 and
those which are expected to be used in the financial statements for the
year ended December 31, 2021.
Results for the three-month period ended March 31, 2021 are not
necessarily indicative of the results that may be expected for the
financial year ending December 31, 2021.
Basis of going concern
Having considered the Group's current financial position and cash flow
projections, the Board of Directors believes that the Group will be able
to continue in operational existence for at least the next 12 months
from the date of approval of these condensed consolidated interim
financial statements and that it is appropriate to continue to prepare
the condensed consolidated interim financial statements on a going
concern basis.
As part of their inquiries, the Board of Directors reviewed budgets,
projected cash flows, and other relevant information for a period not
less than 12 months from the date of approval of the condensed
consolidated interim financial statements for the period ended March 31,
2021.
Basis of consolidation
The condensed consolidated interim financial statements comprise the
financial statements of the Group for the period ended March 31, 2021.
Subsidiaries are entities controlled by the Company. Where the Company
has control over an investee, it is classified as a subsidiary. The
Company controls an investee if all three of the following elements are
present: power over an investee, exposure or rights to variable returns
from its involvement with the investee and the ability to use its power
to affect those variable returns. Control is reassessed whenever facts
and circumstances indicate that there may be a change in any of these
elements of control.
Subsidiaries are fully consolidated from the date that control commences
until the date that control ceases. Accounting policies of subsidiaries
have been changed where necessary to ensure consistency with the
policies adopted by the Group. Intergroup balances and any unrealized
gains or losses, income or expenses arising from intergroup transactions
are eliminated in preparing the condensed consolidated interim financial
statements.
Presentation of balances
The condensed consolidated interim financial statements are presented in
U.S. dollars ("US$"), rounded to the nearest thousand, which is the
functional currency of the Company and presentation currency of the
Group.
The following table discloses the major exchange rates of those
currencies other than the functional currency of US$ that are utilized
by the Group:
Foreign currency units
to 1 US$ EUR GBP CHF SEK NOK DKK
------------------------ ------ ------ ------ ------ ------ ------
Average period to March
31, 2021 (unaudited) 0.8292 0.7253 0.9043 8.3868 8.5171 6.1669
At March 31, 2021
(unaudited) 0.8519 0.7274 0.9414 8.7214 8.5547 6.3351
Foreign currency units
to 1 US$ EUR GBP CHF SEK NOK DKK
--------------------------- ------ ------ ------ ------ ------ ------
Average period to December
31, 2020 (audited) 0.8777 0.7799 0.9391 9.2135 9.4206 6.5432
At December 31, 2020
(audited) 0.8141 0.7365 0.8829 8.1885 8.5671 6.0570
Foreign currency units
to 1 US$ EUR GBP CHF SEK NOK DKK
------------------------ ------ ------ ------ ------ ------- ------
Average period to March
31, 2020 (unaudited) 0.9068 0.7809 0.9679 9.6618 9.4731 6.7750
At March 31, 2020
(unaudited) 0.9043 0.8068 0.9570 9.9977 10.5721 6.7517
(EUR = Euro; GBP = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish
Kroner, NOK = Norwegian Kroner, DKK = Danish Kroner)
Changes in accounting policies and disclosures
There are no new standards and amendments to IFRS effective as of
January 1, 2021 that are relevant to the Group.
Critical accounting judgements and key sources of estimation uncertainty
In preparing these condensed consolidated interim financial statements
in conformity with IFRS management is required to make judgements,
estimates and assumptions that affect the application of policies and
amounts reported in the condensed consolidated interim financial
statements and accompanying notes. The estimates and associated
assumptions are based on historical experience and various other factors
that are believed to be reasonable under the circumstances, the results
of which form the basis of making the judgements about the carrying
value of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing
basis. Revisions to accounting estimates are recognized in the period in
which the estimate is revised if the revision affects only that period
or in the period of the revision and future periods if the revision
affects both current and future periods.
The significant estimates, assumptions or judgements, applied in the
condensed consolidated interim financial statements were the same as
those applied in the Group's audited financial statements for the year
ended December 31, 2020.
Principal accounting policies
The condensed consolidated interim financial statements have been
prepared in accordance with the accounting policies adopted in the
Group's audited financial statements for the year ended December 31,
2020.
3. Segment information
The Group is a global, commercial-stage biopharmaceutical company
dedicated to commercializing and developing novel therapeutics to treat
patients suffering from serious and life-threatening rare diseases.
The Group currently operates as one business segment, pharmaceuticals,
and is focused on the development and commercialization of two
commercial products and two development products. The Group derives its
revenues primarily from one source, being the pharmaceutical sector with
high unmet medical need.
The Group's Chief Executive Officer, Joseph Wiley, is currently the
Company's chief operating decision maker ("CODM"). The Group does not
operate any separate lines of business or separate business entities
with respect to its products. Accordingly, the Group does not accumulate
discrete financial information with respect to separate service lines
and does not have separate reportable segments.
The following table summarizes total revenues from external customers by
product and by geographic region, based on the location of the customer.
Three months ended March 31, 2021 (unaudited)
---------------------------------------------------
U.S. EMEA Other Total
US$'000 US$'000 US$'000 US$'000
Metreleptin 16,239 12,971 750 29,960
Lomitapide 8,324 7,440 2,420 18,184
Other -- 223 65 288
------------ ----------- ----------- -----------
Total revenue 24,563 20,634 3,235 48,432
============ =========== =========== ===========
Three months ended March 31, 2020 (unaudited)
---------------------------------------------------
U.S. EMEA Other Total
US$'000 US$'000 US$'000 US$'000
Metreleptin 14,914 8,628 3,385 26,927
Lomitapide 9,470 5,233 2,718 17,421
Other -- 226 -- 226
------------ ----------- ----------- -----------
Total revenue 24,384 14,087 6,103 44,574
============ =========== =========== ===========
Major Customers
For the three months ended March 31, 2021, one customer accounted for
51%, respectively, of the Group's net revenues (2020: 55%, respectively)
and accounted for 46% of the Group's March 31, 2021 accounts receivable
balance (December 31, 2020: 42%).
4. Share based payments
Under the terms of the Company's Employee Share Option Plan, options to
purchase 26,919,292 shares were outstanding at March 31, 2021. Under the
terms of this plan, options are granted to officers, consultants and
employees of the Group at the discretion of the Remuneration Committee.
A total of 8,465,644 share options were granted to non-executive
directors and employees in the three-month period ended March 31, 2021.
For the year ended December 31, 2020, a total of 4,432,000 share options
were granted to directors and employees.
The terms and conditions of the grants are as follows, whereby all
options are settled by physical delivery of shares:
Vesting conditions
The employee share options vest following a period of service by the
officer or employee. The required period of service is determined by the
Remuneration Committee at the date of grant of the options (usually the
date of approval by the Remuneration Committee) and it is generally over
a three-year period. There are no market conditions associated with the
share option vesting periods.
Contractual life
The term of an option is determined by the Remuneration Committee
provided that the term may not exceed a period of seven to ten years
from the date of grant. All options will terminate 90 days after
termination of the option holder's employment, service or consultancy
with the Group except where a longer period is approved by the Board of
Directors. Under certain circumstances involving a change in control of
the Group, each option will automatically accelerate and become
exercisable in full as of a date specified by the Board of Directors.
Outstanding warrants at March 31, 2021 consisted of 8,966,520 zero cost
warrants (December 31, 2020: 8,966,520) with no expiration date that
were issued to Aegerion creditors in connection with the acquisition of
Aegerion. The remaining warrants consisting of 62,153 warrants (December
31, 2020: 345,542) were issued in connection with the admission to the
AIM in 2016 and have since lapsed in April 2021.
The number and weighted average exercise price (in Sterling pence) of
share options and warrants per ordinary share is as follows:
Share Options Warrants
Weighted average Weighted average
exercise price exercise price
(Sterling (Sterling
Units pence) Units pence)
---------- ---------------- ----------- ----------------
Balance at 1 January 2020 14,481,720 116.00p 17,541,815 0.03p
Granted 4,432,000 144.76p -- --
Lapsed (87,119) 113.42p -- --
Exercised (72,953) 120.72p (8,229,753) --
---------- ---------------- ----------- ----------------
Outstanding at 31 December 2020
(audited) 18,753,648 122.79p 9,312,062 0.05p
========== ================ =========== ================
Exercisable at 31 December 2020
(audited) 5,866,152 114.24p 9,312,062 0.05p
========== ================ =========== ================
Balance at 1 January 2021 18,753,648 122.79p 9,312,062 0.05p
Granted 8,465,644 201.17p -- --
Lapsed -- -- -- --
Exercised (300,000) 93.72p (283,389) 1.44p
---------- ---------------- ----------- ----------------
Outstanding at 31 March 2021
(unaudited) 26,919,292 147.77p 9,028,673 0.01p
========== ================ =========== ================
Exercisable at 31 March 2021
(unaudited) 6,237,902 116.25p 9,028,673 0.01p
========== ================ =========== ================
Fair value is estimated at the date of grant using the Black-Scholes
pricing model, taking into account the terms and conditions attached to
the grant. The following are the inputs to the model for the equity
instruments granted during the period:
March 31, March 31, December 31, December 31,
2021 2021 2020 2020
Options Inputs Warrant Inputs Options Inputs Warrant Inputs
(unaudited) (unaudited) (audited) (audited)
Days to
Expiration 2,555 -- 2,555 --
Volatility 37% -- 33%-37% --
Risk free 0.77% -- 0.39%-0.46% --
interest
rate
Share price 201.2p -- 123.5p--178.9p --
at grant
In the three months ended March 31, 2021, a total of 8,465,644 share
options exercisable at a weighted average price of GBP2.012 were
granted. The fair value of share options granted in the three months
ended March 31, 2021 was GBP17,030,000/US$23,479,000.
The share options outstanding as at March 31, 2021 have a weighted
remaining contractual life of 5.78 years with exercise prices ranging
from GBP0.76 to GBP2.012.
The 2016 warrants outstanding as at March 31, 2021 have since lapsed in
April 2021.
Restricted Share Units
Under the terms of the Company's Employee Share Option Plan, restricted
share units ("RSUs") to purchase 1,834,090 shares were outstanding at
March 31, 2021. Under the terms of this plan, RSUs are granted to
officers, consultants and employees of the Group at the discretion of
the Remuneration Committee. For the period ended March 31, 2021, a total
of 293,180 RSUs were granted to employees of the company. For the year
ended December 31, 2020, a total of 1,556,960 RSUs were granted to
employees of the company. The fair value of the RSUs is based on the
share price at the date of grant, with the expense spread over the
vesting period. The fair value of RSUs granted in the period ended March
31, 2021 was US$861,000. At March 31,2021, the total RSUs granted to
date have a weighted remaining contractual life of 2.45 years. The
following table summarizes the RSU activity for the period:
RSUs
----------------------------
Weighted average
Unit fair value (US$)
--------- -----------------
Balance at January 1, 2021 1,549,910 $2.35
Granted 293,180 $2.80
------------------------------ --------- -----------------
Lapsed (9,000) $2.32
------------------------------ --------- -----------------
Exercised -- --
--------- -----------------
Outstanding at March 31, 2021 1,834,090 $2.43
------------------------------ ========= =================
The value of share options and RSU's charged to the Condensed
Consolidated Statement of Comprehensive Loss during the period is as
follows:
Three months ended
March 31,
--------------------------
2021 2020
(unaudited) (unaudited)
------------ ------------
US$'000 US$'000
Share option expense 879 745
RSU expense 384 --
------------
Total share option expense 1,263 745
============ ============
5. Business combinations and asset acquisitions
Acquisition of Aegerion Pharmaceuticals
On May 20, 2019, Amryt entered into a Restructuring Support Agreement
(as subsequently amended on June 12, 2019) and Plan Funding Agreement
pursuant to which, among other matters, Amryt agreed to the acquisition
of Aegerion Pharmaceuticals, Inc. ("Aegerion"), a former wholly-owned
subsidiary of Novelion Therapeutics Inc. ("Novelion"). On May 20,
2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals
Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11
of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt
completed the acquisition of Aegerion. Amryt acquired Aegerion upon its
emergence from bankruptcy in an exchange for ordinary shares and zero
cost warrants in Amryt. Amryt issued 85,092,423 effective shares at
US$1.793 per share, which is made up of 77,027,423 ordinary shares and
8,065,000 zero cost warrants, to acquire Aegerion for a value of
US$152,615,000.
The Company believes that the acquisition of Aegerion will enable the
Group to advance the Group's ambition to create a global leader in rare
and orphan diseases with a diversified offering of multiple
development-stage and commercial assets and provides it with scale to
support further growth.
As part of the acquisition of Aegerion, it was agreed, for certain
Aegerion creditors who wished to restrict their percentage share
interest in Amryt's issued share capital, to issue to the relevant
Aegerion creditor, as an alternative to Amryt's ordinary shares, an
equivalent number of new zero cost warrants to subscribe for Amryt's
ordinary shares to be constituted on the terms of the zero cost warrant.
Relevant Aegerion creditors are entitled at any time to exercise the
zero cost warrants, at which point in time, the Company would issue to
that Aegerion creditor the relevant number of fully paid ordinary shares
in return for the exercise of the zero cost warrants. Each zero cost
warrant entitles the holder thereof to subscribe for one ordinary share.
The zero cost warrants constitute the Company's direct and unsecured
obligations and rank pari passu and without any preference among
themselves (save for any obligations to be preferred by law) at least
equally with the Company's other present and future unsecured and
unsubordinated obligations. The zero cost warrants are not transferable
except with the Company's prior written consent.
During the three months ended March 31, 2021, the Group incurred no
additional acquisition and restructuring related costs relating to
external legal fees, advisory fees, due diligence costs and severance
costs (March 31, 2020: US$853,000). These costs were included in
operating costs in the Condensed Consolidated Statement of Comprehensive
loss.
Contingent Value Rights
Related to the transaction, Amryt issued Contingent Value Rights
("CVRs") pursuant to which up to US$85,000,000 may become payable to
Amryt's shareholders and optionholders, who were on the register prior
to the completion of the acquisition on September 20, 2019, if certain
approval and revenue milestones are met in relation Oleogel-S10, Amryt's
lead product candidate. If any such milestone is achieved, Amryt may
elect to pay the holders of CVRs by the issue of Amryt shares or loan
notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will
settle such loan notes in cash 120 days after their issue. If none of
the milestones are achieved, scheme shareholders and optionholders will
not receive any additional consideration under the terms of the CVRs. In
these circumstances, the value of each CVR would be zero.
The terms of the CVRs are as follows:
-- The total CVR payable is up to US$85,000,000
-- This is divided into three milestones which are related to the success of
Oleogel-S10 (the Group's lead development asset)
-- FDA approval
-- US$35,000,000 upon FDA approval
-- 100% of the amount due if approval is obtained before December 31,
2021, with a sliding scale on a linear basis to zero if before
July 1, 2022
-- EMA approval
-- US$15,000,000 upon EMA approval
-- 100% of the amount due if approval is obtained before December 31,
2021, with a sliding scale on a linear basis to zero if before
July 1, 2022
-- Revenue targets
-- US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in
any 12-month period prior to June 30, 2024
-- Payment can at the Board's discretion be in the form of either:
-- 120-day loan notes (effectively cash), or
-- Shares valued using the 30 day / 45-day VWAP.
The CVRs were contingent on the successful completion of the acquisition
and, accordingly, have been based on fair value as at September 24,
2019. The CVRs have been classified as a financial liability in the
Condensed Consolidated Statement of Financial Position. Given that CVRs
were issued to legacy Amryt shareholders in their capacity as owners of
the identified acquirer as opposed to the seller in the transaction,
management concluded that the most appropriate classification would be
to recognize the CVR as a distribution on consolidation instead of
goodwill.
Measurement of CVRs
As at March 31, 2021, the carrying value of the CVRs was US$63,180,000
(December 31, 2020: US$61,417,000). The value of the potential payout
was calculated using the probability-weighted expected returns method.
Using this method, the potential payment amounts were multiplied by the
probability of achievement and discounted to present value. The
probability adjusted present values took into account published orphan
drug research data and statistics which were adjusted by management to
reflect the specific circumstances applicable to the type of product
acquired in the Amryt GmbH transaction. The market-based probability
chance of success is based on market benchmarks for orphan drugs was
estimated at 89% in the period ended March 31, 2021 (2020: 89%).
Discount rates of 10% and 16.5%, as applicable, were used in the
calculation of the present value of the estimated contractual cash flows
for the period ended March 31, 2021 (December 31, 2020: 10% and 16.5%).
Management was required to make certain estimates and assumptions in
relation to revenue forecasts, timing of revenues and probability of
achievement of commercialization of Oleogel-S10. However, management
notes that, due to issues outside their control (i.e. regulatory
requirements and the commercial success of the product), the timing of
when such revenue targets may occur may change. Such changes may have a
material impact on the assessment of the expected cash flows of the
CVRs.
Amryt reviews the expected cash flows on a regular basis as the discount
on initial recognition is being unwound as financing expenses in the
Condensed Consolidated Statement of Comprehensive Loss over the life of
the obligation. It is reviewed on a quarterly basis and the appropriate
finance charge is booked in the Condensed Consolidated Statement of
Comprehensive Loss on a quarterly basis. The Group received positive
topline data from the phase 3 EASE trial of Oleogel-S10 in September
2020. The Group recently submitted applications for approval from the
FDA and the EMA.
The total non-cash finance charge recognized in the Condensed
Consolidated Statement of Comprehensive Loss for the three months ended
March 31, 2021 is US$1,763,000 (March 31, 2020: US$1,448,000).
Acquisition of Amryt GmbH (previously "Birken")
Amryt DAC signed a conditional share purchase agreement to acquire Amryt
GmbH on October 16, 2015 ("Amryt GmbH SPA"). The Amryt GmbH SPA was
completed on April 18, 2016 with Amryt DAC acquiring the entire issued
share capital of Amryt GmbH. The consideration included contingent
consideration comprising milestone payments and sales royalties as
follows:
-- Milestone payments of:
-- EUR10,000,000 on receipt of first marketing approval by the EMA of
Episalvan, paid on the completion date (April 18, 2016);
-- Either (i) EUR5,000,000 once net ex-factory sales of Episalvan
have been at least EUR100,000 or (ii) if no commercial sales are
made within 24 months of EMA first marketing approval (being
January 14, 2016), EUR2,000,000 24 months after receipt of such
approval, which was paid in January 2018, and EUR3,000,000
following the first commercial sale of Episalvan;
-- EUR10,000,000 on receipt of marketing approval by the EMA or FDA
of a pharmaceutical product containing Betulin as its API for the
treatment of EB;
-- EUR10,000,000 once net ex-factory sales/net revenue of Oleogel
S-10 first exceed EUR50,000,000 in any calendar year;
-- EUR15,000,000 once net ex-factory sales/ net revenue of Oleogel
S-10 first exceed EUR100,000,000 in any calendar year;
-- Cash consideration of EUR150,000, due and paid on the completion date
(April 18, 2016); and
-- Royalties of 9% on sales of Oleogel-S10 products for 10 years from first
commercial sale.
Fair Value Measurement of Contingent Consideration
As at March 31, 2021, the fair value of the contingent consideration was
estimated to be US$85,884,000 (December 31, 2020: US$86,906,000). The
fair value of the royalty payments was determined using probability
weighted revenue forecasts and the fair value of the milestone payments
was determined using probability adjusted present values (see Note 14,
Fair value measurement and financial risk management, for fair value
hierarchy applied and impact of key unobservable impact data). The
probability adjusted present values took into account published orphan
drug research data and statistics which were adjusted by management to
reflect the specific circumstances applicable to the type of product
acquired in the Amryt GmbH transaction. The market-based probability
chance of success is based on market benchmarks for orphan drugs was
estimated at 89% for the period ended March 31, 2021 (December 31, 2020:
89%) following the positive results from our phase 3 EASE trial of
Oleogel-S10 earlier in the year. A discount rate of 14.4% was used in
the calculation of the fair value of the contingent consideration for
the three months ended March 31, 2021 (December 31, 2020: 14.4%).
The Group received positive top line results from the phase 3 EASE trial
of Oleogel-S10 in September 2020, and the Group recently submitted
applications for approval from the FDA and the EMA.
Amryt reviews the contingent consideration on a regular basis as the
probability adjusted fair values are being unwound as financing expenses
in the Condensed Consolidated Statement of Comprehensive Loss over the
life of the obligation. The finance charge is being unwound as a
financing expense in the Condensed Consolidated Statement of
Comprehensive Loss on a quarterly basis.
The total non-cash finance charge recognized in the Condensed
Consolidated Statement of Comprehensive Loss for the three months ended
March 31, 2021 is US$2,874,000 (March 31, 2020: US$2,906,000).
6. Loss per share - basic and diluted
The weighted average number of shares in the loss per share ("LPS")
calculation, reflects the weighted average total actual shares of Amryt
Pharma plc in issue at March 31, 2021.
Issued share capital - ordinary shares of GBP0.06 each
Number of Weighted average
shares shares
----------- ----------------
March 31, 2021 (unaudited) 179,384,982 178,937,717
March 31, 2020 (unaudited) 154,498,887 154,498,887
--------------------------- ----------- ----------------
The calculation of loss per share is based on the following:
Three months ended March
31
--------------------------
2021 2020
(unaudited) (unaudited)
------------ ------------
Loss after tax attributable to equity holders
of the Company (US$'000) (16,537) (28,897)
Weighted average number of ordinary shares
in issue 178,937,717 154,498,887
------------------------------------------------ ------------ ------------
Fully diluted average number of ordinary shares
in issue 178,937,717 154,498,887
------------------------------------------------ ------------ ------------
Basic and diluted loss per share (US$) (0.09) (0.19)
------------------------------------------------ ============ ============
Where a loss has occurred, basic and diluted LPS are the same because
the outstanding share options and warrants are anti-dilutive.
Accordingly, diluted LPS equals the basic LPS. The share options and
warrants outstanding as at March 31, 2021 totaled 35,947,965 (March 31,
2020: 28,065,710) and are potentially dilutive.
7. Intangible assets and goodwill
The following table summarizes the Group's intangible assets and
goodwill:
Developed Developed
technology technology In process Other intangible Total intangible
- metreleptin - lomitapide R&D assets assets Goodwill
US$'000 US$'000 US$'000 US$'000 US$'000 US$'000
Cost
At January 1, 2020
(audited) 176,000 123,000 54,261 701 353,962 19,131
Additions -- -- -- 372 372 --
Acquired assets -- -- 591 -- 591 --
Disposals -- -- -- (246) (246) --
Foreign exchange movement -- -- 5,276 39 5,315 --
-------------- ------------- ---------- ---------------- ---------------- --------
At December 31, 2020
(audited) 176,000 123,000 60,128 866 359,994 19,131
Additions -- -- -- 416 416 --
Foreign exchange movement -- -- (2,667) (35) (2,702) --
-------------- ------------- ---------- ---------------- ---------------- --------
At March 31, 2021
(unaudited) 176,000 123,000 57,461 1,247 357,708 19,131
============== ============= ========== ================ ================ ========
Accumulated amortization
At January 1, 2020
(audited) 7,314 4,143 -- 178 11,635 --
Amortization charge 27,429 15,537 -- 202 43,168 --
Accumulated amortization
on disposals -- -- -- (246) (246) --
-------------- ------------- ---------- ---------------- ---------------- --------
Foreign exchange movement -- -- -- 68 68 --
-------------- ------------- ---------- ---------------- ---------------- --------
At December 31, 2020
(audited) 34,743 19,680 -- 202 54,625 --
Amortization charge 6,857 3,884 -- 31 10,772 --
Foreign exchange movement -- -- -- (4) (4) --
-------------- ------------- ---------- ---------------- ---------------- --------
At March 31, 2021
(unaudited) 41,600 23,564 -- 229 65,393 --
============== ============= ========== ================ ================ ========
Net book value
At December 31, 2020
(audited) 141,257 103,320 60,128 664 305,369 19,131
============== ============= ========== ================ ================ ========
At March 31, 2021
(unaudited) 134,400 99,436 57,461 1,018 292,315 19,131
============== ============= ========== ================ ================ ========
Developed technology on commercially marketed products
In connection with the acquisition of Aegerion in September 2019, the
Group acquired developed technology, metreleptin and lomitapide. These
intangible assets are amortized over their estimated useful lives and
the remaining useful lives for metreleptin and lomitapide are
approximately 4.9 and 6.4 years, respectively, as of March 31, 2021
(December 31, 2020: 5.2 and 6.7 years, respectively).
In-process R&D
As a result of the acquisition of Amryt GmbH, in 2016, the Group
recognized in-process R&D costs of EUR52,515,000 which is related to the
Group's lead development asset, Oleogel-S10.
Goodwill
During 2019, the Group completed the acquisition of Aegerion, which
resulted in aggregate goodwill of US$19,131,000.
The Group reviews events or changes in circumstances that may indicate a
triggering event for impairment. Management applied its judgment in
determining that there were no events or changes in circumstances
causing any impairment triggers as of March 31, 2021. As such there was
no impairment charge recorded during the three months ended March 31,
2021.
8. Trade and other receivables
As at
--------------------------
March 31, December 31,
2021 2020
(unaudited) (audited)
------------ ------------
US$'000 US$'000
Trade receivables 37,224 33,057
Accrued income and other debtors 6,220 8,423
VAT recoverable 519 1,705
------------ ------------
Trade and other receivables 43,963 43,185
============ ============
9. Cash and cash equivalents
As at
--------------------------
March 31, December 31,
2020 2020
(unaudited) (audited)
------------ ------------
US$'000 US$'000
Cash at bank available on demand 118,522 118,575
Restricted cash 29 223
------------ ------------
Total cash and cash equivalents 118,551 118,798
============ ============
Cash and cash equivalents include cash at bank available on demand and
restricted cash.
At March 31, 2021 and December 31, 2020, there was US$29,000 and
US$223,000 of restricted cash, respectively. The balance at December 31,
2020 includes a deposit on a company credit card facility for an amount
of US$150,000. This was reduced to nil as at March 31, 2021.
Additionally, there was US$29,000 held by a third-party distributor at
March 31, 2021 (December 31, 2020: US$73,000.
10. Share capital and reserves
Details of the number of issued ordinary shares with a nominal value of
Sterling 6 pence (2020: 6 pence) each are in the table below.
Ordinary Treasury
shares shares Total
------------ ------------ -----------
At January 1, 2020 154,498,887 4,864,656 159,363,543
Issue of shares in exchange for
warrants 8,229,753 -- 8,229,753
Issue of shares in equity fund
raises 16,000,000 -- 16,000,000
Issue of treasury shares for
share options exercised 72,953 (72,953) --
At December 31, 2020 (audited) 178,801,593 4,791,703 183,593,296
Issue of treasury shares in exchange
for warrants 283,389 (283,389) --
Issue of treasury shares for
share options exercised 300,000 (300,000) --
At March 31, 2021 (unaudited) 179,384,982 4,208,314 183,593,296
The components of equity are detailed in the Condensed Consolidated
Statement of Changes in Equity and described in more detail below.
The total number of ordinary shares issued at March 31, 2021 of
183,593,296 (December 31, 2020: 183,593,296), includes treasury shares
of 4,208,314 (December 31, 2020: 4,791,703).
In December 2020, the Company issued 3,200,000 American Deposit Shares
("ADSs"), each representing five ordinary shares, as part of a
US$40,000,000 private placement equity raise to existing and new
shareholders.
On March 11, 2021, the Company issued 300,000 ordinary shares from
treasury shares following the exercise of share options. On March 11,
2021, the Company issued 283,389 ordinary shares from treasury shares in
exchange for certain warrants. The Company issued 4,000,000 and
4,229,753 ordinary shares on July 15, 2020 and September 22, 2020,
respectively, in exchange for certain warrants.
Share Capital
Share capital represents the cumulative par value arising upon issue of
ordinary shares of Sterling 6 pence each.
The ordinary shares have the right to receive notice of, attend and vote
at general meetings and participate in the profits of the Company.
Share Premium
Share premium represents the consideration that has been received in
excess of the nominal value on issue of share capital net of issue costs
and transfers to distributable reserves.
Warrant reserve
The warrant reserve represents zero cost warrants issued as part of the
equity raise on September 24, 2019 net of issue costs apportioned to
warrants issued and additional warrants issued to certain shareholders
on November 14, 2019. Each warrant entitles the holder to subscribe for
one ordinary share at zero cost. The Company issued 4,000,000 and
4,229,753 ordinary shares on July 15, 2020 and September 22, 2020,
respectively, in exchange for certain warrants.
Treasury Shares
In October 2020, the Company issued 72,953 ordinary shares from treasury
shares following the exercise of share options. In March 2021, the
Company issued a total of 583,389 ordinary shares from treasury shares,
300,000 ordinary shares relating to the exercise of share options and
283,389 ordinary shares following the exchange of certain warrants.
Share based payment reserve
Share based payment reserve relates to the charge for share based
payments in accordance with IFRS 2. In March 2021, the Company issued
283,389 ordinary shares in exchange for certain warrants.
Merger reserve
The merger reserve was created on the acquisition of Amryt DAC by Amryt
Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were
issued to acquire the entire issued share capital of Amryt DAC. Under
section 612 of the UK Companies Act 2006, the premium on these shares
has been included in a merger reserve.
Reverse acquisition reserve
The reverse acquisition reserve arose during the period ended December
31, 2016 in respect of the reverse acquisition of Amryt Pharma plc by
Amryt DAC. Since the shareholders of Amryt DAC became the majority
shareholders of the enlarged Group, the acquisition is accounted for as
though there is a continuation of Amryt DAC's financial statements. The
reverse acquisition reserve is created to maintain the equity structure
of Amryt Pharma plc in compliance with UK company law.
Equity component of convertible notes
The equity component of convertible notes represents the equity
component of the US$125,000,000 convertible debt and is measured by
determining the residual of the fair value of the instrument less the
estimated fair value of the liability component. The equity component is
recognized in equity and is not subsequently remeasured.
Currency translation reserve
The currency translation reserve arises on the retranslation of non-U.S.
dollar denominated foreign subsidiaries.
Accumulated deficit
Accumulated deficit represents losses accumulated in previous periods
and the current year.
11. Long term loan
As at
--------------------------
March 31, December 31,
2021 2020
(unaudited) (audited)
------------ ------------
US$'000 US$'000
Long term loan principal 89,472 88,037
Unamortized debt issuance costs (703) (735)
Long term loan 88,769 87,302
============ ============
As part of the acquisition of Aegerion on September 24, 2019, Aegerion
entered into a new U.S. dollar denominated US$81,021,000 secured term
loan debt facility ("Term Loan") with various lenders. The Term Loan
is made up of a US$54,469,000 loan that was in place prior to the
acquisition which was refinanced as part of the acquisition and a
US$26,552,000 additional loan that was drawn down on September 24, 2019.
The Term Loan has a five-year term from the date of the draw down,
September 24, 2019 and matures on September 24, 2024. Under the Term
Loan, interest will be payable at the option of the Group at the rate of
11% per annum paid in cash on a quarterly basis or at a rate of 6.5%
paid in cash plus 6.5% paid in kind that will be paid when the principal
is repaid, which rolls up and is included in the principal balance
outstanding, on a quarterly basis. Unpaid accrued interest of
US$1,431,000 as at March 31, 2021 is recognized in current liabilities
with trade and other payables (December 31, 2020: $1,439,000). The Term
Loan may be prepaid, in whole or in part, by Aegerion at any time
subject to payment of an exit fee, which depending on the stage of the
loan term, ranges from 5.00% to 0.00% of the principal then outstanding
on the Term Loan.
In connection with the Term Loan, the Group incurred approximately
US$870,000 of debt issuance costs, which primarily consisted of
underwriting, legal and other professional fees. These costs are being
amortized over the expected life of the loan using the effective
interest method.
The Term Loan is guaranteed by Amryt and certain subsidiaries of the
Group. In connection with the loan agreement, fixed and floating charges
have been placed on property and undertakings of Amryt and certain
subsidiaries of the Group.
The Term Loan agreement includes affirmative and negative covenants,
including prohibitions on the incurrence of additional indebtedness,
granting of liens, certain asset dispositions, investments, and
restricted payments, in each case, subject to certain exceptions set
forth in the Loan Agreement. The Term Loan agreement also includes
customary events of default for a transaction of this type and includes
(i) a cross-default to the occurrence of any event of default under
material indebtedness of Aegerion and certain subsidiaries of the Group
and Amryt, including the convertible notes, and (ii) Amryt or any of its
subsidiaries being subject to bankruptcy or other insolvency
proceedings. Upon the occurrence of an event of default, the lenders may
declare all of the outstanding Term Loan and other obligations under the
Term Loan agreement to be immediately due and payable and exercise all
rights and remedies available to the lenders under the Term Loan
agreement and related documentation. There have been no events of
default or breaches of the covenants occurring for the three months
ended March 31, 2021 (December 31, 2020: no events).
12. Convertible notes
Total
-------
US$'000
------------------------------- -------
At January 1, 2020 96,856
Accreted interest 4,230
------------------------------- -------
At December 31, 2020 (audited) 101,086
------------------------------- -------
Accreted interest 1,130
At March 31, 2021 (unaudited) 102,216
------------------------------- =======
As part of the acquisition, Aegerion issued convertible notes with an
aggregate principal amount of US$125,000,000 to Aegerion creditors.
The convertible notes are senior unsecured obligations and bear interest
at a rate of 5.0% per year, payable semi-annually in arrears on April 1
and October 1 of each year, beginning on April 1, 2020. The convertible
notes will mature on April 1, 2025, unless earlier repurchased or
converted.
The convertible notes are convertible into Amryt's ordinary shares at a
conversion rate of 386.75 ordinary shares per US$1,000 principal amount
of the convertible notes. If the holders elect to convert the
convertible notes, Aegerion can settle the conversion of the convertible
notes through payment or delivery of cash, common shares, or a
combination of cash and common shares, at its discretion. As a result of
the conversion feature in the convertible notes, the convertible notes
were assessed to have both a debt and an equity component. The two
components were assessed separately and classified as a financial
liability and equity instrument. The financial liability component was
measured at fair value based on the discounted cash flows expected over
the expected term of the notes using a discount rate based on a market
interest rate that a similar debt instrument without a conversion
feature would be subject to. Refer to Note 10, Share capital and
reserves, for further details on the equity component of the convertible
notes.
From September 24, 2019 until the close of business on the second
scheduled trading day immediately preceding the maturity date, holders
may convert all or any portion of their convertible notes, in multiples
of US$1,000 principal amount, at the option of the holder.
The indenture does not contain any financial covenants or restrict the
Group's ability to repurchase securities, pay dividends or make
restricted payments in the event of a transaction that substantially
increases the Group's level of indebtedness in certain circumstances.
The indenture contains customary terms and covenants and events of
default. If an event of default (other than certain events of bankruptcy,
insolvency or reorganization involving Aegerion, Amryt and certain
subsidiaries of the Group) occurs and is continuing, the trustee by
notice to Aegerion, or the holders of at least 25% in principal amount
of the outstanding convertible notes by written notice to Aegerion and
the trustee, may declare 100% of the principal of and accrued and unpaid
interest, if any, on all of the convertible notes to be due and payable.
Upon such a declaration of acceleration, such principal and accrued and
unpaid interest, if any, will be due and payable immediately. Upon the
occurrence of certain events of bankruptcy, insolvency or reorganization
involving Aegerion, 100% of the principal and accrued and unpaid
interest, if any, on the convertible notes will become due and payable
automatically. Notwithstanding the foregoing, the indenture provides
that, upon Aegerion's election, and for up to 180 days, the sole remedy
for an event of default relating to certain failures by Aegerion to
comply with certain reporting covenants in the indenture consists
exclusively of the right to receive additional interest on the
convertible notes. There have been no events of default or breaches of
the covenants occurring for the period ended March 31, 2021 (2020: no
events).
13. Provisions and other liabilities
As at
--------------------------
March 31, December 31,
2021 2020
(unaudited) (audited)
------------ ------------
US$'000 US$'000
Non-current liabilities
Provisions and other liabilities 22,292 21,382
Leases due greater than 1 year 4,357 4,569
------------ ------------
26,649 25,951
Current liabilities
Provisions and other liabilities 6,000 9,976
Leases due less than 1 year 967 963
------------ ------------
6,967 10,939
------------ ------------
Total provisions and other liabilities 33,616 36,890
============ ============
Legal matters
Prior to the acquisition of Aegerion by Amryt, Aegerion entered into
settlement agreements with governmental entities including the
Department of Justice ("DOJ") and the FDA in connection with Juxtapid
investigations. The settlement agreements require Aegerion to pay
specified fines and engage in regulatory compliance efforts. Subsequent
to the acquisition, Aegerion made US$23,036,000 of settlement payments,
including interest. The settlements have been paid in full with the last
payment completed in Q1 2021. There is no current liability recognized
as at March 31, 2021 (December 31, 2020: US$3,976,000). There is no
non-current liability at March 31, 2021 (December 31, 2020: nil).
Other matters
The Group recognizes a liability for legal contingencies when it
believes that it is both probable that a liability has been incurred and
that it can reasonably estimate the amount of the loss. The Group
reviews these accruals and adjusts them to reflect ongoing negotiations,
settlements, rulings, advice of legal counsel and other relevant
information. To the extent new information is obtained and the Group's
views on the probable outcomes of claims, suits, assessments,
investigations or legal proceedings change, changes in the Group's
liability accrual would be recorded in the period in which such
determination is made. At March 31, 2021 the Group had recognized
liabilities of US$6,000,000 in relation to ongoing legal matters
(December 31, 2020 US$6,000,000).
14. Fair value measurement and financial risk management
Categories of financial instruments
As at
--------------------------
March 31, December 31,
2021 2020
(unaudited) (audited)
------------ ------------
US$'000 US$'000
Financial assets (all at amortized cost):
Cash and cash equivalents 118,551 118,798
Trade receivables 37,224 33,057
------------ ------------
Total financial assets 155,775 151,855
Financial liabilities:
At amortized cost
Trade payables and accrued expenses 83,631 89,300
Lease liabilities 5,324 5,532
Other liabilities 22,292 25,358
Convertible notes 102,216 101,086
Long term loan 88,769 87,302
Contingent value rights 63,180 61,417
At fair value
Contingent consideration 85,884 86,906
------------ ------------
Total financial liabilities 451,296 456,901
------------ ------------
Net (295,521) (305,046)
============ ============
Financial instruments evaluated at fair value can be classified
according to the following valuation hierarchy, which reflects the
extent to which the fair value is observable:
-- Level 1: fair value evaluations using prices listed on active markets
(not adjusted) of identical assets or liabilities.
-- Level 2: fair value evaluations using input data for the asset or
liability that are either directly observable (as prices) or indirectly
observable (derived from prices), but which do not constitute listed
prices pursuant to Level 1.
-- Level 3: fair value evaluations using input data for the asset or
liability that are not based on observable market data (unobservable
input data).
The contingent consideration has been valued using Level 3. The
contingent consideration comprises:
-- Contingent consideration relating to the acquisition of Amryt GmbH (see
Note 5, Business combinations and asset acquisitions) that was measured
at US$85,884,000 as at March 31, 2021 (December 31, 2020: US$86,906,000).
The fair value comprises royalty payments which was determined using
probability weighted revenue forecasts and the fair value of the
milestones payments which was determined using probability adjusted
present values. It also included a revision to the discount rate used,
and revenue and costs forecasts have been amended to reflect management's
current expectations.
Impact of key unobservable input data
-- An increase of 10% in estimated revenue forecasts would result in an
increase to the fair value of US$6,009,000. A decrease would have the
opposite effect.
-- A 5% increase in the discount factor used would result in a decrease to
the fair value of US$14,718,000. A decrease of 5% would result in an
increase to the fair value of US$19,539,000.
-- A six-month delay in the launch date for Oleogel-S10 would result in a
decrease to the fair value of US$8,576,000.
15. Events after the reporting period
On May 5, 2021, Amryt announced that it had signed a definitive
agreement to acquire Chiasma, Inc. ("Chiasma") in an all-stock
combination. The combined company will be a global leader in rare and
orphan diseases with three on-market commercial products, a global
commercial and operational footprint and a significant development
pipeline of therapies with the financial flexibility to execute its
growth plans. The transaction has been approved and recommended by the
Boards of both Amryt and Chiasma.
Under the terms of the transaction, each share of Chiasma common stock
issued and outstanding prior to the consummation of the transaction will
be exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary
shares. As of the close of trading on May 4, 2021 Amryt's ordinary
shares on AIM were GBP2.00 ($2.78) per share and Amryt's ADS's on Nasdaq
were $12.95 (GBP9.31) per ADS.
There were no other significant events since the end of the reporting
period.
(END) Dow Jones Newswires
May 05, 2021 07:05 ET (11:05 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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