Noven Announces 2008 Second Quarter Financial Results
2008-08-06 07:30:00
Noven Announces 2008 Second Quarter Financial Results
Noven Reports Quarterly EPS of $0.18, Adjusted EPS of $0.23
Quarterly Net Income at Novogyne Joint Venture Increases 34% to
$25.4 Million
MIAMI–(EMWNews)–Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced financial
results for the second quarter and first half of 2008. Noven reported
net income of $4.5 million or $0.18 diluted earnings per share for the
quarter ended June 30, 2008, including a charge of $1.7 million
(discussed below) relating to a previously disclosed voluntary product
recall initiated during the quarter. Excluding this charge and related
tax effects, Noven would have reported net income of $5.6 million or
$0.23 diluted earnings per share for the second quarter of 2008.
Financial & Business Highlights
Novogyne & Vivelle-Dot®.
At Novogyne Pharmaceuticals, Noven’s joint
venture with Novartis Pharmaceuticals Corporation, net income for the
second quarter of 2008 increased 34%, and net revenues increased 21%,
compared to the second quarter of 2007. Total prescriptions for
Vivelle-Dot®, Novogyne’s
lead product, increased 6% in the second quarter of 2008 compared to the
same quarter in 2007, while total prescriptions in the overall U.S.
hormone therapy market decreased 6% for the same period.
Daytrana®.
Sales of Daytrana® by
Shire Limited in the 2008 second quarter were sufficient to trigger the
third and final $25 million sales milestone due to Noven. In addition,
together with Shire, Noven believes the definitive root cause of the
peel force issue affecting Daytrana has been identified, and testing of
solutions expected to address the issue is ongoing.
Stavzor™.
On July 29, 2008, the FDA granted final approval of Noven’s
Stavzor™ product (valproic acid delayed
release capsules). The product will be marketed and sold by Noven
Therapeutics, Noven’s specialty
pharmaceutical subsidiary, and is expected to be available in pharmacies
in the second half of August 2008.
Organizational Initiatives. Since
June 2008, Noven has added three highly experienced pharmaceutical
industry veterans to lead the critical functions of marketing and sales,
transdermal research and development, and clinical, regulatory and
medical affairs. With the participation of these new executives, Noven
is continuing its review of all areas of spending and investment to
assure that they advance the interests of shareholders.
CEO Comment
“The 2008 second quarter included another
strong financial performance by Novogyne, as well as continued
operational improvement in other areas of our business,”
said Peter Brandt, Noven’s President and
Chief Executive Officer. “At Novogyne, net
income increased 34% over the same quarter last year, Vivelle-Dot total
prescriptions and market share continued to increase, and we believe
there is opportunity for continued significant growth in this business.
At Noven Therapeutics, we are well prepared for the August launch of
Stavzor, which received final FDA approval just last week. At Noven
Transdermals, we believe, together with Shire, that we have identified
the definitive root cause of the peel force issue affecting Daytrana,
and we are testing solutions that we believe will address the issue.
Daytrana continues to bring important benefits to patients with ADHD,
and sales of the product by Shire in the second quarter triggered the
third and final $25 million milestone to Noven,”
said Brandt. “In addition, across key
functions within the company – including
research and development, sales and marketing, and clinical and
regulatory – we have added new senior
executives with substantial industry experience that should help us
successfully execute our growth strategy.”
Financial Results
Noven’s financial results for the second
quarter and first six months of 2008 included the results of operations
of Noven Therapeutics (formerly JDS Pharmaceuticals, LLC), a specialty
pharmaceutical company acquired by Noven in August 2007. The second
quarter and first half of 2008 also included charges of $1.7 million and
$1.95 million, respectively, representing reimbursement due to Shire in
connection with the voluntary recall of two lots of Daytrana product
initiated in 2008 (the “Daytrana Charge”).
Second Quarter Results
Including the impact of the Daytrana Charge, for the second quarter of
2008, Noven reported net income of $4.5 million ($0.18 diluted earnings
per share), compared to $7.6 million ($0.30 diluted earnings per share)
for the quarter ended June 30, 2007. Excluding the Daytrana Charge and
the related tax effects, net income for the 2008 second quarter would
have been $5.6 million ($0.23 diluted earnings per share). A
reconciliation of net income and earnings per share on a GAAP basis to
net income and earnings per share as adjusted to reflect the excluded
items is attached to this press release.
Noven’s net revenues in the 2008 second
quarter were $24.6 million, a 31% increase over the second quarter of
2007. This increase reflects the addition of $6.6 million in Pexeva®
and Lithobid®
product sales through Noven Therapeutics, as well as increased license
and contract revenues, primarily due to amortization of deferred revenue
from additional Daytrana sales milestones received in 2007.
Gross margin, as a percentage of total net product revenues, was 35% in
the 2008 second quarter compared to 38% in the same quarter last year.
Gross margin in the second quarter of 2008 was adversely affected by
increased quality assurance activities and expenses, primarily related
to Daytrana production, which offset the favorable impact of higher
gross margins on Noven Therapeutics’ products.
Research and development expenses in the 2008 second quarter, at $3.3
million, were largely unchanged from the second quarter of 2007. Selling
and marketing expenses increased to $5.3 million from $0.2 million in
the 2007 second quarter due to the addition of the Noven Therapeutics
marketing and sales infrastructure supporting Pexeva, Lithobid and
Stavzor (approved by the FDA in July 2008). General and administrative
expenses increased $3.4 million, or 62%, due primarily to the Daytrana
Charge and the addition of Noven Therapeutics.
Noven recognized $12.4 million in earnings from Novogyne in the 2008
second quarter, an increase of 35% compared to the $9.2 million
recognized in the same quarter last year.
Novogyne’s net income for the second quarter
of 2008 increased 34% to $25.4 million, compared to $18.9 million in the
2007 second quarter. Novogyne’s net revenues
for the 2008 second quarter increased 21% to $43.8 million. Novogyne’s
gross margin for the second quarter of 2008 increased slightly to 80%,
and its selling, general and administrative expenses were largely
unchanged at $9.8 million.
First Half Results
Including the impact of the Daytrana Charge, Noven reported net income
of $7.1 million ($0.29 diluted earnings per share) for the first six
months of 2008, compared to $12.6 million ($0.50 diluted earnings per
share) reported for the first six months of 2007. Excluding the Daytrana
Charge and the related tax effects, Noven would have reported net income
for the first six months of 2008 of $8.3 million ($0.34 diluted earnings
per share).
Noven’s net revenues for the first six months
of 2008 were $46.1 million, a 21% increase over the same period last
year. This increase reflects the addition of $12.3 million in Pexeva and
Lithobid product sales, as well as increased license and contract
revenues, primarily due to amortization of deferred revenue from
additional Daytrana sales milestones received in 2007.
Gross margin, as a percentage of total net product revenues, was 33% in
the first six months of 2008 compared to 41% in the same period in 2007.
Gross margin in the first half of 2008 was adversely affected by
inventory write-offs and costs associated with the equipment failure in
transdermal manufacturing described above, as well as increased quality
assurance activities and expenses, primarily related to Daytrana
production, both of which offset the favorable impact of higher gross
margins on Noven Therapeutics’ products.
Research and development expenses were largely unchanged at $6.6 million
for the first half of 2008. Selling and marketing expenses increased to
$10.2 million from $0.5 million in the first six months of 2007 due to
the addition of Noven Therapeutics. General and administrative expenses
increased 49% to $15.9 million, primarily due to the Daytrana Charge and
the addition of Noven Therapeutics.
Noven recognized $20.7 million in earnings from Novogyne in the first
half of 2008, an increase of 47% from the $14.1 million recognized in
the first half of last year.
Novogyne’s net income for the first six
months of 2008 was $48.3 million, a 37% increase from the $35.2 million
reported in the same period last year. Novogyne’s
net revenues for the first six months of 2008 increased 20% to $83.3
million. Novogyne’s gross margin for the
first six months of 2008 increased slightly to 80%, and its selling,
general and administrative expenses decreased 5% to $18.8 million.
Noven Balance Sheet
At June 30, 2008, Noven had $35.4 million in cash and cash equivalents
and $17.5 million in investments in auction rate securities (“ARS”),
representing an aggregate $52.9 million in cash, cash equivalents and
investments in ARS. This compares with $14.0 million in cash and cash
equivalents and $54.4 million in investments in ARS at December 31,
2007, representing an aggregate $68.4 million in cash, cash equivalents
and investments in ARS. In July 2008, Noven established a $15.0 million
revolving credit facility. As of the date of this press release, no
amounts had been borrowed pursuant to the credit facility.
Noven’s investments in ARS at June 30, 2008
had a fair value of $17.5 million and all were classified as non-current
on Noven’s balance sheet following failed
auctions occurring since February 2008. Noven’s
ARS are collateralized primarily by tax-exempt municipal bonds, and to a
lesser extent, guaranteed student loans. Noven does not hold any ARS
collateralized by mortgages or collateralized debt obligations. Noven
believes its ARS are of high credit quality, as nearly 80% carry an AAA
or AA credit rating, and all are considered investment grade securities.
Noven had recorded a temporary change in fair value of $0.5 million
relating to its investments in ARS in the first quarter of 2008; no
additional change in fair value was required in the 2008 second quarter.
In early August 2008, Noven was advised that Shire’s
net sales of Daytrana had triggered the third and final $25 million
milestone due to Noven. Under Noven’s
agreement with Shire, the $25 million milestone is due to be paid in the
third quarter of 2008. As with prior Daytrana sales milestones, Noven
expects to defer recognition of the latest sales milestone and recognize
it as license revenue over time.
Non-GAAP Financial Information
Under accounting principles generally accepted in the U.S. (“GAAP”),
“net income” and “diluted
earnings per share” include all charges for
the periods reported. In addition to results determined in accordance
with GAAP, in this press release Noven has provided net income and
diluted earnings per share for the 2008 periods presented excluding the
Daytrana Charge. Noven believes that comparing Noven’s
period-to-period financial results without giving effect to the Daytrana
Charge may be helpful to investors to permit them to compare Noven’s
period-to-period financial results on a more uniform basis. For the same
reasons, management uses these non-GAAP financial measures to evaluate
Noven’s current performance against its
historical performance and to plan its future business activities. These
measures should not be considered alternatives to measures computed in
accordance with GAAP, nor should they be considered indicators of Noven’s
overall financial performance. Adjusted net income and adjusted diluted
earnings per share are limited by the fact that companies may not
necessarily compute them in the same manner, thereby making these
measures less useful than the same measures calculated in accordance
with GAAP.
Conference Call
A conference call with management relating to Noven’s financial results
will be webcast live at www.noven.com
beginning at 11:00 a.m. Eastern time this morning, August 6. Thereafter,
a rebroadcast of the call will be accessible at the same website for at
least two weeks. A taped replay will be available beginning August 6
through August 8 by calling 877-660-6853 (from within the U.S.) or
201-612-7415 (from outside the U.S.) and entering the access code 286
and conference ID number 290903. The conference call is expected to
contain forward-looking information in addition to that contained in
this press release.
About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the research, development, manufacture, marketing and sale of
prescription pharmaceutical products. Noven’s
business and operations are focused in three principal areas –
transdermal drug delivery, the Novogyne joint venture, and Noven
Therapeutics, Noven’s specialty
pharmaceutical unit.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995
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 that 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
that are, in many instances, beyond Noven’s control.
By category and not necessarily listed in order of priority, these
risks and uncertainties include: Regulatory Matters – the
risk that Noven’s response to the FDA warning
letter that Noven received in January 2008 may not be acceptable to the
FDA or adequately address the FDA’s concerns,
and in such case, the risk that the FDA may take regulatory action
against Noven, which may include fines, product seizures or recalls,
injunctions, suspension of production and/or the withdrawal of product
approval; and the likelihood that any fine or product recall,
injunction, seizure, suspension of production and/or withdrawal of
product approval would have a material adverse effect on Noven,
including the loss of product sales, potentially significant
costs associated therewith and the potential for litigation related to
this matter; Daytrana – the risk that Noven’s
assessment of the root cause of the Daytrana tight release issue may
prove inaccurate or incomplete; the risk that the solutions currently in
testing to address the Daytrana tight release issue may be costly,
require regulatory approval and take time to implement and the
possibility that such solutions ultimately do not resolve the issue; the
risk that Daytrana could be adversely affected by a number of factors,
including: (i) if Noven is unable to adequately resolve the
Daytrana-related issues raised by the FDA in the warning letter and
August 2007 Form 483, (ii) new market entrants, including from other
ADHD products marketed or under development by Shire, (iii) raw material
supply interruptions and/or the inability to obtain the active
ingredient methylphenidate, and (iv) delays or inability to obtain
necessary DEA methylphenidate procurement quota; the risk that any
adverse effect to the market for Daytrana due to the foregoing or other
factors could adversely affect Noven’s
results of operations and/or its financial position; Noven’s Pipeline
– uncertainties as to the cost, timing and success of ongoing and
planned clinical trials, including with respect to Mesafem, 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 approval of
products, including timing; the possibility that product launches may be
delayed; the risk that any expected period of exclusivity for a new
product may not be realized; unexpected adverse events or side effects
or inadequate efficacy of a product that could delay or prevent
regulatory filings, approval or commercialization, or that could result
in recalls or product liability claims of approved products; the
difficulty of predicting acceptance and demand for new pharmaceutical
products; the impact of competitive products and pricing; the risk that
product acceptance may be less than anticipated as well as risks related
to compliance with extensive, costly, complex and evolving governmental
regulations and restrictions, and reimbursement policies of government
and private health insurers and others; the possibility that patent
applications may not result in issued patents, and that issued patents
may not be enforceable or could be invalidated; the impact of
competitive responses to Noven’s sales,
marketing and strategic efforts, and the risk that Noven’s development
partners may have priorities that are different from or conflict with
those of Noven, which may adversely impact their ability or willingness
to assist in the development and commercialization of Noven’s products
or to continue the development program; Liquidity –
liquidity and investment risks related to Noven’s
auction rate securities, including the risk that Noven’s
liquidity will be adversely affected to the extent that auctions for its
auction rate securities experience further failures and the risk that
Noven would be required to record an additional impairment charge if
Noven determines that it is necessary to lower the carrying value of its
auction rate securities to reflect the prevailing fair market value; 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. 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, 2007 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. and Subsidiaries |
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|
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Consolidated Statements of Operations Data: thousands, except per share)
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||
2008 |
|
2007 |
2008 |
|
2007 |
|||||||||
|
||||||||||||||
Revenues: |
||||||||||||||
Product revenues – Novogyne: |
||||||||||||||
Product sales, net |
$ |
5,553 |
$ |
4,804 |
$ |
7,984 |
$ |
10,173 |
||||||
Royalties |
|
2,349 |
|
|
1,899 |
|
4,529 |
|
|
3,664 |
||||
Total net product revenues – Novogyne |
7,902 |
6,703 |
12,513 |
13,837 |
||||||||||
Product revenues, net – third parties |
|
11,641 |
|
|
8,359 |
|
23,226 |
|
|
16,831 |
||||
Total net product revenues |
19,543 |
15,062 |
35,739 |
30,668 |
||||||||||
License and contract revenues |
|
5,060 |
|
|
3,777 |
|
10,346 |
|
|
7,486 |
||||
Total net revenues |
24,603 |
18,839 |
46,085 |
38,154 |
||||||||||
|
||||||||||||||
Costs and Expenses: |
||||||||||||||
Cost of products sold – Novogyne |
3,463 |
3,285 |
6,789 |
6,244 |
||||||||||
Cost of products sold – third parties |
|
9,320 |
|
|
6,029 |
|
17,303 |
|
|
11,997 |
||||
Total cost of products sold |
12,783 |
9,314 |
24,092 |
18,241 |
||||||||||
Research and development |
3,293 |
3,185 |
6,612 |
6,651 |
||||||||||
Selling and marketing |
5,336 |
221 |
10,159 |
461 |
||||||||||
General and administrative |
|
8,906 |
|
|
5,488 |
|
15,928 |
|
|
10,669 |
||||
Total costs and expenses |
|
30,318 |
|
|
18,208 |
|
56,791 |
|
|
36,022 |
||||
Income (loss) from operations |
(5,715 |
) |
631 |
(10,706 |
) |
2,132 |
||||||||
|
||||||||||||||
Equity in earnings of Novogyne |
12,429 |
9,174 |
20,696 |
14,077 |
||||||||||
Interest income, net |
|
500 |
|
|
1,813 |
|
1,122 |
|
|
3,445 |
||||
Income before income taxes |
7,214 |
11,618 |
11,112 |
19,654 |
||||||||||
Provision for income taxes |
|
2,704 |
|
|
4,042 |
|
4,010 |
|
|
7,042 |
||||
Net income |
$ |
4,510 |
|
$ |
7,576 |
$ |
7,102 |
|
$ |
12,612 |
||||
Basic earnings per share |
$ |
0.18 |
|
$ |
0.31 |
$ |
0.29 |
|
$ |
0.51 |
||||
Diluted earnings per share |
$ |
0.18 |
|
$ |
0.30 |
$ |
0.29 |
|
$ |
0.50 |
||||
Weighted average number of common shares outstanding: |
||||||||||||||
Basic |
|
24,603 |
|
|
24,832 |
|
24,582 |
|
|
24,785 |
||||
Diluted |
|
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