Savient (NASDAQ:SVNTE)
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From Jun 2019 to Jun 2024
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.