UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2013

OR

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

FOR THE TRANSITION PERIOD FROM                      TO                     

COMMISSION FILE NUMBER 000-15313

SAVIENT PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware	13-3033811
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)

400 Crossing Blvd., 3^rd Floor, Bridgewater, NJ 08807

(Address of Principal Executive Offices)

(732) 418-9300

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    YES  x    NO  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES  x    NO  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer	¨	Accelerated filer	¨
Non-accelerated filer	¨  (Do not check if a smaller reporting company)	Smaller reporting company	x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    YES  ¨    NO  x

The number of shares outstanding of the issuers’ Common Stock, par value $.01 per share, as of August 9, 2013 was 73,467,367.

SAVIENT PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2013

TABLE OF CONTENTS

		Page
PART I—FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited):		3
	Consolidated Balance Sheets		3
	Consolidated Statements of Operations		4
	Consolidated Statements of Comprehensive Loss		5
	Consolidated Statement of Changes in Stockholders’ Deficit		6
	Consolidated Statements of Cash Flows		7
	Notes to Consolidated Financial Statements		8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk		26
Item 4.	Controls and Procedures		26
PART II—OTHER INFORMATION
Item 1.	Legal Proceedings		26
Item 1A.	Risk Factors		27
Item 6.	Exhibits		53
	Signatures		53
	Exhibit Index		54

2

PART I—FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except per share data)

	June 30, 2013			December 31, 2012
ASSETS
Current Assets:
Cash and cash equivalents	$	38,343		$	50,332
Short-term investments		13,131			45,949
Accounts receivable, net		7,753			4,341
Inventories, net		1,575			4,325
Prepaid expenses and other current assets		3,819			4,367
Total current assets		64,621			109,314
Property and equipment, net		1,804			2,050
Deferred financing costs, net		4,505			4,969
Restricted cash and other assets		2,827			2,873
Total assets	$	73,757		$	119,206
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current Liabilities:
Accounts payable	$	3,425		$	3,435
Deferred revenues		1,480			580
Warrant liability		1,438			2,935
Accrued interest		3,154			3,150
Other current liabilities		16,719			21,516
Total current liabilities		26,216			31,616
Convertible notes, net of discount of $23,388 at June 30, 2013 and $25,354 at December 31, 2012		99,053			97,087
Senior secured notes, net of discount of $38,670 at June 30, 2013 and $45,114 at December 31, 2012		132,271			125,827
Other liabilities		2,839			2,973
Stockholders’ Deficit:
Preferred stock—$.01 par value 4,000,000 shares authorized; no shares issued		—			—
Common stock—$.01 par value 150,000,000 shares authorized; 73,709,000 shares issued and outstanding at June 30, 2013 and 73,083,000 shares issued and outstanding at December 31, 2012		737			731
Additional paid-in-capital		399,340			397,191
Accumulated deficit		(585,793	)		(535,915	)
Accumulated other comprehensive loss		(906	)		(304	)
Total stockholders’ deficit		(186,622	)		(138,297	)
Total liabilities and stockholders’ deficit	$	73,757		$	119,206

The accompanying notes are an integral part of these consolidated financial statements.

3

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

	Three Months Ended June 30,						Six Months Ended June 30,
	2013			2012			2013			2012
Revenues:
Product sales, net	$	6,280		$	4,626		$	10,972		$	8,160
Co-promotion revenue		382			—			382			—
Total Revenues		6,662			4,626			11,354			8,160
Cost and expenses:
Cost of goods sold		2,038			6,727			5,588			8,447
Research and development		6,026			6,705			12,160			13,951
Selling, general and administrative		17,807			27,327			32,963			51,579
		25,871			40,759			50,711			73,977
Operating loss		(19,209	)		(36,133	)		(39,357	)		(65,817	)
Investment income, net		20			41			53			84
Interest expense on debt		(7,237	)		(5,600	)		(14,316	)		(10,157	)
Gain on extinguishment of debt		—			21,800			—			21,800
Other income, net		994			3,513			1,500			3,513
Loss before income taxes		(25,432	)		(16,379	)		(52,120	)		(50,577	)
Income tax benefit		—			—			2,242			—
Net loss	$	(25,432	)	$	(16,379	)	$	(49,878	)	$	(50,577	)
Loss per common share:
Basic and diluted	$	(0.35	)	$	(0.23	)	$	(0.69	)	$	(0.72	)
Weighted-average number of common shares:
Basic and diluted		72,141			70,721			71,905			70,596

The accompanying notes are an integral part of these consolidated financial statements.

4

SAVIENT PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(In thousands)

	Three Months Ended June  30,						Six Months Ended June  30,
	2013			2012			2013			2012
Net loss	$	(25,432	)	$	(16,379	)	$	(49,878	)	$	(50,577	)
Other comprehensive loss:
Foreign currency translation, net		(261	)		197			(602	)		151
Comprehensive loss	$	(25,693	)	$	(16,182	)	$	(50,480	)	$	(50,426	)

The accompanying notes are an integral part of these consolidated financial statements.

5

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT

(Unaudited)

(In thousands)

	Common Stock									Accumulated Deficit			Accumulated Other Comprehensive Loss			Total Stockholders’ Deficit
	Shares			Par Value			Additional Paid-in- Capital
Balance, December 31, 2012		73,083		$	731		$	397,191		$	(535,915	)	$	(304	)	$	(138,297	)
Net loss		—			—			—			(49,878	)		—			(49,878	)
Restricted stock grants		642			6			(6	)		—			—			—
Forfeiture of restricted stock grants		(194	)		(2	)		2			—			—			—
Issuance of common stock		178			2			137			—			—			139
Stock compensation expense		—			—			2,016			—			—			2,016
Other comprehensive loss		—			—			—			—			(602	)		(602	)
Balance, June 30, 2013		73,709		$	737		$	399,340		$	(585,793	)	$	(906	)	$	(186,622	)

The accompanying notes are an integral part of these consolidated financial statements.

6

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

	Six Months Ended June 30,
	2013			2012
Cash flows from operating activities:
Net loss	$	(49,878	)	$	(50,577	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		242			215
Accretion of debt discount		8,410			4,505
Gain on extinguishment of debt		—			(21,800	)
Valuation change in warrant liability		(1,497	)		(3,792	)
Amortization of deferred financing costs		430			287
Stock compensation expense		2,016			3,980
Other		4			255
Changes in:
Accounts receivable, net		(3,412	)		(940	)
Inventories, net		2,750			619
Prepaid expenses and other current assets		582			(3,541	)
Other assets		46			(40	)
Accounts payable		(10	)		(1,495	)
Accrued interest on convertible notes		4			(1,489	)
Other current liabilities		(4,837	)		2,794
Deferred revenues		900			14
Other liabilities		(134	)		511
Net cash used in operating activities		(44,384	)		(70,494	)
Cash flows from investing activities:
Proceeds from maturities of held-to-maturity securities		33,386			35,875
Purchases of held-to-maturity securities		(568	)		(29,929	)
Capital expenditures		—			(279	)
Changes in restricted cash		—			(350	)
Net cash provided by investing activities		32,818			5,317
Cash flows from financing activities:
Proceeds from issuance of common stock		139			337
Proceeds from issuance of debt, net of expenses		—			43,058
Net cash provided by financing activities		139			43,395
Effect of exchange rate changes		(562	)		151
Net decrease in cash and cash equivalents		(11,989	)		(21,631	)
Cash and cash equivalents at beginning of period		50,332			114,094
Cash and cash equivalents at end of period	$	38,343		$	92,463
Supplementary Information
Other information:
Income tax paid	$	—		$	—
Interest paid	$	5,472		$	5,470

The accompanying notes are an integral part of these consolidated financial statements.

7

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Note 1—Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim financial statements furnished herein include all adjustments necessary for a fair presentation of Savient Pharmaceuticals, Inc.’s (“Savient” or the “Company”) financial position at June 30, 2013, the results of its operations for the three and six-month periods ended June 30, 2013 and 2012, and cash flows for the six-month periods ended June 30, 2013 and 2012. Interim financial statements are prepared on a basis consistent with the Company’s annual financial statements. Results of operations for the three and six-month periods ended June 30, 2013 are not necessarily indicative of the operating results that may be expected for the year ending December 31, 2013.

The consolidated balance sheet at December 31, 2012 was derived from the audited financial statements at that date and does not include all of the information and notes required by GAAP for complete financial statements. The interim statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

Basis of consolidation

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Savient Pharma Holdings, Inc., Savient Pharma Ireland Limited and Savient International Limited.

Use of estimates in preparation of financial statements

The preparation of financial statements in conformity with generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including those related to investments, accounts receivable, reserve for product returns, inventories, rebates, property and equipment, share-based compensation and income taxes. The estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Results may differ from these estimates due to actual outcomes differing from those on which the Company bases its assumptions.

Note 2—Summary of Significant Accounting Policies

The Company’s significant accounting policies are described in Note 1 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

Recently Issued Accounting Pronouncements

During the quarter ended June 30, 2013, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012 that affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures.

Note 3—Fair Value of Financial Instruments and Investments

The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). If the inputs used to measure fair value fall within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument.

Financial assets recorded at fair value on the Company’s consolidated balance sheets are categorized as follows:

Level 1: Unadjusted quoted prices for identical assets in an active market.

Level 2: Quoted prices in markets that are not active or inputs that are observable either directly or indirectly for substantially the full-term of the asset. Level 2 inputs include the following:

• quoted prices for similar assets in active markets,

• quoted prices for identical or similar assets in non-active markets,

• inputs other than quoted market prices that are observable, and

• inputs that are derived principally from or corroborated by observable market data through correlation or other means.

Level 3: Prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. They reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset.

8

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 3—Fair Value of Financial Instruments and Investments—continued

There were no transfers between levels in the fair value hierarchy during any period presented herein. The following table presents the Company’s cash and cash equivalents, and investments and including the hierarchy for its financial instruments measured at fair value on a recurring basis at June 30, 2013 and December 31, 2012:

June 30, 2013	Carrying Amount		Estimated Fair  Value		Level 1		Level 2		Level 3
	(In thousands)
Assets:
Cash and cash equivalents:
Cash	$	18,692	$	18,692	$	18,692	$	—	$	—
Money market funds		19,651		19,651		19,651		—		—
Total cash and cash equivalents		38,343		38,343		38,343		—		—
Short-term investments:
Certificates of deposit		13,131		13,131		13,131		—		—
Restricted cash:
Certificates of deposit		1,655		1,655		1,655		—		—
Total	$	53,129	$	53,129	$	53,129	$	—	$	—
Liabilities:
Embedded derivatives:
Debt redemption features	$	848	$	848	$	—	$	—	$	848
Warrant liability		1,438		1,438		—		—		1,438
Total	$	2,286	$	2,286	$	—	$	—	$	2,286

December 31, 2012	Carrying Amount		Estimated Fair  Value		Level 1		Level 2		Level 3
	(In thousands)
Assets:
Cash and cash equivalents:
Cash	$	14,221	$	14,221	$	14,221	$	—	$	—
Money market funds		36,111		36,111		36,111		—		—
Total cash and cash equivalents		50,332		50,332		50,332		—		—
Short-term investments:
Certificates of deposit		45,949		45,949		45,949		—		—
Restricted cash:
Certificates of deposit		2,430		2,430		2,430		—		—
Total	$	98,711	$	98,711	$	98,711	$	—	$	—
Liabilities:
Embedded derivatives:
Debt redemption features	$	848	$	848	$	—	$	—	$	848
Warrant liability		2,935		2,935		—		—		2,935
Total	$	3,783	$	3,783	$	—	$	—	$	3,783

The Company’s short-term investment in certificates of deposits at June 30, 2013 and December 31, 2012 had maturity dates of less than one year.

Level 3 Valuation

Financial assets or liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable. The following table provides a summary of the changes in fair value of the Company’s financial liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the six-month period ended June 30, 2013:

	Warrant Liability			Debt Redemption Features
	(In thousands)
Level 3
Balance at December 31, 2012		2,935			848
Unrealized gain		(1,497	)		—
Balance at June 30, 2013	$	1,438		$	848

9

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 3—Fair Value of Financial Instruments and Investments—continued

The Company determines the fair value of its warrant liability based on the Black-Sholes pricing model. Historical information is the primary basis for the selection of the expected volatility. The risk-free interest rate is selected based upon yields of United States Treasury issues with a term equal to the expected term of the warrants. The expected term is derived from the remaining contractual term of the warrant. The warrant liability is marked-to-market each reporting period with the change in fair value recorded as a gain or loss within other expense or income, net on the Company’s consolidated statements of operations.

In accordance with FASB ASC 815, Derivatives and Hedging, the Company has separately accounted for certain contingent debt features of its senior secured 2019 Notes, as described more fully in Note 7, as embedded derivative instruments, which are measured at fair value. Changes in the fair value of these embedded derivatives are recognized in earnings as a component of other income, net in the consolidated statements of operations. Key inputs into the valuation model are interest rate volatility, risk-free interest rates, bond yields, credit spreads and certain probabilities determined by management.

Disclosure of Fair Value of Financial Instruments

The Company’s financial instruments mainly consist of cash and cash equivalents, short-term investments, accounts receivable, accounts payable, other current liabilities and debt obligations. The carrying amounts of the Company’s cash equivalents, accounts receivable, current liabilities and accounts payable approximate their fair value due to the short-term nature of these instruments.

At June 30, 2013, $170.9 million in principal amount of the 2019 Notes remained outstanding, which had a carrying value of $132.3 million and a fair value of $118.2 million. The fair value of the 2019 Notes is based upon a binomial-tree model using one of more significant unobservable inputs (Level 3). Key inputs into this valuation model are interest rate volatility, risk-free interest rates, bond yields and credit spreads.

At June 30, 2013, $122.4 million in principal amount of the 2018 Convertible Notes remained outstanding, which had a carrying value of $99.1 million and a fair value of $18.4 million. The fair value of the 2018 Convertible Notes at June 30, 2013 and December 31, 2012 is based upon the quoted market prices (Level 1) at June 30, 2013 and December 31, 2012, respectively.

See Note 7 for further discussion of the 2018 Convertible Notes, the 2019 Notes and the exchange agreement.

Note 4—Inventories

At June 30, 2013 and December 31, 2012, inventories at cost, net of reserves, were as follows:

	June 30, 2013			December 31, 2012
	(In thousands)
Raw materials	$	2,949		$	2,949
Work in progress		6,863			7,331
Finished goods		1,290			1,282
Inventory at cost		11,102			11,562
Inventory reserves		(9,527	)		(7,237	)
Total	$	1,575		$	4,325

Note 5—Property and Equipment, Net

Property and equipment, net at June 30, 2013 and December 31, 2012 is summarized below:

	June 30, 2013			December 31, 2012
	(In thousands)
Office equipment	$	662		$	3,071
Office equipment—capital leases		213			231
Leasehold improvements		1,496			3,015
		2,371			6,317
Accumulated depreciation and amortization		(567	)		(4,267	)
Total	$	1,804		$	2,050

Depreciation and amortization expense was approximately $0.1 million and $0.2 million for each of the three and six-month periods ended June 30, 2013 and 2012, respectively. During the three and six-months periods ended June 30, 2013, the Company wrote-off $4.0 million of fully depreciated fixed assets.

10

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 6—Other Current Liabilities

The components of other current liabilities at June 30, 2013 and December 31, 2012, were as follows:

	June 30, 2013		December 31, 2012
	(In thousands)
Reserve for inventory purchase and other contractual commitments	$	3,821	$	5,174
Salaries, bonuses and related expenses		3,101		6,260
Severance		2,797		683
Returned product liability		1,139		1,139
Accrued royalties		845		1,634
Legal and professional fees		762		720
Allowance for product rebates and other chargebacks		682		239
Manufacturing and technology transfer services		625		839
Allowance for product returns		428		525
Selling and marketing expense accruals		388		1,447
Other		2,131		2,856
Total	$	16,719	$	21,516

Note 7—Long-Term Obligations

The Company’s long-term obligations at June 30, 2013 and December 31, 2012 consist of the following:

	June 30, 2013		December 31, 2012
	(In thousands)
Senior secured notes due 2019 (2019 Notes)	$	132,271	$	125,827
4.75% convertible notes due 2018 (2018 Convertible Notes)		99,053		97,087
Capital leases		202		233
		231,526		223,147
Less-current portion of capital leases		59		60
Total	$	231,467	$	223,087

2019 Notes

In February 2011, the Company issued 2018 Convertible Notes at par value of $230.0 million that become due on February 1, 2018. The Company received cash proceeds from the sale of the 2018 Convertible Notes of $222.7 million, net of expenses. On May 9, 2012, the Company issued its 2019 Notes and warrants (as discussed below) in exchange for a portion of the existing 2018 Convertible Notes and $42.6 million in net cash, after debt financing costs. Certain holders exchanged their 2018 Convertible Notes, having an outstanding principal amount of $107.6 million, for units (the “Units”), comprised of the 2019 Notes, having a principal amount at maturity of $107.9 million and warrants to purchase 4.0 million shares of the Company’s common stock at an exercise price of $1.863 per share. A Unit consists of $1,000 principal amount of the 2019 Notes and Warrants to purchase 23.4 shares of common stock. The 2019 Notes are senior to the 2018 Convertible Notes.

The Units and the 2019 Notes and Warrants comprising the Units were issued by the Company without registration in reliance on the exemption provided by Section 4(2) of the Securities Act of 1933, as amended (the “Securities Act”), and were offered only to qualified institutional buyers and accredited investors. The Units, 2019 Notes and Warrants have not been registered under the Securities Act or any state or other securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. The 2019 Notes and the Warrants comprising the Units became separable 180 days after the date of issuance. The 2019 Notes have a cash coupon interest rate of 3% in the first three years and a cash coupon interest rate of 12% per year thereafter.

The 2019 Notes were issued at a discount and will contractually reach their fully accreted principal amount on May 9, 2015, and will mature on May 9, 2019. At any time prior to May 9, 2015, the Company may redeem all or part of the 2019 Notes at a redemption price equal to 100% of the aggregate principal amount of the 2019 Notes to be redeemed, plus the Applicable Premium (as defined in the Indenture). At any time prior to May 9, 2015, the Company may redeem up to 35% of the aggregate principal amount of the 2019 Notes at a redemption price of 106% of the principal amount of the 2019 Notes to be redeemed, with the net cash proceeds of one or more equity offerings. At any time after May 9, 2015 and before May 9, 2016, the Company may redeem all or part of the 2019 Notes at a redemption price of 106% of the principal amount of the 2019 Notes to be redeemed. At any time after May 9, 2016 and before May 9, 2017, the Company may redeem all or part of the 2019 Notes at a redemption price of 103% of the principal amount of the 2019 Notes to be redeemed. At any time after May 9, 2017 and before maturity, the Company may redeem all or part of the 2019 Notes at a redemption price of 100% of the principal amount of the 2019 Notes to be redeemed. All of the above redemptions include accrued but unpaid interest to the redemption date.

The indenture governing the 2019 Notes, or the 2019 Indenture, contains certain agreements and restrictions, including, but not limited to: (i) restrictions on the Company’s ability to pay dividends, repurchase the Company’s stock, make early payments on indebtedness that is junior to the 2019 Notes, and make certain investments; (ii) an obligation for the Company to repurchase the 2019 Notes at 101% of the aggregate principal amount, at the option of the Holders, in the event of certain asset sales, change-in-control and other fundamental change events described in the 2019 Indenture; and (iii) restrictions on the Company’s ability to incur additional debt and liens.

The 2019 Notes are secured by substantially all of the assets of the Company and by the assets and securities of certain of the Company’s subsidiaries pursuant to a pledge and security agreement dated as of May 9, 2012 subject to certain exclusions described in the Indenture and Pledge and Security Agreement.

11

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 7—Long-Term Obligations—continued

Accounting for the 2019 Notes

The Company has accounted for the 2019 Notes in accordance with the guidance as set forth in FASB ASC 470, Debt and ASC 815 Derivatives and Hedging. Accordingly, the Company recorded a gain of $21.8 million upon the extinguishment of the exchanged 2018 Convertible Notes for Units. The gain resulted from the carrying value of the 2018 Convertible Notes exceeding its fair value. The debt issuance costs related to the 2018 Convertible Notes that were exchanged in the amount of approximately $2.2 million are netted against the gain. In addition, the recording of the gain on extinguishment of debt resulted in a $13.4 million decrease to additional-paid-in-capital. The 2019 Notes were recorded at fair value. The 2019 Notes contain certain redemption features, noted below, that are considered to be embedded derivatives under ASC 815 and require bifurcation from the host debt.

Equity Offering Redemption Right. At any time prior to May 9, 2015, the Company may, at its option, redeem up to 35% of the aggregate principal amount of 2019 Notes at redemption price equal to the equity offering redemption price of such 2019 Notes, as defined in the 2019 Indenture, plus accrued and unpaid interest to the applicable redemption date, with the net cash proceeds of one or more equity offerings (as defined in the 2019 Indenture); provided that at least 65% of the sum of the aggregate principal amount of the securities originally issued under the 2019 Notes remains outstanding immediately after the occurrence of each such redemption; provided further that each such redemption occurs within 90 days of the date of closing of each such equity offering. Notice of any redemption upon any equity offering may be given not less than 30 and not more than 60 days prior to the redemption thereof, and any such redemption or notice may, at the Company’s discretion, be subject to one or more conditions, including, but not limited to, completion of the related equity offering.

Change of Control Redemption Right. In the event of a Fundamental Change, as defined in the 2019 Indenture, which includes certain asset sales and change-in-control, each holder of the 2019 Notes shall have the right, at the holder’s option, to require the Company to repurchase all of the holder’s 2019 Notes at a price equal to 101% of the outstanding principal amount at maturity of the 2019 Notes, or portions thereof plus accrued and unpaid interest.

In accordance with FASB ASC 815, Derivatives and Hedging, the Company has separately accounted for the above redemption features as an embedded derivative, which is measured at fair value and included as a component of other liabilities on the Company’s consolidated balance sheets. Changes in the fair value of the embedded derivative are recognized in earnings.

2018 Convertible Notes

The 2018 Convertible Notes bear cash interest at a rate of 4.75% per year, payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2011. At June 30 2013, the 2018 Convertible Notes may be converted into shares of the Company’s common stock based on an initial conversion rate of 86.6739 shares per $1,000 principal amount of 2018 Convertible Notes. The Company may not redeem the 2018 Convertible Notes prior to February 1, 2015. On or after February 1, 2015 and prior to the maturity date, the Company may redeem for cash all or a portion of the 2018 Convertible Notes at a redemption price equal to 100% of the principal amount of the 2018 Convertible Notes to be redeemed, plus accrued and unpaid interest. This conversion rate will be adjusted if the Company makes specified types of distributions or enters into certain transactions with respect to the Company’s common stock. The 2018 Convertible Notes are unsecured and subordinate to the 2019 Notes.

The 2018 Convertible Notes may only be converted: (1) during any calendar quarter commencing after June 30, 2011 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) during the five business day period after any five consecutive trading day period, or the measurement period, in which the trading price per $1,000 principal amount of 2018 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (3) if the Company calls any or all of the 2018 Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (4) upon the occurrence of specified corporate events. At June 30, 2013, the 2018 Convertible Notes were not convertible.

The principal balance, unamortized discount and net carrying amount of the 2019 Notes and 2018 Convertible Notes at June 30, 2013 and December 31, 2012 are as follows:

	Liability Component (In thousands)
	Principal Balance		Unamortized Discount		Net Carrying Amount
June 30, 2013
Senior secured notes due 2019	$	170,941	$	38,670	$	132,271
4.75% convertible notes due 2018		122,441		23,388		99,053
	$	293,382	$	62,058	$	231,324
December 31, 2012
Senior secured notes due 2019	$	170,941	$	45,114	$	125,827
4.75% convertible notes due 2018		122,441		25,354		97,087
	$	293,382	$	70,468	$	222,914

Total interest expense under the Company’s long-term debt obligations for the three and six-month periods ended June 30, 2013 and 2012 is as follows:

	Three Months Ended June  30,				Six Months Ended June 30,
Total Interest Expense	2013		2012		2013		2012
Accretion of debt discount	$	4,280	$	2,852	$	8,410	$	4,505
Amortization of debt issue costs		217		114		430		287
Non-cash interest expense		4,497		2,966		8,840		4,792
Accrued interest		2,740		2,634		5,476		5,365
Total Interest Expense	$	7,237	$	5,600	$	14,316	$	10,157

12

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 8—Commitments and Contingencies

Commitments

On May 13, 2013, as part of the Company’s effort to continue to reassess and re-evaluate its overall cost structure and to identify additional expense reductions, the Company committed to a plan of termination pursuant to which it reduced its workforce by 27 employees, or approximately 21%. The Company recorded a severance charge of approximately $0.8 million against operations related to this workforce reduction for the three and six-month-periods ended June 30, 2013. During the three and six month-periods ended June 30, 2013, the Company has also entered into severance arrangements with other former employees including the Company’s former President and CEO based on his resignation on June 18, 2013, and recorded additional severance charges of $2.1 million related to these severance arrangements for the three and six-month periods ended June 30, 2013. The Company recorded a severance charge of approximately $0.6 million against operations for the three and six-month-periods ended June 30, 2012.

On January 23, 2012, the Company entered into a lease agreement for office space consisting of approximately 48,000 rentable square feet in Bridgewater, NJ, for the Company’s principal offices and corporate headquarters. The Company relocated all of its operations to the new facility in September 2012. The term of the lease is 123 months, and the Company has rights to extend the term for two additional five-year terms at fair market value subject to specified terms and conditions. The aggregate minimum lease commitment over the 123-month term of the new lease is approximately $15.2 million. The Company has arranged for a bank to provide the landlord a letter of credit of $1.6 million, to secure the Company’s obligations under the lease. The lease agreement includes fixed escalations of minimum annual lease payments and accordingly, the Company records rent expense on a straight-line basis over the lease-term.

The Company’s future annual minimum lease payments for each of the following calendar years are as follows:

June 30, 2013	(In thousands)
Remainder of 2013		710
2014		1,412
2015		1,436
2016		1,460
2017		1,484
Thereafter		6,979
Total minimum payments	$	13,481

Rent expense from operations was approximately $0.4 million and $0.9 million for the three-month periods ended June 30, 2013 and 2012, respectively. Rent expense from operations was approximately $1.2 million and $1.6 million, respectively, for the six-month periods ended June 30, 2013 and 2012.

Contingencies

On April 30, 2012, a creditor derivative action complaint was filed by one of the holders of our 2018 Convertible Notes, Tang Capital Partners, LP, against the Company and certain of its current directors and three former directors in the Court of Chancery of the State of Delaware. On May 21, 2012, Tang Capital amended its complaint to add new claims against the Company and its current and former directors and also to add additional note-holders as plaintiffs. On June 29, 2012, the plaintiffs amended their complaint for a second time to add claims against the Company relating to an alleged event of default under the 2018 Indenture. As with the April 30 and May 21 complaints, the June 29 complaint also alleges, among other things, that the Company is insolvent, and seeks the appointment of a receiver. The Company filed a motion to dismiss the receiver claim in the June 29 complaint on the grounds that the note-holders did not have standing to bring that claim and a motion for summary judgment that an event of default has not occurred under the Company’s convertible notes. On July 23, 2012, the Delaware Court of Chancery issued a memorandum opinion granting both of the Company’s motions. Specifically, the Court determined that the note-holders do not have standing to bring an action to appoint a receiver for the Company and that an event of default has not occurred under the Company’s convertible notes. The Company has moved to dismiss the remaining claims in the June 29 complaint, but that motion has not yet been decided. A hearing on this Motion to Dismiss was held on March 27, 2013. On June 26, 2013, plaintiffs filed a motion seeking entry of a partial final judgment of that portion of the Court of Chancery’s July 23, 2012 memorandum opinion dismissing plaintiffs’ claim for appointment of a receiver in order to seek an appeal in the Delaware Supreme Court. The Court issued a letter opinion on July 12, 2013, directing entry of partial final judgment on that limited issue and further staying considering of the Company’s motion to dismiss the remaining claims pending resolution of any appeal. On July 17, 2013, the Court of Chancery entered an order and partial final judgment. Plaintiffs filed a Notice of Appeal with the Delaware Supreme Court on July 19, 2013. Plaintiffs’ opening appellate brief is due on or before September 3, 2013. Defendants’ appellee answering brief is due thirty (30) days after plaintiffs file their brief, and plaintiffs’ reply brief is due fifteen (15) days thereafter. No oral argument date has been scheduled. On June 8, 2012, the Company filed a cross-complaint against Tang Capital, which it later amended on August 31, 2012. The Company’s amended complaint alleges a claim for breach of a non-disclosure agreement between the Company and Tang Capital and for tortious interference with the Company’s business and contractual relations. The Company’s amended complaint remains outstanding. From time to time, the Company is subject to other legal proceedings and claims in the ordinary course of business. Such claims, even if without merit, could result in significant expenditure of the Company’s financial and managerial resources. The Company is not aware of any legal proceedings or claims that it believes will, individually or in the aggregate, materially harm its business, results of operations, financial condition, liquidity or cash flows.

Note 9—Stockholders’ Equity

On May 9, 2012, the Company issued warrants in connection with the issuance of its 2019 Notes and debt exchange transaction between the Company and certain holders of its 2018 Convertible Notes, described more fully in Note 7. Pursuant to the terms of the transactions, the Company issued warrants to purchase an aggregate of 4.0 million shares of the Company’s common stock at an exercise price equal to $1.863 per share. The Company may, at it’s or the warrant holder’s election, issue net shares in lieu of a cash payment of the exercise price by the warrant holder upon exercise.

Due to an exercise price adjustment clause within the warrant agreement, in accordance with ASC 815, Derivatives and Hedging, the Company is required to record the fair value of the warrants as a liability. The Company’s warrant liability is marked-to-market each reporting period with the change in fair value recorded as a gain or loss within other income or expense, net on the Company’s consolidated statement of operations until the warrants are exercised, expire or other facts and circumstances lead the warrant liability to be reclassified as an equity instrument.

13

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 9—Stockholders’ Equity—continued

The Company determines the fair value of its warrant liability based on the Black-Sholes pricing model. Historical information is the primary basis for the selection of the expected volatility. The risk-free interest rate is selected based upon yields of United States Treasury issues with a term equal to the expected term of the warrants. The expected term is derived from the remaining contractual term of the warrant. At the date of the transaction, the Company recorded the warrant liability at its fair value of $5.3 million with a corresponding decrease to additional-paid-in capital. At June 30, 2013, the fair value of the warrant liability was $1.4 million. In February 2011, the Company issued $230 million principal amount of the 2018 Convertible Notes at par that becomes due on February 1, 2018. As part of the accounting for the 2018 Convertible Notes, the Company bifurcated the conversion feature and recorded $35.6 million to additional paid-in-capital, net of a deferred tax liability of $22.7 million and equity issuance costs of $1.9 million. See Note 7 to the consolidated financial statements for further discussion of the 2018 Convertible Notes.

Note 10—Earnings (Loss) per Common Share

The Company accounts for and discloses net earnings (loss) per share using the treasury stock method. Net earnings (loss) per common share, or basic earnings (loss) per share, is computed by dividing net earnings (loss) by the weighted-average number of common shares outstanding. Net earnings (loss) per common share assuming dilutions, or diluted earnings (loss) per share, is computed by reflecting the potential dilution from the exercise of in-the-money stock options, non-vested restricted stock and non-vested restricted stock units.

At June 30, 2013 and 2012, all in-the-money stock options and unvested restricted stock collectively amounting to 1.4 million and 1.8 million shares, respectively, were excluded from the computation of diluted earnings (loss) per share as their effect would have been anti-dilutive, since the Company reported a net loss for these periods. In addition, at June 30, 2013 warrants to purchase an aggregate of 4.0 million shares of the Company’s Common Stock at an exercise price equal to $1.863 per share in connection with the debt exchange transaction between the Company and certain holders of its 2018 Convertible Notes, described more fully in Note 7, were excluded from the computation of diluted earnings (loss) per share as their effect would have been anti-dilutive, since the Company reported a net loss for the period. At June 30, 2013 and 2012, approximately 9.3 million shares, in each respective period, related to the Company’s 2018 Convertible Notes, calculated “as if” the 2018 Convertible Notes had been converted, were excluded from the computation of diluted earnings (loss) per share as their effect would have been anti-dilutive, since the Company reported a net loss for these periods.

Note 11—Share-Based Compensation

In 2011, the Company adopted its 2011 Incentive Plan, pursuant to which up to an aggregate of 7.75 million shares of the Company’s common stock may be issued. Awards may be granted as incentive and non-statutory stock options, stock appreciation rights, restricted stock awards and restricted stock unit awards, performance-based stock option and restricted stock awards, and other forms of equity-based and cash incentive compensation. Under this plan, 1,216,389 shares remain available for issuance pursuant to future grants at June 30, 2013.

Total compensation cost charged against operations for the three-month periods ended June 30, 2013 and 2012 was $1.1 million and $2.8 million, respectively. Total compensation cost charged against operations for the six-month periods ended June 30, 2013 and 2012 was $2.0 million and $4.0 million, respectively. The following table summarizes the components of share-based compensation expense in the consolidated statements of operations for the three and six-month periods ended June 30, 2013 and 2012:

	Three Months Ended June  30,				Six Months Ended June 30,
	2013		2012		2013		2012
	(In thousands)
Research and development	$	288	$	507	$	539	$	758
Selling, general and administrative		768		2,255		1,477		3,222
Total non-cash compensation expense related to share-based compensation included in operating expense	$	1,056	$	2,762	$	2,016	$	3,980

Stock Options

The weighted-average key assumptions used in determining the fair value of stock options granted for the three and six-month periods ended June 30, 2013 and 2012 were as follows:

	Three Months  Ended June 30,						Six Months  Ended June 30,
	2013			2012			2013			2012
Weighted-average volatility		107.4	%		95	%		106.9	%		94	%
Weighted-average risk-free interest rate		0.9	%		0.8	%		0.8	%		1.0	%
Weighted-average expected life in years		5.0			4.9			4.9			5.4
Dividend yield		0.0	%		0.0	%		0.0	%		0.0	%
Weighted-average grant date fair value per share	$	0.56		$	0.60		$	0.73		$	1.27

Historical information is the primary basis for the selection of the expected volatility of options granted. The risk-free interest rate is selected based upon yields of United States Treasury issues with a term equal to the expected life of the option being valued. The expected term of options granted is derived from the output of a lattice option valuation model and represents the period of time that options granted are expected to be outstanding. The Company uses historical data to estimate option exercise behavior and employee termination within the valuation model.

The Company did not issue any shares of common stock upon the exercise of stock options for the three and six-month periods ended June 30, 2013 and 2012. For the three-month periods ended June 30, 2013 and 2012, approximately $0.4 million and $1.8 million, respectively, of stock option compensation expense was charged against operations. For the six-month periods ended June 30, 2013 and 2012, approximately $1.0 million and $3.1 million, respectively, of stock option compensation expense was charged against operations. As of June 30, 2013, there was $2.7 million of unrecognized compensation cost, adjusted for estimated forfeitures, related to unamortized stock option compensation which is expected to be recognized over a weighted-average period of approximately 1.77 years.

14

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 11—Share-Based Compensation—continued

The following table summarizes the activity related to the Company’s stock options for the six-month period ended June 30, 2013:

	Number  of Shares			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (in yrs)		Aggregate Intrinsic Value of In-the-Money Options
	(In thousands, except weighted-average data)
Outstanding at December 31, 2012		4,027		$	5.16		7.76	$	208
Granted		1,290			0.95		—		—
Exercised		—			—		—		—
Cancelled		(626	)		3.33		—		—
Outstanding at June 30, 2013	$	4,691		$	4.24		7.83	$	—
Exercisable at June 30, 2013		2,200		$	5.89		6.41	$	—

The aggregate intrinsic value in the previous table reflects the total pre-tax intrinsic value (the difference between the Company’s closing stock price on the last trading day of the period and the exercise price of the options, multiplied by the number of in-the-money stock options) that would have been received by the option holders had all option holders exercised their options on June 30, 2013. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s common stock.

Stock Options that Contain Performance and Market-Based Conditions

For the three-month periods ended June 30, 2013 and 2012 the company did not recognize any compensation expense related to stock options that contain performance or market based conditions (“performance options”). For the six-month period ended June 30, 2013 approximately $26,000 of compensation expense related to performance options was charged against operations. For the six-month period ended June 30, 2012 the company recognized approximately $0.5 million of income as a result of reversal of previous recorded performance option related compensation expense. As of June 30, 2013, approximately 871,364 performance options remain unvested.

The following table summarizes the activity related to the Company’s performance options for the six-month period ended June 30, 2013:

	Number  of Shares			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (in yrs)		Aggregate Intrinsic Value of In-the-Money Options
	(In thousands, except weighted-average data)
Outstanding at December 31, 2012		953		$	3.73		9.30	$	74
Granted		—			—		—		—
Exercised		—			—		—		—
Cancelled		(81	)		5.14		—		—
Outstanding at June 30, 2013		872		$	3.60		8.57	$	—
Exercisable at June 30, 2013		476		$	3.73		8.35	$	—

Restricted Stock and Restricted Stock Units

For the three-month periods ended June 30, 2013 the Company did not issue any restricted stock or restricted units. For the three-month period ended June 30, 2012, the Company issued 304,000 shares of restricted stock amounting to approximately $0.2 million in total aggregate fair market value. During the six-month periods ended June 30, 2013 and 2012, the Company issued 641,933 and 1,597,000 shares of restricted stock amounting to $0.6 million and $3.0 million in total aggregate fair market value. For the three-month periods ended June 30, 2013 and 2012, approximately $0.6 million and $0.7 million, respectively, of deferred restricted stock compensation cost was charged against operations. For the six-month periods ended June 30, 2013 and 2012, approximately $1.2 million and $1.3 million, respectively, of deferred restricted stock compensation cost was charged against operations. At June 30, 2013, approximately 1,412,464 shares remained unvested and there was approximately $3.4 million of unrecognized compensation cost related to restricted stock and restricted stock units (“RSU’s”).

15

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 11—Share-Based Compensation—continued

The following table summarizes the activity related to the Company’s restricted stock and RSU’s for the six-month period ended June 30, 2013:

	Number  of Shares			Weighted-Average Grant Date Fair Value Per Share
	(Shares in thousands)
Unvested at December 31, 2012		1,830		$	2.74
Granted		642			0.94
Vested		(866	)		2.39
Forfeited		(194	)		1.58
Unvested at June 30, 2013		1,412		$	2.30

The total grant date fair value of restricted shares vested for the six-month periods ended June 30, 2013 and 2012, was $ 2.1 million and $1.7 million, respectively.

Employee Stock Purchase Plan

In April 1998, the Company adopted its 1998 Employee Stock Purchase Plan (the “1998 ESPP”). The 1998 ESPP is qualified as an employee stock purchase plan under Section 423 of the Internal Revenue Code of 1986, as amended (the “IRC”). Under the 1998 ESPP, the Company granted rights to purchase shares of common stock under the 1998 ESPP (“Rights”) at prices not less than 85% of the lesser of (i) the fair value of the shares on the date of grant of such Rights or (ii) the fair value of the shares on the date such Rights are exercised. Therefore, the 1998 ESPP was considered compensatory under FASB ASC 718 since, along with other factors, it includes a purchase discount of greater than 5%. On March 27, 2013, the Company terminated the 1998 ESPP. For the three and six-month periods ended June 30, 2013, the Company recorded minimal expense related to participation in the 1998 ESPP. For the three and six-month periods ended June 30, 2012, the Company recorded approximately $0.3 million and $0.7 million, respectively, of compensation expense related to participation in the 1998 ESPP.

Note 12—Co-Promotion Revenue

In the first quarter of 2013 the Company entered into an agreement with Swedish Orphan Biovitrum AB (“Sobi”), an international specialty healthcare company dedicated to rare diseases, for the co-promotion of Kineret ^®, a treatment for rheumatoid arthritis, in the U.S. Under the terms of the agreement, Sobi has granted to the Company the exclusive right to co-promote the sale of Kineret with Sobi in the U.S. The Company began marketing and promoting Kineret on April 1, 2013. The Company earns a co-promotion fee based on incremental gross profit earned from Kineret in a year as compared to a baseline year. The Company is obligated to perform an agreed upon sales call plan utilizing its current sales representatives. Pursuant to the terms of the agreement, the fee is subject to adjustment by Sobi if the Company fails to meet certain prescribed minimum Kineret product presentation requirements in a given sales quarter.

16

SAVIENT PHARMACEUTICALS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS—Continued

(Unaudited)

Note 13—Income Taxes

The State of New Jersey provides the Technology Business Tax Certificate Transfer Program enabling approved unprofitable biotechnology businesses to sell their unused New Jersey net operating loss carryforwards and other tax attributes to unaffiliated, profitable corporate taxpayers operating in the State of New Jersey, for cash. The Company has participated in this program and sold state tax benefits totaling $2.4 million during the quarter ended March 31, 2013. The attributes sold were New Jersey net operating losses generated during 2007 and 2008. The Company received a cash payment of $2.2 million in connection with the transaction. This amount is reflected in the financial statements as a state tax benefit.

The total amount of federal, foreign, state and local unrecognized tax benefits was $2.7 million at June 30, 2013 and $2.7 million at December 31, 2012. Interest and penalty expense has not been accrued as the company has significant tax benefits to utilize if the liability is actually realized.

The Company files income tax returns in the United States, Ireland and various state jurisdictions. The Company’s federal tax returns have been audited by the Internal Revenue Service through fiscal year ended December 31, 2008. State income tax returns are generally subject to examination for a period of three to five years subsequent to the filing of the respective tax return. The Company is not currently being audited by any state taxing jurisdiction.

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and their basis for income tax purposes and the tax effects of capital loss, net operating loss and tax credit carryforwards. Valuation allowances reduce deferred tax assets to the amounts that are more likely than not to be realized. At June 30, 2013, the Company has recorded additional deferred tax assets which are fully offset by a valuation allowance. Realization of the deferred tax assets is dependent on generating sufficient taxable income in the future. At present, the likelihood of the Company being able to fully realize its deferred income tax benefits against future income is uncertain. For further details of the deferred tax assets and related valuation allowance, please refer to the Company’s 2012 Annual Report on Form 10-K.

Note 14—Other income, Net

The Company’s other income, net for the three and six-month periods ended June 30, 2013 and 2012, was as follows:

	Three Months  Ended June 30,						Six Months Ended June 30,
	2013			2012			2013			2012
	(In thousands)
Unrealized gain on change in fair value of warrant liability	$	752		$	3,792		$	1,497		$	3,792
Foreign currency transaction gains (losses)		259			(273	)		40			(257	)
Other non-operating expenses		(17	)		(6	)		(37	)		(22	)
Total other income, net	$	994		$	3,513		$	1,500		$	3,513

17

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report on Form 10-Q and, in particular, this management’s discussion and analysis of financial condition and results of operations, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. All statements contained in or incorporated by reference into this report, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future results of operations, future cash flows, future actions, future performance, projected costs and expenses, financing plans, product development, commercialization of KRYSTEXXA, possible strategic alliances, projections for current alliances, co-promotes and partnerships, competitive position, prospects, plans and objectives of management, are forward-looking statements. We often use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “may,” “predict,” “will,” “would,” “could,” “should,” “target” and similar expressions, to identify forward-looking statements. These forward-looking statements include, among others, statements relating to the success of our marketing efforts and our ability to commercialize KRYSTEXXA, market demand and our ability to gain market acceptance for KRYSTEXXA among physicians, patients, health care payors and others in the medical community, our plans in the European Union and the rest of the world, the potential for our entering into partnering or collaboration arrangements to commercially launch KRYSTEXXA in the European Union under the marketing authorization received from the European Commission and in the rest of the world, the ability of any partner we may have to gain market acceptance for KRYSTEXXA among physicians, patients, health care payors and others in the medical community within their territory, market acceptance of reimbursement risks with third-party payors generally and in particular following price increase actions, the risk that the market for KRYSTEXXA in the United States, European Union and other regions, is smaller than we have anticipated, our plans for the expansion of clinical utility for KRYSTEXXA, our ability to service our outstanding debt, fund our operations and raise additional capital needed to achieve our business objectives, our reliance on third parties to market, distribute and sell KRYSTEXXA outside the United States, our reliance on third parties to manufacture KRYSTEXXA, and our ability to meet the stringent regulatory requirements governing the biopharmaceutical industry.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We have included important factors in various cautionary statements in this report, including in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make.

You should read this report completely and with the understanding that our actual future results may be materially different from what we expect. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.

Overview

We are a specialty biopharmaceutical company focused on commercializing KRYSTEXXA (pegloticase) throughout the world. KRYSTEXXA was approved for marketing by the U.S. Food and Drug Administration, or FDA, on September 14, 2010 and became commercially available in the United States by prescription on December 1, 2010, when we commenced sales and shipments to our network of specialty and wholesale distributors. On January 8, 2013, our wholly owned subsidiary, Savient Pharma Ireland Limited, was granted a marketing authorization from the European Commission for KRYSTEXXA to be marketed in the European Union, or EU. At this time we cannot estimate the timeline for commercial availability of KRYSTEXXA in the EU and other regions around the world as we require partners or collaborators in order to commercialize the product in those regions. To date, our efforts to commercialize KRYSTEXXA in the EU have not resulted in a partnership or collaboration opportunity that is commercially viable. As a result, we do not expect commercial availability of KRYSTEXXA in the EU in the near term and, while we will continue to explore options for the EU and the rest of the world, we will be focusing our efforts on the commercialization of KRYSTEXXA in the U.S. Additionally, on May 2, 2013, we received a Final Appraisal Determination, or FAD, from the National Institute for Health and Care Excellence, or NICE, of England, in which NICE did not recommend KRYSTEXXA for use by the NHS in England and Wales. NICE agrees that KRYSTEXXA is an effective agent for the treatment of chronic tophaceous gout when used under the approved guidelines for use, however, NICE found that KRYSTEXXA would not be a cost-effective use of NHS resources.

On February 19, 2013, we announced that we entered into an agreement with Swedish Orphan Biovitrum AB, or Sobi, an international specialty healthcare company dedicated to rare diseases, for the co-promotion of Kineret^®, a treatment for rheumatoid arthritis, in the U.S. Under the terms of the agreement, Sobi has granted to us the exclusive right to co-promote the sale of Kineret with Sobi in the U.S. and we began to market and promote Kineret beginning April 1, 2013. We earn a co-promotion fee from this arrangement based upon fifty percent of incremental gross profit earned from Kineret in a year as compared to 2012 adjusted gross profit as the base year.

KRYSTEXXA is indicated in the United States for the treatment of chronic gout in adult patients refractory to conventional therapy, a condition that we refer to as refractory chronic gout, or RCG. RCG occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia, an elevation of blood concentration of uric acid not associated with gout. The active pharmaceutical ingredient, or API, in KRYSTEXXA is a PEGylated uric acid specific enzyme that converts uric acid to allantoin, which is readily eliminated primarily through the kidney. We believe that treatment with KRYSTEXXA provides clinical benefits by dramatically decreasing uric acid in the blood and tissue deposits of urate.

Determining the market size for KRYSTEXXA is difficult to predict with accuracy. In the first half of 2011, we completed what we refer to as the KRYSTEXXA Market Study in collaboration with a leading independent life science consulting firm. This comprehensive market research study, completed using both secondary data sources and primary market research, indicated that there are approximately 120,000 RCG patients in the United States, or approximately 4.2% of the overall annual treated gout population in the United States. However, through further work we have determined that not all of these patients are engaged in the healthcare system and if engaged in the healthcare system, are not seeking treatment with Rheumatologists which is the physician specialty on whom we currently concentrate most of our commercial efforts. Additionally, we estimate that only between 20,000 and 40,000 of the most severe RCG patients in the United States are being treated by the Rheumatologists that we currently target, and that, according to a follow-on study completed in June 2013, only approximately 9,000 of these patients are seen by Rheumatologists most likely to prescribe KRYSTEXXA. Ultimately, the total available market opportunity for KRYSTEXXA and our ability to penetrate that market will depend on, among other things, our patient and physician education programs, our marketing and sales efforts, reimbursement environment, market acceptance by physicians, infusion site personnel, healthcare payors and others in the medical community, referrals by various specialty physicians and those in family practice to administering clinicians, and our financial resources to support commercialization activities.

We believe that the clinical community and payors will continue to see the value of KRYSTEXXA and that there is a certain amount of price inelasticity for the product. Since the beginning of 2012, we increased the selling price of KRYSTEXXA by approximately 134% from the original list price of $2,300 per 8 mg vial to, most recently, $5,390 per 8 mg vial, effective May 17, 2013.

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On July 9, 2012, we initiated a reorganization plan which includes organizational changes designed to improve our operational efficiencies while ensuring continued focus on the commercialization of KRYSTEXXA and the advancement of our clinical development programs. As part of the initiative, we decreased our work-force by approximately 35%, including vacancies, effective September 10, 2012. On May 13, 2013, we committed to a plan of termination pursuant to which 27 employees, or approximately 21% of the current workforce, were terminated. We incurred a charge of approximately $0.8 million against operations in the second quarter of 2013 for the cost of these terminations. As we proceed forward with the commercialization of KRYSTEXXA, we may adjust the size of our organization as necessary. On May 21, 2013, we initiated an additional reorganization plan that resulted from our reassessment of our domestic and international operation. As part of this plan, we have initiated significant non-labor related cost savings initiatives across commercial, research and development and general and administrative functional areas. Additionally, during the second quarter of 2013, we also entered into severance arrangements with other former employees including our former President and CEO based on his resignation on June 18, 2013, and recorded additional severance charges of $2.1 million related to these severance arrangements. We expect that our July 2012 and May 2013 reorganization plans will generate significant operating expense savings during 2013 and thereafter, by reducing workforce and non-workforce related operating expenses across all functional areas.

Our sales force targets rheumatologists and nephrologists with access to infusion centers and healthcare institutions, each of which treat adult patients suffering from RCG, as well as podiatrists who may also refer patients with RCG. To date, our U.S. sales force has reached the majority of key rheumatologists and nephrologists located in private practices, infusion centers, hospitals, academic institutions and U.S. Department of Veterans Affairs, or the VA, medical centers. However, we believe that sales of KRYSTEXXA have been hampered by the lack of information that was available to prescribers at the time of the commercial launch of KRYSTEXXA and concerns over Medicare Part B reimbursement. In an effort to address the lack of information available to prescribers, in August 2011, we published data from our two pivotal KRYSTEXXA Phase 3 clinical trials in patients with RCG in the Journal of the American Medical Association, or JAMA. The data published in JAMA demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial percentage of RCG patients for six months, a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies. The data published also included a summary of adverse events that occurred in at least 5% of the patients in the trial. In addition, a manuscript showing the improvement in patient-reported outcomes following treatment with KRYSTEXXA was published in the June 27, 2012 Journal of Rheumatology. Unlike the objective end points of a clinical trial, such as the lowering of serum uric acid, patient reported outcomes measure subjective aspects, such as reduction in pain, or improvement in the patient’s quality of life.

During the first quarter of 2012, we updated our clinical development plan for KRYSTEXXA and are undertaking a targeted and focused approach to expanding the clinical utility of KRYSTEXXA into populations beyond RCG. For example, a significant number of severe gout patients have underlying chronic renal disease that can affect treatment options. Clinicians are reluctant to use conventional urate lowering agents in patients with significant renal disease and when they do use them, it is often in doses that have little effect on serum uric acid levels. Further, in patients with gout who have undergone solid organ transplantation, including renal transplantation, the use of conventional urate lowering treatments is actually contraindicated in many of those patients receiving certain types of immunosuppressive agents. Certain results observed in the Phase 3 clinical trials for KRYSTEXXA predict the efficacy treatment with KRYSTEXXA in these circumstances. In view of these findings, a key area of focus for our clinical development plan will be to confirm that KRYSTEXXA is not dialyzable. A study looking at the use of KRYSTEXXA in patients undergoing renal dialysis has been completed and the data will be presented at major congresses this fall. We are also interested in exploring whether KRYSTEXXA can be used safely and effectively in patients with gout who have undergone solid organ transplantation. We believe these are areas of significant unmet medical needs in view of the difficulties with conventional urate lowering therapies, or ULTs, in these populations.

We believe there could be potential to mitigate the antibody formation that occurs to the molecule. This could be explored via an immunogenicity clinical trial that would test a new dosing schedule designed to induce a high zone tolerance. We believe that it will further reduce the incidence of infusion reactions and increase the number of patients who maintain their response to KRYSTEXXA over the long term. In the Phase 3 clinical development program, 42% of patients maintained their response to KRYSTEXXA over the six-month period of the trials. Many of the patients who discontinued participation in these trials lost their therapeutic response due to the development of high-titer antibodies. If a potential immunogenicity trial were successful, we believe fewer patients would develop high-titer antibodies and thereby would be better able to maintain their therapeutic response over a longer period of time. We have decided to delay moving forward with this clinical trial until our financial resources are sufficient to fund the significant costs involved to administer this study.

In addition, there is a large pool of patients who have severe tophaceous gout who fall outside of the RCG population primarily because their conventional ULT therapy is not at a maximum dose. The KRYSTEXXA Market Study indicated that approximately 500,000 to 700,000 patients in the U.S. currently have tophaceous gout and uncontrolled uric acid levels but were not considered in the RCG market because their conventional ULT therapy is not at a maximum dose. However, because of the size and/or location of their tophi, their physical functioning is impaired. Because KRYSTEXXA rapidly lowers serum uric acid levels and has a significant and rapid effect on reducing tophi and total body urate stores, we believe these patients can benefit from an induction / maintenance therapy with KRYSTEXXA and ULT’s. While a Phase 4 clinical study to examine the use of KRYSTEXXA as an induction (debulking) therapy in patients with severe tophaceous gout is a possible future strategy for expanding the market opportunity for KRYSTEXXA, we have decided to delay moving forward with this clinical trial until our financial resources are sufficient to fund the significant costs involved to administer this study.

Data from our open label long term extension trial was published in Annals of Rheumatic Disease on-line on November 10, 2012. This article provides key clinical data on patients who received KRYSTEXXA for up to an additional 30 months and is critical for clinicians as they better understand the clinical benefits of long-term KRYSTEXXA use for their patients and how to manage possible side effects. Additionally, a review article on RCG and the use of pegloticase was published in the April 2012 issue of the International Journal of Clinical Rheumatology. Furthermore, an appraisal of the role of pegloticase in the management of gout was published in the 2012 issue of Open Access Rheumatology: Research and Reviews. Finally, a review article on the evaluation and treatment of gout as a chronic disease was published on-line in the journal Advances in Therapy in October 2012. This article describes the population with refractory chronic gout and the role pegloticase plays in the treatment of this condition.

In June 2012, we presented data at an oral session conducted by the European League Against Rheumatism, or EULAR, congress that demonstrated that patients with RCG who also suffer from chronic kidney disease, or CKD, stages one through four, responded to treatment with KRYSTEXXA. We believe this is a significant finding as there are currently limited treatment options available for refractory chronic patients with CKD because impaired kidney function can reduce the ability of conventional gout treatments to lower uric acid and decrease a patient’s threshold for treatment-related toxicity. Six additional abstracts, including a study measuring the impact of gout pain on quality of life in Western Europe, were accepted for presentation or publication at EULAR.

In November 2012, we presented the following eight posters related to KRYSTEXXA at the American College of Rheumatology, or ACR:

• Complete Tophus Response in Patients with Chronic Gout Initiating Pegloticase Treatment,

• Clinical Efficacy Outcomes with Up to 3 Years of Pegloticase Treatment for Refractory Chronic Gout,

• Improvements in Long-Term Health-Related Quality of Life in Chronic Gout Patients Refractory to Conventional Therapies Treated with Pegloticase: Results from Responder Cohort,

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• Patterns of Gout Treatment and Related Outcomes in US Community Rheumatology Practices: the Relation Between Gout Flares, Time in Treatment, Serum Uric Acid Level and Urate Lowering Therapy,

• Pegloticase Long-Term Safety: Data from the Open Label Extension Trial,

• Post-Marketing Safety Surveillance Data Reveals Patterns of Use for Pegloticase in Refractory Chronic Gout,

• Relative Risk of Infusion Reactions with KRYSTEXXA^® (pegloticase) from Post-Approval Safety Data: Results from Sept 2010 to June 2012, and

• Serum Uric Acid as a Biomarker for Mitigation of Infusion Reactions in Patients Treated with Pegloticase for Refractory Chronic Gout.

At the June 2013 EULAR meeting, two abstracts were presented highlighting the post-marketing safety data for KRYSTEXXA. We have submitted six abstracts for presentation at the 2013 ACR meeting in October and submitted one abstract for presentation at the American Society of Nephrology later this year.

On January 1, 2012, KRYSTEXXA received a permanent J Code, which facilitates reimbursement to providers who treat patients suffering with RCG and who rely on Medicare and Medicaid. We were also awarded a contract from the U.S. Veterans Administration, or VA, which covered KRYSTEXXA reimbursement for VA member patients as of April 1, 2011 at an approximate 24% discount to our original list selling price of $2,300 per 8 mg vial. On May 17, 2013, we increased the list selling price of KRYSTEXXA to $5,390 per 8 mg vial and VA member patients now receive an approximate 71% discount to our list price. We expect that this discount will increase in the future contingent on price actions that we may take. The VA has also recently issued a KRYSTEXXA monograph and criteria for use. In addition, KRYSTEXXA currently enjoys broad coverage for RCG patients through managed care and private payor organizations. Also, ACR published their treatment guidelines for gout and KRYSTEXXA was included in these guidelines. In six of nine case scenarios defined by ACR, KRYSTEXXA is considered an appropriate therapeutic option for treatment of refractory disease.

In June 2011, we implemented the KRYSTEXXA Patient Initiation Program, or KPIP, which provided RCG patients with two free doses of KRYSTEXXA. We believe that this initiative allows patients to begin therapy and experience the potential benefits of KRYSTEXXA with no or minimal out of pocket expense.

We have built an inventory of finished KRYSTEXXA product for the United States market at June 30, 2013 that is packaged and labeled for distribution, and have on hand additional supplies of drug product that are scheduled to be packaged and labeled as part of our ongoing approved commercial manufacturing process. Based on our inventory on hand and in process, we believe we have sufficient inventory to meet our internal market estimates until at least the second quarter of 2014.

On January 8, 2013, our wholly owned subsidiary, Savient Pharma Ireland Limited, was granted a marketing authorization from the European Commission for KRYSTEXXA in the EU, for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. As part of the marketing authorization received from the European Commission on January 8, 2013, we are responsible for certain post-marketing commitment clinical trials primarily designed to further examine the safety of KRYSTEXXA. The post-marketing commitment clinical trials required under the marketing authorization and are estimated to cost between $25 million and $30 million over a period of approximately five years. However, because we do not currently have a viable opportunity to commercialize KRYSTEXXA in the EU, and given our lack of capital resources and infrastructure in the EU, on May 28, 2013 we informed the Committee for Medicinal Products for Human Use (CHMP) that some of the commitments will not commence until Krystexxa is commercialized in the EU.

We do not have infrastructure in the EU that is capable of handling the commercial launch and distribution of KRYSTEXXA, nor do we have plans to create such infrastructure. We have therefore been pursuing an examination of various collaboration and partnership opportunities for the commercial launch and distribution of KRYSTEXXA in the EU. Identifying commercially viable EU collaboration and partnering opportunities has proved to be challenging. Potential collaborators and partners have had difficulty assessing the potential market size in the EU, given the slower than originally projected commercial uptake in the United States. Additionally, the cost and infrastructure commitment needed to complete the post marketing commitment clinical trials and the uncertainties surrounding the indicated potential price per vial in the member countries of the EU have also added complications to these discussions. As a result, we do not expect to commercialize KRYSTEXXA in the EU in the near term and we cannot estimate whether we will identify opportunities to commercialize KRYSTEXXA in the EU in the longer term. Given the above developments relating to KRYSTEXXA in Europe, we are and will be significantly moderating our expenditures in the region unless and until such time as there is greater certainty regarding commercialization timing in the region.

We also sell and distribute branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. We launched our authorized generic version of oxandrolone in December 2006 in response to the approval and launch of generic competition to our branded product, Oxandrin^® . The introduction of oxandrolone generics has led to significant decreases in demand for Oxandrin and our authorized generic version of oxandrolone. We believe that revenues from Oxandrin and our authorized generic version of oxandrolone will continue to decrease in future periods primarily as a result of the expiration of our contract agreement with our third-party manufacturer. We do not actively market and do not plan to seek a new third-party manufacturer of Oxandrin or oxandrolone.

On May 9, 2012, certain holders of our currently outstanding 2018 Convertible Notes exchanged approximately $108.0 million (principal amount) of such notes for Units, comprised of 2019 Notes, having a principal amount upon full accretion equivalent to the principal amount of the corresponding exchanged 2018 Convertible Notes, and warrants to purchase approximately 4.0 million shares of our common stock at an exercise price of $1.863 per share. The 2019 Notes were recorded at a 26.22% discount to par. In addition to the accretion of principal, the 2019 Notes have a cash coupon interest rate of 3% in the first three years and a cash coupon interest rate of 12% per year thereafter until their maturity date. The 2019 Notes contractually reach their fully accreted principal amount on May 9, 2015, and will mature on May 9, 2019. Simultaneously, the holders of the 2018 Convertible Notes which were exchanged also purchased additional Units, comprised of 2019 Notes and warrants, the purchase price of which was $46.8 million. The principal amount of the 2019 Notes issued upon the exchange of the 2018 Convertible Notes, plus the 2019 Notes issued to the holders upon purchase of the additional Units, is $170.9 million. The 2019 Notes are secured by substantially all of our assets and by the assets and securities of certain of our subsidiaries. We received net cash proceeds after expenses from this financing transaction of $42.6 million.

We currently operate within one “Specialty Pharmaceutical” segment, which includes the sales and research and development of KRYSTEXXA, co-promotion activities for Kineret and sales of Oxandrin and oxandrolone. Total revenues were $6.7 million for the three months ended June 30, 2013, an increase of $2.1 million, or 44%, from $4.6 million for the three months ended June 30, 2012.

Recent Changes in our Senior Management

On June 18, 2013, our board of directors (the “Board”) formed an Office of the President, consisting of Richard Crowley, who is serving as Co-President and Chief Operating Officer, John P. Hamill, who is serving as Co-President and Chief Financial Officer and Philip K. Yachmetz who is serving as Co-President and Chief Business Officer, upon the departure of Louis Ferrari, who resigned as President, Chief Executive Officer and director on the same day.

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Results of Operations

For six-month period ended June 30, 2013, our operating results were substantially driven by expenses related to the commercialization of KRYSTEXXA. We anticipate net operating losses for the remainder of 2013 and the foreseeable future as we continue to commercialize and develop KRYSTEXXA. Our expenses relating to the commercialization and development of KRYSTEXXA will depend on many factors, including:

• the cost of commercialization activities, including product marketing, sales and distribution,

• the cost of our post-approval commitments to the FDA and European Commission, as applicable,

• the timing of, and the costs involved in, obtaining regulatory approvals for KRYSTEXXA in countries other than the U.S. and EU,

• the cost of manufacturing activities, and

• clinical development for label expansion.

Our net revenues of $11.4 million for the six-month period ended were derived primarily from product sales of KRYSTEXXA.

Our future revenues depend on our success in the commercialization of KRYSTEXXA including:

• whether we are successful in executing our commercial strategy for KRYSTEXXA,

• market acceptance of KRYSTEXXA by physicians and patients in the largely previously untreated RCG patient population,

• market acceptance of the price that we charge for KRYSTEXXA and under what conditions private and public payors will reimburse patients for KRYSTEXXA,

• whether and to what extent our label expansion activities for KRYSTEXXA are successful,

• whether and when we face generic or other competition with respect to KRYSTEXXA, and

• the timing and costs related to the commercial launch of KRYSTEXXA in the EU, as applicable.

Our future revenues will also be impacted by our ability to expand our product offerings beyond KRYSTEXXA.

The following table summarizes net product sales and co-promotion revenue and their percentage of total revenues for the periods indicated:

	Three Months Ended June 30,								Six Months Ended June 30,
	2013				2012				2013				2012
	(In thousands)
KRYSTEXXA	$	6,084	91.3	%	$	3,997	86.4	%	$	10,484	92.3	%	$	7,065	86.6	%
Oxandrolone		103	1.6	%		544	11.8	%		277	2.4	%		966	11.8	%
Oxandrin		93	1.4	%		85	1.8	%		211	1.9	%		129	1.6	%
Product sales, net		6,280	94.3	%		4,626	100.0	%		10,972	96.6	%	$	8,160	100.0	%
Co-promotion revenues		382	5.7	%		—	—	%		382	3.4	%		—	—	%
Total Revenues	$	6,662	100.0	%	$	4,626	100.0	%	$	11,354	100.0	%	$	8,160	100.0	%

The following table summarizes our costs and expenses and indicates the significance of selling, general and administrative costs related to our commercialization of KRYSTEXXA, as well as percentage of total cost of expenses for the periods indicated:

	Three Months Ended June 30,								Six Months Ended June 30,
	2013				2012				2013				2012
	(In thousands)
Cost of goods sold	$	2,038	7.9	%	$	6,727	16.5	%	$	5,588	11.0	%	$	8,447	11.4	%
Research and development		6,026	23.3	%		6,705	16.5	%		12,160	24.0	%		13,951	18.9	%
Selling, general and administrative		17,807	68.8	%		27,327	67.0	%		32,963	65.0	%		51,579	69.7	%
Total costs and expenses	$	25,871	100.0	%	$	40,759	100.0	%	$	50,711	100.0	%	$	73,977	100.0	%

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Results of Operations for the Three-Month Periods Ended June 30, 2013 and June 30, 2012

Revenues

Total net revenues increased $2.1 million, or 44%, to $6.7 million for the three-month period ended June 30, 2013, from $4.6 million for the three-month period ended June 30, 2012, primarily driven by higher KRYSTEXXA net sales.

KRYSTEXXA net sales increased $2.1 million, or 52%, to $6.1 million for the three-month period ended June 30, 2013, from $4.0 million for the three-month period ended June 30, 2012. The increase in KRYSTEXXA net sales is substantially due to the impact of our price increases for the product and to a lesser extent, an increase in year over year sales volume. Since the beginning of 2012, we increased the selling price of KRYSTEXXA by approximately 134% from the original list price of $2,300 per 8 mg vial to, most recently, $5,390 per 8 mg vial, effective May 17, 2013. We sold 2,058 vials and 1,883 vials of KRYSTEXXA during the three-month periods ended June 30, 2013 and 2012, respectively, an increase of 9% year over year. In addition, we sold 1,624 vials and 1,987 vials of KRYSTEXXA during the three-month periods ended March 31, 2013 and December 31, 2012, respectively.

Sales of Oxandrin and our authorized generic version of Oxandrin, oxandrolone, decreased $0.4 million, or 69%, to $0.2 million for the three-month period ended June 30, 2013, from $0.6 million for the three-month period ended June 30, 2012. We expect that sales of Oxandrin and oxandrolone will continue to decline in future periods due to the continued impact of generic competition coupled with the expiration of our agreement with our third-party manufacturer of these products. We do not plan to seek a new third-party manufacturer of Oxandrin and oxandrolone and we are not actively marketing these products.

Co-promotion revenue of $0.4 million for the three-month period ended June 30, 2013 reflects revenue from Kineret based our agreement with Sobi, in the first quarter of 2013, through which Sobi has granted to us the exclusive right to co-promote the sale of Kineret with Sobi in the U.S. We began marketing and promoting Kineret on April 1, 2013. Under the terms of the agreement, we earn a co-promotion fee from this arrangement based upon fifty percent of incremental gross profit earned from Kineret in a year as compared to 2012 adjusted gross profit as the base year.

Cost of goods sold

Cost of goods sold decreased $4.7 million, or 70%, to $2.0 million for the three-month period ended June 30, 2013, from $6.7 million for the three-month period ended June 30, 2012. The decrease is primarily due to a $4.9 million charge against operations for the three-month period ended June 30, 2012, primarily related to in process and finished goods KRYSTEXXA inventory that we did not believe we will be able to sell through to commerce, prior to expiration. A portion of the charge also related to certain future minimum purchase commitments of raw material for use in manufacturing of KRYSTEXXA finished product that we did not believe will be required based upon future estimated production levels.

Research and development expenses

Research and development expenses decreased $0.7 million, or 10%, to $6.0 million for the three-month period ended June 30, 2013, from $6.7 million for the three-month period ended June 30, 2012. The decrease is primarily due to lower expenses related to the timing of incurring post marketing commitment costs for KRYSTEXXA in the U.S. partially offset by approximately $0.3 million in severance charges for the three-month period ended June 30, 2013, which reflects our recent plan of termination as a result of our continuing efforts to reassess and re-evaluate our overall cost structure and to identify significant additional expense reductions.

Selling, general and administrative expenses

Selling, general and administrative expenses decreased $9.5 million, or 35%, to $17.8 million for the three-month period ended June 30, 2013, from $27.3 million for the three-month period ended June 30, 2012. The decrease in expense is substantially due to lower marketing, promotion and compensation costs, resulting from our July 2012 reorganization plan partially offset by approximately $4.9 million in severance charges and other reorganization expenses for the three-month period ended June 30, 2013, reflecting our recent plan of termination as a result of our continuing efforts to reassess and re-evaluate our overall cost structure and to identify significant additional expense reductions.

Interest expense on Debt

Interest expense on our debt increased $1.6 million, or 29%, to $7.2 million for the three-month period ended June 30, 2013, from $5.6 million for the three-month period ended June 30, 2012, as a result of additional interest due on our 2019 Notes, which were issued on May 9, 2012. Interest expense for the three-month period ended June 30, 2013 reflects $2.7 million of coupon interest expense and $4.5 million of non-cash interest expense. Interest expense for the three-month period ended June 30, 2012, reflects $2.6 million of coupon interest expense and $3.0 million of non-cash interest expense.

Other income, net

Other income, net decreased $2.5 million, or 72%, to $1.0 million for the three-month period ended June 30, 2013, from $3.5 million for the three-month period ended June 30, 2012. The decrease is primarily driven by the year-over-year variance related to the change in the mark-to-market valuation adjustment of our warrant liability. For the three-month periods ended June 30, 2013 and 2012, we recorded gains of $0.8 million and $3.8 million, respectively, from the decrease in the fair value of our warrant liability due to the lower underlying price of our common stock resulting in a year-over-year decrease in other income, net of $3.0 million. The decrease is offset by the period-to-period effect of foreign currency gains (losses). For the three-month periods ended June 30, 2013 and 2012, we recorded a gain of $0.3 million and a loss of $0.2 million, respectively, resulting in a year-over-year increase in other income, net of $0.5 million.

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Results of Operations for the Six-Month Periods Ended June 30, 2013 and June 30, 2012

Revenues

Total net revenues increased $3.2 million, or 39%, to $11.4 million for the six-month period ended June 30, 2013, from $8.2 million for the six-month period ended June 30, 2012, primarily driven by higher KRYSTEXXA net sales.

KRYSTEXXA net sales increased $3.4 million, or 48%, to $10.5 million for the six-month period ended June 30, 2013, from $7.1 million for the six-month period ended June 30, 2012. The increase in KRYSTEXXA net sales is substantially due to the impact of our price increases for the product and to a lesser extent, an increase in year over year sales volume. Since the beginning of 2012, we increased the selling price of KRYSTEXXA by approximately 134% from the original list price of $2,300 per 8 mg vial to, most recently, $5,390 per 8 mg vial, effective May 17, 2013. We sold 3,682 vials and 3,387 vials of KRYSTEXXA during the six-month periods ended June 30, 2013 and 2012, respectively, an increase of 9% year over year.

Sales of Oxandrin and our authorized generic version of Oxandrin, oxandrolone, decreased $0.6 million, or 55%, to $0.5 million for the six-month period ended June 30, 2013, from $1.1 million for the six-month period ended June 30, 2012. We expect that sales of Oxandrin and oxandrolone will continue to decline in future periods due to the continued impact of generic competition coupled with the expiration of our agreement with our third-party manufacturer of these products. We do not plan to seek a new third-party manufacturer of Oxandrin and oxandrolone and we are not actively marketing these products.

Co-promotion revenue of $0.4 million for the six-month period ended June 30, 2013 reflects revenue from Kineret based our agreement with Sobi, in the first quarter of 2013, through which Sobi has granted to us the exclusive right to co-promote the sale of Kineret with Sobi in the U.S. We began marketing and promoting Kineret on April 1, 2013. Under the terms of the agreement, we earn a co-promotion fee from this arrangement based upon fifty percent of incremental gross profit earned from Kineret in a year as compared to 2012 adjusted gross profit as the base year.

Cost of goods sold

Cost of goods sold decreased $2.8 million, or 34%, to $5.6 million for the six-month period ended June 30, 2013, from $8.4 million for the six-month period ended June 30, 2012. The decrease is primarily driven by the year-over-year variance related to charges for inventory obsolescence and raw materials commitments. For the six-month periods ended June 30, 2013 and 2012, we recorded charges of $2.4 million and $4.9 million, respectively, against operations, resulting in a year-over-year decrease in cost of goods sold of $2.5 million, primarily related to in process and finished goods KRYSTEXXA inventory that we do not believe we will be able to sell through to commerce, prior to expiration. A portion of these charges relates to certain future minimum purchase commitments of raw material for use in manufacturing of KRYSTEXXA finished product that we do not believe will be required based upon future estimated production levels.

Research and development expenses

Research and development expenses decreased $1.8 million, or 13%, to $12.2 million for the six-month period ended June 30, 2013, from $14.0 million for the six-month period ended June 30, 2012. The decrease is primarily due to lower expenses related to the timing of incurring post marketing commitment costs for KRYSTEXXA in the U.S. partially offset by approximately $0.3 million in severance charges for the three-month period ended June 30, 2013, which reflects our recent plan of termination as a result of our continuing efforts to reassess and re-evaluate our overall cost structure and to identify significant additional expense reductions.

Selling, general and administrative expenses

Selling, general and administrative expenses decreased $18.6 million, or 36%, to $33.0 million for the six-month period ended June 30, 2013, from $51.6 million for the six-month period ended June 30, 2012. The decrease in expense is substantially due to lower marketing, promotion and compensation costs, resulting from our July 2012 reorganization plan partially offset by approximately $6.1 million in severance charges and other reorganization expenses, which reflects the May 2013 plan of termination as a result of our continuing efforts to reassess and re-evaluate our overall cost structure and to identify significant additional expense reductions.

Interest expense on Debt

Interest expense on our debt increased $4.1 million, or 41%, to $14.3 million for the six-month period ended June 30, 2013, from $10.2 million for the six-month period ended June 30, 2012, as a result of additional interest due on our 2019 Notes, which were issued on May 9, 2012. Interest expense for the six-month period ended June 30, 2013 reflects $5.5 million of coupon interest expense and $8.8 million of non-cash interest expense. Interest expense for the six-month period ended June 30, 2012 reflects $5.4 million of coupon interest expense and $4.8 million of non-cash interest expense.

Gain on extinguishment of debt

On May 9, 2012, we completed the closing of transactions contemplated by certain Exchange and Purchase Agreements, dated May 7, 2012, between us and certain holders of our 2018 Notes. Pursuant to the terms of the Purchase and Exchange Agreements, the Holders exchanged their 2018 Notes, having an aggregate outstanding principal amount equal to approximately $108.0 million, for Units comprised of the new 2019 Notes, having an equivalent aggregate principal amount at maturity, and warrants to purchase an aggregate of 4.0 million shares of our common stock at an exercise price equal to $1.863 per share. The Holders also agreed to purchase simultaneously, additional Units, the aggregate purchase price of which resulted in net proceeds to us of approximately $42.6 million. The aggregate principal amount at maturity of the 2019 Notes issued upon the exchange of the 2018 Notes plus the 2019 Notes issued to the Holders upon purchase of the additional Units is approximately $170.9 million. In accordance with the authoritative accounting guidance described more fully in Note 7 to our consolidated financial statements, we recorded a gain of approximately $21.8 million upon the extinguishment of debt for the six month period ended June 30, 2012 as a result of exchanging a significant portion of the 2018 Notes for the 2019 Notes that were issued at a discount. The gain arose as the fair value of the 2018 Notes was less than its carrying value at the time of the transaction.

Other income, net

Other income, net decreased $2.0 million, or 57%, to $1.5 million for the six-month period ended June 30, 2013, from $3.5 million for the six-month period ended June 30, 2012. The decrease in other income, net is primarily driven by the year-over-year variance related to the change in the mark-to-market valuation adjustment of our warrant liability. For the six-month periods ended June 30, 2013 and 2012, we recorded a gain of $1.5 million and $3.8 million, respectively, from the decrease in the fair value of our warrant liability due to the lower underlying price of our common stock resulting in a year-over-year decrease in other income, net of $2.3 million. The decrease is partially offset by the year over year effect of foreign currency gains (losses) resulting in an increase in other income, net of $0.3 million.

Income tax benefit

For the six-month period ended June 30, 2013, we recognized a $2.2 million state income tax benefit as a result of proceeds from the sale of $2.4 million of New Jersey net operating losses through the Technology Business Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority.

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Liquidity and Capital Resources

At June 30, 2013, we had $51.5 million in cash, cash equivalents and short-term investments as compared to $96.3 million at December 31, 2012 and $68.8 million at March 31, 2013. We primarily invest our cash equivalents and short-term investments in highly liquid, interest-bearing, U.S. Treasury money market funds and bank certificates of deposit in order to preserve principal. In February 2011, we completed the sale of $230 million aggregate principal amount of 4.75% Convertible Senior Notes due 2018 which we refer to as the 2018 Convertible Notes. We received cash proceeds from the sale of the Notes of $222.7 million, net of expenses. Additionally, on May 9, 2012, we exchanged approximately $108.0 million of our existing convertible senior notes due in 2018 for units, which we refer to as Units, comprised of senior secured discount notes due 2019, which we refer to as the New Notes, and warrants to purchase approximately four million shares of our common stock at an exercise price of $1.863 per share. Simultaneously therewith, the holders of the New Notes purchased additional Units, the aggregate purchase price of which resulted in net cash proceeds of approximately $44.0 million. The New Notes have an equivalent aggregate principal amount at maturity of approximately $171 million, are secured by a first priority security interest in and liens on certain of our and our subsidiaries’ assets and properties, and have a cash coupon of 3% per year in the first three years and 12% per year thereafter.

We have used and will continue to use in the future, the net proceeds from the issuance of the Convertible Notes and the New Notes to commercialize KRYSTEXXA in the United States, including our promotional activities, funding of clinical development activities directed to FDA post-marketing commitments for KRYSTEXXA in the United States, and for general corporate purposes, including working capital. As a result, our management has broad discretion to allocate the net proceeds from these debt offerings. Pending the application of the net proceeds, we invest the net proceeds in short-term U.S. Treasury money market funds and bank certificates of deposit.

Based on our current commercialization plans for KRYSTEXXA, including our anticipated expenses relating to sales and marketing activities, the cost of purchasing additional inventory, the cost of clinical development activities and our post marketing commitments for KRYSTEXXA in the United States, our current strategy with respect to adjustments to the timelines for initiation and completion of the post authorization commitments in the EU, and assuming that we are able to generate KRYSTEXXA revenues at the level that we are currently expecting after taking into account our current strategy to evaluate and pursue aggressive price increases when appropriate, we believe that our available cash, cash equivalents and short-term investments, which includes the net proceeds of the transactions discussed above, will be sufficient to fund anticipated levels of operations for at least the next twelve months from the date hereof. This estimate also reflects the ongoing effects of our July 2012 and May 2013 reorganization plans, which we expect will generate significant operating expense savings going forward. Our management has broad discretion in the use of our financial resources and may adjust our anticipated plans as circumstances warrant.

We currently have an aggregate of $293.4 million of indebtedness maturing during 2018-2019. Repaying or refinancing this indebtedness will involve substantial challenges to our business operations and require us to raise significant additional debt or equity capital. Such additional capital may only be available on terms unacceptable to us, or not at all. If we are unable to obtain additional capital, our business, results of operations and financial condition may be materially adversely affected.

We have built an inventory of finished KRYSTEXXA product at June 30, 2013 that is packaged and labeled for distribution and additional supplies of drug product that are scheduled to be packaged and labeled as part of our ongoing approved commercial manufacturing process. Based on our inventory on hand and in process, we now believe we have sufficient inventory to meet our internal market estimates until at least the second quarter of 2014.

Tax Benefits

For the six-month period ended June 30, 2013, we recognized a $2.2 million state income tax benefit as a result of proceeds from the sale of $2.4 million of New Jersey net operating losses through the Technology Business Certificate Transfer Program, sponsored by the New Jersey Economic Development Authority.

Cash Flows

Cash used in operating activities for the six-month period ended June 30, 2013 was $44.4 million, which substantially reflects our net loss for the period and non-cash activity resulting from the mark-to-market valuation adjustment to our warrant liability partially offset by non-cash charges for the accretion of the debt discount, stock compensation expense and inventory obsolescence. Cash provided by investing activities of $32.8 million for the six-month period ended June 30, 2013 reflects the maturities of held-to-maturity securities consisting of bank certificates of deposit, which we used to fund our operations. Cash provided by financing activities of $0.1 million for the six-month period ended June 30, 2013 reflects cash proceeds received from the issuance of shares from our employee stock purchase plan.

Cash used in operating activities for the six-month period ended June 30, 2012 was $70.5 million, which substantially reflects our net loss for the period and the non-cash activity resulting from the gain on extinguishment of debt and the mark-to-market valuation adjustment to our warrant liability. Cash provided by investing activities of $5.3 million for the six-month period ended June 30, 2012 reflects the net impact of purchases and maturities of held-to-maturity securities consisting of bank certificates of deposit. Cash provided by financing activities of $43.4 million for the six-month period ended June 30, 2012 primarily reflects cash proceeds received from the 2019 Notes.

Funding Requirements

We continue to focus our efforts on commercializing KRYSTEXXA in the U.S., supporting our development activities and exploring partnership opportunities while seeking regulatory approval outside of the United States and European Union for KRYSTEXXA.

Our future capital requirements will depend on many factors, including:

• whether we are successful in marketing and selling KRYSTEXXA,

• the cost of our post-approval commitments to the FDA and European Commission, as applicable,

• the cost of clinical trials directed to potential expansion of clinical utility opportunities for KRYSTEXXA,

• the cost of commercialization activities, including product marketing, sales and distribution,

• the timing and costs related to the commercial launch of KRYSTEXXA in the EU, if pursued,

• the cost of manufacturing activities,

• market acceptance of KRYSTEXXA by physicians and patients in this largely previously untreated patient population,

• market acceptance of the price that we charge for KRYSTEXXA and under what conditions private and public payors will reimburse patients for KRYSTEXXA, and

• the timing and cost involved in obtaining regulatory approvals for KRYSTEXXA in countries other than the United States and European Union.

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As we continue to commercialize KRYSTEXXA we may need to seek additional funding through customary methods, or to explore a strategic licensing or co-promotion transaction in certain territories as a means of raising additional funding. Should we elect to seek additional funding through customary methods, we may not be able to obtain additional funds or, if such funds are available, such funding may not be on terms that are acceptable to us. If we raise additional funds by issuing equity securities, dilution to our then-existing stockholders will result. If we issue preferred stock, it would likely include a liquidation preference and other terms that would adversely affect our common stockholders. If we raise additional funds through the issuance of debt securities or borrowings, we may incur substantial interest expense and could become subject to financial and other covenants that could restrict our ability to take specified actions, such as incurring additional debt or making capital expenditures. If we explore a strategic licensing or co-promotion transaction, one may not be available to us or may only be available on terms that are not acceptable to us. If funds are not available on favorable terms, or at all, our business, results of operations and financial condition may be materially adversely affected and we may be required to curtail or cease operations.

Contractual Obligations

Below is a table that presents our contractual obligations and commitments as of June 30, 2013:

	Payments Due by Period
Contractual Obligations	Total		Less Than One Year		1-3 Years		3-5 Years		More Than 5 Years
	(In thousands)
Long-term debt obligations	$	293,382	$	—	$	—	$	122,441	$	170,941
Interest on long-term debt obligations		118,233		10,944		39,465		50,234		17,590
Post marketing commitments(1)		18,014		3,914		10,600		3,500		—
Purchase commitment obligations(2)		15,958		12,534		1,422		2,002		—
Operating lease obligations		13,481		1,412		2,872		2,969		6,228
Capital lease obligations		202		59		143		—		—
Other commitments(3)		3,517		2,763		754		—		—
Total	$	462,787	$	31,626	$	55,256	$	181,146	$	194,759

(1) Post marketing commitments represents our current cost estimates for our U.S. post marketing commitments to the FDA. Our U.S. post marketing commitments are primarily related to our U.S. patient observation study. We have excluded the costs of the EU post marketing commitments from the table, given the uncertainties of us entering into a commercially viable collaboration or partnership opportunity for the commercial launch and distribution of KRYSTEXXA in the EU. The cost of the EU post marketing commitments is estimated to range between $25 million and $30 million for duration of approximately five years through 2018, assuming work related to these commitments commences in 2013.

(2) Purchase commitment obligations represent our contractually obligated minimum purchase requirements based on agreements in place with third parties. Our obligation to pay certain of these amounts may be reduced or eliminated based on future events.

(3) Other commitments reflects the following severance and employee retention arrangements:

i. During the three and six-month periods ended June 30, 2013, as part of our continuing efforts to reassess and re-evaluate our overall cost structure and to identify significant additional expense reductions, we committed to a plan of termination pursuant to which we reduced our workforce by 27 employees, or approximately 21%. We recorded a severance charge of approximately $0.8 million against operations related to this workforce reduction for the three and six-month-periods ended June 30, 2013. During the three and six month-periods ended June 30, 2013, we also entered into severance arrangements with other former employees and senior officers including our former President and CEO based on his resignation on June 18, 2013, and recorded additional severance charges of $2.1 million related to these severance arrangements for the three and six-month periods ended June 30, 2013.

ii. In addition, in order to secure the retention of our senior executives key to the successful operations of our company and to prevent any disruption to the strategic development of our business, we granted cash and stock retention awards to our senior executives in 2012 which vest as to 50% of the award on specific dates over a two-year period. Our potential commitment, if all of the executives are employed at the time of vesting, is $0.7 million in cash payments during the first quarter of 2014.

Excluded from the above table are employment agreements with five senior officers. Under these agreements, the Company has committed to total aggregate base compensation per year of approximately $1.9 million plus other benefits and bonuses. These employment agreements generally have an initial-term of three years and are automatically renewed thereafter for successive one-year periods unless either party gives the other notice of non-renewal.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States. Applying these principles requires our judgment in determining the appropriateness of acceptable accounting principles and methods of application in diverse and complex economic activities. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of revenues, expenses, assets and liabilities, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

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For a discussion of our critical accounting estimates, see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations “in our 2012 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on April 1, 2013. There were no material changes in our critical accounting estimates or accounting policies from December 31, 2012.

Accounting Pronouncements

During the quarter ended June 30, 2013, there were no new accounting pronouncements or updates to recently issued accounting pronouncements disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, that materially affect the Company’s present or future results of operations, overall financial condition, liquidity or disclosures.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Market risk is the exposure to loss resulting from changes in interest rates, foreign currency exchange rates, commodity prices and equity prices. To date, our exposure to market risk has been limited. We do not currently hedge any market risk, although we may do so in the future. We do not hold or issue any derivative financial instruments for trading or other speculative purposes.

ITEM 4. CONTROLS AND PROCEDURES

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Principal Executive Officers and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

We do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control systems are met. Further, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in a cost-effective control system, no evaluation of internal control over financial reporting can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our Company have been detected.

These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of control effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.

Our management, with the participation of our Principal Executive Officers and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures. Based on this evaluation, as of the end of the period covered by this Quarterly Report on Form 10-Q, our Principal Executive Officers and Principal Financial Officer have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are effective.

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2013 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

On April 30, 2012, a creditor derivative action complaint was filed by one of the holders of our 2018 Convertible Notes, Tang Capital Partners, LP, against us and certain of our current directors and three former directors in the Court of Chancery of the State of Delaware. On May 21, 2012, Tang Capital amended its complaint to add new claims against us and our current and former directors and also to add additional note-holders as plaintiffs. On June 29, 2012, the plaintiffs amended their complaint for a second time to add claims against us relating to an alleged event of default under the 2018 Indenture. As with the April 30 and May 21 complaints, the June 29 complaint also alleges, among other things, that we are insolvent, and seeks the appointment of a receiver. We filed a motion to dismiss the receiver claim in the June 29 complaint on the grounds that the note-holders did not have standing to bring that claim and a motion for summary judgment that an event of default has not occurred under our convertible notes. On July 23, 2012, the Delaware Court of Chancery issued a memorandum opinion granting both of our motions. Specifically, the Court determined that the note-holders do not have standing to bring an action to appoint a receiver for us and that an event of default has not occurred under our convertible notes. We have moved to dismiss the remaining claims in the June 29 complaint, but that motion has not yet been decided. A hearing on this motion to dismiss was held on March 27, 2013. On June 26, 2013, plaintiffs filed a motion seeking entry of a partial final judgment of that portion of the Court of Chancery’s July 23, 2012 memorandum opinion dismissing plaintiffs’ claim for appointment of a receiver in order to seek an appeal in the Delaware Supreme Court. The Court issued a letter opinion on July 12, 2013, directing entry of partial final judgment on that limited issue and further staying considering of the Company’s motion to dismiss the remaining claims pending resolution of any appeal. On July 17, 2013, the Court of Chancery entered an order and partial final judgment. Plaintiffs filed a Notice of Appeal with the Delaware Supreme Court on July 19, 2013. Plaintiffs’ opening appellate brief is due on or before September 3, 2013. Defendants’ appellee answering brief is due thirty (30) days after plaintiffs file their brief, and plaintiffs’ reply brief is due fifteen (15) days thereafter. No oral argument date has been scheduled. On June 8, 2012, the Company filed a cross-complaint against Tang Capital, which it later amended on August 31, 2012. The Company’s amended complaint alleges a claim for breach of a non-disclosure agreement between the Company and Tang Capital and for tortious interference with the Company’s business and contractual relations. Our amended complaint remains outstanding.

From time to time, we are subject to other legal proceedings and claims in the ordinary course of business. Such claims, even if without merit, could result in significant expenditure of our financial and managerial resources. We are not aware of any legal proceedings or claims that we believe will, individually or in the aggregate, materially harm our business, results of operations, financial condition, liquidity or cash flows.

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ITEM 1A. RISK FACTORS

The following risk factors have been updated to reflect developments subsequent to the filing of our Annual Report on Form 10-K for the year ended December 31, 2012, and we have denoted with an asterisk (*) in the following discussion those risk factors that are materially revised.

Risks relating to the commercialization and further development of KRYSTEXXA^® and our ability to accomplish our future business objectives

Our business focuses primarily on the commercialization of KRYSTEXXA in the United States. Commercializing KRYSTEXXA in the United States is complex and requires substantial capital resources. If our U.S. commercialization strategy is unsuccessful, market acceptance of KRYSTEXXA may be harmed, and we will not achieve the revenues that we anticipate and may need additional funding.

Our business focuses primarily on the commercialization of KRYSTEXXA in the United States. We do not have any material assets other than KRYSTEXXA. As a result of our reliance on this single product and our primary focus on the U.S. market in the near-term, much of our near-term results and value as a company depend on our ability to execute our commercial strategy for KRYSTEXXA in the United States. The successful execution of our commercial strategy continues to be a complex and ongoing process and requires substantial capital resources. We have no prior experience commercializing a biologic drug product. If we are not successful in executing our commercialization strategy, market acceptance of KRYSTEXXA may be harmed, we will not achieve the revenues that we anticipate and we may need additional funding.

We do not plan to commercially launch KRYSTEXXA on our own in Europe or other markets and instead expect to commercialize KRYSTEXXA in those regions through partnership opportunities. However, we may be unsuccessful in identifying such partnerships on favorable terms or consummating such partnerships at all. If we are not successful in these efforts, then the maximum revenues we receive from KRYSTEXXA may be more limited.

On January 8, 2013, the European Commission approved the marketing authorization application for KRYSTEXXA as a treatment for severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. We do not plan to launch KRYSTEXXA on our own in Europe or other markets and instead would expect to commercialize KRYSTEXXA through collaboration and partnership opportunities outside the United States. Identifying commercially viable EU collaboration and partnering opportunities has proved to be challenging. Potential collaborators and partners have had difficulty assessing the potential market size in the EU given the slower than originally projected commercial uptake in the United States. Additionally, the cost and infrastructure commitment needed to complete the EU post marketing commitment clinical trials and the uncertainties surrounding the indicated potential price per vial in the EU have also added complications to these discussions. As a result, at this time we cannot estimate the timeline for the consummation of a potential transaction for EU commercialization, if one can be consummated at all, and thus we also cannot estimate the timeline for commercial availability of KRYSTEXXA in the EU.

In addition, we face significant competition in seeking appropriate partners and such arrangements, if consummated, may not be scientifically or commercially successful or we may not be able to enter into such partnerships on favorable terms. If we are unable to reach agreement with a development and commercialization partner on favorable terms, or if such an arrangement is terminated, our ability to develop, commercialize and market KRYSTEXXA may be harmed and we may fail to meet our business objectives for KRYSTEXXA.

The success of any collaboration arrangement will depend heavily on the efforts and activities of our potential collaborators, who will have significant discretion in determining the efforts and resources that they will apply to such collaborations. The risks that we face in connection with potential collaborations include the following:

• the timing of the actual consummation of a collaboration transaction and the potential that the only available terms for such transaction may allocate a portion of the costs related to the post marketing commitments or the commercial launch of KRYSTEXXA in the EU to us,

• our collaborator may fail to gain adequate market acceptance for KRYSTEXXA among physicians, patients, health care payors and others in the medical community within their territory and fail to achieve the revenues we anticipate in those territories,

• collaboration agreements are generally for fixed terms and subject to termination under various circumstances, including, in many cases, on short notice without cause,

• we expect that any collaboration agreement will require that we not conduct specified types of research and development in the field that is the subject of the collaboration, which may have the effect of limiting the areas of research and development that we may pursue, either alone or in cooperation with third parties,

• collaborators may develop and commercialize, either alone or with others, products and services that are similar to or competitive with our products that are the subject of the collaboration with us, and

• collaborators may change the focus of their development and commercialization efforts.

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Pharmaceutical and biotechnology companies historically have re-evaluated their priorities following mergers and consolidations, which have been common in recent years in our industry. Should our potential collaborator be the subject of a merger or consolidation, the ability of KRYSTEXXA to reach its potential could be limited if our potential collaborator decreases or fails to increase spending related to any collaboration. Collaborations with pharmaceutical companies and other third parties often are terminated or allowed to expire by the other party. Such terminations or expirations can adversely affect us financially as well as harm our business reputation.

Further, entering into collaborative arrangements for the commercialization of KRYSTEXXA in the EU and other foreign jurisdictions may also be time consuming, and may not be on terms favorable to us, if we are successful in entering into such arrangements at all. The commercialization of KRYSTEXXA outside the United States would subject us to additional risks, including:

• potentially reduced protection for intellectual property rights,

• unexpected changes in tariffs, trade barriers and regulatory requirements,

• economic weakness, including inflation, or political instability in particular foreign economies and markets,

• compliance with tax, employment, immigration and labor laws for employees traveling abroad,

• foreign taxes,

• foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country,

• workforce uncertainty in countries where labor unrest is more common than in the United States, and

• business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires.

These and other risks may materially adversely affect our ability to attain or sustain profitable operations or collaborations in jurisdictions outside of the United States.

In order to commercialize KRYSTEXXA outside of the United States and the EU, we or a partner must obtain regulatory approvals and comply with local regulatory requirements. If we fail to achieve regulatory approval for KRYSTEXXA in other jurisdictions outside of the United States and the EU, or if regulatory approval in those jurisdictions is delayed, then the maximum revenues that we receive from KRYSTEXXA may be more limited.

We expect to market KRYSTEXXA outside the United States and the EU only through commercially viable arrangements with partners or collaborators. In order to market KRYSTEXXA in these other foreign jurisdictions, we or our partner must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The procedures for obtaining foreign marketing approvals vary among countries and can involve additional clinical trials or other pre-filing requirements. The time required to obtain foreign regulatory approval may differ from that required to obtain U.S. Food and Drug Administration, or FDA, approval. The foreign regulatory approval process may include all the risks associated with obtaining FDA approval, or different or additional risks, and we may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA and the EMA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries. We expect to pursue the commercialization of KRYSTEXXA outside the United States through development and commercialization collaborations, pursuant to which third parties may be responsible for obtaining such foreign regulatory approvals. We and our collaborators may not be able to file for regulatory approvals until after the completion of additional clinical studies and may not receive necessary approvals to commercialize KRYSTEXXA in any foreign market. If we fail to receive approval in these jurisdictions, or if such approvals are delayed, we will not generate revenue from sales of KRYSTEXXA in these jurisdictions and the maximum revenues that we receive from KRYSTEXXA may be more limited.

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If we are not successful in retaining our existing sales and marketing personnel and maintaining an appropriate sales and marketing infrastructure in the United States, our ability to commercialize KRYSTEXXA, generate product sales in the United States and fulfill our co-promotion obligations will be impaired.

Our efforts to establish and maintain an internal sales, marketing and commercialization infrastructure and capabilities directed toward our commercialization of KRYSTEXXA in the United States have been and will continue to be difficult, expensive and time consuming. We have also recently entered into a Co-Promotion Agreement with Swedish Orphan Biovitrum AB to co-promote their product Kineret^® in the United States, pursuant to which we are obligated to perform an agreed upon sales call plan utilizing our sales representatives. We may not have accurately estimated the size or capabilities of the sales force necessary to successfully commercialize KRYSTEXXA in the U.S. and fulfill our obligations under the Kineret Co-Promotion Agreement. We may not be able to attract, hire, train and retain the qualified sales and marketing personnel necessary to achieve or maintain an effective sales and marketing force for the sale of KRYSTEXXA in the U.S., as well as fulfill our obligations under the Kineret Co-Promotion Agreement, or we may have underestimated the time and expense to achieve these objectives. Similarly, we may not be successful in establishing necessary commercial infrastructure and capabilities, including managed care, medical affairs and pharmacovigilance teams. If our internal sales, marketing, and commercialization infrastructure proves to be inadequate, our ability to market and sell KRYSTEXXA, generate revenue from sales to customers in the U.S. and fulfill our obligations under the Kineret Co-Promotion Agreement will be impaired and result in lower than expected revenues.

(*)Our business and ability to repay our obligations may be harmed if we have inaccurately predicted the market size for KRYSTEXXA, if we fail to appropriately penetrate the market or if we do not price KRYSTEXXA at an appropriate level.

Determining the market size for KRYSTEXXA is difficult to predict with accuracy. In the first half of 2011, we completed what we refer to as the KRYSTEXXA Market Study in collaboration with a leading independent life science consulting firm. This comprehensive market research study, completed using both secondary data sources and primary market research, indicated that there are approximately 120,000 RCG patients in the United States, or approximately 4.2% of the overall annual treated gout population in the United States. However, through further work we have determined that not all of these patients are engaged in the healthcare system and if engaged in the healthcare system, are not seeking treatment with Rheumatologists which is the physician specialty on whom we currently concentrate most of our commercial efforts. Additionally, we estimate that only between 20,000 and 40,000 of the most severe RCG patients in the United States are being treated by the Rheumatologists that we currently target, and that, according to a follow-on study completed in June 2013, only approximately 9,000 of these patients are seen by Rheumatologists most likely to prescribe KRYSTEXXA. Ultimately, the total available market opportunity for KRYSTEXXA and our ability to penetrate that market will depend on, among other things, our patient and physician education programs, our marketing and sales efforts, reimbursement environment, market acceptance by physicians, infusion site personnel, healthcare payors and others in the medical community, referrals by various specialty physicians and those in family practice to administering clinicians, and our financial resources to support commercialization activities.

If we are able to commercialize KRYSTEXXA in the EU, the commercial success of KRYSTEXXA in the EU will, in part, depend upon the pricing and reimbursement achieved and the number of patients placed on treatment. The number of patients placed on treatment will depend on many of the factors that also could affect the US market, including the degree of market acceptance by RCG patients, physicians, infusion site personnel and others in the medical community. Additionally, the lack of payor acceptance could adversely affect the market share and revenues.

There are many mechanisms in the EU at the national, regional and local levels that serve to present barriers to use of products. While we have advanced our development of pricing and reimbursement plans for the EU, particularly in the UK, Germany and France, each member state of the EU separately regulates the pricing and reimbursement of pharmaceutical products. Results in regards to pricing in the EU region and current feedback from the member state pricing authorities indicate a potential price per vial in the EU member states that is significantly below the current average selling price in the U.S. If we fail to receive an appropriate price per vial or course of therapy for KRYSTEXXA, or if such pricing determinations are delayed or unreasonably conditioned, then our revenues may be harmed and our business could be materially harmed.

Additionally, our market size calculations by country and our ability to prove that KRYSTEXXA is an effective, safe and cost-effective treatment for the indicated treatment population carries the risk that not all countries and parts of countries agree with our assessment and therefore do not reimburse/fund it for the indicated patients. For example, on May 2, 2013, we received a FAD from NICE of England in which NICE did not recommend KRYSTEXXA for use by the NHS in England and Wales. While NICE agreed that KRYSTEXXA is an effective agent for the treatment of chronic tophaceous gout when used under the approved guidelines for use, NICE found that KRYSTEXXA would not be a cost-effective use of NHS resources.

While the population of patients in the EU appears more restrictive than the U.S. labeling, we believe that it is in fact a similar patient population. We believe the majority of our potential patients are presently treated by the Rheumatologist in the hospital setting. To the extent that this assumption is wrong and that some of our potential patients are in fact treated by other hospital specialists and outside of the hospital setting, this may affect our ability to access these patients and thus reduce the forecasted market size.

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If we have overestimated the market size for KRYSTEXXA or fail to effectively penetrate the existing market, we could incur significant unrecoverable costs from creating excess manufacturing capacity or commercial sales and marketing capabilities and commercial infrastructure, and our revenues will be lower than expected, possibly materially so. Alternatively, if we underestimated the market size for KRYSTEXXA, we may not be able to manufacture sufficient quantities of KRYSTEXXA to enable us to realize full revenue potential from sales of KRYSTEXXA. Any of these results could materially harm our business.

The commercial success of KRYSTEXXA will depend upon the degree of its market acceptance by RCG patients, physicians, infusion site personnel, healthcare payors and others in the medical community. If KRYSTEXXA does not achieve an adequate level of market acceptance, we may not generate sufficient revenues to achieve or maintain profitability.

Those patients who suffer from RCG comprise a patient population that has previously failed other treatments. However, KRYSTEXXA may not gain or maintain market acceptance by these RCG patients, or by physicians, infusion site personnel, healthcare payors or others in the medical community. Additionally, we believe that a significant number of potential patients for KRYSTEXXA may be treated by nephrologists and podiatrists whom we have recently begun to educate about KRYSTEXXA. While some of these specialists may directly initiate KRYSTEXXA therapy we believe that the majority of these specialists will refer RCG patients to Rheumatologists. Thus our efforts are directed towards facilitating referrals by these specialists of patients to rheumatologists or other infusion providers who will administer KRYSTEXXA. If we are unsuccessful in educating these specialists about KRYSTEXXA, or if they do not refer patients to sites of care, then market acceptance for KRYSTEXXA will be reduced. We could incur substantial and unanticipated additional expense in an effort to increase market acceptance, which would increase the cost of commercializing KRYSTEXXA and could limit its commercial success and result in lower than expected revenues. We believe the degree of market acceptance of KRYSTEXXA will depend on a number of factors, including:

• its efficacy and potential advantages over other treatments,

• the extent to which physicians are successful in treating patients with other products or treatments, such as allopurinol and Uloric^® (febuxostat), which, because they are pills, offer greater convenience and ease of administration and are substantially less expensive compared to KRYSTEXXA,

• whether patients remain on KRYSTEXXA or are able to be successfully managed with allopurinol or Uloric following treatment with KRYSTEXXA,

• the extent to which physicians and patients experience similar or improved clinical results to that reported on the approved product labeling,

• market acceptance of the per vial cost at which we sell KRYSTEXXA in the United States,

• the extent to which sales of KRYSTEXXA are limited by concern among physicians and patients over the boxed warning on the approved product label for KRYSTEXXA warning of anaphylaxis and infusion reactions,

• the prevalence and severity of other side effects that we have observed to date or that we may observe in the future,

• the timing of the release of competitive products or treatments,

• our marketing and sales resources, the quantity of our supplies of KRYSTEXXA and our ability to establish a distribution infrastructure for KRYSTEXXA in available markets,

• whether third-party and government payors cover or reimburse for KRYSTEXXA, and if so, to what extent and in what amount, and

• the willingness of the target patient population to be referred by primary care physicians to rheumatologists, nephrologists or infusion centers.

If market acceptance of KRYSTEXXA is adversely affected by any of these or other factors, then sales of KRYSTEXXA may be reduced and our business will be materially harmed.

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The FDA approved our BLA with a final label that prescribes safety limits and warnings, including a boxed warning, and we are required to implement post-approval commitments and a REMS program to minimize the potential risks of the treatment of KRYSTEXXA. Such additional obligations and commitments may increase the cost of commercializing KRYSTEXXA, limit the commercial success of KRYSTEXXA and result in lower than expected future earnings.

In clinical trials of KRYSTEXXA, anaphylaxis and infusion reactions in patients were reported to occur during and after administration of KRYSTEXXA. In the Phase 3 trial for KRYSTEXXA, anaphylactic reactions were reported in 6.5% of patients treated with KRYSTEXXA, compared to 0% with placebo, and infusion reactions were reported to occur in 26% of patients treated with KRYSTEXXA, compared to 5% of patients treated with placebo. Physicians may be reluctant to treat patients with KRYSTEXXA because of concern regarding the occurrence of these anaphylactic and infusion reactions. In addition, the approved United States full prescribing information, or labeling, for KRYSTEXXA contains safety information, including a prominent warning on the full prescription information, or package insert, referred to as a “black box warning,” regarding anaphylaxis and infusion reactions, as well as contraindications, warnings and precautions. The prevalence and severity of these adverse reactions and the related labeling for KRYSTEXXA may reduce the market for the product and increase the costs associated with the marketing, sale and use of the product.

We are also required to implement a REMS program to minimize the potential risks of KRYSTEXXA treatment. The current REMS program includes a Communication Plan to healthcare providers and an Assessment Plan to survey patients’ and providers’ understanding of the serious risks of KRYSTEXXA. The FDA may further revise the REMS program at any time, which could impose significant additional obligations and commitments on us in the future or may require post-approval clinical or non-clinical studies. The FDA is also requiring that we conduct an observational trial, which is currently underway, in 500 patients treated with KRYSTEXXA for one-year to further evaluate and identify if there are any other serious adverse events associated with the administration of KRYSTEXXA. In addition, the FDA is requiring us to conduct several post-approval non-clinical and CMC studies currently underway. Such additional obligations and commitments may increase the cost of commercializing KRYSTEXXA, limit the commercial success of KRYSTEXXA, result in revised safety labeling or REMS requirements and result in lower than expected future revenues.

Although a number of private managed care organizations and government payors have added medical benefits coverage for KRYSTEXXA, we are continuing to seek reimbursement arrangements with them and additional third-party payors. If we are unable to obtain adequate reimbursement from third-party payors, or acceptable prices, for KRYSTEXXA, our revenues and prospects for profitability will suffer.

Our future revenues and ability to become profitable will depend heavily upon the availability of adequate reimbursement for the use of KRYSTEXXA from government-funded and private third-party payors. Reimbursement by a third-party payor depends on a number of factors, including the third-party payor’s determination that use of a product is:

• a covered benefit under its health plan,

• safe, effective and medically necessary,

• appropriate for the specific patient,

• cost effective, and

• neither experimental nor investigational.

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Obtaining reimbursement approval for KRYSTEXXA from each government-funded and private third-party payor is a time-consuming and costly process, which in some cases requires us to provide to the payor supporting scientific, clinical and cost-effectiveness data for KRYSTEXXA’s use. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement.

For instance, if state-specific Medicaid programs do not provide adequate, or any, coverage and reimbursement for KRYSTEXXA, it may have a negative impact on our operations. Recently enacted legislation has increased the amount that pharmaceutical manufacturers are required to rebate to Medicaid and this may have a negative effect on our revenues. Specifically, the minimum rebate for single-source covered outpatient drugs in the Medicaid program has been 23.1% of average manufacturer price since January 1, 2010.

We were awarded a contract from the VA which covered KRYSTEXXA reimbursement for VA member patients as of April 1, 2011 at an approximate 24% discount to our original list selling price of $2,300 per 8 mg vial. On May 17, 2013, the list selling price of KRYSTEXXA was increased to $5,390 per 8 mg vial and VA member patients now receive an approximate 71% discount to our list price. We expect that this discount will increase contingent on price actions that we may take in the future. If we are unable to negotiate smaller discounts to the list price for KRYSTEXXA with other third-party payors, our profitability will be materially and adversely affected.

Even when a third-party payor determines that a product is generally eligible for reimbursement, third-party payors may impose coverage limitations that preclude payment for some product uses that are approved by the FDA or similar authorities or impose patient co-insurance or co-pay amounts that may result in lower market acceptance, which would lower our revenues. Where third-party payors require substantial co-insurance or co-pay amounts, we subsidize these amounts for some economically disadvantaged patients, which reduces our profit margin on KRYSTEXXA for those patients. Some payors establish prior authorization programs and procedures requiring physicians to document several different parameters, which may impede patient access to therapy. Moreover, eligibility for coverage does not necessarily mean that KRYSTEXXA will be reimbursed in all cases or at a rate that allows us to sell KRYSTEXXA at a price adequate to make a profit or even cover our costs. If we are not able to obtain coverage and adequate reimbursement promptly from third-party payors for KRYSTEXXA, our ability to generate revenues and become profitable will be compromised.

The scope of coverage and payment policies varies among private third-party payors, including indemnity insurers, employer group health insurance programs and managed care plans. These third-party payors may base their coverage and reimbursement on the coverage and reimbursement rate paid by carriers for Medicare beneficiaries, which are traditionally at a substantially discounted rate. Furthermore, many such payors are investigating or implementing methods for reducing healthcare costs, such as the establishment of capitated or prospective payment systems. Cost containment pressures have led to an increased emphasis on the use of cost-effective products by healthcare providers. If third-party payors do not provide adequate coverage or reimbursement for KRYSTEXXA, it could have a negative effect on our revenues, results of operations and liquidity.

Current and future legislation may increase the difficulty and cost of commercializing KRYSTEXXA, affect the prices we may obtain and limit reimbursement amounts.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could restrict or regulate post-approval activities and affect our ability to profitably sell KRYSTEXXA.

The Medicare Modernization Act, or MMA, enacted in December 2003, has altered the way in which some physician-administered drugs and biologics, such as KRYSTEXXA, are reimbursed by Medicare Part B. Under this reimbursement methodology, physicians are reimbursed based on a product’s “average sales price.” This reimbursement methodology has generally led to lower reimbursement levels. This legislation also added an outpatient prescription drug benefit to Medicare, which went into effect in January 2006. These benefits are provided primarily through private entities, which we expect will attempt to negotiate price concessions from pharmaceutical manufacturers.

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The Patient Protection and Affordable Care Act of 2010, or the PPACA, may have a significant impact on the healthcare system. As part of this legislative initiative, Congress enacted a number of provisions that are intended to reduce or limit the growth of healthcare costs, which could significantly change the market for pharmaceuticals and biological products. The provisions of the PPACA could, among other things, increase pressure on drug pricing or make it more costly for patients to gain access to prescription drugs like KRYSTEXXA at affordable prices. This could lead to fewer prescriptions for KRYSTEXXA and could force individuals who are prescribed KRYSTEXXA to pay significant out-of-pocket costs or pay for the prescription entirely by themselves. As a result of such initiatives, market acceptance and commercial success of our product may be limited and our business may be harmed.

While Medicaid coverage for KRYSTEXXA is available, if state-specific Medicaid programs do not provide adequate coverage and reimbursement, if any, for KRYSTEXXA, it may have a negative impact on our operations.

If we fail to comply with regulatory requirements or experience unanticipated problems with KRYSTEXXA, the product could be subject to restrictions and be withdrawn from the countries where it has been granted marketing approval and we may be subject to penalties, which would materially harm our business.

The marketing approval for KRYSTEXXA in the United States, along with the manufacturing processes, reporting of safety and adverse events, post-approval commitments, product labeling, advertising and promotional activities, and REMS program, are subject to continual requirements of, and review by, the FDA, including thorough inspections of third-party manufacturing and testing facilities. Similar requirements are in place for the EU approval.

These requirements include submission of safety and other post-marketing information and reports, registration requirements, current Good Manufacturing Practice, or cGMP, relating to quality control, quality assurance and corresponding maintenance of records and documents, and recordkeeping. The health authorities enforce compliance with cGMP and other requirements through periodic unannounced inspections of manufacturing and laboratory facilities. The health authorities are authorized to inspect manufacturing and testing facilities, marketing literature, records, files, papers, processes, and controls at reasonable times and within reasonable limits and in a reasonable manner, and we cannot refuse to permit entry or inspection.

If, in connection with any future inspection, a health authority finds that we or any of our third-party manufacturers or testing laboratories are not in substantial compliance with cGMP requirements, the health authority may undertake enforcement action against us.

In addition, the approval of KRYSTEXXA is subject to limitations on the indicated uses for which it may be marketed. The approval of KRYSTEXXA also contains requirements for post-marketing testing and surveillance to monitor KRYSTEXXA’s safety and/or efficacy, as well as a commitment to the FDA for an observational trial in 500 patients treated with KRYSTEXXA for one year and a commitment to the EMA for an observational trial in 500 patients treated with KRYSTEXXA for as long as they are on treatment plus three months post treatment with the last dose of KRYSTEXXA to further evaluate and identify if there are any other serious adverse events associated with the administration of KRYSTEXXA. Additionally, we are required by the EMA to perform a clinical study to verify the appropriate dosing in patients weighing greater than 100kg and a clinical study looking at an alternate dosing regimen which could reduce the frequency of gout flares seen with the onset of treatment with KRYSTEXXA. Subsequent discovery of previously unknown problems with KRYSTEXXA or its manufacturing processes, such as safety or adverse events, or failure to comply with regulatory requirements, may result in, for example:

• revisions of or adjustments to the product labeling,

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• warning letters,

• imposition of new or revised REMS requirements, including distribution and use restrictions,

• costly corrective advertising,

• voluntary or mandatory product recall,

• public notice of regulatory violations,

• restrictions on the marketing or manufacturing of KRYSTEXXA,

• refusal to approve pending applications or supplements to approved applications,

• imposition of post-marketing study or post-marketing clinical trial requirements,

• product seizure,

• shutdown or substantial limitations on the operations of manufacturing facilities,

• fines or disgorgement of profits or revenue,

• refusal to permit the import or export of products,

• suspension or withdrawal of regulatory approvals, including license revocation,

• withdrawal of KRYSTEXXA from the market,

• debarment from submitting certain abbreviated applications, and

• injunctions or the imposition of civil or criminal penalties.

If any of these events were to occur, our business could be materially harmed.

We face substantial competition and our competitors may develop or commercialize alternative technologies or products more successfully than we do.

The pharmaceutical and biotechnology industries are intensely competitive. We face competition with respect to KRYSTEXXA from major pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions and other public and private research institutions that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Our competitors may develop products that are safer, are more effective, have fewer side effects, are more convenient or are less costly than KRYSTEXXA.

KRYSTEXXA is approved in the United States for the treatment of chronic gout in adult patients refractory to conventional therapies and recently was approved in the EU as a treatment for severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. By far, the most prevalent current treatment for gout is allopurinol, which can lower uric acid levels by inhibiting uric acid formation. Allopurinol is a generic and inexpensive treatment which has achieved widespread acceptance by payors, physicians and patients. A small number of patients with gout are treated with probenecid, which can lower uric acid levels by promoting excretion of uric acid. In addition, Uloric (febuxostat) was approved by the FDA in early 2009 for the chronic management of hyperuricemia in patients with gout. Febuxostat lowers uric acid levels by inhibiting uric acid formation through a similar mechanism of action as allopurinol. Although febuxostat is labeled for the chronic management of hyperuricemia in patients with gout, febuxostat is also used in patients who cannot tolerate allopurinol or where allopurinol is contraindicated. If patients are given febuxostat prior to treatment with KRYSTEXXA, the market demand for KRYSTEXXA may be affected. Each of these approved treatments is both less expensive than KRYSTEXXA and available as a pill. Pills are significantly more convenient for patients than KRYSTEXXA, which requires a visit to an infusion center, hospital or doctor’s office that has infusion capabilities. If KRYSTEXXA does not achieve an adequate level of market acceptance, we may not generate sufficient additional revenues to achieve or maintain profitability. As a result of our recent approval in the EU, we face competition from Benzbromorone as well as Allopurinol and Uloric.

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There are also a number of companies developing new treatments for gout. Some of these development stage treatments are currently in late stage clinical trials. Depending on their cost, safety, efficacy and convenience, one or more of these new therapies, if approved, could provide substantial competition for KRYSTEXXA.

Moreover, the PPACA permits the FDA to, among other things, approve biosimilar or interchangeable versions of biological products like KRYSTEXXA through an abbreviated approval pathway following periods of data and marketing exclusivity. The approval of such versions could result in the earlier entry of similar, competing, and less costly products by our foreign and domestic competitors, including products that may be interchangeable with our own approved biological products. The market entry of these competing products could decrease the revenue we receive for any approved products, which, in turn, could adversely affect our operating results, our overall financial condition and liquidity.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing and distributing approved products than we do. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific, commercial and management personnel, as well as in acquiring products, product candidates and technologies complementary to, or necessary for, our programs or advantageous to our business.

If we are unable to maintain orphan drug exclusivity for KRYSTEXXA in the United States, we may face increased competition.

Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition affecting fewer than 200,000 people in the United States. A company that first obtains FDA approval for a designated orphan drug for the specified rare disease or condition receives orphan drug marketing exclusivity for that drug for a period of seven years from the date of its approval. This orphan drug exclusivity prevents the approval of another drug containing the same active ingredient and used for the same orphan indication except in very limited circumstances, based upon the FDA’s determination that a subsequent drug is safer, more effective or makes a major contribution to patient care, or if the orphan drug manufacturer is unable to assure that a sufficient quantity of the orphan drug is available to meet the needs of patients with the rare disease or condition. Orphan drug exclusivity may also be lost if the FDA later determines that the initial request for designation was materially defective.

KRYSTEXXA was granted orphan drug designation by the FDA in 2001, which we expect will provide the drug with orphan drug marketing exclusivity in the United States until September 2017, seven years from the date of its approval. However, such exclusivity may not effectively protect the product from competition if the FDA determines that a subsequent PEGylated uricase drug for the same indication is safer, more effective or makes a major contribution to patient care, or if we are unable to assure the FDA that sufficient quantities of KRYSTEXXA are available to meet patient demand. In addition, orphan drug exclusivity does not prevent the FDA from approving competing drugs for the same or similar indication containing a different active ingredient. If a subsequent drug is approved for marketing for the same or similar indication we may face increased competition, and our revenues from the sale of KRYSTEXXA will be adversely affected. KRYSTEXXA does not currently have orphan drug status in the EU or other regions of the world.

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If we do not obtain protection under the PPACA by obtaining data and marketing exclusivity for KRYSTEXXA, our business may be materially harmed.

The PPACA permits the FDA to, among other things, approve biosimilar or interchangeable versions of biological products like KRYSTEXXA through an abbreviated approval pathway following periods of data and marketing exclusivity. Biological products that are considered to be “reference products” are granted two overlapping periods of data and marketing exclusivity: a four-year period during which no abbreviated BLA relying upon the reference product may be submitted, and a 12-year period during which no abbreviated BLA relying upon the reference product may be approved by the FDA. For purposes of the PPACA, a reference product is defined as the single biological product licensed under a full BLA against which a biological product is evaluated in an application submitted under an abbreviated BLA.

We believe that KRYSTEXXA is a “reference product” that is entitled to both four-year and 12-year exclusivity under the PPACA. The FDA, however, has not issued any regulations or final guidance explaining how it will implement the PPACA, including the exclusivity provisions for reference products. In February 2012, the FDA issued three draft guidance documents that provide its preliminary thoughts on how to interpret and implement the abbreviated BLA provisions of the PPACA. The FDA has requested public comments on these draft guidance documents, including the proper interpretation of PPACA’s exclusivity provisions for reference. It is thus possible that the FDA will decide to interpret the PPACA in such a way that KRYSTEXXA is not considered to be a reference product for purposes of the PPACA or be entitled to any period of data or marketing exclusivity. Even if KRYSTEXXA is considered to be a reference product and obtains exclusivity under the PPACA, another company nevertheless could also market another version of the biologic if such company can complete, and the FDA permits the submission of and approves, a full BLA with a complete human clinical data package. Although protection under the PPACA will not prevent the submission or approval of another “full” BLA, the applicant would be required to conduct its own pre-clinical and adequate and well-controlled clinical trials to demonstrate safety, purity, and potency (i.e., effectiveness). The market entry of such competing products could decrease the revenue we receive for KRYSTEXXA, which, in turn, could adversely affect our operating results and our overall financial condition.

(*)We will need to raise additional capital to execute upon our commercial strategy for KRYSTEXXA and to repay our indebtedness. Such financing may only be available on terms unacceptable to us, or not at all. If we are unable to obtain financing on favorable terms, our business, results of operations and financial condition may be materially adversely affected.

At June 30, 2013, we had $51.5 million in cash, cash equivalents and short-term investments, as compared to $96.3 million at December 31, 2012. At June 30, 2013, we had an accumulated deficit of $585.8 million. At June 30, 2013, we had $293.4 million of indebtedness maturing during 2018-2019.

The development and commercialization of pharmaceutical products requires substantial funds and we currently have no committed external sources of capital. Historically, we have satisfied our cash requirements primarily through equity and debt offerings, product sales and the divestiture of assets that were not core to our strategic business plan. Most recently, in May 2012, we increased our cash position through the net proceeds received from the sale of Units comprised of our 2019 Notes and accompanying warrants and in February 2011 from the offer and sale of our 2018 Convertible Notes, a portion of which were exchanged by their holders for Units. We have been less successful in increasing our cash position in recent years through product sales of Oxandrin^® and our authorized generic Oxandrin brand equivalent product, oxandrolone, due to a substantial decline in sales. Although we have considered divesting Oxandrin and oxandrolone, any proceeds of such a divestiture would not significantly improve our cash position and we do not have further non-core assets to divest.

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Although our Board of Directors may from time-to-time evaluate strategic alternatives available to us to maximize value, we are proceeding with our commercialization of KRYSTEXXA in the United States, and we will continue to consider our options for commercialization outside of the United States, including pursuing commercially viable partnership opportunities in the EU and other foreign jurisdictions. Our future capital requirements will depend on many factors, including:

• the cost of commercialization activities, including product marketing, sales and distribution,

• the cost of clinical development activities, if any, directed to potential label expansion for KRYSTEXXA in the United States, EU and other foreign countries,

• the cost and results of our post-approval commitments to the FDA and European Medicines Agency, as applicable,

• our ability to establish and maintain additional collaborative arrangements relating to the commercialization of KRYSTEXXA in the EU or in other jurisdictions outside of the United States, and

• the cost of manufacturing activities.

Based on our current commercialization plans for KRYSTEXXA, including, among other things, our anticipated expenses relating to sales and marketing activities, the cost of purchasing additional inventory, the cost of clinical development activities and our post marketing commitments for KRYSTEXXA in the United States, our current strategy with respect to adjustments to the timelines for initiation and completion of post authorization commitments in the EU, and assuming that we are able to generate KRYSTEXXA revenues at the level that we are currently expecting after taking into account our current strategy to evaluate and pursue aggressive price increases when appropriate, we believe that our available cash, cash equivalents and short-term investments will be sufficient to fund our anticipated level of operations for at least the next twelve months from the date hereof. This estimate also reflects the ongoing effects of our July 2012 and May 2013 reorganization plans, which we expect will generate significant operating expense savings going forward.

We expect that the cash needed to repay our indebtedness, successfully commercialize KRYSTEXXA in the United States and the rest of the world and to seek regulatory approvals in other foreign countries will be substantial, and we may need to seek additional funding through customary methods or explore a strategic licensing or co-promotion transaction in certain territories as a means of raising additional funding. Should we elect to seek additional funding through customary methods, we may not be able to obtain additional financing or, if such financing is available, such financing may not be on terms that are acceptable to us. If we raise additional funds by issuing equity securities, dilution to our then-existing stockholders will result. If we issue preferred stock, it would likely include a liquidation preference and other terms that would adversely affect our common stockholders. If we raise additional funds through the issuance of debt securities or borrowings, we may incur substantial interest expense and could become subject to financial and other covenants that could restrict our ability to take specified actions, such as incurring additional debt or making capital expenditures. If we pursue a strategic licensing or co-promotion transaction, one may not be available to us or may only be available on terms that are not acceptable to us. There are substantial limitations in the indenture governing the 2019 Notes on our ability to issue additional debt securities. If additional funds are not available on favorable terms, or at all, our business, results of operations and financial condition may be materially adversely affected, and we may be required to curtail or cease operations.

Current economic conditions may adversely affect our liquidity and financial condition.

The economies of the United States and other countries, particularly in the EU, continue to be affected by the economic conditions that began with the financial and credit liquidity crisis in late 2008. Although economic conditions began to improve during 2011 and continued to improve into 2012 and 2013, there continues to be significant uncertainty as to whether this improvement is sustainable. Furthermore, energy costs, geopolitical issues, sovereign debt issues, and the depressed state of global real estate markets have contributed to increased market volatility. Continued market volatility could adversely affect our stock price, liquidity and overall financial condition.

Our business partners, including the suppliers on which we depend, may be adversely affected by a worsening of the current economic conditions. We cannot fully predict to what extent our business partners and suppliers may be negatively affected and thus to what extent our operations would in turn be affected. We invest our cash, cash equivalents and short-term investments primarily in demand deposits and other short-term instruments with maturities of one year or less at the date of purchase. Since the advent of the global financial crisis in the first calendar quarter of 2008, we have maintained a balance in our investment strategy between objectives of safety of principal, liquidity and return by investing primarily in short-term United States Treasury obligations.

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If we market KRYSTEXXA in a manner that violates U.S. healthcare fraud and abuse laws, or if we violate false claims laws or fail to comply with our reporting and payment obligations under the Medicaid Rebate Program or other US governmental pricing programs, we may be subject to civil or criminal penalties or additional reimbursement requirements and sanctions, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

The FDA enforces laws and regulations which require that the promotion of pharmaceutical products be consistent with the approved prescribing information. While physicians may prescribe an approved product for a so-called “off label” use, it is unlawful for a pharmaceutical company to promote its products in a manner that is inconsistent with its approved label and any company which engages in such conduct can subject that company to significant liability. Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies from engaging in off-label promotion and regulatory agencies in various countries enforce violations of the code with civil penalties. While we use both internal and external resources to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings. In addition to FDA restrictions on the marketing of pharmaceutical products, several other types of state and federal healthcare fraud and abuse laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include anti-kickback statutes and false claims statutes. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our business activities could be subject to challenge under one or more of these laws.

The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federally financed healthcare program. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending such healthcare items or services may be subject to scrutiny if they do not qualify for an exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement in order to have a claim paid. In recent years, several pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers, reporting inflated average wholesale prices to pricing services that were then used by federal programs to set reimbursement rates and engaging in off-label promotion that caused claims to be submitted to Medicaid for non-covered, off-label uses. Such activities have been alleged to cause the resulting claims for reimbursement to be “false” claims. Most states also have statutes or regulations similar to the federal anti-kickback and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

We participate in the federal Medicaid Rebate Program established by the Omnibus Budget Reconciliation Act of 1990, as well as several state supplemental rebate programs. Under the Medicaid Rebate Program, we pay a rebate to each state Medicaid program for our products that are reimbursed by those programs. Federal law requires that any company that participates in the Medicaid Rebate Program extend comparable discounts to qualified purchasers under the Public Health Service Act pharmaceutical pricing program, which requires us to sell our products to certain customers at prices lower than we otherwise might be able to charge. If products are made available to authorized users of the Federal Supply Schedule, additional pricing laws and requirements apply. Pharmaceutical companies have been prosecuted under federal and state false claims laws in connection with allegedly inaccurate information submitted to the Medicaid Rebate Program, for knowingly submitting or using allegedly inaccurate pricing information in connection with federal pricing and discount programs or for failing to file or timely file periodic drug pricing reports to the Medicaid Rebate Program.

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Pricing and rebate calculations vary among products and programs. The calculations are complex and are often subject to interpretation by us or our contractors, governmental or regulatory agencies and the courts. Our methodologies for calculating these prices could be challenged under false claims laws or other laws. We or our contractors could make a mistake in calculating reported prices and required discounts, revisions to those prices and discounts, determining whether a revision is necessary or we or our contractors may fail to timely file such calculations which could result in retroactive rebates (and interest and penalties, if any). Governmental agencies may also make changes in program interpretations, requirements or conditions of participation, some of which may have implications for amounts previously estimated or paid. If this were to occur or if we were to fail to file or timely file periodic drug pricing reports as required, we could face, in addition to prosecution under federal and state false claims laws, substantial liability and civil monetary penalties, exclusion of our products from reimbursement under government programs, criminal fines or imprisonment or the entry into a Corporate Integrity Agreement, Deferred Prosecution Agreement, or similar arrangement.

In addition, federal legislation now imposes additional requirements. For example, as part of the PPACA, a federal physician payment disclosure provision based on the Physician Payments Sunshine Act was enacted, which requires pharmaceutical manufacturers to report certain transfers of value to physicians and teaching hospitals beginning in 2013. The implementation of this legislation is complex and requires the addition of policies and technology solutions that may not be effective in accurately capturing all reportable data. Failure to report all information accurately and in a timely manner could subject companies to significant financial penalties.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations could be costly. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations, including anticipated activities conducted by our sales team in the sale of KRYSTEXXA, are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Our conduct of the U.S. observational study in a commercial patient population contemplates that participating clinical sites will bill third-party payors for the cost of KRYSTEXXA and physician and infusion services which are incidental to the normal and ordinary therapeutic use of KRYSTEXXA. The clinical trial sites will separately bill us, and we will pay for, any additional tests and services which are required by the study protocol and not incidental to the normal and ordinary use of KRYSTEXXA. Under certain circumstances, a payment being made to a physician or other healthcare provider who is using a commercially available product and billing third parties for its use may be found to be in violation of the federal Anti-Kickback Statute, the federal False Claims Act, and various other federal and state laws. If our conduct of the observational study for KRYSTEXXA is found to be in violation of these laws or any other governmental regulations, we may be subject to significant civil, criminal and administrative penalties, damages, fines, or exclusion from government funded healthcare programs, such as Medicare and Medicaid, which could result in the curtailment or restructuring of our operations.

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Foreign governments tend to impose strict price controls, which may adversely affect our revenues.

In some foreign countries, particularly the member states of the EU and Canada, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take, at a minimum, an additional six to 12 months after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval for KRYSTEXXA in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. The conduct of such a clinical trial would be expensive and result in delays in commercialization of KRYSTEXXA in such markets. If reimbursement is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

Moreover, the Medicare Modernization Act, or the MMA, contains provisions that may change United States importation laws and expand pharmacists’ and wholesalers’ ability to import lower priced versions of certain drugs from Canada, where there are government price controls. Controlled substances, biological products and certain other drugs that are infused, inhaled or intravenously injected are exempt from these provisions, but it is possible that changes to the law could be made that would impact the ability to import these types of products. These changes to United States importation laws will not take effect unless and until the Secretary of Health and Human Services, or HHS, certifies that the changes will pose no additional risk to the public’s health and safety and will result in a significant reduction in the cost of products to consumers. This certification has not yet been made, and the Secretary of HHS has not announced any plans to do so. Even if the importation provisions of the MMA do not become effective, a number of other federal legislative proposals have been offered to implement similar changes to United States importation laws and to broaden permissible imports in other ways, such as expanding the number of countries from which importation is allowed. If the MMA importation provisions become effective, or if similar legislation or regulatory changes are enacted, this could permit more widespread importation of drugs from foreign countries into the United States. This may include re-importation from foreign countries where the drugs are sold at lower prices than in the United States. Such legislation, or similar regulatory changes, could decrease the revenue we receive for any approved products, which, in turn, could adversely affect our operating results, our overall financial condition and liquidity.

As part of the European Commission’s approval of our marketing authorization for KRYSTEXXA, we are required to undertake post-marketing commitments, including certain clinical trials primarily focused on further examining safety aspects of treatment with KRYSTEXXA. These clinical studies are costly and are required to be conducted regardless of whether we consummate a partnership for EU commercialization and thus may adversely affect our liquidity and financial condition. If we fail to conduct these post-marketing commitments, maintenance of our marketing authorization could be at risk and if lost this could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

As part of our European Commission approval, in order to further evaluate additional safety data associated with the administration of KRYSTEXXA, we are required to conduct an observational trial in 500 patients treated with KRYSTEXXA for as long as they are on treatment plus three months post treatment with KRYSTEXXA. Additionally, we are required to perform a clinical study to verify the appropriate dosing in patients weighing greater than 100kg and a clinical study looking at an alternate dosing regimen which could reduce the frequency of gout flares seen with the onset of treatment with KRYSTEXXA. The cost of these post-marketing commitment clinical trials is estimated to be $25 to $30 million which would be incurred over a period of approximately five years. As previously stated, we do not plan to launch KRYSTEXXA on our own in Europe and will instead pursue commercially viable collaboration and partnership opportunities in the EU, pursuant to the terms of which the cost of these post-marketing commitment clinical trials could either be absorbed by the partner or funded by payments that we receive. If we are unable to consummate a collaboration or partnership for the EU, or if such an arrangement is terminated, our ability to fund our post-marketing commitments may be harmed, or our liquidity and financial condition could be adversely affected. If we fail to conduct these post-marketing commitments or obtain modification or relief from these commitments from the European Commission, maintaining our marketing authorization for KRYSTEXXA in the EU could be at risk and if lost our business, results of operations, growth prospects and financial condition may be materially adversely affected.

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We may elect or be required to perform additional clinical trials for other indications or in support of applications for regulatory marketing approval of KRYSTEXXA in jurisdictions outside the United States and EU. These additional trials could be costly and could result in findings inconsistent with or contrary to the data from the clinical trials that supported our United States filings with the FDA, which could restrict our marketing approval of KRYSTEXXA.

Before obtaining regulatory approval for the sale of KRYSTEXXA in their respective jurisdictions, we must provide foreign regulatory authorities with clinical data to demonstrate that KRYSTEXXA is safe and effective. We may also be required, or we may elect, to conduct additional clinical trials or pre-clinical animal studies for or in support of our applications for regulatory marketing approval in jurisdictions outside the United States and EU. Regulatory authorities in jurisdictions outside the United States and EU may require us to submit data from supplemental clinical trials, or pre-clinical animal studies, in addition to data from the clinical trials that supported our United States filings with the FDA. Further, we may decide, or be required by regulators, to conduct additional clinical trials or testing of KRYSTEXXA following its approval in other jurisdictions. For example, we have made a post-approval commitment to the FDA that we will conduct the observational trial to further evaluate and identify any serious adverse events associated with the administration of KRYSTEXXA therapy. Finally, we may conduct additional clinical trials in connection with our efforts to expand the clinical utility of KRYSTEXXA into populations beyond RCG. Clinical trials of KRYSTEXXA must comply with the regulatory requirements of numerous regulatory agencies in other countries. Clinical testing is expensive and difficult to design and implement. Clinical testing can also take many years to complete and the outcome of such testing is uncertain. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful and interim results of a clinical trial do not necessarily predict final results.

Any requirements to conduct supplemental trials would add to the cost of further developing KRYSTEXXA, and we may not be able to complete such supplemental trials. Additional trials could also produce findings that are inconsistent with the data results we have previously submitted to the FDA and EMA, in which case we would be obligated to report those findings to both. This could result in additional restrictions on the marketing approval of KRYSTEXXA, including new safety labeling. Inconsistent trial results could also lead to delays in obtaining marketing approval in the United States for other indications for KRYSTEXXA and could cause regulators to impose restrictive conditions on marketing approvals, including but not limited to the expansion of our REMS program to include distribution and use restrictions, and could even cause our marketing approval to be revoked. Any of these results would materially harm our business and impair our ability to generate revenues and achieve or maintain profitability and adversely affect our liquidity.

If we fail to attract and retain senior management and key personnel, we may not be able to complete the development of or execute upon our commercial and worldwide strategy for KRYSTEXXA.

We depend on key members of our management team. In addition, in recent years, due to challenges we have faced and changes in our senior management, we have relied at various times more heavily on our Board of Directors, particularly our Chairman, Stephen O. Jaeger. The loss of the services of Mr. Jaeger or any member of our senior management team, could harm our ability to complete the development of and execute our commercial strategy for KRYSTEXXA and the strategic objectives for our company. We have employment agreements with key members of our management team, but these agreements are terminable by the individuals on short or no notice at any time without penalty. In addition, we do not maintain, and have no current intention of obtaining, “key man” life insurance on any member of our management team.

Recruiting and retaining qualified scientific and commercial personnel, including clinical development, regulatory, sales and marketing executives and field personnel, is also critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel and based on our company profile. We also experience competition for the hiring of scientific personnel from universities and research institutions. If we fail to recruit and then retain these personnel, we may not be able to effectively pursue the development of and execute our commercial strategy for KRYSTEXXA.

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Expansion of our development and commercialization activities outside of the United States will subject us to an increased risk of inadvertently conducting activities in a manner that violates the U.S. Foreign Corrupt Practices Act and United Kingdom’s Bribery Act of 2010. If that occurs, we may be subject to civil or criminal penalties that could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

We are subject to the U.S. Foreign Corrupt Practices Act, or FCPA, which prohibits corporations and individuals from paying, offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. Additionally, because we conduct business in the United Kingdom, or UK, we are subject to the provisions of the UK Bribery Act of 2010, or UKBA, which prohibits engaging in conduct that results in a bribing a third party in exchange for that person improperly performing a relevant function or activity for purposes of gaining a financial advantage.

In the course of establishing and expanding our commercial operations and seeking regulatory approvals outside of the United States, we will need to establish and expand business relationships with various third parties, such as consultants, advocacy groups and physicians, and we will interact more frequently with foreign officials, including regulatory authorities and physicians employed by state-run healthcare institutions who may be deemed to be foreign officials under the FCPA. Similarly, our interactions with such third parties could be construed as creating potential liability under the UKBA. If our business practices outside the United States are found to be in violation of the FCPA or the UKBA, we may be subject to significant civil and criminal penalties which could have a material adverse effect on our business, financial condition, results of operations, liquidity and growth prospects.

Risks relating to our reliance on third parties

We have no manufacturing capabilities and limited manufacturing personnel. We depend on third parties to manufacture KRYSTEXXA. If these manufacturers fail to meet our manufacturing requirements at acceptable quality levels and at acceptable cost, and if we are unable to identify suitable replacements, our commercialization efforts may be materially harmed.

We have limited personnel with experience in, and we do not own facilities for, the manufacturing of any of our products. We depend on third parties to manufacture KRYSTEXXA. We have entered into commercial supply agreements with third-party manufacturers, including:

• Bio-Technology General (Israel) Ltd., or BTG, for the production of the pegloticase drug substance,

• NOF Corporation of Japan, or NOF, for the supply of mPEG-NPC, a key raw material in the manufacture of the pegloticase drug substance, or drug substance, and

• Sigma-Tau PharmaSource, Inc., or Sigma-Tau, for the filling and packaging functions to finish the KRYSTEXXA drug product.

These companies are our sole source suppliers for the mPEG-NPC, the drug substance and the KRYSTEXXA drug product.

Our third-party manufacturers have limited experience manufacturing KRYSTEXXA on a sustained basis. In addition, based on our current long-range forecast of market demand, our contract manufacturers will need to only periodically run manufacturing campaigns to produce drug substance as well as finished product to meet market demand. If our contract manufacturers experience difficulties in maintaining competency to manufacture KRYSTEXXA drug substance and finished product on this periodic schedule, or if the cost of these periodic manufacturing campaign is uneconomical to us, we may not be able to produce KRYSTEXXA in a sufficient quantity to meet future demand, or at a satisfactory cost, which would adversely affect our projected revenues and gross margins.

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Moreover, the FDA has previously identified manufacturing deficiencies and violations of cGMP at one of our manufacturers in 2010. Some of these deficiencies were significant and required substantial capital to remediate. Although we believe that these violations and deficiencies have since been remediated, the FDA may identify further violations or deficiencies in future inspections of our manufacturers’ facilities, which may impede their ability to timely provide us with product, if they are able to do so at all.

In addition, BTG is located in Israel. Future hostilities in the Middle East could harm BTG’s ability to supply us with drug substance and could harm our commercialization efforts. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured products ourselves, including:

• reliance on the third party for regulatory compliance, quality assurance and adequate training in management of manufacturing staff,

• the possible breach of the manufacturing agreement by the third party because of factors beyond our control, and

• the possibility of termination or non-renewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.

Any of these risks could cause us to be unable to obtain sufficient quantities of KRYSTEXXA to meet future demand, which would adversely affect our projected revenues and gross margins.

In the past, we experienced some batch failures of KRYSTEXXA based on one manufacturing specification. When our third-party manufacturers recommence manufacturing KRYSTEXXA for us, if we experience additional batch failures in the future, our gross margin in selling KRYSTEXXA will decrease and we may not have enough product to meet demand and the FDA may require us to take further steps to address issues related to our manufacturing process, any of which could materially harm our business and commercialization efforts.

In the second half of 2010, we experienced some batch failures of KRYSTEXXA based on one manufacturing specification. Although we believe that these batch failures are within normal industry failure rates experienced for the commencement of biologic commercial manufacturing, this failure rate is nonetheless above the level that we believe to be acceptable for normal ongoing operations. With the assistance of an outside manufacturing and quality consulting firm, we completed a review of these batch failures. Although we believe that we identified the root cause of the batch failures, we may experience further batch failures when our third-party manufacturers recommence manufacturing for us. Under our direction, our third-party contract manufacturers have implemented remediation steps that we believe will continue to minimize or eliminate these failures in the future. However, the remediation steps that we have implemented may fail to minimize or eliminate future batch failures.

If we again experience rates of batch failures above levels that are acceptable for normal ongoing manufacturing operations, then our cost of producing KRYSTEXXA will increase and our gross margin in selling KRYSTEXXA will decrease. We may also have insufficient product to meet demand, and our revenues would suffer. If we are unable to meet demand for an extended period of time we may also experience a decrease in market demand. In addition, the FDA could require us to take further steps to reduce this batch failure rate, which could be costly and could require us to stop manufacturing KRYSTEXXA in order to implement these further remediation steps. Any reduction in our gross margin, inability to meet demand or FDA requirement to implement further remediation steps could materially harm our business and commercialization efforts.

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The manufacture and packaging of pharmaceutical products such as KRYSTEXXA are subject to the requirements of the FDA and similar foreign regulatory bodies. If we, or our third-party manufacturers, fail to satisfy these requirements, our product development and commercialization efforts may be materially harmed.

The manufacture and packaging of pharmaceutical products, such as KRYSTEXXA, are regulated by the FDA and similar foreign regulatory bodies and must be conducted in accordance with the FDA’s cGMPs and comparable requirements of foreign regulatory bodies. Our third-party manufacturers, including BTG, Sigma-Tau and NOF, are subject to periodic inspection by the FDA and similar foreign regulatory bodies. If our third-party manufacturers do not pass such periodic FDA or other regulatory inspections for any reason, including equipment failures, labor difficulties, failure to meet stringent manufacturing, quality control or quality assurance practices, or natural disaster, our ability to execute upon our commercial strategy for KRYSTEXXA will be jeopardized. Failure by us, or our third-party manufacturers, to comply with applicable regulations, requirements, or guidelines could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant approval of pending marketing applications for our product, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business.

A significant disruption at our manufacturing facility based in Israel could materially and adversely affect our business, financial position and results of operations.

We have concentrated third-party manufacturing facilities in Israel. A significant disruption resulting from, but not limited to, fire, tornado, storm, flood, cyber-attacks, geopolitical unrest, terror attacks, acts of war or pandemic could impair the facilities’ abilities to develop, produce and/or ship products on a timely basis, which could have a material adverse effect on our business, financial position, liquidity and operating results.

Qualifying a global secondary source supplier of drug substance, any other change to any of our third-party manufacturers for KRYSTEXXA or any change in the location where KRYSTEXXA is manufactured requires prior health authority review, approval of the manufacturing process and procedures for KRYSTEXXA manufacture. This qualification, regulatory review and approval will be costly and time consuming and could delay or prevent the manufacture of KRYSTEXXA at such facility.

We are continuing our re-evaluation of whether to continue our efforts to validate Fujifilm Diosynth Biotechnologies USA LLC, or Fujifilm, as a potential secondary source supplier of the pegloticase drug substance used in the manufacture of KRYSTEXXA. Should we proceed, this supplier is required to produce validation batches of the drug substance to demonstrate to the relevant health authorities in the countries where KRYSTEXXA is approved, including the FDA, in connection with theirs consideration of Fujifilm as a secondary source supplier, that the materials produced by this supplier are comparable to those produced at BTG. If we do not establish to the satisfaction of the relevant health authorities that the drug substance manufactured by the potential secondary source supplier is comparable to the drug substance manufactured at BTG, we will not be permitted to use the drug substance manufactured by the secondary source supplier in the formulation of KRYSTEXXA for marketing in such country. During the first quarter of 2010, the conformance batch production campaign commenced, and as a result of batch failures, based on one manufacturing specification, the campaign was terminated in December 2010. We renegotiated the agreement with Fujifilm in June 2011.

If a health authority requires that we conduct clinical or non-clinical trials to demonstrate that the drug substance manufactured by Fujifilm is equivalent to the drug substance manufactured by BTG, we would incur significant additional costs and delays in qualifying Fujifilm for the drug substance. If we elect to manufacture the drug substance used in KRYSTEXXA at the facility of another third-party supplier, if we elect to utilize a new facility to fill and finish KRYSTEXXA or if we change the location where KRYSTEXXA is manufactured, we would need to ensure that the new facility and the manufacturing process are in substantial compliance with the relevant heath authority’s cGMPs and obtain prior approval. Any such new facility could also be subject to a pre-approval inspection by the relevant health authority, and a successful technology transfer and subsequent validation of the manufacturing process would be required by such health authority, all of which are expensive and time-consuming endeavors. Any delays or failures in satisfying these requirements could delay our ability to manufacture KRYSTEXXA in quantities sufficient to satisfy market demand and our needs for any future clinical trials or other development purposes.

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If the company from which we source our mPEG-NPC is unable to supply us with product, our business may suffer.

We procure mPEG-NPC, a key raw material in the manufacture of drug substance, from a single supplier, NOF, whose manufacturing facilities are in Japan. Our contract with NOF requires us to purchase this material on an exclusive basis from NOF. Although we have a contractual right to procure this material from another supplier in the event of a supply failure, procuring this material from another source would require time and effort which may interrupt the supply of mPEG-NPC and thereby cause an interruption of the supply of drug substance and KRYSTEXXA to the marketplace and for any future clinical trials or other development purposes. For example, the FDA could require that we conduct additional clinical or non-clinical trials in support of the change to a new manufacturer, which could result in significant additional costs or delays. Any interruption of supply of mPEG-NPC could cause harm to our business.

If the company on which we rely for fill and finish services for KRYSTEXXA is unable to perform these services for us, our business may suffer.

We have outsourced the operation for KRYSTEXXA fill and finish services to a single approved company, Sigma-Tau. Until we determine our path forward with a potential secondary source manufacturing facility, we have placed on hold our efforts to engage a secondary third-party fill and finish manufacturer for KRYSTEXXA and plan to continue to rely on Sigma-Tau for fill and finish services for the foreseeable future. At this time, we do not have redundancy in our supply chain for these fill and finish functions and currently have no substitute that can provide these services. If Sigma-Tau is unable to perform these services for us, we would need to identify and engage an alternative company or develop our own fill and finish capabilities. Any new contract fill and finish manufacturer or capabilities that we acquire or develop will need to obtain FDA approval. Identifying and engaging a new contract fill and finish manufacturer or developing our own capabilities and obtaining FDA approval could involve significant cost and delay. As a result, we might not be able to deliver KRYSTEXXA orders on a timely basis, and we might not have sufficient supply to meet our needs for any future clinical trials or other development purposes, any of which would harm our business.

We rely on third parties to conduct our clinical activities and non-clinical studies for KRYSTEXXA and those third parties may not perform satisfactorily, which could impair our ability to satisfy our post-approval commitments to the FDA and any clinical development activities that we may undertake in the future.

We do not independently conduct clinical activities for KRYSTEXXA. We rely on third parties, such as contract research organizations (CROs), clinical data management organizations, medical institutions and clinical investigators to perform these activities, including the observational study for serious adverse events associated with the administration of KRYSTEXXA therapy that the FDA is requiring that we implement as part of its approval of KRYSTEXXA, any additional clinical trials that may be required in the future by the FDA or similar foreign regulatory bodies, and any other clinical studies that we may elect to conduct. We also will rely on these third parties to perform the post-approval non-clinical studies that the FDA is requiring us to conduct for KRYSTEXXA. We use multiple CROs to coordinate the efforts of our clinical investigators and to accumulate the results of our trials. Our reliance on these third parties for clinical activities and non-clinical studies reduces our control over these activities. We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocol for the trial and in accordance with agreed upon deadlines. Moreover, the FDA requires us and third parties acting on our behalf to comply with good clinical practices, or cGCPs, for conducting, recording and reporting the results of clinical trials to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors.

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If these third parties do not successfully carry out their contractual obligations, meet expected deadlines or conduct our clinical development activities in accordance with regulatory requirements or our stated protocols, we may not be able to, or may be delayed in our efforts to, successfully execute upon our commercial strategy, and obtain additional regulatory approvals, for KRYSTEXXA. We also may be subject to fines and other penalties for failure to comply with requirements applicable to the conduct and completion of post-marketing studies and clinical trials within specified timeframes and to the public reporting of clinical trial information on the registry and results database maintained by NIH.

We also rely on third parties to store and distribute drug supplies for our clinical development activities. Any performance failure on the part of such third parties could delay the commercialization of KRYSTEXXA, causing us to incur additional expenses and harming our ability to generate additional revenue.

Risks relating to intellectual property

If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.

We are party to various license agreements and we may enter into additional license agreements in the future. For example, we license exclusive worldwide rights to patents and pending patent applications that constitute the fundamental composition of matter and underlying manufacturing patents for KRYSTEXXA from Mountain View Pharmaceuticals, Inc., or MVP, and Duke University, or Duke. Under the agreement, we are required to use best efforts to bring to market and diligently market products that use the licensed technology.

The agreement requires us to pay to MVP and Duke quarterly royalty payments within 60 days after the end of each quarter based on KRYSTEXXA net sales made in that quarter by us. The royalty rate for a particular quarter ranges between 8% and 12% of net sales based on the amount of cumulative net sales made by us. In addition, and pursuant to the agreement, we are required to make potential separate milestone payments to MVP and Duke if we successfully commercialize KRYSTEXXA and attain specified KRYSTEXXA sales targets. Also under the agreement, for sales made by sub-licensees and not by us, we are required to pay royalties of 20% on any revenues or other consideration we receive from sub-licensees during any quarter. We record the royalty and sales-based milestone payments pursuant to the MVP and Duke agreement as a component of cost of goods sold in our consolidated statements of operations.

The agreement with MVP and Duke remains in effect, on a country-by-country basis, for the longer of 10 years from the date of first sale of KRYSTEXXA in such country or the date of expiration of the last-to-expire patent covered by the agreement in such country. The licensors may terminate the agreement with respect to the countries affected upon our material breach, if not cured within a specified period of time, immediately after our third or subsequent material breach of the agreement or our fraud, willful misconduct or illegal conduct. The licensors may also terminate the agreement in the event of our bankruptcy or insolvency. Upon a termination of the agreement in one or more countries, all intellectual property rights, regulatory applications and pre-clinical and clinical data conveyed to us by MVP and Duke under the agreement with respect to the terminated countries, revert to MVP and Duke and we are permitted to sell off any remaining inventory of KRYSTEXXA for such countries.

In addition, we could have disputes with our current and future licensors regarding, for example, the interpretation of terms in our agreements. Any such disagreements could lead to delays in the development or commercialization of any potential products or could result in time-consuming and expensive litigation or arbitration, which may not be resolved in our favor.

If we fail to comply with our obligations under these agreements, we could lose the ability to commercialize KRYSTEXXA, which could require us to curtail or cease our operations.

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If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, the value of our technology and products will be adversely affected.

Our success will depend in large part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technology and products. The patent situation in the field of biotechnology and pharmaceuticals is highly uncertain and involves complex legal and scientific questions. We may not be able to obtain additional issued patents relating to our technology or products. Even if issued, patents may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length or term of patent protection we may have for our products. Generic forms of our product Oxandrin were introduced to the market in late 2006. As a result, our results of operations have been harmed. The composition of matter, methods of manufacturing and methods of use patents expire and, if issued, patent applications relating to KRYSTEXXA would expire between 2019 and 2026. Changes in either patent laws or in the interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property or narrow the scope of our patent protection. For example, the PPACA allows applicants seeking approval of biosimilar or interchangeable versions of biological products like KRYSTEXXA to initiate a process for challenging some or all of the patents covering the innovator biological product used as the reference product. This process is complicated and could result in the limitation or loss of certain patent rights. In addition, such patent litigation is costly and time-consuming and may adversely affect our overall financial condition and liquidity.

Our patents also may not afford us protection against numerous competitors with similar technology. Patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing and in some cases not at all. Therefore, because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that we or they were the first to develop the inventions claimed in issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set forth in these patent applications. Even in the event that our patents are upheld as valid and enforceable, they may not foreclose potential competitors from developing new technologies or “workarounds” that circumvent our patent rights. This means that our patent portfolio may not prevent the entry of a competitive product into the market. In addition, patents generally expire, regardless of their date of issue, 20 years from the earliest claimed non-provisional filing date. As a result, the time required to obtain regulatory approval for a product candidate may consume part or all of the patent term. We are not able to accurately predict the remaining length of the applicable patent term following regulatory approval of any of our product candidates.

If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.

In addition to patented technology, we rely upon unpatented proprietary technology, processes and know-how. We seek to protect this information in part through confidentiality agreements with our employees, consultants and third parties. If any of these agreements are breached, we may not have adequate remedies for any such breach. In addition, any remedies we may seek may prove costly. Furthermore, our trade secrets may otherwise become known or be independently developed by competitors. If we are unable to protect the confidentiality of our proprietary information and know-how, competitors may be able to use this information to develop products that compete with our products, which could adversely affect our business.

If we infringe or are alleged to infringe intellectual property rights of third parties, our business may be adversely affected.

Our development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe or be claimed to infringe patents or patent applications under which we do not hold licenses or other rights. We are aware of patent applications filed by, and patents issued to, other entities with respect to technology potentially useful to us and, in some cases, related to products and processes being developed by us. Third parties may own or control these patents and patent applications in the United States and abroad. These third parties could bring claims against us, our licensors or our collaborators that would cause us to incur substantial expenses. If such third-party claims are successful, we could be liable for substantial damages. Further, if a patent infringement suit were brought against us, our licensors or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.

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As a result of patent infringement claims, or in order to avoid potential claims, we, our licensors or our collaborators may choose or be required to seek a license from the third party and be required to pay license fees, royalties or both. These licenses may not be available on acceptable terms or at all. Even if we, our licensors or our collaborators were able to obtain a license, our rights may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms. This could harm our business significantly.

The pharmaceutical and biotechnology industries have experienced substantial litigation and other proceedings regarding patent and other intellectual property rights. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the U.S. Patent and Trademark Office and opposition proceedings in the European Patent Office or in another patent office, regarding intellectual property rights with respect to our products and technology. The costs to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could adversely affect our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

In the future, we may be involved in costly legal proceedings to enforce or protect our intellectual property rights or to defend against claims that we infringe the intellectual property rights of others.

Litigation is inherently uncertain and an adverse outcome could subject us to significant liability for damages or invalidate our proprietary rights and adversely impact our ability to market and further develop KRYSTEXXA. Legal proceedings that we initiate to protect our intellectual property rights could also result in counterclaims or countersuits against us. Any litigation, regardless of its outcome, could be time consuming and expensive to resolve and could divert our management’s time and attention. Any intellectual property litigation also could force us to take specific actions, including any of the following:

• cease selling products or undertaking processes that are claimed to be infringing a third party’s intellectual property,

• obtain licenses to make, use, sell, offer for sale or import the relevant technologies from the intellectual property’s owner, which licenses may not be available on reasonable terms or at all,

• redesign products or processes that are claimed to be infringing a third party’s intellectual property, or

• pursue legal remedies with third parties to enforce our indemnification rights, which may not adequately protect our interests.

We have been involved in several lawsuits and disputes regarding intellectual property in the past. We could be involved in similar disputes or litigation in the future. An adverse decision in any intellectual property litigation could have a material adverse effect on our business, results of operations, financial condition and liquidity.

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Risks relating to our results of operations, common stock and indebtedness.

We have incurred operating losses since 2004 and we have incurred and anticipate that we will continue to incur substantial expenses in connection with our commercial launch of KRYSTEXXA in the United States and further development and efforts to obtain regulatory approval for KRYSTEXXA outside of the United States. If we do not generate significant revenues from the sale of KRYSTEXXA, we will not be able to achieve profitability.

Our ability to achieve operating profitability in the future depends on the successful commercialization and further development of KRYSTEXXA. We have incurred and expect to continue to incur significant expenditures in connection with the commercialization of KRYSTEXXA in the United States and our further development and efforts to seek regulatory approval for KRYSTEXXA outside of the United States when pursued. If sales revenue from KRYSTEXXA is insufficient, we may never achieve operating profitability. Even if we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

(*)We have substantial indebtedness that may adversely affect our cash flow and otherwise negatively affect our operations.

We have $293.4 million in principal amount of outstanding secured and unsecured notes, consisting of our 2018 Convertible Notes and our 2019 Notes. The 2018 Convertible Notes bear interest at a rate of 4.75% per year. The 2019 Notes were issued in an original principal amount equal to 73.78% of their fully accreted principal amount. In addition to the accretion of principal, the 2019 Notes have a cash coupon interest rate of 3% in the first three years and a cash coupon interest rate of 12% per year thereafter. The 2019 Notes will reach their contractually accreted principal amount on May 9, 2015, and will mature on May 9, 2019.

We may in the future incur additional indebtedness, including long-term debt, credit lines and property and equipment financings to finance capital expenditures. We intend to satisfy our current and future debt service obligations from cash generated by our operations, our existing cash and investments and, in the case of principal payments at maturity, funds from external sources. We may not have sufficient funds and we may be unable to arrange for additional financing to satisfy our principal or interest payment obligations when those obligations become due. Funds from external sources may not be available on acceptable terms, or at all.

Our indebtedness could have significant additional negative consequences, including:

• increasing our vulnerability to general adverse economic and industry conditions,

• limiting our ability to obtain additional financing,

• requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including funding our commercial operations, capital expenditures and research and development,

• limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete, and

• placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.

Moreover, the indentures governing both series of our notes provide for repurchase by us, at the note-holders’ option, under certain circumstances. In the event we are required to repurchase all or a substantial portion our outstanding indebtedness, our business will be materially adversely affected.

In addition, the indenture governing our 2019 Notes contains a number of restrictive covenants that impose significant operating and financial restrictions on us and may limit our ability to engage in acts that may be in our long-term best interest, including restrictions on our ability to:

• incur additional indebtedness and guarantee indebtedness,

• pay dividends or make other distributions or repurchase or redeem capital stock,

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• prepay, redeem or repurchase certain debt,

• issue certain preferred stock or similar equity securities,

• make loans and investments,

• sell assets,

• incur liens,

• enter into transactions with affiliates,

• alter the businesses we conduct,

• enter into agreements restricting our subsidiaries’ ability to pay dividends, and

• consolidate, merge or sell all or substantially all of our assets.

However, while the indenture governing the 2019 Notes places limitations on our ability to pay dividends or make other distributions, repurchase or redeem capital stock, and make loans and investments, these limitations are subject to significant qualifications and exceptions. You should read our more detailed descriptions of indebtedness and the indenture governing our 2019 Notes in our filings with the SEC, as well as the documents themselves, for further information about these covenants.

We expect to need to raise substantial additional capital in order to repay our indebtedness when it matures. If we are not able to raise the necessary capital on favorable terms, or at all, our business, results of operations and financial condition may be materially adversely affected, and we may be required to curtail or cease operations.

We expect sales of Oxandrin and oxandrolone to continue to decrease, which may continue to harm our results of operations.

Sales of Oxandrin and oxandrolone have declined substantially in recent years due to generic competition. Our sales of Oxandrin and oxandrolone in the United States are also affected by fluctuations in the buying patterns of the three major drug wholesalers to which we principally sell these products. In the past, wholesalers have reduced their inventories of Oxandrin and oxandrolone. We expect that wholesalers will keep their inventory levels flat or continue to reduce them as a result of generic competition, which could further decrease our revenues from these products.

Sales of Oxandrin and oxandrolone have also decreased as a result of the elimination of reimbursement, or limited reimbursement practices, by some states under their AIDS Drug Assistance Programs via their state Medicaid programs for HIV/AIDS prescription drugs, including Oxandrin and oxandrolone. Other state formularies may follow suit.

In addition, we no longer have an effective agreement with a third-party manufacturer to produce Oxandrin and oxandrolone tablets and therefore our ability to supply the market with Oxandrin and oxandrolone will be materially diminished and our existing market share will decrease.

An event of default under our outstanding indebtedness would irreparably harm our business.

An uncured event of default or cross-default under our 2018 Convertible Notes or our 2019 Senior Notes would result in the acceleration of this indebtedness. In such an event, unless we were able to find alternative means to refinance our outstanding indebtedness or to agree with other holders of our indebtedness not to demand immediate payment of our indebtedness, our business and financial condition would be materially and irreparably harmed.

Our stock price is volatile, which could adversely affect your investment.

Our stock price has been, and will likely continue to be, volatile. The stock market in general and the market for biotechnology companies in particular has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price of our common stock may be influenced by many factors, including:

• the cost of commercialization activities, including product marketing, sales and distribution,

• whether we are successful in marketing and selling KRYSTEXXA,

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• market acceptance of KRYSTEXXA by physicians and patients in this largely previously untreated patient population,

• the cost of our post-approval commitments to the FDA, including an observational study and a REMS program,

• the price that we charge for KRYSTEXXA and under what conditions private and public payors will reimburse patients for KRYSTEXXA,

• whether and when we face generic or other competition with respect to KRYSTEXXA,

• our ability to maintain a sufficient inventory of KRYSTEXXA to meet commercial demand,

• the timing and costs of regulatory approval for KRYSTEXXA in any countries other than the United States and EU,

• the timing of any future capital raising transactions by us, and the structure of such transactions and amount of capital raised,

• our ability to conclude collaborations and partnerships in the EU and other regions of the world on terms favorable to us,

• our ability to successfully obtain a complete dismissal of the remaining claims of the creditor derivative action brought by one of the holders of our Senior Notes,

• announcements of technological innovations or developments relating to competitive products or product candidates,

• market conditions in the pharmaceutical and biotechnology industries and the issuance of new or revised securities analyst reports or recommendations,

• period-to-period fluctuations in our financial results,

• legal and regulatory developments in the United States and foreign countries, and

• other factors described in this “Risk Factors” section.

This volatility may impose a greater risk of capital losses for our stockholders than a less volatile stock, and may make it difficult to ascribe a stable valuation to a stockholder’s holdings of our common stock. This volatility may affect the price at which our investors may sell their common stock, and any sale of substantial amounts of our common stock could adversely affect the market price of our common stock.

(*) Our common stock is at risk of being delisted by NASDAQ.

Our common stock is currently listed on The NASDAQ Global Market, or NASDAQ. NASDAQ has minimum financial and other requirements that a company must meet in order to remain listed on NASDAQ. On April 8, 2013, we received a letter from NASDAQ indicating that for 30 consecutive business days the Company’s common stock did not maintain a minimum bid price of $1.00 per share as required by NASDAQ Listing Rule 5450(a)(1). The letter stated that NASDAQ will provide the Company 180 calendar days, or until October 7, 2013, to regain compliance with NASDAQ listing rules. In order to regain compliance, shares of our common stock must maintain a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. If we do not regain compliance by October 7, 2013, NASDAQ will provide written notification to the Company that our common stock is subject to delisting.

If NASDAQ determines to delist our common stock, the delisting could decrease substantially trading in our common stock, affect adversely the market liquidity of our common stock, decrease the trading price of our common stock, increase the volatility of our stock price, decrease analyst coverage of our common stock, decrease investor demand and information available concerning trading prices and volume of our common stock and make it more difficult for investors to buy or sell shares of our common stock. Delisting could also harm our ability to obtain additional financing on acceptable terms, if at all, and could lead to an event of default under our outstanding indebtedness.

While we intend to engage in efforts to regain compliance, and thus maintain our listing on The NASDAQ Global Market, there can be no assurance that we will be able to regain compliance or keep our listing on The NASDAQ Global Market or transfer our listing to an alternate NASDAQ market. Furthermore, if we pursue a reverse stock split to regain compliance, we would not expect to issue fractional shares of our common stock and therefore the holders of our common stock may have all or part of their holdings exchanged for cash based on the closing price of our common stock on the effective date of such reverse stock split rather than retaining their proportional amount of common stock in the Company.

Effecting a change of control of our company could be difficult, which may discourage offers for shares of our common stock.

Our certificate of incorporation and the Delaware General Corporation Law, or the DGCL, contain provisions that may delay or prevent a merger, acquisition or other change of control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions include the requirements of Section 203 of the DGCL. Section 203 prohibits a publicly held Delaware corporation from engaging in a business combination with an “interested stockholder,” generally deemed a person that, together with its affiliates, owns or within the last three years has owned 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:

• our Board of Directors approves the transaction before the third party acquires 15% of our stock,

• the third party acquires at least 85% of our stock at the time its ownership exceeds the 15% level, or

• our Board of Directors and the holders of two-thirds of the shares of our common stock not held by the third-party vote in favor of the transaction.

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We have also adopted a stockholder rights plan intended to deter hostile or coercive attempts to acquire us. Under the plan, which expires in August 2013 at the earliest, if any person or group acquires more than 15% of our common stock without approval of our board of directors under specified circumstances, our other stockholders have the right to purchase shares of our common stock, or shares of the acquiring company, at a substantial discount to the public market price. As a result, the plan makes an acquisition much more costly to a potential acquirer.

Our certificate of incorporation also authorizes us to issue up to 4,000,000 shares of preferred stock in one or more different series with terms fixed by our Board of Directors. Stockholder approval is not necessary to issue preferred stock in this manner. Issuance of these shares of preferred stock could have the effect of making it more difficult for a person or group to acquire control of our company. No shares of our preferred stock are currently outstanding. Although our Board of Directors has no current intention or plan to issue any preferred stock, issuance of these shares could be used as an anti-takeover device.

Product liability lawsuits could cause us to incur substantial liabilities.

We face an inherent risk of product liability exposure related to product sales of KRYSTEXXA, Oxandrin and oxandrolone. We also face the risk of product liability exposure related to the testing of KRYSTEXXA. If we cannot successfully defend ourselves against claims that our products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

• decreased demand for KRYSTEXXA,

• injury to our reputation,

• withdrawal of clinical trial participants,

• withdrawal or recall of a product from the market,

• modification to product labeling that may be unfavorable to us,

• costs to defend the related litigation,

• substantial monetary awards to trial participants or patients, and

• loss of revenue.

We currently have product liability insurance coverage in place, which is subject to coverage limits and deductibles. The amount of insurance that we currently hold may not be adequate to cover all liabilities that may occur. Product liability insurance is difficult to obtain and increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost and we may not be able to obtain insurance coverage with policy limits that will be adequate to satisfy any liability that may arise.

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ITEM 6. EXHIBITS

a) Exhibits

The exhibits listed in the Exhibit Index are included in this report.

SIGNATURES

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

SAVIENT PHARMACEUTICALS , INC . (Registrant)
By:	/s/    Richard Crowley
	Richard Crowley
	Co-President and Chief Operating Officer (Principal Executive Officer)
By:	/s/    Philip K. Yachmetz         Philip K. Yachmetz
	Co-President and Chief Business Officer (Principal Executive Officer)
By:	/s/    John P. Hamill
	John P. Hamill
	Co-President and Chief Financial Officer
	(Principal Financial Officer)
By:	/s/    David G. Gionco
	David G. Gionco
	Group Vice President, Finance
	Chief Accounting Officer
	(Principal Accounting Officer)

Dated: August 14, 2013

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EXHIBIT INDEX

Exhibit No.	Description
10.1	Separation Agreement and General Release, dated July 23, 2013, between the Company and Louis Ferrari*
31.1	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.3	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1	Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS	XBRL Instance Document
101.SCH	XBRL Taxonomy Extension Schema Document
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	XBRL Taxonomy Extension Label Linkbase Document
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document

* Previously filed as an exhibit to, and incorporated by reference from, the Company’s Current Report on Form 8-K filed on July 25, 2013

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