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

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Dec 28, 2010
Columbia Laboratories Inc. (CBRX, Financial) filed Amended Quarterly Report for the period ended 2010-06-30.

Columbia Laboratories Inc. has a market cap of $188.6 million; its shares were traded at around $2.33 with and P/S ratio of 5.9.

Highlight of Business Operations:

Total net revenues from progesterone products increased 37% to $15.2 million in the six months ended June 30, 2010 as compared to $11.1 million in the six months ended June 30, 2009 on a 35% volume increase. Combined U.S. net revenues for CRINONE and PROCHIEVE increased 38% in the six months ended June 30, 2010, over the same period in 2009 with unit volume up 45%. This increase was dampened by an increase in reserves for returned goods. Domestic CRINONE net revenues increased by 47%, despite the additional returns reserves, as a result of a 58% increase in volume. Total prescriptions for CRINONE for the six months ended June 30, 2010 are higher than in the same period in 2009 by 15%. These increases were achieved despite a major economic downturn impacting patients decisions to postpone or forego elective infertility procedures that are not reimbursed by health insurers in many major markets, including California. Net revenues from international sales of CRINONE® 8% increased 34% over the first six months of 2009 on a 33% volume increase. Net revenues from other products were $1.5 million in the six months ended June 30, 2010 as compared with $4.6 million in the six months ended June 30, 2009, a 67% decrease. The expiration in October 2009 of Columbia's contract with Lil Drug Store Products, Inc.("LDS"), for the OTC products, RepHresh® and Replens®, resulted in a $2.5 million decrease in net revenues in the first half of 2010. In addition, STRIANT net revenues were $0.5 million lower in the 2010 period attributable primarily to the increase in returns reserves.

Selling and distribution expenses increased 0.9% to $6.0 million in the six months ended June 30, 2010, as compared to $5.9 million in the six months ended June 30, 2009, primarily due to increased spending on marketing programs highlighting the several favorable papers and abstracts regarding CRINONE presented at the American Society for Reproductive Medicine Annual Meeting in October 2009, as well as $0.2 million in severance costs. 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 summary, in the first six months of 2010, sales force and management costs were $3.7 million (including $0.2 million of severance), product marketing expenses were $1.7 million and sales information and distribution costs were $0.6 million. The comparable costs for the first six months of 2009 were $3.5 million for sales force and management costs, $1.9 million in product marketing expenses and $0.5 million for sales information and distribution costs.

We purchased the U.S. marketing rights for CRINONE from Merck Serono in December 2006 for $33.0 million. In the second quarter of 2007, we recognized a $1.0 million adjustment to the purchase price to reflect contingent liabilities for Merck Serono sales returns. The $33.0 million charge is being amortized over 6.75 years, and the $1.0 million charge is being amortized over 6.5 years. Amortization of the acquisition cost for the CRINONE U.S. marketing rights for each of the six months ended June 30, 2010 and 2009 was $2.5 million.

Selling and distribution expenses decreased 13% to $2.7 million in the three months ended June 30, 2010, as compared to $3.1 million in the three months ended June 30, 2009. 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 summary, in the three months ended June 30, 2010, sales force and management costs were $1.6 million, product marketing expenses were $0.8 million and sales information and distribution costs were $0.3 million. The comparable costs for the three months ended June 30, 2009 were $1.8 million for sales force and management costs, $1.0 million in product marketing expenses and $0.3 million for sales information and distribution costs.

Net cash used in operating activities for the six months ended June 30, 2010 resulted primarily from $4.1 million in net operating losses after applying non-cash charges and increases in working capital of $0.7 million. The net loss of $17.5 million in the first half of 2010 included non-cash items for depreciation, amortization, a change in the fair value of a derivative, stock-based compensation, provision for sales returns, and non-cash interest expense, which totaled $13.4 million, leaving a net cash loss, of $4.1 million for the first half of 2010. Accounts receivable remained unchanged from the fourth quarter of 2009. Inventories grew by $0.5 million during the period to meet specific customer orders. Accounts payable decreased by $1.0 million and other accrued expenses increased by $0.4 million. The decrease in accounts payable is due primarily to payments for marketing programs and for the PREGNANT Study. The increase in other accrued expenses of $0.4 million related to the accruals for severance payments.

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, 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 other accrued expenses decreased by $0.1 million. The increase in accounts payable is due primarily to higher inventory levels and increased expenses for the PREGNANT Study. The reduction in other accrued expenses of $0.1 million related to the distributor service fees and professional fees paid during the six months ended June 30, 2009.

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