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(Translation of registrant's name into English) 7 Curzon StreetUNITED STATES
SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
December 4, 2003
Commission File Number 0-21392
AMARIN CORPORATION PLC
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:
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
The following exhibits are furnished as part of this Form 6-K: This report on Form
6-K is hereby incorporated by reference in (a) the registration statement on
Form F-3 (Registration No. 333-104748) of Amarin Corporation plc and in the
prospectus contained therein, (b) the registration statement on Form F-3 (Registration
No. 333-13200) of Amarin Corporation plc and in the prospectus contained therein
and (c) the registration statement on Form F-3 (Registration No. 333-12642)
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from the date on which this report is filed, to the extent not superseded by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 or furnished by Amarin Corporation plc
under the Securities Act of 1933 or the Securities Exchange Act of 1934. 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. Date: December 4, 2003
Exhibit
Number
Description
99.1
Press Release
99.2
Amarin Corporation plc Interim financial statements as of and for the three months and nine months ended 30 September 2003 and 2003 (Unaudited)
SIGNATURES
By: /s/ RICHARD A. B. STEWART
Name: Richard A. B. Stewart
Title: Chief Executive Officer
Table of Contents 2EXHIBIT INDEX
Exhibit
Number
Description
99.1
Press Release
99.2
Amarin Corporation plc Interim financial statements as of and for the three and nine months ended 30 September 2003 and 2002 (Unaudited)
Contact: |
||
Rick Stewart Chief Executive Officer Amarin Corporation plc Phone: +44 (0) 20 7907 2440 Email: investor.relations@amarincorp.com |
Ian Garland Chief Financial Officer Amarin Corporation plc Phone: +44 (0) 20 7907 2444 |
For the nine months ended September 30th, 2003 total revenues decreased 81% to $10.4 million compared with $55.0 million for the same period in 2002. This reflects the continuing impact of generic competition to Permax® combined with wholesaler de-stocking across the whole product range.
During the third quarter, the Company experienced an additional generic competitor to Permax and further reductions in inventory levels at wholesalers. The decrease in revenues was in line with expectations and, as reported in the second quarter results, will continue through the remainder of 2003. Permax sales declined from $9.0 million in the third quarter of 2002 to $0.4 million in the current quarter.
Other revenues fell to $4.2 million in the current quarter from $6.2 million in the same quarter of 2002. Third quarter 2003 primary care products sales revenue fell to $2.7 million from $3.6 million in the same quarter of 2002, due primarily to reductions in wholesaler inventories which is expected to continue into the fourth quarter. Third quarter 2003 revenues at Amarin Development declined from $1.5 million to $1.4 million compared with the same period last year.
Total operating expenses, at $8.8 million for the third quarter 2003, are down 1% compared with the same quarter in 2002. The net decrease is primarily due to increased pre-approval costs of Zelapar™ (selegiline orally disintegrating tablets) offset by reductions in amortization arising from the end of 2002 impairment charge to Permax.
Amarin also announced that it has received clarification of the requirements of the U.S. Food and Drug Administration (FDA) to address the items in the approvable letter for Zelapar. As a result, discussions continue with the FDA to finalize protocols and initiate two safety studies in healthy volunteers, not addressing efficacy of the product, following which a complete response to the approvable letter will be submitted. Depending on study results and FDA review timing, submission of a complete response to the approvable letter could occur in mid 2004, with possible approval of Zelapar around 2004 year end. Timing of the studies could also be affected by Amarin's financial position, as discussed below.
Subsequent to the end of the quarter, Amarin has announced the sale of its Swedish drug delivery business, Amarin Development AB (ADAB), to Watson Pharmaceuticals, Inc. The total consideration for the sale was approximately $15 million to settle inter-company debts and acquire the stock of ADAB. At closing, $13.5 million of the cash consideration was received and $1.5 million is now held in escrow, to be paid out over three instalments within the next 12 months upon the satisfaction of certain contingencies. A gain on disposal will be recorded in the fourth quarter. The sale of ADAB is tax-exempt and thus does not give rise to a tax charge. As previously announced, the Company is seeking a buyer for its primary care portfolio and while progress has been made, no definitive transaction has been entered into for the sale of all or part of these products. The Company intends to continue those efforts and is additionally considering the divestment of its rights in one or more of its marketed and development products in neurology, its core area of focus. The Company has retained SG Cowen, investment bankers, to advise it on maximising shareholder value, potentially including a sale of the Company as a whole. Under the terms of the debt restructuring agreement with Elan announced in August, approximately $11 million of the proceeds from the sale of ADAB was to be applied in part payment of the outstanding debt obligations due to Elan. After that part payment, a further amount, approximately $19 million, was due to Elan to satisfy the minimum $30 million that must be paid by the end of the year. The Company has agreed in-principle with Elan that, if the $30 million minimum payment is not made by December 31st, 2003, the present year-end deadline for debt repayment will be extended to March 31st, 2004 in consideration of the payment to Elan of interest (calculated at 1% per month on the outstanding balance) and a one-off payment to Elan of $1.5 million. Adding the consideration for an extension, should it be required, the Company's minimum payment of principal to Elan rises to $31.5 million on or before March 31st, 2004. Elan has also agreed in-principle that the Company can retain a further $2 million per month for the first three months of 2004 from the net proceeds from the sale of ADAB in order to fund the Company's operating deficit through the first quarter of 2004. Draw down of these funds will be subject to the Company demonstrating to Elan's satisfaction that the Company has a reasonable prospect of consummating a transaction to settle the Elan debt by March 31st, 2004. The following table summarises the financial obligations due to Elan: At the current time, the Company has cash sufficient to fund its operations only through the end of 2003 and with the additional funds from the sale of ADAB through the first quarter of 2004. Unless an asset sale or other transaction can be concluded prior to March 31st, 2004 the Company will be unable to continue as a going concern and as a result would be unable to fund the continued development of Zelapar. In addition, in that event, the full amount of debt and deferred payments due to Elan will become due and payable upon demand and Elan will have full rights as a secured creditor and the right, subject to the receipt of shareholder and other approvals, to convert all or part of its debt and deferred payments into the Company's ordinary shares at the then-current market
price of the Company's ADSs. The financial results for the third quarter 2003 reported above do not reflect the adjustments that would be required should the Company cease to be a going concern. ''We are pursuing all possible alternatives which will allow Amarin to meet its obligations to Elan and continue the progress toward approval of Zelapar,'' commented Rick Stewart, Amarin's chief executive officer. ''We are pleased that the divestment of ADAB was consummated on favourable terms and timing. Uncertainties in our sector, combined with a more protracted selling process than we originally anticipated, have resulted in a delay of the sale of our remaining non-core
If Settled By:
$ million
December 31st
2003
March 31st
2004
Minimum payment due to Elan
30.0
31.5
Proceeds from sale of ADAB
(11.1
)
(11.1
)
Retained to fund operating deficit in Q1 2004
6.0
Further funds required to settle debt
18.9
26.4
assets. Given Amarin's financial situation, we have expanded the scope of our asset disposal activities, and have retained SG Cowen to assist us in rapidly pursuing a transaction to maximize shareholder value concluded Mr. Stewart. Mr Stewart and other members of Amarin's management team will participate in a conference call to discuss the quarterly results and the Company's current condition at 9:00 AM EST Thursday December 4th, 2003. The conference call can be accessed by dialling +1 888 896 0863 (tollfree) in the U.S. or +1 973 582 2703 (toll) elsewhere. Permaxt®
(pergolide mesylate tablets) is a dopamine receptor agonist indicated as adjunctive
therapy in the management of Parkinson's disease. Zelapar®
(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 eight pharmaceutical
products on the US market along with a development pipeline that includes two
late-stage candidates: Zelapar™ (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, the ability of the Company to continue to fund its operations and product development 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.
Three
months ended 30 September |
Nine
months ended 30 September |
|||||||||||||||
2002 |
2003 |
2002 |
2003 |
|||||||||||||
$'000 |
$'000 |
$'000 |
$'000 |
|||||||||||||
Revenue: | ||||||||||||||||
Licensing & development fees | 941 | 675 | 2,742 | 1,739 | ||||||||||||
Product sales & royalties | 14,234 | 3,882 | 52,301 | 8,680 | ||||||||||||
|
|
|
|
|||||||||||||
Total revenue from continuing activities | 15,175 | 4,557 | 55,043 | 10,419 | ||||||||||||
|
|
|
|
|||||||||||||
Cost of sales: | ||||||||||||||||
Direct costs | 5,571 | 1,341 | 21,061 | 7,811 | ||||||||||||
Inventory write-off | 4,764 | — | 4,764 | — | ||||||||||||
|
|
|
|
|||||||||||||
10,335 | 1,341 | 25,825 | 7,811 | |||||||||||||
|
|
|
|
|||||||||||||
Gross profit | 4,840 | 3,216 | 29,218 | 2,608 | ||||||||||||
|
|
|
|
|||||||||||||
Operating expenses: | ||||||||||||||||
Selling, General & Administrative | 4,602 | 5,622 | 17,313 | 16,817 | ||||||||||||
Amortisation of intangible assets | 2,367 | 1,404 | 5,277 | 4,100 | ||||||||||||
|
|
|
|
|||||||||||||
6,969 | 7,026 | 22,590 | 20,917 | |||||||||||||
Gain on renegotiation of Elan debt | — | — | — | (7,500 | ) | |||||||||||
Restructuring provision | 522 | — | 522 | — | ||||||||||||
|
|
|
|
|||||||||||||
Total SG&A | 7,491 | 7,026 | 23,112 | 13,417 | ||||||||||||
Research & development | 1,428 | 1,748 | 4,528 | 4,868 | ||||||||||||
Operating expenses from discontinued activities | (37 | ) | — | (28 | ) | — | ||||||||||
|
|
|
|
|||||||||||||
Total operating expenses | 8,882 | 8,774 | 27,612 | 18,285 | ||||||||||||
|
|
|
|
|||||||||||||
Operating (loss)/profit from continuing activities | (4,079 | ) | (5,558 | ) | 1,578 | (15,677 | ) | |||||||||
Operating profit on discontinued activities | 37 | — | 28 | — | ||||||||||||
Net interest payable | (381 | ) | (196 | ) | (1,116 | ) | (643 | ) | ||||||||
Foreign exchange gain | 2,467 | — | 6,199 | — | ||||||||||||
|
|
|
|
|||||||||||||
(Loss)/income before taxes | (1,956 | ) | (5,754 | ) | 6,689 | (16,320 | ) | |||||||||
Income tax (expense)/credit | (214 | ) | (3 | ) | 245 | (146 | ) | |||||||||
Dividends payable | — | — | (48 | ) | (24 | ) | ||||||||||
|
|
|
|
|||||||||||||
Net (loss)/income for the period | (2,170 | ) | (5,757 | ) | 6,886 | (16,490 | ) | |||||||||
|
|
|
|
|||||||||||||
Weighted average shares—basic | 9,838 | 17,932 | 9,838 | 16,810 | ||||||||||||
Weighted average shares—diluted | 11,837 | 17,944 | 11,837 | 16,822 | ||||||||||||
(Loss)/income per share: | ||||||||||||||||
Basic | (0.22 | ) | (0.32 | ) | 0.70 | (0.98 | ) | |||||||||
Diluted | (0.22 | ) | (0.32 | ) | 0.58 | (0.98 | ) | |||||||||
2002 |
2003 |
|||||||||||||||
$'000 | $'000 | |||||||||||||||
(Loss)/earnings before interest, tax, depreciation and amortization | (1,675 | ) | (4,154 | ) | ||||||||||||
|
|
|||||||||||||||
Select Balance Sheet Data | ||||||||||||||||
Net current assets/(liabilities) | 2,845 | (48,352 | ) | |||||||||||||
Cash and debtors | 42,526 | 7,371 | ||||||||||||||
Total assets | 137,542 | 56,987 | ||||||||||||||
Long term creditors and provisions | (56,428 | ) | (410 | ) | ||||||||||||
Called up share capital [ordinary shares] | 16,214 | 29,076 | ||||||||||||||
Total shareholders' funds/(deficit) | 37,199 | (3,226 | ) | |||||||||||||
|
|
|||||||||||||||
Loss for period | (2,170 | ) | (5,757 | ) | ||||||||||||
amortisation | 2,367 | 1,404 | ||||||||||||||
impairment | — | — | ||||||||||||||
gain on restructuring/discontinued operation | — | — | ||||||||||||||
depreciation | — | — | ||||||||||||||
interest | 381 | 196 | ||||||||||||||
taxation | 214 | 3 | ||||||||||||||
foreign exchange | (2,467 | ) | — | |||||||||||||
|
|
|||||||||||||||
EBITDA | (1,675 | ) | (4,154 | ) | ||||||||||||
|
|
These quarterly selected financial data have been prepared on the going concern basis. As reported in the Group's Form 20-F/A for the year ended 31 December, 2002 and in the ''Management's commentary on results'' section of the unaudited interim financial statements filed with the SEC, the Group only had cash resources to fund its operations into the fourth quarter of this year.
These selected financial data should be read in conjunction with the attached press release which sets out an update on the current Group position as a going concern.