424B3 1 f424b3_030421.htm 424B3

 

Prospectus Supplement No. 1
(to Prospectuses dated January 14, 2021 and July 8, 2020)

Filed Pursuant to Rule 424(b)(3)

Registration Nos. 333-251985 and 333-239395

 

 

American Depositary Shares

 

 

Representing Shares of Common Stock

 

This prospectus supplement updates and supplements the prospectuses dated January 14, 2021 and July 8, 2020 (the “Prospectuses”), which form a part of our Registration Statements on Form F-1 (Registration Nos. 333-251985 and 333-239395, respectively) (the “Registration Statements”). This prospectus supplement is being filed to update and supplement the information in the Prospectuses with the information contained in our Current Report on Form 6-K, filed with the Securities and Exchange Commission (the “Commission”) on March 4, 2021 (the “Current Report”). Accordingly, we have attached the Current Report to this prospectus supplement.

 

This prospectus supplement should be read in conjunction with the Prospectuses. This prospectus supplement updates and supplements the information in the Prospectuses. If there is any inconsistency between the information in either of the Prospectuses and this prospectus supplement, you should rely on the information in this prospectus supplement.

 

Our ADSs are listed on the Nasdaq Global Select Markets under the symbol “AMYT.” On March 3, 2021, the last reported sale price of our ADSs was $14.45 per ADS.

 

Investing in our ADSs involves a high degree of risk. See “Risk Factors” in each of the Prospectuses and under similar headings in any further amendments or supplements to the Prospectuses.

None of the Commission, any state securities commission, nor any foreign securities commission has approved or disapproved of these securities or determined if either of the Prospectuses or this prospectus supplement is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus supplement is March 4, 2021.

 

 

 

 

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934

For the month of March 2021

Commission File Number: 001-39365

Amryt Pharma plc
(Translation of registrant's name into English)

Dept 920a 196 High Road, Wood Green,
London, United Kingdom, N22 8HH

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):        

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):        

  

 

Exhibits

The following document, which is attached as an exhibit hereto, is incorporated by reference herein.

Exhibit   Title
     
99.1   Exhibit 99.1

 

  

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

        Amryt Pharma plc    
    (Registrant)
     
   
Date: March 4, 2021       /s/ Rory Nealon    
    Rory Nealon
    Chief Financial Officer
   

 

 

 

 

  

 

Exhibit 99.1

 

 

Amryt Announces Record FY 2020 Results

 

 

18.5% YoY revenue growth to $182.6M1

 

25% YoY revenue growth in metreleptin and 10% YoY revenue growth in lomitapide1

 

4th consecutive quarter of positive cash flow generation

 

Cash of $118.8M at December 31, 2020

 

Positive results reported from EASE pivotal Phase 3 study in Epidermolysis Bullosa

 

Regulatory submissions for Oleogel-S102 (Filsuvez®) on track for Q1 2021

 

Issuing FY 2021 Revenue Guidance of $200M to $205M

 

Conference call and webcast today at 0830 EST / 1330 GMT

 

DUBLIN, Ireland, and Boston MA, March 4, 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 Q4 2020 and the full year ended December 31, 2020.

 

Joe Wiley, CEO of Amryt Pharma, commented: “I am very pleased with today’s strong results for 2020 which demonstrate the very positive performance and growth that our commercial products are delivering, coupled with the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates. Our business continues to perform and grow strongly. In particular, our revenue growth exceeded expectations and the fact that we turned EBITDA profitable has translated into a significant increase in our cash balances. Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY 2021 of $200-$205 million which demonstrates our confidence in Amryt’s prospects.

 

Our EASE study investigating Oleogel-S10 in EB was the first ever Phase 3 study to demonstrate positive results in this devastating disease and we are currently progressing regulatory submissions with the relevant authorities in both the US and Europe.

 

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 we will be able to leverage these capabilities to launch Oleogel-S10, if approved.

 

2020 was a challenging year for us all as a result of the global pandemic but our business model proved resilient and capable of overcoming the challenges the pandemic presented. On a personal note, I would like to thank all of our team, patients, clinical partners and shareholders for their support as we navigated through the past year and completed our merger integration ahead of schedule. I have been truly humbled by the team spirit demonstrated by my Amryt colleagues throughout the period and we and our business have emerged stronger from the experience.”

 

 

 

 

 

FY 2020 & Recent Commercial Highlights:

· 18.5% growth in FY 2020 revenues to $182.6M (2019: $154.1M1)
   
· Operating loss before finance expense for the FY 2020 of $46.5M (2019: $50.5M). Excluding non-cash items and share based compensation expenses, this resulted in EBITDA3 of $30.4M
   
· Strong cash generation during 2020 with $26.9M of cash generated from operating activities, of which $5.8M was generated in Q4 2020. Excluding the legacy Aegerion fines inherited by Amryt, total cash generated from operating activities in 2020 was $42.6M.
   
· Cash of $118.8M at December 31, 2020 (2019: $67.2M)
   
· Amryt listed on the Nasdaq Global Select Market (“Nasdaq”) in July 2020
   
· $40M raised through private placement with leading biotech investors in December 2020
   
· In October, Amryt signed a distribution agreement for Lojuxta® (lomitapide) with Swixx BioPharma AG across 17 jurisdictions in CEE. This follows on from Amryt’s appointment in June 2020 of Swixx as exclusive distributor of Myalepta® (metreleptin) across the CEE territories.
   
· In December, Amryt received Ministry of Health reimbursement approval for Lojuxta® in Saudi Arabia
   

Pipeline and Regulatory:

· Announced positive results from EASE pivotal Phase 3 trial in epidermolysis bullosa (“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 Oleogel-S10 vs control gel (p-value = 0.013) representing a 44% increase in target wound closure with Oleogel-S10 vs the control gel.
   
· The Recessive Dystrophic EB (“RDEB”) sub-group experienced a greater benefit when treated with Oleogel-S10 than the overall population (nominal p-value =0.008) representing a 72% increase in target wound closure with Oleogel-S10 vs the control gel. Favourable trends were evident among secondary endpoints including change in procedural pain, total body wound burden based on EBDASI score and affected body surface area percentage. Oleogel-S10 had an acceptable safety profile and was well tolerated when compared with control gel.
   
· EASE trial data were presented as a late-breaking abstract at the 29th EADV (European Association of Dermatology and Venereology) Virtual Congress 2020
   
· In September, the EMA Committee for Orphan Medicinal Products (“COMP”) adopted a positive opinion for orphan designation for the use of AP103 in EB. In December, the FDA also granted Orphan Drug Designation for AP103.
   
· In December, Amryt received Marketing Authorisation Approval for Lojuxta® in Brazil

 

Q4 & FY 2020 Financial Performance:

· 18.5% YoY growth in FY 2020 revenues to $182.6M (2019: $154.1M1)
   
· 5.5% revenue growth in Q4 2020 to $42.5M (Q4 2019: $40.3M)
   
· 25% increase in metreleptin revenues to $106.9M in FY 2020 (2019: $85.4M1)
   

 

· US accounted for 57% of global metreleptin revenues and EMEA accounted for 30% in FY 2020
   
· Metreleptin revenues in Q4 were $22.2M (Q3 2020: $29.9M). Q3 2020 included a $6.9M LATAM order. As previously disclosed, ordering patterns in LATAM can be sporadic in nature.
   
· 10% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $74.8M in FY 2020 (2019: $68.0M 1).
   
· US accounted for 50% of global lomitapide revenues and EMEA accounted for 35% in FY 2020 with EMEA delivering 38% growth YoY

 

 2 

 

 

· Lomitapide revenues in Q4 were $20.2M (Q3 2020: $19.1M)

 

 

  1 Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on 1 January 2019. It also (i) excludes revenues from sales to end-users in Japan following the out-licencing of Juxtapid to Recordati in February 2019, (ii) excludes up-front payments from Recordati in 2019, and (iii) includes a 22.5% royalty on Japanese sales of Juxtapid from 1 January 2019 as if the Recordati agreement was in place from that date.
  2 For the purposes of this announcement, we use the name Oleogel-S10. 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 Q4 2020 results:

 

US$M

Q4 2019

(unaudited)

as restated6

Q4 2020

(unaudited)

Q4 2020

Non-cash adjustments4

Q4 2020 Non-GAAP Adjusted FY 2020 (unaudited)

FY 2020

Non-cash adjustments5

FY 2020 Non-GAAP Adjusted
Revenue 40.3 42.5 - 42.5 182.6 - 182.6
Gross profit 8.4 12.6 17.3 29.9 63.6 70.6 134.2
R&D (8.2) (5.1) - (5.1) (27.6) - (27.6)
SG&A (24.2) (19.8) 0.4 (19.4) (76.7) 1.5 (75.2)
Acquisition & severance related costs (1.7) - - - (1.0) - (1.0)
Share based compensation expenses (0.5) (1.6) 1.6 - (4.7) 4.7 -
Operating (loss) / profit before finance expense (26.2) (13.9) 19.3

5.43

 

(46.4) 76.8 30.43

 

The Q4 2020 operating loss of $13.9M 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 $5.4M of EBITDA3 for Q4 2020 and $30.4M in FY 2020.

 

  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 ($10.7M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($6.6M), depreciation and amortisation ($0.4M) and share based compensation expenses ($1.6M).

 

  5 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($43.0M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($27.6M), depreciation and amortisation ($1.5M) and share based compensation expenses ($4.7M).

 

  6 See Note 15 in financial statements below.

  

 3 

 

 

 

 

Financial Position:

Cash generated from operating activities in 2020 was $26.9M, of which $5.8M was generated in Q4 2020 (Q3 2020: $11.4M). During the quarter, the Company paid $4.6M in net finance payments, $3.9M in residual payments related to legacy fines levied on Aegerion and $2.1M in capital expenditure. The legacy fines were fully discharged in Q1 2021. At December 31, 2020, the Company had cash of $118.8M (unaudited) as compared to $67.2M at December 31, 2019.

 

Post-Year End Events:

 

  · Issuing full year 2021 revenue guidance of $200M - $205M, representing a 9-12% increase on 2020
     
  · In January 2021, Amryt received reimbursement approval from NICE for Myalepta®(metreleptin) in England and Wales
     
  · In February 2021, Amryt and Medison Pharma signed multi-regional distribution agreements in Israel and Canada
     

 

Conference Call & Webcast:

Amryt will host a call and webcast for analysts and investors on March 4 at 0830 EST/1330 GMT.

 

Webcast Player URL: https://edge.media-server.com/mmc/p/ntt3nmv3

 

Telephone Dial in details:

United States +1 646 787 1226
United Kingdom +44 (0) 203 009 5709
Ireland +353 (1) 506 0626
   
Confirmation Code 7749400

 

A playback facility will be available from March 4, 2021 at 1830 GMT - March 11, 2021 at 1830 GMT. Access details for the playback facility are as follows: Confirmation Code: 7749400 | US: + 1 917 677 7532 | UK: +44 (0) 3333 00 9785 | Ireland : +353 (1) 553 8777.

 

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, Columbia, 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.

 

 4 

 

 

Amryt's lead development candidate, Filsuvez® (Oleogel-S10) 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. Davy (John Frain, Daragh O’Reilly) act as Joint Broker to the company.

 

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, fennell@consilium-comms.com

 

 5 

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Comprehensive Loss

       

Three Months Ended

December 31,

 

Year Ended

December 31,

    Note  

2020

(unaudited)

 

2019

(unaudited)

 

2020

(unaudited)

 

2019

(unaudited)

restated*

          US$’000       US$’000       US$’000       US$’000  
Revenue   3     42,522       40,296       182,607       58,124  
Cost of sales         (29,881 )     (31,902 )     (119,029 )     (38,733 )
Gross profit         12,641       8,394       63,578       19,391  
Research and development expenses         (5,137 )     (8,195 )     (27,618 )     (15,827 )
Selling, general and administrative expenses         (19,790 )     (19,552 )     (76,673 )     (35,498 )
Restructuring and acquisition costs   5     (12 )     (1,676 )     (1,017 )     (13,038 )
Share based payment expenses   4     (1,593 )     (522 )     (4,729 )     (841 )
Impairment charge               (4,670 )           (4,670 )
Operating loss before finance expense         (13,891 )     (26,221 )     (46,459 )     (50,483 )
Non-cash change in fair value of contingent consideration   5     (19,677 )     (1,441 )     (27,827 )     (6,740 )
Non-cash contingent value rights finance expense   5     (7,506 )     (1,511 )     (12,004 )     (1,511 )
Net finance expense - other         (4,077 )     (1,136 )     (19,569 )     (4,759 )
Loss on ordinary activities before taxation         (45,151 )     (30,309 )     (105,859 )     (63,493 )
Tax (credit)/charge on loss on ordinary activities         (1,839 )     588       1,332       495  
Loss for the year attributable to the equity holders of the Company         (46,990 )     (29,721 )     (104,527 )     (62,998 )
Exchange translation differences which may be reclassified through profit or loss         686       696       (2,164 )     755  
Total other comprehensive (loss)/income         686       696       (2,164 )     755  
Total comprehensive loss for the year attributable to the equity holders of the Company         (46,304 )     (29,025 )     (106,691 )     (62,243 )
                                     
Loss per share                                    
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)   6     (0.28 )     (0.19 )     (0.66 )     (0.83 )

* see Note 15

 

 

 

 6 

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Financial Position

        As at December 31,
    Note  

2020

(unaudited)

 

2019

(unaudited)

restated*

        US$’000   US$’000
Assets                    
Non-current assets                    
Goodwill   7     19,131       19,131  
Intangible assets   7     305,369       342,327  
Property, plant and equipment         7,574       3,036  
Other non-current assets         1,542       1,873  
Total non-current assets         333,616       366,367  
Current assets                    
Trade and other receivables   8     43,185       35,500  
Inventories         40,992       58,000  
Cash and cash equivalents, including restricted cash   9     118,798       67,229  
Total current assets         202,975       160,729  
Total assets         536,591       527,096  
                     
Equity and liabilities                    
Equity attributable to owners of the parent                    
Share capital   10     13,851       11,918  
Share premium   10     51,408       2,422  
Other reserves   10     236,488       248,630  
Accumulated deficit         (235,605 )     (131,137 )
Total equity         66,142       131,833  
Non-current liabilities                    
Contingent consideration and contingent value rights   5     148,323       102,461  
Deferred tax liability         6,612       7,147  
Long term loan   11     87,302       81,610  
Convertible notes   12     101,086       96,856  
Provisions and other liabilities   13     25,951       4,963  
Total non-current liabilities         369,274       293,037  
Current liabilities                    
Trade and other payables         90,236       78,351  
Provisions and other liabilities   13     10,939       23,875  
Total current liabilities         101,175       102,226  
Total liabilities         470,449       395,263  
Total equity and liabilities         536,591       527,096  

 

* see Note 15

 

 

 7 

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Cash Flows

        Year ended December 31,
    Note  

2020

(unaudited)

 

2019

(unaudited)

restated*

        US$’000   US$’000
Cash flows from operating activities                    
Loss on ordinary activities after taxation         (104,527 )     (62,998 )
Net finance expense - other         19,569       4,759  
Depreciation and amortization         44,465       12,281  
Amortization of inventory fair value step-up         27,617       7,473  
Loss on disposal of fixed assets         133       43  
Share based payment expenses   4     4,729       841  
Non-cash change in fair value of contingent consideration   5     27,827       6,740  
Non-cash contingent value rights finance expense   5     12,004       1,511  
Impairment of intangible asset               4,670  
Deferred taxation credit         (535 )     (934 )
Movements in working capital and other adjustments:                    
Change in trade and other receivables   8     (7,685 )     (4,732 )
Change in trade and other payables         8,909       (6,337 )
Change in provision and other liabilities   13     4,663       4,928  
Change in inventories         (10,609 )     (5,894 )
Change in non-current assets         331       177  
Net cash flow from (used in) operating activities         26,891       (37,472 )
                     
Cash flow from investing activities                    
Net cash received on acquisition of subsidiary               24,985  
Payments for property, plant and equipment         (1,503 )     (578 )
Payments for intangible assets         (963 )     (74 )
Deposit interest received         87       92  
Net cash flow (used in) from investing activities         (2,379 )     24,425  
                     
Cash flow from financing activities                    
Proceeds from issue of equity instruments, net of expenses   10     37,927       63,009  
Proceeds from long term debt borrowings, net of debt issue costs               31,176  
Repayment of long term debt               (21,990 )
Interest paid         (10,780 )     (6,253 )
Payment of leases         (1,119 )      
Net cash flow from financing activities         26,028       65,942  
                     
Exchange and other movements         1,029       3,108  
                     
Net change in cash and cash equivalents         51,569       56,003  
Cash and cash equivalents at beginning of the year         67,229       11,226  
Restricted cash at end of the year   9     223       2,032  
Cash at bank available on demand at end of the year   9     118,575       65,197  
Total cash and cash equivalents at end of the year   9     118,798       67,229  

* see Note 15

 

 8 

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Changes in Equity

For the year ended December 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, 2019         25,198       68,233                   6,473       42,627       (73,914 )                 (51 )     (72,263 )     (3,697 )
Loss for the year, as restated*                                                                     (62,998 )     (62,998 )
Foreign exchange translation reserve, as restated*                                                               755             755  
Total comprehensive loss, as restated*                                                               755       (62,998 )     (62,243 )
Transactions with owners                                                                                                    
Share consolidation   10     (21,262 )     21,262                                                              
Issue of shares in equity fund raise   10     533       7,467                                                             8,000  
Issue costs associated with equity fund raise   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 equity fund raise   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 )
Transfer to distributable reserves   10           (268,505 )                                         268,505                    
Treasury shares acquired in consideration for additional warrants   10                 7,534       (7,534 )                                                
Issue of shares in exchange for warrants   10     126       2,422       (2,548 )                                                      
Share based payment expense   4                             841                                           841  
Share based payment expense – Lapsed                                 (4,124 )                                   4,124        
Total transactions with owners         (13,280 )     (65,811 )     29,523       (7,534 )     (3,283 )                 29,210       217,634       7,190       4,124       197,773  
Balance at December 31, 2019 as restated*         11,918       2,422       29,523       (7,534 )     3,190       42,627       (73,914 )     29,210       217,634       7,894       (131,137 )     131,833  
Balance at January 1, 2020         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 year                                                                     (104,527 )     (104,527 )
Foreign exchange translation reserve                                                               (2,164 )           (2,164 )
Total comprehensive loss                                                               (2,164 )     (104,527 )     (106,691 )
Transactions with owners                                                                                                    
Issue of shares in exchange for warrants   10     630       14,131       (14,761 )                                                      
Issue of shares in equity fund raise   10     1,303       38,697                                                             40,000  
Issue costs associated with equity fund raise   10           (3,848 )                                                           (3,848 )
Issue of treasury shares for share options exercised   10           6             113                                                 119  
Share based payment expense   4                             4,729                                           4,729  
Share based payment expense – Lapsed                                 (59 )                                   59        
Total transactions with owners         1,933       48,986       (14,761 )     113       4,670                                     59       41,000  
Balance at December 31, 2020         13,851       51,408       14,762       (7,421 )     7,860       42,627       (73,914 )     29,210       217,634       5,730       (235,605 )     66,142  

* see Note 15

 

 9 

 

 

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 Oleogel-S10 trademark in other key jurisdictions.

 

On July 8, 2020, Amryt listed on the NASDAQ Global Select Market under the symbol AMYT. The Company has not issued any new securities in connection with this filing. 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, 2019. 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, 2019 and those which are expected to be used in the financial statements for the year ended December 31, 2020.

 

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.

 

 10 

 

 

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 year ended December 31, 2020.

 

A key consideration for the Directors in assessing the going concern assumption is the continuing impact of the acquisition of Aegerion, which was completed in September 2019. This acquisition represents a significant step forward for Amryt and has created value for Amryt with immediate effect post-deal close through enhanced scale of the combined Group. The integration of Aegerion into the Amryt Group has been successful as demonstrated by growth in revenues and cost reductions. This success demonstrates the potential to continue to drive revenues and deliver operational synergies through a combination of medical, commercial, clinical, development and regulatory infrastructure. Additionally, Amryt completed a private placement of 3,200,000 American Depositary Shares (“ADSs”) yielding gross proceeds of US$40,000,000. In the prior year Amryt also completed a US$60,000,000 fundraising as part of the acquisition of Aegerion.

 

Basis of consolidation

 

The condensed consolidated interim financial statements comprise the financial statements of the Group for the year ended December 31, 2020. 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 three-month period to December 31, 2020 (unaudited)     0.8391       0.7578       0.9043       8.6208       9.0381       6.2461  
Average 12-month period to December 31, 2020 (unaudited)     0.8777       0.7799       0.9391       9.2135       9.4206       6.5432  
At December 31, 2020     0.8141       0.7365       0.8829       8.1885       8.5671       6.0570  

 

Foreign currency units to 1 US$           £       CHF       SEK       NOK       DKK  
Average three-month period to December 31, 2019 (unaudited)     0.9034       0.7773       0.9903       9.6157       9.1073       6.7494  
Average 12-month period to     December 31, 2019 (audited)     0.8932       0.7836       0.9938       9.4533       8.7976       6.6690  
At December 31, 2019 (audited)     0.8929       0.7624       0.971       9.3282       8.8046       6.6698  

 

(€ = Euro; £ = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish Kroner, NOK = Norwegian Kroner, DKK = Danish Kroner)

 

 

 11 

 

 

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

 

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, 2019 other than for those applied in finalizing the acquisition accounting for the Aegerion acquisition (see Note 5, Business combinations and asset acquisitions).

 

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, 2019.

 

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. Revenues represent the revenue from the Group for the full year (the prior year revenues include revenue from Aegerion, with acquired products and additional regions, from September 24, 2019 onward).

 

    Three months ended December 31, 2020 (unaudited)
    U.S.   EMEA   Other   Total
    US$’000   US$’000   US$’000   US$’000
Metreleptin     15,111       6,261       796       22,168  
Lomitapide     9,270       7,461       3,433       20,164  
Other           190             190  
Total revenue     24,381       13,912       4,229       42,522  

 

 12 

 

 

 

 

    Three months ended December 31, 2019 (unaudited)
    U.S.   EMEA   Other   Total
    US$’000   US$’000   US$’000   US$’000
Metreleptin     13,908       7,354       2,061       23,323  
Lomitapide     9,297       4,949       2,416       16,662  
Other           206       105       311  
Total revenue     23,205       12,509       4,582       40,296  

 

    Year ended December 31, 2020 (unaudited)
    U.S.   EMEA   Other   Total
    US$’000   US$’000   US$’000   US$’000
Metreleptin     60,568       32,494       13,810       106,872  
Lomitapide     37,317       26,144       11,289       74,750  
Other           763       222       985  
Total revenue     97,885       59,401       25,321       182,607  

 

    Year ended December 31, 2019 (audited)
    U.S.   EMEA   Other   Total
    US$’000   US$’000   US$’000   US$’000
Metreleptin     14,944       8,048       2,096       25,088  
Lomitapide     10,616       18,985       2,659       32,260  
Other           671       105       776  
Total revenue     25,560       27,704       4,860       58,124  

 

Major Customers

 

For the three months and year ended December 31, 2020, one customer accounted for 57% and 54%, respectively, of the Group’s net revenues (2019: 58% and 44%, respectively) and accounted for 42% of the Group’s December 31, 2020 accounts receivable balance (2019: 44%).

 

4. Share based payments

 

On July 10, 2019, the shareholders of the Company approved a resolution to give authority to the Company to undertake a consolidation of the existing ordinary shares in the capital of the Company under which every six existing ordinary shares were consolidated into one ordinary share.

 

Under the terms of the Company’s Employee Share Option Plan, options to purchase 18,753,648 shares were outstanding at December 31, 2020. 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 4,432,000 share options were granted to non-executive directors and employees in the year ended December 31, 2020. For the year ended December 31, 2019, a total of 11,330,641 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.

 

 13 

 

 

Outstanding warrants at December 31, 2020 consisted of 8,966,520 zero cost warrants (December 31, 2019: 17,196,273) with no expiration date that were issued to Aegerion creditors in connection with the acquisition of Aegerion. The remaining warrants consisting of 345,542 warrants (December 31, 2019: 345,542) were issued in connection with the admission to the AIM in 2016.

 

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 2019 (pre share consolidation)     19,505,131       19.20 p     22,909,951       24.00 p
Balance at 1 January 2019 (restated for 6:1 share
consolidation)
    3,250,855       115.20 p     3,818,325       144.00 p
Granted     11,330,641       117.01 p     18,841,378        
Lapsed     (99,776 )     197.66 p     (3,472,783 )     144.00 p
Exercised                 (1,645,105 )      
Outstanding at 31 December 2019 (audited)     14,481,720       116.00 p     17,541,815       0.03 p
Exercisable at 31 December 2019 (audited)     2,468,310       109.08 p     17,541,815       0.03 p
                                 
Balance at 1 January 2020     14,481,720       116.00 p     17,541,815       0.03 p
Granted     4,432,000       144.76 p            
Lapsed     (87,119 )     113.42 p            
Exercised     (72,953 )     120.72 p     (8,229,753 )      
Outstanding at 31 December 2020 (unaudited)     18,753,648       122.79 p     9,312,062       0.05 p
Exercisable at 31 December 2020 (unaudited)     5,866,152       114.24 p     9,312,062       0.05 p

 

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 year:

 

    December 31, 2020 Options Inputs   December 31, 2020 Warrant Inputs   December 31, 2019 Options Inputs   December 31, 2019 Warrant Inputs
Days to Expiration     2,555             2,555        
Volatility     33% - 37%             27% - 48%        
Risk free interest rate     0.39% - 0.46%             0.38% - 0.83%        
Share price at grant     123.5p – 178.9p             75.84p – 121.5p        

 

In the year ended December 31, 2020, a total of 4,432,000 share options exercisable at a weighted average price of £1.4476 were granted. The fair value of share options granted in the year ended December 31, 2020 was £6,416,000/US$8,230,000. In 2019, a total of 11,330,641 share options exercisable at a weighted average price of £1.17 were granted. The fair value of share options granted in 2019 were £13,258,000/US$16,919,000.

 

The share options outstanding as at December, 2020 have a weighted remaining contractual life of 5.45 years with exercise prices ranging from £0.76 to £1.79. The share options outstanding as at December 31, 2019 had a weighted remaining contractual life of 6.19 years with exercise prices ranging from £0.76 to £1.50.

 

The 2016 warrants outstanding as at December 31, 2020 have a weighted remaining contractual life of 0.3 years with an exercise price of £1.44. The warrants outstanding as at December 31, 2019 had a weighted remaining contractual life of 1.3 years with an exercise price of £1.44.

 

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 December 31, 2020. 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 year ended December 31, 2020, a total of 1,556,960 RSUs were granted to employees of the company. For the year ended December 31, 2019, no RSUs were granted to employees. 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 year ended December 31, 2020 was US$2,609,000 and have a weighted remaining contractual life of 2.59 years. The following table summarises the RSU activity for the year:

 

 14 

 

 

    RSUs
    Unit   Weighted average fair value (US$)
Balance at January 1, 2020            
Granted     1,556,960     $ 11.68  
Lapsed     (7,050 )   $ 11.61  
Exercised            
Outstanding at December 31, 2020     1,549,910     $ 11.68  

 

The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the quarter and the year is as follows:

 

   

Three months ended

December 31,

 

Year ended

December 31,

   

2020

(unaudited)

 

2019

(unaudited)

 

2020

(unaudited)

 

2019

(audited)

      US$’000       US$’000       US$’000       US$’000  
Share option expense     1,224       522       4,134       841  
RSU expense     369             595        
Total share option expense     1,593       522       4,729       841  

 

5. Business combinations and asset acquisitions

 

Acquisition of Aegerion Pharmaceuticals

On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000.

 

The Company believes that the acquisition of Aegerion will enable the Group to advance the Group’s ambition to create a global leader in rare and orphan diseases with a diversified offering of multiple development-stage and commercial assets and provides it with scale to support further growth.

 

As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant.

 

Relevant Aegerion creditors are entitled at any time to exercise the zero cost warrants, at which point in time, the Company would issue to that Aegerion creditor the relevant number of fully paid ordinary shares in return for the exercise of the zero cost warrants. Each zero cost warrant entitles the holder thereof to subscribe for one ordinary share. The zero cost warrants constitute the Company’s direct and unsecured obligations and rank pari passu and without any preference among themselves (save for any obligations to be preferred by law) at least equally with the Company’s other present and future unsecured and unsubordinated obligations. The zero cost warrants are not transferable except with the Company’s prior written consent.

 

On November 14, 2019, the Company repurchased a combined 4,864,656 ordinary shares from Highbridge Tactical Master Fund L.P., Highbridge SCF Special Situations SPV, L.P. and Nineteen77 Global Multi Strategy Alpha Master Limited. In exchange for the ordinary shares, these institutions were issued an equivalent number of zero cost warrants.

 

During the three months and year ended December 31, 2020, the Group incurred acquisition and restructuring related costs of US$12,000 and US$1,017,000, respectively (2019: US$1,676,000 and US$13,038,000, respectively) relating to external legal fees, advisory fees, due diligence costs and severance costs. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive loss.

 

 15 

 

 

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 performed on a provisional basis and included in the consolidated financial statement for the year ended December 31, 2019 and subsequent consolidated interim financial statements due to the relative size of the acquisition and the timing of the transaction. The Group finalized the fair values of the assets and liabilities of Aegerion in 2020. The adjustments made in finalizing fair values primarily relate to the measurement of intangible assets separately from goodwill, valuation of inventory and associated deferred tax liabilities. 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.

 

   

As at September 24, 2019

(unaudited)

    As previously reported in December 31, 2019 financial statements   Adjustments*   Fair value, as restated
    US$’000   US$’000   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       (12,507 )     1,918  
Total non-current liabilities     202,253       (12,507 )     189,746  
Total liabilities     286,778       (10,514 )     276,264  
                         
Total identifiable net assets at fair value     121,802       11,682       133,484  
Goodwill arising on acquisition     30,813       (11,682 )     19,131  
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.

 

 16 

 

 

Contingent Value Rights

 

Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero.

 

The terms of the CVRs are as follows:

 

  · The total CVR payable is up to US$85,000,000
  · This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset)
  · FDA approval
  o US$35,000,000 upon FDA approval
  o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022
     
  · EMA approval
  o US$15,000,000 upon EMA approval
  o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022
     
  · Revenue targets
  o US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024
     
  · Payment can at the Board’s discretion be in the form of either:
  o 120-day loan notes (effectively cash), or
  o 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 December 31, 2020, the carrying value of the CVRs was US$61,417,000 (2019: US$49,413,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs, was increased to 89% in 2020 (2019: 72%) following the positive results from our phase 3 EASE trial of Oleogel-S10 earlier in the year. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2020 (2019: 10% and 16.5%). Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs.

 

Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge is booked in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive top-line data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The Group expects this to be followed by applications for approval from the FDA and the EMA.

 

 17 

 

 

The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months and year ended December 31, 2020 is US$7,506,000 and US$12,004,000, respectively (2019: US$1,511,000 and US$1,511,000, respectively).

 

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:
  o €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016);
  o 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;
  o €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;
  o €10,000,000 once net ex-factory sales/net revenue first exceed €50,000,000 in any calendar year;
  o €15,000,000 once net ex-factory sales/ net revenue 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 December 31, 2020, the fair value of the contingent consideration was estimated to be US$86,906,000 (2019: US$53,048,000). The fair value of the royalty payments was determined using probability weighted revenue forecasts and the fair value of the milestone payments was determined using probability adjusted present values (see Note 14, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs, was increased to 89% in 2020 (2019: 72%) following the positive results from our phase 3 EASE trial of Oleogel-S10 earlier in the year. A discount rate of 14.4% (2019: 24.4%) was used in the calculation of the fair value of the contingent consideration for the year ended December 31, 2020. The decrease in the discount rate is mainly driven by the significant change in Group over the last 12 months where the Group has significantly de-risked with growth in commercial revenues, positive top-line data on the phase 3 EASE trial of Oleogel-S10, increasing cash balances during the year, increasing share price and additional equity fund raises during the year.

 

The Group received positive top line results from the phase 3 EASE trial of Oleogel-S10 in September 2020, and the Group expects this to be followed by applications for approval from the FDA and the EMA. These factors have resulted in a change to the probability weighted revenue forecasts and the probability of the adjusted present values which are used in the calculation of the contingent consideration balance and impact the amount being unwound to the Condensed Consolidated Statement of Comprehensive Loss. Changes may have a material impact on the assessment of the fair value of the contingent consideration.

 

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 and year ended December 31, 2020 is US$19,677,000 and US$27,827,000, respectively (2019: US$1,441,000 and US$6,740,000, respectively).

 

 

 18 

 

 

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 December 31, 2020.

 

Issued share capital - ordinary shares of £0.06 each

      Number of shares       Weighted average shares  
December 31, 2020 (unaudited)     178,801,593       158,591,356  
December 31, 2019 (audited)     154,498,887       75,871,562  

 

The calculation of loss per share is based on the following:

    Three months ended December 31  

Year ended

December 31

    2020 (unaudited)  

2019

(unaudited)

  2020 (unaudited)  

2019

(unaudited)

restated*

Loss after tax attributable to equity holders of the Company (US$’000)     (46,990 )     (29,721 )     (104,527 )     (62,998 )
Weighted average number of ordinary shares in issue     166,974,713       155,216,888       158,591,356       75,871,562  
Fully diluted average number of ordinary shares in issue     166,974,713       155,216,888       158,591,356       75,871,562  
Basic and diluted loss per share (US$)     (0.28 )     (0.19 )     (0.66 )     (0.83 )

* see Note 15

 

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 December 31, 2020 totaled 28,065,710 (2019: 32,023,535) 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, 2019 (unaudited)                 60,091       258       60,349        
Additions                       74       74        
Acquired assets, as restated*     176,000       123,000             374       299,374       19,131  
Impairment charge                 (4,670 )           (4,670 )      
Foreign exchange movement                 (1,160 )     (5 )     (1,165 )      
At December 31, 2019, as restated* (unaudited)     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 (unaudited)     176,000       123,000       60,128       866       359,994       19,131  
                                                 
Accumulated amortization                                                
At January 1, 2019 (unaudited)                       52       52        
Amortization charge, as restated*     7,314       4,143             126       11,583        
At December 31, 2019, as restated* (unaudited)     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(unaudited)     34,743       19,680             202       54,625        
                                                 
Net book value                                                
At December 31, 2019, as restated* (unaudited)     168,686       118,857       54,261       523       342,327       19,131  
At December 31, 2020
(unaudited)
    141,257       103,320       60,128       664       305,369       19,131  

* see Note 15

 

 19 

 

 

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 5.2 and 6.7 years, respectively, as of December 31, 2020 (2019: 6.2 and 7.7 years, respectively). 

 

The amortization associated with metreleptin and lomitapide is recorded as part of cost of sales. As of December 31, 2020, the estimated amortization expense related to these intangibles for future periods is as follows:

    Metreleptin   Lomitapide
Years Ending December 31,   US$’000   US$’000
2021     27,429       15,537  
2022     27,429       15,537  
2023     27,429       15,537  
2024     27,429       15,537  
2025     27,429       15,537  
Thereafter     4,112       25,635  
      141,257       103,320  

 

In-process R&D

 

On October 12, 2020, Amryt acquired Cala Medical Limited (“Cala Medical”) for a consideration of US$723,000. As a result of the acquisition of Cala Medical the Group recognized in-process R&D costs of US$591,000 as an intangible asset. This is related to the Group’s development project AP104, which is an early-stage drug asset. Cala Medical is focused on the development of a therapeutic enzyme (ScpA) targeting a molecule in the complement pathway, C5a, that mediates immune responses and inflammation. Initial research efforts focused on the use of a modified form of ScpA as part of a medical device used to remove C5a from the circulation of patients suffering from sepsis. Amryt has redirected efforts towards the development of a pharmaceutical agent that may be administered locally or systemically to address multiple other disease areas of interest that may be favorably impacted by inhibition of C5a activity.

 

As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of US$54,268,000 which is related to the Group’s lead development asset, Oleogel-S10.

 

As a result of the acquisition of Som Therapeutics Corp., in 2016, the Group recognized in-process R&D costs of US$4,522,000 as an intangible. This is related to the Group’s development project AP102, which is an early-stage drug asset. AP102 may represent a novel, next generation somatostatin analogue (‘‘SSA’’) peptide medicine for patients with rare neuroendocrine diseases, where there is a high unmet medical need, including acromegaly. Acromegaly is a rare endocrine disorder in which the body produces excessive growth hormone, leading to abnormal growth throughout the body over time.

 

In 2019, following the acquisition of Aegerion by the Group, a decision was made not to pursue the development of AP102 and therefore, the Group wrote off this asset, resulting in an impairment charge of US$4,670,000 recognized as other expense during the year ended December 31, 2019. The decision to impair this intangible asset is primarily based on the grounds that the acquisition of Aegerion has been transformational for the Group, as it has now become 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’s diversified portfolio is comprised of two commercial rare disease products, as well as a development-stage pipeline focused on rare skin diseases. Since the commercial products, lomitapide for the treatment of homozygous familial hypercholesterolemia (‘‘HoFH’’), and metreleptin for the treatment of generalized lipodystrophy (‘‘GL’’) and partial lipodystrophy (‘‘PL’’), have each been sold globally through the Group’s commercial infrastructure for over six years, management believes it is in the best interest of the Group to concentrate resources on these new development pipeline activities which will better complement the existing commercial products. The Group may look to partner AP102 in the long-term future but in the short and medium term, the Group will continue to concentrate on Oleogel-S10, AP103 and expansion opportunities for the existing commercial products.

 

 20 

 

 

Other intangible assets

 

Other intangible assets include website costs and the Group’s computer software and hardware. The amortization associated with computer software, hardware and website costs is recorded in both SG&A and R&D expenses. These assets are stated at cost and amortized using the straight-line method based on the estimated economic lives, ranging from 3 - 10 years.

 

Goodwill

 

During 2019, the Group completed the acquisition of Aegerion, which resulted in aggregate goodwill of US$19,131,000, as restated (See Note 15, Restatement of prior year comparatives). Refer to Note 5, Business combinations and asset acquisitions, for further details. The Group believes that the business, as a whole, represents a single CGU, as it is the smallest identifiable group of assets that generates cash inflows that are largely independent of the cash inflows from other assets or groups of assets. Additionally, the Group only operates in one business segment and 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.

 

Impairment

 

The Group reviews the carrying amount of intangible assets on an annual basis or when there is a triggering event that may be an indication of possible impairment. The Group conducts an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of the asset is estimated in order to determine the extent of the impairment loss. Impairment indications include events causing significant changes in any of the underlying assumptions used in the income approach utilized in valuing intangible assets. The key assumptions are the probability of success; the discount factor; the timing of future revenue flows; market penetration and peak sales assumptions; and expenditures required to complete development.

 

These cash flows are projected forward to the year 2032 using projected revenue and cost growth to determine the basis for an annuity-based terminal values. The terminal values are used in the value in use calculation. The value in use represents the present value of the future cash flows, including the terminal value, discounted at a rate that is considered appropriate for the Group’s size and structure.

 

The key assumptions employed in arriving at the estimates of future cash flows are subjective and include projected EBITDA, an orphan drug market-based probability chance of success, net cash flows, discount rates and the duration of the discounted cash flow model. The assumptions and estimates used were derived from a combination of internal and external factors based on historical experience. The pre-tax discount rate used in 2020 and 2019 was 14.4% and 16.5%, respectively.

 

The value-in-use calculation is subject to significant estimation, uncertainty and accounting judgements and key sensitivities arise in the following areas:

 

 

· In the event that there was a variation of 10% in the assumed level of future growth in revenues, which would, in management’s view, represent a reasonably likely range of outcomes, this variation would not result in an impairment loss at December 31, 2020.
   
· In the event there was a 5% increase in the discount rate used in the value in use model which would in management’s view represent a reasonably likely range of outcomes, this variation would not result in an impairment loss at December 31, 2020.

 

Goodwill is subject to impairment testing on an annual basis. The recoverable amount of the Group’s CGU is determined based on a value-in-use computation. The Group’s value-in-use calculations included the cash flow projections based on the 2021 budget which has been approved by the Board of Directors and the Group’s strategic plan for a further three years using projected revenue growth rates of between 10% - 33% and cost growth rates of between -4% and 38%. At the end of the four-year forecast period, the terminal value, based on a long-term growth rate of 2%, was used in the value-in-use calculations. The value-in-use represents the present value of the future cash flows, including the terminal value, discounted at a rate appropriate to the Group. The key assumptions employed in arriving at the estimates of future cash flows are subjective and include projected EBITDA, net cash flows, discount rates and the duration of the discounted cash flow model. The Group have used a discount rate of 14.4% (2019: 16.5%) which we believe is a realistic estimate for the Group as well as the Group’s risk profile.

 

 21 

 

 

The 2020 annual impairment testing process resulted in no impairment for the year ended December 31, 2020 (2019: nil).

 

8. Trade and other receivables

 

    December 31,
   

2020

(unaudited)

 

2019

(unaudited)

restated*

    US$’000   US$’000
Trade receivables     33,057       28,607  
Accrued income and other debtors     8,423       5,493  
VAT recoverable     1,705       1,400  
Trade and other receivables     43,185       35,500  

* see Note 15

 

Trade receivables at December 31, 2020 includes US$1,186,000 (2019: US$752,000) which is due greater than 120 days. No impairment is considered necessary.

 

The December 31, 2020 accrued income and other debtors balance includes US$287,000 (2019: US$857,000) in relation to prepaid phase 3 clinical trial costs.

 

9. Cash and cash equivalents

 

    December 31,
   

2020

(unaudited)

 

2019

(audited)

    US$’000   US$’000
Cash at bank available on demand     118,575       65,197  
Restricted cash     223       2,032  
Total cash and cash equivalents     118,798       67,229  

 

Cash and cash equivalents include cash at bank available on demand and restricted cash.

 

At December 31, 2020 and December 31, 2019, there was US$223,000 and US$2,032,000 of restricted cash, respectively. The balance at December 31, 2020 includes a deposit on a company credit card facility for an amount of US$150,000 (December 31, 2019: US$150,000). Of the US$2,032,000 held in restricted cash at December 31, 2019, $1,069,000 was in an escrow account, which was set-up in accordance with Aegerion’s bankruptcy plan as approved by the U.S. Bankruptcy Court, and it was fully utilized to pay the costs associated with the bankruptcy process. Additionally, there was US$73,000 held by a third-party distributor at December 31, 2020 (December 31, 2019: US$813,000).

 

 

 22 

 

 

10. Share capital and reserves

 

Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2019: 6 pence) each are in the table below.

 

 

    Ordinary shares   Treasury shares   Deferred shares
   

2020

(unaudited)

 

2019

(audited)

 

2020

(unaudited)

 

2019

(audited)

 

2020

(unaudited)

 

2019

(audited)

At 1 January     154,498,887       274,817,283       4,864,656                   43,171,134  
Share consolidation in 2019           (229,014,401 )                       (43,171,134 )
Issue of shares in exchange for warrants     8,229,753       1,645,105                          
Issue of shares in equity fund raises     16,000,000       34,888,133                          
Issue of shares in consideration of Aegerion Acquisition           77,027,423                          
Issue of treasury shares for share options exercised     72,953             (72,953 )                  
Treasury shares acquired in consideration for additional warrants           (4,864,656 )           4,864,656              
At December 31     178,801,593       154,498,887       4,791,703       4,864,656              

 

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 December 31, 2020 of 183,593,296 (2019: 159,363,543), includes treasury shares of 4,791,703 (2019: 4,864,656).

 

In December 2020, the Company issued 3,200,000 American Deposit Shares (“ADSs”), each representing five ordinary shares, as part of a US$40,000,000 private placement equity raise to existing and new shareholders.

 

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.

 

On December 27, 2019, the Company issued 1,645,105 shares to certain shareholders in consideration of warrants.

 

On September 24, 2019, the following equity issuances were conducted:

 

· 77,027,423 ordinary shares and 8,065,000 warrants for a consideration of US$152,615,000 were issued as part of the Aegerion acquisition whereby the company acquired the entire share capital of Aegerion.
   
· 27,541,944 ordinary shares and 5,911,722 warrants were issued as part of a US$60,000,000 fund raising.

 

 

In an US$8,000,000 equity raise, the Company issued 7,346,189 ordinary shares, 4,580,288 shares in August 2019 and 2,765,901 shares in September 2019.

 

In July 2019, the Company repurchased all of the 43,171,134 Deferred Ordinary Shares for an aggregate consideration of £0.01 and the Deferred Shares were immediately cancelled. Simultaneously the Company allotted four additional ordinary shares of par value £0.01 each in the capital of the Company, in connection with a 6 to 1 consolidation of the Company’s share capital.

 

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.

 

 23 

 

 

 

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. On December 27, 2019, the company issued 1,645,105 ordinary shares in consideration for certain warrants.

 

Treasury Shares

On November 14, 2019, the Company repurchased a combined 4,864,656 ordinary shares from certain shareholders. In exchange for the ordinary shares, these shareholders were issued an equivalent number of zero cost warrants. These ordinary shares are now held as treasury shares. In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options.

 

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 April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve.

 

Reverse acquisition reserve

The reverse acquisition reserve arose during the period ended December 31, 2016 in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law.

 

Equity component of convertible notes

The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured.

 

Other distributable reserves

Other distributable reserves comprise the following:

 

 

· Distribution of the share premium amount on November 6, 2019 of US$268,505,000. By special resolution of the Company duly passed on September 23, 2019, in accordance with section 283 of the UK Companies Act 2006, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on November 5, 2019.
· 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 in September 2019 whereby Amryt Pharma plc, which was incorporated in July 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-U.S. dollar denominated foreign subsidiaries.

 

Accumulated deficit

Accumulated deficit represents losses accumulated in previous periods and the current year.

 

 24 

 

 

 

11. Long term loan

 

    December 31,
   

2020

(unaudited)

 

2019

(audited)

    US$’000   US$’000
Long term loan principal     88,037       82,456  
Unamortized debt issuance costs     (735 )     (846 )
Long term loan     87,302       81,610  

 

As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan is made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan has a five-year term from the date of the draw down, September 24, 2019 and matures on September 24, 2024. Under the Term Loan, interest will be payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that will be paid when the principal is repaid, which rolls up and is included in the principal balance outstanding, on a quarterly basis. Unpaid accrued interest of US$1,439,000 as at December 31, 2020 is recognized in current liabilities with trade and other payables (2019: nil). The Term Loan may be prepaid, in whole or in part, by Aegerion at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan.

 

In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are being amortized over the expected life of the loan using the effective interest method.

 

The Term Loan is guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group.

 

The Term Loan agreement includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Aegerion and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There have been no events of default or breaches of the covenants occurring for the year ended December 31, 2020 (2019: no events).

 

    Total
    US$’000
Changes in long term loans from financing activities:        
At January 1, 2020 (audited)     81,610  
Cash-flows        
Proceeds from loans and borrowings      
Repayment of loans and borrowings      
Liability related        
Paid in kind interest     5,585  
Amortization of debt costs     107  
Accrued interest     1,439  
At December 31, 2020 (unaudited)     88,741  

 

 

 25 

 

 

12. Convertible notes

 

    Total
    US$’000
At January 1, 2019      
Issuance of convertible notes     125,000  
Amount classified as equity     (29,210 )
Accreted interest     1,066  
At December 31, 2019 (audited)     96,856  
Accreted interest     4,230  
At December 31, 2020 (unaudited)     101,086  

 

As part of the acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors.

 

The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted.

 

The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Aegerion can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 10, Share capital and reserves, for further details on the equity component of the convertible notes.

 

From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder.

 

The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances.

 

The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Aegerion, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Aegerion and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Aegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the year ended December 31, 2020 (2019: no events).

 

 

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13. Provisions and other liabilities

    December 31,
   

2020

(unaudited)

 

2019

(unaudited)

restated*

    US$’000   US$’000
Non-current liabilities                
Provisions and other liabilities     21,382       3,910  
Leases due greater than 1 year     4,569       1,053  
      25,951       4,963  
Current liabilities                
Provisions and other liabilities     9,976       23,304  
Leases due less than 1 year     963       571  
      10,939       23,875  
Total provisions and other liabilities     36,890       28,838  

* see Note 15

 

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$19,108,000 of settlement payments, including interest. The settlements remaining to be paid are due for payment in Q1 2021 and the amount totaling US$3,976,000 is recognized in Other liabilities as a current liability (2019: US$15,547,000). There is no non-current liability at December 31, 2020 (2019: US$3,910,000).

 

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 December 31, 2020 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (2019 US$7,757,000, as restated, see Note 15, Restatement of prior year comparatives).

 

14. Fair value measurement and financial risk management

 

Categories of financial instruments

    December 31,
   

2020

(unaudited)

 

2019

(audited)

restated*

    US$’000   US$’000
Financial assets (all at amortized cost):                
Cash and cash equivalents     118,798       67,229  
Trade receivables     33,057       28,607  
Total financial assets     151,855       95,836  
                 
Financial liabilities:                
At amortized cost                
Trade payables and accrued expenses     89,300       77,555  
Lease liabilities     5,532       1,624  
Other liabilities     25,358       19,457  
Convertible notes     101,086       96,856  
Long term loan     87,302       81,610  
Contingent value rights     61,417       49,413  
At fair value                
Contingent consideration     86,906       53,048  
Total financial liabilities     456,901       379,563  
Net     (305,046 )     (283,727 )

* see Note 15

 

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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$86,906,000 as at December 31, 2020 (2019: US$53,048,000). 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$6,079,000. 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$15,656,000. A decrease of 5% would result in an increase to the fair value of US$20,965,000.
  · A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$8,667,000.

 

 

 

 

 

 

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15. Restatement of prior year comparatives

 

As described in Note 5, Business combinations and asset acquisitions, IFRS 3 requires fair value adjustments to be recorded with effect from the date of acquisition and consequently result in the restatement of previously reported financial results. The impact on the statement of financial position as at December 31, 2019 is shown below:

 

    As previously reported   Adjustments   Note   As restated
    US$’000   US$’000       US$’000
Assets                            
Non-current assets                            
Goodwill     30,813       (11,682 )   15a     19,131  
Intangible assets     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       (20,741 )         366,367  
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       (7,251 )         527,096  
                             
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       (11,774 )   15e     7,147  
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       (11,774 )         293,037  
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       (9,762 )         395,263  
Total equity and liabilities     534,347       (7,251 )         527,096  

 

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 interim financial statements:

  a) 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.
  b) 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.
  c) 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.

 

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  d) 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.
  e) 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 Condensed Consolidated Statement of Comprehensive Loss of the fair value adjustments for the year ended December 31, 2019 is shown below:

 

    As previously reported   Adjustments   Note   As restated
    US$’000   US$’000       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 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 income     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:

  f) 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.
  g) 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.

 

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16. Events after the reporting period

 

There were no significant events since the end of the reporting period.

 

 

 

 

 

 

 

 

31