SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUERS PURSUANT TO RULE
13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT
OF 1934
Dated: August 11, 2003
Commission file number 0-21392
AMARIN CORPORATION PLC
(Exact name of Registrant as Specified in its Charter)
ENGLAND
(Jurisdiction of Incorporation or
organization of Issuer)
7 Curzon Street
London W1J 5HG, England
(Address of Principal Executive Offices)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or
Form 40-F.
[X] Form 20-F [ ] Form 40-F
Indicate by check mark whether the registrant by
furnishing the information contained in this Form is
also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
[ ] Yes [X] No
Attachment:
Material Events
(a) Amarin Corporation Reports Second Quarter 2003 Financial Results
This report on Form 6-K is hereby incorporated
by reference in the registration statement on Form F-3
(Registration Statement No. 333-12642) of Amarin
Corporation plc and in the prospectus contained therein,
and in the Registration Statement on Form F-3
(Registration No. 333-13200) of Amarin Corporation plc
and in the prospectus contained therein, and this report
on Form 6-K shall be deemed a part of each such
registration statement from the date on which this
report is filed, to the extent not superseded by
documents or reports subsequently filed.
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AMARIN CORPORATION PLC
By: /s/ Richard A B Stewart
Richard A B Stewart
Chief Executive Officer
Date: August 11, 2003
Index to Exhibits
Exhibit Item Sequentially Numbered Page
(a) Material Event description- 4
STATEMENT OF DIFFERENCES
------------------------
The registered trademark symbol shall be expressed as.....................'r'
The trademark symbol shall be expressed as................................'TM'
Exhibit a
Contact:
Rick Stewart Ian Garland
Chief Executive Officer Chief Financial Officer
Amarin Corporation plc Amarin Corporation plc
Phone: +44 (0) 20 7907 2440 Phone: +44 (0) 20 7907 2444
Email: investor.relations@amarincorp.com
---------------------------------
AMARIN CORPORATION REPORTS SECOND QUARTER 2003
FINANCIAL RESULTS
---
Permax'r' generic competition and continuing wholesaler inventory management
reduce revenues to $2.6 million from $20.2 million
---
Agreement reached with Elan for a substantial restructuring of debt
obligations and terms of Zelapar option, subject to financing
---
LONDON, United Kingdom, August 11, 2003 - Amarin Corporation plc (NASDAQ: AMRN)
today reported revenues for the second quarter of 2003 of $2.6 million, a
decrease of 87% compared with revenues of $20.2 million in the second quarter of
2002. For the quarter, net loss was $7.0 million or $0.39 per American
Depositary Share (ADS), versus net income of $7.3 million or $0.61 per ADS
(fully diluted) for the second quarter ended June 30th, 2002. The 2002 second
quarter net income benefited from an exchange gain of $3.9 million (2003 second
quarter: $nil).
For the six months ended June 30th, 2003 total revenues decreased 85% to $5.9
million compared with the same period in 2002. This reflects the impact of
generic competition to Permax'r' combined with wholesaler inventory management
resulting from generics.
During the second quarter, the Company continued to experience significant
generic competition to Permax'r' with a corresponding reduction in inventory
levels at wholesalers. The reduction in sales was in line with expectations and
will continue through the remainder of 2003. Permax'r' sales declined from $15.2
million in the second quarter of 2002 to $0.1 million in the current quarter.
"The decline in Permax'r' revenues as a result of generic competition is in line
with our expectations. The rate of erosion has stabilised with approximately 49%
of June 2003 prescriptions filled with generic pergolide compared to 47% for the
second quarter as a whole. However, we anticipate that a second generic will be
launched in September and this has already been factored into our expectations",
said Rick Stewart, Chief Executive of Amarin.
"Our current focus is on obtaining FDA approval for Zelapar. Since the receipt
of an approvable letter from the FDA, efforts have been made by Amarin and our
development partner Elan, a related party, to resolve the matters raised by the
FDA."
Other revenues fell to $2.5 million in the current quarter from $5.0 million in
the same quarter of 2002. Second quarter 2003 primary care products sales
revenue fell to $0.9 million from $2.4 million in the same quarter of 2002,
largely due to a reduction in wholesaler inventories. Second quarter 2003
revenues at Amarin Development declined from $2.6 million to $1.6 million
compared with the same period last year largely due to timing differences.
Total operating expenses, at $8.3 million for the second quarter 2003, are down
3% compared with the same quarter in 2002. The decrease is primarily due to
Selling, General and Administrative costs which are lower than in 2002 due to
reductions in Permax'r' promotion following the launch of the generic.
Management is, however, maintaining the Company's infrastructure in preparation
for the approval and launch of Zelapar.
Amarin also announces that it has reached agreement with Elan Corporation PLC
and certain of its affiliates (together "Elan") (NYSE: ELN), a related party, to
restructure existing financial commitments. This agreement provides that Amarin
may pay:
o $30 million in cash no later than December 31, 2003;
o $10 million in equity when Zelapar annual sales reach $20 million.
o Amarin will continue to pay a 12.5% royalty on future sales of
Zelapar; and
o in the event that Amarin raises funds in excess of $40 million
from the disposal of non-core assets and/or financing, Amarin will
use half the excess to buy down existing Zelapar royalties of
12.5% from Elan for $1 million per half of 1%, up to a maximum of
5%
in consideration for:
o a moratorium on debt and interest payments until December 31,
2003;
o full and final settlement of all debt and deferred payments due to
Elan (currently $46.5 million); and
o elimination of existing option and milestone payments relating
to Zelapar.
In connection with this agreement, Amarin has granted to Elan a fixed and
floating charge over all of its assets, to be reduced to $5 million upon payment
of the $30 million no later than the year-end.
If Amarin is unable or otherwise fails to pay the $30 million by year-end, or if
it is in breach of any agreement with Elan for a period of at least 30 days or
suffers certain insolvency-related events, the full amount of the debt and
deferred payments due to Elan will become payable upon demand and Elan will have
full rights as a secured creditor. Elan will also be able, at its sole option,
to convert all or part of its debt into Amarin equity, subject to obtaining the
necessary consents. In addition, the option rights to Zelapar would revert to
Elan.
After the benefit of the moratorium on debt and interest payments due to Elan,
together with existing cash balances at the end of the second quarter, Amarin
estimates that it has cash resources sufficient to meet its operating needs
through to the end of the year. Management intends to now embark on additional
financing to raise sufficient cash to make the $30 million payment to Elan due
by year-end and to fund the Group's ongoing working capital requirements. In
addition, in parallel with
raising additional financing, management intends to pursue strategic alliances
for the Group. If management is unsuccessful in its effort to raise financing,
Amarin will not be able to meet its $30 million payment obligation to Elan due
at December 31, 2003 or meet its working capital requirements after the end of
the year.
"Amarin disclosed in the first quarter results that additional funding was
required in the second half of the year to meet operational and debt
obligations. The Elan transaction provides clarity to our funding needs and
improves the potential value and return on Zelapar. Under the terms of the Elan
agreement financing must be concluded by year-end", added Rick Stewart.
Permax'r' (pergolide mesylate tablets) is a dopamine receptor agonist indicated
as adjunctive therapy in the management of Parkinson's disease. Zelapar'TM'
(selegiline orally disintegrating tablets), an MAO-B inhibitor, is a potential
adjunct therapy for Parkinson's disease.
Amarin Corporation plc is a specialty pharmaceutical company focused on
neurology and pain management. The company plans to become a leader in these
therapeutic categories by providing innovative products and solutions that
address significant unmet medical needs. Amarin has eleven pharmaceutical
products on the US market along with a development pipeline that includes two
late-stage candidates: Zelapar'TM' (selegeline orally disintegrating tablets),
for Parkinson's disease and LAX-101, a proprietary compound for Huntington's
disease.
For press release and other Company information, visit our web site at
http://www.amarincorp.com
- -------------------------
Statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties which may cause
the Company's actual results in future periods to be materially different from
any performance suggested herein. Such risks and uncertainties include, without
limitation, risks associated with the inherent uncertainty of pharmaceutical
research, product development and commercialisation, the impact of competitive
products and patents, as well as other risks and uncertainties detailed from
time to time in periodic reports. For more information, please refer to Amarin
Corporation's Annual Report for 2002 on Form 20-F and its Form 6-Ks as filed
with the U.S. Securities and Exchange Commission. The company assumes no
obligation to update information on its expectations.
Amarin Corporation plc
Period Ended 30 June 2003 Selected Data (UK GAAP - UNAUDITED)
Three months Six months
ended 30 June ended 30 June
------------------------ ------------------------
2002 2003 2002 2003
--------- ----------- --------- ------------
$'000 $'000 $'000 $'000
Revenue:
Licensing & development fees 597 526 1,801 1,064
Product sales & royalties 19,615 2,069 38,067 4,798
--------- ---------- --------- -----------
Total revenue from continuing activities 20,212 2,595 39,868 5,862
--------- ---------- --------- -----------
Cost of sales:
Direct costs 8,362 1,070 15,490 6,470
--------- ---------- --------- -----------
Gross profit 11,850 1,525 24,378 (608)
--------- ---------- --------- -----------
Operating expenses:
Selling, General & Administrative 5,907 5,329 12,712 11,195
Amortisation of intangible assets 1,046 1,348 2,910 2,696
--------- ---------- --------- -----------
6,953 6,677 15,622 13,891
Gain on renegotiation of Elan debt - - - (7,500)
--------- ---------- --------- -----------
Total SG&A 6,953 6,677 15,622 6,391
Research & development 1,615 1,632 3,100 3,120
Operating expenses from discontinued activities 3 - 9 -
--------- ---------- --------- -----------
Total operating expenses 8,571 8,309 18,731 9,511
--------- ---------- --------- -----------
Operating profit/(loss) from continuing activities 3,282 (6,784) 5,656 (10,119)
Operating loss on discontinued activities (3) - (9) -
Net interest payable (312) (192) (735) (447)
Foreign exchange gain 3,896 - 3,732 -
--------- ---------- --------- -----------
Income/(loss) before taxes 6,863 (6,976) 8,644 (10,566)
Income tax credit/(expense) 389 (41) 459 (143)
Dividends payable - - (48) (24)
--------- ---------- --------- -----------
Net income/(loss) for the period 7,252 (7,017) 9,055 (10,733)
--------- ---------- --------- -----------
Weighted average shares - basic 9,838 17,932 9,838 16,250
Weighted average shares - diluted 11,837 18,791 11,837 17,109
Income/(loss) per share:
Basic 0.74 (0.39) 0.92 (0.66)
Diluted 0.61 (0.39) 0.76 (0.66)
--------- ----------
2002 2003
--------- ----------
$'000 $'000
Earnings before interest, tax, depreciation and amortization 4,325 (5,436)
--------- ----------
Select Balance Sheet Data
Net current liabilities (26,373) (9,714)
Cash and debtors 46,909 14,928
Total assets 147,263 68,311
Long term creditors and provisions (26,549) (34,356)
Called up share capital [ordinary shares] 16,728 29,076
Total shareholders' funds 40,278 2,982
Income/(loss) for period 7,252 (7,017)
amortisation 1,046 1,348
impairment - -
gain on restructuring/discontinued operation - -
depreciation - -
interest 312 192
taxation (389) 41
foreign exchange (3,896) -
--------- ----------
EBITDA 4,325 (5,436)
--------- ----------
1. Basis of preparation - Going Concern
These selected financial data have been prepared on a going concern basis,
consistent with the basis of preparation of the Group's current annual financial
statements, filed under form 20-F. As indicated in the first quarter 2003 press
release, subsequent to the filing of the 20-F, the Group has obtained new data
on wholesaler inventories and has more data on the impact of generic competition
to Permax. Updating Amarin's projected cash flows to take account of these new
data indicated that Amarin must restructure its debt obligations and raise
additional funding in order to fund ongoing operations (as presently conducted)
from September onward.
Subsequent to the first quarter announcement, the Group has reached agreement
with Elan under which interest and debt payments falling due in 2003 are
deferred through to the year end. In addition, the Group has entered into an
agreement with Elan that provides the Group the opportunity to settle all
debt due to Elan and restructure the terms of the Zelapar option provided that
it makes a cash payment of $30 million to Elan by the year end.
Based on the deferral of debt and interest payments to Elan, the Group estimates
that it has sufficient cash to finance its operations through the year end, an
improvement of approximately one quarter compared to the position prior to
reaching agreement with Elan. The Group's management has now embarked on
financing discussions to raise funds sufficient to make the $30 million payment
due to Elan at the end of 2003 and to meet the Group's working capital needs
beyond year-end. The Group has through to year end to secure this additional
financing. Should management be unsuccessful in its effort to raise financing,
Amarin will not be able to meet its $30 million payment obligation to Elan due
at December 31, 2003 or meet its working capital requirements after the end of
the year. These selected financial data do not reflect the potential adjustments
that would be necessary should the Group cease to be a going concern.