NOVEN
REPORTS SECOND QUARTER 2007 FINANCIAL RESULTS
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Second
Quarter EPS Increases to $0.30 from $0.14 in the 2006 Second Quarter
Miami, FL, August
7, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced
financial results for the three-month and six-month periods ended June
30, 2007.
Robert C. Strauss, Noven’s President, CEO & Chairman,
said: “Our transdermal products business had a very good quarter
and an outstanding first half, led by increased revenues from Daytrana™,
improved gross margins, and a solid performance by our Novogyne joint
venture due to increased sales of Vivelle-Dot®, our market leading
estrogen patch. In fact, quarterly total prescriptions for Vivelle-Dot® were
the highest in the product’s history.”
Strauss added: “As
previously announced, we are expanding our business beyond transdermal
products. We expect to close the pending acquisition of JDS Pharmaceuticals
this month, augmenting our existing business with a psychiatry-based
sales and marketing infrastructure, two in-market oral products, and
a substantial new product pipeline of oral products in psychiatry and
women’s health. We believe that these new capabilities and opportunities,
added to our existing transdermal business and new product pipeline,
will position Noven for a higher growth rate over the longer term,
and will provide greater visibility into our business and opportunities
than ever before.”
Second Quarter Results
For the quarter
ended June 30, 2007 (the "current quarter"), Noven reported
net income of $7.6 million ($0.30 diluted earnings per share), compared
to $3.3 million ($0.14 diluted earnings per share) for the quarter
ended June 30, 2006 (the "2006 quarter").
Noven’s net
revenues in the current quarter were $18.8 million, an increase of
7% compared to the 2006 quarter. This increase primarily reflected
higher Daytrana™ product sales to Shire plc (“Shire”),
partially offset by lower quarterly Vivelle-Dot® sales due to the
timing of orders by Novogyne (a women’s health products company
owned jointly by Noven and Novartis Pharmaceuticals Corporation).
Noven’s
gross margin percentage in the current quarter was 38% compared to
11% in the 2006 quarter. Gross margin in the 2006 quarter was negatively
affected by start-up and other expenses associated with the initial
production and launch of Daytrana™, which was launched during
the 2006 quarter. Gross margin in the current quarter benefited from
higher product revenues and production volumes, cost savings associated
with Noven’s cost reduction program implemented in the third
quarter of 2006, and a $0.3 million increase in price reconciliation
payments relating to international HT product sales. Noven continues
to expect its overall gross margin for full-year 2007 to be in the
35% range.
Research and development expenses for the current quarter
increased 10% to $3.2 million, primarily attributable to increased
clinical trial costs. At $5.7 million, current quarter marketing, general
and administrative expenses were largely unchanged from the 2006 quarter.
Noven recognized $9.2 million in earnings from Novogyne in the current
quarter, an increase of 36% compared to the $6.8 million recognized
in the 2006 quarter. Current quarter net revenues at Novogyne increased
18% to $36.1 million, primarily due to increased sales of Vivelle-Dot®.
Novogyne’s gross margin for the current quarter, at 78%, was
consistent with the 2006 quarter, and selling, general and administrative
expenses were largely unchanged at $9.6 million. Novogyne’s net
income for the current quarter increased 35% to $18.9 million, compared
to $14.0 million in the 2006 quarter.
2007 First Half Results
Noven
reported net income of $12.6 million ($0.50 diluted earnings per share)
for the six-months ended June 30, 2007 (the "current period"),
compared to $3.8 million ($0.16 diluted earnings per share) reported
for the six-months ended June 30, 2006 (the "2006 period").
Noven’s net revenues for the current period were $38.2 million
compared to $27.7 million reported for the 2006 period. This 38% increase
was primarily due to increases in sales of Daytrana™ and in license
revenues associated with that product. Daytrana™ was launched
in June 2006, and the current period benefited from a full six months
of sales.
Noven’s gross margin percentage in the current period
was 41% compared to 18% in the 2006 quarter. Gross margin in the 2006
period was negatively affected by start-up and other expenses associated
with the initial production and launch of Daytrana™. Gross margin
in the current period benefited from higher product revenues and production
volumes, cost savings associated with Noven’s cost reduction
program implemented in the third quarter of 2006, and a $0.8 million
increase in price reconciliation payments relating to international
HT product sales.
Research and development expenses increased 4% to
$6.7 million in the current period, and marketing, general and administrative
expenses increased 7% to $11.1 million.
Noven recognized $14.1 million
in earnings from Novogyne in the current period, an increase of 27%
from the $11.1 million recognized in the 2006 period. Novogyne’s
current period net revenues increased 11% to $69.2 million, reflecting
increased sales of Vivelle-Dot®, partially offset by increased
sales allowances. Novogyne’s gross margin for the current period
increased to 79% from 76% in the 2006 period, largely due to higher
pricing. Novogyne’s selling, general and administrative expenses
in the current period increased 5% to $19.7 million. Novogyne’s
net income for the current period was $35.2 million, a 21% increase
over the $29.1 million reported in the 2006 period.
Noven Balance Sheet
At June 30, 2007, Noven had an aggregate $186.7 million
in cash and cash equivalents and short-term investments, compared to
$153.6 million at year-end 2006. This increase reflected Noven’s
receipt of a $25.0 million sales milestone relating to Shire’s
2006 sales of Daytrana™, $11.0 million in distributions from Novogyne,
and $5.9 million received from Shire in connection with the ongoing development
of an amphetamine patch for ADHD, partially offset by certain payments,
including $14.1 million in income tax payments.
In July 2007, Shire
advised Noven that Shire’s sales of Daytrana™ through June
30, 2007 were sufficient to trigger the second of three potential $25
million sales milestones. Accordingly, Noven expects to receive this
$25 million payment in the 2007 third quarter. In addition, Noven will
fund the proposed acquisition of JDS Pharmaceuticals (expected to close
in August 2007) from existing cash and short-term investments. The
purchase price for the acquisition is $125 million in cash payable
at closing plus approximately $10 million in net assumed non-contingent
liabilities.
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 declined 7% for the same period. Total prescriptions
for Daytrana (launched in June 2006) decreased 6% in the current quarter
compared to the quarter ended March 31, 2007, while prescriptions for
ADHD stimulant therapies as a class decreased 4% for the same period.
These declines reflect the impact of the completion of the school year
at the end of the current quarter.
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 11:00 a.m. Eastern
time this morning, August 7th. 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 August 7th through August 9th 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 249632. The conference call will
contain forward-looking information in addition to that contained in
this press release.
About JDS Pharmaceuticals
JDS Pharmaceuticals,
LLC, headquartered in New York City, is a privately-held specialty
pharmaceutical company that currently markets two branded prescription
psychiatry products through a targeted sales force and is advancing
a significant development pipeline of high-potential products in psychiatry
and women’s health.
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. Statements that are not
historical facts, including statements which are preceded by, followed
by, or that include, the words "believes," "anticipates," "plans," "expects" or
similar expressions and statements are forward-looking statements. Noven’s
estimated or anticipated future results, product performance or other non-historical
facts are forward-looking and reflect Noven’s current perspective
on existing trends and information. 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 that past Daytrana™ results may not be indicative of future
Daytrana™ results; the risk that the market for Daytrana as well
as future sales of Daytrana™ could be adversely affected by a number
of factors, including as a result of: (i) issues relating to difficulties
in removing the release liner from the Daytrana™ patch, (ii) the
resolution of the observations made by the FDA in the Form 483 that Noven
received in July 2007, (iii) new market entrants, including from other
ADHD products marketed or under development by Shire (iv) supply interruptions
of methylphenidate, and (v) delays or inability to obtain necessary DEA
methylphenidate procurement quota, ; the risk that any adverse effect to
the market for Daytrana™ due the foregoing or other factors could
adversely affect Noven’s results of operations and/or its financial
position, including limiting Noven’s ability to achieve the additional
milestone payments under its agreement with Shire; 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; JDS Acquisition – the failure of the transaction
to close or a significant delay in the closing for any reason, including
but not limited to failure by either party to satisfy the closing conditions
in the merger agreement, the occurrence of any event, change or other circumstances
that could give rise to the termination of the merger agreement, or the
failure to obtain regulatory approvals required for the transaction; the
required regulatory approvals may delay the transaction or result in the
imposition of conditions on Noven which could have a material adverse effect
on Noven or otherwise cause the parties to abandon the transaction; the
proposed acquisition of JDS may involve unexpected costs, unexpected liabilities
or unexpected delays; the expected benefits of the proposed acquisition
of JDS, including expected revenue growth, may take longer than anticipated
to achieve and may not be achieved in their entirety or at all; any costs
or difficulties that Noven may encounter in the process of integration
of the organization and operations of the acquired business into Noven’s
existing organization and operations, including the possibility that such
integration may be delayed or more costly or difficult than expected and
may adversely affect Noven’s results of operations and financial
condition; disruption from the transaction making it more difficult for
Noven to maintain its relationships with its partners, customers, employees
or suppliers; uncertainties as to the future success of ongoing and planned
clinical trials and the risk that results from early-stage clinical trials
may not be indicative of results in later-stage trials; the unproven safety
and efficacy of products under development; the difficulty of predicting
FDA approvals, including timing, and that any expected period of exclusivity
may not be realized; the difficulty of predicting acceptance and demand
for new pharmaceutical products; the impact of competitive products and
pricing; risks relating to new product development and launch, including
the possibility that any product launch may be delayed or that product
acceptance may be less than anticipated; the possibility that patent applications
may not result in issued patents, and that issued patents may not be enforceable
or could be invalidated; and the impact of competitive responses to Noven’s
sales, marketing and strategic efforts. 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 for the year ended December
31, 2006 as well as other reports filed from time to time with the Securities
and Exchange Commission. Unless required by law, Noven undertakes no obligation
to publicly update or revise any forward-looking statements, whether as
a result of new information, future events, or otherwise.
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 |
|
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 |
|
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. |