Savient Pharmaceuticals Reports Fourth Quarter and Year End 2006 Results.Company Ends Year with Strong Financial Position to Advance Puricase([R]) Through Clinical Development to Commercialization Puricase Development on Target for Reporting Phase 3 Top Line Results by End of 2007 EAST BRUNSWICK, N.J. -- Savient Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SVNT) today reported financial results for the three months and year ended December 31, 2006. The Company ended the fourth quarter with a net loss of $8.8 million, or $0.17 per share on total revenues of $8.2 million. The Company ended the year with net income of $60.3 million of which $61.8 million resulted from a $56.5 million net gain after taxes on the sale of its subsidiary, Rosemont Pharmaceuticals in August 2006, coupled with Rosemont's operating income Operating Income The profit realized from a business' own operations. Notes: This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit. prior to the sale. Net income per share was $1.03 on total revenues of $47.5 million. "In 2006 we completed the repositioning repositioning Laparoscopic surgery The changing of a Pt's position during a procedure to improve access or visualization of the operative field, which may be linked to complications, as it changes anatomic planes of operation. Cf Laparoscopic surgery. of the Company for the future, a process we started a little more than two years ago," stated Christopher Clement Clement, in the Bible Clement, in Philippians, one of Paul's coworkers. He is traditionally identified with St. Clement of Rome, the likely author of a letter written from there to the Corinthian church in c.A.D. 96. , President and Chief Executive Officer. "During the past year, we completed a series of divestitures of business assets that did not fit into our strategic plan, repurchased 10 million shares of our common stock and significantly enhanced our financial resources to fully support the continued development of Puricase in 2007 and beyond. We believe Puricase will be the major driver in the success of our business and during the past year, we significantly advanced the development of this unique drug. In May, we initiated our Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. in treatment-failure gout gout, condition that manifests itself as recurrent attacks of acute arthritis, which may become chronic and deforming. It results from deposits of uric acid crystals in connective tissue or joints. patients and last week we announced, on schedule, the completion of patient enrollment into these trials." Mr. Clement continued, "The approval of Oxandrin([R]) generics in December was an eventuality e·ven·tu·al·i·ty n. pl. e·ven·tu·al·i·ties Something that may occur; a possibility. eventuality Noun pl -ties we anticipated and planned for, and while it will result in a significant reduction in our future revenue and cash flow, it will be offset somewhat by our partnership with Watson Pharmaceuticals Watson Pharmaceuticals, Incorporated (NYSE: WPI) is the 5th largest pharmaceutical company in the United States based on number of prescriptions dispensed. Based in Corona, California, Watson's Generics division markets over 150 pharmaceutical product families, including one of the on the sale and distribution of an authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: generic version of Oxandrin. Despite the impact of generic competition, our strengthened balance sheet of $179.4 million cash on hand and short-term investments at December 31, 2006 will allow us to advance the development of Puricase through clinical development, BLA BLA abbr. Bachelor of Liberal Arts filing and commercialization." "During 2006, we also focused on and successfully addressed our previously reported internal control deficiencies which I am pleased to report that we have remediated all of our material weaknesses as of December 31, 2006 and we will certify cer·ti·fy v. cer·ti·fied, cer·ti·fy·ing, cer·ti·fies v.tr. 1. a. To confirm formally as true, accurate, or genuine. b. in our 2006 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. that our internal controls over financial reporting are effective. This is a significant accomplishment for this organization as we position the Company for future success," stated Mr. Clement. Total revenues for the fourth quarter of 2006 were $8.2 million, compared with $13.2 million for the fourth quarter of 2005, a decrease of $5.0 million, or 38%. In December 2006, Oxandrin, the Company's product for the treatment of weight gain following involuntary involuntary adj. or adv. without intent, will, or choice. Participation in a crime is involuntary if forced by immediate threat to life or health of oneself or one's loved ones, and will result in dismissal or acquittal. INVOLUNTARY. weight loss related to disease or medical condition, began competing against generic competition. To mitigate some of the financial impact of the generic competition, the Company launched an authorized generic version of Oxandrin through a distribution agreement with Watson Pharmaceuticals and discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: its sales and marketing efforts on the branded product. Product sales of Oxandrin for the fourth quarter of 2006 were $7.8 million, compared with $12.0 million for the same period in 2005. The $4.2 million reduction in product sales resulted from wholesaler purchases in the third quarter in speculation of a potential price increase thereby reducing the fourth quarter demand, the impact of the generic competition in the quarter and product reserves recorded based on estimated future product returns. Cost of sales for the fourth quarter of 2006 was $4.9 million, compared with $1.1 million for the fourth quarter of 2005, an increase of $3.8 million. In the fourth quarter of 2006, the Company recorded inventory reserves of $2.6 million for Oxandrin raw material and finished goods based on estimated demand and expiration EXPIRATION. Cessation; end. As, the expiration of, a lease, of a contract, or statute. 2. In general, the expiration of a contract puts an end to all the engagements of the parties, except to those which arise from the non- fulfillment of obligations created dating, due to generic competition and $2.0 million in future purchase commitments for Oxandrin raw materials which, based on estimated future demand, will not be utilized. Research and development expenses for the fourth quarter of 2006 were $8.5 million, compared with $3.8 million for the fourth quarter of 2005, an increase of $4.7 million. The increase in the fourth quarter of 2006 over the same period in 2005 was primarily due to the initiation in May 2006 of the Company's Phase 3 clinical trials for Puricase and the expenses related to the validation of manufacturing processes at our contract manufacturer in preparation for a BLA filing for Puricase. The Company announced last week the completion of the patient enrollment of these Phase 3 clinical trials. Top line results from the study will be reported in the fourth quarter of this year. Selling and marketing expenses for the fourth quarter of 2006 were $3.2 million, compared with $3.9 million for the fourth quarter of 2005, a decrease of $0.7 million. This reduction in selling and marketing expenses was primarily due to a reduction in Oxandrin promotion and marketing activities and lower sales force expenses due to the reduction in our sales force that occurred in late 2005. Additionally, in January 2007, because of generic competition, the company ceased its promotional activities related to Oxandrin and terminated its remaining sales force. General and administrative expenses for the fourth quarter of 2006 were $4.7 million, compared with $6.9 million for the fourth quarter of 2005, a decrease of $2.2 million. The reduction in general and administrative expenses in the fourth quarter of 2006 was primarily due to lower accounting and consulting expenses including Sarbanes-Oxley compliance work and a reduction in legal consulting activities. As a result of the generic Oxandrin competition in the fourth quarter of 2006, the company recorded sales and inventory reserves totaling $5.0 million which negatively impacted the fourth quarter and year-to-date 2006 operating results. The Company reported a loss from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the for the fourth quarter of 2006 of $9.4 million, including the $5.0 million reserves, compared with income from continuing operations for the fourth quarter of 2005 of $8.0 million. For the fourth quarter of 2006, the net loss per basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share from continuing operations was $0.18 compared with a net income per basic and diluted share from continuing operations of $0.13 for the fourth quarter of 2005. The Company ended the year with $179.4 million in cash and short-term investments, an increase of $104.0 million over the December 31, 2005 year-end balance. Cash and short-term investments decreased in the fourth quarter of 2006 from September 30, 2006 by $19.5 million, $20.5 million of which was due to an estimated tax Federal and state tax laws require a quarterly payment of estimated taxes due from corporations, trusts, estates, non-wage employees, and wage employees with income not subject to withholding. payment on the gain from the sale of Rosemont. CONFERENCE CALL Savient will host a live web cast to review fourth quarter 2006 results on March 14, 2007 at 10:00 a.m. EST EST electroshock therapy. EST abbr. electroshock therapy . Both the live and archived web cast can be accessed from the Investor Relations Investor relations The process by which the corporation communicates with its investors. page of Savient's website at www.savientpharma.com. A digital recording of the web cast will be available following the conclusion of the call and will be archived for thirty days. To access the recording, use the Dial-In Number and the Conference ID listed below. Dial: (800) 642-1687 (domestic) or (706) 645-9291 (international) Conf ID: 1299827 ABOUT SAVIENT PHARMACEUTICALS, INC. Savient Pharmaceuticals is a specialty biopharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that target unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs in both niche and broader markets. The Company's product development candidate, Puricase([R]) for treatment failure gout, has reported positive Phase 1 and 2 clinical data; patient dosing in Phase 3 clinical studies began in June 2006 with patient enrollment completed in March 2007. 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 biopharmaceuticals with an initial focus in rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc. rheu·ma·tol·o·gy n. . Savient also distributes Oxandrin([R]) (oxandrolone tablets, USP USP - unique sales point ) C III in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on Savient can be accessed by visiting: www.savient.com. FORWARD-LOOKING LANGUAGE This news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond Savient's control. 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. These forward-looking statements involve substantial risks and uncertainties and are based on current expectations, assumptions, estimates and projections about Savient's business and the biopharmaceutical and specialty pharmaceutical industries in which Savient operates. Such risks and uncertainties include, but are not limited to, Savient's stock price and market conditions, delay or failure in developing Puricase([R]) (PEG-uricase) and other product candidates, difficulties of expanding Savient'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, Savient's continuing to incur substantial net losses for the foreseeable fore·see tr.v. fore·saw , fore·seen , fore·see·ing, fore·sees To see or know beforehand: foresaw the rapid increase in unemployment. 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 Savient's products, economic, political and other risks associated with foreign operations, risks of maintaining protection for Savient's intellectual property, risks of an adverse determination in ongoing or future intellectual property litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and risks associated with stringent government regulation of the biopharmaceutical industry. Savient may not actually achieve the plans, intentions or expectations disclosed in Savient's forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Savient makes. Stockholders should not place undue reliance on the forward-looking statements, which speak only as to the date of this press release. Savient's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that Savient may make. Except as required by law, Savient does not assume any obligation to update any forward-looking statements. SVNT-I [TABLE OMITTED] [TABLE OMITTED] |
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