Columbia Laboratories Reports Third Quarter 2005 Results; Net Revenues up 28%, Operating Expenses Down 41% from Prior Year Period.LIVINGSTON, N.J. -- Columbia Laboratories, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CBRX) today announced results for the third quarter ended September 30, 2005. Financial highlights of the quarter include: --Net revenues of $6.5 million, a 28% increase from $5.1 in the third quarter of 2004, and a 3% increase from $6.3 million in the second quarter of 2005 --Operating expenses of $4.8 million, a 41% decrease from $8.1 million in the third quarter of 2004, and a 5% decrease from $5.0 million in the second quarter of 2005 --Loss from operations of $650,000, an improvement from loss from operations of $5.2 million in the third quarter of 2004, and from $959,000 in the second quarter of 2005 --Net loss of $1.3 million, an improvement from net loss of $6.0 million in the third quarter of 2004, and from $1.6 million in the second quarter of 2005 --Net loss 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 of $0.03, an improvement from a net loss per basic and diluted share of $0.14 in the third quarter of 2004, and from a net loss per basic and diluted share of $0.04 in the second quarter of 2005 "The successful implementation of operational efficiencies positively impacted our financial results," stated Fred Wilkinson, Columbia's president and chief executive officer. "For the past three quarters we have consistently increased revenues and decreased 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. , both of which are in line with our expectations for year end 2005." Recent operational highlights include: --Continued improvement in enrollment in the Prochieve(R) preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. study, albeit at a slower than anticipated rate --Successful completion of a pharmacokinetics pharmacokinetics /phar·ma·co·ki·net·ics/ (fahr?mah-ko-ki-net´iks) the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion. study for lidocaine lidocaine /li·do·caine/ (li´do-kan) an anesthetic with sedative, analgesic, and cardiac depressant properties, applied topically in the form of the base or hydrochloride salt as a local anesthetic; also used in the latter form as a 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 for the prevention and treatment of 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. --Two new independent directors elected to the Company's board During the third quarter, Columbia implemented new strategies to accelerate recruiting and enrollment of patients in its Prochieve(R) preterm study, which is designed to show the effect of Prochieve(R) 8% in reducing the incidence of preterm delivery in women who are predisposed pre·dis·pose v. pre·dis·posed, pre·dis·pos·ing, pre·dis·pos·es v.tr. 1. a. To make (someone) inclined to something in advance: to this problem. Fifteen additional study centers were added during the past three months bringing the total number of centers to 48. The Company also supports the study centers through a publicity campaign that includes the distribution of a video news release (VNR VNR Video News Release VNR Van Nostrand Reinhold (publishing company) VNR Video Noise Reduction VNR Veranstaltungsnummer VNR VFR Flight Not Recommended VNR Video News Reel VNR Very Nice Roll VNR Variable Navigation Ratio ) about the study and preterm birth, local television and radio advertising, telemarketing telemarketing, the practice of selling goods or services to customers by means of the telephone or of surveying consumer preferences in telephone conversations. to referral physicians, national advertising on the Discovery Health cable network, newspaper and journal advertising, and Internet Internet Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the links to the study web page. This publicity campaign, coupled with the increase in the number of study centers, helped Columbia achieve the highest monthly patient enrollments to date in September, and again in October. Columbia now anticipates that, as a result of the publicity campaign and other support activities, enrollment in the preterm study will continue to accelerate and will be completed by the end of first quarter, 2006. However, should the Company experience additional delays in recruiting at some of the new study centers, continued reluctance of some obstetricians to refer their patients, and lower than anticipated willingness by eligible patients to enroll in a placebo-controlled study, completion of enrollment could extend beyond the first quarter. The Company now expects, if positive results are obtained, to file with 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. for a label indication in the second half of 2006. Columbia continues to evaluate the possibility of conducting an interim analysis of the study, which could permit the Company to complete the trial with fewer patients and on an earlier timeframe. Columbia recently announced the successful completion of a pharmacokinetics study for its lidocaine vaginal gel for the prevention and treatment of dysmenorrhea and pelvic pelvic /pel·vic/ (pel´vik) pertaining to the pelvis. pel·vic adj. Of, relating to, or near the pelvis. pain. The study evaluated both the blood levels obtained by, as well as the relative safety from, three doses of lidocaine formulated for·mu·late tr.v. for·mu·lat·ed, for·mu·lat·ing, for·mu·lates 1. a. To state as or reduce to a formula. b. To express in systematic terms or concepts. c. with Columbia's patented bioadhesive vaginal gel. Based on those results a Phase II study is scheduled to start in the fourth quarter of 2005. Also, Columbia recently strengthened its Board of Directors through the election of Valerie L. Andrews and James S. Crofton. Both are independent directors and bring to seven the number of independent directors on the Company's eight-person Board. Financial Overview Net revenues for the third quarter of 2005 were $6.5 million, up from $5.1 million in the third quarter of 2004. Net revenues for the first and second quarters of 2005 were $4.3 million and $6.3 million, respectively. Net revenues from Promoted Products were $2.3 million in the third quarter of 2005 as compared with $3.6 million in the third quarter of 2004, primarily as a result of lower purchases of both Striant(R) and the Prochieve(R) line of products by trade customers. Net revenues from Partnered Products were $4.2 million in the third quarter of 2005 as compared with $1.5 million in the third quarter of 2004, primarily due to an increase in the sale of RepHresh(R) and Crinone Crinone® Gynecology A topical progesterone used to manage infertility and 2º amenorrhea. See Hormone replacement therapy. (R) to our marketing partners. Gross profit as a percentage of 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 was 63% in the third quarter of 2005, versus 57% in the third quarter of 2004. The higher percentage resulted from an increase in overall production and a change in product mix in the third quarter of 2005. The gross profit margins Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. in the first and second quarters of 2005 were 58% and 65%, respectively. Selling and distribution expenses were $1.7 million in the third quarter of 2005, a 67% decrease from $5.2 million in the third quarter of 2004, reflecting decreased sales force costs for promotion of the Company's 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. which resulted from the February 2005 sales force and marketing 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). and concurrent reduction of the sales force from approximately 80 persons in the third quarter of 2004 to approximately 28 persons in the third quarter of 2005. Selling and distribution expenses for the first and second quarters of 2005 were $2.9 million and $2.1 million, respectively. General and administration costs decreased 14% to $1.6 million in the third quarter of 2005 from $1.9 million a year ago. The reduction in expenses was primarily the result of a decrease in insurance premiums. General and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. for the first and second quarters of 2005 were $1.8 million and $1.7 million, respectively. Research and development costs were $1.5 million in the third quarter of 2005, a 43% increase from $1.0 million in third quarter of 2004. The increase is primarily related to an increase in the on-going Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial for Prochieve(R) 8% in preventing preterm delivery in pregnant women who are at high risk. These increased costs were offset by a reduction in the costs of outside consultants. As a result, for the third quarter of 2005 the Company reported a net loss of $1.3 million, or $0.03 per basic and diluted share, as compared to a net loss of $6.0 million, or $0.14 per basic and diluted share, in the third quarter of 2004. As of September 30, 2005, Columbia had cash and cash equivalents of $7.2 million. Outlook The third quarter net loss from operations of $650,000 and the first nine months net loss from operations of $5.2 million are in line with the Company's previously projected net loss from operations of between $3.0 million and $6.0 million for fiscal year 2005. Third quarter net revenues of $6.5 million and the first nine months net revenues of $17.1 million are also in line with the Company's previously projected revenue range of $22 million to $28 million for fiscal year 2005. With respect to fiscal year 2005, the Company is now narrowing its anticipated revenue range to between $22 million and $25 million and its net loss from operations range to between $5.0 million and $6.0 million. The Company now anticipates revenues from Partnered Products in the range of $15 to $16 million, and revenue from Promoted Products in the range of $7 to $9 million, for fiscal year 2005. Quarterly Conference Call As previously announced, Columbia Laboratories will hold a conference call on November 7, 2005 at 12:00 noon ET to review financial results of the third quarter ended September 30, 2005.
Access information
Date: November 7, 2005
Time: 12:00 noon ET
U.S./Canada dial-in number: (866) 202-3109
International dial-in number: (617) 213-8844
Access code: 26374633
Live webcast: www.columbialabs.com, under
the investors or events tabs
A recording of the conference call will be available two hours after completion until November 14, 2005 at 11:59 PM ET at (888) 286-8010 (U.S.) and (617) 801-6888 (International). The replay password is 98222378. The webcast will be archived for on-demand listening for one year on Columbia Laboratories website, www.columbialabs.com. About Prochieve(R) 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) and Preterm Delivery The Company is conducting a multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blinded, placebo-controlled Phase III clinical study designed to assess the efficacy, safety, and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol of Prochieve(R) 8% (progesterone gel) in preventing preterm delivery in pregnant women who are at increased risk for preterm delivery. The study protocol defines 'at risk' patients as those with a history of a spontaneous spontaneous /spon·ta·ne·ous/ (spon-ta´ne-us) 1. voluntary; instinctive. 2. occurring without external influence. spontaneous having no apparent external cause. preterm delivery or a cervical cervical /cer·vi·cal/ (ser´vi-k'l) 1. pertaining to the neck. 2. pertaining to the neck or cervix of any organ or structure. cer·vi·cal adj. length of less than or equal to 2.5 cm (as measured by transvaginal ultrasound Transvaginal Ultrasound Definition Transvaginal ultrasound is a imaging technique used to create a picture of the genital tract in women. The hand-held device that produces the ultrasound waves is inserted directly into the vagina, close to the pelvic ) with the current pregnancy. Under the study protocol, patients are treated with either Prochieve 8% or placebo placebo (pləsē`bō), inert substance given instead of a potent drug. Placebo medications are sometimes prescribed when a drug is not really needed or when one would not be appropriate because they make patients feel well taken care of. for approximately seventeen weeks, or until delivery. Treatment is initiated between 18 and 22 weeks gestation GESTATION, med. jur. The time during which a female, who has conceived, carries the embryo or foetus in her uterus. By the common consent of mankind, the term of gestation is considered to be ten lunar months, or forty weeks, equal to nine calendar months and a week. . The primary endpoint is time to delivery. The Prochieve study is designed to enroll 636 patients, and is currently enrolling patients at 48 study centers worldwide. Please visit www.PretermDeliveryTrial.com for additional information or to see if you may be eligible to participate in this study. Pregnant women who have had a prior preterm birth and who may wish to participate in the study, but who do not have Internet access See how to access the Internet. , may contact Columbia Laboratories toll-free at 866-566-5636. About Columbia Laboratories Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization 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. Columbia markets Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology Assisted reproductive technology (ART) is a general term referring to methods used to achieve pregnancy by artificial or partially artificial means. It is reproductive technology used in infertility treatment, which is the only application routinely used today of treatment for infertile in·fer·tile adj. Not capable of initiating, sustaining, or supporting reproduction. infertile, adj unable to produce offspring. women with progesterone deficiency and Prochieve(R) 4% (progesterone gel) for the treatment of secondary amenorrhea secondary amenorrhea n. Amenorrhea in which menstruation begins at puberty but then is subsequently suppressed. secondary amenorrhea . The Company also markets Striant(R) (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 system) 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. in men. Columbia's products and product candidates utilize the Company's bioadhesive drug delivery technology, which is able to deliver a broad range of compounds, including peptides, across many of the body's mucosal Mucosal Refers to tissues that produce mucus, such as the digestive, genital and urinary tracts. Mentioned in: Intestinal Polyps mucosal pertaining to or emanating from mucosa. surfaces to address numerous therapeutic areas. The Company is investigating the potential utility of Prochieve(R) 8% in the prevention of preterm birth and developing a vaginally-administered lidocaine product to treat dysmenorrhea and pelvic pain. For more information, please visit www.columbialabs.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.'s expectations made in this press release, including those regarding the Company's clinical research programs, anticipated revenues, net loss from operations, attainment of quarterly profitability, as well as Columbia Laboratories, Inc.'s strategic direction, prospects and future results, 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 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve certain risks and uncertainties. Those statements include statements regarding the intent, belief or current expectations of Columbia Laboratories and its management team. 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. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of Striant(R), Prochieve(R) 8% and Prochieve(R) 4% in the U.S.; the timing and size of orders for out-licensed products from our marketing partners; the timely receipt of the national marketing authorizations and individual licenses for Striant(R) in European countries; the timely payment of milestone payments by our marketing and product development partners; the timely and successful development of products; the timely and successful completion of clinical studies, including the Prochieve(R) 8% study for preventing preterm delivery and lidocaine vaginal gel studies; success in obtaining acceptance and approval of new products and indications for current products by the FDA 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 acceptance and approval of an indication for preventing preterm delivery for Prochieve(R) 8% from the FDA; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and health care 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 undertakes no obligation to publicly update any forward-looking statements. Striant(R), Prochieve(R) and Crinone(R) are registered trademarks of Columbia Laboratories, Inc.
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Nine Months Ended Three Months Ended
September 30, September 30,
2005 2004 2005 2004
----------- ------------ ----------- -----------
NET REVENUES $17,148,364 $ 14,296,456 $ 6,533,942 $ 5,092,819
COST OF REVENUES 6,452,554 5,685,011 2,390,114 2,182,140
----------- ------------ ----------- -----------
Gross profit 10,695,810 8,611,445 4,143,828 2,910,679
----------- ------------ ----------- -----------
OPERATING EXPENSES:
Selling and
distribution 6,700,682 14,958,153 1,700,286 5,210,005
General and
administrative 5,163,342 5,687,018 1,640,620 1,904,281
Research and
development 3,993,397 4,072,932 1,452,575 1,016,269
----------- ------------ ----------- -----------
Total
operating
expenses 15,857,421 24,718,103 4,793,481 8,130,555
----------- ------------ ----------- -----------
Loss from
operations (5,161,611) (16,106,658) (649,653) (5,219,876)
----------- ------------ ----------- -----------
OTHER INCOME (EXPENSE):
Interest income 127,995 182,321 41,596 63,345
Interest
expense (2,031,630) (2,206,489) (665,664) (770,953)
Loss on sale of
intangible
assets - (577,917) - -
Other, net (21,439) (131,205) (8,221) (54,355)
----------- ------------ ----------- -----------
(1,925,074) (2,733,290) (632,289) (761,963)
----------- ------------ ----------- -----------
Net loss $(7,086,685) $(18,839,948) $(1,281,942) $(5,981,839)
=========== ============ =========== ===========
NET LOSS PER
COMMON SHARE: $ (0.17) $ (0.47) $ (0.03) $ (0.14)
(Basic and =========== ============ =========== ===========
diluted)
WEIGHTED AVERAGE
NUMBER OF COMMON 41,751,934 40,726,264 41,751,934 41,751,934
SHARES =========== ============ =========== ===========
OUTSTANDING:
(Basic and diluted)
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
2005 2004
-------------- --------------
ASSETS (Unaudited)
Current assets-
Cash and cash equivalents $ 7,202,394 $ 19,781,591
Accounts receivable, net 6,232,910 4,260,379
Inventories 2,160,898 2,742,544
Prepaid expenses and other current
assets 675,739 1,155,673
-------------- --------------
Total current assets 16,271,941 27,940,187
Property and equipment, net 1,065,102 1,207,041
Other assets 120,101 121,140
-------------- --------------
TOTAL ASSETS $ 17,457,144 $ 29,268,368
============== ==============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Note payable $ --- $ 10,000,000
Current portion of financing
agreements 995,790 2,753,486
Accounts payable 2,539,479 2,772,107
Accrued sales returns and other
accrued expenses 2,524,508 3,111,198
-----------------------------
Total current liabilities 6,059,777 18,636,791
Deferred revenue 4,204,608 4,239,060
Long-term portion of financing
agreements 20,085,444 18,923,440
-----------------------------
TOTAL LIABILITIES 30,349,829 41,799,291
-----------------------------
Stockholders' equity (deficiency)-
Preferred stock, $0.01 par value; 1,000,000 shares
authorized:
Series B Convertible Preferred Stock,
130 shares issued and outstanding in
2005 and 2004 1 1
Series C Convertible Preferred Stock,
3,250 shares issued and outstanding
in 2005 and 2004 32 32
Series E Convertible Preferred Stock,
69,000 shares issued and outstanding
in 2005 690
Common stock, $0.01 par value;
100,000,000 authorized:
41,751,934 shares issued and
outstanding in 2005 and 2004 417,519 417,519
Capital in excess of par value 175,371,709 168,587,536
Accumulated deficit (188,864,523) (181,777,838)
Accumulated other comprehensive income 181,887 241,827
-------------- --------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (12,892,685) (12,530,923)
-------------- --------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 17,457,144 $ 29,268,368
=============================
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