|
NOVEN REPORTS FIRST QUARTER EARNINGS PER SHARE OF $0.06 |
BackVivelle® Family Claims Top Spot in U.S. Transdermal Estrogen Market
Estradot® Launched in First Major European Market
Once-Daily MethyPatch® Proceeding Towards Mid-Year NDA Filing
Miami, FL, April 30,
2002 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN),a leading developer
of advanced transdermal drug delivery technologies and prescription transdermal
products, today announced financial results for the first quarter of 2002
and provided an update on its business and outlook for 2002.
"The year is
off to a good start," said Robert C. Strauss, Noven's President,
Chief Executive Officer & Chairman. "Solid first quarter financial
results, an improved outlook for international product sales in 2002,
and other favorable business developments provide a sound basis for optimism
with regard to Noven's prospects in the coming quarters."
Financial Results
Noven's revenues
for the quarter ended March 31, 2002 (the "current quarter")
were $12.7 million, in line with revenues reported for the quarter ended
March 31, 2001 (the "2001 quarter"). Research and development
expense increased 51% to $3.4 million, reflecting higher MethyPatch®
clinical trial and related expenses. Net income was $1.5 million ($0.06
diluted earnings per share), compared to $2.7 million ($0.11 diluted earnings
per share) in the 2001 quarter.
Novogyne Pharmaceuticals,
Noven's women's health products company owned jointly with Novartis Pharmaceuticals
Corporation (NPC), produced sufficient income in the current quarter to
satisfy NPC's $6.1 million preferred return for the year and to contribute
$1.5 million in pre-tax profit to Noven. Novogyne's revenues nearly doubled
to $27.5 million in the current quarter, reflecting increased sales of
Vivelle-Dot® and the addition of CombiPatch®
to Novogyne's product line in March 2001. Novogyne's selling, general
and administrative expenses increased to $11.2 million from $4.8 million,
reflecting primarily CombiPatch promotion expenses and an approximate
20% increase in the size of the Novogyne sales force. Novogyne amortized
$1.5 million of CombiPatch acquisition cost in the current quarter, and
had no comparable amortization expense in the 2001 quarter. In the current
quarter, Novogyne's net income increased 29% to $9.6 million.
Business Update
Novogyne. "During the first quarter, the Vivelle family of
products (Vivelle-Dot and Vivelle) continued to increase market share,"
said Strauss. "In February, it became the most prescribed family
of estrogen patches in the United States, achieving a goal we have worked
towards since the launch of Vivelle-Dot in 1999. In March, the Vivelle
family extended its lead, garnering a 34% share of the U.S. estrogen patch
market. Among the physicians targeted by Novogyne, the Vivelle family
holds a 45% share of the estrogen patch market, and in some sales territories,
its market share exceeds 60%."
Novogyne also markets
CombiPatch, which is the only FDA-approved combination estrogen/progestin
patch in the U.S. With the relaunch of CombiPatch by Novogyne in May 2001,
Novogyne became the only company in the U.S. offering transdermal therapies
for both the estrogen-only and combination HRT markets. CombiPatch total
prescriptions have not meaningfully increased since relaunch. "In
2002, a key Novogyne objective is to help more physicians and patients
appreciate the benefits of CombiPatch therapy," said Strauss, "and
Novogyne is implementing supplemental sales and marketing programs in
support of that goal."
International.
"Late in the first quarter of 2002, the international version of
Vivelle-Dot (called Estradot) was launched by Novartis Pharma AG (Novartis
Pharma) in some European countries," said Strauss. "In April,
Novartis Pharma launched the product in Germany, which is the first major
European market to receive the world's smallest estrogen patch. Novartis
Pharma has planned a series of additional Estradot launches over the next
18 to 24 months, and we are encouraged by the level of preparation that
we have seen in this regard."
MethyPatch. Strauss
continued: "In March, Noven completed a Phase III clinical trial
for once-daily MethyPatch, our transdermal methylphenidate patch for ADHD.
In early April, we unblinded the study data. The primary outcome measure
in the study was teacher ratings of patient attention and behavior using
the IOWA Conners Rating Scale, a standard rating scale used for this condition
in classroom and other settings. By this measure, MethyPatch offered highly
statistically significant improvement (p < .001) in patient attention
and behavior compared to placebo. We are now focused on completion of
our MethyPatch New Drug Application, which we expect to submit to the
FDA this summer. If approved by the FDA, we expect that MethyPatch will
reach the U.S. market in the second half of 2003, and that it will be
the first transdermal therapy available for ADHD."
Financial Guidance
"Based primarily on an improved outlook for international product
sales this year, we are raising our guidance for 2002 revenues and earnings,"
said James Messiry, Noven's Vice President & Chief Financial Officer.
"For full year 2002, we expect revenues to increase 15% to 20% over
2001, and we expect to report fully diluted earnings of $0.50 to $0.55
per share. As we have previously indicated, we expect 2002 to include
increased investment in research and development, as well as MethyPatch
launch preparation costs. We expect that a disproportionate share of the
year's product sales will occur in the second quarter. Accordingly, we
are forecasting second quarter revenues of nearly $16 million, and diluted
earnings per share of $0.14 to $0.17, and we expect that the second quarter
will be the strongest quarter of the year in terms of both revenues and
net income."
Conference Call
A public telephone conference with management 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. A taped replay of
the conference call will be available by telephone from April 30 at 8:30
p.m. 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 636871. The conference call will contain forward-looking information
in addition to that contained in this press release.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading
developer of advanced transdermal drug delivery technologies and prescription
transdermal products. Together with NPC, Noven owns a highly profitable
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 Pharma) and combination estrogen/progestin transdermal
delivery systems (including CombiPatch®, licensed to Novogyne,
and Estalis, licensed to Novartis Pharma). 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 drug delivery systems. For additional information
on Noven, visit www.noven.com.
This release contains
forward-looking statements related to the business of Noven that can be
identified by the use of forward-looking terminology such as "outlook",
"basis for optimism", "may provide", "encouraged",
"expect", "planned", "guidance", "should",
"will" and "forecast". Such statements are qualified
by and subject to the risks and uncertainties specified in Noven's most
recent filings with the Securities and Exchange Commission and those specified
herein, including the risk that planned or expected milestones may not
be achieved and that results for future periods may be materially different
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; the failure of Novogyne to increase
sales of CombiPatch or continue growing sales of the Vivelle family either
as a result of the supplemental sales and marketing programs or otherwise;
the inability of Noven to manufacture and supply Novartis Pharma's Estradot
launch orders or any of Noven's other products; delays in the launch of
Estradot abroad and/or lower than expected sales of Estradot to Novartis
Pharma due to the failure of Novartis Pharma to receive regulatory approvals
and/or uncertainty regarding Novartis Pharma's strategy with regard to
launching and marketing Estradot together with competitive products marketed
by Novartis Pharma; issues that may arise following a complete analysis
of MethyPatch clinical data and/or in the course of the NDA preparation
process; delays in filing a MethyPatch New Drug Application; the inability
of Noven to receive FDA approval to market MethyPatch in a timely manner
or at all and/or to successfully commercialize MethyPatch; lower than
expected Estalis orders by Novartis Pharma due to the failure of Novartis
Pharma to successfully commercialize and support Estalis due to inventory
levels, the absence of preferred dosing ranges, regulatory strategies
or other factors; and potential fluctuations in research and development,
sales and marketing and other expenses. FDA will examine efficacy data
from the recently completed MethyPatch Phase III study together with safety
and other data from this and other MethyPatch studies sponsored by Noven,
and there can be no assurance that FDA will deem all of such data sufficient
to approve the product for marketing or to authorize the product's use
in the manner described by Noven. Noven believes that MethyPatch will
be the first transdermal ADHD product submitted to FDA for approval, and
there can be no assurance that FDA will not have questions or raise objections
that could delay or prevent an approval. There are several other once-daily
ADHD medications on the market, and other products that may have improved
safety and efficacy profiles are also in development.
Noven Pharmaceuticals, Inc.
Statements of Operations Data: Three Months Ended
(amounts in thousands, except March 31,
per share amounts) ------------------
2002 2001
---- ----
(Unaudited)(Unaudited)
Revenues:
Product sales $11,991 $12,022
License revenue 744 667
------- -------
Total revenues 12,735 12,689
Expenses:
Cost of products sold 5,900 4,816
Research and development 3,369 2,227
Marketing, general and administrative 2,933 2,660
------- -------
Total expenses 12,202 9,703
------- -------
Income from operations 533 2,986
Equity in earnings of Novogyne 1,515 595
Interest income, net 207 619
------- -------
Income before income taxes 2,255 4,200
Provision for income taxes 802 1,533
------- -------
Net income $ 1,453 $ 2,667
======= =======
Basic earnings per share $ 0.06 $ 0.12
======= =======
Diluted earnings per share $ 0.06 $ 0.11
======= =======
Weighted average number of common
shares outstanding:
Basic 22,491 22,236
======= =======
Diluted 23,456 23,606
======= =======
As Of
March 31, December 31,
Balance Sheet Data: 2002 2001
---- ----
(Unaudited) (Unaudited)
Cash and cash equivalents $ 47,270 $ 49,389
Investment in Novogyne $ 33,558 $ 32,043
Total assets $ 128,628 $ 136,228
Deferred license revenue $ 32,014 $ 32,758
Stockholders' equity $ 83,585 $ 81,898
Investor &
Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2002 Noven Pharmaceuticals, Inc. All rights reserved.