Spectrum Pharmaceuticals Inc. Reports Operating Results (10-Q)

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Aug 09, 2010
Spectrum Pharmaceuticals Inc. (SPPI, Financial) filed Quarterly Report for the period ended 2010-06-30.

Spectrum Pharmaceuticals Inc. has a market cap of $206.9 million; its shares were traded at around $4.18 with and P/S ratio of 5.44.

Highlight of Business Operations:

Our expenditures for research and development consist of direct product specific costs, including but not limited to, upfront license fees, milestone payments, active pharmaceutical ingredients, clinical trials, patent related costs, and non-product specific, or indirect costs. During the six-month period ended June 30, 2010, our total research and development expenditure, including indirect expenditures, but excluding the $30 million onetime fee for the license of belinostat, was approximately $12.8 million. The principal components of direct expenses for that period relate to the development of apaziquone approximately $3.5 million; belinostat approximately $2.6 million; and ZEVALIN approximately $1.1 million.

During the six-month period ended June 30, 2010, net cash used in operations was approximately $29.4 million, comprised primarily of the upfront payment for belinostat of $30.0 million and $17.5 million received from the out-licensing of apaziquone from Nippon Kayaku and Handok and an enrollment milestone payment from Allergan, off setting operational cash needs. During the six-month period ended June 30, 2009, net cash provided by operations was approximately $4.3 million. The positive operating cash flows in 2009 were primarily attributable to revenues derived from sales of FUSILEV and the arbitration settlement related to ZEVALIN.

During the three-months ended June 30, 2010, we recorded $9.3 million from product sales with approximately $6.9 million related to sales of ZEVALIN and approximately $2.4 million related to sales of FUSILEV (each net of estimates for promotional, price and other adjustments, including adjustment of the allowance for product returns), with a total cost of product sold being approximately $3.6 million. Product revenues recorded in the three-month period ended June 30, 2009 were approximately $6.0 million with approximately $3.3 million related to sales of ZEVALIN and approximately $2.7 million related to sales of FUSILEV, with a total cost of product sold being approximately $1.4 million. The increase in ZEVALIN revenues in 2010 results from a combination of increased sales volume and selling price adjustments. We expect ZEVALIN revenues for the remainder of 2010 to continue at a pace similar to the quarter ended June 30, 2010. Revenues from the sales of FUSILEV have fluctuated in 2009 and 2010. During the 1st and 2nd quarters of 2009, FUSILEV sales were higher due to the supply disruption of leucovorin, described elsewhere herein. The disruption in supply abated in the 2nd quarter of 2009, and subsequent FUSILEV sales were significantly lower than experienced in the 1st half of 2009. Commencing towards the end of the 2nd quarter of 2010, a similar disruption has emerged; and accordingly, the 2nd quarter of 2010 sales of FUSILEV have seen growth over the prior quarter of 2010. We are unable to determine how long the current disruption in supplies of leucovorin will last. During the three-month periods ended June 30, 2010 and 2009, we recognized approximately $2.1 and $2.2 million, of licensing revenues from the amortization of $41.5 million upfront payment we received from Allergan in 2008. We also recognized $1.0 million of licensing revenues from the amortization of the $16.0 million upfront payment we received from Nippon Kayaku and Handok in the first quarter of 2010.

Total research and development expenses were virtually unchanged, being approximately $6.3 million and $6.4 million in the three-month periods ended June 30, 2010 and 2009, respectively (net of approximately $2.2 million and $2.5 million reimbursed by Allergan for development costs related to apaziquone during the same period of 2010 and 2009, respectively). We expect research and development expenses for the remainder of 2010 to continue at a pace similar to the quarter ended June 30, 2010.

During the six-months ended June 30, 2010, we recorded approximately $16.4 million from product sales with approximately $13.4 million related to sales of ZEVALIN and approximately $3.0 million related to sales of FUSILEV (each net of estimates for promotional, price and other adjustments, including adjustment of the allowance for product returns), with a total cost of product sold being $6.8 million. Product revenues recorded in the six-month period ended June 30, 2009 were approximately $18.1 million with approximately $5.9 million related to sales of ZEVALIN and approximately $12.2 million related to sales of FUSILEV, with a total cost of product sold being $3.2 million. The increase in ZEVALIN sales is attributable to a combination of increases in unit sales and selling prices. Revenues from the sales of FUSILEV have fluctuated in 2009 and 2010. During the 1st and 2nd quarters of 2009, FUSILEV sales were higher due to the supply disruption of generic leucovorin, described elsewhere herein. The disruption in supply abated in the 2nd quarter of 2009, and subsequent FUSILEV sales were significantly lower than experienced in the 1st half of 2009. Commencing in the 2nd quarter of 2010, a similar disruption has emerged; and accordingly, the 2nd quarter of 2010 sales of FUSILEV have seen growth over the prior quarter of 2010. We are unable to determine how long the current disruption in supplies of leucovorin will last. During the six-month periods ended June 30, 2010 and 2009, we recorded approximately $4.2 million and approximately $4.3 million of licensing revenues from the amortization of the $41.5 million upfront payment we received from Allergan in 2008. We also recognized $2.0 million of licensing revenues from the amortization of the $16 million upfront payment we received from Nippon Kayaku and Handok in 2010. In January 2007, we received approximately $0.9 million, representing our 50% share of an economic interest that Aeterna Zentaris had from an arrangement with Nippon Kayaku for certain rights to Ozarelix in Japan and recognized the amount as deferred revenue. During the six-month period ended June 30, 2010, we reevaluated the basis for deferral having determined that there are no further ongoing obligations and recorded approximately $0.9 million as license revenue. No similar revenue was recorded in the same period of 2009.

Total research and development expenses increased by approximately $30.8 million, from approximately $12.0 million in the six-month period ended June 30, 2009 to approximately $42.8 million in the six-month period ended June 30, 2010, primarily related to the one-time $30 million upfront payment for the licensing of belinostat (net of approximately $4.9 million and $5.2 million reimbursed by Allergan for development costs related to apaziquone during the same period of 2010 and 2009, respectively). We expect research and development expenses for the remainder of 2010 to continue at a pace similar to the quarter ended June 30, 2010, excluding the one-time upfront payment of $30.0 million for the licensing of belinostat.

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