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Interim Results

26 Sep 2018 07:00

RNS Number : 9285B
Amryt Pharma PLC
26 September 2018
 

26 September 2018

AIM: AMYTESM: AYP

Amryt Pharma plc

("Amryt" or the "Company")

Interim Results

 

EASE study in EB on track; first Lojuxta orders received from the UK and Saudi Arabia

Amryt, a revenue generating orphan drug company focused on acquiring, developing & commercialising products that help improve the lives of patients where there is a high unmet medical need, today announces interim results, covering the six months to 30 June 2018.

Operational & Financial Highlights

·

Lojuxta revenues for H1 amounted to €6.6 million, which represents a 14.6% increase on the same period in 2017. The Group saw a 13.6% increase in total revenues to €7.0 million for H1 2018 as compared to €6.2 million for H1 2017

·

Significant expansion of the Lojuxta licence territories to include Russia and the Commonwealth of Independent States ("CIS")

·

Eight new Lojuxta distribution agreements signed in H1 2018 (nine signed since November 2017), which together cover 23 countries

·

Continued progress of the Group's lead development asset, AP101, currently in a Phase III clinical trial (EASE) which is the largest ever global Phase III study in EB

·

New gene therapy platform for EB (AP103) acquired in March 2018 with pre-clinical efficacy data expected in Q4 2018

·

Cash at 30 June 2018 was €12.2 million with a €10.0 million undrawn balance on the European Investment Bank ("EIB") facility as of June 2018. €5.0 million of this undrawn balance was subsequently drawn down in September 2018

 

Post Period-End Events & Outlook

·

A Paediatric Rare Disease designation was granted by the FDA which means if a New Drug Application ("NDA") for AP101 is approved, Amryt will be eligible to receive a priority review voucher that can be used, sold or transferred. Disclosed sale prices for vouchers have ranged from $67.5m to $350m

·

An Investigational New Drug ("IND") approval, recently obtained from the FDA, permits the Group to open EASE clinical trial sites in the US which should accelerate enrolment into EASE

·

The EASE study is progressing well and it is expected that the final patient required for the unblinded interim efficacy analysis to be enrolled by the end of September. Accordingly, the unblinded interim efficacy analysis is on track and expected to be completed in late Q4 2018 as planned

·

AP103 pre-clinical studies to be concluded in the coming months with initial results expected Q4 2018

·

The significant momentum built in Lojuxta revenues in H1 has continued into H2, underpinned by the recent NHS England reimbursement approval and the first orders already being received for patients in the UK & Saudi Arabia. Anticipated growth in distributor markets will also provide opportunities for continued growth in 2018 and beyond. Forecasted full-year revenues are anticipated to be in line with expectations

Joe Wiley, CEO of Amryt Pharma, commented: "During the first half of 2018, we made significant progress across all three pillars of our growth strategy. Our lead commercial product, Lojuxta, has seen revenue grow by 14.6% compared to the same period in 2017, and, with the momentum we are seeing from our distributors and the orders already being received in the UK and Saudi Arabia, forecasted full-year revenues are anticipated to be in line with expectations.

"Separately, and in our active pipeline, our lead asset AP101 is on the cusp of enrolling the last patient in its Phase III trial which means we are on track to report our unblinded interim efficacy analysis in late Q4, with read out of top-line data expected in Q2 2019. We have also received interest from physicians and are reviewing the potential of the product in other indications that could see even further growth for this product beyond EB. We also continue to actively review further growth opportunities that could expand the Group's commercial product portfolio by in-licensing or acquiring further commercial or near commercial assets which will drive future growth."

- Ends -

Enquiries:

Amryt Pharma plc

+353 (1) 518 0200

Joe Wiley, CEO

Rory Nealon, CFO/COO

 

 

Shore Capital

+44 (0) 20 7408 4090

NOMAD and Joint Broker

 

Edward Mansfield, Mark Percy, Daniel Bush

 

 

Stifel

+44 (0) 20 7710 7600

Joint Broker

 

Jonathan Senior, Ben Maddison

 

 

Davy

+353 (1) 679 6363

ESM Adviser and Joint Broker

 

John Frain, Anthony Farrell

 

 

Consilium Strategic Communications

+44 (0) 20 3709 5700

Amber Fennell, Matthew Neal, Nicholas Brown 

 

 

About Amryt

 

Amryt is a revenue generating orphan drug company focused on acquiring, developing & commercialising products that help improve the lives of patients where there is a high unmet medical need.

 

Lojuxta, Amryt's lead commercial asset, is an approved treatment for adult patients with the rare cholesterol disorder - Homozygous Familial Hypercholesterolaemia ("HoFH"). This disorder 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 narrowing and blocking of blood vessels, heart attacks and strokes, even at a very young age if not properly diagnosed or receiving adequate treatment. Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without LDL apheresis in adult patients with HoFH.

 

Amryt holds an exclusive licence to sell Lojuxta (lomitapide) across the European Economic Area, Middle East and North Africa, Switzerland, Turkey, Israel, Russia, the Commonwealth of Independent States and the non-EU Balkan states.

 

Amryt's lead development asset, AP101, is a potential treatment for Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no treatment. It is currently in Phase III clinical trials. The European and US market opportunity for EB is estimated to be in excess of €1 billion.

 

Amryt's earlier stage product, AP102, is focused on developing novel, next generation somatostatin analogue ("SSA") peptide medicines for patients with rare neuroendocrine diseases, where there is a high unmet medical need, including Acromegaly and Cushing's disease. 

 

In March 2018, Amryt in-licensed 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, please visit amrytpharma.com

 

 

Chairman's and Chief Executive Officer's Statement

 

Overview

Amryt is a revenue generating pharmaceutical company focused on acquiring, developing and commercialising innovative new treatments for patients affected by rare or orphan diseases where there is high unmet medical need. The Group has built a diverse portfolio of commercial and development stage assets and the Company's ambition is to become a world leader in rare and orphan diseases. Our strategy is focused on three pillars:

 

· Lojuxta - driving further revenue growth of our lead commercial asset in existing and new territories

· In-licence Opportunities - actively seeking to expand the Group's commercial product portfolio by acquiring further commercial or near commercial assets to leverage our successful Lojuxta business

· Epidermolysis Bullosa ("EB") Pipeline - developing our lead development asset, AP101, which is in Phase III as a potential treatment for EB as well as progressing our gene therapy technology (AP103) into the clinic

 

2017 was a very strong year for Amryt, marked by excellent financial, operational and strategic progress with our lead commercial product, Lojuxta, and our lead development asset, AP101. The Group has continued to achieve significant milestones in the first half of 2018.

 

Operational Update

 

Lead Commercial Asset - Lojuxta  

Following the completion of the Lojuxta in-licensing deal in December 2016, Amryt became a commercial pharmaceutical company, generating sales across Europe, the Middle East and other licenced territories. Amryt's Lojuxta business has grown significantly since the product was in-licenced in December 2016. Amryt has been growing its distribution network with eight new distribution agreements in H1 2018.

 

In May 2018, Amryt signed a licence extension with Novelion to expand significantly its exclusive licence agreement for Lojuxta into Russia and CIS, as well as the non-EU Balkan states and is actively seeking distribution partners in these territories. As part of this agreement Amryt, has formally become the Marketing Authorisation holder for Lojuxta in Europe which has marginally increased the level of royalties payable to Novelion. Amryt estimates there may be up to 450 additional patients who could benefit from treatment with Lojuxta across the countries covered by the extended agreement, representing an increase of approximately 25% in the total number of addressable patients in the Amryt territories. The Company believes the total addressable market opportunity for Lojuxta in its territories to be in excess of €125 million.

 

Patent extensions for Lojuxta have recently been granted in multiple markets within our territories including France, Germany, Italy and Spain. The Company expects that these extensions will prolong our product patent in these territories through 2028. The Company has also recently received enquiries from physicians to study Lojuxta in an orphan indication called Familial Chylomicronaemia. Amryt has agreed to provide the product for an investigator led study which, if successful, would provide important proof of concept data in this indication and may support further studies.

 

Lojuxta revenues for the six months to 30 June 2018 amounted to €6.6 million which represents a 14.6% increase on the same period in 2017. Our focus on adoption of, and access to, Lojuxta in new and existing territories is already delivering significant returns and we are confident that this positive momentum will continue to grow revenues for the balance of 2018 and beyond. This anticipated full year growth is underpinned by:

 

(i) The recent reimbursement decision by NHS England for Lojuxta which has already resulted in the first orders being received; and

(ii) Amryt's strategy to appoint local distribution partners for new territories which is already resulting in new prescriptions as evidenced by the recent order being received for patients in Saudi Arabia.

 

Since November 2017, Amryt has agreed nine new distributor relationships, which together cover 23 countries. In November 2017, Amryt signed a distribution agreement with El Seif for the key territory of Saudi Arabia and since then has identified over 100 of the estimated 150 patients eligible to be treated. Recently, the first orders for patients in Saudi Arabia have been received and Amryt expects this significant market to help drive growth in H2 2018 and beyond. In May 2018, Amryt signed distribution agreements with Al Hafez Trading Establishment, which operates in Kuwait, Ebn Sina Medical, the leading medical organisation in Qatar, Muscat Pharmacy and Stores in Oman, and Goro Healthcare of the UAE and Bahrain.  In addition, Amryt's distributor for Central and Eastern Europe is seeing good revenue momentum in Austria and Lithuania where the first patients have been initiated. 

 

Future sales growth will be driven by existing markets and from new territories. The Group is actively negotiating the initiation of reimbursement in a number of markets and we are optimistic that some of these discussions will conclude successfully during the course of the second half of 2018. In particular, the Group is expecting a decision from France in the coming weeks. If successful, these market-access decisions will allow Amryt to provide access for a cohort of HoFH patients in these territories, which should result in accelerated growth for the business. We have ambitious plans for the remainder of 2018 and we look forward to updating the market in due course. 

 

Lead Development Asset - AP101 (Oleogel-S10)

The Group has continued to make strong progress with its lead development asset, AP101, as a new potential treatment for EB. In January 2016, we received marketing approval for AP101 for the treatment of Partial Thickness Wounds ("PTW") in adults from the European Commission.

 

In February 2017, Amryt was granted a patent in Japan for AP101. This followed key patents grants for AP101 in Europe and the US in 2016. In March 2017, Amryt commenced the pivotal Phase III clinical trial, EASE (Efficacy and safety of AP101 in patients with EB), to examine AP101's efficacy for EB patients. The first patient was enrolled to EASE in April 2017.

 

Clinical Trials Update

Adult and paediatric patients with EB are currently being enrolled into a randomised double-blind placebo-controlled trial. The proportion of patients with completely healed target wounds within 45 days will be evaluated as the primary endpoint. Secondary endpoints include the time to achieve wound healing and changes in pain and pruritus (itch).

 

Amryt expects the final patient required for the unblinded interim efficacy analysis to be enrolled by the end of September. Accordingly, the unblinded interim efficacy analysis is on track and expected to be completed in late Q4 2018. The unblinded interim efficacy analysis will be conducted by an independent data safety monitoring board and will result in three possible outcomes:

 

· Continue the study with no change to sample size, which would reflect conditional statistical power of at least 80% or better;

· Increase the number of patients in the study to maintain an 80% conditional statistical power; or

· Discontinue the study due to futility

 

Assuming a positive unblinded interim efficacy analysis and no additional patients are added to the study, the Group expects read out of top-line data from the EASE Phase III study in Q2 2019.

 

The Board believes that the unblinded interim efficacy analysis read out represents a significant milestone for Amryt in EB.

 

During H1 2018, various non-clinical studies, requested by the FDA as part of an IND filing to open clinical trial sites in the US, have been successfully completed. No safety signals or concerns were noted from the preliminary data and IND approval has recently been received from the FDA. This will enable us to open clinical trial sites in the US, thereby accelerating enrolment of patients into the EASE study. Amryt recently received Paediatric Rare Disease designation from the FDA for AP101, which, pending successful approval of AP101 in EB, will allow the Group apply for a priority review voucher that can be used, sold or transferred. The Board also intends to apply for breakthrough designation following the opening of the IND in the USA. Breakthrough designation would expedite the review by the FDA of AP101 upon completion of the Phase III clinical trial.

 

Potential Future Indications for AP101

In January 2016, Amryt received marketing approval for AP101 for the treatment of PTW in adults from the European Commission. This followed three positive Phase III studies of 280 patients in Grade II burns and split thickness skin graft donor sites. To date, the Group has not launched in PTW. This approval gives Amryt the option to target PTW indications where there is a high unmet medical need.

 

Amryt has recently received enquiries from physicians to study AP101 in various PTW indications also with high unmet medical need. In response to this interest from physicians, the Group is evaluating some exciting new life cycle opportunities for AP101.

 

Dermatological conditions currently under consideration include:

 

· Severe burns

· Toxic Epidermal Necrolysis Syndrome (TENS)(including Stevens-Johnson Syndrome (SJS))

· Bullous Pemphigoid

· Pemphigus Vulgaris

· Grade III/IV radiotherapy and chemotherapy induced dermatitis 

 

In addition to the indications studied in the PTW Phase III studies (burns and split thickness skin grafts), the scope of the current European Commission approval for AP101 may offer the opportunity to also launch AP101 in some of these indications in Europe.

 

In order to maximise the value of this asset and following the EASE trial for AP101 in EB, the Group further intends to file applications for orphan designation for some of these new potential orphan indications in the US, Europe and Japan and believes there is significant scope to maximise the value of the AP101 asset through either a global multi-orphan strategy or via the current EMA marketing approval to secure long-term growth.

 

AP102

In February 2017, we received positive results from a pre-clinical study that compared AP102 with pasireotide, an approved product for treating patients with resistant acromegaly. Significantly, AP102 did not demonstrate the potential to cause diabetes, an observation which, if replicated in clinical studies, could be clinically beneficial in treating acromegaly. Throughout 2017 and the first half of 2018, the Group initiated various additional pre-clinical studies which are ongoing. However, the Board has decided to focus the Group's resources and is currently prioritising its EB franchise and the growth of our commercial business. The Board may seek to find a partner for AP102 in due course.

 

AP103 (Gene Therapy in EB)

In March 2018, Amryt concluded an exclusive in-licencing of a novel non-viral platform technology for gene therapy in EB with potential applicability across a range of other genetic disorders. This technology has been exclusively in-licenced from University College Dublin ("UCD") and involves the delivery of gene therapy using High Branched Poly (β-Amino Ester) ("HPAE") polymer technology. The initial focus of development efforts to date has been in the area of EB and preliminary data suggests that the treatment could be a potentially disease-modifying therapy for patients with Recessive Dystrophic Epidermolysis bullosa ("RDEB"). Patients with RDEB lack collagen VII and pre-clinical data in a xenograft model has shown significant levels of collagen VII in the skin post-therapy. Patients with RDEB lack collagen VII due to a defect in their gene coding for collagen VII. Consequently, the replacement of the collagen VII gene could be transformative for these patients.

 

Potential competitors working in the area of gene therapy in EB are mostly working with viral vectors to deliver collagen VII to the cell. The patented technology which Amryt has exclusively licenced from UCD involves the use of a novel non-viral gene delivery mechanism using HPAE polymer technology. If successful, this could eliminate the requirement for viruses as delivery vectors and provides a potential competitive advantage to Amryt.

 

Amryt intends to conclude various confirmatory pre-clinical studies in the coming months and will report the initial results of the studies in Q4 2018. 

 

Imlan

Amryt has a range of derma-cosmetic products that we acquired with the acquisition of Birken AG (now Amryt AG). These products are sold under the Imlan brand. Completely free of emulsifiers, preservatives, colorants and fragrances and other additives or irritants, Imlan is marketed in Germany as a treatment for sensitive, allergy-prone and dry skin. It is also recommended for the basic care of eczema or psoriasis. 

 

Financial Performance

The unaudited results for the current period are those of the Company and its subsidiaries for the six months to 30 June 2018.

 

Total revenues for the six-month period to 30 June 2018 amounted to €7,020,000, which represents a 13.6% increase on total revenues for the same period in 2017. Lojuxta generated revenues of €6,591,000 and revenues from Imlan, the Group's derma-cosmetics range of products, amounted to €429,000. This compares to total revenues for the 6-month period 30 June 2017 of €6,180,000, with Lojuxta generating revenues of €5,751,000 and Imlan generating revenues of €429,000. Total revenues for the year ended 31 December 2017 amounted to €12,778,000. 

 

Gross margin for the six months to 30 June 2018 was 61.4% compared to 59.3% for the six-month period ended 30 June 2017.

 

The operating loss before finance expense for the period amounted to €6,497,000 which includes non-cash depreciation and amortisation of €158,000 and non-cash share-based payments of €382,000. This compares to an operating loss before finance expense for the period ended 30 June 2016 of €5,789,000, which includes non-cash depreciation and amortisation of €131,000 and non-cash share-based payment expenses of €312,000. Excluding depreciation, amortisation and share based payment expenses, the operating loss before finance costs for the six-month period to 30 June 2018 would have been €5,957,000 (2017: €5,346,000).

 

The non-cash change in fair value of contingent consideration which arose as part of the acquisition of Amryt AG in 2016 amounted to €4,154,000 during the period. The fair value of this contingent consideration was initially determined by discounting the contingent amounts payable to their present value at the date of acquisition. The discount component is being unwound as a non-cash financing charge in the statement of comprehensive income over the life of the obligation. This current non-cash financing charge of €4,154,000 reflects the impact of the discount component being unwound to the statement of comprehensive income in H1 2018.

 

The loss on ordinary activities after the non-cash fair value of contingent consideration amounted to €11,384,000 (2017: €13,826,000).

 

As of 30 June 2018, the Group had cash on hand of €12.2 million (30 June 2017: €10.9 million). On 2 December 2016, Amryt entered into a five year €20 million debt facility agreement with the EIB. The first tranche of €10 million was drawn down in April 2017. The second tranche of €5 million was drawn down post-period end in September 2018.

 

The AIM rules on how companies communicate their governance practices have changed and the board recently elected to adopt the ten principles as set out in the Quoted Companies Alliance ("QCA"). These principles will serve as a framework for communicating our governance practices to shareholders and the wider market. Our website and annual report for the year ended 2018 will set out how we currently comply with the principles of the QCA code.

 

Outlook

The Board is optimistic about the growth prospects for the Group across all three pillars of our strategy. Lojuxta revenues for the first six months were in line with the Board's expectations for the period and we are very encouraged with the momentum created in the first half of 2018, which continues into the second half. We believe there is a significant opportunity to further grow revenues, particularly given the latent and significant opportunities that exist in the territories we currently cover. This will remain a core focus for us over the coming quarters and beyond.

 

Our active pipeline, including the Phase III clinical trial EASE for our lead development asset AP101, is progressing well. We expect the final patient required for the unblinded interim efficacy analysis to be enrolled by the end of September. Accordingly, the unblinded interim efficacy analysis is on track and expected to be completed in late Q4 2018 as planned. It is estimated that the addressable market for AP101 is more than €1 billion. In addition, AP103 pre-clinical studies are expected to be concluded in the coming months with initial results anticipated in Q4 2018.

 

Amryt is actively seeking to expand the Group's commercial product portfolio by in-licensing or acquiring further commercial or near commercial assets to leverage on our successful Lojuxta business, grow our revenues and provide further cashflow to support continued growth.

 

Forecasted full-year revenues are anticipated to be in line with expectations.

 

Harry Stratford

Non-executive Chairman

26 September 2018

Joe Wiley

CEO

26 September 2018

 

 

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2018

 

 

 

 

 

 

 

 

Unaudited

6 months to

 30 June

2018

Unaudited

6 months to

30 June

2017

Audited

12 months to

31 December 2017

 

Note

€'000

€'000

€'000

Revenue

 

7,020

6,180

12,778

Cost of sales

 

(2,711)

(2,515)

(5,373)

Gross profit

 

4,309

3,665

7,405

Research and development expenses

 

(4,240)

(5,359)

(10,564)

Administrative, selling and marketing expenses

 

(6,184)

(3,783)

(10,483)

Share based payment expenses

3

(382)

(312)

(565)

Operating loss before finance expense

 

(6,497)

(5,789)

(14,207)

Non-cash change in fair value of contingent consideration

4

(4,154)

(7,706)

(11,104)

Net finance expense

 

(733)

(331)

(825)

Loss on ordinary activities before taxation

 

(11,384)

(13,826)

(26,136)

Tax on loss on ordinary activities

 

-

-

-

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

 

(11,384)

(13,826)

(26,136)

 

 

 

 

 

Exchange translation differences which may be reclassified through the profit and loss

 

(10)

(5)

22

Total other comprehensive (loss)/ profit

 

(10)

(5)

22

 

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

 

(11,394)

 

(13,831)

 

(26,114)

 

Loss per share:

 

 

 

 

 

 

 

 

 

 

Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (cent)

 

5

 

(4.14)

 

(6.64)

 

(11.72)

 

Consolidated Statement of Financial Position

As at 30 June 2018

 

 

 

 

Unaudited

30 June

2018

Audited

31 December

 2017

 

Note

€'000

€'000

Assets

 

 

 

Non-current assets

 

 

 

Intangible assets

6

52,679

52,606

Property, plant and equipment

7

1,055

1,160

Total non-current assets

 

53,734

53,766

 

 

 

 

Current assets

 

 

 

Trade and other receivables

 

4,539

4,729

Inventories

 

1,360

1,083

Cash and cash equivalents

 

12,209

20,512

Total current assets

 

18,108

26,324

Total assets

 

71,842

80,090

 

 

 

 

Equity and liabilities

 

 

 

Equity attributable to owners of the parent

 

 

 

Share capital

8

21,173

21,173

Share premium

8

57,334

57,334

Other reserves

 

(21,162)

(21,512)

Accumulated deficit

 

(46,493)

(35,109)

Total equity

 

10,852

21,886

 

 

 

 

Non-current liabilities

 

 

 

Contingent consideration

4

36,572

32,418

Long term loan

9

11,045

10,603

Deferred tax liability

 

5,384

5,384

Total non-current liabilities

 

53,001

48,405

 

 

 

 

Current liabilities

 

 

 

Trade and other payables

 

7,989

9,799

Total current liabilities

 

7,989

9,799

Total liabilities

 

60,990

58,204

 

 

 

 

Total equity and liabilities

 

71,842

80,090

 

Consolidated Statement of Cash Flows

For the six months ended 30 June 2018

 

 

Unaudited

Unaudited

Audited

 

 

6 months to

30 June

2018

 

6 months to

30 June

2017

 

12 months to

31 December

2017

 

Note

€'000

€'000

€'000

Cash flows from operating activities

 

 

 

 

Loss on ordinary activities before taxation

 

(11,384)

(13,826)

(26,136)

Finance expense

 

733

331

825

Depreciation and amortisation

 

158

131

259

Share based payment expense

3

382

312

565

Non-cash change in fair value of contingent consideration

4

4,154

7,706

11,104

Movements in working capital and other adjustments:

 

 

 

 

Change in trade and other receivables

 

190

(1,331)

(2,189)

Change in trade and other payables

 

116

(380)

6,022

Change in contingent consideration

 

-

-

(2,000)

Change in inventories

 

(277)

(215)

(313)

Net cash flow used in operating activities

 

(5,928)

(7,272)

(11,863)

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

Payments for property, plant and equipment

7

(34)

(8)

(243)

Payments for intangible assets

6

(91)

-

(87)

Cash inflow on sale of property, plant and equipment

 

-

5

9

Deposit interest received

 

5

-

5

Bank charges and interest paid

 

(300)

-

-

Net cash flow used in investing activities

 

(420)

(3)

(316)

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

Acquisition of Amryt AG - milestone payment

4

(2,000)

-

-

Proceeds from issue of equity instruments - net of expenses

 

-

-

14,393

Long term loan received

9

-

10,000

10,000

Repayment of short-term loan

 

-

(47)

(47)

Net cash flow from financing activities

 

(2,000)

9,953

23,346

 

 

 

 

 

Exchange and other movements

 

45

(8)

74

 

 

 

 

 

Net change in cash and cash equivalents

 

(8,303)

2,670

12,241

Cash and cash equivalents at beginning of period

 

20,512

8,271

8,271

Restricted cash at end of period

 

-

-

537

Cash at bank available on demand at end of period

 

12,209

10,941

19,975

Total cash and cash equivalents at end of period

 

12,209

10,941

20,512

 

Consolidated Statement of Changes in Equity

For the six months ended 30 June 2018

 

 

 

 

 

 

Share

capital

 

 

 

 

Share premium

 

 

 

Share based payment reserve

 

 

 

 

Merger reserve

 

 

 

 

Reverse acquisition

 

 

 

Exchange translation reserve

 

 

 

 

Accumulated deficit

 

 

 

 

 

Total

 

Note

€'000

€'000

€'000

€'000

€'000

€'000

€'000

€'000

Balance at 1 January 2017 (Audited)

 

20,419

43,695

4,215

35,818

(62,107)

(5)

(8,998)

33,037

 

 

 

 

 

 

 

 

 

 

Loss for the year

 

-

-

-

-

-

-

(26,136)

(26,136)

Translation reserve

 

-

-

-

-

-

27

-

27

Total comprehensive (loss)/ income

 

-

-

-

-

-

27

(26,136)

(26,109)

 

 

 

 

 

 

 

 

 

 

Issue of placing shares - gross of costs

 

754

14,329

-

-

-

-

-

15,083

Issue of placing shares - costs

 

-

(690)

-

-

-

-

-

(690)

Share based payment expenses

 

-

-

565

-

-

-

-

565

Share based payment expenses - lapsed

 

-

-

(25)

-

-

-

25

-

Balance at 31 December 2017

(Audited)

 

21,173

57,334

4,755

35,818

(62,107)

22

(35,109)

21,886

 

 

 

 

 

 

 

 

 

 

Balance at 1 January 2018

 

21,173

57,334

4,755

35,818

(62,107)

22

(35,109)

21,886

Loss for the period

 

-

-

-

-

-

-

(11,384)

(11,384)

Translation reserve

 

-

-

-

-

-

(32)

-

(32)

Total comprehensive loss

 

-

-

-

-

-

(32)

(11,384)

(11,416)

 

 

 

 

 

 

 

 

 

 

Share based payment expenses

3

-

-

382

-

-

-

-

382

Balance at 30 June 2018

(Unaudited)

 

21,173

57,334

5,137

35,818

(62,107)

(10)

(46,493)

10,852

 

Share capital represents the cumulative par value arising upon issue of ordinary shares of 1p each and deferred shares of 29.4p each.

Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital.

Share based payment reserve relates to the charge for share based payments in accordance with International Financial Reporting Standard 2.

The reverse acquisition reserve arose during the period ended 31 December 2016 in respect of the reverse acquisition of Amryt Pharma plc by Amryt Pharmaceuticals DAC ("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.

The merger reserve was created on the acquisition of Amryt DAC. Consideration on the acquisition included the issuance of shares. Under section 612 of the Companies Act 2006, the premium on these shares has been included in a merger reserve.

The exchange translation reserve was created on the retranslation of non-Euro denominated foreign subsidiaries.

Accumulated deficit represents losses accumulated in previous years and the current period.

 

 

Notes to the Interim Results

 

1. General Information

 

Amryt Pharma plc is a company incorporated in England and Wales. Details of the registered office, the officers and advisers to the Company are presented on the Company Information page at the end of this report. The Company is listed on the AIM market of the London Stock Exchange (ticker: AMYT.L) and the Enterprise Securities Market of the Irish Stock Exchange (ticker: AYP). As used herein, references to "we", "us", "Amryt" or the "Group" in this unaudited interim report shall mean Amryt Pharma plc and its world-wide subsidiaries, collectively. References to the "Company" in this interim report shall mean Amryt Pharma plc.  

 

Amryt is a commercial stage pharmaceutical company focused on acquiring, developing and delivering innovative new treatments that help improve the lives of patients with rare and orphan diseases. The Group has built a diverse portfolio of assets to treat patients with rare and orphan diseases through the acquisition of its AP101 and AP102 assets in April 2016, the in-licencing of Lojuxta in December 2016 and the in-licencing of a gene therapy platform in March 2018.

 

Following on from its acquisition by the Group in 2016, Birken AG was renamed Amryt AG in 2017. All references in the notes to the accounts to Amryt AG relate to the entity that was formerly called Birken AG.

 

The unaudited interim results for the six-month period ended 30 June 2018 comprise the Company and its subsidiaries (together the "Group"). The information for the year ended 31 December 2017 contained within the condensed financial statements does not constitute statutory accounts as defined in Section 435 of the Companies Act 2006. The financial statements for the year ended 31 December 2017 have been delivered to the Registrar of Companies and the auditor's report on those financial statements was unqualified, did not include an emphasis of matter, and did not contain a statement made under Section 498 of the Companies Act 2006.

 

2. Accounting Policies

 

Basis of preparation

The interim results have been prepared on the basis of the recognition and measurement requirements of International Financial Reporting Standards ("IFRS") as adopted by the European Union ("EU"), and their interpretations adopted by the International Accounting Standards Board ("IASB") as adopted by the EU and with those parts of the Companies Act 2006 applicable to companies reporting under IFRS. As is permitted by the AIM rules the Directors have not adopted the requirements of IAS 34 "Interim Financial Reporting" in preparing the financial statements. Accordingly, the financial statements are not in full compliance with IFRS and have not been audited or reviewed pursuant to guidance issued by the Auditing Practices Board. 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 31 December 2017 and those which are expected to be used in the financial statements for the year ended 31 December 2018.

 

The Directors consider that the financial information presented in this Interim Report represents fairly the financial position, operations and cash flows for the period, in conformity with IFRS.

 

Consolidation

The consolidated financial statements comprise the financial statements of the Company and its subsidiaries. Subsidiaries are entities controlled by the Group. Where the Group has control over an investee, it is classified as a subsidiary. The Group controls an investee if all three of the following elements are present: power over an investee, exposure to variable returns from the investee, and the ability of the investor 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 unrealised gains or losses or income or expenses arising from intergroup transactions are eliminated in preparing the consolidated Financial Statements.

 

Presentation of Balances

The Financial Statements are presented in Euro ('€') which is the functional and presentational currency of the Group. Balances in the Financial Statements are rounded to the nearest thousand (€'000) except where otherwise indicated.

 

The following table discloses the major exchange rates of those currencies utilised by the Group:

 

Foreign currency units to 1 €

US$

£

CHF

SEK

NOK

DKK

Average period to 30 June 2018

1.2113

0.8809

1.1672

10.1422

9.6526

7.4459

At 30 June 2018

1.1675

0.8769

1.1529

10.2943

9.5437

7.4429

 

 

 

 

 

 

 

Average year to 31 December 2017

1.1259

0.8715

1.1082

9.6085

9.2979

7.4411

At 31 December 2017

1.1901

0.8813

1.1678

9.8719

9.9537

7.4412

 

 

 

 

 

 

 

Average period to 30 June 2016

1.1101

0.7698

1.0967

-

-

-

At 30 June 2016

1.1143

0.7626

1.1053

-

-

-

(US$ = US Dollars; £ = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish Kroner, NOK = Norwegian Kroner, DKK = Danish Kroner)

 

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 recognised 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.

 

Summary of principal accounting policies

The principal accounting policies are summarised below. They have been consistently applied throughout the period covered by the Financial Statements.

 

Revenue recognition

Revenue from the sale of goods is recognised in the consolidated statement of comprehensive income when the significant risks and rewards of ownership have been transferred to the buyer. Imlan revenue is generally recorded as of the date of shipment, consistent with typical ex-works shipment terms. For Lojuxta revenues, the Group sells direct to customers and also uses third parties in the distribution of the product to customers. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its obligations to the customer in accordance with the shipping terms. Revenue, including any amounts invoiced for shipping and handling costs and excluding sales taxes, represents the value of the goods supplied to external customers.

 

Revenue from services rendered in the consolidated statement of comprehensive income is recognised in proportion to the stage of completion of the transaction at the reporting date.

 

Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group, that risks and rewards of ownership have passed to the buyer and the revenue can be reliably measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction or the possible return of goods.

 

Research and Development Expenses

The costs relating to the development of products are accounted for in accordance with IAS 38 "Intangible Assets", where they meet the criteria for capitalization. Research costs are expensed when they are incurred.

 

The assessment whether development costs can be capitalized requires management to make significant judgements. In management's opinion, the criteria prescribed under IAS 38.57 "Intangible Assets" for capitalising development costs as assets have not yet been met by the Group. Accordingly, all of the Group's costs related to research and development projects are recognised as expenses in the income statement in the period in which they are incurred. Management expects that criteria prescribed under IAS 38.57 will be met on filing of a submission to the regulatory authority for final drug approval or potentially in advance of that on the receipt of information that strongly indicates that the development will be successful.

 

Business Combinations

Business combinations are accounted for using the acquisition method. The cost of an acquisition is measured as the aggregate of the consideration transferred, measured at acquisition date fair value and the amount of any non-controlling interest in the acquiree. Fair values are attributed to the identifiable assets and liabilities unless the fair value cannot be measured reliably, in which case the value is subsumed into goodwill. In the consolidated Financial Statements, acquisition costs incurred are expensed and included in general and administrative expenses.

 

To the extent that settlement of all or any part of the consideration for a business combination is deferred, the fair value of the deferred component is determined through discounting the amounts payable to their present value at the date of the exchange. The discount component is unwound as an interest charge in the consolidated statement of comprehensive income over the life of the obligation. Any contingent consideration is recognised at fair value at the acquisition date and included in the cost of the acquisition. The fair value of contingent consideration at acquisition date is arrived at through discounting the expected payment (based on scenario modelling) to present value. In general, in order for contingent consideration to become payable, pre-defined revenues and/or milestones dates must be exceeded. Subsequent changes to the fair value of the contingent consideration will be recognised in profit or loss unless the contingent consideration is classified as equity, in which case it is not re-measured and settlement is accounted for within equity.

 

Frequently, the acquisition of pharmaceutical patents and licences is effected through a non-operating corporate structure. As these structures do not represent a business, it is considered that the transactions do not meet the definition of a business combination. Accordingly, the transactions are accounted for as the acquisition of an asset. The net assets acquired are recognised at cost.

 

Acquired Intangibles Assets

Acquired intangible assets outside business combinations are stated at the lower of cost less provision for amortisation and impairment or the recoverable amount. Acquired intangibles assets are amortised over their expected useful economic life on a straight-line basis. In determining the useful economic life each acquisition is reviewed separately and consideration given to the period over which the Group expects to derive economic benefit.

 

Share based payments

The Company issues share options as an incentive to certain senior management and staff. The fair value of options granted is recognised as an expense with a corresponding credit to the share-based payment reserve. The fair value is measured at grant date and spread over the period during which the awards vest.

 

For equity-settled share-based payment transactions, the goods or services received and the corresponding increase in equity are measured directly at the fair value of the goods or services received, unless that fair value cannot be estimated reliably. If it is not possible to estimate reliably the fair value of the goods or services received, the fair value of the equity instruments granted as calculated using the Black-Scholes model is used as a proxy.

 

The Company may issue warrants to key consultants, advisers and suppliers in payment or part payment for services or supplies provided to the company. In addition, the Company may grant warrants to subscribers as part of the issue of new ordinary shares in the Company. The fair value of warrants granted is recognised as an expense unless the grant relates to the issue of new ordinary shares in the Company in which case the fair value is recognised in share premium. The corresponding credits are charged to the share-based payment reserve. The fair value is measured at grant date and spread over the period during which the warrants vest. The fair value is measured using the Black-Scholes model if the fair value of the services received cannot be measured reliably.

 

3. Share-based payments

 

The Company has issued share options as an incentive to certain senior management and staff. In addition, the Company has issued warrants to equity investors and to key consultants and advisers in payment or part payment for services or supplies provided to the Group.

 

Each share option and warrant convert into one Ordinary Share of Amryt Pharma plc on exercise and are accounted for as equity-settled share-based payments. The options and warrants may be exercised at any time from the date of vesting to the date of their expiry. The equity instruments granted carry neither rights to dividends nor voting rights.

 

No share options or warrants were granted in the 6-month period to 30 June 2018. All share options granted in 2016 and 2017 were granted under the terms of the Amryt Share Option Plan and are subject to vesting conditions. No warrants were granted in 2017 and all warrants granted in 2016 were granted under individual agreements as part of the April 2016 share placing. In addition to the share options and warrants granted during 2016 and 2017, a total of 537,280 share options and warrants were in existence at 30 June 2018 that relate to the old oil and gas business.

 

 

 

 

Share options and warrants in issue:

 

Share Options

Warrants

 

Units

Weighted average exercise price

Units

Weighted average exercise price

Balance at 1 January 2017

15,795,314

19.8p

23,307,269

25.4p

Granted during the period

3,265,867

18.97p

-

-

Lapsed during the period

(4,993,188)

22.98p

(203,788)

88.0p

Balance at 30 June 2017

14,067,993

18.45p

23,103,481

24.74p

Exercisable at 30 June 2017

2,781,961

21.08p

23,103,481

24.74p

Balance at 1 July 2017

14,067,993

18.45p

23,103,481

24.74p

Granted during the period

5,628,593

20.95p

-

-

Lapsed during the period

-

-

-

-

Balance at 31 December 2017

19,696,586

19.16p

23,103,481

24.74p

Exercisable at 31 December 2017

3,281,961

20.61p

23,103,481

24.74p

Balance at 1 January 2018

19,696,586

19.16p

23,103,481

24.74p

Granted during the period

 

-

-

-

Lapsed during the period

-

-

-

-

Balance at 30 June 2018

19,696,586

19.16p

23,103,481

24.74p

Exercisable at 30 June 2018

6,115,854

19.07p

23,103,481

24.74p

 

The 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. There were no new share options or warrants granted in the 6 month period to 30 June 2018. The following are the inputs to the model for the equity instruments granted in 2017:

 

 

 

2018 Options Inputs

2018 Warrant Inputs

2017 Options Inputs

2017 Warrant Inputs

Days to Expiry

-

-

2,555

-

Volatility

-

-

44%-48%

-

Risk free interest rate

-

-

0.42%-0.77%

-

Share price at grant

-

-

18.18p-25.88p

-

 

The share options outstanding as at 30 June 2018 have a weighted remaining contractual life of 5.44 years with exercise prices ranging from £0.155 to £0.48.

 

The warrants outstanding as at 30 June 2018 have a weighted remaining contractual life of 0.71 years with exercise prices ranging from £0.24 to £1.12.

 

The value of share options and warrants charged to the Statement of Comprehensive Income during the period is as follows:

 

6 months to

30 June

2018

6 months to

30 June

2017

12 months to

31 December

2017

 

€'000

€'000

€'000

Share options

382

312

565

Total

382

312

565

 

 

4. Business Combinations and Asset Acquisitions

Acquisition of Amryt AG ("Birken")

Amryt DAC signed a conditional share purchase agreement to acquire Amryt AG on 16 October 2015 ("Amryt AG SPA"). The Amryt AG SPA was completed on 18 April 2016 with Amryt DAC acquiring the entire issued share capital of Amryt AG. The consideration comprises:

· Initial cash consideration of €1,000,000 (paid by Amryt DAC prior to its acquisition by the Company);

· Cash consideration of €150,000, due and paid on the completion date (18 April 2016);

· Milestone payments of:

o €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (18 April 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 14 January 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 Epidermolysis Bullosa (EB);

o €10,000,000 once net ex-factory sales/net revenue in any calendar year exceed €50,000,000;

o €15,000,000 once net ex-factory sales/ net revenue in any calendar year exceed €100,000,000;

· Royalties of 9% on sales of Episalvan products for 10 years from first commercial sale; and

· Shares in Amryt DAC that equated to a 30% equity shareholding prior to the acquisition of Amryt DAC by the Company. The Amryt AG sellers received 37,048,622 in Consideration Shares (valued at the date of acquisition at €11.2 million) for their shareholding in Amryt DAC.

 

Fair Value Measurement of Contingent Consideration

Contingent consideration comprises the milestone payments and sales royalties detailed above. As at the acquisition date, the fair value of the contingent consideration was estimated to be €23,314,000. The fair value of the royalty payments was determined using probability weighted revenue forecasts and the fair value of the milestones payments was determined using probability adjusted present values. 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 drugs acquired in the Amryt AG transaction. A discount rate of 28.5% was used in the calculation of the fair value of the contingent consideration and this was sense checked by management against the Implied Rate of Return ("IRR") on the project. The size of the market for the products under development provides a real opportunity to the Group to meet its forecast revenue targets and therefore the milestone targets which underpin the contingent consideration payments. At that time management anticipated that AP101 for EB would be ready to launch in 2019. However, management noted 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 fair value of the contingent consideration.

 

It is necessary to review the contingent consideration on a regular basis as the probability adjusted fair values are being unwound as financing expenses in the Statement of Comprehensive Income over the life of the obligation. Contingent consideration is reviewed on a bi-annual basis and is disclosed in the published interim results for the 6-month period to 30 June and the year end results to 31 December. The total non-cash finance charge recognised in the statement of comprehensive income statement for the period ended 30 June 2018 is €4,154,000.

 

One milestone payment consisted of (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, €2,000,000 24 months after receipt of such approval and €3,000,000 following the first commercial sale. No commercial sales of Episalvan have been made since EMA first marketing approval. However, if no commercial sales occur, €2,000,000 is due for payment 24 months after the EMA first marketing approval. The Group made this payment of €2,000,000 in January 2018. The contingent consideration balance at 30 June 2018 is €36,571,000 (31 December 2017: €32,418,000).

 

5. 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 number of shares in issue.

 

Issued share capital - Ordinary Shares of £0.01 each

 

Number of shares

Weighted average shares

1 January 2017

208,339,632

 163,336,437

30 June 2017

208,339,632

208,339,632

 

 

 

11 October 2017 - Issue of share by Amryt Pharma plc - share placing

66,477,651

 

 

 

 

31 December 2017

274,817,283

223,075,123

30 June 2018

274,817,283

274,817,283

 

 

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

 

6 months to

30 June 2018

6 months to

30 June 2017

 12 months to 31 December 2017

Loss after tax attributable to equity holders of the Company (€'000)

(11,384)

(13,826)

(26,136)

Weighted average number of Ordinary Shares in issue

274,817,283

208,339,632

223,075,123

Fully diluted average number of Ordinary Shares in issue

274,817,283

208,339,632

223,075,123

Basic and diluted loss per share (cent)

(4.14)

(6.64)

(11.72)

 

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 30 June 2018 totalled 42,800,067 (30 June 2017: 37,430,035) (31 December 2017: 42,800,067) and are potentially dilutive in the future.

 

 

 

6. Intangible Assets

 

In process R&D

Software

Patents and Licenses

Website development

Total

 

€'000

€'000

€'000

€'000

€'000

Cost

 

 

 

 

 

At 1 January 2017

52,515

8

-

-

52,523

Additions

-

-

-

87

87

At 31 December 2017 (audited)

52,515

8

-

87

52,610

At 1 January 2018

52,515

8

-

87

52,610

Additions

-

-

91

-

91

At 30 June 2018 (unaudited)

52,515

8

91

87

52,701

 

 

 

 

 

 

Accumulated amortisation

 

 

 

 

 

At 1 January 2017

-

2

-

-

2

Amortisation charge 2017

-

2

-

-

2

At 31 December 2017 (audited)

-

4

-

-

4

At 1 January 2018

-

4

-

-

4

Amortisation charge 2018

-

1

3

15

19

At 30 June 2018 (unaudited)

-

5

3

15

23

 

 

 

 

 

 

Net book value

 

 

 

 

 

 

Net book value at 31 December 2017 (audited)

 

 

52,515

 

 

3

-

 

 

87

52,606

 

Net book value at 30 June 2018 (unaudited)

 

 

52,515

 

 

4

 

 

88

 

 

72

52,679

 

Additions during the period relate to the cost of the licence extension to expand the territories covered under the licence agreement signed with Novelion for our commercial product, Lojuxta.

 

The Group reviews the carrying amounts of its intangible assets on an annual basis to determine whether there are any indications that those assets have suffered an impairment loss. If any such indications exist, 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 utilised in valuing in process R&D. These 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.

 

 

 

7. Property, plant and equipment

 

 Property

 Plant and Machinery

Office Equipment

 

Total

 

€'000

€'000

€'000

€'000

Cost

 

 

 

 

1 January 2017

337

801

237

1,375

Additions

-

147

96

243

Disposals

-

(43)

(6)

(49)

At 31 December 2017 (audited)

337

905

327

1,609

At 1 January 2018

337

905

327

1,609

Additions

-

6

28

34

At 30 June 2018 (unaudited)

337

911

355

1,643

Accumulated depreciation

 

 

 

 

At 1 January 2017

61

88

43

192

Depreciation charge

87

116

54

257

Depreciation charge on disposals

-

(35)

(5)

(40)

At 31 December 2017 (audited)

148

169

92

449

At 1 January 2018

148

169

92

449

Depreciation charge

44

65

30

139

At 30 June 2018 (unaudited)

192

234

122

588

Net book value

 

 

 

 

Net book value at 31 December 2017 (audited)

189

736

235

1,160

Net book value at 30 June 2018 (unaudited)

145

677

233

1,055

 

8. Share capital - Company

 

Details of ordinary shares of 1p each issued are in the table below:

 

 

 

 

 

 

 

 

Date

Number of

ordinary shares

Number of deferred shares

Total Share Capital

€'000

Total Share Premium

€'000

At 31 December 2016

208,339,632

43,171,134

20,419

43,695

11 October 2017 - Issue of ordinary shares at £0.20p

66,477,651

-

754

13,639

At 31 December 2017 and 30 June 2018

274,817,283

43,171,134

21,173

57,334

          

 

On 11 October 2017, 66,477,651 ordinary shares of 1p were issued as part of a €15,083,000 (before expenses) fund raising. Share issue costs amounted to €690,000. Net proceeds amounted to €14,393,000.

 

 

 

9. Long term loan

 

 

30 June 2018

31 December 2017

 

 

€'000

€'000

 

Long term loan

10,000

10,000

 

Long term loan interest

1,045

603

 

Long term loan and interest

11,045

10,603

 

 

In December 2016, Amryt DAC entered into a €20m facility agreement ("facility") with the EIB on attractive terms for the Group. The facility is significant because it provides non-dilutive funding that secures the Group's near and mid-term funding needs for its lead product, AP101.

 

The facility is split into three tranches, with €10 million available immediately and two further tranches of €5 million available upon the achievement of certain milestones. In April 2017, the Group drew down the first tranche of €10 million. In October 2017, the terms of the second tranche of €5 million were amended by the EIB so the Group has the option to draw this amount down any time it wishes. Subsequent to the period end in September 2018 this tranche of €5 million was drawn by the Company. The third tranche is conditional on the primary clinical endpoints for the EASE Phase III clinical trials in the US or EU being achieved and therefore it can be concluded that the Phase III clinical trial has been successfully completed. The facility is secured and there is also a negative pledge whereby Amyrt cannot permit any security to be granted over any of its assets over the course of the loan period.

 

The facility has a five-year term from the date of drawdown for each tranche. The facility has an interest rate of 3% to be paid on an annual basis, with the first instalment paid in April 2018. At 30 June 2018, the Group has short term interest payable accrued amounting to €76,000 (31 December 2017: €227,000) which covers the period from 3 April 2018 to 30 June 2018. This interest will be paid on the second anniversary of the first tranche drawdown, being April 2019.

 

A further annual fixed rate of 10% is payable together with the outstanding principal amount on expiry of the facility. Long-term interest payable at 30 June 2018 amounted to €1,045,000 (31 December 2017: €603,000) which represents the present value of the long-term interest accrued but not payable until April 2022.

 

10. Copy of the Interim Report

Copies of the Interim Report are available to download from the Company's website at

www.amrytpharma.com  

Company Information

Registered Office

Dept 920A

196 High Road

Wood Green

London N22 8HH

United Kingdom

 

Company Number

5316808

 

Directors

Harry Stratford - Non-executive Chairman

Joseph Wiley - CEO

Rory Nealon - CFO

James Culverwell - Non-executive Director

Ray Stafford - Non-executive Director

Markus Ziener - Non-executive Director

 

Company Secretary

Rory Nealon

 

Company Website

www.amrytpharma.com

 

AIM Nominated Adviser

Shore Capital and Corporate Limited

Bond Street House

14 Clifford Street

London, W1S 4JU

United Kingdom

 

Joint Broker

Shore Capital Stockbrokers Limited

Bond Street House

14 Clifford Street

London, W1S 4JU

United Kingdom

 

Joint Broker

Stifel Nicolaus Europe Limited

150 Cheapside

London, EC2V 6ET

United Kingdom

 

ESM Adviser and Joint Broker

J & E Davy

Davy House

49 Dawson Street

Dublin 2

Ireland

Auditors

Grant Thornton

24-26 City Quay

Dublin 2

Ireland

 

Registrars

Link Asset Services

The Registry

34 Beckenham Road

Kent, BR3 4TU

United Kingdom

 

 

 

 

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END
 
 
IR UVSKRWOAKUAR
Date   Source Headline
6th Jan 20225:30 pmRNSAmryt Pharma
6th Jan 20227:00 amGNWKey Dates for AIM Delisting
4th Jan 202212:00 pmGNWThe Lancet Diabetes & Endocrinology Publishes Positive Results for the MPOWERED Phase 3 Trial for Mycapssa® (oral octreotide) in Acromegaly Patients
4th Jan 20227:00 amGNWTotal Voting Rights
1st Dec 20217:00 amGNWTotal Voting Rights
30th Nov 20217:00 amGNWDirector/PDMR Shareholding
23rd Nov 202112:00 pmGNWAmryt Provides Update on Regulatory Review Process for Oleogel-S10
22nd Nov 20217:00 amGNWAmryt Announces the Cancellation of Admission of its Ordinary Shares to Trading on AIM
3rd Nov 202111:00 amGNWAmryt Reports Strong Q3 2021 Results
1st Nov 20211:00 pmGNWTotal Voting Rights
1st Nov 20217:00 amRNSAmryt Supports Acromegaly Awareness Day
22nd Oct 20217:00 amRNSAmryt Supports Global EB Awareness Week 2021
20th Oct 202112:00 pmGNWAmryt to Report Q3 2021 Results and Host Conference Call & Webcast on November 3
19th Oct 202112:00 pmGNWAmryt Announces New Patents for Oleogel-S10 and Mycapssa®
23rd Sep 202112:00 pmRNSAmryt Supports Global FH Awareness Day
13th Sep 202112:00 pmGNWAmryt Raises Full Year 2021 Revenue Guidance to $220M - $225M
1st Sep 20217:00 amGNWTotal Voting Rights
19th Aug 20217:00 amGNWAmryt Issues Ordinary Shares and Total Voting Rights
13th Aug 20211:23 pmRNSHolding(s) in Company - Replacement
11th Aug 202111:30 amRNSHoldings in Company
11th Aug 202110:36 amRNSHolding(s) in Company
10th Aug 20212:20 pmGNWDirector/PDMR Shareholding
10th Aug 20219:53 amRNSHolding(s) in Company
9th Aug 202112:00 pmGNWAmryt Virtual Capital Markets Event - September 13, 2021 – 1000-1200 EDT
6th Aug 202112:00 pmGNWAmryt Reports Record Q2 2021 Results and Raises FY 2021 Guidance
5th Aug 20213:50 pmGNWAmryt Successfully Completes Acquisition of Chiasma, Inc., Board Appointments, Issues Ordinary Shares and Total Voting Rights
28th Jul 20213:00 pmGNWResult of General Meetings
12th Jul 202112:00 pmGNWAmryt to Report Q2 2021 Results and Host Conference Call & Webcast on August 6
28th Jun 202112:00 pmGNWPublication of Circular to Amryt Shareholders in relation to the acquisition of Chiasma, Inc., and posting of Annual Report and Notices of General Meetings
15th Jun 202111:45 amGNWAmryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.
7th Jun 202112:00 pmGNWFDA confirms NDA for Oleogel-S10 will not require an Advisory Committee Meeting
3rd Jun 20217:00 amGNWFDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
2nd Jun 20211:30 pmGNWAmryt Announces FDA Acceptance of New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa
5th May 20214:41 pmRNSSecond Price Monitoring Extn
5th May 20214:35 pmRNSPrice Monitoring Extension
5th May 202112:05 pmGNWAmryt Reports Record Q1 2021 Financial and Operating Results
5th May 202112:00 pmGNWAmryt Pharma to Acquire Chiasma, Inc. to Further Strengthen Global Leadership in Rare and Orphan Diseases
15th Apr 202112:00 pmGNWAmryt to Report Q1 2021 Results and Host Conference Call & Webcast on May 5
6th Apr 20217:00 amGNWAmryt Announces the Appointment of Sheila Frame as President Americas
31st Mar 202111:00 amRNSAmryt Supports World Lipodystrophy Day
31st Mar 20217:00 amGNWAmryt Submits a New Drug Application to the US Food and Drug Administration for Oleogel-S10* (Filsuvez®)
30th Mar 20217:00 amGNWAmryt Announces Results from an Investigator Sponsored Study of Lomitapide in FCS
29th Mar 20217:00 amGNWAmryt Announces Validation of its MAA by the EMA for Oleogel-S10* (Filsuvez®)
23rd Mar 20217:00 amGNWAmryt Receives Positive Feedback from the FDA on the Path Forward for Myalept® (metreleptin) Indication in Partial Lipodystrophy
22nd Mar 20217:00 amGNWAmryt Receives Reimbursement Approval from the French Ministry of Social Affairs and Health for Myalepta® (metreleptin)
15th Mar 202110:00 amGNWDirector/PDMR Shareholding
12th Mar 20217:00 amGNWExercise of Options and Total Voting Rights
11th Mar 202111:30 amGNWExercise of Warrants & Issue of Ordinary Shares and Total Voting Rights
8th Mar 20216:00 pmGNWDirector/PDMR Shareholding
8th Mar 20217:00 amGNWAmryt and Medison Pharma Sign Distribution Agreement for Myalepta® (metreleptin) in Canada

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