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8-K - SAVIENT PHARMACEUTICALS INCrrd325303.htm
EX-99 - PRESS RELEASE DATED NOVEMBER 3, 2011 - SAVIENT PHARMACEUTICALS INCrrd325303_36437.htm
EX-99 - TRANSCRIPT DATED NOVEMBER 3, 2011 - SAVIENT PHARMACEUTICALS INCrrd325303_36436.htm

[Savient Letterhead]

 

Contact:

Mary Coleman Kelly Sullivan / Jennifer Friedman

Savient Pharmaceuticals, Inc. Joele Frank, Wilkinson Brimmer Katcher

information@savient.com ksullivan@joelefrank.com / jfriedman@joelefrank.com

 

Savient Pharmaceuticals Reports Third Quarter 2011 Financial Results

EAST BRUNSWICK, N.J. - (November 3, 2011) - Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today reported financial results for the three and nine months ended September 30, 2011, which reflect the Company's continuing investment in the U.S. launch of KRYSTEXXA(R) (pegloticase). Savient ended the quarter with $202.7 million in cash and short-term investments, a decrease of $37.6 million for the quarter. For the third quarter of 2011, the Company had a net loss of $27.4 million, or $0.39 per share, on total revenues of $2.6 million, compared with a net loss of $59.4 million, or $0.89 per share, on total revenues of $1.0 million for the same period in 2010. The net loss for the first nine months of 2011 was $71.2 million, or $1.02 per share, on total revenues of $5.9 million, compared with a net loss of $72.7 million, or $1.09 per share, on total revenues of $3.1 million for the same period in 2010.

"As pioneers in the refractory chronic gout market, we have spent the last several quarters building the foundation to support the commercialization of this one-of-a-kind treatment," said John H. Johnson, Chief Executive Officer and President. "Through the validation of the importance of our Phase III clinical data published in JAMA and our expanding education programs, we are increasing awareness and understanding of KRYSTEXXA and beginning to change the lives of patients suffering from refractory chronic gout."

Operational Highlights:

Data from two pivotal KRYSTEXXA (pegloticase) Phase III clinical trials in patients with refractory chronic gout (RCG) were published in The Journal of the American Medical Association. The data published demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial proportion of RCG patients for six months, a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies.

Total accounts ordering KRYSTEXXA increased to 329, a gain of 189 for the quarter.

A comprehensive market research study of the U.S. refractory chronic gout market was completed that demonstrated a significant market for KRYSTEXXA.

Four abstracts were accepted for presentation at the American College of Rheumatology Congress.

The executive management team expanded with the addition of a very experienced Chief Medical Officer and Chief Financial Officer.

Financial Results of Operations for the Three Months Ended September 30, 2011

Total revenues increased to $2.6 million, or 161%, for the three months ended September 30, 2011, as compared to $1.0 million for the three months ended September 30, 2010.  The higher net sales for the three months ended September 30, 2011 were the result of the Company's launch of KRYSTEXXA, which generated approximately $1.9 million in revenue for the quarter.

Cost of sales increased by $4.2 million to $4.6 million for the three months ended September 30, 2011, from $0.4 million for the three months ended September 30, 2010. The increase for the three months ended September 30, 2011 was substantially due to a $3.4 million charge against income to reserve for excess KRYSTEXXA inventory that had expiration dates such that it was unlikely the product would be sold.

 

Research and development expenses decreased by $3.1 million, or 35%, to $5.9 million for the three months ended September 30, 2011, from $9.0 million for the three months ended September 30, 2010. The decrease for the three months ended September 30, 2011 was primarily due to costs incurred in the prior year related to commercial batches of KRYSTEXXA that were expensed as research and development expense prior to the U.S. FDA approval. All manufacturing costs for KRYSTEXXA after FDA approval are recorded as inventory as opposed to research and development prior to approval.

Selling, general and administrative expenses increased $15.0 million to $22.3 million for the three months ended September 30, 2011, from $7.3 million for the three months ended September 30, 2010. The higher expenses for the three months ended September 30, 2011 were primarily due to increased selling and marketing expenses associated with the full commercial launch of KRYSTEXXA.

Interest expense on the Company's convertible notes was $3.4 million for the three months ended September 30, 2011.

Conference Call and Webcast

The Company will host a live conference call and webcast beginning at 9:00 a.m. Eastern Time on November 3, 2011 to discuss these results and to answer questions. To participate by telephone, please dial:

Domestic: 866-393-9370

International: 706-679-1207

Conference ID: 17722127

The live and archived webcast can be accessed on the investor relations section of the Savient website at www.savient.com. Please log on to Savient's website fifteen minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.

A telephone replay will be available from 12:00 p.m. Eastern Time on November 3, 2011 through 12:00 a.m. Eastern Time on November 17, 2011 by dialing:

Domestic: 855-859-2056 or 800-585-8367

International: 404-537-3406

Conference ID: 17722127

 

ABOUT SAVIENT PHARMACEUTICALS, INC.

Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA(R)(pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. For more information, please visit the Company's website at www.savient.com.

FORWARD-LOOKING STATEMENTS

All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the safety and efficacy of KRYSTEXXA(R), status of our KRYSTEXXA marketing efforts and additional plans related thereto, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout (RCG) market size, and our market expansion plans including our MAA filing before the EMA are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, our ability to commercialize KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have anticipated; our ability to retain the personnel; our reliance on third parties to manufacture KRYSTEXXA; competition from existing therapies and therapies that are currently under development, including therapies that are significantly less expensive than KRYSTEXXA; our ability to gain market acceptance for KRYSTEXXA among physicians, patients, health care payers and others in the medical community; whether we are able to obtain financing, if needed; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. 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, which speak only as of the date of publication of this press release. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.

 

###

SVNT-I

(Tables to Follow)

 

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

  

September 30,
2011

   

December 31,
2010

 

 

  

(Unaudited)

 

 

 

 

ASSETS

  

     

 

     

Current Assets:

  

     

 

     

Cash and cash equivalents

  

$

154,773

  

 

$

44,791

  

Short-term investments

  

 

47,935

  

 

 

20,070

  

Accounts receivable, net

  

 

3,709

  

 

 

909

  

Inventories, net

  

 

8,004

  

 

 

3,140

  

Prepaid expenses and other current assets

  

 

5,295

  

 

 

2,415

  

 

  

 

 

 

 

 

 

 

Total current assets

  

 

219,716

  

 

 

71,325

  

 

  

 

 

 

 

 

 

 

     

Deferred income taxes, net

  

 

-  

  

 

 

4,200

  

Property and equipment, net

  

 

680

  

 

 

809

  

Deferred financing costs, net

  

 

4,246

  

 

 

-  

  

Other assets (including restricted cash)

  

 

1,280

  

 

 

1,284

  

 

  

 

 

 

 

 

 

 

Total assets

  

$

225,922

  

 

$

77,618

  

 

  

 

 

 

 

 

 

 

     

LIABILITIES AND STOCKHOLDERS' EQUITY

  

     

 

     

Current Liabilities:

  

     

 

     

Accounts payable

  

$

6,947

  

 

$

1,601

  

Deferred revenues

  

 

335

  

 

 

428

  

Deferred income taxes

  

 

5,769

  

 

 

-  

  

Accrued interest on convertible notes

  

 

1,912

  

 

 

-  

  

Other current liabilities

  

 

14,861

  

 

 

16,023

  

 

  

 

 

 

 

 

 

 

Total current liabilities

  

 

29,824

  

 

 

18,052

  

 

  

 

 

 

 

 

 

 

     

Convertible notes, net of discount of $56,155

  

 

173,845

  

 

 

-  

  

Other liabilities

  

 

3,412

  

 

 

10,299

  

Commitments and contingencies

  

     

 

     

Stockholders' Equity:

  

     

 

     

Preferred stock-$.01 par value 4,000,000 shares authorized; no shares issued

  

 

-  

  

 

 

-  

  

Common stock-$.01 par value 150,000,000 shares authorized; 71,473,000 issued and outstanding at September 30, 2011 and 70,259,000 shares issued and outstanding at December 31, 2010

  

 

715

  

 

 

703

  

Additional paid-in-capital

  

 

404,873

  

 

 

364,139

  

Accumulated deficit

  

 

(386,747

)

 

 

(315,576

)

Accumulated other comprehensive income

  

 

-  

  

 

 

1

  

 

  

 

 

 

 

 

 

 

Total stockholders' equity

  

 

18,841

  

 

 

49,267

  

 

  

 

 

 

 

 

 

 

Total liabilities and stockholders' equity

  

$

225,922

  

 

$

77,618

  

 

  

 

 

 

 

 

 

 

 

 

 

SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

 

 

  

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

  

2011

 

 

2010

 

 

2011

 

 

2010

 

Revenues:

  

     

 

     

 

     

 

     

Product sales, net

  

$

2,581

  

 

$

988

  

 

$

5,855

  

 

$

3,068

  

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Cost and expenses:

  

     

 

     

 

     

 

     

Cost of goods sold

  

 

4,584

  

 

 

421

  

 

 

6,008

  

 

 

998

  

Research and development

  

 

5,858

  

 

 

8,958

  

 

 

17,315

  

 

 

22,521

  

Selling, general and administrative

  

 

22,268

  

 

 

7,265

  

 

 

62,761

  

 

 

16,764

  

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

32,710

  

 

 

16,644

  

 

 

86,084

  

 

 

40,283

  

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Operating loss

  

 

(30,129

 

 

(15,656

 

 

(80,229

 

 

(37,215

Investment income, net

  

 

39

  

 

 

33

  

 

 

107

  

 

 

82

  

Interest expense on convertible notes

  

 

(3,406

 

 

-  

  

 

 

(11,393

 

 

-  

  

Other (expense) income, net

  

 

(141

 

 

(43,729

)  

 

 

1,289

  

 

 

(35,525

)  

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Loss before income taxes

  

 

(33,637

 

 

(59,352

 

 

(90,226

 

 

(72,658

Income tax benefit

  

 

(6,245

 

 

-  

  

 

 

(19,055

 

 

-  

  

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Net loss

  

$

(27,392

 

$

(59,352

 

$

(71,171

 

$

(72,658

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Loss per common share:

  

     

 

     

 

     

 

     

Basic and diluted

  

$

(0.39

 

$

(0.89

 

$

(1.02

 

$

(1.09

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

         

Weighted-average number of common and common equivalent shares:

  

     

 

     

 

     

 

     

Basic and diluted

  

 

70,122

  

 

 

67,047

  

 

 

70,037

  

 

 

66,773