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NOVEN ANNOUNCES RECORD FINANCIAL RESULTS |
BackNoven
Income Before Tax Benefits Increases 110%, Revenues Up 36%
Novogyne Net Income Increases 172%, Revenues Up 71%
MethyPatch™
Phase III Trials Completed, New Drug Application Underway
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MIAMI, FL. - February
26, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN), today announced
record financial results for the quarter and year ended December 31, 2000.
It also announced that, during the first quarter of 2001, it completed
Phase III clinical trials for its once-daily MethyPatch™,
a transdermal methylphenidate delivery system for Attention Deficit Hyperactivity
Disorder (ADHD).
Noven Financial
Results
Noven reported net income of $10.7 million ($.45 diluted earnings per
share) for the fourth quarter of 2000, compared to $7.5 million ($.34
diluted earnings per share) for the fourth quarter of 1999. Income before
tax benefits for the fourth quarter of 2000 was $2.6 million ($.11 diluted
pre-tax earnings per share). Revenues for the 2000 fourth quarter were
$11.7 million, compared to $8.6 million for the same quarter in 1999.
For full-year 2000,
Noven reported net income of $19.6 million ($.84 diluted earnings per
share), compared to $10.5 million ($.48 diluted earnings per share) for
1999. Income before tax benefits for 2000 was $12.0 million ($.52 diluted
earnings per share). Revenues for 2000 were $42.9 million, compared to
$31.6 million for 1999.
As of December 31,
2000, Noven had cash and cash equivalents of $41.0 million, compared to
$15.3 million as of December 31, 1999.
Novogyne Pharmaceuticals,
Noven's women's health joint venture with Novartis, contributed $2.9 million
and $9.3 million to Noven's 2000 fourth quarter and full-year financial
results, respectively, which amounts are reported as "Equity in earnings
of Novogyne" on Noven's Statements of Operations. Novogyne contributed
$1.5 million to Noven's financial results during all of 1999.
Novogyne Financial
Results
For full-year 2000, Novogyne's net income increased to $29.1 million,
compared to $10.7 million in 1999, and revenues increased to $58.5 million,
compared to $34.3 million in 1999. "The Novogyne sales force proved
what it could do in 2000, making the Vivelle® family the
second largest selling family of estrogen patches in the country, and
the number one seller in our target markets," said Neil Jones, Noven's
Vice President, Sales and Marketing, and head of the Novogyne sales effort.
"These market share gains led to increases of 172% and 71% in Novogyne's
2000 net income and revenues, and we saw additional market share gains
in January 2001."
MethyPatch™
Phase III Trials
Noven also announced that, during the first quarter of 2001, it completed
pivotal Phase III clinical trials for its once-daily MethyPatch™ transdermal
methylphenidate delivery system for ADHD. "With Phase III studies
completed, we are actively preparing our New Drug Application for MethyPatch™,"
said Dr. Anthony de Padova, Noven's Vice President, Clinical Research
and Regulatory Affairs. "Our goal is to file the application with
the Food and Drug Administration in the second quarter of 2001, and to
publicly release study results in the latter half of the year."
Business Outlook
"With a 36% increase in revenues and a 110% increase in pre-tax income,
Noven had another outstanding year in 2000," said Robert C. Strauss,
Noven's President, CEO and Co-Chairman. "We achieved these results
while investing significantly in our MethyPatch™ clinical trials, particularly
in the fourth quarter. For 2001 and beyond, we believe we have the growth
drivers in place to continue to rapidly improve our top and bottom lines.
We expect that, through Novogyne, our transdermal estrogen patches will
continue to gain share in the U.S. hormone replacement therapy (HRT) market,
and that Novartis will begin to extend the reach of our estrogen and our
combination patches internationally. In 2002, as our HRT products are
gaining momentum, our once-daily MethyPatch™ product for ADHD should be
launched in the U.S. In the years to follow, a more advanced line of Noven
patches should take our HRT franchise to new levels of success, and our
developmental androgen patch for Female Sexual Dysfunction may help pioneer
a new therapeutic category. As we look to the future, Noven has never
been in a stronger position to reward shareholders as it helps patients
around the world."
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, February 26. Thereafter,
a rebroadcast of the call will be accessible at the same web site. For
those without Internet access, a taped replay of the conference call will
be available by telephone from February 26 at 8:15 p.m. Eastern time until
the evening of February 28 by calling 800-475-6701 (from within the U.S.)
or 320-365-3844 (from outside the U.S.) and entering the access code 572745.
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 Aventis, and Estalis®, licensed
to Novartis). With a range of additional products in development, including
MethyPatch™, 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's most 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 estrogen patches and other products,
the inability to develop or in-license 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, delays in filing a MethyPatch™ New Drug Application,
and the inability of Noven to receive FDA approval to market any of MethyPatch™,
its androgen patch, or its developmental HRT patches and/or to successfully
commercialize such products.
Noven Pharmaceuticals, Inc.
Statement of
Operations Data: Three Months Ended Twelve Months Ended
(amounts in December 31, December 31,
thousands, except 2000 1999 2000 1999
per share amounts) -------- -------- -------- --------
(Unaudited)
Revenues:
Product sales $ 11,191 $ 8,473 $ 41,998 $ 31,334
License revenue 486 147 926 316
-------- -------- -------- --------
Total revenues 11,677 8,620 42,924 31,650
Expenses:
Cost of
products
sold 5,268 2,652 19,219 12,721
Research
and development 4,934 2,444 13,621 7,171
Marketing,
general and
administrative 2,368 2,414 8,737 7,860
-------- -------- -------- --------
Total expenses 12,570 7,510 41,577 27,752
-------- -------- -------- --------
Income (loss)
from operations (893) 1,110 1,347 3,898
Equity in
earnings of
Novogyne 2,911 1,487 9,294 1,487
Interest
income, net 612 150 1,385 343
-------- -------- -------- --------
Income before
income taxes 2,630 2,747 12,026 5,728
Income tax benefit 8,078 4,800 7,608 4,732
-------- -------- -------- --------
Net income $ 10,708 $ 7,547 $ 19,634 $ 10,460
-------- -------- -------- --------
Basic earnings
per share $ 0.48 $ 0.35 $ 0.90 $ 0.49
-------- -------- -------- --------
Diluted earnings
per share $ 0.45 $ 0.34 $ 0.84 $ 0.48
-------- -------- -------- --------
Weighted average number of
common shares outstanding:
Basic 22,132 21,529 21,914 21,508
-------- -------- -------- --------
Diluted 23,682 22,410 23,249 21,897
-------- -------- -------- --------
As of December 31,
Balance Sheet Data: 2000 1999
-------- --------
Cash and
cash equivalents $ 40,976 $ 15,338
Working capital $ 46,734 $ 16,581
Property, plant
and equipment, net $ 15,154 $ 15,329
Investment in
Novogyne $ 15,431 $ 8,365
Total assets $ 104,031 $ 56,888
Deferred license
revenue $ 27,220 $ 8,028
Stockholders'
equity $ 65,277 $ 39,393
Investor &
Media Contact:
Joseph C. Jones
Vice President, Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2000 Noven Pharmaceuticals, Inc. All rights reserved.