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Title: |
Elan Reports First Quarter 2004 Financial Results |
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Entities: |
Biogen Idec Inc.; Eisai Co., Ltd.; Elan Corp., plc; King Pharmaceuticals Inc.; Ligand Pharmaceuticals, Inc.; Vernalis plc |
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Date: |
2004 |
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Preview shows 10KB of 52KB total |
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$37 |
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ID: |
#302544 |
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Investors: Media:
Emer Reynolds Anita Kawatra
Ph: 353-1-709-4000 Ph: 212-407-5755
800-252-3526 800-252-3526
ELAN REPORTS FIRST QUARTER 2004 FINANCIAL RESULTS
DUBLIN, IRELAND, MAY 13, 2004--Elan Corporation, plc today announced its first
quarter 2004 results and provided an update on the progress of its product
development activities.
Commenting on the results Kelly Martin, Elan's President and Chief Executive
Officer, said " In the first quarter of 2004, we continued our execution
momentum across our core therapeutic areas of neurodegenerative diseases,
autoimmune diseases and severe pain. Our key second-quarter filings are on track
- Antegren for multiple sclerosis in the United States and Europe, and Prialt
for severe pain in the United States - and we continue discussions with the
United States and European regulators regarding potential filings for Antegren
as a treatment in Crohn's disease. Operationally, we are preparing for the
anticipated launches of Antegren and Prialt, with specific targeted investments
in the specialised infrastructure and personnel required for successful product
launches".
The financial highlights of Elan's performance from continuing operations are
set out below. The results of the group's discontinued operations under U.S.
GAAP are presented as a separate component of net loss for the current and prior
periods. Details of the group's discontinued operations are discussed on page 8.
{PAGE}
Elan First Quarter 2004 Financial Results
Page 2
First Quarter 2004 Financial Highlights - Continuing Operations
o Total revenue decreased 29% to $159.0 million compared to $224.7 million in
the first quarter of 2003 due principally to the divestment of a number of
products as part of the completed recovery plan.
o Revenue from retained products increased 7% to $75.4 million from $70.5
million in the first quarter of 2003.
o Net loss from continuing operations was reduced by 52% to $67.1 million
($0.17 loss per share) from $140.2 million ($0.40 loss per share) in the
first quarter of 2003.
o Total operating expenses were reduced by 29% to $212.6 million from $298.9
million in the first quarter of 2003.
o Negative EBITDA was reduced by 57% to $32.4 million from $75.4 million in
the first quarter of 2003. (See "Non-GAAP Financial Information" on page
5).
o Net investment related gains of $10.7 million compared to net investment
losses of $39.4 million in the first quarter of 2003.
o Cash and cash equivalents at March 31, 2004 of $910.9 million compared to
$807.5 million at December 31, 2003.
o The sale of Elan's interests in Zonegran(TM)to Eisai Co., Ltd. and Eisai
Inc. was completed realising approximately $130 million in April 2004.
Additional future deferred purchase payments of up to $110.0 million could
be received.
o Agreed to terminate the development and license agreements regarding
Frova(TM) and to sell Elan's commercialisation rights for Frova to Vernalis
plc for up to $55.0 million.
R&D Highlights
o Elan, in collaboration with Biogen Idec is on target to submit a Biologics
License Application ("BLA") to the U.S. Food and Drug Administration
("FDA") and a Marketing Authorisation Application ("MAA") to the European
Agency for the Evaluation of Medicinal Products ("EMEA") for Antegren(TM)
(natalizumab) as a potential treatment for multiple sclerosis ("MS") in the
second quarter of 2004.
{PAGE}
Elan First Quarter 2004 Financial Results
Page 3
o Elan, in collaboration with Biogen Idec, continues its discussions with the
regulatory agencies in the United States and Europe regarding the timing of
filings for Antegren as a potential treatment in Crohn's disease. Data from
the Phase III induction trial (ENACT-1) and the maintenance trial (ENACT-2)
for Crohn's disease will be presented at the Digestive Disease Week meeting
in New Orleans next week.
o During the first quarter of 2004, two new trials with Antegren were
initiated: A Phase III induction study to evaluate Antegren in patients
with Crohn's disease and a Phase II trial to evaluate Antegren in patients
suffering from rheumatoid arthritis.
o In January 2004, Elan announced that it had met the primary endpoint in its
Phase III trial evaluating Prialt(TM) (ziconotide) in patients with severe
chronic pain. Based on the positive results, the company is on target to
file a supplement to its New Drug Application ("sNDA") with the FDA in the
second quarter of 2004.
{PAGE}
Elan First Quarter 2004 Financial Results
Page 4
{TABLE}
{CAPTION}
Three Months
Ended March 31
Unaudited Consolidated US GAAP Income Statement Data 2003 2004
US$m US$m
-------------------------------------------------------------------------------------------------------------------------
Revenue (see page 8)
{S} {C} {C}
Product revenue 181.9 133.5
Contract revenue 42.8 25.5
---------- --------------
Total revenue 224.7 159.0
---------- --------------
Operating Expenses (see page 12)
Research & development 82.6 67.5
Cost of goods sold 74.4 50.3
Selling, general & administrative 119.8 85.7
Loss on disposal of businesses (net) 5.6 3.7
Recovery plan and other significant charges 16.5 5.4
---------- --------------
Total operating expenses 298.9 212.6
---------- --------------
Operating loss (74.2) (53.6)
---------- --------------
Net Interest and Investment Gains and Losses (see page 13)
Net interest expense (23.2) (23.3)
Investment gains - 44.8
Investment losses and other (39.4) (34.1)
---------- --------------
Net interest and investment gains and losses (62.6) (12.6)
---------- --------------
Net loss from continuing operations before tax (136.8) (66.2)
Taxation (3.4) (0.9)
---------- --------------
Net loss before discontinued operations (140.2) (67.1)
Net income from discontinued operations (see page 17) 12.7 4.9
---------- --------------
Net loss (127.5) (62.2)
========== ==============
Basic and diluted loss per ordinary share - continuing operations ($0.40) ($0.17)
Basic and diluted income per ordinary share - discontinued operations $0.04 $0.01
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