Savient Pharmaceuticals Provides Business Update; Financial Overview and Recent Strategic Developments
November 07 2005 - 6:41AM
Business Wire
Savient Pharmaceuticals, Inc., (NASDAQ: SVNTE) an emerging
specialty pharmaceutical company engaged in developing,
manufacturing and marketing pharmaceutical products that address
unmet medical needs in niche and broader markets, today provides a
business and financial overview for the quarter ended September 30,
2005. Savient announced on August 19, 2005 that it had received a
Nasdaq Staff Determination Letter stating that it was not in
compliance with Nasdaq Marketplace Rule 4310(c)(14) because the
Company did not timely file its Quarterly Report on Form 10-Q for
the period ended June 30, 2005, and that the Company's common stock
was, therefore, subject to delisting from The Nasdaq Stock Market.
As subsequently announced, the Nasdaq Listing Qualifications Panel
(the "Panel") agreed to continue the listing of the Company's
securities provided that the Company files its restated financial
statements for fiscal years ended December 31, 2002, 2003 and 2004
and Quarterly Report on Form 10-Q/A for the three months ended
March 31, 2005, and Quarterly Report on Form 10-Q for the period
ending June 30, 2005 by no later than December 26, 2005, and files
its Quarterly Report on Form 10-Q for the period ended September
30, 2005 by no later than January 3, 2006. The Company is in the
process of preparing these restated financial statements and
periodic reports and 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. Until these restatements and Quarterly Reports
on Form 10-Q are filed, the Company is only able to provide gross
sales, and cash and cash equivalents for the quarter ended
September 30, 2005, and net sales are not available. These
financial results remain subject to review by the Company's
independent auditors, and are therefore subject to change. -- For
the three months ended September 30, 2005, total gross sales were
$23.6 million. For the first nine months of 2005, gross sales were
$81.0 million. Cash and cash equivalents as of September 30, 2005
were $68 million and the Company is free of debt. -- Gross sales of
Oxandrin(R) for the three months ended September 30, 2005 were
$12.3 million compared to $17.9 million for the same period in
2004. Gross sales of Oxandrin(R) for the nine months ended
September 30, 2005 were $38.7 million compared to $44.3 million for
the same period in 2004. -- Gross sales of Rosemont's oral liquid
pharmaceuticals for the three months ended September 30, 2005 were
$10.1 million compared to $8.8 million for the three months ended
September 30, 2004, a 14.6% increase. Gross sales of Rosemont's
oral liquid pharmaceuticals for the nine-months ended September
2005 were $28.8 million compared to $24.8 million for the same
period in 2004. Christopher Clement, President and Chief Executive
Officer of Savient, said, "Although issues related to our
restatements have occupied much of our efforts throughout the third
quarter and will continue to do so through the filing of our
restated financials and periodic reports, nevertheless, we have
continued successfully to drive the Company business." The Company
also announced that it would provide an update on the conference
call today with respect to recent developments regarding its
co-promotion agreement with Ferring for Euflexxa(TM) and certain
matters related to the divestiture of the global biologics
manufacturing business. The Company highlighted recent progress
with respect to its strategy to be a product development driven
specialty pharmaceutical company as evidenced by the following:
Optimizing our in-line products: While management has focused on
the strategic re-positioning of the company, it remains committed
to optimize the value of its primary in-line product, Oxandrin(R)
and its lifecycle management. To date, this year: -- The Company
introduced a new marketing strategy highly focused to a select
customer group; -- A new sales model was created with 20 dedicated
sales professionals versus the previous hybrid model with contract
sales representatives; -- Oxandrin(R) was granted a 3-year
geriatric exclusivity by the FDA in June; -- The Company has filed
its Second Citizen's Petition with FDA for Oxandrin(R); and -- In
Q2 2005, Oxandrin(R) total Rx's increased 1.7 percent over the
previous quarter which represented the first quarterly Rx increase
in recent years. Advancing our Pipeline -- The Company completed a
successful end-of-Phase 2 meeting with the FDA for Puricase(R)
(PEG-uricase); -- Decision to file Special Protocol Assessment
(SPA) for Puricase(R) (PEG-uricase) Phase 3 development program was
reached in consultation with the FDA. Extending our Reach --
Received FDA approval for Soltamox(TM), the first oral liquid
tamoxifen approved in the U.S. Clement stated, "We've made
significant progress with our Company strategy in the third
quarter. In respect to Oxandrin(R), the threat of a potential
generic still exists. However, the company is committed to increase
brand performance until product exclusivity issues are resolved. In
addition, the brand reduced annual expenses going forward by
approximately $6 million with the sales model optimization and
ending its long-term care promotion agreement with Ross Labs. In
September, we filed an additional citizen's petition with the FDA
requesting clarification with respect to the three-years of
exclusivity we received in June of this year for geriatric
labeling. To date, we have not received a response from the FDA.
"The Company is on track with respect to advancing our clinical
pipeline. We are excited to initiate our Phase 3 development
program with clearly-defined endpoints for the evaluation of
Puricase(R)'s (PEG-uricase) efficacy as well as measure
improvements in clinical outcomes. The promising clinical results
of Puricase(R) (PEG-uricase) to date are becoming increasingly
better known as word of its potential effectiveness spreads among
clinical rheumatologists specializing in the treatment of gout. We
look forward to showcasing Puricase(R) (PEG-uricase) at the
American College of Rheumatology Annual Scientific Meeting later
this month with the presentation of two Puricase(R) (PEG-uricase)
Phase 2 Abstracts. "Rosemont continues to perform at historical
levels. In particular, the FDA approval of Soltamox(TM), oral
liquid tamoxifen to treat breast cancer, marks a significant
achievement in our strategy. While we are currently in discussions
with potential marketing and distribution partners for a platform
of additional Rosemont products for entry into the United States,
we are separately seeking and in discussions with several partners
for the marketing of Soltamox(TM) in the U.S. and anticipate
finalizing discussions to select a partner that would enable a
launch in early 2006. The geographic expansion of this business,
particularly in the U.S., will remain a key focus moving forward."
Clement concluded, "We were very pleased to be granted an extension
from The Nasdaq Stock Market as we work to file our restated
financial statements. We are making every effort to meet the
deadline and continue to work with our Audit Committee and
independent auditors to complete the necessary filings. Despite the
challenges we faced in the recent quarter, we believe the
underlying fundamentals of the Company remain strong. Our strong
cash position will allow us to continue to implement our strategy
and advance our lead product candidate, Puricase(R) (PEG-uricase)
into our Phase 3 development program. We are very encouraged by the
results to date and see a clear path to regulatory approval. We
intend to strengthen our presence within the Rheumatology community
and are taking a focused, systematic proactive approach in seeking
additional opportunities as we look to expand our portfolio.
Additionally, we continue to be pleased with the growth of Rosemont
and the advancements in our strategy to extend the geographic reach
resulting in further value creation." Savient will host a
conference call/live webcast today to provide a Business Update
today, Monday, November 7 at 11:00 a.m. EST. The live webcast can
be accessed under the Webcast page under the News section of
Savient's website at www.savientpharma.com and will be archived
through November 21, 2005. In addition, an audio replay will be
available until November 21, 2005. The replay numbers are
800-642-1687 for domestic callers and 706-645-9291 for
international callers. The replay access code is 1996046. 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. Puricase
is a registered trademark of Mountain View Pharmaceuticals, Inc.
Further information on the Company can be accessed by visiting
http://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, the statements regarding 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 and September 30, 2005 Form 10-Q, the timing of
the filing of restated financial statements for the years ended
2002, 2003 and 2004, the continued implementation of the Company's
strategic plan, the development of the Company's pipeline, the
commencement of Phase 3 clinical trials for Puricase, FDA approval
of the marketing and sale of Puricase, timing of the completion of
a potential partnering alliance in the U.S. and the launch of
Soltamox and growth at Rosemont 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, delay or failure in developing Prosaptide, Puricase
and other product candidates; difficulties of expanding the
Company's product portfolio through in-licensing; introduction of
generic competition for Oxandrin; 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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