(Source: PRNewswire-FirstCall)
EAST BRUNSWICK, N.J., May 6 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today reported financial results for the three months ended March 31, 2009. For the first quarter of 2009, the Company had a net loss of $21.9 million, or $0.41 per basic and diluted share, on total revenues of $1.1 million compared with a net loss of $17.6 million, or $0.33 per basic and diluted share on total revenues of $1.2 million for the same period in 2008. The Company ended the quarter with $58.1 million in cash and short-term investments, a reduction of $20.5 million during the quarter. In April 2009, we raised $31.0 million from a registered direct offering, which yielded $29.0 million in cash, net of offering and related expenses. Our pro forma cash and short-term investments balance as of March 31, 2009, reflecting receipt of the net proceeds from the April registered direct offering, is $87.1 million.
Operational Highlights: -- Filed key amendments to our Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) to strengthen and clarify data included in our previously submitted BLA. The BLA priority review Prescription Drug User Fee Act (PDUFA) action date was extended by three months to August 1, 2009. -- First published study to document a significant loss in the quality of life and increased functional disability in patients with treatment failure gout appeared in the Journal of Rheumatology.
"We began the year with the notification from the Food and Drug Administration (FDA) of a priority review for KRYSTEXXA and we focused our Company priorities on obtaining FDA approval," said Paul Hamelin, President of Savient. "Early in the quarter, we combined the insights and strategic input of our panel of world class external experts with our internal understanding of this application resulting in our decision to file several key amendments which we believe strengthened and clarified the BLA. The FDA reviewed the amendments and determined that the additional information contained in the submissions constituted major amendments, accepted the amendments to the BLA and elected to extend the current review period and revised our PDUFA date to August 1, 2009. We also took aggressive steps to maintain a stable balance sheet by effectively controlling expenses during the period despite growing resource needs for manufacturing, the approval process and prelaunch preparation. In conjunction with being financially prudent, we successfully completed an important financing in the face of extraordinary market conditions, allowing us to strengthen our cash position as we approach our PDUFA action date. We believe the first quarter of 2009 has been an important transitionary quarter for the Company, resulting in significant progress achieved towards our commitment to bring KRYSTEXXA to the market to treat the disabling aspects of the treatment failure gout population."
Financial Results of Operations for the Three Months Ended March 31, 2009
Total revenues decreased $0.1 million, or 8%, to $1.1 million for the three months ended March 31, 2009, from $1.2 million for the three months ended March 31, 2008. The decrease was due to lower gross product sales of Oxandrin(R), our product that promotes weight gain following involuntary weight loss due to disease or medical condition, as a result of the continued impact of generic competition partially offset by lower provisions for product returns year over year. We expect that revenues from Oxandrin and our authorized generic product oxandrolone will decrease or remain flat in future periods, due to generic competition and overall demand for the product.
Cost of goods sold increased $0.2 million, or 47%, to $0.5 million for the three months ended March 31, 2009, from $0.3 million for the three months ended March 31, 2008. The increase is substantially due to a change in our product mix, as our authorized generic oxandrolone has become a greater percentage of overall gross sales and carries higher costs of sales than Oxandrin.
Research and development expenses increased by $1.6 million, or 14%, to $12.8 million for the three months ended March 31, 2009, from $11.2 million for the three months ended March 31, 2008. The increase was primarily due to $1.8 million of costs associated with the manufacturing of commercial batches of pegloticase active pharmaceutical ingredient (API) by our third-party manufacturer and an additional severance liability recorded during the quarter. Partially offsetting these higher expenses were lower validation and technology transfer costs relating to our secondary source supplier for pegloticase API.
Selling, general and administrative expenses increased $0.2 million, or 2%, to $9.5 million for the three months ended March 31, 2009, from $9.3 million for the three months ended March 31, 2008.
