Amryt Reports Q3 2022 Financial and Operational Results

Amryt Pharma plc

Amryt Reports Q3 2022 Financial and Operational Results

8.2% YoY revenue growth in Q3 to $61.1M - 12.5% on a constant currency basis

11^th consecutive quarter of positive EBITDA generation; $12.5M in Q3 2022

Operating cash flows of $14.3M for Q3 2022

Cash of $83.4M at September 30, 2022

Mycapssa® revenues increased 26.9% QoQ to $5.7M and 292.8% YoY

CHMP positive opinion for Mycapssa® for the treatment of acromegaly in the EU

Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023

Filsuvez® European launch progressing well

Significant metreleptin LATAM $8.3M tender won - revenue expected to be recognized in Q4

Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth

Conference call and webcast today at 0830 ET / 1230 GMT

DUBLIN, Ireland, and Boston MA, November 3, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the third quarter ended September 30, 2022.

Joe Wiley, CEO of Amryt Pharma, commented: “We are pleased to report today’s strong operational and financial results which reflect another excellent quarter for Amryt. These results demonstrate the robust growth we are experiencing and represent our eleventh consecutive quarter of positive EBITDA generation.

Our commercial team delivered a record Mycapssa® quarter with revenue growth of 26.9% QoQ and 292.8% YoY which illustrates the success of the relaunch initiatives we highlighted previously. In Q3, we added an additional 31 new prescribers which brings the YTD total new prescribers to 89, the vast majority of whom are community-based physicians. During the quarter, we also successfully negotiated our first PBM contract with Express Scripts which will greatly simplify the patient access process for Mycapssa®.

Regarding Filsuvez®, the MHRA approved the product for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients 6 months and older in Great Britain.   This follows on from the approval earlier on in the summer of Filsuvez® in the EU. Filsuvez® has now been launched successfully in Europe and we are encouraged by early demand.

Given the strong underlying performance of our business year to date and notwithstanding the significant impact of the strengthening US dollar on our Euro revenues, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021.”

Q3 2022 and Recent Business Highlights:
Metreleptin

• Metreleptin delivered significant growth in the US with revenues growing by 10.3% YoY in Q3 2022 with patients on therapy in the US now at an all time high

• Robust EMEA patient demand continued in Q3 and patients on therapy grew by 25.4% YoY, however revenues were impacted by a strong US dollar. Growth on a constant currency basis during Q3 would have been 13.8% YoY.

• EMEA growth drivers include reimbursement for partial lipodystrophy (PL) in Italy, general lipodystrophy (GL) in the Netherlands and a strong performance in Turkey and the Middle East

• Reimbursement processes are also being progressed in six other EMEA markets

• Significant LATAM tender process won and order for $8.3M expected in Q4 revenues
  
  

Lomitapide

• EMEA lomitapide revenues impacted by strong US dollar despite increasing patient numbers

• Robust EMEA patient demand continued in Q3 and patients on therapy grew by 20.6% YoY. Revenue growth on a constant currency basis during Q3 would have been 11.8% YoY.

• Performance in Q3 has been strong in all EU countries - driven by Germany, Greece and Spain

• Recent $6M annualized Saudi Arabia tender awarded with deliveries expected in Q4 2022

Mycapssa®

• Mycapssa® relaunch progressing well - steady increase in prescriber base with an additional 31 new prescribers added in Q3, 97% of whom were community-based physicians - this brings the YTD total for new prescribers to 89

• Continued engagement with broad group of endocrinologists during the quarter through in person calls and presence at 11 regional conferences

• Additional 22 million covered lives for Mycapssa®️, as a result of successful removal from Express Scripts National Formulary Exclusion list effective early September

• Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023

• CHMP positive opinion for the use of Mycapssa® in Acromegaly in the EU - European Commission (EC) recommendation is expected on Mycapssa® by end of Q4 2022

• COMP positive opinion on Orphan Disease Designation for Mycapssa® for the treatment of acromegaly

• Presented Mycapssa® data from MPOWERED Phase 3 trial at ENEA 2022 meeting

• Mycapssa® new US patent announced, further strengthening IP portfolio with protection to 2040

• Received Orphan Drug Designation from the FDA for Mycapssa® for the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET)
  
  

Filsuvez®¹

• Filsuvez® launched in Germany in September

• Good demand since launch - exceeding forecasts in first month

• Strong inbound interest from other EU countries

• Expect to begin deliveries to EB patients in other EU countries by end Q4

• Filsuvez® approved in Great Britain for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients 6 months and older

• Presented new positive open-label 12-month data analyses from the EASE Phase 3 trial in EB at SPD 2022

• British Journal of Dermatology published results from EASE Phase 3 Trial in EB
  
  

Corporate

• Stock repurchase program - 294,182 ADSs purchased in Q3 2022 at a weighted average price of $7.43 for a total cost of approx. $2.19M

• Distribution agreements signed with Farmamondo for markets within the APAC region

• Legacy Aegerion Corporate Integrity Agreement (CIA) - term of enforcement ended in September 2022

• FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021

Q3 2022 Commercial Product Performance:

	Q3 2022 (unaudited)
US$’000	US	EMEA	Other	Total
Metreleptin	20,670	16,381	875	37,926
Lomitapide	7,967	6,149	3,069	17,185
Mycapssa®	5,708	-	-	5,708
Filsuvez®	-	27	192	219
Other	-	88	-	88
Total revenue	34,345	22,645	4,136	61,126

	Q3 2021 (unaudited)
US$’000	US	EMEA	Other	Total
Metreleptin	18,748	15,618	1,926	36,292
Lomitapide	8,568	6,406	3,565	18,539
Mycapssa®	1,453	-	-	1,453
Filsuvez®	-	-	69	69
Other	-	166	-	166
Total revenue	28,769	22,190	5,560	56,519

• 8.2% YoY revenue growth in Q3 2022 to $61.1M (Q3 2021: $56.5M); 12.5% YoY revenue growth on a constant currency basis

• 4.5% increase in metreleptin revenues YoY to $37.9M in Q3 2022 (Q3 2021: $36.3M)

• US accounted for 54.5% of global metreleptin revenues and EMEA accounted for 43.2% in Q3 2022

• US metreleptin revenues grew by 10.3% YoY and EMEA metreleptin revenues grew by 4.9% YoY in Q3 2022

• US accounted for 46.4% of global lomitapide revenues and EMEA accounted for 35.8% in Q3 2022

• 292.8% increase in Mycapssa® revenues YoY to $5.7M in Q3 2022 (Q3 2021: $1.5M) and 26.9% growth versus Q2 2022

Q3 2022 Financial Highlights:

• $10.5M operating loss before finance expense for Q3 2022 (Q3 2021: $21.4M operating loss). Excluding non-cash items and share based compensation expenses, this resulted in EBITDA³ of $12.5M.

• Filsuvez® EMA approval €10.0M ($9.7M) milestone payment paid in Q3 2022

• Filsuvez® CVR on EMA approval of $5.7M paid in Q3 2022

• Cash of $83.4M at September 30, 2022 (June 30, 2022: $90.7M). Excluding the impact of the EMA milestone payment and CVR, cash would have increased to $98.8M at September 30, 2022.

• The strengthening US dollar impacts Euro denominated revenues but has a negligible effect on EBITDA given the natural hedge created by Euro denominated costs
  
  

IFRS and non-GAAP adjusted Q3 2022 results:

US$M	Q3 2021 (unaudited)	Q3 2022 (unaudited)	Q3 2022 Non-cash adjustments2	Q3 2022 Non-GAAP Adjusted
Revenue	56.5	61.1	-	61.1
Gross profit	29.3	27.4	19.7	47.1
R&D expenses	(11.0)	(8.0)	-	(8.0)
SG&A expenses	(25.7)	(27.0)	0.4	(26.6)
Restructuring and acquisition costs	(11.3)	-	-	-
Share based compensation expenses	(2.7)	(2.9)	2.9	-
Operating (loss) / profit before finance expense	(21.4)	(10.5)	23.0	12.53
Operating (loss) / profit before finance expense and restructuring and acquisition costs	(10.1)	(10.5)	23.0	12.53

1  Filsuvez® (birch extract) gel (“Filsuvez®”) has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older.

2  Non-cash items include amortisation of the acquired metreleptin, lomitapide, Mycapssa® and Filsuvez® intangible assets ($16.6M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($3.1M), depreciation and amortisation ($0.4M) and share based compensation expenses ($2.9M).

3  EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS.

Filsuvez® Regulatory Update:
In June and September respectively, Amryt announced the European Commission (EC) and UK Medical Healthcare & Products Regulatory Agency (MHRA) approval of Filsuvez® in the European Union (EU) and Great Britain for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

The EC and MHRA approvals of Filsuvez® are supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

As previously announced, Amryt plans to proceed to the Formal Dispute Resolution pathway with the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. The Company expects to submit the formal dispute resolution in November 2022.

Guidance & Outlook:
Given the continued strong performance of the Company’s commercial products and notwithstanding the impact of the strengthening US dollar on the Company’s Euro denominated revenues, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021.

Conference Call & Webcast:
Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1230 GMT.

Webcast Player URL: https://edge.media-server.com/mmc/p/6nxxorrj

Telephone Dial in details:

Standard International Number	+ 39 (0) 02 802 0911
United States	+1 718 705 8796
United Kingdom	+44 (0) 1212 818004
Ireland	+353 (1) 526 9444

A playback facility will be available from November 3, 2022 - November 10, 2022. Access details for the playback facility are as follows: Dial +39 02 802 0987 then press 700723# and 723#.

About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®).

Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link.

Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and has received a positive opinion by the CHMP recommending the approval of Mycapssa® in the European Union (EU). For additional information, please follow this link.

Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

Filsuvez® (Oleogel-S10) is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older.

Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders.

For more information on Amryt, including products, please visit www.amrytpharma.com.

Forward-Looking Statements
This announcement may contain forward-looking statements and 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 Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management.

Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com
Tim McCarthy, LifeSci Advisors, LLC, +1 (917) 679 9282, tim@lifesciadvisors.com

Amryt Pharma plc
Condensed Consolidated Statement of Comprehensive Loss

			Three Months Ended September 30,				Nine Months Ended September 30,
	Note		2022 (unaudited)		2021 (unaudited)		2022 (unaudited)		2021 (unaudited)
			US$’000		US$’000		US$’000		US$’000
Revenue	3		61,126		56,519		188,791		167,713
Cost of product sales			(14,036)		(14,127)		(45,502)		(41,108)
Amortization of acquired intangibles			(16,593)		(12,701)		(45,490)		(34,184)
Inventory fair value step-up			(3,074)		(437)		(6,850)		(1,641)
Total of cost of sales			(33,703)		(27,265)		(97,842)		(76,933)
Gross profit			27,423		29,254		90,949		90,780
Research and development expenses			(8,005)		(11,000)		(28,556)		(28,454)
Selling, general and administrative expenses			(26,976)		(25,706)		(82,918)		(62,438)
Restructuring and acquisition costs	5		(9)		(11,226)		(676)		(14,679)
Share based payment expenses	4		(2,902)		(2,689)		(8,930)		(5,905)
Operating loss before finance expense			(10,469)		(21,367)		(30,131)		(20,696)
Non-cash change in fair value of contingent consideration	5		(771)		(3,030)		3,522		(8,897)
Non-cash contingent value rights (loss)/gain	5		(504)		(1,915)		781		(5,515)
Net finance expense – other			(6,356)		(6,424)		(24,243)		(20,163)
Loss on ordinary activities before taxation			(18,100)		(32,736)		(50,071)		(55,271)
Tax (charge)/credit on loss on ordinary activities			(2,695)		15,527		7,736		14,726
Loss for the period attributable to the equity holders of the Company			(20,795)		(17,209)		(42,335)		(40,545)
Exchange translation differences which may be reclassified through profit or loss			(14)		240		(383)		2,583
Total other comprehensive (loss)/income			(14)		240		(383)		2,583
Total comprehensive loss for the period attributable to the equity holders of the Company			(20,809)		(16,969)		(42,718)		(37,962)
Loss per share
Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)	6		(0.06)		(0.07)		(0.13)		(0.20)

Amryt Pharma plc
Condensed Consolidated Statement of Financial Position

			As at,
	Note		September 30, 2022 (unaudited)		December 31, 2021 (restated*)
			US$’000		US$’000
Assets
Non-current assets
Goodwill	7		54,124		54,124
Intangible assets	7		449,816		503,330
Property, plant and equipment			6,738		7,416
Other non-current assets			1,749		1,885
Total non-current assets			512,427		566,755
Current assets
Trade and other receivables	8		50,810		53,908
Inventories	9		90,238		81,835
Cash and cash equivalents, including restricted cash	10		83,400		113,032
Total current assets			224,448		248,775
Total assets			736,875		815,530
Equity and liabilities
Equity attributable to owners of the parent
Share capital	11		25,561		25,500
Share premium	11		322,982		318,153
Other reserves	11		247,122		246,303
Accumulated deficit			(271,388)		(231,194)
Total equity			324,277		358,762
Non-current liabilities
Contingent consideration and contingent value rights	5		51,820		81,113
Deferred tax liability			5,809		15,144
Long term loan	12		98,945		93,395
Convertible notes	13		109,655		105,788
Provisions and other liabilities	14		3,225		4,049
Total non-current liabilities			269,454		299,489
Current liabilities
Trade and other payables			134,947		149,734
Provisions and other liabilities	14		6,966		7,545
Contingent consideration	5		1,231		—
Total current liabilities			143,144		157,279
Total liabilities			412,598		456,768
Total equity and liabilities			736,875		815,530

*see Note 16

Amryt Pharma plc
Condensed Consolidated Statement of Cash Flows

	Nine months ended September 30,
	Note		2022 (unaudited)		2021 (unaudited)
			US$’000		US$’000
Cash flows from operating activities
Loss on ordinary activities after taxation			(42,335)		(40,545)
Net finance expense - other			24,243		20,163
Depreciation and amortization			46,672		35,238
Amortization of inventory fair value step-up			6,850		1,641
Share based payment expenses	4		8,930		5,905
Non-cash change in fair value of contingent consideration	5		(3,522)		8,897
Non-cash contingent value rights (loss)/gain	5		(781)		5,515
Deferred taxation credit			(9,335)		(15,677)
Movements in working capital and other adjustments:
Change in trade and other receivables	8		3,287		(2,609)
Change in trade and other payables			(17,205)		(108,468)
Change in provision and other liabilities	14		(848)		(2,756)
Change in inventories			(15,253)		39
Change in non-current assets			136		763
Net cash flow from/(used in) operating activities			839		(91,894)
Cash flow from investing activities
Net cash received on acquisition of subsidiary			—		107,942
Milestone payments for contingent consideration and contingent value rights			(16,208)		—
Payments for property, plant and equipment			(892)		(92)
Payments for intangible assets			(109)		(830)
Deposit interest received			135		3
Net cash flow used in investing activities			(17,074)		107,023
Cash flow from financing activities
Net proceeds/(costs) from issue of equity instruments			1,311		(116)
Payments for share repurchases under Share buyback program			(2,197)		—
Proceeds from long term borrowings - net of debt issue costs			98,344		—
Repayment of long term debt			(98,761)		—
Interest paid			(8,997)		(7,597)
Payment of leases			(912)		(789)
Net cash flow used in financing activities			(11,212)		(8,502)
Exchange and other movements			(2,185)		(2,248)
Net change in cash and cash equivalents			(29,632)		4,379
Cash and cash equivalents at beginning of the period			113,032		118,798
Restricted cash at end of the period	10		150		50
Cash at bank available on demand at end of the period	10		83,250		123,127
Total cash and cash equivalents at end of the period	10		83,400		123,177

Amryt Pharma plc
Condensed Consolidated Statement of Changes in Equity
For the period ended September 30, 2022

	Note		Share capital		Share premium		Treasury shares		Share based payment reserve		Merger reserve		Reverse acquisition reserve		Equity component of convertible notes		Other distributable reserves		Currency translation reserve		Accumulated deficit		Total
			US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000
Balance at January 1, 2022 as restated*			25,500		318,153		—		20,593		42,627		(73,914)		29,210		217,634		10,153		(231,194)		358,762
Loss for the period			—		—		—		—		—		—		—		—		—		(42,335)		(42,335)
Foreign exchange translation reserve			—		—		—		—		—		—		—		—		(383)		—		(383)
Total comprehensive loss			—		—		—		—		—		—		—		—		(383)		(42,335)		(42,718)
Transactions with owners
Issue of shares for share options exercised and vesting of RSUs	11		120		6,535		—		(5,155)		—		—		—		—		—		—		1,500
Shares repurchased from Share buyback	11		(59)		(1,706)		(432)		—		—		—		—		—		—		—		(2,197)
Share based payment expense	4		—		—		—		8,930		—		—		—		—		—		—		8,930
Share based payment expense – Lapsed			—		—		—		(2,141)		—		—		—		—		—		2,141		—
Total transactions with owners			61		4,829		(432)		1,634		—		—		—		—		—		2,141		8,233
Balance at September 30, 2022 (unaudited)			25,561		322,982		(432)		22,227		42,627		(73,914)		29,210		217,634		9,770		(271,388)		324,277

* see Note 16

For the period ended September 30, 2021

	Note		Share capital		Share premium		Warrant reserve		Treasury shares		Share based payment reserve		Merger reserve		Reverse acquisition reserve		Equity component of convertible notes		Other distributable reserves		Currency translation reserve		Accumulated deficit		Total
			US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000		US$’000
Balance at January 1, 2021 (audited)			13,851		51,408		14,762		(7,421)		7,860		42,627		(73,914)		29,210		217,634		5,730		(235,605)		66,142
Loss for the period			—		—		—		—		—		—		—		—		—		—		(40,545)		(40,545)
Foreign exchange translation reserve			—		—		—		—		—		—		—		—		—		2,583		—		2,583
Total comprehensive loss			—		—		—		—		—		—		—		—		—		2,583		(40,545)		(37,962)
Transactions with owners
Issue of treasury shares in exchange for warrants	11		23		99		—		439		—		—		—		—		—		—		—		561
Issue of treasury shares for share options exercised	11		25		89		—		465		(191)		—		—		—		—		—		—		388
Issue of shares and treasury shares in exchange for warrants	11		749		7,496		(14,762)		6,517		—		—		—		—		—		—		—		—
Issue of shares in consideration of Chiasma acquisition	5		10,547		249,789		—		—		—		—		—		—		—		—		—		260,336
Share based payment reserve recognized on Chiasma acquisition	11		—		—		—		—		10,157		—		—		—		—		—		—		10,157
Issue of shares for share options exercised and vesting of RSUs	11		66		1,897		—		—		(1,467)		—		—		—		—		—		—		496
Share based payment expense	4		—		—		—		—		5,905		—		—		—		—		—		—		5,905
Share based payment expense - Lapsed			—		—		—		—		(54)		—		—		—		—		—		54		—
Total transactions with owners			11,410		259,370		(14,762)		7,421		14,350		—		—		—		—		—		54		277,843
Balance at September 30, 2021 (unaudited)			25,261		310,778		—		—		22,210		42,627		(73,914)		29,210		217,634		8,313		(276,096)		306,023

1. General information

Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.

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

Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”) remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was January 10, 2022.

Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®).

Filsuvez® (Oleogel-S10) is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older.

During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s New Drug Application (NDA) for Oleogel-S10. Following this meeting, Amryt is proceeding to the Formal Dispute Resolution pathway in the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. The Company expects to submit the formal dispute resolution in November.

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 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, 2021. 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, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022.

Results for the nine-month period ended September 30, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022.

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.

As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended September 30, 2022.

Basis of consolidation

The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended September 30, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control.

Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements.

Presentation of balances

The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group.

The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group:

Foreign currency units to 1 US$	€		£		ILS		NOK		DKK
Average three-month period to September 30, 2022 (unaudited)	0.9919		0.8496		3.3994		9.9752		7.3795
Average nine-month period to September 30, 2022 (unaudited)	0.9403		0.7966		3.3118		9.4089		6.9958
At September 30, 2022 (unaudited)	1.0275		0.9148		3.5461		10.7479		7.6414

Foreign currency units to 1 US$	€		£		ILS		NOK		DKK
Average period to December 31, 2021 (audited)	0.8454		0.7271		3.2322		8.5975		6.2875
At December 31, 2021 (audited)	0.8830		0.7413		3.1115		8.8074		6.5664

Foreign currency units to 1 US$	€		£		ILS		NOK		DKK
Average three-month period to September 30, 2021 (unaudited)	0.8479		0.7252		3.2342		8.7609		6.3057
Average nine-month period to September 30, 2021 (unaudited)	0.8358		0.7221		3.2573		8.5522		6.2158
At September 30, 2021 (unaudited)	0.8589		0.7417		3.2149		8.7140		6.3870

(€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, 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, 2022, that are relevant to the Group.

Critical accounting judgements and key sources of estimation uncertainty

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

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

The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021.

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, 2021.

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 four commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need.

The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer.

	Three months ended September 30, 2022 (unaudited)
	U.S.		EMEA		Other		Total
	US$’000		US$’000		US$’000		US$’000
Metreleptin	20,670		16,381		875		37,926
Lomitapide	7,967		6,149		3,069		17,185
Mycapssa®	5,708		—		—		5,708
Filsuvez®	—		27		192		219
Other	—		88		—		88
Total revenue	34,345		22,645		4,136		61,126

	Three months ended September 30, 2021 (unaudited)
	U.S.		EMEA		Other		Total
	US$’000		US$’000		US$’000		US$’000
Metreleptin	18,748		15,618		1,927		36,293
Lomitapide	8,568		6,406		3,564		18,538
Mycapssa®	1,453		—		—		1,453
Filsuvez®	—		—		69		69
Other	—		166