NOVEN
TO FILE FORM 12b-25 TO EXTEND FILING DATE OF 2007 FORM 10-K |
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Noven Postpones Earnings Announcement and Related Analyst
Conference Call
Noven Provides Preliminary Unaudited Financial Information
Miami, FL, March
12, 2008 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced
that, for the reasons described below, it intends to file a Form 12b-25
with the United States Securities and Exchange Commission (the “SEC”),
which will extend the due date for filing Noven’s 2007 Form 10-K
to April 1, 2008. Noven also announced that it has postponed its planned
press release and conference call related to its financial results
for the quarter and year ended December 31, 2007, and provided preliminary
unaudited financial information for those periods.
SEC
Comment Letters
Noven is extending the due date for filing its 2007
Form 10-K in order to address an open accounting matter relating to revenue
recognition raised in an SEC comment letter. The open matter relates
to Noven’s
accounting policy of deferring revenue recognition of non-refundable
upfront milestone payments and recognizing them as revenues over the
estimated life of its related licensed products. In an SEC comment
letter received in December 2007, and in a follow-up comment letter
received in February 2008 following Noven’s response to the first
letter, the SEC staff has asked Noven to clarify its basis for deferring
the recognition of such milestone payments, including the approval
and sales milestones that Noven has received from Shire in connection
with the license of Noven’s Daytrana™ product.
Noven has
responded to the SEC comment letters. Based on recent communications
with the SEC staff, Noven has determined that the revenue recognition
comment remains under consideration and analysis by the SEC. Noven
is continuing to work with the SEC staff to resolve the open matter.
While Noven expects to file its 2007 Form 10-K by the extended filing
date, it cannot assure that it will be able to satisfactorily resolve
the open matter and file within that timeframe.
“Noven has
consistently applied an accounting policy of recognizing license revenues
from these milestone payments over the estimated life of its licensed
products,” said Michael D. Price, Noven’s Vice President & Chief
Financial Officer. “We believe that this is an appropriate method
of accounting because, among other things, it properly reflects the
manner and period over which the licensee has the benefit of the license.
We are working closely with the SEC staff to resolve this matter, and
look forward to reporting 2007 financial results as soon as possible.”
Preliminary
Unaudited Information Based on Current Accounting Policy
In connection
with its decision to extend the due date for filing its 2007 Form 10-K,
Noven is providing preliminary unaudited information for the quarter
and year ended December 31, 2007. This information assumes that there
is no required change to Noven’s current accounting policy on
revenue recognition as a result of the SEC comment letters or otherwise.
Under
the company’s current policy of deferring milestone and
similar payments, for the quarter ended December 31, 2007, Noven would
report net revenues of $23.2 million, equity in earnings of Novogyne
Pharmaceuticals (its joint venture with Novartis Pharmaceuticals Corporation)
of $10.8 million, and net income of $1.0 million, or $0.04 diluted
earnings per share. Noven’s results for the fourth quarter will
include a $3.3 million charge related to employee separation arrangements,
as noted below.
Also under its current accounting policy, for the year
ended December 31, 2007, Noven would report net revenues of $83.2 million,
equity in earnings of Novogyne of $35.9 million, and a net loss of
$45.4 million, or $1.84 loss per share. Noven’s results for 2007
will include charges aggregating $106.8 million, as described below.
Noven's
2007 consolidated financial results will include the results of operations
of JDS Pharmaceuticals, a specialty pharmaceutical company acquired
by Noven, from the acquisition date of August 14, 2007 through December
31, 2007. Noven’s 2007 results will also
include the following charges:
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a
one-time charge of $100.2 million reported in the 2007 third quarter
relating to the portion of the JDS acquisition purchase price allocated
to in-process research and development; |
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a $3.3 million
charge reported in the 2007 third quarter related to payments to
Shire plc in connection with the voluntary market withdrawal of
a portion of Daytrana™ product; and |
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an aggregate
$3.3 million charge expected to be reported in the 2007 fourth
quarter related to separation arrangements associated with the
retirement of certain executive officers. |
Noven’s actual
results for 2007 would be materially different than the preliminary
unaudited information discussed in this press release if Noven were
required to change its revenue recognition accounting policy for upfront
milestone payments. Such a change in accounting policy would also likely
result in a restatement of Noven’s financial results for 2006
and/or other periods. In any event, resolution of the accounting for
milestone payments is not expected to have any impact on Noven’s
cash flows or liquidity since it relates only to the timing of the
recognition of previously-received milestone payments.
Postponement of Earnings Release and Conference
Call
Noven is postponing its earnings press release and related earnings
conference call (previously scheduled for 8:30 a.m. Eastern time on
March 13, 2008). Noven will announce plans for the rescheduled press
release and conference call in a future press release.
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida,
is a specialty pharmaceutical company engaged in the research, development,
manufacture, marketing and sale of prescription pharmaceutical products.
Noven’s commercialized transdermal products utilize its proprietary
DOT Matrix® drug delivery technology and include Vivelle-Dot® (estradiol
transdermal system), the most prescribed estrogen patch in the U.S.,
and Daytrana™ (methylphenidate transdermal system), the first
and only patch approved for the treatment of ADHD. Oral products currently
offered through the Noven marketing and sales infrastructure consist
of Pexeva® (paroxetine mesylate) and Lithobid® (lithium
carbonate). Developmental products in psychiatry consist of Stavzor™ (delayed
release valproic acid capsule), Lithium QD (once-daily lithium carbonate),
and Stavzor™ ER (extended release valproic acid capsule). The
development program in women’s health consists of Mesafem™ (low-dose
paroxetine mesylate), a non-hormonal product scheduled to enter Phase
3 clinical trials for vasomotor symptoms (hot flashes). See www.noven.com
for additional information.
Safe Harbor Statement under the Private 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.
These risks and uncertainties include: the risk that
the SEC may not ultimately agree with Noven’s accounting for its
Daytrana™ and other milestone payments, which would, among other
things, require Noven to restate its financial results for prior years,
result in materially different financial results in 2007 than the preliminary
unaudited financial information referred to in this press release, and
cause Noven to cease amortizing all or a portion of its deferred Daytrana
and other license revenues in future periods, which would have the effect
of reducing Noven’s revenues in future periods by the amount that
would have otherwise been recognized; the risk that Noven is unable to
resolve the open accounting issue discussed in this release and file
its Form 10-K within the 15-day extended filing deadline, in which case
Noven would, among other things, likely be required to seek from NASDAQ
an extension of time to file its Form 10-K in order to avoid possible
de-listing of its common stock from the NASDAQ Global Market. 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. 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.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2008 Noven
Pharmaceuticals, Inc. All rights reserved. |