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

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Nov 05, 2009
Columbia Laboratories Inc. (CBRX, Financial) filed Quarterly Report for the period ended 2009-11-05.

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 $49.2 million; its shares were traded at around $0.9001 with and P/S ratio of 1.3.

Highlight of Business Operations:

Selling and distribution expenses decreased 8% to $9.0 million in the nine months ended September 30, 2009, as compared to $9.8 million in the nine months ended September 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. For the nine months ended September 30, 2009, sales force and management costs were $5.2 million and market research and other sales and marketing costs were $3.8 million. The comparable costs for the nine months ended September 30, 2008 were $5.1 million for sales force and management costs and $4.7 million for market research and other sales and marketing costs

Net revenues from Other Products decreased 66% to $1.6 million in the three months ended September 30, 2009, as compared to $4.7 million in the three months ended September 30, 2008, primarily as a result of the termination of royalty revenues related to Ardana s bankruptcy in June 2008. During the third quarter of 2008, the Company recognized $2.9 million of deferred revenue from the cancellation of the Ardana contract for STRIANT due to Ardana s bankruptcy. Unit volumes for the three months ended September 30, 2009 for RepHresh decreased 33% from the same period in 2008, which was related to timing of bulk purchases from period to period. Net revenues for Replens increased by $0.3 million and STRIANT net revenues decreased by $0.3 million for the three months ended September 30, 2009 from the same period in 2008.

Selling and distribution expenses decreased 11% to $3.1 million in the three months ended September 30, 2009, as compared to $3.5 million in the three months ended September 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 September 30, 2009, sales force and management costs were $1.8 million and market research and other sales and marketing costs were $1.3 million. The comparable costs for the third quarter of 2008 were $1.7 million for sales force and management costs and $1.8 million for market research and other sales and marketing costs.

Net cash used in operating activities of $5.8 million for the nine months ended September 30, 2009 resulted primarily from $6.3 million in net operating losses after applying non-cash charges and increases in working capital of $0.5 million. The net loss of $16.4 million in the nine months ended September 30, 2009 included non-cash items for depreciation, amortization, stock-based compensation, provision for sales returns and non-cash interest expense, which totaled $10.1 million in the aggregate, leaving a net cash loss, net of non-cash items, of $6.3 million for the nine months ended September 30, 2009. Inventories increased by $0.1 million during the period to meet specific customer orders. Accounts payable increased by $0.4 million and accrued expenses decreased by $1.0 million.

Net cash used in operating activities for the nine month period ended September 30, 2008 was $4.9 million. The net loss of $10.6 million in the nine months ended September 30, 2008 included non-cash items for depreciation, amortization, stock-based compensation, provision for sales returns, non-cash interest expense and deferred revenue related to Ardana which totaled $7.3 million in aggregate, leaving a net cash loss of $3.3 million for the 2008 period. Accounts receivable increased by $1.4 million as a result of increased sales. Inventories increased by $0.2 million during the period. Accounts payable increased by $0.5 million. The increase in accounts payable is due primarily to higher inventory levels and increased expenses for clinical trials.

Net cash provided by financing activities in the nine months ended September 30, 2008 was $1.0 million. The Company raised $4.1 million, net of expenses, through the sale of 1,333,000 shares of the Company's Common Stock at $3.50 per share. During 2008, the Company made a $3.5 million final payment to PharmaBio under the financing agreement relating to the Company s women s healthcare products. The balance of the cash provided by financing activities is comprised of proceeds from the exercise of stock options in the amount of $0.6 million, purchase of treasury stock for $0.1 million and dividends on the Company s Series C Preferred Stock.

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