Savient (NASDAQ:SVNTE)
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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.