Columbia Laboratories Reports Third Quarter 2002 Financial Results; Third Quarter Revenues of $4.0 Million.Business Editors LIVINGSTON, N.J.--(BUSINESS WIRE)--Nov. 4, 2002 Columbia Laboratories (AMEX AMEX See: American Stock Exchange : COB) today announced financial results for the third quarter and nine months ended September 30, 2002. For the third quarter of 2002, the company reported a net loss of $1,879,189, or a loss of $0.05 per basic and diluted share, on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of $4,040,534 as compared to a net loss of $3,240,507, or a loss of $0.10 per basic and diluted share, on net sales of $411,354 in the third quarter of 2001. The third quarter of 2002 marked both the formation of the company's dedicated 55-person sales force through the Quintiles/Innovex agreement and the initiation of its marketing and sales activities for Prochieve(TM) 8% (progesterone progesterone (prōjĕs`tərōn'), female sex hormone that induces secretory changes in the lining of the uterus essential for successful implantation of a fertilized egg. gel), Advantage-S(R) Bioadhesive Contraceptive contraceptive /con·tra·cep·tive/ (-sep´tiv) 1. diminishing the likelihood of or preventing conception. 2. an agent that so acts. Gel and RepHresh Vaginal vag·i·nal adj. 1. Of or relating to the vagina. 2. Relating to or resembling a sheath. vaginal pertaining to the vagina, the tunica vaginalis testis, or to any sheath. Gel(TM) in the U.S. For the nine-month period ended September 30, 2002, the net loss was $10,115,630, or a loss of $0.30 per basic and diluted share, on net sales of $7,072,494 as compared to a net loss of $11,489,560, or a loss of $0.38 per basic and diluted share, on net sales of $1,993,076 in the nine months ended September 30, 2001. "We are proud to have accomplished several of our stated goals in recent months," said Fred Wilkinson, president and chief executive officer of Columbia. "These include the development of a commercialization unit through an innovative agreement with Quintiles/Innovex followed by the launch of Prochieve 8% and RepHresh, and the relaunch Relaunch can refer to several things:
Wilkinson continued, "Additionally, we made significant strides forward on the next product in our pipeline, Striant(TM) (testosterone testosterone (tĕstŏs`tərōn), principal androgen, or male sex hormone. One of the group of compounds known as anabolic steroids, testosterone is secreted by the testes (see testis) but is also synthesized in small quantities in the buccal buc·cal adj. 1. Of, relating to, adjacent to, or in the direction of the cheek. 2. Of or relating to the mouth cavity. buccal bioadhesive product) for the treatment of hypogonadism Hypogonadism Definition Hypogonadism is the condition more prevalent in males in which the production of sex hormones and germ cells are inadequate. . The NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any was filed and accepted for review by the U.S. Food and Drug Administration and a PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) date set for June 19, 2003. We anticipate filing the U.K. application before year-end, and will file mutual recognition applications in the rest of Europe following initial regulatory approval of the U.K. application. Additionally, we executed a license and supply agreement with Ardana Bioscience, Ltd for marketing Striant(TM) in eighteen European countries, which marks the first commercial partnership for this product." During the third quarter of 2002, Columbia received a $1.125 million payment, the first of four equal quarterly installments, from PharmaBio Development, Inc., a Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. company. These payments grant PharmaBio a 5% royalty on the net sales of Columbia's current women's healthcare products in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. over the next five years. Additionally, the company received $5.5 million from the sale of Columbia stock to PharmaBio at the price of $4.90 per share. Under the terms of the Ardana agreement, Columbia will receive total payments of $8 million, including $4 million in signature and milestone fees in the fourth quarter of 2002. Additional milestone payments totaling $2 million are due upon marketing approvals in major European countries included in the agreement. A performance payment of $2 million is also due upon achievement of a certain level of sales. "The completion of these two strategic agreements significantly strengthens our balance sheet and provides the resources to fully execute our business plan. As a result of the Quintiles and Ardana agreements, we now have near-term commitments for $18 million, of which $11.75 million will be received by year-end 2002. These deals establish a strong foundation for the execution of our U.S. commercial plan and strengthen the partnering program for our products outside the U.S. We are extremely pleased with the progress the company has made, and believe that the accomplishment of these goals creates a solid base upon which to establish growing revenues and a future earnings stream," concluded Wilkinson. Columbia Laboratories, Inc. is an international pharmaceutical company dedicated to research and development of women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. care and endocrinology endocrinology Medical discipline dealing with regulation of body functions by hormones and other biochemicals and treatment of endocrine system imbalances. In 1841 Friedrich Gustav Henle first recognized “ductless glands,” which secrete products directly into products, including those intended to treat infertility infertility, inability to conceive or carry a child to delivery. The term is usually limited to situations where the couple has had intercourse regularly for one year without using birth control. , dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. , endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. 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 System (BDS BDS abbr. Bachelor of Dental Surgery BDS Bachelor of Dental Surgery BDS n abbr (= Bachelor of Dental Surgery) → título universitario BDS ) technology. This press release contains statements that constitute forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of the company and its management team. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Such risks and uncertainties include, among other things, the successful launch and marketing of Prochieve, RepHresh Vaginal Gel and Advantage-S, timely and successful development of products, timely and successful completion of clinical studies, success in obtaining FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. acceptance and approval of new products, including the company's Striant(TM) (testosterone buccal bioadhesive product), and competitive economic and regulatory factors in the pharmaceutical and healthcare industry, general economic conditions and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission.
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Nine Months Three Months
Ended Ended
September 30, September 30,
2002 2001 2002 2001
-------- -------- -------- --------
NET SALES $7,072,494 $1,993,076 $4,040,534 $411,354
COST OF SALES 3,769,402 1,991,971 1,916,372 675,021
--------- --------- --------- -------
Gross profit 3,303,092 1,105 2,124,162 (263,667)
--------- --------- --------- -------
OPERATING EXPENSES:
Selling and distribution 2,221,096 789,082 1,384,804 272,173
General and
administrative 3,507,664 2,980,217 1,232,148 1,067,590
Research and development 3,457,346 4,872,652 1,139,717 1,482,556
Litigation settlement
expense 3,960,000 - - -
Product recall costs (449,489) 1,500,000 - -
Corporate restructuring
expense - 1,000,000 - -
---------- ---------- --------- ---------
Total operating
expenses 12,696,617 11,141,951 3,756,669 2,822,319
---------- ---------- --------- ---------
Loss from operations (9,393,525)(11,140,846)(1,632,507)(3,085,986)
--------- ---------- --------- ---------
OTHER INCOME (EXPENSE):
Interest income 33,814 228,453 12,125 53,390
Interest expense (643,445) (566,514) (237,447) (188,838)
Other, net (112,474) (10,653) (21,360) (19,073)
--------- ---------- --------- --------
(722,105) (348,714) (246,682) (154,521)
--------- ---------- --------- --------
Net loss $(10,115,630)$(11,489,560)$(1,879,189)$(3,240,507)
========== ========== ========= =========
NET LOSS PER COMMON
SHARE - BASIC AND DILUTED $(0.30) $(0.38) $(0.05) $(0.10)
===== ===== ===== =====
WEIGHTED AVERAGE NUMBER
OF COMMON SHARES OUTSTANDING:
BASIC AND DILUTED 34,034,284 31,031,883 35,087,980 31,429,067
========== ========== ========== ==========
Note - Prior year financial statements have been reclassified to
conform to the 2002 presentation.
Sept. 30, 2002 Dec. 31, 2001
-------------- -------------
(unaudited)
Balance Sheet Data:
Cash and cash equivalents $ 4,306,544 $ 4,060,836
Working capital 6,185,697 4,622,083
Total assets 14,660,736 8,560,024
Convertible subordinated note payable 10,000,000 10,000,000
Stockholders' equity (deficiency) (1,636,733) (3,421,179)
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