Amryt Reports Record Q3 2020 Results - Raising FY 2020 Revenue Guidance
AMRYT REPORTS RECORD Q3 2020 RESULTS
19% YoY revenue growth in the quarter to
Raising full year revenue guidance to
Both metreleptin and lomitapide driving revenue performance and growth
Strong cash generation with cash of
Positive results reported from EASE pivotal Phase 3 study in Epidermolysis Bullosa
Conference call and webcast today at
- 19% YoY growth in unaudited Q3 revenues to
$49.3M (Q3 20191 unaudited combined revenues:$41 .4M) - 23% YoY growth in unaudited cumulative YTD revenues to
$140.1M (Nine months 20191 unaudited combined revenues:$113 .6M) - 7% QoQ revenue growth in Q3 versus Q2 (
$46.2M ) - Raising FY 2020 revenue guidance from
$170M -$175M to$180M -$182M (20191:$154.1m ) $3.6M operating loss before finance expense in Q3. Excluding non-cash items and share based compensation expenses, this resulted in EBITDA3 of$13.5M in Q3 representing 96% QoQ growth- Strong cash generation during the nine months to
September 2020 with$21.1M of cash generated from operating activities YTD and$11.4M during the quarter - Increase in cash from
$67.1M atJune 30, 2020 to$75.4M atSeptember 30, 2020 - Amryt announced positive results from EASE pivotal Phase 3 trial in EB. The primary endpoint of the trial was achieved and demonstrated a statistically significant acceleration of target wound healing by day 45 in patients treated with FILSUVEZ®2 vs control gel (p-value = 0.013) representing a 44% increase in target wound closure with FILSUVEZ® vs the control gel. EASE is the largest ever Phase 3 randomized controlled study conducted in EB.
- The RDEB sub-group was observed to experience a greater benefit when treated with FILSUVEZ® than the overall population (nominal p=0.008) representing a 72% increase in target wound closure with FILSUVEZ® vs the control gel
- Favourable trends were evident among secondary endpoints including change in procedural pain, EBDASI score and BSAP
- FILSUVEZ® had an acceptable safety profile and was well tolerated when compared with control gel
- On
July 8 , Amryt listed on the Nasdaq Global Select Market (“Nasdaq”)
“I am very pleased with today’s record results which demonstrate the positive performance and growth that our commercial products are delivering alongside the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates. The positive momentum we experienced during the first half of the year has continued through Q3 and I am very pleased with both our revenue growth and positive cash momentum. Furthermore, given the strong performance of the business year to date we are now increasing our revenue guidance for 2020 from
We are also very pleased with the positive results for FILSUVEZ® from our EASE Phase 3 trial in EB. EASE is the first ever Phase 3 study to demonstrate positive data in this devastating disease and we look forward to submitting this data to regulatory authorities in both the US and
Our two commercial products, metreleptin and lomitapide continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion. We have the management team, systems and infrastructure in place to continue to grow our existing commercial products and also to launch FILSUVEZ® if approved next year”.
Q3 and Recent Business Highlights:
- In July, Amryt listed on Nasdaq
- In September, Amryt announced positive top line data from the pivotal EASE Global Phase 3 trial in EB. The primary endpoint was achieved with statistical significance (p-value=0.013) representing a 44% increase in target wound closure with FILSUVEZ® vs the control gel. EASE is the largest ever Phase 3 study conducted in EB.
- The RDEB sub-group was observed to experience a greater benefit when treated with FILSUVEZ® than the overall population (nominal p-value=0.008) representing a 72% increase in target wound closure with FILSUVEZ® vs the control gel
- In September, the European Medicines Agency (“EMA”) Committee for Orphan Medicinal Products (“COMP”) adopted a positive opinion for orphan designation for the use of AP103 in EB
- In October, Amryt signed a distribution agreement for Lojuxta® (lomitapide) with Swixx BioPharma AG (“Swixx”) across 17 jurisdictions in Central and Eastern Europe. This follows on from Amryt’s appointment in
June 2020 of Swixx as exclusive distributor of Myalepta® (metreleptin) across the CEE territories.
Q3 2020 Financial Highlights:
·$49.3M unaudited Q3 revenues representing a 19% increase on unaudited combined revenues of
·7% QoQ unaudited revenue growth in Q3 versus Q2 (
·31% growth in Myalept® / Myalepta® (metreleptin) revenues to $29.9M in the quarter (Q3 2019: unaudited combined revenues1 $22.9M). Metreleptin revenues were bolstered by a
·4% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $19.1M in the quarter (Q3 2019: unaudited combined revenues1
·US accounted for 51% of global revenues and EMEA accounted for 28% of global revenues in Q3
1 Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on
2 For the purposes of this announcement, we use the name FILSUVEZ® which has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for FILSUVEZ® to treat EB
IFRS and non-GAAP adjusted Q3 results:
US$M | Q3 2019 (unaudited) | Q3 2020 (unaudited) | Q3 2020 Non-cash Items4 | Q3 2020 Non-GAAP Adjusted |
Revenue | 8.6 | 49.3 | - | 49.3 |
Gross profit | 5.5 | 22.3 | 15.1 | 37.4 |
R&D | (2.4) | (7.4) | - | (7.4) |
SG&A | (6.0) | (16.9) | 0.5 | (16.4) |
Acquisition & severance related costs | (8.7) | (0.1) | - | (0.1) |
Share based compensation expenses | (0.1) | (1.5) | 1.5 | - |
Operating (loss) / profit before finance expense | (11.7) | (3.6) | 17.1 | 13.53 |
The Q3 operating loss of
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.
4 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets (
Financial Position:
Cash generated from operating activities in Q3 was
Raising FY 2020 Financial Guidance:
Revenues for the FY 2020 are expected to be in the range of
Webcast and Conference Call:
Management will host a webcast for analysts and investors today at
Webcast Player URL: https://edge.media-server.com/mmc/p/dor9m4ay
Telephone Dial in details:
Standard International Number | +44 (0) 203 009 5709 |
| +1 646 787 1226 |
| +44 (0) 844 493 6766 |
| + 353 (1) 506 0626 |
Confirmation Code | 2865629 |
A playback facility will be available from
Enquiries:
Amryt Pharma plc | +353 (1) 518 0200 |
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LifeSci Advisors, LLC | +1 (212) 915 2564 |
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Consilium Strategic Communications | +44 (0) 20 3709 5700 |
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About Amryt
Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.
Amryt’s commercial business comprises two orphan disease products.
Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. In September and
Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in
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,
In
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
Financial Advisors
Shore Capital (Edward Mansfield,
Forward-Looking Statements
Statements in this announcement with respect to Amryt's business, strategies, timing for completion of and announcing results from the EASE trial, the potential impact of closing enrollment in the EASE trial, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt 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.
Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
2020 (unaudited) | 2019 (unaudited) | 2020 (unaudited) | 2019 (unaudited) | |||||||||
Note | US$’000 | US$’000 | ||||||||||
Revenue | 3 | 49,326 | 8,637 | 140,085 | 17,828 | |||||||
Cost of sales | (27,057 | ) | (3,127 | ) | (89,148 | ) | (6,831 | ) | ||||
Gross profit | 22,269 | 5,510 | 50,937 | 10,997 | ||||||||
Research and development expenses | (7,350 | ) | (2,414 | ) | (22,481 | ) | (7,632 | ) | ||||
Selling, general and administrative expenses | (16,889 | ) | (5,999 | ) | (56,883 | ) | (15,946 | ) | ||||
Acquisition and severance related costs | (105 | ) | (8,743 | ) | (1,005 | ) | (11,362 | ) | ||||
Share based payment expenses | 4 | (1,533 | ) | (97 | ) | (3,136 | ) | (319 | ) | |||
Operating loss before finance expense | (3,608 | ) | (11,743 | ) | (32,568 | ) | (24,262 | ) | ||||
Non-cash change in fair value of contingent consideration | 5 | (2,126 | ) | (1,448 | ) | (8,150 | ) | (5,299 | ) | |||
Non-cash contingent value rights finance expense | 5 | (1,557 | ) | — | (4,498 | ) | — | |||||
Net finance expense - other | (1,359 | ) | (2,291 | ) | (15,492 | ) | (3,623 | ) | ||||
Loss on ordinary activities before taxation | (8,650 | ) | (15,482 | ) | (60,708 | ) | (33,184 | ) | ||||
Tax (charge)/credit on loss on ordinary activities | (1,821 | ) | (77 | ) | 3,171 | (93 | ) | |||||
Loss for the period attributable to the equity holders of the Company | (10,471 | ) | (15,559 | ) | (57,537 | ) | (33,277 | ) | ||||
Exchange translation differences which may be reclassified through profit or loss | (1,921 | ) | 59 | (2,850 | ) | 59 | ||||||
Total other comprehensive loss | (1,921 | ) | 59 | (2,850 | ) | 59 | ||||||
Total comprehensive loss for the period attributable to the equity holders of the Company | (12,392 | ) | (15,500 | ) | (60,387 | ) | (33,218 | ) | ||||
Loss per share | ||||||||||||
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) | 6 | (0.07 | ) | (0.28 | ) | (0.37 | ) | (0.69 | ) |
Amryt Pharma plc Condensed Consolidated Statement of Financial Position | |||||||
As at, | |||||||
2020 (unaudited) | 2019 restated (see note 15) | ||||||
Note | US$’000 | ||||||
Assets | |||||||
Non-current assets | |||||||
Goodwill | 7 | 24,086 | 24,086 | ||||
Intangible assets | 7 | 312,704 | 342,327 | ||||
Property, plant and equipment | 6,859 | 3,036 | |||||
Other non-current assets | 1,277 | 1,873 | |||||
Total non-current assets | 344,926 | 371,322 | |||||
Current assets | |||||||
Trade and other receivables | 8 | 42,195 | 35,500 | ||||
Inventories | 44,932 | 58,000 | |||||
Cash and cash equivalents, including restricted cash | 9 | 75,382 | 67,229 | ||||
Total current assets | 162,509 | 160,729 | |||||
Total assets | 507,435 | 532,051 | |||||
Equity and liabilities | |||||||
Equity attributable to owners of the parent | |||||||
Share capital | 10 | 12,548 | 11,918 | ||||
Share premium | 10 | 16,553 | 2,422 | ||||
Other reserves | 234,099 | 248,630 | |||||
Accumulated deficit | (188,618 | ) | (131,137 | ) | |||
Total equity | 74,582 | 131,833 | |||||
Non-current liabilities | |||||||
Contingent consideration and contingent value rights | 5 | 117,791 | 102,461 | ||||
Deferred tax liability | 9,649 | 12,102 | |||||
Long term loan | 11 | 85,835 | 81,610 | ||||
Convertible notes | 12 | 99,986 | 96,856 | ||||
Provisions and other liabilities | 13 | 4,657 | 4,963 | ||||
Total non-current liabilities | 317,918 | 297,992 | |||||
Current liabilities | |||||||
Trade and other payables | 100,226 | 78,351 | |||||
Provisions and other liabilities | 13 | 14,709 | 23,875 | ||||
Total current liabilities | 114,935 | 102,226 | |||||
Total liabilities | 432,853 | 400,218 | |||||
Total equity and liabilities | 507,435 | 532,051 |
Amryt Pharma plc Condensed Consolidated Statement of Cash Flows | ||||||
Nine Months Ended | ||||||
2020 (unaudited) | 2019 (unaudited) | |||||
Note | US$’000 | |||||
Cash flows from operating activities | ||||||
Loss on ordinary activities after taxation | (57,537 | ) | (33,277 | ) | ||
Net finance expense - other | 15,492 | 3,623 | ||||
Depreciation and amortization | 33,313 | 447 | ||||
Amortization of inventory fair value step-up | 21,015 | — | ||||
Share based payment expenses | 4 | 3,136 | 319 | |||
Non-cash change in fair value of contingent consideration | 5 | 8,150 | 5,299 | |||
Non-cash contingent value rights finance expense | 5 | 4,498 | — | |||
Deferred taxation credit | (2,452 | ) | — | |||
Movements in working capital and other adjustments: | ||||||
Change in trade and other receivables | 8 | (6,695 | ) | (1,575 | ) | |
Change in trade and other payables | 21,875 | 3,951 | ||||
Change in provision and other liabilities | 13 | (12,328 | ) | — | ||
Change in inventories | (7,948) | (1,078 | ) | |||
Change in non-current assets | 596 | 72 | ||||
Net cash flow from (used in) operating activities | 21,115 | (22,219 | ) | |||
Cash flow from investing activities | ||||||
Net cash received on acquisition of subsidiary | — | 24,985 | ||||
Payments for property, plant and equipment | (147 | ) | (465 | ) | ||
Payments for intangible assets | (298 | ) | — | |||
Deposit interest received | 86 | 2 | ||||
Net cash flow (used in) from investing activities | (359 | ) | 24,522 | |||
Cash flow from financing activities | ||||||
Proceeds from issue of equity instruments | — | 45,162 | ||||
Proceeds from long term debt borrowings net of debt issue costs | — | 27,551 | ||||
Repayment of long term debt | — | (21,990 | ) | |||
Payment of leases | (846 | ) | (239 | ) | ||
Interest paid | (6,190 | ) | (2,019 | ) | ||
Net cash flow (used in) from financing activities | (7,036 | ) | 48,465 | |||
Exchange and other movements | (5,567 | ) | (354 | ) | ||
Net change in cash and cash equivalents | 8,153 | 50,414 | ||||
Cash and cash equivalents at beginning of the period | 67,229 | 11,226 | ||||
Restricted cash at end of the period | 792 | 16,051 | ||||
Cash at bank available on demand at end of the period | 74,590 | 45,589 | ||||
Total cash and cash equivalents at end of the period | 75,382 | 61,640 |
Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended | ||||||||||||||||||||||||||
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 | |||||||||||||||
Note | US$’000 | |||||||||||||||||||||||||
Balance at | 11,918 | 2,422 | 29,523 | (7,534 | ) | 3,190 | 42,627 | (73,914 | ) | 29,210 | 217,634 | 7,894 | (131,137 | ) | 131,833 | |||||||||||
Loss for the period | — | — | — | — | — | — | — | — | — | — | (57,537 | ) | (57,537 | ) | ||||||||||||
Foreign exchange translation reserve | — | — | — | — | — | — | — | — | — | (2,850 | ) | — | (2,850 | ) | ||||||||||||
Total comprehensive loss for the period | — | — | — | — | — | — | — | — | — | (2,850 | ) | (57,537 | ) | (60,387 | ) | |||||||||||
Transactions with owners | ||||||||||||||||||||||||||
Issue of shares in exchange for warrants | 10 | 630 | 14,131 | (14,761 | ) | — | — | — | — | — | — | — | — | — | ||||||||||||
Share based payment expense | 4 | — | — | — | — | 3,136 | — | — | — | — | — | — | 3,136 | |||||||||||||
Share based payment expense – lapsed | — | — | — | — | (56 | ) | — | — | — | — | — | 56 | — | |||||||||||||
Total transactions with owners | 630 | 14,131 | (14,761 | ) | — | 3,080 | — | — | — | — | — | 56 | 3,136 | |||||||||||||
Balance at | 12,548 | 16,553 | 14,762 | (7,534 | ) | 6,270 | 42,627 | (73,914 | ) | 29,210 | 217,634 | 5,044 | (188,618 | ) | 74,582 | |||||||||||
Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended | ||||||||||||||||||||||||||
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 | |||||||||||||||
Note | US$’000 | |||||||||||||||||||||||||
Balance at | 25,198 | 68,233 | — | — | 6,473 | 42,627 | (73,914 | ) | — | — | (51 | ) | (72,263 | ) | (3,697 | ) | ||||||||||
Loss for the period | — | — | — | — | — | — | — | — | — | — | (33,277 | ) | (33,277 | ) | ||||||||||||
Foreign exchange translation reserve | — | — | — | — | — | — | — | — | — | 59 | — | 59 | ||||||||||||||
Total comprehensive loss for the period | — | — | — | — | — | — | — | — | — | 59 | (33,277 | ) | (33,218 | ) | ||||||||||||
Transactions with owners | ||||||||||||||||||||||||||
Share consolidation | 10 | (21,262 | ) | 21,262 | — | — | — | — | — | — | — | — | — | — | ||||||||||||
Issue of shares in | 10 | 533 | 7,467 | — | — | — | — | — | — | — | — | — | 8,000 | |||||||||||||
Issue costs associated with | 10 | — | (1,886 | ) | — | — | — | — | — | — | — | — | — | (1,886 | ) | |||||||||||
Acquisition of subsidiary without a change of control | 10 | (495 | ) | (3,726 | ) | — | — | — | — | — | — | (2,969 | ) | 7,190 | — | — | ||||||||||
Issue of shares and warrants in consideration of Aegerion Acquisition | 10 | 5,759 | 132,392 | 14,464 | — | — | — | — | — | — | — | — | 152,615 | |||||||||||||
Issue of shares and warrants in equity fund raise | 10 | 2,059 | 47,338 | 10,603 | — | — | — | — | — | — | — | — | 60,000 | |||||||||||||
Issue costs associated with | 10 | — | (2,575 | ) | (530 | ) | — | — | — | — | — | — | — | — | (3,105 | ) | ||||||||||
Issue of convertible notes | 12 | — | — | — | — | — | — | — | 29,210 | — | — | — | 29,210 | |||||||||||||
Issue of contingent value rights | 5 | — | — | — | — | — | — | — | — | (47,902 | ) | — | — | (47,902 | ) | |||||||||||
Share based payment expense | 4 | — | — | — | — | 319 | — | — | — | — | — | — | 319 | |||||||||||||
Total transactions with owners | (13,406 | ) | 200,272 | 24,537 | — | 319 | — | — | 29,210 | (50,871 | ) | 7,190 | — | 197,251 | ||||||||||||
Balance at | 11,792 | 268,505 | 24,537 | — | 6,792 | 42,627 | (73,914 | ) | 29,210 | (50,871 | ) | 7,198 | (105,540 | ) | 160,336 |
1. General information
We are a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases.
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
Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’), a former subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’), 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
On
On
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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
Results for the nine-month period ended
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.
A key consideration for the impact on going concern is the acquisition of Aegerion, which was completed in
Since a novel strain of coronavirus (SARS-CoV-2) causing a disease referred to as COVID-19 was first reported in
Amryt provides therapeutic products to Homozygous Familial Hypercholesterolemia (‘‘HoFH’’) and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) is prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient. To date the Group has seen minimal impact of the COVID-19 pandemic on the business given the majority of revenues are recurring in nature and the Group has a strong cash position and resources to support the Group’s ability to continue as a going concern.
Basis of consolidation
The condensed consolidated interim financial statements comprise the financial statements of the Group for the nine months ended
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 consolidated financial statements.
Presentation of balances
The condensed consolidated interim financial statements are presented in
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 | € | £ | CHF | SEK | NOK | DKK | ||||||||||||
Average three-month period to | 0.8898 | 0.7857 | 0.9950 | 9.3993 | 8.6944 | 6.6422 | ||||||||||||
Average nine-month period to | 0.8992 | 0.8110 | 0.9855 | 9.5838 | 8.8586 | 6.7109 | ||||||||||||
At | 0.9140 | 0.8137 | 0.9910 | 9.7939 | 9.0757 | 6.8240 |
Foreign currency units to | € | £ | CHF | SEK | NOK | DKK | ||||||||||||
Average period to | 0.8932 | 0.7836 | 0.9938 | 9.4533 | 8.7976 | 6.6690 | ||||||||||||
At | 0.8929 | 0.7624 | 0.971 | 9.3282 | 8.8046 | 6.6698 |
Foreign currency units to | € | £ | CHF | SEK | NOK | DKK | ||||||||||||
Average three-month period to | 0.8905 | 0.7873 | 0.9508 | 9.4111 | 9.5480 | 6.6422 | ||||||||||||
Average nine-month period to | 0.8562 | 0.7749 | 0.9203 | 8.8756 | 9.1384 | 6.3740 | ||||||||||||
At | 0.8543 | 0.7777 | 0.9220 | 9.0060 | 9.4528 | 6.3604 |
(€ = Euro; £ = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish Kroner, NOK = Norwegian Kroner, DKK =
Changes in accounting policies and disclosures
In the current year, the Group has applied the amendments to IFRS related to IFRS 3 and the definition of a business. These amendments and interpretations do not have significant impact on the disclosures or the amounts reported in these condensed consolidated interim financial statements.
Critical accounting judgements and key sources of estimation uncertainty
The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the 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
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
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, the pharmaceutical sector with high unmet medical need.
The Group’s Chief Executive Officer,
The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Revenues represent the revenue from the Group for the three and nine months ended
Three months ended | ||||||||
| EMEA | Other | Total | |||||
US$’000 | ||||||||
Metreleptin | 15,877 | 6,423 | 7,578 | 29,878 | ||||
Lomitapide | 9,233 | 7,109 | 2,771 | 19,113 | ||||
Other | — | 201 | 134 | 335 | ||||
Total revenue | 25,110 | 13,733 | 10,483 | 49,326 |
Three months ended | ||||||||
| EMEA | Other | Total | |||||
US$’000 | ||||||||
Metreleptin | 1,036 | 694 | 35 | 1,765 | ||||
Lomitapide | 1,319 | 5,143 | 243 | 6,705 | ||||
Other | — | 167 | — | 167 | ||||
Total revenue | 2,355 | 6,004 | 278 | 8,637 |
Nine months ended | ||||||||
| EMEA | Other | Total | |||||
US$’000 | ||||||||
Metreleptin | 45,457 | 26,233 | 13,014 | 84,704 | ||||
Lomitapide | 28,047 | 18,683 | 7,856 | 54,586 | ||||
Other | — | 573 | 222 | 795 | ||||
Total revenue | 73,504 | 45,489 | 21,092 | 140,085 |
Nine months ended | ||||||||
| EMEA | Other | Total | |||||
US$’000 | ||||||||
Metreleptin | 1,036 | 694 | 35 | 1,765 | ||||
Lomitapide | 1,319 | 14,036 | 243 | 15,598 | ||||
Other | — | 465 | — | 465 | ||||
Total revenue | 2,355 | 15,195 | 278 | 17,828 |
Major Customers
For the three and nine months ended
4. Share based payments
Share Options and Warrants
On
Under the terms of the Company’s Employee Share Option Plan, options to purchase 18,753,648 shares were outstanding at
Outstanding warrants at
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 | 3,250,855 | 115.20p | 3,818,325 | 144.00p | ||||||
Granted | 11,330,641 | 117.01p | 18,841,378 | — | ||||||
Lapsed | (99,776 | ) | 197.66p | (3,472,783 | ) | 144.00p | ||||
Exercised | — | — | (1,645,105 | ) | — | |||||
Outstanding at | 14,481,720 | 116.00p | 17,541,815 | 0.03p | ||||||
Exercisable at | 2,468,310 | 109.08p | 17,541,815 | 0.03p | ||||||
Balance at | 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 | 18,753,648 | 122.79p | 9,312,062 | 0.05p | ||||||
Exercisable at | 3,025,547 | 107.49p | 9,312,062 | 0.05p |
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:
(unaudited) | (unaudited) | (audited) | (audited) | ||||||||
Days to Expiration | 2,555 | — | 2,555 | — | |||||||
Volatility | 33% - 37% | — | 27% - 48% | — | |||||||
Risk free interest rate | 0.35% - 0.46% | — | 0.38% - 0.83% | — | |||||||
Share price at grant | 123.5p – 178.94p | — | 75.84p – 121.5p | — |
In the nine months ended
The 2016 warrants outstanding as at
Restricted Share Units
Under the terms of the Company’s Employee Share Option Plan, restricted share units (“RSUs”) to purchase 1,556,960 shares were outstanding at
RSUs | ||||
Units | Weighted average fair value (US$) | |||
Balance at | — | — | ||
Granted | 1,556,960 | | ||
Lapsed | — | — | ||
Exercised | — | — | ||
Outstanding at | 1,556,960 | |
The total share based payment expense charged to the Consolidated Statement of Comprehensive Loss during the three and nine-month periods are as follows:
Three months ended | Nine months ended | |||||||
2020 (unaudited) | 2019 (unaudited) | 2020 (unaudited) | 2019 (unaudited) | |||||
US$’000 | ||||||||
Share option expense | 1,307 | 97 | 2,910 | 319 | ||||
RSU expense | 226 | — | 226 | — | ||||
Total share option expense | 1,533 | 97 | 3,136 | 319 |
5. Business combinations and asset acquisitions
Acquisition of Aegerion Pharmaceuticals (“Aegerion acquisition”)
On
The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes.
IFRS 3 Business combinations requires the assignment of fair values to identifiable assets and liabilities acquired to be completed within 12 months of the acquisition date. The initial assignment of fair values was included in the consolidated financial statement for the year ending
As at | ||||||
As previously reported in | Adjustments* | Fair value | ||||
US$’000 | ||||||
Assets | ||||||
Non-current assets | ||||||
Property, plant and equipment | 276 | — | 276 | |||
Right of use assets | 924 | — | 924 | |||
Intangible Assets | 308,374 | (9,000 | ) | 299,374 | ||
Other assets | 2,334 | (433 | ) | 1,901 | ||
Total non-current assets | 311,908 | (9,433 | ) | 302,475 | ||
Current assets | ||||||
Cash and cash equivalents | 24,985 | — | 24,985 | |||
Trade and other receivables | 23,259 | — | 23,259 | |||
Inventory | 45,959 | 11,482 | 57,441 | |||
Prepaid expenses and other assets | 2,469 | (881 | ) | 1,588 | ||
Total current assets | 96,672 | 10,601 | 107,273 | |||
Total assets | 408,580 | 1,168 | 409,748 | |||
Current liabilities | ||||||
Accounts payable | 5,137 | (1,186 | ) | 3,951 | ||
Accrued liabilities | 64,088 | 2,922 | 67,010 | |||
Lease liabilities – current | 384 | — | 384 | |||
Provision for legal settlements – current | 14,916 | 257 | 15,173 | |||
Total current liabilities | 84,525 | 1,993 | 86,518 | |||
Non-current liabilities | ||||||
Lease liabilities - long term | 538 | — | 538 | |||
Long term debt | 54,469 | — | 54,469 | |||
Convertible notes debt and equity components - long term | 125,000 | — | 125,000 | |||
Provision for legal settlements - long term | 7,821 | — | 7,821 | |||
Deferred tax liability | 14,425 | (7,552 | ) | 6,873 | ||
Total non-current liabilities | 202,253 | (7,552 | ) | 194,701 | ||
Total liabilities | 286,778 | (5,559 | ) | 281,219 | ||
Total identifiable net assets at fair value | 121,802 | 6,727 | 128,529 | |||
Goodwill arising on acquisition | 30,813 | (6,727 | ) | 24,086 | ||
Consideration | 152,615 | — | 152,615 | |||
Consideration | ||||||
Issue of fully paid up ordinary shares and zero cost warrants | 152,615 | — | 152,615 | |||
Total consideration | 152,615 | — | 152,615 |
*Adjustments relate to finalization of fair values following completion of the fair value assignment to identifiable assets and liabilities acquired. See Note 15, Restatement of prior year comparatives, for more details on the adjustments.
Contingent Value Rights
Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to
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 FILSUVEZ® (the Group’s lead development asset, currently in Phase 3 clinical trials)
- 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 beforeJuly 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 beforeJuly 1, 2022
- Revenue targets
US$35,000,000 upon FILSUVEZ® revenues exceedingUS$75,000,000 in any 12-month period prior toJune 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
Measurement of CVRs
As at
Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the 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 on a quarterly basis. The Group received positive top-line data from the Phase 3 trial of FILSUVEZ® in Epidermolysis Bullosa (‘‘EB’’) in September, 2020. The Group expects this to be followed by 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 and nine months ended
Acquisition of Amryt AG (previously ‘‘Birken’’)
Amryt DAC signed a conditional share purchase agreement to acquire Amryt AG on
- 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 inJanuary 2018 , and €3,000,000 following the first commercial sale; - €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 in any calendar year exceed €50,000,000;
- €15,000,000 once net ex-factory sales/ net revenue in any calendar year exceed €100,000,000;
- €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (
- Cash consideration of €150,000, due and paid on the completion date (
April 18, 2016 ); and - Royalties of 9% on sales of Episalvan products for 10 years from first commercial sale;
Fair Value Measurement of Contingent Consideration
As of
In
Amryt reviews the contingent consideration on a regular basis as the probability adjusted fair values are being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. The finance charge is being unwound as a financing expense in the Consolidated Statement of Comprehensive Loss on a quarterly basis.
The total non-cash finance charge recognized in the Consolidated Statement of Comprehensive Loss for the three and nine months ended
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
Issued share capital - ordinary shares of £0.06 each
Number of shares | Weighted average shares | ||||
| 162,728,640 | 155,776,507 | |||
| 157,718,438 | 48,126,074 |
The calculation of loss per share is based on the following:
Three months ended | Nine months ended | |||||||
2020 (unaudited) | 2019 (unaudited) | 2020 (unaudited) | 2019 (unaudited) | |||||
Loss after tax attributable to equity holders of the Company (US$’000) | (10,471 | ) | (15,559 | ) | (57,537 | ) | (33,277 | ) |
Weighted average number of ordinary shares in issue | 158,303,972 | 55,683,096 | 155,776,507 | 48,126,074 | ||||
Fully diluted average number of ordinary shares in issue | 158,303,972 | 55,683,096 | 155,776,507 | 48,126,074 | ||||
Basic and diluted loss per share (US$) | (0.07 | ) | (0.28 | ) | (0.37 | ) | (0.69 | ) |
The basic and diluted loss per share for the three and nine-month period ended
Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options and warrants outstanding as at
7. Intangible assets and goodwill
The following table summarizes the Group’s intangible assets and goodwill:
Developed technology - metreleptin | Developed technology - lomitapide | In process R&D | Other intangible assets | Total intangible assets | Goodwill | ||||||||||||
US$’000 | |||||||||||||||||
Cost | |||||||||||||||||
At (audited) | — | — | 60,091 | 258 | 60,349 | — | |||||||||||
Additions | — | — | — | 74 | 74 | — | |||||||||||
Acquired assets as restated (see note 15) | 176,000 | 123,000 | — | 374 | 299,374 | 24,086 | |||||||||||
Impairment charge | — | — | (4,670 | ) | — | (4,670 | ) | — | |||||||||
Foreign exchange movement | — | — | (1,160 | ) | (5 | ) | (1,165 | ) | — | ||||||||
At | 176,000 | 123,000 | 54,261 | 701 | 353,962 | 24,086 | |||||||||||
Additions | — | — | — | 298 | 298 | — | |||||||||||
Disposals | — | — | — | (246 | ) | (246 | ) | — | |||||||||
Foreign exchange movement | — | — | 2,456 | 36 | 2,492 | — | |||||||||||
At | 176,000 | 123,000 | 56,717 | 789 | 356,506 | 24,086 | |||||||||||
Accumulated amortization | |||||||||||||||||
At (audited) | — | — | — | 52 | 52 | — | |||||||||||
Amortization charge as restated (see note 15) | 7,314 | 4,143 | — | 126 | 11,583 | — | |||||||||||
Foreign exchange movement | — | — | — | — | — | — | |||||||||||
At | 7,314 | 4,143 | — | 178 | 11,635 | — | |||||||||||
Amortization charge | 20,571 | 11,653 | — | 176 | 32,400 | — | |||||||||||
Amortization charge on disposals | — | — | — | (246 | ) | (246 | ) | ||||||||||
Foreign exchange movement | — | — | — | 13 | 13 | — | |||||||||||
At | 27,885 | 15,796 | — | 121 | 43,802 | — | |||||||||||
Net book value | |||||||||||||||||
At | 168,686 | 118,857 | 54,261 | 523 | 342,327 | 24,086 | |||||||||||
At | 148,115 | 107,204 | 56,717 | 668 | 312,704 | 24,086 |
Developed technology on commercially marketed products
In connection with the acquisition of Aegerion in
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. The acquisition resulted in aggregate goodwill of
The Group reviews events or changes in circumstances that may indicate a triggering event for impairment. As of
8. Trade and other receivables
As at | |||||
(unaudited) | restated (see note 15) | ||||
US$’000 | |||||
Trade receivables | 32,403 | 28,607 | |||
Accrued income and other debtors | 8,988 | 5,493 | |||
VAT recoverable | 804 | 1,400 | |||
Trade and other receivables | 42,195 | 35,500 |
9. Cash and cash equivalents
As at | |||||
(unaudited) | (audited) | ||||
US$’000 | |||||
Cash at bank available on demand | 74,590 | 65,197 | |||
Restricted cash | 792 | 2,032 | |||
Total cash and cash equivalents | 75,382 | 67,229 |
Cash and cash equivalents include cash at bank available on demand and restricted cash.
At
10. Share capital and reserves
Details of issued ordinary shares with a nominal value of Sterling
Date | Number of ordinary shares | Total Share Capital US$’000 | Total Share Premium US$’000 | |||
At | 167,593,296 | 12,548 | 16,553 | |||
At | 159,363,543 | 11,918 | 2,422 |
The number of ordinary shares issued at
Share Capital
Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling
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
Treasury Shares
On
Share based payment reserve
Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2.
Merger reserve
The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in
Reverse acquisition reserve
The reverse acquisition reserve arose during the period ended
Equity component of convertible notes
The equity component of convertible notes represents the equity component of the
Other distributable reserves
Other distributable reserves comprise the following:
- Distribution of the share premium amount on
November 6, 2019 ofUS$268,505,000 . - A deemed distribution of
US$47,902,000 arising from the issuance of CVRs. - A deemed distribution of
US$2,969,000 arising from the scheme of arrangement inSeptember 2019 whereby Amryt Pharma plc, which was incorporated inJuly 2019 , became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the ‘‘Acquisition of subsidiary without a change of control’’).
Currency translation reserve
The currency translation reserve arises on the retranslation of non-
Accumulated deficit
Accumulated deficit represents losses accumulated in previous periods and the current year.
11. Long term loan
As at | ||||||
(unaudited) | (audited) | |||||
US$’000 | ||||||
Long term loan | 86,603 | 82,456 | ||||
Unamortized debt issuance costs | (768 | ) | (846 | ) | ||
Long term loan | 85,835 | 81,610 |
As part of the acquisition of Aegerion on
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 nine months ended
12. Convertible notes
As at | |||||
(unaudited) | (audited) | ||||
US$’000 | |||||
Issuance of convertible notes | 125,000 | 125,000 | |||
Amount classified as equity | (29,210 | ) | (29,210 | ) | |
Accreted interest | 4,196 | 1,066 | |||
Total convertible notes | 99,986 | 96,856 |
As part of the acquisition, Aegerion issued convertible notes with an aggregate principal amount of
The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on
The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per
From
The indenture does not contain any financial covenants and does not 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 nine months ended
13. Provisions and other liabilities
As at | |||||
(unaudited) | restated (see note 15) | ||||
US$’000 | |||||
Non-current liabilities | |||||
Provisions and other liabilities | — | 3,910 | |||
Leases due greater than 1 year | 4,657 | 1,053 | |||
4,657 | 4,963 | ||||
Current liabilities | |||||
Provisions and other liabilities | 13,887 | 23,304 | |||
Leases due less than 1 year | 822 | 571 | |||
14,709 | 23,875 | ||||
Total provisions and other liabilities | 19,366 | 28,838 |
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. The settlements that remain due as a current liability and a non-current liability is
Other legal 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
14. Fair value measurement and financial risk management
Categories of financial instruments
As at | ||||||
(unaudited) | restated (see note 15) | |||||
US$’000 | ||||||
Financial assets (all at amortized cost): | ||||||
Cash and cash equivalents | 75,382 | 67,229 | ||||
Trade receivables | 32,403 | 28,607 | ||||
Total financial assets | 107,785 | 95,836 | ||||
Financial liabilities: | ||||||
At amortized cost | ||||||
Trade payables and accrued expenses | 99,483 | 77,556 | ||||
Lease liabilities | 5,479 | 1,624 | ||||
Other liabilities | 7,887 | 19,457 | ||||
Convertible notes | 99,986 | 96,856 | ||||
Long term loan | 85,835 | 81,610 | ||||
Contingent value rights | 53,911 | 49,413 | ||||
At fair value | ||||||
Contingent consideration | 63,880 | 53,048 | ||||
Total financial liabilities | 416,461 | 379,564 | ||||
Net | (308,676 | ) | (283,728 | ) |
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
Impact of key unobservable input data:
• An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of
• A 5% increase in the discount factor used would result in a decrease to the fair value of
• A six-month delay in the launch date for FILSUVEZ® for EB would result in a decrease to the fair value of
15. Restatement of prior year comparatives
As described in Note 5, Business combinations and asset acquisitions, the fair values of the assets and liabilities of the Aegerion Group were finalized in
As previously reported | Adjustments | Note | As restated | |||||||
US$’000 | ||||||||||
Assets | ||||||||||
Non-current assets | ||||||||||
Goodwill | 30,813 | (6,727 | ) | 15a | 24,086 | |||||
Intangible assets - net | 350,953 | (8,626 | ) | 15b | 342,327 | |||||
Property, plant and equipment | 3,036 | — | 3,036 | |||||||
Other non-current assets | 2,306 | (433 | ) | 15c | 1,873 | |||||
Total non-current assets | 387,108 | (15,786 | ) | 371,322 | ||||||
Current assets | ||||||||||
Trade and other receivables | 36,387 | (887 | ) | 15c | 35,500 | |||||
Inventories | 43,623 | 14,377 | 15d | 58,000 | ||||||
Cash and cash equivalents, including restricted cash | 67,229 | — | 67,229 | |||||||
Total current assets | 147,239 | 13,490 | 160,729 | |||||||
Total assets | 534,347 | (2,296 | ) | 532,051 | ||||||
Equity and liabilities | ||||||||||
Equity attributable to owners of the parent | ||||||||||
Share capital | 11,918 | — | 11,918 | |||||||
Share premium | 2,422 | — | 2,422 | |||||||
Other reserves | 248,656 | (26 | ) | 248,630 | ||||||
Accumulated deficit | (133,674 | ) | 2,537 | (131,137 | ) | |||||
Total equity | 129,322 | 2,511 | 131,833 | |||||||
Non-current liabilities | ||||||||||
Contingent consideration and contingent value rights | 102,461 | — | 102,461 | |||||||
Deferred tax liability | 18,921 | (6,819 | ) | 15e | 12,102 | |||||
Long term loan | 81,610 | — | 81,610 | |||||||
Convertible notes | 96,856 | — | 96,856 | |||||||
Provisions and other liabilities | 4,963 | — | 4,963 | |||||||
Total non-current liabilities | 304,811 | (6,819 | ) | 297,992 | ||||||
Current liabilities | ||||||||||
Trade and other payables | 76,596 | 1,755 | 15c | 78,351 | ||||||
Provisions and other liabilities | 23,618 | 257 | 15c | 23,875 | ||||||
Total current liabilities | 100,214 | 2,012 | 102,226 | |||||||
Total liabilities | 405,025 | (4,807 | ) | 400,218 | ||||||
Total equity and liabilities | 534,347 | (2,296 | ) | 532,051 |
The above adjustments to the statement of financial position relate to the completion of the fair value assignment to identifiable assets and liabilities acquired as part of the Aegerion acquisition, the following adjustments have been reflected in the condensed consolidated financial statements:
- The adjustments to goodwill are a consequence of the fair value adjustments described in more detail below, which primarily relate to the measurement of intangible assets, valuation of inventory and associated deferred tax liabilities.
- The fair value of intangible assets acquired, consisting of developed technology for metreleptin and lomitapide, was adjusted as a consequence of the detailed review and update to the expected future usage of inventory, the valuation of which was a factor in determining the fair value of acquired developed technology. See more detail on the update to the inventory valuation below.
- Accruals, provisions, and prepayments as at the acquisition date were reviewed during the twelve months following the acquisition and the fair values as at the acquisition date were updated based on the results of a review of the conditions that existed at this date.
- Fair value of inventory recognized at the date of acquisition was updated to reflect the results of detailed reviews of both raw material and finished good acquired. This involved a review the expected timing of transition from usage of acquired finished goods to usage of new inventory, including the review of expected timing of manufacture runs and the review of expected inventory usage. Additionally, a review was conducted on the demand and production that would be saleable in the future. The review resulted in a change in the assumptions and estimates regarding the usage of acquired inventory, leading to an increase in the estimated usage of acquired inventory and consequently resulting in an increase in the fair value of acquired inventory.
- Deferred tax was updated to reflect the above changes to the fair value of the inventory and of intangible assets. In addition, deferred tax was updated to reflect the results of a review of the historic tax basis of US intangible assets included in the Aegerion acquisition. This review identified that the tax basis of the asset in question was understated at the time of the acquisition. The closing deferred tax liability as of
December 31, 2019 was adjusted for the correct tax basis.
As noted above, IFRS 3 requires fair value adjustments to be recorded as if the accounting for the business combination had been completed at the acquisition date. Consequently, the comparative information for prior periods presented in financial statements were revised, including changes in inventory fair value step-up amortization, intangible amortization and deferred tax effects recognized in completing the acquisition accounting. The impact on the income statement of the fair value adjustments for the year ended
Year ended | |||||||||||||||
As previously reported | Adjustments* | Note | As restated | ||||||||||||
US$’000 | |||||||||||||||
Revenue | 58,124 | 58,124 | |||||||||||||
Cost of sales | (42,001 | ) | 3,268 | 15f | (38,733 | ) | |||||||||
Gross profit | 16,123 | 3,268 | 19,391 | ||||||||||||
Research and development expenses | (15,827 | ) | (15,827 | ) | |||||||||||
Selling, general and administrative expenses | (35,498 | ) | (35,498 | ) | |||||||||||
Restructuring and acquisition costs | (13,038 | ) | (13,038 | ) | |||||||||||
Share based payment expenses | (841 | ) | (841 | ) | |||||||||||
Impairment charge | (4,670 | ) | (4,670 | ) | |||||||||||
Operating loss before finance expense | (53,751 | ) | 3,268 | (50,483 | ) | ||||||||||
Non-cash change in fair value of contingent consideration | (6,740 | ) | (6,740 | ) | |||||||||||
Non-cash contingent value rights finance expense | (1,511 | ) | (1,511 | ) | |||||||||||
Net finance expense – other | (4,759 | ) | (4,759 | ) | |||||||||||
Loss on ordinary activities before taxation | (66,761 | ) | 3,268 | (63,493 | ) | ||||||||||
Tax credit/(charge) on loss on ordinary activities | 1,226 | (731 | ) | 15g | 495 | ||||||||||
Loss for the year attributable to the equity holders of the Company | (65,535 | ) | 2,537 | (62,998 | ) | ||||||||||
Exchange translation differences which may be reclassified through profit or loss | 781 | (26 | ) | 755 | |||||||||||
Total other comprehensive profit/(loss) | 781 | (26 | ) | 755 | |||||||||||
Total comprehensive loss for the year attributable to the equity holders of the Company | (64,754 | ) | 2,511 | (62,243 | ) | ||||||||||
Loss per share | |||||||||||||||
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) | (0.86 | ) | (0.83 | ) |
The above adjustments relate to the impact on the statement of comprehensive loss as result of the fair value adjustments following the completion of the fair value assignment to identifiable assets and liabilities acquired as part of the Aegerion acquisition.
Non-cash adjustments to the statement of comprehensive loss:
- Cost of sales has been adjusted for the impact on the non-cash amortization of inventory fair value step-up and acquired intangibles, for the period from the date of acquisition to the year end, as a result of the update to acquired inventory and intangible fair values following the finalization of acquisition accounting for the Aegerion acquisition. See Note 15b and 15d, above, for further detail on the fair value adjustments to acquired inventory and intangible.
- As a result of a change in the measurement of the deferred tax liability at the acquisition date, there was a non-cash adjustment to the tax charge for the period from the date of acquisition to the year end.
16. Events after the reporting period
COVID-19
Since a novel strain of coronavirus (SARS-CoV-2) causing a disease referred to as COVID-19 was first reported in
In response to the spread of COVID-19, Amryt has closed its executive offices with its administrative employees continuing their work outside of our offices and limited the number of staff in Amryt’s manufacturing facility in Germany. Amryt provides therapeutic products to HoFH and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) is prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient.
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Quick facts: Amryt Pharma PLC
Price: 191.5
Market: AIM
Market Cap: £342.41 m
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