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NOVEN ANNOUNCES FIRST QUARTER 2001 FINANCIAL RESULTS |
BackPre-Tax
Income Increases 126%
Vivelle Family Market Share Increases to Nearly 30%
MIAMI, FL. - April
30, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) today announced financial
results for the quarter ended March 31, 2001.
Noven reported net
income of $2.7 million ($.11 diluted earnings per share) for the first
quarter of 2001, compared to $1.8 million ($.08 diluted earnings per share)
for the first quarter of 2000. Income
before income taxes for the 2001 first quarter was $4.2 million, compared
to $1.9 million for the first quarter of last year. Revenues for the 2001
first quarter were $12.7 million, compared to $9.6 million for the same
quarter in 2000. Noven recorded $1.5 million in taxes in the first quarter
of 2001, compared to $35,000 in the first quarter of last year.
Novogyne Pharmaceuticals,
Noven's women's health products company owned jointly with Novartis Pharmaceuticals
Corporation, produced sufficient income in the first quarter of 2001 to
satisfy Novartis' $6.1 million preferred return for the year and for Noven
to recognize $0.6 million in earnings from Novogyne. In the first quarter
of 2000, Noven recognized $0.5 million in earnings from Novogyne.
As of March 31, 2001,
Noven had cash and cash equivalents of $46.2 million, compared to $41.0
million as of December 31, 2000.
"With a 126%
increase in pre-tax income and several strategic advancements during the
first quarter, Noven is off to a good start in 2001,'" said Robert
C. Strauss, Noven's President, CEO and Co-Chairman. "In the U.S.,
Vivelle® family prescriptions continue to increase. As
of the end of the first quarter, the Vivelle family's share of the U.S.
transdermal estrogen market had increased to nearly 30%. In late March,
we added CombiPatch™ to the Novogyne portfolio, making Novogyne the only
company in the country to offer patch products for both the estrogen-only
and combination hormone therapy markets. This should help continue Novogyne's
market share momentum. As long as prescriptions continue to grow, we know
that sales will follow. In fact, preliminary sales reports for April suggest
that Novogyne is completing the best sales month in its history, even
excluding CombiPatch sales.
"Also during
the first quarter, Estradot™ received its first European approval. Novartis
is now expected to advance the Mutual Recognition Procedure process to
get the product broadly approved in Europe. Novartis' license of Estradot,
combined with their previous license of Estalis® and their
recent acquisition of rights to future versions of the combination patch,
give us great confidence that Novartis is committed to Noven's products
and technologies. This should bode well for the long-term growth of Noven's
hormone replacement therapy business.
"Not all first quarter news was favorable; we announced that Phase III study results for our methylphenidate patch, unblinded in late March, were inconclusive. Since then, we have identified issues with the study design, not with the product itself. In fact, among patients manifesting significant ADHD symptoms, our product demonstrated efficacy with statistical significance. At a constructive meeting held in the latter half of April, we found the Food & Drug Administration to be supportive of our plan to proceed with an additional clinical study with a revised protocol. We look forward to finalizing our protocol, completing the study, submitting our NDA in the first half of 2002, and ultimately making an important contribution to the world of ADHD therapy."
Analyst Conference
Call
A telephone conference among management and equity analysts relating to
Noven's financial results will be broadcast live via the Internet at www.noven.com
beginning at 5:00 p.m. Eastern time this afternoon, April 30. Thereafter,
a rebroadcast of the call will be accessible at the same website. For
those without Internet access, a taped replay of the conference call will
be available by telephone from April 30 at 9:00 p.m. Eastern time until
the evening of May 2 by calling 800-475-6701 (from within the U.S.) or
320-365-3844 (from outside the U.S.) and entering the access code 584092.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader
in the development of transdermal and transmucosal drug delivery technologies
and products. Together with Novartis Pharmaceuticals, Noven owns a women's
health products company called Novogyne Pharmaceuticals. Noven's existing
products include advanced estrogen transdermal delivery systems (including
Vivelle-Dot™, licensed to Novogyne, and Estradot, licensed to Novartis)
and combination estrogen/progestin transdermal delivery systems (including
CombiPatch, licensed to Novogyne, and Estalis, licensed to Novartis).
With a range of additional products in development, Noven is committed
to becoming the world's premier developer, manufacturer and marketer of
transdermal and transmucosal drug delivery systems.
For additional information
on Noven, visit the company's web site at www.noven.com. For information
on Noven's Vivelle and Vivelle-Dot products, visit www.vivelledot.com.
Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven'smost recent filings with the Securities and Exchange Commission, including the risk that results for future periods may be less than anticipated because of, among other factors, competitive market conditions affecting Noven's hormone replacement patches and other products, the inability to develop new products, delays in the launch of Estalis by Novartis in certain countries, delays in the launch of Estradot abroad due to the failure to receive regulatory approvals or other factors, the failure of MethyPatch® clinical studies, delays in filing a MethyPatch New Drug Application, and the inability of Noven to receive FDA approval to market MethyPatch or its developmental HRT patches and/or to successfully commercialize such products.
Noven Pharmaceuticals, Inc.
Statements of Operations Data: Three Months Ended
(amounts in thousands, except March 31,
per share amounts) 2001 2000
---- ----
(Unaudited) (Unaudited)
Revenues:
Product sales $ 12,022 $ 9,456
License revenue 667 147
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Total revenues 12,689 9,603
Expenses:
Cost of products sold 4,816 4,511
Research and development 2,227 1,825
Marketing, general and administrative 2,660 2,082
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Total expenses 9,703 8,418
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Income from operations 2,986 1,185
Equity in earnings of Novogyne 595 477
Interest income, net 619 200
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Income before income taxes 4,200 1,862
Provision for income taxes 1,533 35
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Net income $ 2,667 $ 1,827
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Basic earnings per share $ 0.12 $ 0.08
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Diluted earnings per share $ 0.11 $ 0.08
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Weighted average number of common
shares outstanding:
Basic 22,236 21,682
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Diluted 23,606 22,827
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As Of
March 31, December 31,
Balance Sheet Data: 2001 2000
---- ----
Cash and cash equivalents $ 46,235 $ 40,976
Working capital $ 50,978 $ 46,734
Investment in Novogyne $ 18,076 $ 15,431
Total assets $149,923 $104,031
Deferred license revenue $ 30,053 $ 27,220
Stockholders' equity $ 69,534 $ 65,277
Investor &
Media Contact:
Joseph C. Jones
Vice President, Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2000 Noven Pharmaceuticals, Inc. All rights reserved.