Amryt Reports Record Q1 2021 Financial and Operating Results
Amryt reported a strong Q1 2021, with revenues reaching $48.4M, up 8.7% YoY. Underlying revenue growth was 16.5% when excluding a LATAM order from Q1 2020. EBITDA increased by 115% compared to Q1 2020, reaching $9.9M. The company achieved national reimbursement for metreleptin in England, Wales, and France, alongside regulatory submissions for Oleogel-S101 to the FDA and EMA. Amryt has raised its FY 2021 revenue guidance to $205M-$210M and announced the proposed acquisition of Chiasma, Inc., aiming for a combined potential peak revenue of $1BN.
- 8.7% YoY revenue growth to $48.4M.
- 16.5% underlying revenue growth excluding a LATAM order.
- 115% increase in EBITDA to $9.9M from Q1 2020.
- National reimbursement achieved for metreleptin in major markets.
- Regulatory submissions for Oleogel-S101 made to FDA and EMA.
- Raised FY 2021 revenue guidance to $205M-$210M.
- None.
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
5th consecutive quarter of positive EBITDA generation
National reimbursement achieved for metreleptin in England, Wales and France
Regulatory submissions for Oleogel-S101 (Filsuvez®) made to the FDA and EMA
Raising FY 2021 revenue guidance to
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
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
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
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 grew25.3% in Q1.- US accounted for
54.2% of global metreleptin revenues and EMEA accounted for43.3% 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 for40.9% in Q1 2021. EMEA lomitapide revenues increased by42.2% in Q1 2021 versus Q1 2020. 13.9% QoQ revenue growth in Q1 2021 versus Q4 2020 ($42.5M)
Q1 Financial Highlights:
$3.4 M 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: $118.8M) - Legacy fines levied on Aegerion were fully discharged in Q1 2021
1 For the purposes of this announcement, we use the name Oleogel-S10. Filsuvez® has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for Filsuvez® to treat EB.
IFRS and non-GAAP adjusted Q1 2021 results:
| US$M | Q1 2020
| Q1 2021 | Q1 2021 | Q1 2021 Non-GAAP 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 | 9.93
|
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 EBITDA3 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
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://edge.media-server.com/mmc/p/hdecnon9
Telephone Dial in details:
| United States | +1 646 787 1226 |
| United Kingdom | +44 (0) 203 009 5709 |
| Ireland | +353 (1) 506 0626 |
| Confirmation Code | 8698345 |
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®/ Myalepta®) and lomitapide (Juxtapid®/ Lojuxta®).
Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) 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.
Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.
Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) 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® 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 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
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 | |
|
| Note | 2021 | 2020 |
|
|
| 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, | ||
|
| Note |
| March 31, 2021 |
| December 31, 2020 |
|
|
|
| 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 | ||
|
| Note |
| 2021 |
| 2020 |
|
|
|
| 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)
|
| Note | Share capital | Share premium | Warrant reserve | Treasury shares | Share based payment reserve | Merger reserve | Reverse acquisition reserve | Equity component of convertible notes | Other distributable reserves | Currency translation reserve | Accumulated 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)
|
| Note | Share capital | Share premium | Warrant reserve | Treasury shares | Share based payment reserve | Merger reserve | Reverse acquisition reserve | Equity component of convertible notes | Other distributable reserves | Currency translation reserve | Accumulated 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®/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® has been selected as the brand name for the product. On September 20, 2019, Amryt registered Filsuvez® 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$ |
| € |
| £ |
| 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$ |
| € |
| £ |
| 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$ |
| € |
| £ |
| 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 |
(€ = Euro; £ = 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
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 | ||
|
| Units | Weighted average exercise price (Sterling pence) | Units | Weighted average exercise price (Sterling 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, 2020 | December 31, 2020 |
| Days to Expiration | 2,555 | — | 2,555 | — |
| Volatility | | — | | — |
| Risk free interest rate | | — | | — |
| Share price at grant | 201.2p | — | 123.5p–178.9p | — |
In the three months ended March 31, 2021, a total of 8,465,644 share options exercisable at a weighted average price of
The share options outstanding as at March 31, 2021 have a weighted remaining contractual life of 5.78 years with exercise prices ranging from
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
|
| RSUs | ||
|
| Unit |
| Weighted average fair value (US$) |
| Balance at January 1, 2021 | 1,549,910 |
| |
| Granted | 293,180 |
| |
| Lapsed | (9,000) |
| |
| Exercised | — |
| — |
| Outstanding at March 31, 2021 | 1,834,090 |
| |
The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows:
|
| Three months ended | ||
|
| 2021 |
| 2020 |
|
| US$’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
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
Contingent Value Rights
Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US
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
- US
- 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
- US
- 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
- US
- 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
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
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:
€10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016);- Either (i)
€5,000,000 once net ex-factory sales of Episalvan have been at least€100,000 or (ii) if no commercial sales are made within 24 months of EMA first marketing approval (being January 14, 2016),€2,000,000 24 months after receipt of such approval, which was paid in January 2018, and€3,000,000 following the first commercial sale of Episalvan; €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB;€10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed€50,000,000 in any calendar year;€15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed€100,000,000 in any calendar year;
- Cash consideration of
€150,000 , 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
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
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
|
| Number of shares |
| Weighted average 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 (unaudited) |
| 2020 |
| 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$) | (0.09) |
| (0.19) |
Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options and warrants outstanding as at March 31, 2021 totaled 35,947,965 (March 31, 2020: 28,065,710) and are potentially dilutive.
7. Intangible assets and goodwill
The following table summarizes the Group’s intangible assets and goodwill:
|
| Developed technology - metreleptin | Developed technology - lomitapide | In process R&D | Other intangible assets | Total intangible assets | Goodwill |
|
| US$’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
Goodwill
During 2019, the Group completed the acquisition of Aegerion, which resulted in aggregate goodwill of US
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, 2021 |
| December 31, 2020 |
|
| US$’000 |
| US$’000 |
| Trade receivables | 37,224 |
| 33,057 |
| Accrued income and other debtors | 6,220 |
| 8,423 |
| VAT recoverable | 519 |
| 1,705 |
| Trade and other receivables | 43,963 |
| 43,185 |
9. Cash and cash equivalents
|
| As at | ||
|
| March 31, 2020 |
| December 31, 2020 |
|
| US$’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
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 shares | Treasury 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
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
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, 2021 |
| December 31, 2020 |
|
| US$’000 |
| US$’000 |
| Long term loan principal | 89,472 |
| 88,037 |
| Unamortized debt issuance costs | (703) |
| (735) |
| Long term loan | 88,769 |
| 87,302 |
As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US
In connection with the Term Loan, the Group incurred approximately US
The Term Loan is guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group.
The Term Loan agreement includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Aegerion and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There have been no events of default or breaches of the covenants occurring for the three months ended March 31, 2021 (December 31, 2020: no events).
12. Convertible notes
|
| Total |
|
| US$’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
The convertible notes are senior unsecured obligations and bear interest at a rate of
The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US
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
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
13. Provisions and other liabilities
|
| As at | ||
|
| March 31, 2021 |
| December 31, 2020 |
|
| 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
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
14. Fair value measurement and financial risk management
Categories of financial instruments
|
| As at | ||
|
| March 31, 2021 |
| December 31, 2020 |
|
| 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 of5% 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
There were no other significant events since the end of the reporting period.
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