Savient Pharmaceuticals Announces Expected Availability of KRYSTEXXATM for Prescription and Reports Third Quarter 2010 Financial Results
EAST BRUNSWICK, N.J., Nov. 4, 2010 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that it plans to commence shipments of KRYSTEXXATM to specialty distributors on November 30, 2010. KRYSTEXXA, a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy, is then expected to be commercially available for prescription as of December 1, 2010. In conjunction with the commercial availability of KRYSTEXXA, Savient plans to launch its reimbursement and pharmacovigilance hotline services on November 22, 2010 for use by prescribers and patients. Savient expects to announce the pricing for KRYSTEXXA at the time it commences commercial distribution.
"The commercial availability of KRYSTEXXA marks another significant milestone for both patients and the company as it is the first FDA approved therapy that addresses a significant unmet medical need in the treatment of chronic gout in adult patients refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals. "We believe that making KRYSTEXXA commercially available is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering from this crippling disease. These patients have been waiting for decades for a therapy that gives them hope of reversing this severely debilitating disease."
Savient also today reported financial results for the three and nine months ended September 30, 2010. The Company ended the quarter with $78.1 million in cash and short-term investments, a decrease of $10.9 million for the quarter and $30.1 million since December 31, 2009. As of November 2, 2010, the Company had $75.7 million in cash and short-term investments.
For the third quarter of 2010, the Company had a net loss of $59.4 million, inclusive of a non-cash valuation adjustment of $43.2 million relating to warrants, or $0.89 per share, on total revenues of $1.0 million, compared with a net loss of $13.9 million, or $0.23 per share on total revenues of $0.3 million for the same period in 2009.
Subsequent to September 30, 2010, warrant holders from our April 2009 registered direct offering exercised warrants to purchase an aggregate of 4.6 million shares of common stock either through a cashless exercise or cash exercise. We received $3.4 million of cash proceeds from the cash exercise portion of these warrants. As a result, the Company's outstanding shares increased from 67.7 million as of September 30, 2010, to 70.3 million as of November 1, 2010, and the warrant liability on our balance sheet has subsequently been reclassified as an increase to stockholders' equity.
The net loss for the first nine months of 2010 was $72.7 million, or $1.09 per share, on total revenues of $3.1 million, compared with a net loss of $90.6 million, or $1.56 per share, on total revenues of $2.1 million for the same period in 2009.
Received U.S. Food and Drug Administration (FDA) approval on September 14, 2010 for KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Three abstracts about pegloticase have been accepted for presentation at the 2010 ACR/ARHP Annual Scientific Meeting addressing various aspects relating to the use of KRYSTEXXA and outcomes in patients with chronic gout refractory to conventional therapy.
A late breaking abstract was submitted to ACR/ARHP in September 2010 entitled Safety and Efficacy of Long-Term Pegloticase (KRYSTEXXA) Treatment in Adult Patients with Chronic Gout Refractory to Conventional Therapy and was accepted for a podium presentation in a general plenary session.
Financial Results of Operations for the Three Months Ended September 30, 2010
Total revenues increased $0.7 million, or 202%, to $1.0 million for the three months ended September 30, 2010, as compared to $0.3 million for the three months ended September 30, 2009. The increased net sales resulted primarily from higher prior year experience adjustments relating to reserves for product returns and customer rebates for our branded product Oxandrin®.
Research and development expenses decreased by $8.7 million, or 49%, to $9.0 million for the three months ended September 30, 2010, from $17.7 million for the three months ended September 30, 2009. The lower expenses resulted primarily from a $5.1 million decrease in manufacturing development related expenses associated with an amendment to the services agreement with our planned secondary source supplier for pegloticase drug substance during the quarter ended September 30, 2009. Additionally, clinical trial costs were lower by $2.2 million resulting from the wind down of the Open Label Extension (OLE) Study for KRYSTEXXA during 2009.
Selling, general and administrative expenses decreased $1.2 million, or 15%, to $7.3 million for the three months ended September 30, 2010, from $8.5 million for the three months ended September 30, 2009.
Other expense, net was $43.7 million for the third quarter of 2010 compared with other income, net of $11.8 million for the third quarter of 2009, an increase in the current period of $55.5 million primarily as a result of the mark-to-market valuation adjustment to our warrant liability. We recorded a $43.2 million non-cash loss due to the appreciation in fair market value of our warrants during the three months ended September 30, 2010 that resulted primarily from a higher price per share of our common stock. Additionally, we recorded an $11.8 million non-cash gain on the mark-to-market valuation adjustment to our warrant liability during the three months ended September 30, 2009 resulting from depreciation in the fair market value of our warrants during that period. As a result of the exercise of all of the outstanding warrants after September 30, 2010, the warrant liability on our balance sheet has subsequently been reclassified as an increase to stockholders' equity.
Savient's management team will host a live conference call and webcast on Friday November 5, 2010, at 9:00 a.m. Eastern Time to review the third quarter 2010 financial results. To participate by telephone, please dial 888-357-3694 (Domestic) or 973-890-8276 (International). The conference identification number is 21650025. 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 15 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 1:00 p.m. Eastern Time on November 5, 2010 through 11:59 p.m. Eastern Time on November 18, 2010 by dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering conference ID number 21650025.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXATM (pegloticase), which was approved by the FDA on September 14, 2010 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® (oxandrolone tablets, USP) CIII in the U.S.