Prepared and filed by St Ives Burrups

-----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, SdNcHw/Wms1tobiU01rPOPRLkBjLKhsQTzBAkKg7XTkeHQC2lnTMc1wJOoeNwn6M /gJ9rOWvxGyJN4Wwxdkalg== 0001125282-04-003763.txt : 20040811 0001125282-04-003763.hdr.sgml : 20040811 20040811150628 ACCESSION NUMBER: 0001125282-04-003763 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20040809 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20040811 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: 04966871 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 b400285_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): August 9, 2004

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)

Item 12. Results of Operations and Financial Condition

On August 9, 2004, Savient Pharmaceuticals, Inc. (“Savient”) announced its financial results for the quarter ended June 30, 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 August 9, 2004, Savient held a publicly available live webcast discussion of its financial results for the quarter ended June 30, 2004. The transcript of the August 9, 2004 conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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: August 11, 2004	SAVIENT PHARMACEUTICALS, INC.

	By:	/s/ Philip K. Yachmetz

		Philip K. Yachmetz
		Senior Vice President, General Counsel and Secretary

EXHIBIT INDEX

Exhibit No.		Description

99.1		Press release dated August 9, 2004
99.2		Transcript dated August 9, 2004

EX-99.1 2 b400285ex99_1.htm PRESS RELEASE Prepared and filed by St Ives Burrups

Exhibit 99.1



Contact		Company Contact
Don Weinberger		Leah Berkovits
Wolfe Axelrod Weinberger Associates		Savient Pharmaceuticals, Inc.
212-370-4500		732-418-9300

FOR IMMEDIATE RELEASE

SAVIENT PHARMACEUTICALS, INC. REPORTS SECOND QUARTER
AND FIRST HALF 2004 FINANCIAL RESULTS

EAST BRUNSWICK, N.J. – August 9, 2004 – Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) today reported financial results for the three and six months ended June 30, 2004.

Recent News

On August 5, 2004 the Company announced that the United States District Court for the District of Delaware has found Novo Nordisk’s (NYSE:NVO) U.S. Patent No. 5,633,352 relating to recombinant human growth hormone invalid and unenforceable due to inequitable conduct. As a result, the Company is now proceeding with plans to bring its FDA approved human growth hormone to market in the United States later this year. The product is licensed to and will be marketed by Teva under the name Tev-Tropin™. The U.S. pediatric market for recombinant human growth hormones is approximately $500 million and currently growing at an annual rate of 12%.

In July 2004, the Company announced a major revision to its strategic direction. The new business plan targets a repositioning of the Company with the primary focus on the full development of its pipeline products. This will include an enhanced focus on the clinical development of the Company’s two product candidates currently in Phase 2 clinical trials – Prosaptide for peripheral neuropathic pain, and Puricase® for severe, refractory gout. The Company also intends to concentrate on an active in-licensing program to access and develop novel compounds in clinical stage development.

As part of this plan, the Company intends to divest assets that are not consistent with its revised business objectives and is exploring its strategic options for the divestiture of its operations in Israel, including its wholly owned subsidiary, Bio-Technology General (Israel) Ltd. The Company believes that a sale of its Israeli operations should provide incremental resources to fund the advancement of its drug development programs.

Based on the Company’s current business outlook resulting from the expectation that a generic version of Oxandrin® may eventually be approved as well as the change in the Company’s strategic direction, the Company believes that it is uncertain that it will be able to apply deferred tax assets against anticipated future income. Accordingly, the Company recognized certain non-recurring, non-cash expenses in the second quarter, including a valuation allowance of $16.3 million against deferred tax assets, which increased its net loss in the three months ended June 30, 2004. In addition, the Company wrote down its investment in Marco Hi-Tech JV, Ltd.’s huperzine A project, which the Company decided to terminate upon completion of a critical review and analysis of this opportunity.

Quarter ended June 30, 2004

Revenues

•	Total revenues in the three months ended June 30, 2004 were $17.6 million compared to $30.9 million in the three months ended June 30, 2003, due primarily to lower product sales.

•

Net product sales in the second quarter of 2004 were $14.3 million compared to $28.0 million in the second quarter of 2003. Following changes in the structure of our sales force, Oxandrin prescriptions increased approximately 3% from the first quarter to the second quarter of 2004, with the growth primarily from the oncology market. However, in the second quarter of 2004, Oxandrin sales were reduced by: returns and a provision for future returns of expiring product, and lower purchases by wholesalers in the second quarter of 2004 as they reduced their inventory to below their historical level. In addition, other product sales were reduced by the reintroduction of a generic testosterone product into the market in March 2004 that competes with Delatestryl® and lower sales of human growth hormone and BioLon®, partially offset by a 35% increase in (measured in U.S. dollars) in sales of oral liquid pharmaceutical products (20% measured in pounds sterling).

Provision for Product Returns

•

Historically the Company has experienced virtually no product returns of the Oxandrin 2.5-mg tablet because of its five-year shelf life. However, based on the return of some expiring 2.5-mg Oxandrin tablets in the second quarter and in anticipation of returns of expiring 10-mg product, which currently has a two-year shelf life, the Company recorded a corresponding provision for product returns.

Expenses

•	Operating expenses in the second quarter of 2004 were $32.3 million, compared to $27.3 million in the second quarter of 2003.

•

Cost of sales represented 53% of product sales in the second quarter of 2004, compared to 19% in the corresponding 2003 quarter. This increased cost of sales primarily resulted from costs associated with the operation of the Company’s new manufacturing facility in Israel. In the 2003 period, such costs were capitalized because the facility was not yet ready for its intended use. Although much of the operating costs of this new manufacturing facility in the first half of 2004 relate to process validation and similar qualification activities rather than manufacture of products for commercial sale, depreciation of the facility began in the first quarter of 2004.

Net Loss

•	The Company recorded a net loss in the three months ended June 30, 2004 of $31.9 million, or $(0.53) per share, compared to net income of $2.5 million, or $0.04 per share in the corresponding 2003 period.

Balance Sheet

•	The Company had cash, cash equivalents, and short-term investments of $26.4 million at June 30, 2004, compared to $22.8 million at December 31, 2003.

Comment from Savient Pharmaceuticals’ Chief Executive Officer, Christopher Clement:

“Our results for the quarter and six months ended June 30, 2004 were negatively affected by several non-cash non-recurring events stemming from our business outlook and the change in our strategic direction. While net product sales were lower, Rosemont, our oral liquids pharmaceuticals business in the U.K., demonstrated robust growth. We look forward to completing modifications to the Rosemont manufacturing facility with a view to its FDA qualification for the introduction of oral liquid products in the United States.”

Six months ended June 30, 2004

•	Total revenues in the six months ended June 30, 2004 were $51.2 million compared to $58.9 million in the six months ended June 30, 2003.

•	Net product sales in the first half of 2004 were $46.6 million compared to $55.0 million in the first half of 2003.

•	Operating expenses in the first half of 2004 were $64.1 million, compared to $51.3 million in the first half of 2003, reflecting significant increases in research and development, general and administrative, and cost of sales, as well as a retirement payment to the Company’s former CEO and the negative effect of the relatively weak dollar compared to the corresponding 2003 period.

•	Net loss in the first half of 2004 was $30.6 million, or $(0.51) per share, compared to net income of $5.5 million, or $0.09 per share in the corresponding 2003 period.

Outlook Comment from Savient Pharmaceuticals’ Chief Executive Officer, Christopher Clement:

“We continue to believe that Savient’s asset base is significantly undervalued and that our oral liquid pharmaceuticals business and our drug candidates Prosaptide and Puricase® have strong potential to advance our business objectives and prospects for growth and success. Both of these compounds address disease areas of serious unmet medical need. The strength of our development program justifies our enthusiasm for the future of Savient moving forward. Through ongoing revision of our strategic plan and a focus on our key assets and priorities, we see Savient well positioned for the future.”

Savient will offer a live webcast discussion of the earnings and the Company’s business outlook, hosted by Christopher Clement, President and CEO, on Monday, August 9, 2004, at 10:00 a.m. ET. The webcast can be accessed at www.savientpharma.com, and will be archived through August 16, 2004.

An audio replay will also be available from 12:00 p.m. ET on August 9, 2004 through August 16, 2004 and can be accessed by dialing 888-203-1112 (in the U.S.) or 719-457-0820 (outside the U.S.); passcode number is 280629.

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’s sales force 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), 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 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, 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; 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.

#####

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

	Three Months Ended June 30,

	2004			2003

Revenues:
Product sales, net	$	14,262		$	28,048
Contract fees		220			377
Royalties		2,872			1,047
Other		254			1,464

Total revenues		17,608			30,936


Expenses:
Research and development		6,882			7,408
Cost of sales		7,570			5,194
Marketing and sales		5,868			5,407
General and administrative		7,395			6,445
Retirement		2,110			—
Commissions and royalties		1,507			1,821
Amortization of intangibles		1,012			1,012

Total expenses		32,344			27,287


Operating (loss) income		(14,736	)		3,649
Other (expense) income, net		(769	)		39

(Loss) income before income taxes		(15,505	)		3,688
Income taxes		16,409			1,176

Net (loss) income	$	(31,914	)	$	2,512



(Loss) earnings per common share:
Basic	$	(0.53	)	$	0.04

Diluted	$	(0.53	)	$	0.04


Weighted average number of common and common equivalent shares:
Basic		59,962			59,044

Diluted		59,962			59,485

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

	Six Months Ended June 30,

	2004			2003

Revenues:
Product sales, net	$	46,633		$	54,998
Contract fees		450			743
Royalties		3,804			1,570
Other		294			1,601

Total revenues		51,181			58,912


Expenses:
Research and development		15,546			13,856
Cost of sales		16,233			9,680
Marketing and sales		12,534			11,978
General and administrative		12,767			11,496
Retirement		2,110			—
Commissions and royalties		2,910			2,231
Amortization of intangibles		2,025			2,025

Total expenses		64,125			51,266


Operating (loss) income		(12,944	)		7,646
Other (expense) income, net		(696	)		421

(Loss) income before income taxes		(13,640	)		8,067
Income taxes		16,986			2,572

Net (loss) income	$	(30,626	)	$	5,495



(Loss) earnings per common share:
Basic	$	(0.51	)	$	0.09

Diluted	$	(0.51	)	$	0.09


Weighted average number of common and common equivalent shares:
Basic		59,849			58,942

Diluted		59,849			59,182

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

	June 30, 2004		December 31, 2003

Assets:
Cash, cash equivalents and short-term investments	$	26,391	$	22,801
Accounts receivable, net		14,009		33,375
Inventories		19,912		20,216
Other current assets		4,067		7,051

Total current assets		64,379		83,443

Property and equipment, net		68,912		70,426
Intangible assets		73,713		75,743
Goodwill		40,121		40,121
Other long-term assets		6,593		20,807

Total assets	$	253,718	$	290,540

Liabilities and stockholders’ equity:
Current portion of long-term debt	$	7,034	$	7,020
Other current liabilities		34,239		37,510
Long-term debt		2,383		5,903
Other long-term liabilities and deferred items		52,388		52,677
Stockholders’ equity		157,674		187,430

Total liabilities and stockholders’ equity	$	253,718	$	290,540

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Exhibit 99.2

Q2 2004 Savient Pharmaceuticals, Inc. Earnings Conference Call
August 9, 2004

I. SPEAKER LIST

Corporate:
Gwen Harning; Savient Pharmaceuticals Inc.
Christopher Clement; Savient Pharmaceuticals Inc.; Chairman and CEO

All other participants:
Jason Aria, Analyst
Tim Dodd, Credit Suisse First Boston, Analyst

II. PRESENTATION:

Operator: Good morning and welcome to the Savient Pharmaceuticals second quarter earnings release conference call. This call is being recorded.

At this time, I’d like to turn the call over to Gwen Harning. Please go ahead, ma’am.

Gwen Harning: Good morning. I am Gwen Harning of Savient Pharmaceuticals, and I thank you for joining us today.

Before I introduce Mr. Clement, please bear with me as I provide the requisite Safe Harbor statement.

Statements in this discussion concerning our business outlook or future economic performance, product developments, anticipated profitability, revenues, expenses, earnings, or other financial items, and statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements” as that term is defined under the Federal Securities laws.

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 product development plans and schedules, 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, and general economic conditions, as well as other risks detailed in our filings with the Securities and Exchange Commission.

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

Christopher Clement: Good day to all, and thank you for joining us. As you know, in July we announced a major revision to our strategic business plan. I’d like to briefly outline for you the rationale for that change. In looking at our market performance we believe we are not realizing full value for our assets, so it necessitated a thorough review of our business.

In addition, our current business is likely to face revenue risk if Oxandrin is genericized. We believe very strongly in the potential of our pipeline, Prosaptide for neuropathic pain and Puricase for severe, refractory gout, and thus our primary focus going forward will be on dedicating the resources necessary to bring these compounds, which address unmet medical needs, to the market as quickly as possible.

As a means of supplementing our late stage clinical pipeline, we will also dedicate the necessary resources to an active in-licensing program to access and develop novel clinical stage compounds.

The full funding of our pipeline and the resources necessary to support an aggressive business development program will require the divestment of assets that are not consistent with our revised strategic plan.

After a thorough evaluation of all of our assets, our intention is to divest our subsidiary Bio-technology General Israel Ltd., which would include our manufacturing site, offices and the products that are manufactured there.

So why BTG-Israel?

Number one. The products manufactured in Israel are all marketed by partners and their revenue streams can be valued as part of the sale.

Number two. None of the products we currently market ourselves are biologics and we no longer have a basic research program in biologics. Thus our new facility in Be’er Tuvia will have excess capacity, which could be better utilized by other companies already heavily invested in the biologics field.

Rosemont will remain an important contributor to the company and we fully expect its value and contribution to increase as we enter the US market, which we hope will occur late next year.

Rosemont continues to perform as expected and the modifications to the manufacturing plant remain on schedule for an approval that we hope will occur later this year, at which point we will file our first US submission.

A recently completed study of the US market finds commercial opportunities for oral liquid pharmaceuticals across the long-term care, hospital and retail market segments.

So a sale of our Israeli business along with the earnings contributions from Rosemont and other commercial operations will fuel the late stage development of our pipeline.

Let me turn to a discussion of our Q2 results. Given our current business outlook, where I mentioned earlier, we are at revenue risk with Oxandrin, and the change in our strategy, we recognize certain non-recurring, non-cash expenses in the second quarter, which adversely have impacted our results for the three and six months ended June 30, 2004.

Accordingly, we’ve created a valuation allowance of $16.3 million against deferred tax assets given the uncertainty that we will be able to apply these assets against anticipated future income.

We also wrote down our investment in the huperzine A project, which we decided to terminate after completing a critical review and analysis of this opportunity. I think it’s important to emphasize the considerable impact of these non-cash, non-recurring items on our results, which, combined with other non-recurring items, accounted for approximately 75% of our net loss in the second quarter.

In addition, our expenses and results for the period were negatively impacted by a one-time retirement payment to our former CEO.

While these were the major factors that impacted our results for the quarter, other factors also contributed; total revenues were $17.6 million compared to $30.9 million in the three months ended June 30^th, 2003, with the revenue decline due primarily to lower product sales.

Net product sales were $14.3 million compared to $28 million in the second quarter of 2003. Following changes in the structure of our sales force, Oxandrin prescriptions grew 3% from the first to the second quarter of 2004, with the growth primarily from the oncology sector.

However, the net Oxandrin sales actually realized do not reflect this because of provision for the return of goods; increased purchases of Oxandrin by wholesalers in the first quarter of 2004 in anticipation of a price increase and lower purchases by wholesalers in the second quarter of 2004, as inventories were reduced to below their historical level in anticipation of a generic entry.

Other factors negatively impacting our total product sales were, the previously announced reintroduction of a generic testosterone product into the market in March 2004 that competes with Delatestryl, and lower sales of human growth hormone and BioLon.

On the plus side, these were partially offset by a 35% increase in sales of oral liquid pharmaceutical products or a 20% increase as measured in pounds sterling.

I’d like to clarify my comment regarding provision for product returns for Oxandrin and its impact on sales. Our Oxandrin 2.5-milligram tablet has a five-year shelf life, and our 10- milligram Oxandrin tablet currently has a two-year shelf life.

Historically, we’ve experienced virtually no product returns but based on the return of some expiring 2.5- milligram tablets in the second quarter and anticipated returns of expiring 10- milligram product, we recorded a corresponding provision for product returns, which affected our net sales of Oxandrin.

Turning now to our expenses, operating expenses were $32.3 million, compared to $27.3 million in the second quarter of 2003. Cost of sales represented 53% of product sales, compared to 19% in the corresponding 2003 quarter, the increase being primarily due to costs associated with the operation of our new manufacturing facility in Israel. In the 2003 period, we capitalized comparable costs because the facility was not yet ready for its intended use.

Additionally, although much of the operating costs of the facility in the first half of 2004 relate to process validation and other qualification activities rather than manufacture of products for commercial sale, depreciation of the facility began in the first quarter of 2004. So we’ve seen depreciation effect without corresponding revenues from product sales.

Including the effect of the non-cash and non-recurring items, we recorded a net loss of $31.9 million, or 53 cents per diluted share, compared to net income of $2.5 million, or 4 cents per diluted share in the second quarter of 2003.

Our cash, cash equivalents and short-term investments were $26.4 million at June 30^th, 2004, compared to $22.8 million at December 31^st, 2003. Our total debt outstanding at June 30, 2004 was $9.4 million.

Before taking your questions, I’d like to provide a brief update on recent events, and return for a few minutes to a discussion of our new strategic direction. Just last week, we received a favorable ruling in the patent litigation relating to our human growth hormone product, which is FDA approved.

We’re delighted at the court decision and look forward to the launch of the product by Teva later this year under the Tev-Tropin label. We have every confidence in Teva’s ability to establish a significant presence in the US pediatric human growth hormone market, which today is close to $500 million and currently growing at an annual rate of 12%.

As to the pending US approval of Nuflexxa, our sodium hyaluronate product for the treatment of knee pain due to osteoarthritis, as we’ve previously disclosed, an approvable letter from the FDA has been issued subject to a satisfactory inspection of our manufacturing facility and approval of labeling.

I’m pleased to report that we’re making progress with the final steps toward FDA approval and look forward to communicating further developments as they occur. Our product is approved in Europe and we are presently seeking a marketing partner to optimize its European sales potential and planning for its introduction here in the United States. Both of these products would eventually be sourced out of our new manufacturing facility in Israel.

Let me now share with you now why we’re so excited about Prosaptide and Puricase, our drug candidates in clinical development. First, they’re both targeting disease areas of significant unmet medical need, and second, they’re both advancing through Phase II clinical trials.

Prosaptide, as you know, is our nerve growth factor to treat neuropathic pain. According to a recent study by Decision Resources, Inc., neuropathic pain is one of the largest commercial opportunities among all therapeutic classes, cutting across a number of neuropathic pain areas from HIV to diabetes to cancer to other pain syndromes.

Available treatments offer modest relief, so there is a tremendous need for new therapies. To give you a sense of the market potential here, Neurontin, a drug approved for epilepsy, is the most widely prescribed therapy for neuropathic pain, with annual sales in this area estimated at over $1.5 billion.

Unlike Neurontin and other compounds in development, Prosaptide does not appear to have their central nervous system side effects. Therefore, we believe, if effective in treating neuropathic pain, Prosaptide could be a unique product entry in this market, with an improved side effect profile. If Prosaptide becomes a new and superior class of therapy for neuropathic pain, it should be able to generate revenues in the hundreds of millions of dollars. Our goal is to complete this study in the first half of 2005.

However, we also believe that Prosaptide is a potential platform molecule that could address the symptoms of pain associated with neuropathy as well as – if our pre-clinical data from animal studies is borne out in human clinical trials – perhaps the underlying neurodegeneration itself.

Let’s talk about Puricase. This is uricase enzyme targeting severe gout patients who are refractory to other therapies. This is an orphan indication so the patient population is small. However, there are no other available therapies, so we think we can capture a significant portion of this market.

Beyond this orphan indication, we also believe there is upside, subject to successful completion of additional clinical studies for Puricase as a potential treatment of gout in symptomatic patients to normalize high serum levels of uric acid, which would significantly expand the market for this exciting drug. Our goal is to complete the Phase II study and reach a go-no-go decision toward the end of this year or early next year.

In conclusion, I am sure you can see why we’re so excited about all of the potential I have presented to you. The strength of our development program justifies our enthusiasm for the future of Savient moving forward.

Through a revision of our strategic plan and a focus on the key assets and priorities of the company, we’ve taken the necessary steps to position Savient for the future. I look forward to sharing with you new developments related to our business during the course of this year as they evolve.

I will now be pleased to take your questions at this time.

III. Question and Answer Session:

Operator: The question-and-answer session will be conducted electronically. If you’d like to ask a question today, please do so by pressing the “star” key followed by the digit “one” on your touchtone telephone. If you’re using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. We’ll proceed in the order that you signal as and take as many questions as time permits.

Again, that is “star” “one” to ask a question or make a comment. Additionally, if you find that your question has been answered, you may remove yourself from the queue by pressing the “pound” key.

We’ll take our first question from Jason Aria (ph).

Unidentified Speaker: Hello, Jason.

Operator: One moment please. Mr. Aria, your line is open

Jason Aria: Thank you. Chris.

Christopher Clement: Hi, Jason

Jason Aria: Hi. Question on the HGH sales, when do you expect Teva to begin the sales and can you give us an idea of what your sales projection would be?

Christopher Clement: Jason, we fully expect that Teva will launching into the market later this year. I’m not in a position at this point to give you specific details about sales projection, although, you know, as I mentioned during the discussion here that this is a market that’s 500 million and growing at double-digit growth per year.

Jason Aria: And can you just give us a competitive landscape of the class and can you just give us what your relationship with Teva is on the product again?

Christopher Clement: OK. Well, Teva as you know will do the actual – they will do the actual marketing of the product. We will supply them with finished goods. And there are about five or so competitors in the marketplace now, although, you know, I think given the strength of Teva from a marketing and sales perspective, we fully expect them to compete very effectively with the other competitors.

Jason Aria: One more question, and where is the growth in hGH coming from?

Christopher Clement: I’m not sure. I understand your question, I mean...

Jason Aria: I mean the growth is so dramatic, can you give us a – just the profile of the patient population and why the phase of growth is so high?

Christopher Clement: Well, yes, I mean, first of all, the market has historically – have historically been a fairly solid market growing at fairly standard rates, but there has been recently and I believe that was last – year sometime, there was an expanded indication for short statured children.

So on the basis of that ruling that came out but expanded Lily’s use of the product, that’s when the growth rate really started to increase. I think there is also a future belief going-forward, that – we would see this market continues to grow, people believe that will also be used eventually in the adult population. But I think right now, we’re seeing the primary growth coming from this expanded use in the pediatric population.

Jason Aria: Great. And Chris, last question relating to this, obviously, the company was in discussions with Teva a year or so on a broader strategic opportunity, does – this ruling potentially put back, back on the table and while you’ve addressed the new strategic direction for the company that was prior to this ruling, might this ruling, affect that at all?

Christopher Clement: No, Jason. I mean this agreement with Teva has been in place for some period of time. So, this is not a new arrangement and we – fully expect be very good partners with Teva here on getting the Tev-Tropin into the market – US market as quickly as possible.

Jason Aria: OK. Thank you, Chris.

Christopher Clement: Thanks, Jason.

Operator: Mr. Dodd your line is open.

Tim Dodd: Yes. Hello. This is Tim Dodd from Credit Suisse. I had a question regarding the compensation arrangement with Teva on this growth hormone and could you give us the breakdown as to the relationship there percentage wise and your plan on marketing that as a generic or a branded generic?

Christopher Clement: Well, the products will be – finished products, as I mentioned, will be provided to Teva under the trade name “Tev-Tropin” and relative to Teva’s specific marketing plans and strategy, you would have to check with Teva. Relative to our arrangement with them, we have a royalty-bearing arrangement with them, which is a solid double-digit type of royalty.

Tim Dodd: Have you all disclosed that specific number?

Christopher Clement: No, we have not.

Tim Dodd: OK. And at this point you are saying that you do not know whether this is going to be marketed as a generic or a branded generic because it’s up to Teva?

Christopher Clement: Yes. I would say that – right, I mean we are providing them with a product and it’s in Teva’s decision as to how they will market and sell this product.

Tim Dodd: OK. All right. Thank you.

Christopher Clement: Thank you.

Operator: Once again, it is “star”, “one” to ask a question or make a comment. This time it appears there are no further questions. Mr. Clement please go ahead.

Christopher Clement: OK. Well, I would like to certainly thank everybody who participated in this conference call this morning, and as I mentioned earlier as further developments warrant, we will continue to communicate with you as those events evolve. Thank you very much everyone.

Have a very nice day.

Operator: That concludes today’s conference. If you wish to access the replay for this call, you may do so by dialing 1-888-203-1112 or 719-457-0820 with the pass-code of 280629.

Once again, this concludes our conference call today.

Thank you for your participation and have a great day.

You may now disconnect your line.

This transcript 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 transcript 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 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, 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; 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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