FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of March, 2004
Commission File Number 001-13896
Elan Corporation, plc
(Translation of registrant's name into English)
Lincoln House, Lincoln Place, Dublin 2, Ireland
(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 if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(1):
Yes / / No /X/
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of
a Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(7):
Yes / / No /X/
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Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of
a Form 6-K if submitted to furnish a report or other document that the
registrant foreign private issuer must furnish and make public under the laws of
the jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrant's "home country"), or under the rules of the home
country exchange on which the registrant's securities are traded, as long as the
report or other document is not a press release, is not required to be and has
not been distributed to the registrant's security holders, and, if discussing a
material event, has already been the subject of a Form 6-K submission or other
Commission filing on EDGAR.
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/
If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b):
This Report of Foreign Issuer on Form 6-K is incorporated by reference into the
Post-Effective Amendments on Forms F-3 and S-8 to Form F-4 Registration
Statement of Elan Corporation, plc (Registration No. 333-12756), the
Registration Statement on Form F-3 of Elan Corporation, plc and Athena
Neuroscience Finance, LLC (Registration No. 333-13130), and the Registration
Statements on Form S-8 of Elan Corporation, plc (Registration Nos. 333-13996,
333-12344, 333-11940, 333-09644, 333-09284, 333-09048, 333-08384, 333-07361,
333-07136, 333-14240, 33-27506, 333-100252 and 333-100556).
EXHIBIT LIST
Exhibit Description
99.1 Press release dated March 30, 2004 titled:
Elan announces agreement with Vernalis regarding North American
rights for Frova(TM).
99.2 Press release dated March 30, 2004 titled:
Elan announces strategic transaction - Eisai to purchase Elan's
interests in Zonegran(TM) in North America and Europe.
SIGNATURES
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.
ELAN CORPORATION, plc
By: /s/ William F. Daniel
-----------------------------------
William F. Daniel
Company Secretary
Date: March 30, 2004
Exhibit 99.1
FOR IMMEDIATE RELEASE
Investors: Media:
Emer Reynolds Anita Kawatra
Ph: 353-1-709-4000 Ph: 212-407-5755
800-252-3526 800-252-3526
Elan ANNOUNCES AGREEMENT WITH VERNALIS REGARDING
NORTH AMERICAN RIGHTS FOR FROVA(TM)
Dublin, Ireland, March 30, 2004--Elan Corporation, plc today announced an
agreement with Vernalis plc for the termination of the development and license
agreements between Elan and Vernalis regarding Frova (frovatriptan). Vernalis
agreed to purchase Elan's commercialisation rights in North America for Frova.
Kelly Martin, Elan's president and chief executive officer, said, "This
transaction allows Elan to further align against our strategic architecture in
research, development and marketing. We will focus our resources on preparing
for the expected launch of our late-stage pipeline candidates, Antegren for
multiple sclerosis and Crohn's disease, and Prialt for pain."
Under the terms of the agreement, Vernalis will pay Elan a total of
approximately $55 million for rights to frovatriptan in North America,
comprising the following payments. Upon closing, Elan will receive $5 million;
on December 31, 2004 and December 31, 2005, Elan will receive payments of $20
million and $25 million respectively; and no later than December 31, 2004, Elan
will receive a payment for its Frova inventory, estimated at approximately $5
million. Additionally, Elan's co-promotion agreement with UCB Pharma, Inc. will
be terminated at closing, and Elan will pay UCB about $10 million as a result of
the termination.
For the full-year 2003, Elan recorded net revenue and gross profit for Frova of
$37.5 million and $8.1 million, respectively. The carrying value of the Frova
intangible asset is approximately $23 million.
The sale proceeds will be used for development and launch of late-stage pipeline
candidates. The completion of the transaction is subject to the approval of
Vernalis' shareholders, U.S. anti-trust clearance if required, third party
consents and other customary conditions. The transaction is expected to close
before the end of the second quarter of 2004.
About Frova
Frova is a prescription medicine used for acute treatment of migraine attacks in
adults. It is in the class of drugs called selective serotonin receptor
agonists.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company that is
focused on discovering, developing, manufacturing and marketing advanced
therapies in neurology, autoimmune diseases, and severe pain. Elan (NYSE: ELN)
shares trade on the New York, London and Dublin Stock Exchanges.
Safe Harbor/Forward Looking Statements
This news release contains forward-looking statements that involve risks and
uncertainties and reflects Elan's judgment as of the date of this release.
Actual events or results may differ from Elan's expectations. For example, the
proposed transaction may not close. In addition, the late stage pipeline
candidates mentioned in this news release may never be launched. A further list
of risks, uncertainties and other matters can be found in Elan's Annual Report
on Form 20-F for the fiscal year ended December 31, 2002, and in its Reports of
Foreign Issuer on Form 6-K. Elan assumes no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.
Exhibit 99.2
FOR IMMEDIATE RELEASE
Investors: Media:
Emer Reynolds Anita Kawatra
Ph: 353-1-709-4000 Ph: 212-407-5755
800-252-3526 800-252-3526
ELAN ANNOUNCES STRATEGIC TRANSACTION
Eisai to Purchase Elan's Interests in Zonegran(TM) in North America and Europe
Dublin, Ireland, March 30, 2004--Elan Corporation, plc today announced an
agreement with Eisai Co., Ltd. for the purchase of Elan's interests in Zonegran
(zonisamide) in North America and Europe.
Elan President and CEO Kelly Martin said, "This transaction further aligns
Elan's strategy in research, development, sales and marketing with our
therapeutic areas. In research, it sharpens our focus in neurology, in which we
continue research and advances in neurodegenerative diseases, including multiple
sclerosis, Alzheimer's disease, and Parkinson's disease. In development, sales,
and marketing, it enables us to focus our resources on the expected launch of
our late-stage pipeline candidates, Antegren for multiple sclerosis and Crohn's
disease, and Prialt for severe pain. In addition, the agreement creates an
opportunity for Eisai to leverage the potential for Zonegran."
Terms of Transaction
Under the terms of the agreement, if the transaction closes by April 30, 2004,
Eisai will pay Elan total consideration of approximately $130 million for Elan's
interests in Zonegran in North America and Europe. Elan's interests comprise
U.S., Canadian, Mexican, and European rights to Zonegran, along with related
assets and liabilities, Zonegran inventory with an estimated value of $26
million, and the associated sales team of approximately 115 employees.
If the transaction closes after April 30, 2004, the amount paid to Elan will be
adjusted downward. In addition, Elan may earn future deferred purchase payments
of up to $110 million,
primarily contingent on when generic zonisamide is introduced in the U.S., and
including up to $25 million contingent on receiving marketing approval for
Zonegran in Europe. Elan will also receive additional deferred purchase payments
on net sales of Zonegran in North America and Europe if certain additional
conditions are met.
Elan will continue to manufacture Zonegran in all three dosage strengths of 25
mg, 50 mg, and 100 mg capsules in Athlone, Ireland.
Based on a closing by April 30, Elan expects to record a pre-tax gain of
approximately $25 million from this transaction, after writing off the
intangible assets related to Zonegran, a payment of $17 million to Dainippon
Pharmaceutical Co., Ltd. for the assignment of the Zonegran North American and
European license agreements to Eisai and other transaction costs. Additionally,
Elan expects to record further pre-tax gains of up to $110 million on receipt of
future milestone payments. For the full-year 2003, Elan recorded net revenue and
gross profit for Zonegran of $80.7 million and $59.4 million, respectively.
The transaction is subject to regulatory approvals, third party consents and
other customary conditions, and is expected to close before the end of second
quarter 2004. The proceeds of this transaction will be used for development and
potential launch of late-stage pipeline candidates.
EBITDA Guidance
As a result of this transaction and the Vernalis transaction announced earlier
today, negative EBITDA guidance for 2004 will change from the range of negative
$150-170 million to negative $180-200 million, and product revenue guidance for
2004 will decrease from $575-625 million to $475-525 million. This guidance does
not include any additional costs, which may be substantial, that may be incurred
from anticipated early filings and potential launch preparation for Antegren for
multiple sclerosis in the U.S. and Europe.
About Zonegran
Zonegran is an anti-epileptic drug approved by the U.S. Food and Drug
Administration in March 2000 as adjunctive therapy for the treatment of partial
seizures in adults with epilepsy. Zonegran
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is commercially available in 25 mg, 50 mg, and 100 mg capsules. Zonegran was
developed in Japan and in the United States by Dainippon Pharmaceutical Co.,
Ltd. of Osaka, Japan. Elan licensed the sales and marketing rights for Zonegran
from Dainippon for North America and Europe, and these rights will be
transferred to Eisai.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company that is
focused on discovering, developing, manufacturing and marketing advanced
therapies in neurology, autoimmune diseases, and severe pain. Elan (NYSE: ELN)
shares trade on the New York, London and Dublin Stock Exchanges.
Safe Harbor/Forward Looking Statements
This news release contains forward-looking statements that involve risks and
uncertainties and reflects Elan's judgment as of the date of this release.
Actual events or results may differ from Elan's expectations. For example, the
proposed transaction may not close. Even if the proposed transaction is
consummated, it may not close by April 30, 2004. If the transaction closes after
April 30, 2004, the consideration to be received by Elan will be diminished. The
agreements governing the transaction contain additional provisions that could
cause the payments to Elan to be reduced. In addition, Elan may not receive any
of the milestone payments or deferred compensation discussed in this news
release. Further, the early regulatory filings for the late stage pipeline
candidates mentioned in this news release may not be made, and such product
candidates may never be launched. Elan may not achieve the results forecast in
the EBITDA or product revenue guidance for 2004. A further list of risks,
uncertainties and other matters can be found in Elan's Annual Report on Form
20-F for the fiscal year ended December 31, 2002, and in its Reports of Foreign
Issuer on Form 6-K. Elan assumes no obligation to update any forward-looking
statements, whether as a result of new information, future events or otherwise.
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