Columbia Laboratories' net revenues from US progesterone sales for first-quarter up 36%

Apr 22 2010

Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced preliminary results for the quarter ended March 31, 2010. As compared to the first quarter of 2009:

“We are pleased to exploit the several factors leading to the improved competitive landscape for CRINONE recognizing that some may be only temporary while others may be more reflective of the recently released data on the effectiveness of Crinone and its preference by patients versus painful and frequent intramuscular injections.”

• Net revenues from U.S. progesterone products increased 36% on a 46% volume increase. This increase was dampened by higher reserves for returned goods.
• International revenues from Merck Serono increased 9%.
• Total progesterone sales increased 25% on a 30% volume increase
• With the previously disclosed cessation of sales of the OTC products, Replens and RepHresh, total net revenues for the first quarter of 2010 decreased 3% as compared to the first quarter of 2009.

The growth in domestic sales was driven in part by higher prescriptions resulting from the clinical data on CRINONE that was reported at the Annual Meeting of the American Society of Reproductive Medicine (ASRM) in October 2009, coupled with manufacturing supply issues with CRINONE's primary competitor, Endometrin.

Frank C. Condella, Jr., Columbia's interim chief executive officer, said, "We are pleased to exploit the several factors leading to the improved competitive landscape for CRINONE recognizing that some may be only temporary while others may be more reflective of the recently released data on the effectiveness of Crinone and its preference by patients versus painful and frequent intramuscular injections."

On March, 3, 2010, Columbia entered into a definitive agreement to sell, subject to stockholder approval, substantially all of its progesterone related assets, including our preterm birth patents and applications, and 11.2 million shares of common stock to Watson Pharmaceuticals, Inc. (the "Watson Transaction") for a $47 million upfront payment plus royalties of 10 to 20 percent of annual net sales of certain progesterone products. Additional payments up to $45.5 million can be earned by the successful completion of clinical development milestones in the ongoing PREGNANT Study, regulatory filings, receipt of regulatory approvals and product launches. Watson will fund the development of a second-generation vaginal progesterone product as part of a comprehensive life-cycle management strategy.

The closing of the transaction is subject to customary conditions, including approval by Columbia's stockholders. Columbia will retain certain assets and rights to its progesterone business, including all rights necessary to perform its obligations under its agreement with Merck Serono S.A.