Printer Friendly
The Free Library
19,595,259 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Columbia Laboratories Reports Second Quarter Results; Company Provides Initial Sales Guidance.


Business Editors/Health & Medical Writers

LIVINGSTON, N.J.--(BUSINESS WIRE)--Aug. 13, 2002

Columbia Laboratories (AMEX AMEX

See: American Stock Exchange
: COB) today announced financial results for the second quarter and six months ended June 30, 2002.

For the second quarter of 2002, the company reported a loss of $4,855,498, or $0.14 per share, on sales of $2,225,378, as compared to a net loss of $4,430,124, or $0.14 per share, on sales of $427,554 in the second quarter of 2001. After excluding the one-time charges and credit mentioned in the following paragraph, the loss per share for the three months ended June 30, 2002 would have been $1,344,987 or $0.04 per share, compared with a loss of $3,430,124 or $0.11 per share for the three months ended June 30, 2001.

The second quarter 2002 results reflect a one-time litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 settlement expense of $3,960,000 resulting from the June 2002 settlement of litigation with Ares Trading S.A. and Serono, Inc. As a result of the settlement, the Company reduced operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 in the second quarter of 2002 by $449,489, reflecting a reduction in the accrual accrual,
n continually recurring short-term liabilities. Examples are accrued wages, taxes, and interest.
 for product recall costs. The original estimate of $1,500,000 for product recall costs was booked in the first quarter of 2001. The second quarter 2001 results included a one-time restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics).  expense of $1,000,000 to record the estimated costs of downsizing (1) Converting mainframe and mini-based systems to client/server LANs.

(2) To reduce equipment and associated costs by switching to a less-expensive system.

(jargon) downsizing
 the Company's presence outside 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. .

For the six-month period ended June 30, 2002, the net loss was $8,236,441 or $.25 per 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 $2,717,770 as compared to a net loss of $8,249,053 or $.27 per share on net sales of $1,275,369 in the six months ended June 30, 2001.

Over the last several months, Columbia has achieved a number of significant accomplishments including:
-- Resolution of the outstanding litigation with Serono resulting in the reintroduction of Crinone 8% (progesterone gel) to the "Infertility Specialist Market";

-- Securing the rights to market 4% and 8% progesterone gel under a second brand name, "Prochieve(TM)," to a defined audience of obstetricians, gynecologists and primary care physicians in the United States;

-- Signing of an agreement with Quintiles Transnational Corp. to commercialize Prochieve along with Advantage-S(R) and RepHresh Vaginal Gel(TM) through a dedicated team of 55 sales representatives commencing in the second half of 2002;

-- Raising $10.0 million from PharmaBio, Quintiles' strategic investment group, through a Stock Purchase Agreement and an Investment and Royalty Agreement;

-- Filing of a New Drug Application (NDA) with the FDA for testosterone buccal bioadhesive product.


Fred Wilkinson, Columbia's president and chief executive officer, stated, "We are extremely pleased with the progress the Company has made and believe that these achievements create a solid foundation from which to establish a growing revenue base and a future earnings stream."

Columbia is providing initial guidance for the remainder of 2002 through 2004. Based on the launch of Prochieve and RepHresh, and the re-launch of Advantage-S in the U.S., the company estimates sales for 2002 in the range of $12 to 15 million. Assuming a second-half 2003 approval and launch of 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, the company estimates sales for 2003 in the range of $32 to 40 million and sales in 2004 in the range of $75 to 100 million.

Operating expenses are expected to be in the range of $14 to 16 million in 2002, $27 to $31 million in 2003, and $36 to 40 million in 2004. Based on these estimates, profitability is anticipated during the second half of 2003.

These 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.
 reflect Columbia Laboratories' expectations as of August 13, 2002, and are being provided so that the Company can discuss its future outlook during its upcoming investor conference call and with investors, potential investors, the media, financial analysts and others. The statements are subject to the cautionary paragraph at the end of this press release. The Company does not intend to update its forward-looking statements until its next quarterly earnings announcement.

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 hormonal,
adj/n beneficial component in some essential oils that helps to bring hormone secretions to normal levels.


hormonal

emanating from or pertaining to hormones.
 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 within the meaning of Section 27A of the Securities Act of 1933, as amended a·mend  
v. a·mend·ed, a·mend·ing, a·mends

v.tr.
1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive.

2.
, 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 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 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 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)

                     Six Months Ended             Three Months Ended
                          June 30,                     June 30,
                     2002          2001           2002          2001

NET SALES         $ 2,717,770  $ 1,275,369   $ 2,225,378   $  427,554


COST OF SALES       1,538,840    1,010,597       671,977      485,131
                  -----------  -----------   -----------  -----------

    Gross profit    1,178,930      264,772     1,553,401      (57,577)
                  -----------  -----------   -----------  -----------

OPERATING EXPENSES:
  Selling and
   distribution       836,292      516,909       469,242      254,158

  General and
   administrative   2,275,516    1,912,627     1,091,586    1,151,867

  Research and
   development      2,317,629    3,390,096     1,079,264    1,837,111

  Litigation
   settlement
    expense         3,960,000            -     3,960,000            -

  Product recall
   costs             (449,489)   1,500,000      (449,489)           -

  Corporate
   restructuring
    expense                 -    1,000,000             -    1,000,000

    Total operating
     expenses       8,939,948    8,319,632     6,150,603    4,243,136
                  -----------  -----------   -----------  -----------

    Loss from
     operations    (7,761,018)  (8,054,860)   (4,597,202)  (4,300,713)
                  -----------  -----------   -----------  -----------

OTHER INCOME(EXPENSE):
  Interest
   income              21,689      175,063        11,192       70,219


  Interest
   expense           (405,998)    (377,676)     (217,159)    (188,838)

  Other, net          (91,114)       8,420      (52,329)      (10,792)
                  -----------  -----------   -----------  -----------

                     (475,423)    (194,193)     (258,296)    (129,411)
                  -----------  -----------   -----------  -----------

Net loss          $(8,236,441) $(8,249,053) $ (4,855,498)$ (4,430,124)
                  ===========  ===========  ============ ============


NET LOSS PER COMMON
 SHARE - BASIC
  AND DILUTED       $   (0.25)    $  (0.27)    $   (0.14)   $   (0.14)
                  ===========  ===========  ============  ===========

WEIGHTED AVERAGE
 NUMBER OF COMMON
  SHARES OUTSTANDING:
   BASIC AND
    DILUTED        33,498,703   30,830,000    34,034,705   30,969,453
                  ===========  ===========  ============  ===========


                June 30, 2002  Dec. 31, 2001
                  (unaudited)
                  -----------  -------------
Balance Sheet Data:

Cash and cash
 equivalents    $   3,471,101  $ 4,060,836

Working capital     3,708,628    4,622,083

Total assets       11,262,297    8,560,024

Convertible
 subordinated
  note payable     10,000,000   10,000,000

Stockholders'
 equity
 (deficiency)      (5,238,582)  (3,421,179)

COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Comment:Columbia Laboratories Reports Second Quarter Results; Company Provides Initial Sales Guidance.
Publication:Business Wire
Geographic Code:1USA
Date:Aug 13, 2002
Words:1222
Previous Article:'DAC Bonds' Fast Becoming the Electronic Disclosure System of Choice for the Municipal Bond Market.
Next Article:American Group: Plant Opens, Expected Media Coverage Begins.
Topics:



Related Articles
IMPAX Reports Second Quarter Financial Results; Quarter Highlights Include Strategic Alliance With Teva Pharmaceuticals, FDA Approval of Generic...
Mylan Increases Third Quarter Earnings Estimates.
Medicis Reports Second Quarter Fiscal 2002 Financial Results.
Merck Plans To Expand ArcoxiaTM U.S. New Drug Application To Include New Efficacy Data; Withdraws Original U.S. NDA.
Ligand Updates AVINZA Launch Progress, Revises Second Quarter Revenue Guidance, and Reiterates Full-Year Revenue Guidance with Different Product...
Columbia Laboratories Reports Fourth Quarter and Year-End 2002 Financial Results.
Lilly Provides Update on Earnings Guidance and Manufacturing Reinspection Process; Update Provided in Advance of Company Presentation at Goldman...
USANA Expects Second Quarter Sales and Earnings to Exceed Earlier Forecast.
Columbia Laboratories Reports Second Quarter 2006 Financial Results; Management to Host Conference Call at 11:00 am Today.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles