Amryt Reports Record Q3 2020 Results

AMRYT REPORTS RECORD Q3 2020 RESULTS

19% YoY revenue growth in the quarter to $49.3M

Raising full year revenue guidance to $180M – $182M

Both metreleptin and lomitapide driving revenue performance and growth

Strong cash generation with cash of $75.4M at September 30

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

Conference call and webcast today at 0930 EST / 1430 GMT

DUBLIN, Ireland, and Boston MA, November 5, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases, today announces unaudited financial results and provides a business update for the third quarter ended September 30, 2020.

  • 19% YoY growth in unaudited Q3 revenues to $49.3M (Q3 2019 1 unaudited combined revenues: $41.4M) 

  • 23% YoY growth in unaudited cumulative YTD revenues to $140.1M (Nine months 2019 1 unaudited combined revenues: $113.6M) 

  • 7% QoQ revenue growth in Q3 versus Q2 ($46.2M)

  • Raising FY 2020 revenue guidance from $170M – $175M to $180M – $182M (2019 1 : $154.1m)

  • $3.6M operating loss before finance expense in Q3.  Excluding non-cash items and share based compensation expenses, this resulted in EBITDA 3 of $13.5M in Q3 representing 96% QoQ growth

  • Strong cash generation during the nine months to September 2020 with $21.1M of cash generated from operating activities YTD and $11.4M during the quarter

  • Increase in cash from $67.1M at June 30, 2020 to $75.4M at September 30, 2020

  • Amryt announced positive results from EASE pivotal Phase 3 trial in EB. The primary endpoint of the trial was achieved and demonstrated a statistically significant acceleration of target wound healing by day 45 in patients treated with FILSUVEZ® 2 vs control gel (p-value = 0.013) representing a 44% increase in target wound closure with FILSUVEZ® vs the control gel.  EASE is the largest ever Phase 3 randomized controlled study conducted in EB.

  • The RDEB sub-group was observed to experience a greater benefit when treated with FILSUVEZ® than the overall population (nominal p=0.008) representing a 72% increase in target wound closure with FILSUVEZ® vs the control gel

  • Favourable trends were evident among secondary endpoints including change in procedural pain, EBDASI score and BSAP

  • FILSUVEZ® had an acceptable safety profile and was well tolerated when compared with control gel

  • On July 8, Amryt listed on the Nasdaq Global Select Market (Nasdaq)

Joe Wiley, CEO of Amryt Pharma, commented:  

I am very pleased with todays record results which demonstrate the positive performance and growth that our commercial products are delivering alongside the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates. The positive momentum we experienced during the first half of the year has continued through Q3 and I am very pleased with both our revenue growth and positive cash momentum. Furthermore, given the strong performance of the business year to date we are now increasing our revenue guidance for 2020 from $170-$175 million to $180-$182 million. 

We are also very pleased with the positive results for FILSUVEZ® from our EASE Phase 3 trial in EB.  EASE is the first ever Phase 3 study to demonstrate positive data in this devastating disease and we look forward to submitting this data to regulatory authorities in both the US and Europe in early 2021.  If approved, we intend to launch FILSUVEZ® in the US in Q4 2021 and in Europe in Q1 2022.

Our two commercial products, metreleptin and lomitapide continue to deliver growth across a host of metrics including revenue and EBITDA growth, cash generation and market expansion.  We have the management team, systems and infrastructure in place to continue to grow our existing commercial products and also to launch FILSUVEZ® if approved next year.

Q3 and Recent Business Highlights:

  • In July, Amryt listed on Nasdaq

  • In September, Amryt announced positive top line data from the pivotal EASE Global Phase 3 trial in EB. The primary endpoint was achieved with statistical significance (p-value=0.013) representing a 44% increase in target wound closure with FILSUVEZ® vs the control gel.  EASE is the largest ever Phase 3 study conducted in EB.

  • The RDEB sub-group was observed to experience a greater benefit when treated with FILSUVEZ® than the overall population (nominal p-value=0.008) representing a 72% increase in target wound closure with FILSUVEZ® vs the control gel

  • In September, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted a positive opinion for orphan designation for the use of AP103 in EB

  • In October, Amryt signed a distribution agreement for Lojuxta® (lomitapide) with Swixx BioPharma AG (Swixx) across 17 jurisdictions in Central and Eastern Europe.  This follows on from Amryts appointment in June 2020 of Swixx as exclusive distributor of Myalepta® (metreleptin) across the CEE territories.

Q3 2020 Financial Highlights:

·$49.3M unaudited Q3 revenues representing a 19% increase on unaudited combined revenues of $41.4M in Q3 2019 1

·7% QoQ unaudited revenue growth in Q3 versus Q2 ($46.2M)

·31% growth in Myalept® / Myalepta® (metreleptin) revenues to $29.9M in the quarter (Q3 2019: unaudited combined revenues 1  $22.9M).  Metreleptin revenues were bolstered by a $6.9M order in LATAM during Q3 2020.  Unlike in other regions, ordering patterns in LATAM can be sporadic in nature and therefore we do not expect this revenue to recur in Q4.

·4% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $19.1M in the quarter (Q3 2019: unaudited combined revenues 1   $18.3M) 

·US accounted for 51% of global revenues and EMEA accounted for 28% of global revenues in Q3

1       Unaudited combined revenues for 2019 represent the combined unaudited revenues of the Company assuming the acquisition by Amryt of Aegerion happened on 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 FILSUVEZ® which has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for FILSUVEZ® to treat EB

IFRS and non-GAAP adjusted Q3 results:

US$M

Q3 2019
(unaudited)

Q3 2020
(unaudited)

Q3 2020 Non-cash Items 4

Q3 2020 Non-GAAP Adjusted

Revenue

8.6

49.3

49.3

Gross profit

5.5

22.3

15.1

37.4

R&D

(2.4)

(7.4)

(7.4)

SG&A

(6.0)

(16.9)

0.5

(16.4)

Acquisition & severance related costs

(8.7)

(0.1)

(0.1)

Share based compensation expenses

(0.1)

(1.5)

1.5

Operating (loss) / profit before finance expense

(11.7)

(3.6)

17.1

13.5 3

The Q3 operating loss of $3.6M 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 $13.5M of EBITDA 3 for the quarter.  R&D expenses increased to $7.4M in Q3 (Q2: $6.2M).  SG&A expenses decreased  in Q3 to $16.9M (Q2: $21.6M).

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 ($10.0M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($5.1M), depreciation ($0.5M) and share based compensation expenses ($1.5M).

Financial Position:

Cash generated from operating activities in Q3 was $11.4M. During the quarter, the Company paid $1.5M in net finance payments, $4.2M in residual payments related to legacy fines levied on Aegerion and $0.4M in capital expenditure.  The legacy fines will be fully discharged by the end of Q1 2021. At September 30, 2020, the Company had cash of $75.4M (unaudited), compared to cash at June 30, 2020 of $67.1M (unaudited).

Raising FY 2020 Financial Guidance:

Revenues for the FY 2020 are expected to be in the range of $180M-$182M compared to prior guidance of $170M -$175M.

Webcast and Conference Call:

Management will host a webcast for analysts and investors today at 0930 EST / 1430 GMT.

Webcast Player URL: https://edge.media-server.com/mmc/p/dor9m4ay

Telephone Dial in details :

Standard International Number

+44 (0) 203 009 5709

United States

+1 646 787 1226

United Kingdom (Local)

+44 (0) 844 493 6766

Ireland

+ 353 (1) 506 0626

 

 

Confirmation Code

2865629

A playback facility will be available from November 5, 2020 at 1930 GMT November 12, 2020 at 1930 GMT.  Access details as follows: Confirmation Code: 2865629 ; US: +1 917 677 7532 ; UK/International: +44 (0) 3333 00 9785 ; Ireland: +353 (1) 553 8777.

Enquiries :                                                                                                                    

Amryt Pharma plc

+353 (1) 518 0200

Joe Wiley, CEO

Rory Nealon, CFO/COO

 

 

LifeSci Advisors, LLC

+1 (212) 915 2564

Tim McCarthy

 

 

Consilium Strategic Communications

 

+44 (0) 20 3709 5700

Amber Fennell, Matthew Neal, Ashley Tapp

 

About Amryt

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.  

Amryts commercial business comprises two orphan disease products.

Amryt’s lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.  In September and October 2020, Amryt reported positive results from its pivotal global phase 3 trial of FILSUVEZ® in EB.  FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration.

Myalept® / Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. Metreleptin is also approved for lipodystrophy in Japan. Generalised and partial lipodystrophy are rare disorders characterised by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and are associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

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 (under the trade name Lojuxta®). HoFH is a rare genetic disorder which impairs the body’s ability to remove low density lipoprotein (“LDL”) cholesterol (“bad” cholesterol) from the blood, typically leading to abnormally high blood LDL cholesterol levels in the body from before birth – often ten times more than people without HoFH – and subsequent aggressive and premature cardiovascular disease.

In March 2018, Amryt in-licenced a pre-clinical gene-therapy platform technology, AP103, which offers a potential treatment for patients with Recessive Dystrophic Epidermolysis Bullosa, a subset of EB, and is also potentially relevant to other genetic disorders.  For more information on Amryt, 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 OReilly) act as Joint Broker to the company.

Forward-Looking Statements

Statements in this announcement with respect to Amryt’s business, strategies, timing for completion of and announcing results from the EASE trial, the potential impact of closing enrollment in the EASE trial, as well as other statements that are not historical facts are forward-looking statements involving risks and uncertainties which could cause the actual results to differ materially from such statements. Statements containing the words “expect”, “anticipate”, “intends”, “plan”, “estimate”, “aim”, “forecast”, “project” and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt’s present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond each of Amryt’s ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt’s ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Companys current beliefs and assumptions and are based on information currently available to management.

Amryt Pharma plc
 
Condensed Consolidated Statement of Comprehensive Loss

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

2020 (unaudited)

 

2019 (unaudited)

 

2020 (unaudited)

 

2019 (unaudited)

 

Note

US$000

 

US$000

Revenue

3

 49,326

 

 

 8,637

 

 

 140,085

 

 

 17,828

 

Cost of sales

 

 (27,057

)

 

 (3,127

)

 

 (89,148

)

 

 (6,831

)

Gross profit

 

 22,269

 

 

 5,510

 

 

 50,937

 

 

 10,997

 

Research and development expenses

 

 (7,350

)

 

 (2,414

)

 

 (22,481

)

 

 (7,632

)

Selling, general and administrative expenses

 

 (16,889

)

 

 (5,999

)

 

 (56,883

)

 

 (15,946

)

Acquisition and severance related costs

 

 (105

)

 

 (8,743

)

 

 (1,005

)

 

 (11,362

)

Share based payment expenses

4

 (1,533

)

 

 (97

)

 

 (3,136

)

 

 (319

)

Operating loss before finance expense

 

 (3,608

)

 

 (11,743

)

 

 (32,568

)

 

 (24,262

)

Non-cash change in fair value of contingent consideration

5

(2,126

)

 

 (1,448

)

 

(8,150

)

 

 (5,299

)

Non-cash contingent value rights finance expense

5

 (1,557

)

 

 

 

 (4,498

)

 

                   

 

Net finance expense – other

 

 (1,359

)

 

 (2,291

)

 

 (15,492

)

 

 (3,623

)

Loss on ordinary activities before taxation

 

(8,650

)

 

 (15,482

)

 

(60,708

)

 

 (33,184

)

Tax (charge)/credit on loss on ordinary activities

 

 (1,821

)

 

 (77

)

 

 3,171

 

 

 (93

)

Loss for the period attributable to the equity holders of the Company

 

(10,471

)

 

(15,559

)

 

(57,537

)

 

(33,277

)

Exchange translation differences which may be reclassified through profit or loss

 

(1,921

)

 

59

 

 

(2,850

)

 

59

 

Total other comprehensive loss

 

(1,921

)

 

59

 

 

(2,850

)

 

59

 

Total comprehensive loss for the period attributable to the equity holders of the Company

 

(12,392

)

 

(15,500

)

 

(60,387

)

 

(33,218

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share – basic and diluted, attributable to ordinary equity holders of the parent (US$)

6

(0.07

)

 

(0.28

)

 

(0.37

)

 

(0.69

)

Amryt Pharma plc
 
Condensed Consolidated Statement of Financial Position

 

 

As at,

 

 

 

September 30,
2020
(unaudited)

December 31,
2019 restated
(see note 15)

 

 

Note

US$000

 

 

 

 

 

 

Assets

 

 

 

 

Non-current assets

 

 

 

 

Goodwill

7

 

 24,086

 

 24,086

 

 

Intangible assets

7

 

 312,704

 

 342,327

 

 

Property, plant and equipment

 

 

 6,859

 

 3,036

 

 

Other non-current assets

 

 

 1,277

 

 1,873

 

 

Total non-current assets

 

344,926

 

371,322

 

 

Current assets

 

 

 

 

Trade and other receivables

8

 

 42,195

 

 35,500

 

 

Inventories

 

 

 44,932

 

 58,000

 

 

Cash and cash equivalents, including restricted cash

9

 

 75,382

 

 67,229

 

 

Total current assets

 

162,509

 

160,729

 

 

Total assets

 

507,435

 

532,051

 

 

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity attributable to owners of the parent

 

 

 

 

Share capital

10

 

 12,548

 

11,918

 

 

Share premium

10

 

16,553

 

2,422

 

 

Other reserves

 

 

234,099

 

248,630

 

 

Accumulated deficit

 

 

(188,618

)

(131,137

)

 

Total equity

 

74,582

 

131,833

 

 

Non-current liabilities

 

 

 

 

Contingent consideration and contingent value rights

5

 

117,791

 

 102,461

 

 

Deferred tax liability

 

 

 9,649

 

12,102

 

 

Long term loan

11

 

 85,835

 

 81,610

 

 

Convertible notes

12

 

 99,986

 

 96,856

 

 

Provisions and other liabilities

13

 

 4,657

 

4,963

 

 

Total non-current liabilities

 

317,918

 

297,992

 

 

Current liabilities

 

 

 

 

Trade and other payables

 

 

 100,226

 

78,351

 

 

Provisions and other liabilities

13

 

 14,709

 

 23,875

 

 

Total current liabilities

 

114,935

 

102,226

 

 

Total liabilities

 

432,853

 

400,218

 

 

Total equity and liabilities

 

507,435

 

532,051

 

 

 

Amryt Pharma plc
 
Condensed Consolidated Statement of Cash Flows

 

 

Nine Months Ended September 30,

 

 

2020
(unaudited)

2019
(unaudited)

 

Note

US$000

Cash flows from operating activities

 

 

 

Loss on ordinary activities after taxation

 

(57,537

)

(33,277

)

Net finance expense – other

 

 

15,492

 

3,623

 

Depreciation and amortization

 

33,313

 

447

 

Amortization of inventory fair value step-up

 

21,015

 

 

Share based payment expenses

4

 

3,136

 

319

 

Non-cash change in fair value of contingent consideration

5

 

8,150

 

5,299

 

Non-cash contingent value rights finance expense

5

 

4,498

 

 

Deferred taxation credit

 

(2,452

)

 

Movements in working capital and other adjustments:

 

 

 

    Change in trade and other receivables

8

 

(6,695

)

(1,575

)

    Change in trade and other payables

 

 

21,875

 

3,951

 

    Change in provision and other liabilities

13

 

(12,328

)

 

    Change in inventories

 

 

(7,948)

 

(1,078

)

    Change in non-current assets

 

596

 

72

 

Net cash flow from (used in) operating activities

 

21,115

 

(22,219

)

 

 

 

 

Cash flow from investing activities

 

 

 

Net cash received on acquisition of subsidiary

 

 

 

24,985

 

Payments for property, plant and equipment

 

 

(147

)

(465

)

Payments for intangible assets

 

 

(298

)

 

Deposit interest received

 

86

 

2

 

Net cash flow (used in) from investing activities

 

(359

)

24,522

 

 

 

 

 

Cash flow from financing activities

 

 

 

Proceeds from issue of equity instruments

 

 

 

45,162

 

Proceeds from long term debt borrowings net of debt issue costs

 

 

 

27,551

 

Repayment of long term debt

 

 

 

(21,990

)

Payment of leases

 

 

(846

)

(239

)

Interest paid

 

(6,190

)

(2,019

)

Net cash flow (used in) from financing activities

 

(7,036

)

 48,465

 

 

 

 

 

Exchange and other movements

 

(5,567

)

(354

)

Net change in cash and cash equivalents

 

8,153

 

50,414

 

Cash and cash equivalents at beginning of the period

 

67,229

 

11,226

 

Restricted cash at end of the period

 

 

792

 

16,051

 

Cash at bank available on demand at end of the period

 

 

74,590

 

45,589

 

Total cash and cash equivalents at end of the period

 

 

75,382

 

61,640

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Changes in Equity

For the period ended September 30, 2020

 

 

Share capital

Share premium

Warrant reserve

Treasury shares

Share based payment reserve

Merger reserve

Reverse acquisition reserve

Equity component of convertible notes

Other distributable reserves

Currency translation reserve

Accumulated deficit

Total

 

Note

US$000

Balance at January 1, 2020 restated (see note 15)

 

11,918

 

  2,422

 

 29,523

 

 (7,534

)

 3,190

 

42,627

 

 (73,914

)

 29,210

 

  217,634

 

7,894

 

(131,137

)

131,833

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

(57,537

)

(57,537

)

Foreign exchange translation reserve

 

 

 

 

 

 

 

 

 

 

(2,850

)

 

(2,850

)

Total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

(2,850

)

(57,537

)

(60,387

)

Transactions with owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issue of shares in exchange for warrants

  10

 

630

 

14,131

 

(14,761

)

 

 

 

 

 

 

 

 

 

Share based payment expense

  4

 

 

 

 

 

3,136

 

 

 

 

 

 

 

3,136

 

Share based payment expense lapsed

 

 

 

 

 

(56

)

 

 

 

 

 

56

 

 

Total transactions with owners

 

630

 

14,131

 

(14,761

)

 

3,080

 

 

 

 

 

 

56

 

3,136

 

Balance at September 30, 2020 (unaudited)

 

12,548

 

16,553

 

14,762

 

 (7,534

)

6,270

 

42,627

 

 (73,914

)

 29,210

 

  217,634

 

5,044

 

(188,618

)

74,582

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amryt Pharma plc
Condensed Consolidated Statement of Changes in Equity

For the period ended September 30, 2019

 

 

Share capital

Share premium

Warrant reserve

Treasury shares

Share based payment reserve

Merger reserve

Reverse acquisition reserve

Equity component of convertible notes

Other distributable reserves

Currency translation reserve

Accumulated deficit

Total

 

Note

US$000

Balance at January 1, 2019 (audited)

 

25,198

 

68,233

 

 

 

6,473

 

42,627

 

 (73,914

)

 

 

(51

)

(72,263

)

(3,697

)

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

(33,277

)

(33,277

)

Foreign exchange translation reserve

 

 

 

 

 

 

 

 

 

 

59

 

 

59

 

Total comprehensive loss for the period

 

 

 

 

 

 

 

 

 

 

59

 

(33,277

)

(33,218

)

Transactions with owners

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share consolidation

10

(21,262

)

21,262

 

 

 

 

 

 

 

 

 

 

 

Issue of shares in August 2019 equity fund raise

10

533

 

7,467

 

 

 

 

 

 

 

 

 

 

8,000

 

Issue costs associated with August 2019 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 September 2019 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

)

Share based payment expense

  4

 

 

 

 

 

319

 

 

 

 

 

 

 

319

 

Total transactions with owners

 

(13,406

)

200,272

 

24,537

 

 

319

 

 

 

29,210

 

(50,871

)

7,190

 

 

197,251

 

Balance at September 30, 2019 (unaudited)

 

11,792

 

268,505

 

24,537

 

 

6,792

 

42,627

 

 (73,914

)

29,210

 

(50,871

)

7,198

 

(105,540

)

160,336

 

 

1. General information

We are a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases.

As used herein, references to we, us, Amryt or the Group in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the Company in these condensed consolidated interim financial statements shall mean Amryt Pharma plc.

Amryt Pharma plc is a company incorporated in 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. (Novelion), is a rare and orphan disease company with a diversified offering of multiple commercial and development stage assets. The acquisition of Aegerion by Amryt in 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)).

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. The number of shares in issue at September 30, 2019 has been adjusted to reflect this share consolidation on July 10, 2019 for the purposes of the loss per share calculation. The number of share options outstanding at January 1, 2019 and the share options granted and lapsing during the nine months ended September 30, 2019 have been restated to reflect the 2019 share consolidation.

On September 20, 2019, Amryt registered FILSUVEZ® as the trademark name for the Groups lead development asset, AP101, 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 FILSUVEZ® 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 announced that the Company gave Euronext Dublin (Euronext) notice of its intention to cancel the admission of the Companys 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 Companys American Depositary Shares (ADSs) which trade on the NASDAQ Global Select Market under the symbol AMYT or on Amryts 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 Groups 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 Groups 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 ending December 31, 2020.

Results for the nine-month period ended September 30, 2020 are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2020.

Basis of going concern

Having considered the Groups current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis.

A key consideration for the impact on going concern is the acquisition of Aegerion, which was completed in 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, which Amryt believes has the potential to drive revenues and deliver operational synergies through a combination of medical, commercial, clinical, development and regulatory infrastructure. Additionally, Amryt completed a US$60,000,000 fundraising as part of the acquisition of Aegerion.

Since a novel strain of coronavirus (SARS-CoV-2) causing a disease referred to as COVID-19 was first reported in December 2019, the disease has spread across the world, including countries in which we have patients and in which we have planned or active clinical trial sites.  The outbreak and government measures taken in response have had a significant impact, both direct and indirect, on all businesses and commerce as supply chains have been disrupted, facilities and production have been suspended and demand for certain goods and services has spiked while demand for other goods and services has fallen.  As COVID-19 continues to spread around the globe, Amryt may experience disruptions that could affect its business, preclinical studies and clinical trials.

Amryt provides therapeutic products to Homozygous Familial Hypercholesterolemia (HoFH) and lipodystrophy patients globally on a recurring basis. Once lomitapide (for the treatment of HoFH) or metreleptin (for the treatment of lipodystrophy) is prescribed by physicians, patients are typically on treatment over a long period of time with repeat prescriptions for each patient. To date the Group has seen minimal impact of the COVID-19 pandemic on the business given the majority of revenues are recurring in nature and the Group has a strong cash position and resources to support the Groups ability to continue as a going concern.

Basis of consolidation

The condensed consolidated interim financial statements comprise the financial statements of the Group for the nine months ended September 30, 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 consolidated financial statements.

Presentation of balances

The condensed consolidated interim financial statements are presented in U.S. dollars (US$) 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 September 30, 2019 (unaudited)

 

0.8898

 

 

0.7857

 

 

0.9950

 

 

9.3993

 

 

8.6944

 

 

6.6422

 

Average nine-month period to September 30, 2019 (unaudited)

 

0.8992

 

 

0.8110

 

 

0.9855

 

 

9.5838

 

 

8.8586

 

 

6.7109

 

At September 30, 2019 (unaudited)

 

0.9140

 

 

0.8137

 

 

0.9910

 

 

9.7939

 

 

9.0757

 

 

6.8240

 

Foreign currency units to 1 US$

 

¬

 

£

 

CHF

 

SEK

 

NOK

 

DKK

Average 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

 

Foreign currency units to 1 US$

 

¬

 

£

 

CHF

 

SEK

 

NOK

 

DKK

Average three-month period to September 30, 2020 (unaudited)

 

0.8905

 

 

0.7873

 

 

0.9508

 

 

9.4111

 

 

9.5480

 

 

6.6422

 

Average nine-month period to September 30, 2020 (unaudited)

 

0.8562

 

 

0.7749

 

 

0.9203

 

 

8.8756

 

 

9.1384

 

 

6.3740

 

At September 30, 2020 (unaudited)

 

0.8543

 

 

0.7777

 

 

0.9220

 

 

9.0060

 

 

9.4528

 

 

6.3604

 

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

Changes in accounting policies and disclosures

In the current year, the Group has applied the amendments to IFRS related to IFRS 3 and the definition of a business. These amendments and interpretations do not have significant impact on the disclosures or the amounts reported in these condensed consolidated interim financial statements.

Critical accounting judgements and key sources of estimation uncertainty

The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.

The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Groups 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 Groups 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, the pharmaceutical sector with high unmet medical need.

The Groups Chief Executive Officer, Joseph Wiley, is currently the Groups 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 three and nine months ended September 30, 2020 and 2019. Revenue in the three and nine months ended September 30, 2020 include revenues from the acquired Aegerion Group and associated products and regions following the acquisition of the Aegerion Group that was completed on September 24, 2019.

 

Three months ended September 30, 2020 (unaudited)

 

U.S.

EMEA

Other

Total

 

US$000

Metreleptin

 15,877

 

 6,423

 

 7,578

 

 29,878

 

Lomitapide

 9,233

 

 7,109

 

 2,771

 

 19,113

 

Other

   

 

 201

 

 134

 

 335

 

Total revenue

 25,110

 

 13,733

 

10,483

 

 49,326

 

 

Three months ended September 30, 2019 (unaudited)

 

U.S.

EMEA

Other

Total

 

US$000

Metreleptin

 1,036

 

 694

 

 35

 

 1,765

 

Lomitapide

 1,319

 

 5,143

 

 243

 

 6,705

 

Other

  

 

 167

 

  

 

 167

 

Total revenue

 2,355

 

 6,004

 

 278

 

 8,637

 

 

Nine months ended September 30, 2020 (unaudited)

 

U.S.

EMEA

Other

Total

 

US$000

Metreleptin

 45,457

 

 26,233

 

 13,014

 

 84,704

 

Lomitapide

 28,047

 

 18,683

 

 7,856

 

 54,586

 

Other

  

 

 573

 

 222

 

 795

 

Total revenue

 73,504

 

 45,489

 

 21,092

 

 140,085

 

 

Nine months ended September 30, 2019 (unaudited)

 

U.S.

EMEA

Other

Total

 

US$000

Metreleptin

 1,036

 

 694

 

 35

 

 1,765

 

Lomitapide

 1,319

 

 14,036

 

 243

 

 15,598

 

Other

  

 

 465

 

  

 

 465

 

Total revenue

 2,355

 

 15,195

 

 278

 

 17,828

 

Major Customers

For the three and nine months ended September 30, 2020, one customer accounted for 51% and 52%, respectively, of the Groups net revenues and accounted for 37% of the Groups September 30, 2020 accounts receivable balance. For the three and nine months ended September 30, 2019, the Group generated over 51% and 61%, respectively, of its lomitapide revenue in Italy, the Netherlands and Greece. The largest lomitapide customer in the three and nine months ended September 30, 2019 was a distributor in Italy.

4. Share based payments

Share Options and Warrants
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 6 existing ordinary shares were consolidated into one ordinary share.

Under the terms of the Companys Employee Share Option Plan, options to purchase 18,753,648 shares were outstanding at September 30, 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 nine-month period ended September 30, 2020. For the year ended December 31, 2019, a total of 11,330,641 share options were granted to directors and employees.

Outstanding warrants at September 30, 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