NOVEN
REPORTS FIRST QUARTER 2007 FINANCIAL RESULTS
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Quarterly
EPS Increases to $0.20 from $0.02 in 2006 First Quarter
Quarterly Net Revenues Increase 90% to $19.3 Million
Miami, FL, April
30, 2007 -- 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 2007.
"We’re off to
a strong start in 2007," said Robert C. Strauss, Noven’s
President, CEO & Chairman. "Sales of our Vivelle-Dot® and
Daytrana™ products contributed to a 90% increase in first quarter
revenues. This increase in revenues, together with a significant
improvement in our overall gross margin, contributed to a near ten-fold
increase in net income. Additionally, we received during the quarter
the first of three potential $25 million milestones related to Shire’s
sales of Daytrana™. We expect Shire’s Daytrana™ sales
will trigger the second milestone, and possibly the third, in 2007."
Noven
First Quarter Results
For the quarter ended March 31, 2007 (the “current
quarter”), Noven reported net income of $5.0 million ($0.20
diluted earnings per share), compared to $0.5 million ($0.02 diluted
earnings per share) for the quarter ended March 31, 2006 (the "2006
quarter").
Net revenues for the current quarter increased 90%
to $19.3 million, primarily reflecting $4.4 million in Daytrana™ product
sales to Shire plc, $3.0 million in Daytrana™ license revenues,
and higher hormone therapy ("HT") product sales to Novogyne
Pharmaceuticals, the women’s health joint venture between Noven
and Novartis Pharmaceuticals Corporation ("Novartis").
Noven’s
gross margin percentage in the current quarter was 43% compared to
29% in the 2006 quarter. Gross margin in the 2006 quarter was negatively
affected by start-up and other expenses associated with initial production
of Daytrana™, which was launched by
Shire in the second quarter of 2006. Gross margin in the current
quarter benefited from significantly higher product revenues, primarily
due to Daytrana™ sales; higher production volumes, which contributed
to improved overhead absorption; cost savings associated with Noven’s
cost reduction program implemented in the third quarter of 2006;
and a $0.5 million increase in price reconciliation payments relating
to international sales of HT products, which payments increase product
revenues without increasing costs. Noven continues to expect its
overall gross margin for full-year 2007 to be in the 35% range.
Research
and development expenses, at $3.5 million, were largely unchanged
from the 2006 quarter. Marketing, general and administrative expenses
increased $0.7 million or 14% to $5.4 million, primarily reflecting
higher compensation costs due to additional personnel.
Noven recognized
$4.9 million in earnings from Novogyne in the current quarter, 13%
higher than the $4.3 million recognized in the 2006 quarter.
Novogyne
First Quarter Results
Novogyne’s net income for the current
quarter was $16.2 million, an 8% increase over the 2006 quarter.
Current quarter net revenues at Novogyne were $33.1 million, up 5%
from the 2006 quarter, reflecting lower sales and returns allowances
and increased sales of Vivelle-Dot®. Novogyne’s gross margin
for the current quarter increased to 79% from 76% in the 2006 quarter
due to lower sales and returns allowances and increased Vivelle-Dot® sales,
which have a higher margin than sales of Novogyne’s other products.
Novogyne’s selling, general and administrative expenses increased
11% to $10.1 million, primarily reflecting the timing of the purchase
of samples from Noven. In the current quarter, Novogyne satisfied
the $6.1 million annual preferred profit distribution to Novartis
required by the joint venture agreements, as it did in the 2006 quarter.
Noven
Balance Sheet
At March 31, 2007, Noven had an aggregate $184.5 million
in cash and cash equivalents and short-term investments, compared
to $153.6 million at year-end 2006. This increase reflected receipt
of a $25.0 million sales milestone relating to Shire’s
2006 sales of Daytrana™, and $9.8 million in distributions
from Novogyne.
Prescription Update
Total prescriptions for Vivelle-Dot® increased
4% in the current quarter compared to the 2006 quarter, and total
prescriptions for Novogyne’s products, taken as a whole, increased
2%. By comparison, the overall U.S. HT market decreased 7% during
the same period. Total prescriptions for Daytrana™ (launched
in June 2006) increased 14% in the current quarter compared to the
quarter ended December 31, 2006, while prescriptions for ADHD stimulant
therapies as a class increased 5% for the same period.
Analyst Conference
Call
A conference call with management relating to Noven's financial
results will be broadcast live via the Internet at www.noven.com
beginning at 9:00 a.m. Eastern time this morning, April 30th. Thereafter,
a rebroadcast of the call will be accessible at the same website
for at least two weeks. A taped replay of the conference call will
be available from the afternoon of April 30th through May 2nd by
calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from
outside the U.S.) and entering the access code number 286 and ID
number 237437. 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. Noven is committed to expanding
the universe of available transdermal therapies for the benefit of
patients, partners and shareholders. Noven’s prescription patches
are approved in over 30 countries and include Vivelle-Dot® (the
most prescribed estrogen patch in the U.S.) and Daytrana™ (the
first and only patch approved for the treatment of ADHD). See www.noven.com
for additional information.
Except for
historical information contained herein, the matters discussed in this
press release contain 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 that involve substantial risks and
uncertainties. When used in this press release, the word “expect” and
similar expressions identify certain of such forward-looking statements.
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. By category,
these risks and uncertainties include: Daytrana™ –
the risk of supply interruptions of methylphenidate, which is necessary
for the production of Daytrana™, including uncertainties relating to
future DEA awards of methylphenidate procurement quota, which interruptions
could negatively affect production, facility utilization and Noven’s
revenues and gross margin in future periods as well as market acceptance
for Daytrana™; the risk that Noven may encounter
production inefficiencies or other issues in the process of manufacturing
Daytrana™, which
could adversely affect the success of the product and Noven’s
results of operations; risks related to competition (including from
other ADHD products marketed or under development by Shire) and market
acceptance of Daytrana™ that could adversely affect the commercial
success of Daytrana™ and could, among other things, limit Noven’s
ability to achieve additional milestone payments under its agreement
with Shire; and the possibility that the market for methylphenidate
products may be negatively affected by the ongoing public debate in
the United States regarding the appropriateness of using methylphenidate
and other medications to treat children with ADHD, as well as the outcome
of the FDA’s ongoing inquiry into the possible cardiac, psychiatric
and other side effects of ADHD medications, and that the FDA’s
inquiry could result in related “black-box” warnings being
added to the labeling for these medications; 2007
Gross Margin – the
risk that Noven may not achieve its targeted overall gross margin percentage
for 2007; the risk that forecasted revenues and production volumes
in 2007 are lower than expected; the risk that Noven may encounter
production inefficiencies, higher than expected costs, supply interruptions
or other issues in the process of manufacturing Daytrana™ and
other Noven products, which could adversely affect Noven’s revenues
and/or gross margin; and the expectation that Noven’s overall
gross margin in 2007 will fluctuate from quarter to quarter; HT
Market – risks associated with increased competition
in the HT market; any further impact on Noven’s HT business due
to the announcement of additional negative clinical results or otherwise,
which could reduce or eliminate any profit contribution by Novogyne
to Noven and/or sales of HT products from Noven to Novogyne and Novartis
Pharma; the risk that Novogyne may not be able to realize the full
value of the marketing rights for Noven's CombiPatch product; and risks
and uncertainties related to the fact that Vivelle-Dot® comprises
a substantial majority of Novogyne's aggregate total prescriptions; Noven's Partners – the risk that Noven's development
partners may have different or conflicting priorities than Noven's,
which may adversely impact their ability or willingness to assist in
the development and commercialization of Noven's products or to continue
the development programs; the possibility that Noven's development
programs may not proceed on schedule or as expected, which could, among
other things, prevent Noven from achieving milestone objectives and/or
cause delays or cancellations of programs; and the possibility that
Noven's current development priorities could render Noven unable to
advance Noven's other development projects or increase the cost of
advancing those projects. For additional information regarding these
and other risks associated with Noven’s business, readers
should refer to Noven’s Annual Report on Form 10-K as well as
other reports filed from time to time with the Securities and Exchange
Commission.
Noven Pharmaceuticals, Inc.
Statements
of Operations Data:
(amounts
in thousands, except per share amounts) (unaudited) |
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Three
Months Ended
March
31, |
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2007 |
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2006 |
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Revenues: |
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Product
revenues – Novogyne: |
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Product
sales |
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$ 5,369 |
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$ 3,087 |
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Royalties |
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1,765 |
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1,689 |
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Total
product revenues - Novogyne |
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7,134 |
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4,776 |
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Product
revenues – third parties |
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8,472 |
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3,871 |
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Total
product revenues |
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15,606 |
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8,647 |
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Contract
and license revenues: |
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Contract |
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(130) |
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664 |
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License |
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3,839 |
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881 |
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Contract
and license revenues |
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3,709 |
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1,545 |
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Net
revenues |
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19,315 |
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10,192 |
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Expenses: |
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Cost
of products sold – Novogyne |
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2,959 |
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2,143 |
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Cost
of products sold – third parties |
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5,968 |
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3,997 |
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Total
cost of products sold |
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8,927 |
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6,140 |
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Research
and development |
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3,466 |
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3,482 |
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Marketing,
general and administrative |
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5,421 |
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4,738 |
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Total
expenses |
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17,814 |
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14,360 |
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Income
(loss) from operations |
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1,501 |
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(4,168) |
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Equity
in earnings of Novogyne |
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4,903 |
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4,327 |
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Interest
income, net |
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1,632 |
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611 |
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Income
before income taxes |
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8,036 |
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770 |
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Provision
for income taxes |
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3,000 |
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266 |
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Net
income |
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$ 5,036 |
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$ 504 |
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Basic
earnings per share |
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$ 0.20 |
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$ 0.02 |
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Diluted
earnings per share |
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$ 0.20 |
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$ 0.02 |
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Weighted
average number of common
shares
outstanding: |
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Basic |
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24,738 |
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23,657 |
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Diluted |
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25,384 |
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23,774 |
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As
Of |
Balance
Sheet Data:
(amounts
in thousands) (unaudited) |
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March
31, 2007 |
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December
31, 2006 |
Cash
and cash equivalents |
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$ 34,625 |
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$ 9,144 |
Short-term
investments |
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149,869 |
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144,455 |
Investment
in Novogyne |
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18,439 |
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23,296 |
Total
assets |
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283,644 |
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281,365 |
Deferred
license revenues |
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85,433 |
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89,272 |
Stockholders’ equity |
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183,834 |
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176,675 |
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2007 Noven
Pharmaceuticals, Inc. All rights reserved. |