NOVEN
EARNS MILESTONE PAYMENT
UNDER P&G COLLABORATION
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Miami, FL, December
29, 2004 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced
that it has earned a $3.0 million success fee for attaining a development
milestone under its development collaboration with P&G Pharmaceuticals,
Inc., a subsidiary of The Procter & Gamble Company. Noven expects
to report the $3.0 million success fee as license and contract revenues
for the quarter ending December 31, 2004.
In light of the success fee, Noven also updated its previously
issued financial guidance for full-year 2004. Noven currently expects
its earnings per share for full-year 2004 to be in the $0.45 to
$0.50 range and its 2004 net revenues to exceed 2003 levels. This
guidance is based on Noven’s current assumptions and expectations
regarding the business and operations of Noven and Novogyne Pharmaceuticals
(Noven’s women’s health products company owned jointly
with Novartis Pharmaceuticals Corporation). Actual financial results
could differ materially if these assumptions or expectations prove
to be incorrect.
Noven, headquartered in Miami, Florida, is a leading developer
of advanced transdermal drug delivery technologies and prescription
transdermal products. Noven’s prescription patches are approved
in over 30 countries, and a range of new patches are being developed
in collaboration with Novartis Pharma AG, Shire Pharmaceuticals
Group plc, Procter & Gamble Pharmaceuticals, Endo Pharmaceuticals
Inc. and others. Together with Novartis Pharmaceuticals Corporation,
Noven owns Novogyne Pharmaceuticals, a profitable women’s
health products company with 2003 sales of over $100 million. Among
other products, Novogyne markets and sells Noven’s Vivelle-Dot® product
– the smallest estrogen patch in the world, and the most dispensed
transdermal estrogen product in the U.S. Noven is committed to
expanding the universe of available transdermal therapies for the
benefit of patients, partners and shareholders. See www.noven.com
for additional information.
This press release contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. When used in this press
release, the words “expects” and “could” identify
certain of such forward-looking statements. Readers are cautioned
that actual results, performance or achievements could differ materially
from those contemplated, expressed or implied by the forward-looking
statements contained herein. These forward-looking statements are
based largely on the current expectations of Noven and are subject
to a number of risks and uncertainties that are subject to change
based on factors which are, in many instances, beyond Noven’s
control. These risks and uncertainties include but are not limited
to: the inherent uncertainties associated with financial projections;
the possibility that one or more assumptions underlying Noven’s
financial guidance may prove to be incorrect, including the assumptions
that there will be no additional recalls of CombiPatch beyond the
one lot described in Noven’s Form 10-Q for the quarter ended
September 30, 2004, and that there will not be any unforeseen material
transactions, changes in Noven’s or Novogyne’s accounting
or accounting principles, developments regarding regulatory matters
or clinical studies, changes in the supply of, demand for, or distribution
of Noven’s HT products (including any changes resulting from
the impact of competitive HT products that have been launched in
2004); the risk that Novogyne may not be able to realize the full
value of the marketing rights for Noven’s CombiPatch product;
uncertainties regarding the timing and magnitude of any product
recall, including those which may be related to the CombiPatch
stability issue discussed in Noven’s Form 10-Q for the quarter
ended September 30, 2004 and, in particular, the risk that additional
lots of CombiPatch could be recalled if Noven’s stability
testing related to the October 2004 stability failure reveals that
additional lots do not meet specification; risks and uncertainties
related to the fact that the decision to recall product resides
with Novartis as the holder of the CombiPatch NDA and is not within
Noven’s control; the possibility that Noven’s or Novogyne’s
estimates of the impact of future returns and other charges may
prove inaccurate, incomplete or otherwise incorrect; the impact
of detected or undetected product stability failures or other product
defects on Noven’s ability to estimate its reserves for sales
returns and other associated accounting consequences; risks related
to Noven’s dependence on Novartis to perform Novogyne’s
financial, accounting, inventory, distribution, revenues and sales
deductions functions (including return reserves and any asset impairment
decisions for Novogyne), including the risk that Novartis may perform
these functions differently than Noven would have, inadequately
or incorrectly; the possibility that Noven’s financial results
could fluctuate from period to period or otherwise be affected
by Novartis’ monitoring of trade inventory levels for Novogyne
and its decisions related thereto; the risk that the products under
development with P&G Pharmaceuticals may not be successfully
developed, approved by the FDA or commercialized; the risk of losses
from product liability claims resulting from the use of HT products
such as the lawsuits presently pending against Noven and Novartis
with respect to Noven’s products, as well as any indemnification
or contribution obligations that Noven may have to Novartis or
Novogyne related to product liability claims; the risk that the
actual amount incurred by Noven in connection with the current
IRS audit (as previously disclosed in Noven’s Form 10-Q for
the quarter ended September 30, 2004) exceeds the amount that Noven
has accrued; risks and uncertainties relating to changes in our
business relationships/collaborations; and risks and uncertainties
arising from changes in the economy or the health care sector generally.
Noven cautions that the foregoing list is not exhaustive. In addition
to the risks and factors identified above, reference is made to
the risks and factors detailed in Noven’s Annual Report on
Form 10-K as well as other reports filed by Noven with the Securities
and Exchange Commission.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2004 Noven
Pharmaceuticals, Inc. All rights reserved. |