-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SeoS1t9clysB9MN+AxydNU8pFOjCmLH5tqDKy494eUgm9WfBm3AhnbvZRVBXVMpl bRZ38gHDKBUBb6cYq3u9qw== 0001125282-05-001418.txt : 20050317 0001125282-05-001418.hdr.sgml : 20050317 20050316215229 ACCESSION NUMBER: 0001125282-05-001418 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20050316 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050317 DATE AS OF CHANGE: 20050316 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SAVIENT PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000722104 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 133033811 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15313 FILM NUMBER: 05687248 BUSINESS ADDRESS: STREET 1: ONE TOWER CENTER CITY: EAST BRUNSWICK STATE: NJ ZIP: 08816 BUSINESS PHONE: 7324189300 MAIL ADDRESS: STREET 1: ONE TOWER CENTER CITY: EAST BRUNSWICK STATE: NJ ZIP: 08816 FORMER COMPANY: FORMER CONFORMED NAME: BIO TECHNOLOGY GENERAL CORP DATE OF NAME CHANGE: 19920703 8-K 1 b405461_8k.htm CURRENT REPORT Prepared and filed by St Ives Burrups

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

________________________

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): March 16, 2005

Savient Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware 0-15313 13-3033811

(State or Other Juris-
diction of Incorporation
(Commission
File Number)
(IRS Employer
Identification No.)


One Tower Center, 14th Floor
East Brunswick, New Jersey 08816


(Address of Principal Executive Offices) (Zip Code)

Registrant’s telephone number, including area code: (732) 418-9300

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

     Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the obligation of the registrant under any of the following provisions:

         Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

          Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

          Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

          Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


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Item 2.02. Results of Operations and Financial Condition

     On March 16, 2005, Savient Pharmaceuticals, Inc. (“Savient”) announced its financial results for the quarter and fiscal year ended December 31, 2004. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

     In addition, on March 16, 2005, Savient held a publicly available live webcast discussion of its financial results for the quarter and fiscal year ended December 31, 2004. The transcript of the March 16, 2005 conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

Item 9.01.Financial Statements And Exhibits

   (c)  Exhibits
       
     99.1 Press release dated March 16, 2005
       
    99.2 Transcript dated March 16, 2005

 


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SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: March 16, 2005 SAVIENT PHARMACEUTICALS, INC.
     
  By: /s/ Philip K. Yachmetz
    Philip K. Yachmetz
Senior Vice President, General Counsel
and Secretary

 


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Exhibit 99.1

FOR IMMEDIATE RELEASE

SAVIENT PHARMACEUTICALS REPORTS UNAUDITED RESULTS
FOR THE FOURTH QUARTER AND FULL YEAR 2004

East Brunswick, NJ – March 16, 2005 – Savient Pharmaceuticals, Inc., (Nasdaq: SVNT) an emerging specialty pharmaceutical company engaged in developing, manufacturing and marketing pharmaceutical products that address unmet medical needs in niche and broader markets, announced today unaudited results for the fourth quarter and year ended December 31, 2004 and reviewed recent highlights for 2005 to date.

For the fourth quarter of 2004, total revenues were $36.6 million, down from $39.8 million a year ago, and up from $25.6 million in the third quarter of 2004. Net income for the fourth quarter of $647 thousand, or 1 cent per share, compared to a net income of $4.1 million, or 7 cents per share, a year ago and a net loss of $5.2 million, or 9 cents per share in the third quarter of 2004. The fourth quarter 2004 net income is solely attributable to the recorded tax benefit of $3.6 million.

For the full year, total revenues were $113.3 million, down 15% from a year ago. The net loss of $35.3 million, or 59 cents per share, compared to net income of $13.9 million or 23 cents on a fully diluted basis.

Christopher Clement, President and Chief Executive Officer of Savient, said, “We were encouraged by our performance in the fourth quarter and remain committed to our new strategic initiatives which are redefining Savient and are focused on developing our pipeline and enhancing the value of our oral liquids business. In addition, we plan to pursue business development opportunities to in-license novel compounds in clinical stage development as well as marketed products initially directed towards the rheumatology specialist. We ended 2004 on an upbeat note and have moved into 2005 more focused than ever on executing our chosen strategy.”


Clement highlighted some of Savient’s major accomplishments in the fourth quarter of 2004 and recent developments in 2005 that are transforming Savient into an emerging specialty pharmaceutical company including:

Received final bids with respect to the potential sale of our global biologics manufacturing business;
Terminated early the failed Phase 2 clinical trial for Prosaptide designed to test the safety and analgesic efficacy of Prosaptide in HIV/AIDS patients with peripheral neuropathic pain;
Completed patient treatment and follow-up in Savient’s Phase 2 clinical trial of Puricase for severe gout;
Launched the TEV-TROPIN™ brand of the Company’s human growth hormone in the U.S. through Teva;
Submitted New Drug Application to the FDA for Soltamox™, Savient’s first oral liquids product for the U.S. market;
Received FDA approval for Nuflexxa™ for the treatment of pain due to osteoarthritis of the knee.
Entered exclusive marketing collaboration in Germany for Soltamox for the treatment of hormonally sensitive breast cancer;
Settled the human growth hormone intellectual property dispute with Novo Nordisk;
Received FDA manufacturing site approval for the Company’s new biologics manufacturing facility in Israel;
Established a Science and Development Advisory Board with the appointment of three scientific leaders in drug discovery and development; and
Strengthened Savient’s finance team with the addition of a Chief Accounting Officer.

Quarter ended December 31, 2004

Revenues

Total revenues for the three months ended December 31, 2004 were $36.6 million compared to $39.8 million for three months ended December 31, 2003.
Net product sales for the fourth quarter of 2004 were $35.9 million compared to $37.7 million in the fourth quarter of 2003 and $23.6 million in the third quarter of 2004.
Net sales of Oxandrin®, Savient’s largest selling brand, in the fourth quarter were $15.2 million up from $14.8 million during the same period in 2003.
Net sales of Delatestryl® were $1.3 million down 73% from a year ago as generics captured 40% of market unit volume.
Net sales of human growth hormone were flat compared to year ago and rose 127% versus the immediately preceding quarter due to the initial sales of product to Teva in support of its February 2005 launch of TEV-TROPIN.

 

Expenses

Total expenses for the fourth quarter were $37.5 million compared to $33.9 million in the fourth quarter of last year driven primarily by higher cost of sales and a $3.0 million reserve for the settlement of a long-standing patent infringement suit.
   
Cost of sales as a percentage of product sales increased from 27% in the fourth quarter last year to 32% in the fourth quarter of 2004. The increase was driven by the product validation and depreciation costs at the new Israeli biologics manufacturing facility, offset in part by lower sales-related cost of goods sold.

Other Expenses

As reported earlier, Savient incurred in the fourth quarter a one-time restructuring charge of $2.0 million.

Net Income

Savient reported net income for the three months ended December 31, 2004 of about $647 thousand, or 1 cent per share, compared to net income of $4.1 million, or 7 cents per share for the same period a year ago. Fourth quarter 2004 net income reflects primarily the benefitof certain tax adjustments applicable to foreign subsidiaries and the favorable settlement of prior years’ tax exposures.

Balance Sheet

Savient had cash, cash equivalents, and short-term investments of $25.3 million at the year end, December 31, 2004, compared to $24.7 million in the immediately preceding quarter and $22.8 million a year ago. Long-term debt, Savient’s only debt, was reduced $7.0 million during 2004 to $5.9 million as of December 31, 2004.

Outlook on 2005 and beyond from Savient’s Chief Executive Officer and President, Christopher Clement:

“We are working continuously toward unlocking the value of our under-appreciated assets. We are progressing with our previously announced plan to divest our global biologics manufacturing business.  We are currently in advanced discussions with a potential purchaser, and while we cannot guarantee that we will ultimately reach a definitive agreement with that potential purchaser, we hope to have news to announce in the near future. We expect the net proceeds from the sale of the global biologics manufacturing business to fund the advancement of Puricase, our Phase 2 candidate for the treatment of severe, refractory gout, and the pursuit of licensing or acquisition of novel compounds in clinical development as well as marketed products complementary to our strategy.

“We are pleased with the direction of Puricase. In February, we completed patient treatment and follow-up in the Phase 2 study and laboratory analyses are ongoing. The data analysis is expected in April. Our next step will be a request for an end of Phase 2 meeting with the FDA. We believe that the clinical and toxicology data analyses will support the drug’s progression to Phase 3 clinical trials later this year.

 


“We received some disappointing news last week with respect to our Prosaptide Phase 2 trial. As a result of our scheduled interim analysis, we are terminating the trial early based upon a lack of efficacy with respect to the trial’s analgesia endpoints. On the positive side, our process worked in identifying sooner rather than later the study shortcomings. More importantly, we can now begin to focus on evaluating the potential future course for this drug candidate. We are considering the options for further exploring the drug’s potential use to treat peripheral neuropathy and other possible indications.

“Oxandrin remains without generic competition. Although we never lose sight of the fact that a generic competitor could enter the market at any time, we continue to strengthen our position with respect to the citizen’s petition we filed in the interest of public health on February 17, 2004. On February 25, 2005, we filed a supplement to our petition with the FDA building on our concern for patient safety by advocating the adoption of appropriately rigorous impurity standards for oxandralone, consistent with those published in a recent USP In-Process Review article.

“At Rosemont, our free-standing oral liquid pharmaceutical business based in the U.K., we continue to perform well with double-digit growth in sales. Late in 2004, we submitted to the FDA our first U.S. marketing application for a product from Rosemont. In the fourth quarter, Rosemont completed modifications to its U.K.-based facility to meet the FDA’s Current Good Manufacturing Practices and to prepare itself for the inspection required for approval of the Soltamox NDA. We hope to introduce other Rosemont products into the U.S. market in the years ahead.

“In summary, we took a new and bold change of direction last summer. We detailed a very specific and ambitious agenda and have delivered upon each of our key milestones for 2004. We believe that this new direction and the steps we have already taken along the path to implementation, have paved the way for an exciting year ahead. Our milestones for 2005 include:

Concluding of our efforts with respect to the sale of our global biologics manufacturing business;
Advancing Puricase to Phase 3 clinical trials;
Obtaining approval of our NDA for Soltamox;
Receiving FDA manufacturing site approval for Rosemont; and
Continuing the growth and geographic expansion of Rosemont’s oral liquids business.”

The financial information contained in this press release is unaudited because Savient has been unable to complete prior to March 16, 2005 all of the information requested by Savient’s independent auditors in connection with their audit of Savient’s financial statements for the fiscal year ended December 31, 2004, to be included in Savient’s Form 10-K for the fiscal year ended December 31, 2004. As a result, Savient’s independent auditors were unable to complete by March 16, 2005 their audit and report on the financial statements for the fiscal year ended December 31, 2004. Therefore, Savient expects to delay filing its Annual Report on Form 10-K for the period ended December 31, 2004. This delay results principally from the significant demands on Savient’s management in recent months, including those resulting from:


   
the restatement in February 2005 of Savient’s unaudited financial statements for the quarterly periods ended March 31, 2004, June 30, 2004 and September 30, 2004;
preparation for Savient’s evaluation of the effectiveness of its internal controls over financial reporting as of December 31, 2004, as required by Section 404 of the Sarbanes-Oxley Act of 2002, including addressing the material weaknesses described below; and
Savient’s efforts to divest its global biologics business (which includes its operations in Israel), including advanced discussions with a potential purchaser.

Savient will file its Annual Report on Form 10-K for the year ended December 31, 2004 no later than March 31, 2005. The financial information contained in this press release may change as a result of the completion of the audit.

In connection with Savient’s review of the effectiveness of its internal controls over financial reporting as of December 31, 2004, Savient identified several material weaknesses in its internal control over financial reporting, and related defects in its disclosure controls and procedures. The material weaknesses relate primarily to Savient’s financial reporting process, internal communications and lack of expertise in areas including revenue recognition, accounting for taxes and other matters. Consequently, management will be unable to conclude that Savient’s internal controls over financial reporting and disclosure controls and procedures were effective as of December 31, 2004. An assessment of Savient’s internal controls and disclosure controls and procedures will be included in its Annual Report on Form 10-K.

Savient will host a conference call/live webcast to review 2004 fourth quarter and full year results today, March 16, 2005 at 11:00 a.m. EST.

The live webcast can be accessed from the investor relations page of Savient’s website at www.savientpharma.com and will be archived through April 16, 2005.

In addition, an audio replay will be available until March 28, 2005. The replay numbers are (888) 203-1112 for domestic callers and (719) 457-0820 for international callers. The replay access code is 4566212.

About Savient Pharmaceuticals, Inc.

Savient Pharmaceuticals, Inc. 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® (oxandrolone, USP) and Delatestryl® (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. The Company's Israeli subsidiary, Bio-Technology General (Israel) Ltd., manufactures and markets in Israel Bio-Tropin (recombinant human growth hormone), BioLon® (sodium hyaluronate for ophthalmic surgery), Bio-Hep-B® (hepatitis B vaccine), and Arthrease (sodium hyaluronate for osteoarthritis). Products marketed by Savient's licensees are Mircette® (oral contraceptive), and BioLon® in the United States, and Bio-Tropin, BioLon®, Bio-Hep-B®, Silkis® (vitamin D derivative), and recombinant human insulin, in international markets. Savient's news releases and other information are available on the Company's website at www.savientpharma.com. Arthrease is a trademark of DePuy Orthopaedics, Inc., except in Israel, where it is owned by Bio-Technology General (Israel) Ltd., Savient's wholly owned subsidiary; Mircette is a registered trademark of Organon, Inc.; Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.; Silkis is a registered trademark of Galderma S.A.


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 completion of the audit of the Company’s financial statements for the year ended December 31, 2004, the divestiture of the Company’s global biologics manufacturing business, the Company's new strategic direction and its potential effects on the Company's business 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, our ability to complete the audit of our financial statements for the year ended December 31, 2004; our ability to complete the divestiture of our global biologics manufacturing business for an attractive price or at all; 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/Gregory Tiberend
646-536-7017/7005

scarrington@theruthgroup.com
gtiberend@theruthgroup.com

 


TABLES TO FOLLOW

 

 

 

 

 

 


SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands except per share data)

   
Three Months Ended December 31,
   
2004
2003
Revenues:  
 
 
  Product sales, net   35,873   37,736  
  Contract fees   251   270  
  Royalties   504   802  
  Other   0   1,024  
     
 
 
    Total revenues   36,628   39,832  
     
 
 
              
Expenses:          
  Research and development   5,989   6,413  
  Cost of sales   11,335   10,189  
  Marketing and sales   5,889   5,913  
  General and administrative   11,531   8,905  
  Retirement   (25 ) 0  
  Commissions and royalties   1,798   1,503  
  Amortization of intangibles   1,012   1,012  
     
 
 
    Total expenses   37,529   33,935  
     
 
 
              
  Operating (loss) income   (901 ) 5,897  
             
  Other (expense) income, net   (2,035 ) (303 )
     
 
 
  (Loss) income before income taxes   (2,936 ) 5,594  
  Income taxes   (3,583 ) 1,525  
     
 
 
  Net (loss) income   647   4,069  
     
 
 
              
(Loss) earnings per common share:          
  Basic   0.01   0.07  
     
 
 
  Diluted   0.01   0.07  
     
 
 
              
Weighted average number of common and common equivalent shares:          
  Basic   60,381   59,541  
     
 
 
  Diluted   60,390   60,519  
     
 
 

 


 

SAVIENT PHARMACEUTICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands except per share data)

 
Twelve Months Ended
December 31,
 
 
2004
2003
     
 
 
Revenues:          
  Product sales, net   106,009   124,846  
  Contract fees   923   1,340  
  Royalties   5,352   3,227  
  Other   991   3,112  
     
 
 
    Total revenues   113,275   132,525  
     
 
 
             
Expenses:          
  Research and development   27,800   31,797  
  Cost of sales   37,118   24,745  
  Marketing and sales   23,598   23,303  
  General and administrative   30,297   26,744  
  Retirement   2,085   0  
  Commissions and royalties   6,328   5,438  
  Amortization of intangibles   4,050   4,050  
     
 
 
    Total expenses   131,276   116,077  
     
 
 
             
  Operating (loss) income   (18,001 ) 16,448  
  Other (expense) income, net   (2,718 ) 3,635  
     
 
 
  (Loss) income before income taxes   (20,719 ) 20,083  
  Income taxes   14,553   6,161  
     
 
 
  Net (loss) income   (35,272 ) 13,922  
     
 
 
             
(Loss) earnings per common share:          
  Basic   (0.59 ) 0.24  
     
 
 
  Diluted   (0.59 ) 0.23  
     
 
 
             
Weighted average number of common and common equivalent shares:          
  Basic   60,066   59,194  
     
 
 
  Diluted   60,066   59,798  
     
 
 

 


SAVIENT PHARMACEUTICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands)

  December 31,
2004
  December 31,
2003
 
 
 
 
Assets:        
Cash, cash equivalents and short-term investments 25,282   22,801  
Accounts receivable, net 15,659   33,375  
Inventories, net 21,098   20,216  
Other current assets 4,250   7,051  
 
 
 
Total current assets 66,289   83,443  
         
Property and equipment, net 67,018   70,426  
Intangible assets, net 71,688   75,743  
Goodwill 40,121   40,121  
Other long term-assets 6,053   20,807  
 
 
 
Total assets 251,169   290,540  
 
 
 
         
Liabilities and stockholders' equity:        
Current portion of long-term debt 5,903   7,020  
Other current liabilities 36,117   37,510  
Long-term debt 0   5,903  
Other long-term liabilities and deferred items 54,481   52,677  
Stockholders’ equity 154,668   187,430  
 
 
 
Total liabilities and stockholders’ equity 251,169   290,540  
 
 
 

 


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Exhibit 99.2

Q4 2004 Savient Pharmaceuticals, Inc. Earnings
March 16, 2005

Speaker List:
Jenene Thomas, Savient Pharmaceuticals, Inc., Director, Investor Relations
Chris Clement, Savient Pharmaceuticals, Inc., President and CEO
Richard Mansouri, Para Partners, Analyst
Jason Aria, Jalla Equities, Analyst

Presentation
Operator: Good morning and welcome to Savient Pharmaceuticals fourth quarter earnings release call. This call is being recorded. At this time I would like to turn the call over to Jenene Thomas, Savient’s Director, Investor Relations.

Jenene Thomas: Thank you and good morning. Before I introduce Mr. Clement, please bear with me as I provide the requisite Safe Harbor statement.

Statements in this discussion concerning our business strategy, business outlook or future economic performance, product developments, anticipated profitability, revenues, expenses, earnings, or other financial items, including completion of the audit of our financial statements for the year ended December 31, 2004, and statements concerning assumptions made or expectations as to any future events, conditions, performance, competitive position, strategic alliances, plans and objectives of management, including without limitation the planned divestiture of the our global biologics manufacturing business, or other matters, are “forward-looking statements” as that term is defined under Section 21E of the Securities Exchange Act of 1934.

Forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to, the timing of the introduction of a generic version of Oxandrin, changes and delays in our product development plans and schedules, the identification and completion of strategic transactions in support of our business plans, the development, introduction or consumer acceptance of competing products, customer acceptance of new products, changes in pricing or other actions by competitors, patents owned or licensed by us and our competitors, our ability to complete the divestiture of our global biologics manufacturing business on favorable terms, and general economic conditions, as well as other risks detailed in our filings with the Securities and Exchange Commission. We do not assume any obligations to update any forward-looking statements.

I would now like to introduce Christopher Clement, President and Chief Executive Officer of Savient Pharmaceuticals.


 

Chris Clement: Good morning everyone and welcome to Savient’s fourth quarter 2004 conference call. I will begin by reviewing the quarter we completed on December 31 as well as a discussion of our recent accomplishments and future milestones for 2005.

First, the financial highlights, our fourth quarter showed signs of momentum as earnings improved compared to the previous quarter and we approached profitability. As we had indicated back in October, we took a $2 million one-time restructuring charge as part of the downsizing and re-orientation of our staff in connection with our new strategic focus. After accounting for a $3.0 million reserve established for the settlement of a long-standing patent infringement lawsuit on hGH with Genentech, our net income was $647 thousand or 1 cent per share.

Revenues in the fourth quarter 2004 were 43% higher than the preceding quarter and reached $36.6 million.

Cost of sales as a percentage of product sales for the fourth quarter increased from 27% a year ago to 32%, reflecting first year’s depreciation expense on our new state-of –the art biologics manufacturing facility.

Our cash position is strong and continues to improve. Cash, cash equivalents and short term investments at the end of 2004 was $25.2 million, compared to $24.7 million last quarter and $22.8 million a year ago. Our debt position was reduced by $7 million with total debt outstanding as of December 31, 2004 of $5.9 million.

Now let me outline for you the key results for the fourth quarter and full year and other major developments with respect to sales of our branded pharmaceuticals, our oral liquids business and the biologic manufacturing business.

Sales of Oxandrin, our largest selling brand, were $15.2 million in the fourth quarter, up 61% from the previous quarter which was burdened by returned goods reserves and 3% from the same quarter a year ago. The full year’s results for Oxandrin were lower due to reductions in wholesaler-held inventories earlier in 2004 and an increase in the provision for future product returns. Today, Oxandrin has no generic competition. However, as we have mentioned before, we fully expect that a generic competitor could enter the market at anytime. Nevertheless, we continue to support Oxandrin in the market to HIV specialists and clinical oncologists through our field force comprised of Savient sales representatives and Innovex sales representatives.

Since August of 2004 when FDA informed us they were evaluating the arguments detailed in our citizen’s petition we have had no further communication with FDA. However, we continue to support the petition and most recently filed a supplement on February 25, 2005. This supplement building on our concerns outlined in the petition, advocates the adoption of appropriately rigorous impurity standards for oxandrolone, consistent with those published in a recent USP in-process review article.


 

Last month, we announced the U.S. launch of TEV-TROPIN, which is manufactured by Savient and marketed in the United States by Teva. Sales for human growth hormone in 2004 were down from 2003 primarily due to lower sales from JCR our distributor in Japan as they continue to match inventory to demand. However, fourth quarter results were positively impacted in preparation for the introduction of TEV-TROPIN.

Net sales of Delatestryl declined in 2004 from $5.5 million to $4.3 million from a year ago. In the fourth quarter of 2004, after approximately nine months on the market, generics captured approximately 40% of all prescriptions for the hypogonadism market. While Delatestryl will likely continue to erode, the decline has been less than expected, given a generic has been in the market for over a year.

Let me turn now to our oral liquids business, where I am pleased to report that Rosemont achieved double-digit sales for the fourth quarter and the full year. Net sales for the year were up 25% to $34 million. After giving effect, to foreign exchange translation, sales were up 12% over 2003.

Let me now discuss the delay in filing the 10-K to March 31, 2005 as noted in the earnings release. This delay was caused by our restatement in February of the financial statements for the first three quarters of 2004 in connection with the recognition of revenues for 2003 and 2004. In addition, like many companies, the preparation for our evaluation of effectiveness of our internal controls for Sarbanes-Oxley compliance also contributed to the delay as we needed to address certain “material weaknesses” which I will discuss in a moment. And finally, our efforts with respect to the divestiture of our global biologics manufacturing business placed a huge burden on both our folks in Israel and here at Headquarters.

With all if that in mind we have been unable to complete prior to the deadline of today, all of the information requested by our independent auditors in connection with their audit of our financial statements for fiscal year ended December 31, 2004.

The material weaknesses I mentioned relate primarily to our financial reporting process, internal communications and lack of expertise in areas including revenue recognition and accounting for income taxes. These were some complex matters. But know that we have already taken several steps in correcting these material weaknesses. We recently announced the appointment of a Chief Accounting Officer to bolster our accounting and finance group under Larry Gyenes, our Chief Financial Officer who joined us in the middle of the third quarter last year. In addition in an effort to address the accounting for income taxes, last week we hired a Director of Taxes. We have taken some significant steps to strengthen the financial reporting of Savient in the months and years ahead.

Overall, we are encouraged by our performance in the fourth quarter and remain committed to our new strategic initiatives which are redefining Savient. In July 2004, we announced a new direction for our company to drive the development of our pipeline and pursue business development opportunities to in-license novel compounds in clinical late-stage development or marketed products initially directed towards the rheumatology specialist. By taking a more focused approach, we believe we will unlock the value of all our under-appreciated assets. We provided several key milestones for 2004 and set the stage to execute on our strategy. I am please to announce an update on the status on the following 2004 milestones – the divestiture of our global biologics business, enhancing the value of our oral liquids business, and the development of our pipeline.


 

We are progressing with our previously announced plan to divest our global biologics manufacturing business.  We are currently in advanced discussions with a potential purchaser, and while we cannot guarantee that we will ultimately reach a definitive agreement, we hope to have news to announce in the near future. The funds from the sale will allow us to drive the advancement of Puricase, our Phase 2 candidate for the treatment of severe, refractory gout, and the pursuit of licensing or acquisition of novel compounds in clinical development as well as marketed products.

Rosemont, our free-standing oral liquids business continues to play major in our corporate strategy. We are excited about opportunities in the future for Rosemont and believe that our oral liquid products provide significant potential for continued growth in the U.K. and for product expansion in the U.S. and Europe. We have taken several major steps in achieving this potential.

First, this past December, we submitted a New Drug Application to the FDA for Soltamox, an oral liquid version of tamoxifen, which is for the treatment of hormonally sensitive breast cancer. This is the first of Rosemont’s products for the U.S. market and expect approval by the end of the year.

Second, we entered into an exclusive marketing collaboration for Soltamox in Germany with a specialty oncology company who launched the product in the first quarter of 2005. Preliminary feedback from the launch has been very positive.

And third, we made important modifications during 2004 to the Rosemont facility to meet FDA Current Good Manufacturing Practices. We have completed that work and are now preparing for the FDA’s inspection which is scheduled for the second quarter of this year.

Let me now comment on the status of our pipeline. We are very encouraged with the progress of Puricase. We completed patient treatment and follow-up for the Phase 2 trial this quarter. A preliminary assessment of efficacy data from this open label Phase 2 study indicates that in a majority of patients Puricase achieves a rapid, dramatic and sustained reduction in circulating uric acid levels in this orphan population of severely symptomatic, refractory gout patients. Our expectation is to complete the full data analysis in April at which point we would request an end of Phase 2 meeting with the FDA. We anticipate initiating the Phase 3 program later this year. Severe refractory gout is also an issue outside the U.S. and we are presently in discussions to partner the development of Puricase as an orphan drug in Europe and other markets. It is our hope that Puricase will prove to be the first disease-modifying treatment for severe gout, going beyond simply lowering uric acid levels.


 

We were disappointed with the termination of our Phase 2 study for Prosaptide in HIV patients with neuropathic pain, however on the positive side, our process worked in identifying sooner rather than later the study shortcomings. As we outlined a few days ago, this termination was based upon a lack of efficacy demonstrated in a scheduled interim analysis. Simply stated, the trial failed, not because of safety issues – , in fact, the drug appears to be generally safe and well tolerated – but because of lack of analgesic efficacy distinguishable from placebo. Our next step will be to evaluate the potential for this drug candidate and explore its use to treat peripheral neuropathy and other possible indications. Over the next few months we will analyze all the available data from this study and from recently completed pre-clinical pharmacology studies. Once the Prosaptide data set has been thoroughly reviewed by our staff and a panel of independent experts, we will determine the future course of action with this drug.

In January, we announced the creation of our Science and Development Advisory Board. We named three independent external scientific leaders, Leslie A. Benet, Ph.D.,founder and Chairman of AvMax, a Professor and former Chairman, Department of Biopharmaceutical Sciences, University of California; Lee S. Simon, M.D. who is currently the Head of Regulatory Consultants at MEDACorp. and formerly from the FDA where he was the Division Director of the Analgesic, Anti-inflammatory and Ophthalmologic Drug Products Division; and Wise Young, M.D., Ph.D., Founding Director of the W. M. Keck Center for Collaborative Neuroscience, and is recognized as one of the world leaders in the field of spinal cord injury research. We believe these independent advisors will offer management and the Board of Directors strategic insights as we focus on key decisions relative to our current pipeline and future product candidates.

We committed to a focus on our internal pipeline and we believe we are delivering on advancing our candidates or making the appropriate decisions regarding future development. Beyond our pipeline however, we are committing the necessary resources to establish a dynamic business development function to enhance our ability to supplement our product portfolio with development-stage or marketed products which satisfy the unmet medical needs of the rheumatology specialist, our therapeutic area of initial focus.

In summary the first steps towards our new strategy have been achieved. While we are pleased with our accomplishments, our agenda remains ambitious. Looking ahead to an exciting 2005, we are confident we will execute our strategy and deliver upon the milestones we outlined for you. We are on track with our plans to divest our global biologics manufacturing business. We are in final negotiations and anticipate the closing by the end of the first half of 2005.


 

We anticipate a successful end of Phase 2 Puricase meeting with the FDA in the June-July timeframe and look forward to initiating Phase 3 later this year. We anticipate FDA approval of our NDA for Soltamox by the end of this year. Rosemont will continue to perform well in the U.K. market, but we are very excited about growth prospects outside the U.K. as we begin to focus on specific opportunities in the U.S. and other markets.

So in conclusion, 2004 was a year of transition in many respects, and what has emerged is a focused specialty pharmaceutical company with a clear strategic plan. We have done what we said and we are saying what we’ll do. We have begun to achieve critical milestones, and we will continue to achieve our goals in 2005 and beyond. We believe this strategy will also begin to unlock embedded value in all of our assets and create shareholder value.

We’re very excited about the prospects for 2005 and for the future of Savient Pharmaceuticals and look forward to updating you as we progress. At this point, we will now open the call up to questions.

Question and Answer Session:
Operator: Thank you Mr. Clement. Today’s question and answer session will be conducted electronically. If you would like to ask a question please do so by pressing the star key followed by the digit one on your touchtone phone. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Once again that’s star one if you’d like to ask a question and we’ll pause for just a moment to give everyone an opportunity to signal. We’ll take our first question from Richard Mansouri (ph) of Para Partners.

Richard Mansouri: Hi. Two questions if I may. The first one – as far as Rosemont your oral liquids business. You said that it did about $34 million in revenue for 2004. When you bought Rosemont a few years ago it was doing EBITDA margins somewhere in the mid-40 percent range. Is it fair to assume that if EBITDA margins held fairly steady at that mid-40 percent level?

Christopher Clement: Well Richard hello. Welcome to the call.

Richard Mansouri: Thank you.

Christopher Clement: When we acquired Rosemont in 2002, Rosemont actually had an after-tax margin of 29 percent and when you look at their results for this year for 2004 after-tax profit of $11 million on sales of 34 that gives an after-tax return of 32 percent.

Richard Mansouri: Right. So you would assume then that adding back depreciation and amortization could get you to somewhere in the mid-40 percent range for EBITDA.

Christopher Clement: Yes that’s correct.


 

Richard Mansouri: So that business on a stand alone basis if I’m doing my math right is throwing off about $15 million of EBITDA a year. Is that fair to say?

Christopher Clement: That’s fair to say.

Richard Mansouri: Okay and my next question. As far as this Puricase compound, I understand your targeted market might be only 40-50,000 patients, but can you just shine a little bit more light on the potential pricing? If I recall you’d said that you might – you thought you might be able to achieve pricing of Puricase I guess to the market similar to something like a – I don’t know like embrell (ph). Can you just comment in terms of like what sort of annual price point that would be?

Christopher Clement: Well first let me say that we believe that in the orphan population that we would be going forward with Puricase that we estimate that patient population in the U.S. to be somewhere in the 30-50,000 patient range and we also estimate that in Europe for example that the market is of an equal major. So for that orphan population you’re right it’s a relatively small market, but it’s certainly a very underserved market. Because it is such an underserved market and there are no therapeutic alternatives for these patients we believe a product like Puricase would be able to command a premium price and so while we’re still early in the game here and there’s much research and market analysis that needs to be done we do believe that should safety and efficacy profile of Puricase continue to be as exciting as it is thus far we do believe – we estimate that pricing similar to a Remicade let’s say would be possible. So we’d be looking at a pricing of somewhere in the $1,500 range.

Richard Mansouri: Fifteen hundred dollars a month?

Christopher Clement: That’s correct.

Richard Mansouri: So $18,000 a year effectively?

Christopher Clement: You know Richard, I’m not in a position here because we’re still in a Phase 2 trial to give you – to pin down pricing errors. As I said, there’s a lot of analysis that needs to be done. What I’m saying is that I believe that given the efficacy and safety we think Puricase will demonstrate for us that we’d be able to get that type of a premium in the market.

Richard Mansouri: Oh, no, no. I understand and I appreciate that. We’re still early – you’re still early in the game. Just on that topic. Will you say you’re fairly confident – I understand the data now, because it hasn’t been completed yet, but are you – would you say highly confident that you think you’ll be able to advance the Puricase compound into the Phase 3?


 

Christopher Clement: We are finishing up our data. We will be finishing up our data analysis in April including all of the laboratory results, but since this was an open label trial we do believe that – we know what the results are so we’re very confident that we will be requesting our end of Phase 2 meeting with FDA and we anticipate moving into Phase 3 later this year.

Richard Mansouri: Okay thank you.

Christopher Clement: You’re welcome.

Operator: And once again if you’d like to signal for a question please press star one. We’ll go next to Jason Aria with Jalla Equities.

Jason Aria: Good morning Chris.

Christopher Clement: Hello Jason.

Jason Aria: First of all let me say I think you’ve done a wonderful job with Rosemont and I think you’re certainly moving the company in the right direction with the Israeli asset sale. There was really one concern I had in today’s press release. This company and Prosaptide is a prime example has been know to – love to acquire products that fortunately fall short of that expectations and clearly I think under your leadership this company is changed its direction positively and I was concerned to see again in today’s press release a mention of us looking to acquire clinical candidates or approved products and I was hoping that the company would as you’ve enunciated several times today continue to realize the value of its under appreciated assets and not go down the path that we’ve seemed to have gone down so many times before brining in other peoples under appreciated assets.

Christopher Clement: Well you know Jason I appreciate – first of all let me say that I appreciate your comments. First and foremost we are focused on unlocking the value in this company. We do believe that the assets are undervalued and we are doing everything we can to create additional shareholder value for every investor in Savient. Having said that, as a pharmaceutical company this is an industry as you know that’s driven by acquiring additional technologies and additional products to sustain growth out into the future. I think by having a focus now which we have which is very clear and a methodology for how we go about evaluating compounds and the criteria that we establish for that, I think you give yourself the best possible chance – I mean there’s always risk in this industry. There has always been risk in this industry, but you give yourself the best possible chance for either licensing or acquiring something that’s going to have a good probability of success. So we think that by our focus, we think that by the methodologies and the processes that we’ve put in place that we’ve given ourselves a much better chance as we continue to move forward.


 

Jason Aria: I understand and let me just one more piece on this. It seems every specialty pharma company that we speak to is interested in acquiring new products and I think one of the reasons we see so few deals in this industry is because everybody perceives themselves as a buyer and it seems to be a wonderful sellers market whenever a deal gets done whether it be an example of Espiron with Pfizer on down the line Prosaptide with Savient and I think that the company should consider being on the other side of that fence which seems to be a much more fruitful area with every other company in this industry looking to acquire products. So anyway as I said, I appreciate the direction you’re taking us Chris and please keep it up. Thank you.

Christopher Clement: Thank you Jason.

Operator: Mr. Clement there are no further questions at this time sir. I’ll turn the call back over to you.

Christopher Clement: Okay well as I said we are very excited about the progress we have made relative to our strategy. We’re very excited about the future here and I look forward to being able to speak with you on a frequent basis and give you progress and updates on our strategic plan as we move forward. Thanks very much for your time this morning.

Operator: And if you wish to access the replay for today’s call you may do so by dialing 1-888-203-1112 or 719-457-0820 with the pass code of 4566212 and this does conclude our conference call today. Thank you for your participation and have a great day.

 


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