AMYT.L Regulatory News (AMYT)

AMRYT ANNOUNCES Q2 2020 RESULTS AND ISSUES POSITIVE REVENUE GUIDANCE FOR FY 2020

New revenue guidance of $170M - $175M in 2020

Conference call and webcast today 0830 ET / 1330 BST

DUBLIN, Ireland, and Boston MA, August 6, 2020, Amryt (Nasdaq: AMYT, AIM: AMYT, Euronext Growth: AYP), 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 second quarter ended June 30, 2020.

· 22% YoY growth in unaudited Q2 revenues to $46.2M (Q2 20191 unaudited combined revenues: $37.9M)

· 26% YoY increase in unaudited H1 revenues to $90.8M (H1 20191 unaudited combined revenues: $72.3M)

· 4% QoQ unaudited revenue growth in Q2 versus Q1 ($44.6M). 9% growth QoQ excluding the impact of irregular orders in Q1 and Q2

· $12.0M operating loss before finance expense in Q2. Excluding non-cash items and share based compensation expenses, this resulted in EBITDA2 of $6.9M in Q2 representing 50% QoQ growth and delivering $11.5M EBITDA2 for H1

· Strong cash generation during H1 with $9.7M of cash generated from operating activities

· Robust financial position with $67.0M in unrestricted cash at June 30, 2020

· Issuing FY 2020 revenue guidance of between $170M and $175M (20191: $154.1m)

· On July 8, 2020, Amryt listed on the Nasdaq Global Select Market ("Nasdaq")

Joe Wiley, CEO of Amryt Pharma, commented: 

"The very positive momentum we experienced during 2019 and Q1 this year has been maintained through Q2 and I am pleased to report that our business continues to perform and grow beyond our expectations, notwithstanding the obvious challenges we have faced in working through the very different environment presented by the COVID-19 pandemic. Our primary focus remains the health and well-being of our team, patients, carers, partners and their families.

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 had in place for some time, the management team, systems and infrastructure to support and scale the growth of our global business.

Our exciting development pipeline of new therapeutic drug candidates for diseases where there is a high unmet medical need continues to progress in line with our expectations. In particular, we look forward to announcing top-line data from our EASE Phase 3 global clinical trial in late Q3 / early Q4.

Despite the uncertainties brought about by COVID-19, we believe we have good visibility on our commercial business in the second half of the year. Our confidence in the stability and prospects for our business is illustrated today as we are issuing formal and positive guidance to the market for FY 2020 revenues."

Q2 and Recent Business Highlights:

· In June 2020, Amryt publicly filed a Registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to the listing of American Depositary Shares ("ADSs") on Nasdaq. Amryt's ADSs began trading on Nasdaq on July 8, 2020 under the symbol AMYT

· Amryt signed a distribution agreement for Myalepta® with Swixx BioPharma AG ("Swixx") across 17 jurisdictions in Central and Eastern Europe in June 2020

· EASE, Amryt's global pivotal Phase 3 trial in patients with dystrophic and junctional Epidermolysis Bullosa ("EB"), closed enrolment in April and is on track for top-line data readout in late Q3 / early Q4 2020

Q2 Financial Highlights:

Revenues

· $46.2M unaudited Q2 revenues representing a 22% increase on unaudited combined revenues of $37.9M in Q2 20191

· 4% quarter on quarter unaudited revenue growth in Q2 2020 versus Q1 2020 ($44.6M). 9% growth quarter on quarter excluding the impact of irregular orders in Q1 and Q2

· 33% growth in Myalept® / Myalepta® (metreleptin) revenues to $27.9M in the quarter (Q2 2019: unaudited combined revenues1  $20.9M). Metreleptin revenues were bolstered by a $1.1M order which typically occurs once annually

· 8% increase in Juxtapid®/Lojuxta® (lomitapide) revenues to $18.1M in the quarter (Q2 2019: unaudited combined revenues1  $16.8M)

· US revenues accounted for 52% of total global revenues in Q2

· EMEA revenues accounted for 38% of global revenues, driven by the continued rollout of metreleptin post European Medicines Agency ("EMA") approval in 2018. Q2 revenues for EMEA were favourably impacted by seasonal patterns and by forward ordering in certain jurisdictions driven by the COVID-19 pandemic

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.

Statutory and adjusted Q2 results:

2 EBITDA is earnings before interest, tax, depreciation, amorstisation 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.

3 Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($11.1M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($6.5M), depreciation ($0.5M) and share based compensation expenses ($0.8M).

The Q2 operating loss of $12.0M 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 $6.9M of EBITDA2 for the quarter. R&D expenses decreased to $6.2M in Q2 (Q1: $8.9M). SG&A expenses increased in Q2 to $21.6M (Q1: $18.4M).

Financial Position:

Cash generated from operating activities in Q2 was $3.5M. During the quarter, the Company paid $4.0M in net finance payments, $4.2M in residual payments related to legacy fines levied on Aegerion and $0.1M in capital expenditure. The legacy fines will be fully discharged by the end of Q1 2021. At June 30, 2020, the Company had unrestricted cash and cash equivalents of $67.0M (unaudited), compared to unrestricted cash and cash equivalents at December 31, 2019 of $65.2M (audited).

Financial Guidance and Outlook:

Revenues for the FY 2020 are expected to be in the range $170M - $175M. This forecast takes into account the seasonality and forward-ordering patterns already identified in Q2 and the impact of variable orders in H1.

Webcast and Conference Call:

Management will host a webcast for analysts and investors today at 0830 ET / 1330 BST.

Webcast Player URL: https://edge.media-server.com/mmc/p/7ujspsgk 

Telephone Dial in details:

A playback facility will be available from August 6, 2020 at 1330 ET / 1830 BST - August 13, 2020 at 1330 ET / 1830 BST. Access details as follows: Confirmation Code: 7674874 | US: + 1 917 677 7532 | UK/International: +44 (0) 3333 00 9785 | Ireland: +353 (1) 553 8777.

Enquiries:

About Amryt

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

Amryt's commercial business comprises two orphan disease products.

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.

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.

Amryt's lead development candidate, FILSUVEZ® is a potential treatment for the cutaneous manifestations of Epidermolysis Bullosa ("EB"), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. FILSUVEZ® has been granted Rare Pediatric Disease Designation and has also received a Fast Track Designation from the U.S. Food and Drug Administration. The European and US market opportunity for EB is estimated by the Company to be in excess of $1.0 billion.

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, Nicholas Moore) are Joint Broker to the company in the UK. Davy (John Frain, Daragh O'Reilly) act as Euronext Growth advisor and Joint Broker to the company in Dublin.

Forward-Looking Statements

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

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), the AIM market of the London Stock Exchange (ticker: AMYT) and the Euronext Growth Exchange of the Irish Stock Exchange (ticker: AYP).

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 June 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 six months ended June 30, 2019 have been restated to reflect the 2019 share consolidation.

On September 20, 2019, Amryt registered FILSUVEZ as the trademark name for the Group's 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 ("AIM") and the Euronext Growth Market in Dublin ("Euronext").

2. Accounting policies

Basis of preparation

The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (''IFRS'') and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2019. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group's financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group's audited financial statements for the year ended December 31, 2019 and those which are expected to be used in the financial statements for the year ending December 31, 2020.

Results for the six-month period ended June 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 Group's current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis.

A key consideration for the impact on going concern is the acquisition of Aegerion, which was completed in 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 Group's ability to continue as a going concern.

Basis of consolidation

The condensed consolidated interim financial statements comprise the financial statements of the Group for the six months ended June 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:

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

Changes in accounting policies and disclosures

There are no new standards and amendments to IFRS effective as of January 1, 2020 that are relevant to the Group.

Critical accounting judgements and key sources of estimation uncertainty

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

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

The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group's audited financial statements for the year ended December 31, 2019.

Principal accounting policies

The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group's audited financial statements for the year ended December 31, 2019.

3. Segment information

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

The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of two commercial products and two development products. The Group derives its revenues primarily from one source, the pharmaceutical sector with high unmet medical need.

The Group's Chief Executive Officer, Joseph Wiley, is currently the Group's chief operating decision maker (''CODM''). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments.

The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Revenues represent the revenue from the Group for the three and six months ended June 30, 2020 and 2019. Revenue in the three and six months ended June 30, 2020 include revenues from the acquired Aegerion Group and associated products and regions. Revenues in the three and six months ended June 30, 2019 do not include revenues from the acquired Aegerion Group as this acquisition was completed in September 2019.

Major Customers

For the three and six months ended June 30, 2020, one customer accounted for 52% and 53%, respectively, of the Group's net revenues and accounted for 31% of the Group's June 30, 2020 accounts receivable balance. For the three and six months ended June 30, 2019, the Group generated over 66% and 68%, respectively, of its lomitapide revenue in Italy, the Netherlands and Greece. The largest lomitapide customer in the three and six months ended June 30, 2019 was a distributor in Italy.

4. Share based payments

On July 10, 2019, the shareholders of the Company approved a resolution to give authority to the Company to undertake a consolidation of the existing ordinary shares in the capital of the Company under which every 6 existing ordinary shares were consolidated into one ordinary share.

Under the terms of the Company's Employee Share Option Plan, options to purchase 17,081,601 shares were outstanding at June 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 2,687,000 share options were granted to employees in the six-month period ended June 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 June 30, 2020 and December 31, 2019 consisted of 17,196,273 zero cost warrants 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 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:

Fair value is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period:

In the six months ended June 30, 2020, a total of 2,687,000 share options exercisable at a weighted average price of £1.235 were granted. The fair value of share options granted in the six months ended June 30, 2020 was £3,318,445/US$4,249,000. The share options outstanding as at June 30, 2020 have a weighted remaining contractual life of 5.84 years with exercise prices ranging from £0.76 to £1.55.

The 2016 warrants outstanding as at June 30, 2020 have a weighted remaining contractual life of 0.8 years with an exercise price of £1.44.

The value of share options charged to the Consolidated Statement of Comprehensive Loss during the three and six month periods are as follows:

5. Business combinations and asset acquisitions

Acquisition of Aegerion Pharmaceuticals

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

The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group's existing business. No amount of goodwill is expected to be deductible for tax purposes.

The initial assignment of fair values to identifiable net assets acquired has been performed on a provisional basis due to the relative size of the acquisition and the timing of the transaction. Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the consolidated financial statements for the year ending December 31, 2020, as stipulated by IFRS 3 Business combinations.

Contingent Value Rights

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

The terms of the CVRs are as follows:

· The total CVR payable is up to US$85,000,000

· This is divided into three milestones which are related to the success of FILSUVEZ (the Group's lead development asset, currently in Phase 3 clinical trials)

· FDA approval

o US$35,000,000 upon FDA approval

o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022

· EMA approval

o US$15,000,000 upon EMA approval

o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022

· Revenue targets

o US$35,000,000 upon FILSUVEZ revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024

· Payment can, at the Board's discretion, be in the form of either:

o 120-day loan notes (effectively cash), or

o Shares valued using the 30 day / 45-day VWAP.

The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. On consolidation, given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill.

Measurement of CVRs

As at June 30, 2020, the carrying value of the CVRs was US$52,354,000 (December 31, 2019: US$49,413,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. Discount rates of 10% and 16.5% (December 31, 2019: 10% and 16.5%), as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the six months ended June 30, 2020. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of FILSUVEZ. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the expected cash flows of the CVRs.

Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge is booked on a quarterly basis. The Group expects to read out top-line data from the Phase 3 trial of FILSUVEZ in Epidermolysis Bullosa (''EB'') in late Q3 / early Q4 of 2020, followed by applications for approval from the FDA and the EMA, if top-line data is positive. Coupled with this, management has completed its annual forecast and revenues and costs reflect these current expectations.

The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and six months ended June 30, 2020 is US$1,493,000 and US$2,941,000, respectively (June 30, 2019: US$nil and US$nil, respectively).

Acquisition of Amryt AG (previously ''Birken'')

Amryt DAC signed a conditional share purchase agreement to acquire Amryt AG on October 16, 2015 (''Amryt AG SPA''). The Amryt AG SPA was completed on April 18, 2016 with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows:

· Milestone payments of:

o €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016);

o Either (i) €5,000,000 once net ex-factory sales of Episalvan have been at least €100,000 or (ii) if no commercial sales are made within 24 months of EMA first marketing approval (being January 14, 2016), €2,000,000 24 months after receipt of such approval, which was paid in January 2018, and €3,000,000 following the first commercial sale;

o €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB;

o €10,000,000 once net ex-factory sales/net revenue 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;

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

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

Fair Value Measurement of Contingent Consideration

As of June 30, 2020, the fair value of the contingent consideration was estimated to be US$59,353,000 (December 31, 2019: US$53,048,000). The fair value of the royalty payments was determined using probability weighted revenue forecasts and the fair value of the milestone payments was determined using probability adjusted present values (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. A discount rate of 24.4% (December 31, 2019: 24.4%) was used in the calculation of the fair value of the contingent consideration for the six months ended June 30, 2020. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of FILSUVEZ. However, management noted that due to issues outside their control, 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.

In January 2019, the Group received the results of an unblinded interim efficacy analysis for the Phase 3 trial of FILSUVEZ in EB. This analysis was conducted by an independent data safety monitoring committee and recommended that the trial should continue with an increase of 48 patients in the study to a total of 230 evaluable patients in order to be able to achieve 80% statistical power. In April 2020, given that the EASE study was already close to full enrollment, the Group announced that it had taken advice from an independent expert and concluded that the statistical impact of further patient recruitment would most likely be negligible. Amryt therefore decided to close the EASE study to further enrollment. The Group expects to read out top-line data from this trial in the second half of 2020, followed by applications for approval from the FDA and the EMA, if top-line data is positive. Coupled with this, management has completed its annual forecast and revenues and costs have been amended to reflect current expectations. These factors have resulted in a change to the probability weighted revenue forecasts and the probability of the adjusted present values which are used in the calculation of the contingent consideration balance and impact the amount being unwound to the consolidated statement of comprehensive loss.

Amryt reviews the contingent consideration on a regular basis as the probability adjusted fair values are being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. The finance charge is being unwound as a financing expense in the Consolidated Statement of Comprehensive Loss on a quarterly basis.

The total non-cash finance charge recognized in the Consolidated Statement of Comprehensive Loss for the three and six months ended June 30, 2020 is US$3,118,000 and US$6,024,000, respectively (June 30, 2019: US$1,913,000 and US$3,851,000, respectively).

6. Loss per share - basic and diluted

The weighted average number of shares in the loss per share (''LPS'') calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at June 30, 2020, as adjusted (see below).

Issued share capital - ordinary shares of £0.06 each

The number of shares in issue at June 30, 2019 has been adjusted to reflect the share consolidation on July 10, 2019, whereby each ordinary shareholder received one ordinary share for every six shares held at that date.

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

The basic and diluted loss per share for the three and six month period ended June 30, 2020 of US$0.12 and US$0.30, respectively (June 30, 2019: US$0.27 and US$0.39, respectively) was calculated using the post consolidation number of ordinary shares in issue.

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 June 30, 2020 totalled 34,623,416 (June 30, 2019: 4,654,351 as adjusted) and are potentially dilutive.

7. Intangible assets and goodwill

The following table summarizes the Group's intangible assets and goodwill: