Columbia Laboratories Reports Fourth Quarter and Year-End 2005 Financial Results.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 financial results for the fourth quarter and year ended December 31, 2005. Highlights of fiscal 2005 included: --Revenues increased 23% to $22.0 million from $17.9 million in 2004; --Operating expenses decreased 34% to $21.2 million from $32 million in 2004; --Net loss improved 63% to $9.3 million from a net loss of $25.1 million in 2004; --Net loss per share improved to $0.23 per share versus a net loss of $0.62 per share in 2004; --The European patent office granted a patent for the use of carbamide peroxide Carbamide peroxide, also called urea peroxide, is an oxidising agent, consisting of hydrogen peroxide compounded with urea. The molecular formula is CH6N2O3, or CH4N2O.H2O2. in Columbia's bioadhesive delivery system for the treatment of bacterial vaginosis Bacterial Vaginosis Definition Bacterial vaginosis (BV) is a type of vaginal infection in which the normal balance of bacteria in the vagina is disrupted, allowing the overgrowth of harmful anaerobic bacteria at the expense of protective bacteria. ; --The IND for a new Phase II study of vaginally-administered 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 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. was filed with and accepted 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, --Enrollment in the 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 study of Prochieve(R) 8% for the prevention of preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. birth continued to increase and passed the 400-patient mark in February 2006. Robert S Robert, Henry Martyn 1837-1923. American army engineer and parliamentary authority. He designed the defenses for Washington, D.C., during the Civil War and later wrote Robert's Rules of Order (1876). Noun 1. . Mills, Columbia's president and chief executive officer, said, "Columbia's focused sales programs and aggressive cost containment cost containment, n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan. initiatives delivered tangible results in fiscal 2005. Revenues increased by 23%, with underlying increases in revenues from both our Partnered Products and our Promoted Products. 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. decreased by 34% from the 2004 levels, and our net loss decreased by 63%. We are pleased with our continued progress, particularly given the 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). of our U.S. sales organization early in the year and related challenges, and higher-than-anticipated research and development expenses in the second half of 2005. "We achieved these results while advancing our two later-stage research and development programs, Prochieve 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) for the prevention of preterm birth and vaginally-administered lidocaine 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. These programs have strong revenue-generating potential, and hold great promise for the Company and its shareholders as well as patients in need. "Columbia's objectives for 2006 are clear: to complete the preterm study, advance our lidocaine candidate into Phase II clinical trials Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II and optimize the return on our current portfolio of products while continuing to control expenses. These are attainable targets, and I look forward to leading Columbia as we achieve these goals and move the Company forward." Prochieve(R) 8% (progesterone gel) for Preterm Birth During the fourth quarter of 2005 and into 2006, Columbia continued to execute strategies to accelerate recruiting and enrollment of patients in the Prochieve(R) preterm study. This 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-blind, placebo-controlled Phase III study is 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% in preventing preterm delivery in pregnant 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. The goal of this program is to expand the Prochieve(R) 8% label beyond 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. and secondary amenorrhea secondary amenorrhea n. Amenorrhea in which menstruation begins at puberty but then is subsequently suppressed. secondary amenorrhea , for which it is currently approved and commercially available, to include this potential new indication. This study is designed to enroll 636 patients; 414 patients were enrolled at the end of February. From October 2005 through February 2006, enrollment has averaged 35 patients per month, a rate the Company expects to maintain going forward through the addition of new study centers and execution of its study-related marketing efforts. During the aforementioned a·fore·men·tioned adj. Mentioned previously. n. The one or ones mentioned previously. aforementioned Adjective mentioned before Adj. 1. period, the Company added 10 study centers. The Company had 53 study centers (42 domestic and 11 foreign) open at the end of February and plans to open up to 10 more in March and April. Based on average monthly enrollment of 35 patients, and with 222 patients yet to enroll, Columbia projects that enrollment in the preterm study will be complete by the end of third quarter 2006. The Company now expects, if positive results are obtained, to file with the FDA for a label indication in mid-2007. Because there is no approved treatment for preterm birth, and because of the growing prevalence and vast economic and social impact of this problem, the Company is hopeful that the FDA will grant an expedited review during 2007. Vaginally-administered Lidocaine for Dysmenorrhea and Pelvic Pain Building on positive results 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 of three doses of lidocaine 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 concluded in September 2005, during the fourth quarter of 2005 Columbia completed the design of its Phase II study of vaginally-administered lidocaine for the prevention and treatment of dysmenorrhea and pelvic pain, and the IND for this study was filed and accepted. Because the Company intends to maintain its focus on completing the preterm study, it is now planning to initiate the Phase II lidocaine clinical trial in the third quarter of 2006. New Patent Family In June 2005, the Company received a patent for the use of carbamide peroxide for the treatment of bacterial vaginosis (BV) from the European patent office. BV is the most common vaginal infection in women of childbearing child·bear·ing n. Pregnancy and parturition. child bear ing adj. age. This new patent family is valid through
mid-2022; similar patents are pending 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. .Financial Overview The Company recorded revenues of $4.9 million during the fourth quarter of 2005, an increase of 37.3% from the fourth quarter of 2004. In the 2004 quarter, the Company had established additional reserves in the amount of $2.8 million resulting from the reevaluation of the accounting estimate for future product returns based on such factors as historical trends, distributor inventory levels and product prescription data. Fourth quarter revenues decreased from $6.5 million in the third quarter 2005 due to the timing of full batch sales of product to our marketing partners in the third quarter. Gross profit as a percentage of revenues was 66% in the fourth quarter of 2005 compared to 41% in the fourth quarter of 2004, an increase due to the impact of previously reported wholesaler returns on fourth quarter 2004 revenues and to the reduction of overhead costs overhead costs see fixed costs. in 2005. The gross profit margin 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. increased from 63% in the third quarter of 2005. Selling and distribution expenses were $1.9 million in the fourth quarter, a 53.6% decrease from the fourth quarter of 2005. This decrease mainly reflects decreased sales force costs for promotion of the Company's products in the United States which primarily resulted from the reduction of the sales force from approximately 80 persons in the fourth quarter of 2004 to approximately 28 persons in the fourth quarter of 2005. Selling and distribution expenses in the fourth quarter of 2005 were 10.4% higher than in the third quarter of 2005 as a result of higher marketing costs. General and administration costs were $1.7 million, a 12.6% decrease from the fourth quarter of 2004 and essentially unchanged from third quarter 2005 levels. Research and development costs were $1.8 million, a 28.2% increase over fourth quarter 2004, predominantly due to costs related to the ongoing Phase III study of Prochieve(R) 8% for the prevention of preterm birth. Research and development costs increased $311,000 from the third quarter of 2005, reflecting costs associated with marketing programs intended to increase the patient enrollment rate of this study. As a result, the Company reported a net loss of $2.2 million, or $0.05 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 for the fourth quarter of 2005, compared to a net loss of $6.3 million, or $0.15 per basic and diluted share, in the fourth quarter of 2004. For the third quarter of 2005, the Company reported a net loss of $1.3 million, or $0.03 per basic and diluted share. For the year ended December 31, 2005, revenues were $22.0 million, a 23% increase compared to $17.9 million in 2004. The higher 2005 revenues reflect a 25% increase in revenues from Partnered Products and a 21% increase in revenues from Promoted Products. Gross profit as a percentage of revenues was 63.2% in 2005 compared to 56.4% in 2004. Selling and distribution expenses decreased 54.9% to $8.6 million from $19.0 million in 2004, reflecting the reduction of the sales force as previously mentioned. General and administration expenses decreased to $6.8 million in 2005 from $7.6 million in 2004. This 11.1% decrease was primarily the result of lower insurance costs. Research and development expenses were $5.8 million in 2005 compared to $5.4 million in 2004 for reasons mentioned above. As a result, the Company reported a net loss of $9.3 million, or $0.23 per basic and diluted share, for the year ended December 31, 2005, as compared to a net loss of $25.1 million, or $0.62 per basic and diluted share, for the year ended December 31, 2004. The Company had cash and cash equivalents of $7.1 million at December 31, 2005. Conference Call As previously announced, Columbia Laboratories will hold a conference call to review financial results of the fourth quarter and year ended December 31, 2005 as follows:
Date: Tuesday, March 7, 2006
Time: 11:00 a.m. ET
U.S./Canada dial-in number: (866) 713-8395
International dial-in number: (617) 597-5309
Access passcode: 62581078
Live webcast: www.columbialabs.com, under the investor relations
tab
A recording of the conference call will be available two hours after completion until 11:59 p.m. ET March 14, 2006 at 888-286-8010 (U.S.) and 617-801-6888 (International). The replay passcode is 68735406. The webcast will be archived for on-demand listening for one year on Columbia Laboratories website, www.columbialabs.com, under the investor relations Investor relations The process by which the corporation communicates with its investors. tab. 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. 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, 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 Prochieve(R) 8%, Prochieve(R) 4%, and Striant(R) in the U.S.; the timing and size of orders for out-licensed products from our marketing partners; the timely and successful completion of clinical studies, including the Prochieve(R) 8% study for preventing preterm delivery and vaginally-administered lidocaine studies; our ability to refinance Refinance 1. When a business or person revises their payment schedule for repaying debt. 2. Replacing an older loan with a new loan offering better terms. Notes: When a business refinances they typically extend the maturity date. our short term indebtedness; 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 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 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
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2005 2004
----------- -----------
ASSETS
Current assets-
Cash and cash equivalents $7,136,854 $19,781,591
Accounts receivable, net 4,020,019 4,260,379
Inventories 1,821,433 2,742,544
Prepaid expenses and other current assets 625,908 1,155,673
----------- -----------
Total current assets 13,604,214 27,940,187
Property and equipment, net 1,002,580 1,207,041
Other assets 124,756 121,140
----------- -----------
TOTAL ASSETS $14,731,550 $29,268,368
----------- -----------
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Note payable - short-term $ --- $10,000,000
Current portion of financing agreements 12,840,161 2,753,486
Accounts payable 1,905,381 2,772,107
Accrued expenses 2,329,475 3,111,198
----------- -----------
Total current liabilities 17,075,017 18,636,791
Deferred revenue 4,058,327 4,239,060
Long-term portion of financing agreements 8,747,743 18,923,440
----------- -----------
TOTAL LIABILITIES 29,881,087 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
Series E Convertible Preferred Stock, 32 32
69,000 shares issued and Outstanding
in 2005 690 ---
Common stock, $0.01 par value; 100,000,000
authorized:
41,754,784 and 41,751,934 shares issued
and outstanding in 2005 and 2004,
respectively 417,548 417,519
Capital in excess of par value 175,340,023 168,587,536
Accumulated deficit (191,084,974)(181,777,838)
Accumulated other comprehensive income 177,143 241,827
----------- -----------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (15,149,537) (12,530,923)
----------- -----------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $14,731,550 $29,268,368
----------- -----------
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Twelve months ended Three months ended
December 31, December 31,
2005 2004 2005 2004
----------- ----------- ---------- ----------
(unaudited) (unaudited)
REVENUES $22,040,842 $17,860,404 $4,892,478 $3,563,948
COST OF GOODS SOLD 8,111,497 7,788,601 1,658,943 2,103,590
----------- ----------- ---------- ----------
Gross profit 13,929,345 10,071,803 3,233,535 1,460,358
----------- ----------- ---------- ----------
OPERATING EXPENSES:
Selling and
distribution 8,578,022 19,006,585 1,877,340 4,048,432
General and
administrative 6,825,148 7,588,437 1,661,806 1,901,419
Research and
development 5,756,856 5,448,685 1,763,459 1,375,753
----------- ----------- ---------- ----------
Total operating
expenses 21,160,026 32,043,707 5,302,605 7,325,604
----------- ----------- ---------- ----------
Loss From
operations (7,230,681) (21,971,904) (2,069,070) (5,865,246)
----------- ----------- ---------- ----------
OTHER INCOME
(EXPENSE):
Interest income 165,886 241,342 37,891 59,021
Interest expense (2,694,041) (2,991,136) (662,411) (784,647)
Loss on sale of
intangible
assets --- (577,917) --- ---
Other, net 451,700 169,991 473,139 301,196
----------- ----------- ---------- ----------
(2,076,455) (3,157,720) (151,381) (424,430)
----------- ----------- ---------- ----------
Net loss $(9,307,136) $(25,129,624) $(2,220,451) $(6,289,676)
----------- ----------- ---------- ----------
NET LOSS PER
COMMON SHARE:
(Basic and
diluted) $(0.23) $(0.62) $(0.05) $(0.15)
----------- ----------- ---------- ----------
WEIGHTED AVERAGE
NUMBER OF COMMON
SHARES
OUTSTANDING: 41,752,422 40,984,083 41,753,870 41,751,934
(Basic and ----------- ----------- ---------- ----------
diluted
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