Market Newsdesk

An Emerging Markets Sponsored Commentary

ORLANDO, Fla., May 05, 2021 (GLOBE NEWSWIRE) — Allow us to introduce Relay Medical Corp. (CSE: RELA, OTC: RYMDF, Frankfurt: EIY2). The Company is a technology innovation company headquartered in Toronto, Ontario, with a team of Canadian experts focused on the development of novel technologies in the diagnostics, AI data science sectors, and IoT cybersecurity sectors. Relay Medical announced on April 14, 2021 that together in conjunction with Fio Corporation and Fio’s joint venture company, Fionet Rapid Response Group, an agreement with LifeLabs was completed, to deploy the Fionet Platform for COVID-19 rapid testing and real-time tracking across Canada, and will be used to launch the Company’s platform to support COVID-19 testing at Canada’s largest international airport Pearson International.

For those south of the Canadian border, LifeLabs is Canada’s largest provider of specialty laboratory testing services, laboratory diagnostic information and digital health connectivity systems. For Relay Medical, this is a major partner who can introduce this technology far and wide.

LifeLabs supports 20 million patient visits annually and conducts over 100 million laboratory tests through leading edge technologies and its 6,000 employees.

It’s a massive footprint. And it’s much needed.

A quote from Dr. Greenberg who is the CEO of Fionet Rapid Response, says it best.

“COVID-19’s threat to personal and economic well-being across the country created a need for innovation in technology and service. Through this alliance, LifeLabs and FRR are bringing into any community setting the caliber of automated, quality-controlled testing and tracking that previously was available only in centralized lab facilities.”

And that’s what’s significant here in our estimation… that FRR can bring this fast, accurate testing to any community directly, instead of compelling them to go to a lab and wait to find out results.

Now, LifeLabs will provide the Fionet Platform in community-based settings at multiple sites across Canada, including airports, pop-up labs, and installations for small businesses.

The business opportunity on top of this public service is that each Fionet device can process 60 tests an hour and provide results within 15 minutes, on a fee per test basis.

There is both a massive need and a massive opportunity in the offering which provides rapid results in real time.

About The Emerging Markets Report:

The Emerging Markets Report is owned and operated by Emerging Markets Consulting (EMC), a syndicate of investor relations consultants representing years of experience. Our network consists of stockbrokers, investment bankers, fund managers, and institutions that actively seek opportunities in the micro and small-cap equity markets.

For more informative reports such as this, please sign up at http://www.emergingmarketsllc.com/newsletter.php

Must Read OTC Markets/SEC policy on stock promotion and investor protection

• https://www.otcmarkets.com/learn/policy-on-stock-promotion
• https://www.otcmarkets.com/learn/investor-protection
• https://www.sec.gov/news/press-release/2017-79
• https://www.sec.gov/oiea/investor-alerts-bulletins/ia_promotions.html

Section 17(b) of the Securities Act of 1933 requires that any person that uses the mails to publish, give publicity to, or circulate any publication or communication that describes a security in return for consideration received or to be received directly or indirectly from an issuer, underwriter, or dealer, must fully disclose the type of consideration (i.e. cash, free trading stock, restricted stock, stock options, stock warrants) and the specific amount of the consideration. In connection therewith, EMC has received the following compensation and/or has an agreement to receive in the future certain compensation, as described below.

We may purchase Securities of the Profiled Company prior to their securities becoming publicly traded, which we may later sell publicly before, during or after our dissemination of the Information, and make profits therefrom. EMC does not verify or endorse any medical claims for any of its client companies.

EMC has been paid $175,000 by Relay Medical Corp. for various marketing services including this report. EMC does not independently verify any of the content linked-to from this editorial.

http://emergingmarketsllc.com/disclaimer.php

Emerging Markets Consulting, LLC

Florida Office
390 North Orange Ave Suite 2300
Orlando, FL 32801
E-mail: [email protected]
Web: www.emergingmarketsllc.com

An Emerging Markets Sponsored Commentary

ORLANDO, Fla., May 05, 2021 (GLOBE NEWSWIRE) — There are very few ‘Zoom Moments” in the market, when lightning strikes and massive markets and market caps arise instantaneously. The pandemic driven move to video conferencing company Zoom was clearly one of these moments.

But many times it’s the small wonders that can be proof of concept, tipping points even, simple marks of progress if you look close enough. And they can portend much greater things.

Last week, One World Pharma Inc. (OTCQB: OWPC) reported the first sale of cannabis plantlets in Colombia. Plantlets or “cuttings” are tiny germinated plants that can be immediately transplanted and grown in new areas. This cuts down on time and risk for the buyers and ensures OWP genetic quality of the mature plant.

For us, this is powerful news if you view it from the lens of what it proves. First, the plantlet sales in Colombia to other growers shows two things; that OWP has the permissions and licenses (in Colombia) to grow, and that the superior genetics that the Company has often referred to are highly desirable by other operators.

And the cuttings biz can be lucrative. According to OWP, “cuttings can be grown in a 20 day cycle with a current capacity of approximately 9,000 per cycle, with an expected scaling to a capacity of 18,000 cuttings per cycle by year end.”

That’s a lot of cuttings and of course, cuttings aren’t even the Company’s primary business.

Keep in mind that this cuttings announcement comes on the heels of these impressive news pieces:

NBA Star and Television Personality John Salley Joins One World Pharma’s Board of Advisors

Colombian Ministry of Health Calls for International Export of Flower

Isiah Thomas pledges to put $3 million of his own money into One World Pharma.

One World Pharma Receives Colombian Approval for Five THC Strains

It’s a year’s worth of news for many companies, this potential for huge new markets to open, a CEO buying in, a celebrity joining the team, and Colombian approval of even MORE strains… all joining the small wonders of these tiny plants that simultaneously grow into elite cannabis ingredients and an ever expanding revenue stream.

For more information on One World Pharma please visit:

www.OneWorldPharma.com

About Emerging Markets Report:

Emerging Markets Report is owned and operated by Emerging Markets Consulting (EMC), a syndicate of investor relations consultants representing years of experience. Our network consists of stock brokers, investment bankers, fund managers, and institutions that actively seek opportunities in the micro and small-cap equity markets.

For more informative reports such as this, please sign up at http://www.emergingmarketsllc.com/newsletter.php

Must Read OTC Markets/SEC policy on stock promotion and investor protection

• https://www.otcmarkets.com/learn/policy-on-stock-promotion
• https://www.otcmarkets.com/learn/investor-protection
• https://www.sec.gov/news/press-release/2017-79
• https://www.sec.gov/oiea/investor-alerts-bulletins/ia_promotions.html

Section 17(b) of the Securities Act of 1933 requires that any person that uses the mails to publish, give publicity to, or circulate any publication or communication that describes a security in return for consideration received or to be received directly or indirectly from an issuer, underwriter, or dealer, must fully disclose the type of consideration (i.e. cash, free trading stock, restricted stock, stock options, stock warrants) and the specific amount of the consideration. In connection therewith, EMC has received the following compensation and/or has an agreement to receive in the future certain compensation, as described below.

We may purchase Securities of the Profiled Company prior to their securities becoming publicly traded, which we may later sell publicly before, during or after our dissemination of the Information, and make profits therefrom. EMC does not verify or endorse any medical claims for any of its client companies.

EMC has been paid $215,000 dollars and 425,000 restricted shares by One World Pharma. for various marketing services including this report. EMC does not independently verify any of the content linked-to from this editorial. KP Investment Partners owns 500,000 shares of One World Pharma. The CEO of Emerging Markets Consulting, James Painter, has a 50% ownership stake in KP Investment Partners. A contributor to this report, Integrity Media, has been provided 780,000 shares and is under contract to receive $4,000 a month for a period of twenty-four months for investor relations services on behalf of One World Pharma by One World Pharma and its principals. Integrity Media is currently under a two-month extension at $5,000 per month. http://emergingmarketsllc.com/disclaimer.php

Emerging Markets Consulting, LLC
Florida Office
390 North Orange Ave Suite 2300
Orlando, FL 32801
E-mail: [email protected]

A
mryt
R
e
ports Record
Q1 2021
Financial and Operating
Results

8.
7
%
YoY
revenue growth
in the quarter
to $
48
.
4
M

16.
5
%
YoY underlying revenue growth
excluding the impact of a LATAM periodic order in Q1 2020

5

^th

consecutive
quarter of positive
EBITDA
generation

N
ational reimbursemen
t
achieved for
metreleptin in England, Wales and France

Regulatory submissions
for
Oleogel-S10
¹
(Filsuvez®)
made
to
the FDA and EMA

Raising FY 2021
r
evenue
g
uidance to $20
5
M
–
$2
10
M

Today announced proposed acquisition of Chiasma
,
Inc. (Nasdaq: CHMA)

Conference call and webcast today at 0


830


E


D


T / 1


330


BST

DUBLIN, Ireland, and Boston
MA,
May 5
, 2021
, Amryt (Nasdaq: AMYT, AIM: 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 first quarter ended March 31, 2021.

Joe Wiley, CEO of Amryt Pharma, commented: “I am very pleased with today’s very strong results for Q1 which represent a 13.9% increase in revenues on Q4 and which demonstrate the continued positive momentum and growth we are experiencing in our business across our twocommercial products globally. Q1 was extremely busy and we delivered a number of commercial and regulatory successes during the quarter.Our two commercial products, metreleptin and lomitapide, continue to deliver solid growth across a host of metrics including revenue, EBITDA growth, cash generation and market expansion. Our EBITDA has increased 115% compared to the same quarter in 2020.

We
also
achieved a number of positive reimbursement decisions in the quarter, notably for metreleptin in
England, Wales
and France.
On the development front, w
e
made
regulatory submissions
to
both
the FDA and EMA for Oleogel-S10 and
we continue to work with the respective agencies as we progress towards
potential
approval and prepare for launch. I
f approved, we have the
commercial
team, systems and infrastructure in place to both grow our existing products and to leverage these capabilities to launch
Oleogel-S10
.

G
iven the strong performance of the business
during the quarter
, we
are
now increasing our revenue guidance for 2021 from $200-$205 million to $20
5
-$2
10
million
excluding any potential contribution from the proposed Chiasma transaction,
which represents growth of
between 12% – 1
5
% on 2020
.

Furthermore, we today announced the proposed acquisition of Chiasma
,
Inc
.
(Nasdaq: CHMA).
We believe t
his transformational deal
can
pave a path to a
combined
potential
$1BN peak
revenue for Amryt.
”

Q1
202
1
& Recent
Business
Highlights:        

• 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)

Q
1
Commercial Product
Performance
:

	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	3,23 5	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 a periodic 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 revenues increased by 50.3% 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)

Q1 Financial Highlights
:

• $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

¹           For the purposes of this announcement, we use the name Oleogel-S10. Filsuvez® has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for Filsuvez® to treat EB.

IFRS and non-GAAP adjusted Q
1
202
1
results
:

US$M	Q1 2020 (unaudited)	Q1 2021 (unaudited)	Q1 2021 Non-cash adjustments 2	Q1 2021 Non-GAAP Adjusted
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 related costs	(0.9)	–	–	–
Share based compensation expenses	(0.8)	(1.3)	1.3	–
Operating (loss) / profit before finance expense	(17.0)	( 3.4 )	13.3	9.9 3

The Q1 operating loss of $3.4M 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 $9.9M of EBITDA³ for the quarter.

²  Non-cash items include amortisation of the acquired metreleptin and lomitapide intangible assets ($10.7M), amortisation of the inventory fair value step-up that was acquired at the acquisition date ($1.0M), depreciation and amortisation ($0.3M) and share based compensation expenses ($1.3M).

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.

Post-
Period
End Events:

The company earlier today announced that it has signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA). The combined Company will be a global leader in rare and orphan diseases with three 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.

Guidance & Outlook:

Amryt issued FY 2021 revenue guidance on March 4, 2021 indicating that FY 2021 revenues were expected to be in the range of $200M-$205M. Given the continued strong performance of the Company’s commercial products, the board is now increasing FY 2021 revenue guidance to a range of $205M-$210M excluding any potential contribution from the proposed Chiasma transaction, which represents growth of 12-15% versus FY 2020.

Conference Call & Webcast:

Amryt will host a conference call and webcast for analysts and investors on May 5 at 0830 EDT/1330 BST. Webcast Player URL: https://edge.media-server.com/mmc/p/hdecnon9

Telephone Dial in details:

United States	+1 646 787 1226
United Kingdom	+44 (0) 203 009 5709
Ireland	+353 (1) 506 0626
Confirmation Code	8698345

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 two orphan disease products – metreleptin (Myalept®/ Myalepta®) and lomitapide (Juxtapid®/ Lojuxta®).

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.

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 and Brazil (under the trade name Lojuxta®). For additional information, please follow this link.

Amryt’s lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic 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 selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB.

Amryt’s pre-clinical gene therapy platform, AP103, offers a potential treatment for patients with Dystrophic EB, and is also potentially relevant to other genetic disorders. 

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

This announcement contains inside information for the purposes of article 7 of the Market Abuse Regulation (EU) 596/2014. The person making this notification on behalf of Amryt is Rory Nealon, CFO/COO and Company Secretary.

Financial Advisors        

Shore Capital (Edward Mansfield, Daniel Bush, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK.

Forward-Looking Statements

This press release may contain forward-looking 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.

Contacts

Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, [email protected]

Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906, [email protected]

Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, [email protected]

Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700

Amryt Pharma plc

Condensed Consolidated Statement of Comprehensive Loss

		Three Months Ended March 31,
	Note	2021 (unaudited)	2020 (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 consideration	5	(2,874)	(2,906)
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 holders of the Company		(16,537)	(28,897)
Exchange translation differences which may be reclassified through profit or loss		2,547	(13)
Total other comprehensive income/(loss)		2,547	(13)
Total comprehensive loss for the period attributable to the equity holders of the Company		(13,990)	(28,910)
Loss per share
Loss per share – basic and diluted, attributable to ordinary equity holders of the parent (US$)	6	(0.09)	(0.19)

Amryt Pharma plc

Condensed Consolidated Statement of Financial Position

			As at,
	Note		March 31, 2021 (unaudited)		December 31, 2020 (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 restricted cash	9		118,551		118,798
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 value rights	5		149,064		148,323
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

Amryt Pharma plc

Condensed Consolidated Statement of Cash Flows

			Three months ended March 31,
	Note		2021 (unaudited)		2020 (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 consideration	5		2,874		2,906
Non-cash contingent value rights finance expense	5		1,763		1,448
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 period			118,798		67,229
Restricted cash at end of the period	9		29		1,093
Cash at bank available on demand at end of the period	9		118,522		66,974
Total cash and cash equivalents at end of the period	9		118,551		68,067

Amryt Pharma plc

Condensed Consolidated Statement of Changes in Equity

For the period ended March 31, 2021

(unaudited)

	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		—	—	—	—	—	—	—	—	—	—	(16,537)	(16,537)
Foreign exchange translation reserve		—	—	—	—	—	—	—	—	—	2,547	—	2,547
Total comprehensive loss		—	—	—	—	—	—	—	—	—	2,547	(16,537)	(13,990)
Transactions with owners
Issue of treasury shares in exchange for warrants	10	23	99	—	439	—	—	—	—	—	—	—	561
Issue of treasury shares for share options exercised	10	25	89	—	465	(191)	—	—	—	—	—	—	388
Share based payment expense	4	—	—	—	—	1,263	—	—	—	—	—	—	1,263
Share based payment expense – Lapsed		—	—	—	—	—	—	—	—	—	—	—	—
Total transactions with owners		48	188	—	904	1,072	—	—	—	—	—	—	2,212
Balance at March 31, 2021 (unaudited)		13,899	51,596	14,762	(6,517)	8,932	42,627	(73,914)	29,210	217,634	8,277	(252,142)	54,364

For the period ended March 31, 2020

(unaudited)

	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, 2020 (audited)		11,918	2,422	29,523	(7,534)	3,190	42,627	(73,914)	29,210	217,634	7,920	(133,674)	129,322
Loss for the period		—	—	—	—	—	—	—	—	—	—	(28,897)	(28,897)
Foreign exchange translation reserve		—	—	—	—	—	—	—	—	—	(13)	—	(13)
Total comprehensive loss		—	—	—	—	—	—	—	—	—	(13)	(28,897)	(28,910)
Transactions with owners
Share based payment expense	4	—	—	—	—	745	—	—	—	—	—	—	745
Share based payment expense – Lapsed		—	—	—	—	(2)	—	—	—	—	—	2	—
Total transactions with owners		—	—	—	—	743	—	—	—	—	—	2	745
Balance at March 31, 2020 (unaudited)		11,918	2,422	29,523	(7,534)	3,933	42,627	(73,914)	29,210	217,634	7,907	(162,569)	101,157

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) and the AIM market of the London Stock Exchange (ticker: AMYT).

Aegerion Pharmaceuticals, Inc. (“Aegerion”), a former subsidiary of Novelion Therapeutics Inc., 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)).

Amryt’s lead development asset, Filsuvez®/Oleogel-S10, is a potential treatment for Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder for which there is currently no treatment. Oleogel-S10 is currently an investigational product and has not received regulatory approval by the FDA or EMA. Filsuvez® has been selected as the brand name for the product. On September 20, 2019, Amryt registered Filsuvez® as the trademark name for Oleogel-S10 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 trademark in other key jurisdictions.

On July 8, 2020, Amryt listed on the NASDAQ Global Select Market under the symbol AMYT. The Ordinary Shares will continue to trade on the AIM market of the London Stock Exchange.

On August 11, 2020 Amryt announced that the Company gave Euronext Dublin (“Euronext”) notice of its intention to cancel the admission of the Company’s Ordinary Shares (‘Ordinary Shares”) to trading on the Euronext Growth Market (“Cancellation”). The last day of trading in Ordinary Shares on the Euronext Growth Market was September 8, 2020. The Cancellation applies only to the Euronext Growth Market and will have no effect on the Company’s American Depositary Shares (“ADSs”) which trade on the NASDAQ Global Select Market under the symbol AMYT or on Amryt’s Ordinary Shares trading on the AIM market of the London Stock Exchange.

2. Accounting policies

Basis of preparation

The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2020. 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, 2020 and those which are expected to be used in the financial statements for the year ended December 31, 2021.

Results for the three-month period ended March 31, 2021 are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2021.

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 March 31, 2021.

Basis of consolidation

The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended March 31, 2021. 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$		€		£		CHF		SEK		NOK		DKK
Average period to March 31, 2021 (unaudited)		0.8292		0.7253		0.9043		8.3868		8.5171		6.1669
At March 31, 2021 (unaudited)		0.8519		0.7274		0.9414		8.7214		8.5547		6.3351

Foreign currency units to 1 US$		€		£		CHF		SEK		NOK		DKK
Average period to December 31, 2020 (audited)		0.8777		0.7799		0.9391		9.2135		9.4206		6.5432
At December 31, 2020 (audited)		0.8141		0.7365		0.8829		8.1885		8.5671		6.0570

Foreign currency units to 1 US$		€		£		CHF		SEK		NOK		DKK
Average period to March 31, 2020 (unaudited)		0.9068		0.7809		0.9679		9.6618		9.4731		6.7750
At March 31, 2020 (unaudited)		0.9043		0.8068		0.9570		9.9977		10.5721		6.7517

(€ = 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, 2021 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, 2020.

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, 2020.

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, 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 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	3,23 5	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

Major Customers

For the three months ended March 31, 2021, one customer accounted for 51%, respectively, of the Group’s net revenues (2020: 55%, respectively) and accounted for 46% of the Group’s March 31, 2021 accounts receivable balance (December 31, 2020: 42%).

4. Share based payments

        
Under the terms of the Company’s Employee Share Option Plan, options to purchase 26,919,292 shares were outstanding at March 31, 2021. 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 8,465,644 share options were granted to non-executive directors and employees in the three-month period ended March 31, 2021. For the year ended December 31, 2020, a total of 4,432,000 share options were granted to directors and employees.

The terms and conditions of the grants are as follows, whereby all options are settled by physical delivery of shares:

Vesting conditions
The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee) and it is generally over a three-year period. There are no market conditions associated with the share option vesting periods.

Contractual life
The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, each option will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors.

Outstanding warrants at March 31, 2021 consisted of 8,966,520 zero cost warrants (December 31, 2020: 8,966,520) with no expiration date that were issued to Aegerion creditors in connection with the acquisition of Aegerion. The remaining warrants consisting of 62,153 warrants (December 31, 2020: 345,542) were issued in connection with the admission to the AIM in 2016 and have since lapsed in April 2021.

The number and weighted average exercise price (in Sterling pence) of share options and warrants per ordinary share is as follows:

	Share Options		Warrants
	Units	Weighted average exercise price (Sterling pence)	Units	Weighted average exercise price (Sterling pence)
Balance at 1 January 2020	14,481,720	116.00p	17,541,815	0.03p
Granted	4,432,000	144.76p	—	—
Lapsed	(87,119)	113.42p	—	—
Exercised	(72,953)	120.72p	(8,229,753)	—
Outstanding at 31 December 2020 (audited)	18,753,648	122.79p	9,312,062	0.05p
Exercisable at 31 December 2020 (audited)	5,866,152	114.24p	9,312,062	0.05p
Balance at 1 January 2021	18,753,648	122.79p	9,312,062	0.05p
Granted	8,465,644	201.17p	—	—
Lapsed	—	—	—	—
Exercised	(300,000)	93.72p	(283,389)	1.44p
Outstanding at 31 March 2021 (unaudited)	26,919,292	147.77p	9,028,673	0.01p
Exercisable at 31 March 2021 (unaudited)	6,237,902	116.25p	9,028,673	0.01p

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:

	March 31, 2021 Options Inputs (unaudited)	March 31, 202 1 Warrant Inputs (unaudited)	December 31, 2020 Options Inputs (audited)	December 31, 2020 Warrant Inputs (audited)
Days to Expiration	2,555	—	2,555	—
Volatility	37%	—	33%-37%	—
Risk free interest rate	0.77%	—	0.39%-0.46%	—
Share price at grant	201.2p	—	123.5p–178.9p	—

In the three months ended March 31, 2021, a total of 8,465,644 share options exercisable at a weighted average price of £2.012 were granted. The fair value of share options granted in the three months ended March 31, 2021 was £17,030,000/US$23,479,000.

The share options outstanding as at March 31, 2021 have a weighted remaining contractual life of 5.78 years with exercise prices ranging from £0.76 to £2.012.

The 2016 warrants outstanding as at March 31, 2021 have since lapsed in April 2021.

Restricted Share Units


Under the terms of the Company’s Employee Share Option Plan, restricted share units (“RSUs”) to purchase 1,834,090 shares were outstanding at March 31, 2021. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the period ended March 31, 2021, a total of 293,180 RSUs were granted to employees of the company. For the year ended December 31, 2020, a total of 1,556,960 RSUs were granted to employees of the company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the period ended March 31, 2021 was US$861,000. At March 31,2021, the total RSUs granted to date have a weighted remaining contractual life of 2.45 years. The following table summarizes the RSU activity for the period:

	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

The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows:

	Three months ended March 31,
	2021 (unaudited)		2020 (unaudited)
	US$’000		US$’000
Share option expense	879		745
RSU expense	384		—
Total share option expense	1,263		745

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 Pharmaceuticals, Inc. (‘‘Aegerion’’), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘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 Company believes that the acquisition of Aegerion will enable the Group to advance the Group’s ambition to create a global leader in rare and orphan diseases with a diversified offering of multiple development-stage and commercial assets and provides it with scale to support further growth.

As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant.

Relevant Aegerion creditors are entitled at any time to exercise the zero cost warrants, at which point in time, the Company would issue to that Aegerion creditor the relevant number of fully paid ordinary shares in return for the exercise of the zero cost warrants. Each zero cost warrant entitles the holder thereof to subscribe for one ordinary share. The zero cost warrants constitute the Company’s direct and unsecured obligations and rank pari passu and without any preference among themselves (save for any obligations to be preferred by law) at least equally with the Company’s other present and future unsecured and unsubordinated obligations. The zero cost warrants are not transferable except with the Company’s prior written consent.

During the three months ended March 31, 2021, the Group incurred no additional acquisition and restructuring related costs relating to external legal fees, advisory fees, due diligence costs and severance costs (March 31, 2020: US$853,000). These costs were included in operating costs in the Condensed Consolidated Statement of Comprehensive loss.

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 optionholders, 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 Oleogel-S10, 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 optionholders 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 Oleogel-S10 (the Group’s lead development asset)
• FDA approval
  • US$35,000,000 upon FDA approval
  • 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
  • US$15,000,000 upon EMA approval
  • 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
  • US$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 Board’s discretion be in the form of either:
  • 120-day loan notes (effectively cash), or
  • 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. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. 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 March 31, 2021, the carrying value of the CVRs was US$63,180,000 (December 31, 2020: US$61,417,000). 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. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% in the period ended March 31, 2021 (2020: 89%). Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the period ended March 31, 2021 (December 31, 2020: 10% and 16.5%). Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. 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 assessment of 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 Condensed 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 in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The Group recently submitted applications for approval from the FDA and the EMA.

The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2021 is US$1,763,000 (March 31, 2020: US$1,448,000).

Acquisition of Amryt


GmbH (previously ‘‘Birken’’)

Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbH 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:
  • €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.

Fair Value Measurement of Contingent Consideration

As at March 31, 2021, the fair value of the contingent consideration was estimated to be US$85,884,000 (December 31, 2020: US$86,906,000). 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 14, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). 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. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% for the period ended March 31, 2021 (December 31, 2020: 89%) following the positive results from our phase 3 EASE trial of Oleogel-S10 earlier in the year. A discount rate of 14.4% was used in the calculation of the fair value of the contingent consideration for the three months ended March 31, 2021 (December 31, 2020: 14.4%).

The Group received positive top line results from the phase 3 EASE trial of Oleogel-S10 in September 2020, and the Group recently submitted applications for approval from the FDA and the EMA.

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

The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2021 is US$2,874,000 (March 31, 2020: US$2,906,000).

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 March 31, 2021.

Issued share capital – ordinary shares of £0.06 each

	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

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

	Three months ended March 31
	2021 (unaudited)		2020 (unaudited)
Loss after tax attributable to equity holders of the Company (US$’000)	(16,537)		(28,897)
Weighted average number of ordinary shares in issue	178,937,717		154,498,887
Fully diluted average number of ordinary shares in issue	178,937,717		154,498,887
Basic and diluted loss per share (US$)	(0.09)		(0.19)

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 March 31, 2021 totaled 35,947,965 (March 31, 2020: 28,065,710) and are potentially dilutive.

7. Intangible assets and goodwill

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

	Developed technology – metreleptin	Developed technology – lomitapide	In process R&D	Other intangible assets	Total intangible assets	Goodwill
	US$’000	US$’000	US$’000	US$’000	US$’000	US$’000
Cost
At January 1, 2020 (audited)	176,000	123,000	54,261	701	353,962	19,131
Additions	—	—	—	372	372	—
Acquired assets	—	—	591	—	591	—
Disposals	—	—	—	(246)	(246)	—
Foreign exchange movement	—	—	5,276	39	5,315	—
At December 31, 2020 (audited)	176,000	123,000	60,128	866	359,994	19,131
Additions	—	—	—	416	416	—
Foreign exchange movement	—	—	(2,667)	(35)	(2,702)	—
At March 31, 2021 (unaudited)	176,000	123,000	57,461	1,247	357,708	19,131
Accumulated amortization
At January 1, 2020 (audited)	7,314	4,143	—	178	11,635	—
Amortization charge	27,429	15,537	—	202	43,168	—
Accumulated amortization on disposals	—	—	—	(246)	(246)	—
Foreign exchange movement	—	—	—	68	68	—
At December 31, 2020 (audited)	34,743	19,680	—	202	54,625	—
Amortization charge	6,857	3,884	—	31	10,772	—
Foreign exchange movement	—	—	—	(4)	(4)	—
At March 31, 2021 (unaudited)	41,600	23,564	—	229	65,393	—
Net book value
At December 31, 2020 (audited)	141,257	103,320	60,128	664	305,369	19,131
At March 31, 2021 (unaudited)	134,400	99,436	57,461	1,018	292,315	19,131

Developed technology on commercially marketed products

In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 4.9 and 6.4 years, respectively, as of March 31, 2021 (December 31, 2020: 5.2 and 6.7 years, respectively). 

In-process R&D

As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €52,515,000 which is related to the Group’s lead development asset, Oleogel-S10.

Goodwill

During 2019, the Group completed the acquisition of Aegerion, which resulted in aggregate goodwill of US$19,131,000.

The Group reviews events or changes in circumstances that may indicate a triggering event for impairment. Management applied its judgment in determining that there were no events or changes in circumstances causing any impairment triggers as of March 31, 2021. As such there was no impairment charge recorded during the three months ended March 31, 2021.

8. Trade and other receivables

	As at
	March 31, 2021 (unaudited)		December 31, 2020 (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

9. Cash and cash equivalents

	As at
	March 31, 2020 (unaudited)		December 31, 2020 (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

Cash and cash equivalents include cash at bank available on demand and restricted cash.

At March 31, 2021 and December 31, 2020, there was US$29,000 and US$223,000 of restricted cash, respectively. The balance at December 31, 2020 includes a deposit on a company credit card facility for an amount of US$150,000. This was reduced to nil as at March 31, 2021. Additionally, there was US$29,000 held by a third-party distributor at March 31, 2021 (December 31, 2020: US$73,000.

10. Share capital and reserves

Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2020: 6 pence) each are in the table below.

	Ordinary shares	Treasury shares	Total
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 options exercised	72,953	(72,953)	—
At December 31, 2020 (audited)	178,801,593	4,791,703	183,593,296
Issue of treasury shares in exchange for warrants	283,389	(283,389)	—
Issue of treasury shares for share options exercised	300,000	(300,000)	—
At March 31, 2021 (unaudited)	179,384,982	4,208,314	183,593,296

The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below.

The total number of ordinary shares issued at March 31, 2021 of 183,593,296 (December 31, 2020: 183,593,296), includes treasury shares of 4,208,314 (December 31, 2020: 4,791,703).

In December 2020, the Company issued 3,200,000 American Deposit Shares (“ADSs”), each representing five ordinary shares, as part of a US$40,000,000 private placement equity raise to existing and new shareholders.

On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020 and September 22, 2020, respectively, in exchange for certain warrants.

Share Capital


Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each.
The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company.

Share Premium


Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves.

Warrant


reserve


The warrant reserve represents zero cost warrants issued as part of the equity raise on September 24, 2019 net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020 and September 22, 2020, respectively, in exchange for certain warrants.
Treasury Shares
In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants.

Share based payment reserve


Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants.

Merger reserve


The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve.

Reverse acquisition reserve


The reverse acquisition reserve arose during the period ended December 31, 2016 in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law.

Equity component of convertible notes


The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured.

Currency translation reserve


The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries.

Accumulated deficit


Accumulated deficit represents losses accumulated in previous periods and the current year.

11. Long term loan

	As at
	March 31, 2021 (unaudited)		December 31, 2020 (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

As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan is made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan has a five-year term from the date of the draw down, September 24, 2019 and matures on September 24, 2024. Under the Term Loan, interest will be payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that will be paid when the principal is repaid, which rolls up and is included in the principal balance outstanding, on a quarterly basis. Unpaid accrued interest of US$1,431,000 as at March 31, 2021 is recognized in current liabilities with trade and other payables (December 31, 2020: $1,439,000). The Term Loan may be prepaid, in whole or in part, by Aegerion at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan.

In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are being amortized over the expected life of the loan using the effective interest method.

The Term Loan is guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group.

The Term Loan agreement includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Aegerion and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There have been no events of default or breaches of the covenants occurring for the three months ended March 31, 2021 (December 31, 2020: no events).

12. Convertible notes

	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 part of the acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors.

The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted.

The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Aegerion can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 10, Share capital and reserves, for further details on the equity component of the convertible notes.

From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder.

The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances.

The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Aegerion, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Aegerion and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Aegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended March 31, 2021 (2020: no events).
13. Provisions and other liabilities

	As at
	March 31 , 2021 (unaudited)		December 31, 2020 (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

Legal matters

Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements require Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. There is no current liability recognized as at March 31, 2021 (December 31, 2020: US$3,976,000). There is no non-current liability at March 31, 2021 (December 31, 2020: nil).

Other matters

The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. At March 31, 2021 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2020 US$6,000,000).

14. Fair value measurement and financial risk management

Categories of financial instruments

	As at
	March 31, 2021 (unaudited)		December 31 , 2020 (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)

Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable:

• 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).

The contingent consideration has been valued using Level 3. The contingent consideration comprises:

• 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 management’s current expectations.

Impact of key unobservable input data

• 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.

15. Events after the reporting period

On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (“Chiasma”) in an all-stock combination. The combined company will be a global leader in rare and orphan diseases with three 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. The transaction has been approved and recommended by the Boards of both Amryt and Chiasma.

Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction will be exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. As of the close of trading on May 4, 2021 Amryt’s ordinary shares on AIM were £2.00 ($2.78) per share and Amryt’s ADS’s on Nasdaq were $12.95 (£9.31) per ADS.

There were no other significant events since the end of the reporting period.

FORT LAUDERDALE, Fla., May 05, 2021 (GLOBE NEWSWIRE) — via InvestorWire — The Movie Studio (OTC: MVES) today announces it has officially launched its over-the-top streaming platform on the Apple App Store for iPhone users. The company previously announced the completion the official launch of its over-the-top (“OTT”) streaming platform and the symbiotic app in the Google Play Store for Android users. The platform, now available through both app stores, incorporates the initial core components of the company’s business models of “Watch Our Movies!” and “Be in Our Movies!”

“We are very pleased with the Movie Studio’s successful launch of our OTT streaming platform, which straddles between a free Advertiser Video On Demand (AVOD) to attract users and the value proposition of our Subscriber Video On Demand (SVOD) application. This is a unique hybrid in the OTT universe, and the integration of a feature enabling consumers to potentially participate in the content of upcoming motion pictures is pioneering,” said Gordon Scott Venters, MVES president and CEO. “We look forward to launching our traffic-driving campaign for the OTT and app on social media, and we intend to launch the campaign with prominent features of our slogans, ‘Watch Our Movies!’, ‘Be in Our Movies!’, ‘Everyone’s a Star!’, and utilizing all social media resources and influencers to drive traffic to the OTT and app.”

About The Movie Studio Inc.

The Movie Studio is a first-mover digital disruptor operating an over-the-top (“OTT”) platform and blockchain platform for foreign licensing of content for distribution. The company is focused on the independent motion picture content sector as a disruptor of the Hollywood model and operates as a vertically integrated motion picture and reality show production and distribution company.

The company has completed the full launch of its apps, with a free content ingestion option via advertiser video-on-demand (“AVOD”) and a “Be in Our Movies!” value proposition via subscription video-on-demand (“SVOD”), providing multiple revenue streams from the company’s owned, produced, licensed or aggregated content for worldwide consumption in VOD, foreign sales and on various media devices.

The Movie Studio is disrupting traditional media content delivery systems with its digital business model of motion picture fabrication and distribution and intends direct-server access of its content with geo-fractured territories for worldwide distribution.

The Movie Studio is headquartered in a 6,500-square-foot venue at the prestigious Galleria Mall of Fort Lauderdale, Florida, and will continue to add shareholder value by providing in-studio acting classes, event venue bookings, green screen self-booking and talent management, as well as pursuing strategic partnerships, mergers and acquisitions.

For information about the company, please visit www.TheMovieStudio.com.

The Movie Studio, Inc.
2542 E. Sunrise Boulevard
Fort Lauderdale, FL 33304
(954) 332-6600

NOTE TO INVESTORS: The latest news and updates relating to MVES are available in the company’s newsroom at http://ibn.fm/MVES.

Corporate Communications:

InvestorBrandNetwork (IBN)

Los Angeles, California


www.InvestorBrandNetwork.com


310.299.1717 Office


[email protected] 

Announced agreement to merge with Amryt

Combination to create a global commercial stage rare and orphan disease leader with a diversified portfolio of therapies and a meaningful late-stage development pipeline

Q1 2021 Net Product Revenues of $1.9M, a 100% increase over Q4 2020

Achieved payor coverage of MYCAPSSA for over 185 million lives

Submitted an Investigational New Drug (IND) application for the study of MYCAPSSA in patients with carcinoid syndrome associated with Neuroendocrine Tumors (NET)

NEEDHAM, Mass., May 05, 2021 (GLOBE NEWSWIRE) — Chiasma, Inc. (NASDAQ: CHMA), a commercial stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to reduce the burden of chronic injections for people with rare diseases, as evidenced by its initiation of a phased U.S. commercial launch of MYCAPSSA® as the first oral therapy for treatment of acromegaly, today announced financial results for the first quarter ended March 31, 2021 and provided a business update.

Recent Business Highlights

• Announced entry into a definitive merger agreement for the acquisition of the company by Amryt Pharma plc, a biopharmaceutical company focused on acquiring, developing and delivering innovative treatments to help improve the lives of patients with rare and orphan diseases
• Generated MYCAPSSA net product revenue of $1.9 million in Q1 2021
• Increased payor coverage of MYCAPSSA to over 185 million lives
• Submitted an Investigational New Drug (IND) application to the FDA for a Phase 1 relative bioavailability study followed by a single Phase 3 randomized, double-blind, placebo-controlled study of MYCAPSSA in patients with carcinoid syndrome associated with NET. These studies are designed to support a potential modified 505(b)(2) regulatory pathway.
• Exited the first quarter with $115.0 million of cash, cash equivalents and marketable securities

“While we continue to experience customer access challenges related to COVID-19, we are pleased with the launch progress we made in the first quarter and it reiterates our intent of making MYCAPSSA the new standard of pharmacological care,” stated Raj Kannan, Chief Executive Officer of Chiasma. “During the quarter we saw an increase in launch momentum as we continued to expand payor coverage for MYCAPSSA. Additionally, we submitted an IND to begin the process of expanding the potential benefits of MYCAPSSA in patients with carcinoid syndrome.”

“Importantly, we believe the merger with Amryt represents a transformational moment in unlocking and accelerating the potential value of Chiasma efficiently for both our patients and for our shareholders,” concluded Mr. Kannan.

First Quarter 2021 Financial Results

Product Revenue, Net: Net product revenue related to the sales of MYCAPSSA were $1.9 million for the first quarter of 2021, as compared to $1.0 million for the fourth quarter of 2020, MYCAPSSA’s first full quarter of sales.

SG&A Expenses: Selling, general and administrative expenses were $15.7 million for the first quarter of 2021, as compared with $7.6 million for the first quarter of 2020. The increase was driven by commercial activities, an increase in personnel-related expenses, and other administrative costs to support the launch and commercialization of MYCAPSSA® in the U.S., and diligence costs associated with merger agreement with Amryt.

R&D Expenses: Research and development expenses were $4.2 million for the first quarter of 2021 compared to $8.1 million for the first quarter of 2020. The decrease was primarily related to the costs associated with the manufacturing of octreotide capsules to support the Company’s U.S. commercial launch, which were expensed prior to FDA approval of MYCAPSSA in June 2020.

Net Loss: Net loss for the first quarter of 2021 was ($30.5) million, or ($0.49) per basic share, as compared with ($15.4) million, or ($0.36) per basic share for the first quarter of 2020.

Cash Position: Chiasma ended the first quarter 2021 with cash, cash equivalents, and marketable securities of $115.0 million, as compared with $135.4 million as of December 31, 2020.

Conference Call Information

Given the recently announced agreement for Chiasma to be acquired by Amryt, Chiasma will not be hosting a conference call.

About MYCAPSSA

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

MYCAPSSA (octreotide) delayed-release capsules, for oral use, is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

CONTRAINDICATIONS

Hypersensitivity to octreotide or any of the components of MYCAPSSA. Anaphylactoid reactions, including anaphylactic shock, have been reported in patients receiving octreotide.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
MYCAPSSA can cause problems with the gallbladder. Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.

Blood sugar, thyroid levels, and vitamin B₁₂ levels should be monitored and treated accordingly.

Bradycardia, arrhythmia, or conduction abnormalities may occur. Treatment with drugs that have bradycardia effects may need to be adjusted.

ADVERSE REACTIONS

The most common adverse reactions (incidence >10%) are nausea, diarrhea, headache, arthralgia, asthenia, hyperhidrosis, peripheral swelling, blood glucose increased, vomiting, abdominal discomfort, dyspepsia, sinusitis, and osteoarthritis.

DRUG INTERACTIONS

The following drugs require monitoring and possible dose adjustment when used with MYCAPSSA: cyclosporine, insulin, antidiabetic drugs, calcium channel blockers, beta blockers, lisinopril, digoxin, bromocriptine, and drugs mainly metabolized by CYP3A4. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when MYCAPSSA is used with combined oral contraceptives.

Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

PREGNANCY

Advise premenopausal females of the potential for an unintended pregnancy.

To report SUSPECTED ADVERSE REACTIONS, contact the product information department at 1-844-312-2462 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

The full Prescribing Information for MYCAPSSA is available at 

www.MYCAPSSA.com

.

About Acromegaly

Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. Chiasma estimates that approximately 8,000 adult acromegaly patients are chronically treated with somatostatin analog injections in the United States.

About Neuroendocrine Tumors

NETs arise from neuroendocrine cells throughout the body, most commonly in the gastrointestinal tract, lung, and rarely, the pancreas. While well differentiated neuroendocrine tumors are known to be slow growing, they are often asymptomatic in early stages leading to a substantial number of patients being diagnosed when the tumors have already spread regionally or distantly. Capable of secreting hormones and bioactive amines, approximately 19% of patients have carcinoid syndrome characterized by secretory diarrhea and flushing. With an annual incidence rate of 6.98 per 100,000, it is estimated there are greater than 170,000 individuals living with a diagnosis of NET in the United States.

About Chiasma

Chiasma is a commercial stage biopharmaceutical company focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In June 2020, Chiasma received FDA approval of MYCAPSSA for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA, the first and only oral somatostatin analog approved by the FDA, is available for commercial sale. Chiasma is headquartered in Needham, MA with a wholly owned subsidiary in Israel. MYCAPSSA, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the company’s website at www.chiasma.com.

Important Additional Information and Where to Find It

In connection with the proposed transaction, Amryt intends to file with the Securities and Exchange Commission (the “SEC”) a Registration Statement on Form F-4 that will include a proxy statement of Chiasma and that also constitutes a prospectus of Amryt, and each of Chiasma and Amryt may file with the SEC other documents regarding the proposed transaction. This press release is not a substitute for the proxy statement/prospectus or registration statement or any other document that Amryt or Chiasma may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Chiasma. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT ON FORM F-4 AND THE PROXY STATEMENT/PROSPECTUS, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS AND ANY OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION, IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AMRYT, CHIASMA AND THE PROPOSED TRANSACTION.

Investors and security holders may obtain copies of these documents, once such documents are filed with the SEC, free of charge through the website maintained by the SEC at www.sec.gov or from Amryt at its website, https://amrytpharma.com, or from Chiasma at its website, https://chiasma.com. Documents filed with the SEC by Amryt will be available free of charge by accessing Amryt’s website under the heading Investors, or, alternatively, by contacting Amryt’s Investor Relations department at [email protected], and documents filed with the SEC by Chiasma will be available free of charge by accessing Chiasma’s website at https://chiasma.com under the heading News and Investors or, alternatively, by contacting Chiasma’s Investor Relations department at [email protected].

No Offer or Solicitation

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

Participants in Solicitation

Amryt and Chiasma and certain of their respective directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Chiasma in respect of the proposed transaction under the rules of the SEC. Information about Chiasma’s directors and executive officers is available in Chiasma’s definitive proxy statement dated April 26, 2021 for its 2021 Annual Meeting of Stockholders. Information about Amryt’s directors and executive officers is available in Amryt’s Registration Statement on Form F-1 filed with the SEC on June 23, 2020, as amended. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Chiasma or Amryt using the sources indicated above.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the proposed acquisition of the company by Amryt, the potential development of MYCAPSSA as a treatment for neuroendocrine tumors, the company’s expectations relating to MYCAPSSA for the long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, the commercialization of MYCAPSSA, including potential market adoption and commercial success and the commercial or therapeutic potential of MYCAPSSA. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company’s control, that may cause actual events or results to differ materially from the company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including the following: uncertainties related to the timing and occurrence of the closing of the proposed acquisition of the company by Amryt, the reaction to the proposed acquisition by our business partners as well as our customers and patients, the reaction by competitors to the proposed acquisition, the retention of our employees, Amryt’s plans for us, the future growth of our and Amryt’s businesses and the possibility that integration following the proposed acquisition may be more difficult than expected; the content and timing of decisions made by the FDA or EMA, the company’s ability to retain requisite regulatory approvals for the continued commercial sale of MYCAPSSA in the United States, the timing and costs involved in establishing and maintaining a commercial organization and launching the sale of MYCAPSSA, and the impact the ongoing COVID-19 pandemic may have on the company’s business, including its expected development, manufacturing, regulatory and commercialization timelines for MYCAPSSA. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

Investor Relations and Corporate Communications:

Ashley Robinson 
LifeSci Advisors, LLC 
617-430-7577 
[email protected]  

Media Relations:

Patrick Bursey
LifeSci Communications
646-876-4932
[email protected]

Chiasma, Inc.
Condensed Consolidated Statements of Operations
(amounts in thousands except share and per share data)
(unaudited)
	For the three months ended
	March 31, 2021				March 31, 2020
Product revenue, net	$	1,924			$	—
Cost of goods sold		67				—
Gross Profit		1,857				—
Operating expenses:
Selling, general and administrative		15,698				7,582
Research and development		4,199				8,125
Total operating expenses		19,897				15,707
Loss from operations		(18,040	)			(15,707	)
Interest and other income (loss), net		(9,583	)			398
Interest expense		(2,873	)			—
Loss before income taxes		(30,496	)			(15,309	)
Provision for income taxes		52				77
Net loss	$	(30,548	)		$	(15,386	)
Earnings per share of common stock:
Basic	$	(0.49	)		$	(0.36	)
Diluted	$	(0.49	)		$	(0.36	)
Weighted-average shares outstanding:
Basic		62,831,141				42,187,694
Diluted		62,831,141				42,187,694

Chiasma, Inc.
Condensed Consolidated Balance Sheets Information
(amounts in thousands)
(unaudited)
	March 31, 2021			December 31, 2020
Cash and cash equivalents	$	24,576		$	15,462
Marketable securities		90,457			119,959
Accounts receivable		1,015			538
Inventory		14,381			10,955
Prepaid expenses and other current assets		6,603			6,444
Property and equipment, net		487			534
Other assets		1,744			1,883
Restricted cash		20,272			20,563
Total assets	$	159,535		$	176,338
Accounts payable	$	6,356		$	4,240
Accrued expenses		10,338			11,858
Other current liabilities		625			633
Deferred royalty obligation		73,368			63,548
Long-term liabilities		6,160			4,274
Total liabilities		96,847			84,553
Total stockholders’ equity		62,688			91,785
Total liabilities and stockholders’ equity	$	159,535		$	176,338