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

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Mar 12, 2012
Columbia Laboratories Inc. (CBRX, Financial) filed Annual Report for the period ended 2011-12-31.

Columbia Labs has a market cap of $57.6 million; its shares were traded at around $0.6696 with a P/E ratio of 3.3 and P/S ratio of 1.3.

Highlight of Business Operations:

Total net revenues decreased 6% in 2011 to $43.1 million as compared to $45.7 million in 2010. The decrease in net revenues is in part due to Watson's assumption of domestic progesterone product sales for the second half of 2010 with direct sales by Columbia in the first half of 2010, offset by the recognition of the $5.0 million milestone payment from Watson for the filing of the PREGNANT Study NDA by the FDA in the second quarter of 2011. Total net revenues increased 42% in 2010 to $45.7 million as compared to $32.2 million in 2009. The significant increase in net revenues was driven primarily by the amortization of $17.1 million in revenue recorded as part of Other Revenues and related to the gain on the sale of the progesterone assets to Watson, offset in part by Watson's assumption of domestic progesterone product sales for the second half of 2010.

Total net product revenues decreased by 34% to $18.0 million in 2011 as compared to $27.0 million in 2010. This decrease takes into account the transfer of CRINONE and PROCHIEVE assets, including responsibility for product sales in the U.S., to Watson, the absence of sales in 2011 to Lil' Drug Store Products for Replens and RepHresh as a result of the contract expiration and to a smaller extent, the transfer of STRIANT product sales in the U.S. to Actient Pharmaceuticals, LLC. Net product revenues from Merck Serono for international sales of CRINONE 8% increased by 40% primarily due to higher volume. STRIANT net product revenues were $0.4 million lower than in the 2010 period, as a result of the sale to Actient Pharmaceuticals, LLC.

Total other revenues were $22.1 million in 2011 as compared to $17.4 million in 2010,. The increase is a result of the recognition of the $5.0 million milestone payment from Watson for the filing of the PREGNANT Study NDA by the FDA. The other major component of other revenues in 2010 and 2011 was the amortization of the $34 million in deferred gains from the sale of the progesterone assets to Watson, at an average rate of $8.5 million over four quarters (two in 2010 and two in 2011), representing the estimated remaining development period for PROCHIEVE 8%.

Historically, selling and distribution expenses have included 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 2011, these expenses represented selling and distribution costs related to STRIANT. Selling and distribution expenses were approximately $0.1 million, $9.7 million and $12.0 million in 2011, 2010 and 2009, respectively. The reduction in expenses is a result of the elimination of Columbia's sales and marketing organization following the closing of the Watson Transactions on July 2, 2010. Selling and distribution expenses decreased by approximately 99% in 2011 compared to 2010 and decreased by approximately 19% in 2010 compared to 2009. Major expenses during 2010 included the settlement in the amount of $1.8 million of the Bio-Mimetics, Inc. litigation (this represents a reduction in the reserve taken in the third quarter of 2010 of $0.4 million), $0.9 million in stock compensation costs from the accelerated vesting of all stock options and restricted shares and the extension of the expiration period for options as a result of the Watson Transactions and approximately $0.5 million in severance costs. These costs were offset by reductions in expenses of $2.5 million as our direct selling and marketing organization was shut down following the closing of the Watson Transactions on July 2, 2010. In summary, in 2010, sales force and management costs were $5.1 million, product marketing expenses were $1.4 million and sales information and distribution costs were $0.8 million, in addition to the Bio-Mimetics settlement, stock compensation expense and severance costs mentioned above.

We purchased the U.S. marketing rights for CRINONE® 8% 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 was being amortized over 6.75 years, and the $1.0 million charge was being amortized over 6.5 years. The $1.0 million adjustment charge was fully amortized in 2010. Amortization expenses of the acquisition cost for CRINONE® U.S. marketing rights for 2011, 2010 and 2009 were $0.0 million, $2.5 million and $5.0 million, respectively. The reduction in 2010 from 2009 reflects the sale of the Crinone assets to Watson and elimination of future amortization expense.

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