GlobeNewswire Inc | May 5, 2021 07:05AM EDT

May 05, 2021































-- Submitted a New Drug Application to the FDA for Oleogel-S10 -- Marketing Authorisation Application (MAA)accepted by the EMA for Oleogel-S10 -- Reimbursement approval for metreleptin in England, Wales and France -- Positive feedback from the FDA on the path forward for metreleptin indication in partial lipodystrophy (PL) Phase 3 planned for Q4 2021 -- Positive results reported from an investigator sponsored study of lomitapide in familial chylomicronaemia syndrome(FCS) -- Multi-regional distribution and product agreements signed with Medison in Canada and in Israel -- Announced proposed acquisition of Chiasma, Inc. (Nasdaq: CHMA)



Q1 2021 (unaudited)

US EMEA Other Total

US$?000 US$?000 US$?000 US$?000

Metreleptin 16,239 12,971 750 29,960

Lomitapide 8,324 7,440 2,420 18,184

Other - 223 65 288

Total revenue 24,563 20,634 3,235 48,432

Q1 2020 (unaudited)

US EMEA Other Total

US$?000 US$?000 US$?000 US$?000

Metreleptin 14,914 8,628 3,385 26,927

Lomitapide 9,470 5,233 2,718 17,421

Other - 226 - 226

Total revenue 24,384 14,087 6,103 44,574

-- 8.7% revenue growth in Q1 2021 to $48.4M (Q1 2020: $44.6M) -- 16.5% underlying YoY revenue growth excluding aperiodic LATAM order in Q1 2020 that did not occur in Q1 2021. A significant order has now been received and will be booked in Q2 2021. -- 11.3% increase in metreleptin revenues YoY to$30.0M in Q1 2021 (Q1 2020: $26.9M).Excluding impact of periodic LATAM ordering, metreleptin revenues grew 25.3% in Q1. -- US accounted for 54.2% of global metreleptin revenues and EMEA accounted for 43.3% in Q1 2021. EMEA metreleptin revenuesincreased by50.3%in Q1 2021 versus Q1 2020. -- 4.4% increase in lomitapide revenues to$18.2M in Q1 (Q1 2020: $17.4M) -- US accounted for 45.8% of global lomitapide revenues and EMEA accounted for 40.9% in Q1 2021. EMEA lomitapide revenues increased by 42.2% in Q1 2021 versus Q1 2020. -- 13.9% QoQ revenue growth in Q1 2021 versus Q4 2020 ($42.5M)



-- $3.4M operating loss before finance expense for Q1 2021 (Q1 2020: $17.0M). Excluding non-cash items and share based compensation expenses, this resulted in EBITDA3 of $9.9M (Q1 2020: $4.6M). -- Cash of $118.6M at March 31, 2021 (Dec 31, 2020: $118.8M) -- Legacy fines levied on Aegerion were fully discharged in Q1 2021





Q1 2020 Q1 2021 Q1 2021US$M (unaudited) Q1 2021 Non-cash Non-GAAP (unaudited) adjustments^ Adjusted 2

Revenue 44.6 48.4 - 48.4

Gross profit 12.0 24.9 11.7 36.7

R&D expenses (8.9) (8.9) - (8.9)

SG&A expenses (18.4) (18.2) 0.3 (17.9)

Acquisition & severance (0.9) - - -related costs

Share based compensation (0.8) (1.3) 1.3 -expenses

Operating (loss) / profit 9.9^3before finance expense (17.0) (3.4) 13.3













https://edge.media-server.com/mmc/p/hdecnon9



United States +1 646 787 1226

United Kingdom +44 (0) 203 009 5709

Ireland +353 (1) 506 0626

Confirmation Code 8698345













www.amrytpharma.com























Three Months Ended March 31,

Note 2021 2020 (unaudited) (unaudited)

US$?000 US$?000

Revenue 3 48,432 44,574

Cost of sales (23,489) (32,620)

Gross profit 24,943 11,954

Research and development expenses (8,916) (8,934)

Selling, general and administrative expenses (18,156) (18,406)

Restructuring and acquisition costs 5 ? (853)

Share based payment expenses 4 (1,263) (745)

Operating loss before finance expense (3,392) (16,984)

Non-cash change in fair value of contingent 5 (2,874) (2,906)consideration

Non-cash contingent value rights finance expense 5 (1,763) (1,448)

Net finance expense - other (7,898) (9,416)

Loss on ordinary activities before taxation (15,927) (30,754)

Tax (charge)/credit on loss on ordinary activities (610) 1,857

Loss for the period attributable to the equity (16,537) (28,897)holders of the Company

Exchange translation differences which may be 2,547 (13)reclassified through profit or loss

Total other comprehensive income/(loss) 2,547 (13)

Total comprehensive loss for the period (13,990) (28,910)attributable to the equity holders of the Company



Loss per share

Loss per share - basic and diluted, attributable 6 (0.09) (0.19)to ordinary equity holders of the parent (US$)



As at,

March 31, December 31, Note 2021 2020 (unaudited) (audited)

US$?000 US$?000

Assets

Non-current assets

Goodwill 7 19,131 19,131

Intangible assets 7 292,315 305,369

Property, plant and equipment 7,156 7,574

Other non-current assets 1,484 1,542

Total non-current assets 320,086 333,616

Current assets

Trade and other receivables 8 43,963 43,185

Inventories 39,371 40,992

Cash and cash equivalents, including 9 118,551 118,798restricted cash

Total current assets 201,885 202,975

Total assets 521,971 536,591



Equity and liabilities

Equity attributable to owners of the parent

Share capital 10 13,899 13,851

Share premium 10 51,596 51,408

Other reserves 10 241,011 236,488

Accumulated deficit (252,142) (235,605)

Total equity 54,364 66,142

Non-current liabilities

Contingent consideration and contingent 5 149,064 148,323value rights

Deferred tax liability 6,753 6,612

Long term loan 11 88,769 87,302

Convertible notes 12 102,216 101,086

Provisions and other liabilities 13 26,649 25,951

Total non-current liabilities 373,451 369,274

Current liabilities

Trade and other payables 87,189 90,236

Provisions and other liabilities 13 6,967 10,939

Total current liabilities 94,156 101,175

Total liabilities 467,607 470,449

Total equity and liabilities 521,971 536,591





Three months ended March 31,

Note 2021 2020 (unaudited) (unaudited)

US$?000 US$?000

Cash flows from operating activities

Loss on ordinary activities after taxation (16,537) (28,897)

Net finance expense - other 7,898 9,416

Depreciation and amortization 11,058 11,241

Amortization of inventory fair value step-up 951 9,503

Share based payment expenses 4 1,263 745

Non-cash change in fair value of contingent 5 2,874 2,906consideration

Non-cash contingent value rights finance 5 1,763 1,448expense

Deferred taxation credit 141 (1,576)

Movements in working capital and other adjustments:

Change in trade and other receivables 8 (778) (4,792)

Change in trade and other payables (3,483) 9,416

Change in provision and other liabilities 13 (3,138) (3,435)

Change in inventories 670 216

Change in non-current assets 58 (4)

Net cash flow from operating activities 2,740 6,187



Cash flow from investing activities

Payments for property, plant and equipment (71) (79)

Payments for intangible assets (416) ?

Deposit interest received 1 66

Net cash flow used in investing activities (486) (13)



Cash flow from financing activities

Net costs from issue of equity instruments (175) ?

Interest paid (1,418) (1,506)

Payment of leases (263) ?

Net cash flow from financing activities (1,856) (1,506)



Exchange and other movements (645) (3,830)



Net change in cash and cash equivalents (247) 838

Cash and cash equivalents at beginning of the 118,798 67,229period

Restricted cash at end of the period 9 29 1,093

Cash at bank available on demand at end of the 9 118,522 66,974period

Total cash and cash equivalents at end of the 9 118,551 68,067period



Share Equity Share Share Warrant Treasury based Merger Reverse component Other Currency Accumulated Note capital premium reserve shares payment reserve acquisition of distributable translation deficit Total reserve reserve convertible reserves reserve notes

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 atJanuary 1, 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,1422021(audited)

Loss for the ? ? ? ? ? ? ? ? ? ? (16,537) (16,537)period

Foreignexchange ? ? ? ? ? ? ? ? ? 2,547 ? 2,547translationreserve

Totalcomprehensive ? ? ? ? ? ? ? ? ? 2,547 (16,537) (13,990)loss

Transactions with owners

Issue oftreasuryshares in 10 23 99 ? 439 ? ? ? ? ? ? ? 561exchange forwarrants

Issue oftreasuryshares for 10 25 89 ? 465 (191) ? ? ? ? ? ? 388share optionsexercised

Share basedpayment 4 ? ? ? ? 1,263 ? ? ? ? ? ? 1,263expense

Share basedpayment ? ? ? ? ? ? ? ? ? ? ? ?expense ?Lapsed

Totaltransactions 48 188 ? 904 1,072 ? ? ? ? ? ? 2,212with owners

Balance atMarch 31, 13,899 51,596 14,762 (6,517) 8,932 42,627 (73,914) 29,210 217,634 8,277 (252,142) 54,3642021(unaudited)



Share Equity Share Share Warrant Treasury based Merger Reverse component Other Currency Accumulated Note capital premium reserve shares payment reserve acquisition of distributable translation deficit Total reserve reserve convertible reserves reserve notes

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 atJanuary 1, 11,918 2,422 29,523 (7,534) 3,190 42,627 (73,914) 29,210 217,634 7,920 (133,674) 129,3222020(audited)

Loss for the ? ? ? ? ? ? ? ? ? ? (28,897) (28,897)period

Foreignexchange ? ? ? ? ? ? ? ? ? (13) ? (13)translationreserve

Totalcomprehensive ? ? ? ? ? ? ? ? ? (13) (28,897) (28,910)loss

Transactions with owners

Share basedpayment 4 ? ? ? ? 745 ? ? ? ? ? ? 745expense

Share basedpayment ? ? ? ? (2) ? ? ? ? ? 2 ?expense ?Lapsed

Totaltransactions ? ? ? ? 743 ? ? ? ? ? 2 745with owners

Balance atMarch 31, 11,918 2,422 29,523 (7,534) 3,933 42,627 (73,914) 29,210 217,634 7,907 (162,569) 101,1572020(unaudited)











































Foreign currency units to ? CHF SEK NOK DKK1 US$

Average period to March 0.8292 0.7253 0.9043 8.3868 8.5171 6.166931, 2021 (unaudited)

At March 31, 2021 0.8519 0.7274 0.9414 8.7214 8.5547 6.3351(unaudited)

Foreign currency units to ? CHF SEK NOK DKK1 US$

Average period toDecember 31, 2020 0.8777 0.7799 0.9391 9.2135 9.4206 6.5432(audited)

At December 31, 2020 0.8141 0.7365 0.8829 8.1885 8.5671 6.0570(audited)

Foreign currency units ? CHF SEK NOK DKKto 1 US$

Average period to March 0.9068 0.7809 0.9679 9.6618 9.4731 6.775031, 2020 (unaudited)

At March 31, 2020 0.9043 0.8068 0.9570 9.9977 10.5721 6.7517(unaudited)





























Three months ended March 31, 2021 (unaudited)

U.S. EMEA Other Total

US$?000 US$?000 US$?000 US$?000

Metreleptin 16,239 12,971 750 29,960

Lomitapide 8,324 7,440 2,420 18,184

Other ? 223 65 288

Total revenue 24,563 20,634 3,235 48,432

Three months ended March 31, 2020 (unaudited)

U.S. EMEA Other Total

US$?000 US$?000 US$?000 US$?000

Metreleptin 14,914 8,628 3,385 26,927

Lomitapide 9,470 5,233 2,718 17,421

Other ? 226 ? 226

Total revenue 24,384 14,087 6,103 44,574

















Share Options Warrants

Weighted average Weighted average Units exercise price Units exercise price (Sterling pence) (Sterling pence)

Balance at 1 14,481,720 116.00p 17,541,815 0.03pJanuary 2020

Granted 4,432,000 144.76p ? ?

Lapsed (87,119) 113.42p ? ?

Exercised (72,953) 120.72p (8,229,753) ?

Outstanding at31 December 2020 18,753,648 122.79p 9,312,062 0.05p(audited)

Exercisable at31 December 2020 5,866,152 114.24p 9,312,062 0.05p(audited)



Balance at 1 18,753,648 122.79p 9,312,062 0.05pJanuary 2021

Granted 8,465,644 201.17p ? ?

Lapsed ? ? ? ?

Exercised (300,000) 93.72p (283,389) 1.44p

Outstanding at31 March 2021 26,919,292 147.77p 9,028,673 0.01p(unaudited)

Exercisable at31 March 2021 6,237,902 116.25p 9,028,673 0.01p(unaudited)



March 31, March 31, December 31, December 31, 2021 2021 2020 2020 Options Inputs Warrant Inputs Options Inputs Warrant Inputs (unaudited) (unaudited) (audited) (audited)

Days to 2,555 ? 2,555 ?Expiration

Volatility 37% ? 33%-37% ?

Risk free 0.77% ? 0.39%-0.46% ?interest rate

Share price at 201.2p ? 123.5p?178.9p ?grant









RSUs

Unit Weighted average fair value (US$)

Balance at January 1, 2021 1,549,910 $2.35

Granted 293,180 $2.80

Lapsed (9,000) $2.32

Exercised ? ?

Outstanding at March 31, 2021 1,834,090 $2.43



Three months ended March 31,

2021 2020 (unaudited) (unaudited)

US$?000 US$?000

Share option expense 879 745

RSU expense 384 ?

Total share option expense 1,263 745





















-- The total CVR payable is up to US$85,000,000 -- This is divided into three milestones which are related to the success of Oleogel-S10 (the Groups lead development asset) -- FDA approvalUS$35,000,000 upon FDA approval100% 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 approvalUS$15,000,000 upon EMA approval100% 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 targetsUS$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 -- Payment can at the Boards discretion be in the form of either:120-day loan notes (effectively cash), orShares valued using the 30 day / 45-day VWAP.















-- Milestone payments of:10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016);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 of Episalvan;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;10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed 50,000,000 in any calendar year;15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed 100,000,000 in any calendar year; -- Cash consideration of 150,000, due and paid on the completion date (April 18, 2016); and -- Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale.

















Number of shares Weighted average shares

March 31, 2021 (unaudited) 179,384,982 178,937,717

March 31, 2020 (unaudited) 154,498,887 154,498,887



Three months ended March 31

2021 2020 (unaudited) (unaudited)

Loss after tax attributable to equity holders of the (16,537) (28,897)Company (US$?000)

Weighted average number of ordinary shares in issue 178,937,717 154,498,887

Fully diluted average number of ordinary shares in 178,937,717 154,498,887issue

Basic and diluted loss per share (US$) (0.09) (0.19)







Developed Developed In Other Total technology - technology - process intangible intangible Goodwill metreleptin lomitapide R&D assets assets

US$?000 US$?000 US$?000 US$?000 US$?000 US$?000

Cost

At January 1, 176,000 123,000 54,261 701 353,962 19,1312020 (audited)

Additions ? ? ? 372 372 ?

Acquired ? ? 591 ? 591 ?assets

Disposals ? ? ? (246) (246) ?

Foreignexchange ? ? 5,276 39 5,315 ?movement

At December31, 2020 176,000 123,000 60,128 866 359,994 19,131(audited)

Additions ? ? ? 416 416 ?

Foreignexchange ? ? (2,667) (35) (2,702) ?movement

At March 31,2021 176,000 123,000 57,461 1,247 357,708 19,131(unaudited)



Accumulated amortization

At January 1, 7,314 4,143 ? 178 11,635 ?2020 (audited)

Amortization 27,429 15,537 ? 202 43,168 ?charge

Accumulatedamortization ? ? ? (246) (246) ?on disposals

Foreignexchange ? ? ? 68 68 ?movement

At December31, 2020 34,743 19,680 ? 202 54,625 ?(audited)

Amortization 6,857 3,884 ? 31 10,772 ?charge

Foreignexchange ? ? ? (4) (4) ?movement

At March 31,2021 41,600 23,564 ? 229 65,393 ?(unaudited)



Net book value

At December31, 2020 141,257 103,320 60,128 664 305,369 19,131(audited)

At March 31,2021 134,400 99,436 57,461 1,018 292,315 19,131(unaudited)

















As at

March 31, 2021 December 31, 2020 (unaudited) (audited)

US$?000 US$?000

Trade receivables 37,224 33,057

Accrued income and other debtors 6,220 8,423

VAT recoverable 519 1,705

Trade and other receivables 43,963 43,185



As at

March 31, 2020 December 31, 2020 (unaudited) (audited)

US$?000 US$?000

Cash at bank available on demand 118,522 118,575

Restricted cash 29 223

Total cash and cash equivalents 118,551 118,798









Ordinary Treasury Total shares shares

At January 1, 2020 154,498,887 4,864,656 159,363,543

Issue of shares in exchange for warrants 8,229,753 ? 8,229,753

Issue of shares in equity fund raises 16,000,000 ? 16,000,000

Issue of treasury shares for share 72,953 (72,953) ?options exercised

At December 31, 2020 (audited) 178,801,593 4,791,703 183,593,296

Issue of treasury shares in exchange for 283,389 (283,389) ?warrants

Issue of treasury shares for share 300,000 (300,000) ?options exercised

At March 31, 2021 (unaudited) 179,384,982 4,208,314 183,593,296





























As at

March 31, 2021 December 31, 2020 (unaudited) (audited)

US$?000 US$?000

Long term loan principal 89,472 88,037

Unamortized debt issuance costs (703) (735)

Long term loan 88,769 87,302











Total

US$?000

At January 1, 2020 96,856

Accreted interest 4,230

At December 31, 2020 (audited) 101,086

Accreted interest 1,130

At March 31, 2021 (unaudited) 102,216













As at

March 31, 2021 December 31, 2020 (unaudited) (audited)

US$?000 US$?000

Non-current liabilities

Provisions and other liabilities 22,292 21,382

Leases due greater than 1 year 4,357 4,569

26,649 25,951

Current liabilities

Provisions and other liabilities 6,000 9,976

Leases due less than 1 year 967 963

6,967 10,939

Total provisions and other liabilities 33,616 36,890













As at

March 31, 2021 December 31, 2020 (unaudited) (audited)

US$?000 US$?000

Financial assets (all at amortized cost):

Cash and cash equivalents 118,551 118,798

Trade receivables 37,224 33,057

Total financial assets 155,775 151,855



Financial liabilities:

At amortized cost

Trade payables and accrued expenses 83,631 89,300

Lease liabilities 5,324 5,532

Other liabilities 22,292 25,358

Convertible notes 102,216 101,086

Long term loan 88,769 87,302

Contingent value rights 63,180 61,417

At fair value

Contingent consideration 85,884 86,906

Total financial liabilities 451,296 456,901

Net (295,521) (305,046)



-- Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. -- Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. -- Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data).



-- Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$85,884,000 as at March 31, 2021 (December 31, 2020: US$86,906,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect managements current expectations.



-- An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$6,009,000. A decrease would have the opposite effect. -- A 5% increase in the discount factor used would result in a decrease to the fair value of US$14,718,000. A decrease of 5% would result in an increase to the fair value of US$19,539,000. -- A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$8,576,000.