Savient Pharmaceuticals Determines Periods Affected for Restatement Include Six Months Ended June 30, 2005 and Fiscal Years Ende
October 26 2005 - 4:59PM
Business Wire
Savient Pharmaceuticals, Inc. (NASDAQ: SVNTE) an emerging specialty
pharmaceuticals company focused on developing, manufacturing and
marketing novel therapeutic products for unmet medical needs,
announced today that the Company's Audit Committee, with the
assistance of management, counsel and independent accounting
consultants, and as discussed with its independent auditors, has
determined that the periods affected by an error in recording the
Company's reserve for product returns and inventory include the six
months ended June 30, 2005, as reported in the Company's press
release dated August 9, 2005, and the fiscal years ended 2004, 2003
and 2002. The Company has determined that it had made an error in
recording its reserve for product returns and inventory in the
first quarter of 2005. The Company has also determined its reserve
for product returns and inventory were based, in part, on
notifications received from customers advising the Company, through
its third-party fulfillment center, of their intent to return
product. As previously announced, certain of those reported returns
were in error and actual units of product returned were
significantly less than the amounts originally expected to be
returned. The Company has further determined that in recording its
reserves for product returns and inventory, it had failed to
properly evaluate the data and the resulting impact on such
reserves. As previously reported, on September 29, 2005, at a
hearing before a Nasdaq Listing Qualifications Panel (the "Panel"),
the Company presented a plan of compliance including the
description of steps it had taken as of the date of the hearing to
evaluate the issues presented by the previously announced errors in
its reserve for product returns and anticipated future actions that
will be necessary to enable the Company to regain compliance with
Nasdaq's listing requirements. The Company expects to announce the
Panel's decision promptly after such decision is received. The
delisting of the Company's common stock is stayed pending receipt
of the Panel's decision. The Company cannot provide any assurances
that the Panel will grant its request for an extension of time
within which it may regain compliance with Nasdaq's listing
requirements. The Company is in the process of preparing restated
financial statements for the fiscal years ended December 31, 2002,
2003 and 2004, and the quarter ended March 31, 2005, as well as its
Quarterly Report on Form 10-Q for the three months ended June 30,
2005. It will then need to allow adequate time for its independent
auditors to review such financial statements and periodic reports
prior to their filing with the Securities and Exchange Commission.
About Savient Pharmaceuticals, Inc. Based in East Brunswick, New
Jersey, Savient Pharmaceuticals, Inc. is a specialty pharmaceutical
company dedicated to developing, manufacturing and marketing novel
therapeutic products that address unmet medical needs. The
Company's lead product development candidate, Puricase(R), for the
treatment of refractory gout has reported positive Phase 1 and 2
clinical data. Savient's experienced management team is committed
to advancing its pipeline and expanding its product portfolio by
in-licensing late stage compounds and exploring co-promotion and
co-development opportunities that fit the Company's expertise in
specialty pharmaceuticals and initial focus in rheumatology. The
Company's operations also include a wholly-owned U.K. subsidiary,
Rosemont Pharmaceuticals Ltd., which develops, manufactures and
markets liquid formulations of prescription pharmaceutical
products. Rosemont's product portfolio includes over 90 liquid
formulations primarily targeting the geriatric population. Further
information on the Company can be accessed by visiting
www.savientpharma.com. Safe Harbor Statement This news release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934. All statements, other
than statements of historical facts, included in this report
regarding the Company's strategy, expected future financial
position, discovery and development of products, strategic
alliances, competitive position, plans and objectives of management
are forward-looking statements. Words such as "anticipate,"
"believe," "estimate," "expect," "intend," "plan," "will" and other
similar expressions help identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. In particular, statements as to the possible
outcome of the hearing before the Panel, the possible continued
listing of the Company's common stock on The Nasdaq Stock Market,
the timing of the filing of the Company's June 30, 2005 Form 10-Q,
whether any amendments to any prior filing are necessary, the
timing of the filing of any such amendments, and the amounts of any
reductions in or additions to the Company's reserve for product
returns and inventory and increase in reported sales are
forward-looking statements. These forward-looking statements
involve substantial risks and uncertainties and are based on
current expectations, assumptions, estimates and projections about
the Company's business and the biopharmaceutical and specialty
pharmaceutical industries in which the Company operates. Such risks
and uncertainties include, but are not limited to, delisting of the
Company's common stock from The Nasdaq Stock Market, delay or
failure in developing Prosaptide(TM), Puricase(R) and other product
candidates; difficulties of expanding the Company's product
portfolio through in-licensing; introduction of generic competition
for Oxandrin(R); fluctuations in buying patterns of wholesalers;
potential future returns of Oxandrin or other products; our
continuing to incur substantial net losses for the foreseeable
future; difficulties in obtaining financing; potential development
of alternative technologies or more effective products by
competitors; reliance on third-parties to manufacture, market and
distribute many of the Company's products; economic, political and
other risks associated with foreign operations; risks of
maintaining protection for the Company's intellectual property;
risks of an adverse determination in on-going or future
intellectual property litigation; and risks associated with
stringent government regulation of the biopharmaceutical and
specialty pharmaceutical industries. The Company may not actually
achieve the plans, intentions or expectations disclosed in its
forward-looking statements, and you should not place undue reliance
on the Company's forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that the
Company makes. The Company's forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments that the Company may
make. The Company does not assume any obligation to update any
forward-looking statements.
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