Columbia Laboratories Inc. Reports Operating Results (10-Q)

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Aug 07, 2009
Columbia Laboratories Inc. (CBRX, Financial) filed Quarterly Report for the period ended 2009-06-30.

Columbia Laboratories Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of reproductive healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE prand PROCHIEVE in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and PROCHIEVE for the treatment of secondary amenorrhea. The Company also markets STRIANT for the treatment of hypogonadism in men. The Company recently completed the treatment phase of its 669-patient pivotal Phase III study to evaluate the possible utility of PROCHIEVE for the prevention of recurrent preterm birth. The Company expects to announce efficacy and preliminary safety results from this randomized double-blind placebo-controlled clinical trial in mid-February. Columbia Laboratories Inc. has a market cap of $72.1 million; its shares were traded at around $1.32 with and P/S ratio of 2.

Highlight of Business Operations:

Selling and distribution expenses decreased 7% to $5.9 million in the six months ended June 30, 2009, as compared to $6.3 million in the six months ended June 30, 2008. The primary reason for the decrease was lower marketing and market research expenses. Selling and distribution expenses include payroll, employee benefits, equity compensation and other personnel-related costs associated with sales and marketing personnel, and advertising, market research, market data capture, promotions, tradeshows, seminars, other marketing related programs and distribution costs. In the first half of 2009, market research costs were $2.6 million and sales force and management costs were $3.3 million. The comparable costs for the first half of 2008 were $2.9 million for market research related costs and $3.4 million for sales force and management costs.

The Company purchased the marketing rights for U.S. sales of CRINONE 8% from Merck Serono in December 2006 for $33 million. In the second quarter of 2007, the Company recognized a $1 million adjustment to the purchase price to reflect contingent liabilities for Merck Serono sales returns. The $33 million charge is being amortized over 6.75 years, and the $1 million charge is being amortized over 6.5 years. Amortization of the acquisition cost for the CRINONE U.S. marketing rights for the six months ended June 30, 2009 and June 30, 2008 was $2.5 million.

As a result, the net loss for the six months ended June 30, 2009 was $10.6 million or $0.19 basic and diluted per share, as compared to the net loss for the six months ended June 30, 2008 of $8.6 million or $0.17 basic and diluted per share.

Selling and distribution expenses decreased 3% to $3.1 million in the three months ended June 30, 2009, as compared to $3.2 million in the three months ended June 30, 2008. The primary reason for the decrease was lower marketing and market research expenses. Selling and distribution expenses include payroll, employee benefits, equity compensation and other personnel-related costs associated with sales and marketing personnel, and advertising, market research data capture, promotions, tradeshows, seminars, other marketing related programs and distribution costs. In the three months ended June 30, 2009, market research costs were $1.4 million and sales force and management costs were $1.7 million. The comparable costs for the second quarter of 2008 were $1.6 million for market research related costs and $1.6 million for sales force and management costs.

Net cash used in operating activities of $4.0 million for the six months ended June 30, 2009 resulted primarily from $3.9 million in net operating losses after applying non-cash charges and increases in working capital of $0.1 million. The net loss of $10.6 million in the six months ended June 30, 2009 included non-cash items for depreciation, amortization, stock-based compensation, provision for sales returns and non-cash interest expense, which totaled $6.7 million in aggregate, leaving a net cash loss, net of non-cash items, of $3.9 million for the six months ended June 30, 2009. Inventories grew by $0.6 million during the period to meet specific customer orders. Accounts payable increased by $0.2 million and accrued expenses decreased by $0.1 million. The increase in accounts payable is due primarily to higher inventory levels and increased expenses for the clinical trials. The reduction in accrued expenses of $0.1 million related to the distributor service fees and professional fees paid during the six months ended June 30, 2009.

Net cash used in operating activities of $3.3 million for the six month period ended June 30, 2008 resulted primarily from $2.1 million net operating losses after applying non-cash charges and an increase in working capital of $1.2 million. The net loss of $8.6 million in 2008 included non-cash items for depreciation, amortization, stock-based compensation, provision for sales returns and non-cash interest expense, which total $6.5 million in aggregate, leaving a net cash loss, net of non-cash items, of $2.1 million for the 2008 period. Accounts receivable increased by $0.5 million as a result of increased sales. Inventories increased by $0.7 million during the period to cover anticipated summer shut downs of key suppliers. Accounts payable increased by $1.0 million and accrued expenses decreased by $1.2 million. The increase in accounts payable is due primarily to higher inventory levels, and increased expenses for the clinical trials. The reduction in accrued expenses of $1.2 million related to the combination of bonuses and distributor service fees paid during the period and realized sales returns.

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