75 million of non-recurring income following Novartis' decision to
forego certain
development rights.0
million from $57.4 million for the same period of 2003, due principally
to
revenues earned from sanofi-aventis.3 million,
respectively, for the same periods of 2003.0 million
sanofi-aventis up-front payment has been
deferred as of December 31, 2004 and will be recognized
as revenue in
future periods.9 million in the fourth quarter of 2004
and 15% to $17. The collaboration
will not
currently pursue systemic delivery of the VEGF Trap for eye disease.
In February 2005
, the Company and Merck amended their long-term
manufacturing agreement for production of an intermediate
for a Merck
pediatric vaccine at the Company's Rensselaer, New York facility.
jock diseases
1
million in the
comparable quarter of 2003 as higher revenue earned
from sanofi-aventis in the fourth quarter of
2004 replaced revenue
earned from Novartis in the same quarter of 2003. Contract research
and
development revenue increased to $113. This compares
with $21. Contract manufacturing
revenue
increased to $3.5 million in the fourth quarter of 2004
from $0.8 million
shares of the Company
's Common Stock to Novartis and sanofi-aventis,
respectively, in 2003. Goldberg, Senior Vice President
, Finance and
Administration and Chief Financial Officer at Regeneron, will provide
an overview
of the Company and its clinical candidates.m. One of the tablet formulations has been selected for
use in the
pivotal Phase III studies in Trypanosomiasis and Pneumocystis pneumonia (PCP),
as well
as for commercialization.health infectious
0 million research
progress payment related to a clinical development milestone
that was
earned in the fourth quarter of 2004 and received in January 2005. In the first quarter
of 2004, Novartis also
forgave all of its outstanding loans to Regeneron, totaling $17.1 million
for the full year
of 2004 compared with the same periods of 2003. Regeneron has therapeutic candidates
for the potential treatment of cancer, eye diseases, rheumatoid
arthritis and other inflammatory
diseases, asthma and allergies and
has preclinical programs in other diseases and disorders.
Additional
information about Regeneron and recent news releases
are available on Regeneron's web site at www
.biz.musculoskeletal disorders
The increase in net income for
2004 was due primarily to the Company's collaboration agreements
with
the sanofi-aventis Group and Novartis Pharma AG.3 million in the same period of 2003.4 million
of contract research and development revenue under
the Novartis collaboration for the full year 2003
.1
million, 12% higher than the same quarter in 2003 and $168. The
amendment extends the manufacturing
agreement for one full year
through October 2006 and provides Merck an opportunity, upon
twelve
-months' prior notice, to extend the agreement for an additional
year through October 2007. A more
complete
description of these risks can be found in Regeneron's filings with
the United States
Securities and Exchange Commission, including its
Form 10-K/A for the year ended December 31, 2003
and the Form 10-Q for
the quarter ended September 30, 2004.regeneron. The advantage of the pressed
tablet is that it is less
expensive to manufacture and more stable in conditions with high temperatures
and humidity, such as those found in certain countries in sub-Sahara Africa,
South America, and
Asia.
For additional information, please go to http://www.
genetic infections
74 per diluted share, for
the
full year 2004 compared with a net loss of $107.8 million in the fourth
quarter of 2004 and
less than 1% to $136.1 million for the full year 2004 compared with the same
periods in 2003. Interleukin
-1 (IL-1) appears to play a
significant role in these diseases.35) $0.fungal joint
7 million and $14.2 million
for the same period of 2003 and to $18.
Current Business Highlights
Regeneron has built
a broad-based clinical development program
that is evaluating several product candidates in different
stages of
clinical development. In
addition, the companies agreed that the exclusive right to
develop and
commercialize the VEGF Trap for eye diseases through local delivery
systems would
revert to Regeneron.immtech.syndrome jock
Regeneron Reports Fourth Quarter and Full Year 2004 Financial and Operating
Results
----Regeneron
Pharmaceuticals, Inc. The Company reported net income of $41. As a result
, $65. In 2004, the Company
incurred higher development expenses for the VEGF Trap (which are
fully
reimbursed by sanofi-aventis) and the IL-4/13 Trap. The Company's two lead candidates are the VEGF
Trap
and the IL-1 Trap.
The Company plans to initiate, in the second quarter of 2005, a
phase 1 trial
of the VEGF Trap in the neovascular form of age-related
macular degeneration (wet AMD) utilizing
local delivery to the eye.
This news release discusses historical information and includes
forward
-looking statements about Regeneron and its products, programs,
finances, and business, all of which
involve a number of risks and
uncertainties, such as risks associated with preclinical and clinical
development of drugs and biologics, determinations by regulatory and
administrative governmental
authorities, competitive factors,
technological developments, the availability and cost of capital
, the
costs of developing, producing, and selling products, the potential
for any collaboration
agreement to be canceled or to terminate without
any product success, and other material risks.05
($0.----Regeneron
Pharmaceuticals, Inc.regn. An archived
version of the presentation will be
available after the live webcast
through June 1, 2005. VERNON HILLS, Ill.infectious arthritis
Regeneron reported
net income of $2.8 million, or $0.4 million
for the full year 2004, 7% higher than in 2003.5 million
shares (basic and diluted)
last year, due primarily to the sale of 7. The study's objective was
to compare the
bioavailability of the current capsule formulation to two new formulations in
pressed
tablets. is a pharmaceutical company advancing the
development and commercialization of oral drugs
to treat infectious diseases
and neoplastic (cancer) and metabolic (diabetes) disorders.'s
business
which are not historical facts are "forward-looking statements" that
involve risks and uncertainties
.jacobsen conditions
75 per basic share and $0.6 million at December 31, 2003.0 million of convertible notes, which bear
interest at
5.
Regeneron recognized contract research and development revenue of
$16. 104,
Revenue Recognition. Regeneron does not
expect to recognize any future contract research and development
revenue from Novartis.
Regeneron recently announced plans to move the IL-1 Trap
development
program forward in 2005 with the initiation of pivotal
studies in rheumatoid arthritis and in rare
genetic auto-inflammatory
diseases and exploratory proof-of-concept studies in a wide variety of
other diseases.74 ($2.
Business Editors/Health/Medical Writers
Deutsche Bank Securities
Health Care Conference 2005
BIOWIRE2K
TARRYTOWN, N.
Immtech is focused on providing practical
solutions to solve major global
health crises.fungal genetic
7
million, or $0. The
Company's total revenue
for the full year 2004 increased to $174.1 million for the
full year 2004 from $10.
In the first
quarter of 2004, in connection with its decision to
forego its rights to jointly develop the IL-1
Trap, Novartis agreed to
pay Regeneron $42.
For the full year 2004, the weighted average number
of shares
outstanding increased to 55. The VEGF Trap has been granted Fast
Track designation by
the US Food and Drug Administration (FDA) for a
specific niche cancer indication.infections health
3 million for the
full year 2004 related to the Company's collaboration with
sanofi-aventis, compared with $11. Contract
research and
development revenue from the sanofi-aventis collaboration for the full
year 2004
consisted of $67. The increase in contract
manufacturing revenue principally resulted from an increase
in product
shipments to Merck in 2004 compared with the same periods of 2003. Regeneron has therapeutic
candidates in
clinical trials for the potential treatment of cancer, eye diseases,
rheumatoid
arthritis, asthma, and obesity and has preclinical programs
in other diseases and disorders. The
session may be accessed through the
Company's website (www.Immtech Announces Results of DB289 Formulation
Trial
j juvenile
Business Editors/Biotech Writers/Health Writers
BIOWIRE2K
TARRYTOWN, N.Y
.13
per share (basic and diluted), in 2003.9 million compared with $366.8
million, based on Regeneron
's achieving a pre-defined development
milestone, which was recognized as a research progress payment
.
Contract manufacturing revenue relates to Regeneron's long-term
manufacturing agreement with
Merck + Co.3 million in the fourth quarter of 2004 from
$2. Investment income increased in the fourth
quarter and
for the full year 2004 compared with prior year periods due primarily
to higher effective
interest rates on investment securities.0 million payment to Regeneron in January
2005, 50% of which
is repayable to sanofi-aventis following
commercialization of the VEGF Trap.13)
Diluted
$0. (Nasdaq: REGN) will webcast its presentation at
the Deutsche Bank 30th Annual
Health Care Conference on Tuesday, May
3, 2005. The results showed that the pressed tablets produced
similar
blood concentrations when compared to the capsule formulation and that the
tablet formulations
yielded more consistent blood levels of the active drug
that is formed in the body from DB289. We
are developing
treatments for fungal infections, malaria, tuberculosis, cancer, diabetes,
Pneumocystis
pneumonia ("PCP") and tropical diseases, including African
sleeping sickness (trypanosomiasis) and
leishmaniasis.health diseases
05 per share
(basic and diluted), for the fourth quarter of 2004 compared with a
net
loss of $19. Contract research and development
revenue was $18.8 million for reimbursement of VEGF
Trap
development expenses and $10.7 million in 2003, primarily because
more product was shipped
to Merck and the Company incurred unfavorable
manufacturing costs in the fourth quarter and for the
full year 2004
compared with the same periods of 2003. Interest expense is
attributable primarily
to the Company's convertible notes.4 million shares (basic) and 56.
In January 2005, sanofi-aventis
reaffirmed their commitment to
develop the VEGF Trap in oncology in collaboration with Regeneron
.75 ($2.
Regeneron is a biopharmaceutical company that discovers, develops,
and intends to
commercialize therapeutic medicines for the treatment
of serious medical conditions."
About Immtech International
Immtech International, Inc.genetic arthritis
In
connection with the Novartis collaboration
, in the first quarter of
2004 the Company recognized a $17. The
Company's $200.5 million in 2003
.
During the last quarter of 2004, Regeneron initiated an
exploratory trial of the IL-1 Trap in
patients with CIAS1-Associated
Periodic Syndrome (CAPS), a spectrum of rare diseases associated with
mutations in the CIAS1 gene.
The Company expects the preliminary results from this study to be
reported at a scientific meeting later this year.13)
Weighted average shares
outstanding:
Basic 55,541 55,183 55,419 50,490
Diluted
55,719 55,183 56,172 50,490
Blood was
collected at regular intervals from
each volunteer to determine the level of
DB289 in the blood.tinea jock
4 million, or $0.1 million in the fourth
quarter of 2004 from $21. The Company recognizes revenue in
connection with collaborations in
accordance with Staff Accounting
Bulletin No.2 million
for the full year 2004 from $6.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per
share data)
For the three months For the year
ended December 31, ended December 31,
2004 2003 2004 2003
-------- --------- ---------
----------
Revenues
Contract research and
development $18,780 $19
,121 $113,157 $47,366
Research progress payments 25,000 42,770
Contract
manufacturing 3,310 2,151 18,090 10,131
-------
- --------- --------- ----------
47,090 21,272 174,017 57
,497
-------- --------- --------- ----------
Expenses
Research and development 34,789 33,267 136,095 136,024
Contract manufacturing
3,474 907 15,214 6,676
General and administrative 4,853 4,237 17,062
14,785
-------- --------- --------- ----------
43,116 38,411 168,371 157,485
-------
- --------- --------- ----------
Income (loss) from operations 3,974 (17,139) 5,646
(99,988)
-------- --------- --------- ----------
Other income
(expense)
Other contract income 42,750
Investment income
1,832 868 5,478 4,462
Interest expense (3,014) (3,106)
(12,175) (11,932)
-------- --------- --------- ----------
(1,182) (2,238) 36,053 (7,470)
-------- --------- --------- ----------
Net income (loss) $2,792 ($19,377)
$41,699 ($107,458)
======== ========= ========= ==========
Net
income (loss) per share:
Basic $0. The
presentation is scheduled to
be broadcast live on Tuesday, May 3, 2005
at 4:30 p.
"Safe Harbor" Statement under the
Private Securities Reform Act of 1995:
Statements in this press release regarding Immtech International
, Inc.genetic fungal
5 million, or $2.2 million for the full year
2004 from $47.8 million of
the original $80
. The
Company recognizes revenue and the related manufacturing expense as
product is shipped to
Merck.
Contract manufacturing expense, which relates to the Merck
agreement, increased to $3. Interest
expense was essentially unchanged for the fourth quarter and full year
of 2004 compared with the
same periods in 2003. In connection with this agreement,
sanofi-aventis made a $25. In January 2005
, the Company
received Orphan Drug designation for the IL-1 Trap in these diseases.05 ($0.
Murray
A. (Amex: IMM) announced today the results of the safety trial comparing
three different formulations
of DB289, the Company's first oral drug
candidate.fungal arthritis
5% per annum, mature in October 2008.5 million
related to a September 2003
up-front, non-refundable payment.1 million for the full year 2004, representing
the remaining deferred amount of the March 2003 up-front,
non-refundable payment of $27. General
and administrative
expenses increased 15% to $4.75 million to satisfy certain funding obligations
under their collaboration agreement, which was recognized as other
contract income.
Regeneron
and sanofi-aventis plan to evaluate the VEGF Trap in a
variety of cancer types, both in single-agent
studies and in
combination with chemotherapy.
T. We have a worldwide,
exclusive license
to commercialize a dicationic pharmaceutical platform from
which a pipeline of products may be developed
to target large, global markets.jacobsen genetic
8 million research progress payment
based on Regeneron's achieving
a pre-defined development milestone and
$42.
At December 31, 2004, cash and marketable securities
totaled
$348.8 million in the fourth quarter of 2004 and $19.
Total operating expenses for the
fourth quarter of 2004 were $43. In 2004, the Company incurred higher accounting and
other professional
fees, primarily related to its efforts to comply
with the requirements of Section 404 of the Sarbanes
-Oxley Act of 2002
and incurred costs associated with higher administrative headcount
needed to
support the Company's operations.2 million
shares (diluted) compared with 50.Regeneron Announces
Presentation at Deutsche Bank 30th Annual Health Care Conference
Eastern Time.
The study
, conducted in Miami, Florida with 42 healthy volunteers,
required each volunteer to take a single
oral dose of DB289 in each of the
three formulations, with a seven-day period between each dose.
disorders infectious
35 per share (basic and diluted), for
the fourth quarter of 2003.
Regeneron's total revenue increased
to $47.3 million in the fourth quarter of 2004 and $78.
Contract research and development revenue
related to the Novartis
collaboration was $22. Regeneron does not undertake any
obligation to
update publicly any forward-looking statement, whether
as a result of new information, future events
, or otherwise unless
required by law.
REGENERON PHARMACEUTICALS, INC.
, Immtech International,
Inc.musculoskeletal tinea
1 million in 2003. These were
partially offset by a decline in expenses
for the Company's AXOKINE(R)
and IL-1 Trap clinical development programs, compared with 2003.9 million
in the same quarter of 2003, and to $15.
Per share amounts are based on the weighted average number
of
shares of the Company's Common Stock and Class A Stock outstanding.5 million and 2.
About
Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops,
and intends to commercialize therapeutic medicines for the treatment
of serious medical conditions
.
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands
)
December 31,
2004 2003
--------- ---------
ASSETS
Cash and marketable securities (including
restricted marketable
securities in 2003) $348,912 $366,566
Receivables 43
,102 15,529
Inventory 3,229 9,006
Property, plant
and equipment, net 71,239 80,723
Other assets
6,626 7,731
--------- ---------
Total assets $473,108 $479,555
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts
payable and accrued expenses $18,872 $18,933
Deferred revenue
71,693 109,003
Notes payable 200,000 200
,000
Other liabilities 13,976
Stockholders' equity
182,543 137,643
--------- ---------
Total liabilities and
stockholders
' equity $473,108 $479,555
========= =========
REGENERON PHARMACEUTICALS, INC.Y.com on the Events page, under the Investor
Relations heading) at the time of the presentation. Stephen Thompson, President and CEO said, "The
selection of a tablet
formulation of DB289 is an important step in our preparations for the Phase
III human trials and commercialization of DB289. We believe that the pressed
tablets will be
less expensive and easier to manufacture, ship and store.disorders joubert
(Nasdaq: REGN) today announced financial and
operating results for the fourth quarter and year ended December 31,
2004. In connection with
the sanofi-aventis collaboration for the joint development and
commercialization of the VEGF Trap
, Regeneron recognized both higher
contract research and development revenue and a $25.0 million from
Novartis., Inc. Research and
development (R+D) expenses increased 5% to $34. These other diseases
may include other rheumatological
disorders and diseases associated with inflammation in blood vessels
.35) $0.com
For a discussion of such risks and
uncertainties that could cause actual
results to differ from those contained
in the forward-looking statements, see "Risk Factors" in the
Company's Annual
Report on Form 10-K/A for the most recently reported fiscal year.juvenile joint
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