Columbia Laboratories Reports Fourth Quarter and Year-End 2002 Financial Results.Business Editors/Health/Medical Writers LIVINGSTON, N.J.--(BUSINESS WIRE)--March 11, 2003 Columbia Laboratories (AMEX AMEX See: American Stock Exchange : COB) today announced financial results for the fourth quarter and year ended December 31, 2002. For the fourth quarter of 2002, the Company reported a net loss of $6,734,160, or a loss of $0.19 per basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. 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 $2,346,055 as compared to a net loss of $4,356,067, or a loss of $0.14 per basic and diluted share, on net sales of $160,778 in the fourth quarter of 2001. The fourth quarter of 2002 marked the first full quarter of promotion by the Company's dedicated 55-person sales force through Innovex, L.P., 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, and the initiation of U.S. 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). For the twelve-month period ended December 31, 2002, the net loss was $16,849,789, or a loss of $0.50 per basic and diluted share, on net sales of $9,418,549 as compared to a net loss of $15,845,627, or a loss of $0.51 per basic and diluted share, on net sales of $2,153,854 in the twelve months ended December 31, 2001. "Although the overall results for both the quarter and the year were disappointing, 2002 was an important year in which we implemented strategies and tactics that will position the company to be a commercial player in the 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. 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 markets." said Fred Wilkinson, president and chief executive officer of Columbia. "During the fourth quarter, we realized our first full quarter of promotional activities for our women's health product line. As a result, we launched Prochieve 8% and RepHresh Vaginal Gel, and re-launched Advantage-S, to approximately 10,000 OB/GYN offices nationwide. This marketing effort is an important step for Columbia, and will make it possible for us to generate increasing U.S. revenues from our portfolio of women's healthcare products." Sales revenues during the fourth quarter were adversely affected by a number of factors. First, the Company experienced slower than anticipated prescriptions by the OB/GYNs during the launch quarter of Prochieve 8%. However, based on January IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data, these trends are improving and the Company believes that increases in Prochieve prescriptions indicate growing acceptance of the product. Second, the Company experienced a reduction in sales to its distribution partners due to the previously reported industrial accident at Maropack, a contract packager. Repairs were made and the facility is now fully operational, enabling Columbia to deliver last year's orders to the affected partners in January 2003. Third, the Company had slower than anticipated placement of RepHresh and Advantage-S by pharmacy retailers. These products now have distribution in all major wholesale accounts as well as several major chains. Finally, the Company elected to delay the introduction of Prochieve 4% until 2003; this product is now planned for launch before the end of March 2003. Wilkinson continued, "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) 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 June 19, 2003 has been set as the goal date to review and act on the NDA under the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. . We filed the U.K. application in November 2002, and will file mutual recognition applications in the rest of Europe following initial regulatory approval of the U.K. application." During the fourth quarter of 2002, Columbia received a payment of $1.125 million, the second of four equal quarterly installments, from PharmaBio Development, Inc., a Quintiles company. In exchange for these payments, Columbia will pay 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 beginning with the first quarter of 2003. Columbia also executed a marketing and supply agreement with Ardana BioSciences Ltd. for the commercialization of Striant in 18 European countries. Under the terms of this agreement, Columbia will receive total payments of $8 million, including $4 million in signature and milestone fees received in the fourth quarter of 2002. Additional milestone payments totaling $2 million are due upon marketing approvals in major European countries covered by the agreement. A performance payment of $2 million is also payable upon achievement of a certain level of sales. During the fourth quarter, Columbia completed another agreement with Ardana for the co-development of a terbutaline terbutaline /ter·bu·ta·line/ (ter-bu´tah-len) a ß agonist; used as the sulfate salt as a bronchodilator and as a tocolytic in the prevention of premature labor. vaginal gel product and received an initial payment of $250,000 in the first quarter of 2003. Under the terms of this agreement, Ardana will be responsible for the next stage of development of this product for the treatment of 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. and 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. . "As a result of the 2002 agreements with Quintiles (PharmaBio) and Ardana, the Company received payments amounting to $11,750,000 in 2002, with commitments in 2003 projected at $3,550,000 and $3,200,000 beyond 2003. On March 6, 2003, we announced an additional agreement with PharmaBio to commercialize Striant. In this agreement, Columbia will receive $12,000,000 in 2003 and $3,000,000 in 2004. These strategic agreements, together with partnering programs for our products outside the U.S., help to strengthen our balance sheet significantly and provide the required resources to fully execute our business plan," concluded Wilkinson. Columbia Laboratories, Inc. is an 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 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 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 acceptance and approval of new products by the 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. and international regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , including the timely and successful approval of Striant(TM), the successful launch and marketing of Striant(TM), 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
Year Ended Three Months Ended
December 31, December 31,
2002 2001 2002 2001
------------- ------------- ------------- ------------
NET SALES $9,418,549 $2,153,854 $2,346,055 $160,778
COST OF SALES 5,228,519 2,658,690 1,459,118 666,719
------------- ------------- ------------- ------------
Gross profit
(loss) 4,190,030 (504,836) 886,937 (505,941)
------------- ------------- ------------- ------------
OPERATING EXPENSES:
Selling and
distribution 6,053,732 1,054,472 3,832,636 265,390
General and
administrative 5,135,121 4,254,143 1,627,457 1,273,926
Research and
development 5,350,156 7,132,720 1,892,810 2,260,068
Litigation
settlement
expense 3,960,000 - - -
Product recall
costs (449,489) 1,500,000 - -
Corporate
restructuring
expense - 1,000,000 - -
------------- ------------- ------------- ------------
Total operating
expenses 20,049,520 14,941,335 7,352,903 3,799,384
------------- ------------- ------------- ------------
Loss from
operations (15,859,490) (15,446,171) (6,465,966) (4,305,325)
------------- ------------- ------------- ------------
OTHER INCOME (EXPENSE):
Interest income 51,844 246,937 18,030 18,484
Interest expense (852,864) (755,398) (209,419) (188,884)
Other, net (189,279) 109,005 (76,805) 119,658
------------- ------------- ------------- ------------
(990,299) (399,456) (268,194) (50,742)
------------- ------------- ------------- ------------
Net loss $(16,849,789) $(15,845,627) $(6,734,160) $(4,356,067)
============= ============= ============= ============
NET LOSS PER COMMON
SHARE - BASIC AND
DILUTED $(0.50) $(0.51) $(0.19) $(0.14)
============= ============= ============= ============
WEIGHTED AVERAGE
NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC AND
DILUTED 34,392,060 31,243,307 35,453,722 31,870,683
============= ============= ============== ============
Note - 2001 financial statements have been reclassified to conform to
the 2002 presentation.
Dec. 31, 2002 Dec. 31, 2001
------------- -------------
Balance Sheet Data:
Cash and cash
equivalents $5,018,365 $4,060,836
Working capital 4,717,320 4,622,083
Total assets 12,766,307 8,560,024
Convertible
subordinated note
payable 10,000,000 10,000,000
Stockholders' equity
(deficiency) (8,394,943) (3,421,179)
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