Clement stated, “Oxandrin was a clear disappointment for the quarter. Our new commercial leadership and ongoing evaluation of the effectiveness of our related sales and marketing support should benefit the brand’s future performance in advance of a potential generic competitor.
“On the positive front, we are very pleased with our progress this quarter toward the evolution of our new strategic focus. The announced divestiture of our global biologics manufacturing business was a critical first step, and we remain confident this transaction will close before the end of the first half of the year. The continued expansion and growth of Rosemont, our oral liquids business, was another important step as we await the approval of our first product, Soltamox®, in the United States later this year following the FDA’s completion of its inspection of our manufacturing facility yesterday. We continue to be encouraged by our steady progress in the development of our lead drug candidate, Puricase, and look forward to an end-of-Phase 2 meeting with the FDA in July to define the critical components of the Phase 3 program. And lastly, we look ahead to building a new commercial infrastructure here in the U.S. with our rheumatology-focused sales and marketing team who will initially focus on the co-promotion of Nuflexxa with Ferring.
“The milestones achieved this quarter signify our commitment to transforming Savient into a specialty pharmaceutical company by advancing our proprietary development projects. I look forward to the remainder of 2005 being a year of continued transformation and delivering results for the many valued shareholders of Savient.”
Savient will host a conference call/live webcast today to review first quarter 2005 results today, May 10, 2005, at 11:00 a.m. EDT.
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 June 7, 2005.
In addition, an audio replay will be available until May 24, 2005. The replay numbers are (888) 203-1112 for domestic callers and (719) 457-0820 for international callers. The replay access code is 9746867.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc., an emerging specialty pharmaceuticals company, is engaged in developing, manufacturing, and marketing pharmaceutical products that address unmet medical needs in both niche and wider markets. Products marketed by Savient in the United States are Oxandrin(R) (oxandrolone, USP) and Delatestryl(R) (testosterone enanthate). The Company's subsidiary, Rosemont Pharmaceuticals Limited, develops, manufactures, and markets through its own sales force oral liquid formulations of prescription products for the UK pharmaceutical market. Savient's product Mircette(R), an oral contraceptive, is marketed by its licensee, Organon, Inc. Savient's news releases and other information are available on the Company's website at www.savientpharma.com. Mircette is a registered trademark of Organon, Inc. and Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
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, results of operations, cash flows, financing plans, 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 divestiture of the Company's global biologics manufacturing business and the potential for commercializing the Company's Puricase drug product candidate 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, the possibility that the divestiture of our global biologics manufacturing business will fail to close, due to failure to achieve regulatory approval or otherwise; delay or failure in developing Prosaptide, Puricase and other product candidates; difficulties of expanding the Company's product portfolio through in-licensing; disruption of management and costs associated with the divestiture of the Company's operations in Israel; 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.
SOURCE: Savient Pharmaceuticals, Inc.
CONTACTS:
Savient Pharmaceuticals, Inc.
Jenene Thomas
Director, Investor Relations
732-565-4716
jdthomas@savientpharma.com
Investors/Media:
The Ruth Group
Stephanie Carrington/Janine McCargo
646-536-7017/7033
scarrington@theruthgroup.com
jmccargo@theruthgroup.com
SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands except per share data)
| | Three Months Ended March 31, | |
| | | 2005 | | | 2004 | |
| |
| |
| |
Revenues: | | | | | |
Product sales, net | | | 22,615 | | | 32,201 | |
Contract fees | | | 291 | | | 230 | |
Royalties | | | — | | | 932 | |
Other | | | 75 | | | 40 | |
| |
| |
| |
Total revenues | | | 22,981 | | | 33,403 | |
| |
| |
| |
| | | | | | | |
Expenses: | | | | | | | |
Cost of sales | | | 8,721 | | | 8,651 | |
Research and development | | | 6,282 | | | 8,664 | |
Marketing and sales | | | 5,154 | | | 6,666 | |
General and administrative | | | 6,177 | | | 5,372 | |
Commissions and royalties | | | 1,224 | | | 1,403 | |
Amortization of intangibles and negative goodwill associated with acquisitions | | | 1,013 | | | 1,013 | |
| |
| |
| |
Total expenses | | | 28,571 | | | 31,769 | |
| |
| |
| |
| | | | | | | |
Operating (loss) income | | | (5,590 | ) | | 1,634 | |
Other income (expense) – net | | | 2,057 | | | 73 | |
| |
| |
| |
(Loss) income before income taxes | | | (3,533 | ) | | 1,707 | |
Income tax expense | | | 332 | | | 529 | |
| |
| |
| |
Net (Loss) Income | | | (3,865 | ) | | 1,178 | |
| |
| |
| |
| | | | | | | |
(Loss) earnings per common share: | | | | | | | |
Basic: | | | | | | | |
Net (loss) income | | | (0.06 | ) | | 0.02 | |
| |
| |
| |
Diluted: | | | | | | | |
Net (loss) income | | | (0.06 | ) | | 0.02 | |
| |
| |
| |
| | | | | | | |
Weighted average number of common and common equivalent shares: | | | | | | | |
Basic | | | 60,545 | | | 59,734 | |
| |
| |
| |
Diluted | | | 60,545 | | | 60,331 | |
| |
| |
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SAVIENT PHARMACEUTICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
((in thousands)
| | March 31, 2005 (unaudited) | | December 31, 2004 | |
| |
| |
| |
Assets: | | | | | | | |
Cash, cash equivalents and short-term investments | | | 26,668 | | | 25,282 | |
Accounts receivable, net | | | 1,185 | | | 6,118 | |
Inventories, net | | | 12,870 | | | 15,456 | |
Other current assets | | | 2,492 | | | 1,677 | |
Assets available for sale | | | 75,616 | | | 80,851 | |
| |
| |
| |
Total current assets | | | 118,831 | | | 129,384 | |
| | | | | | | |
Property and equipment, net | | | 6,851 | | | 6,985 | |
Intangible assets, net | | | 70,675 | | | 71,688 | |
Goodwill | | | 40,121 | | | 40,121 | |
Other long term-assets | | | 1,365 | | | 2,991 | |
| |
| |
| |
Total assets | | | 237,843 | | | 251,169 | |
| |
| |
| |
| | | | | | | |
Liabilities and stockholders' equity: | | | | | | | |
Current portion of long-term debt | | | 4,144 | | | 5,903 | |
Liabilities available for sale | | | 11,954 | | | 12,743 | |
Other current liabilities | | | 23,549 | | | 29,998 | |
Long-term debt | | | 0 | | | 0 | |
Other long-term liabilities and deferred items | | | 47,313 | | | 47,857 | |
Stockholders’ equity | | | 150,883 | | | 154,668 | |
| |
| |
| |
Total liabilities and stockholders’ equity | | | 237,843 | | | 251,169 | |
| |
| |
| |
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