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COLUMBIA LABORATORIES REPORTS LOSS FOR 4TH QUARTER.


Columbia Laboratories (AMEX:COB), Livingston, N.J., has reported a loss for the fourth quarter ended December 31, 2001 of $4,356,067, or $0.14 per share, on sales of $160,778, as compared to a net gain of $207,392, or $0.01 per share, on sales of $3,953,257 in the comparable 2000 period.

The revenue figure for the fourth quarter of 2001 does not reflect any sales of Crinone to Serono, which were halted in March 2001 pending resolution of a viscosity issue associated with the gel that resulted in a voluntary recall of certain batches of Crinone. Columbia has since manufactured new product under a revalidation protocol. On March 12, 2002, Serono, S.A., the parent company of Columbia's licensee, announced that it has reintroduced Crinone 8% to the United States market, effective March 8, 2002 and that the return to the markets in the rest of the world would be announced in due course. Serono further stated that their decision was based upon evaluation of product data from new batches indicating that the viscosity changes, which led to the voluntary recall in April 2001, have been fully resolved. However, Serono and Columbia have not yet reached a settlement of the legal actions between the two companies following the recall.

For the year ended December 31, 2001, the net loss was $15,845,627 or $0.51 per share on net sales of $1,847,501 as compared to a net loss of $2,602,931 or $0.09 per share on net sales of $13,173,129. The results for the year ended December 31, 2001 include a $1.0 million charge to record the estimated costs of downsizing and restructuring Columbia's presence outside the United States and a $1.5 million charge for estimated out-of-pocket expenses associated with the recall of Crinone. Excluding these charges, the net loss for the year would have been $13,345,627 or $0.43 per share. Research and development costs of $7,607,267 for the year were dedicated to the completion of two Phase III clinical studies that were conducted on the company's male testosterone product and the progression of the peptide development activities.

Fred Wilkinson, Columbia's president and chief executive officer said, "Our results for the fourth quarter and year ended December 2001 clearly reflect a period of significant revalidation, restructuring, and refocus. We are committed to reaching a beneficial conclusion on the pending litigation with Serono and achieving appreciable market penetration of a re-validated Crinone product. Furthermore, we are focused on maximizing the value of Crinone in the marketplace and creating shareholder value."

Wilkinson added, "The basis of Columbia's growth is founded in our Bioadhesive Delivery System, which we are aggressively positioning for continued progress. We maintain a clear focus on our efforts to fund our research and development projects with the highest potential and probability of success including those that could attract potential partners who could clearly benefit from our Bioadhesive delivery systems as it relates to peptides."

On February 28, 2002 and March 13, 2002 Columbia received proceeds of $1.0 million and $2.0 million, respectively from the sale of its common stock to Acqua Wellington North American Equities Fund, Ltd. pursuant to an existing stock purchase agreement.

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to research and development of women's health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies. Columbia is also developing hormonal products for men and a buccal delivery system for peptides. Columbia's products primarily utilize the company's patented bioadhesive delivery technology.

For more information, call 973/994-3999.
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Comment:COLUMBIA LABORATORIES REPORTS LOSS FOR 4TH QUARTER.
Publication:Biotech Financial Reports
Article Type:Brief Article
Geographic Code:1USA
Date:May 1, 2002
Words:613
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