Columbia Laboratories Reports Second Quarter 2005 Financial Results; Net Revenues up 36%, Operating Expenses Down 38%, 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 financial results for the second quarter ended June 30, 2005. Highlights of the quarter included: --Net revenues of $6.3 million, a 36% increase from $4.7 in the second quarter of 2004, and a 48% increase from $4.3 million in the first quarter of 2005 --Operating expenses of $5.0 million, a 38% decrease from $8.2 million in the second quarter of 2004, and a 16% decrease from $6.0 million in the first quarter of 2005 --Loss from operations of $1.0 million, an improvement from loss from operations of $5.3 million in the second quarter of 2004, and from $3.6 million in the first quarter of 2005 --Net loss of $1.6 million, an improvement from net loss of $6.6 million in the second quarter of 2004, and from $4.2 million in the first 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 $0.04, an improvement from a net loss per basic and diluted share of $0.16 in the second quarter of 2004, and from a net loss per basic and diluted share of $0.10 in the first quarter of 2005 --Raised $6.9 million in gross proceeds through the sale of Series E Convertible Preferred Stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". in a private placement to institutional investors Institutional Investor A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. "We are pleased to report that our second quarter financial results were in line with our expectations," stated Fred Wilkinson, Columbia's president and chief executive officer. "Per our previously stated goals, we increased revenues quarter over quarter and significantly reduced expenses, which positively impacted our bottom line. Our goal of quarterly profitability remains in sight; however, increased R&D expenses related principally to the Prochieve(R) study in preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. birth and slower than anticipated prescription growth for Striant(R) from our target audience make it unlikely that we will achieve that objective in 2005." Columbia's re-structured sales force has established its new territories and continues to emphasize the Company's "user-based" selling strategy, which is aimed at generating additional prescriptions from physicians who are already prescribers of the Company's products, while prospecting for select new prescribers. Columbia expects to realize improved results from this promotional effort behind the Company's promoted products during the next several quarters. During the second quarter, the 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, continued to recruit and enroll patients. New centers were added during the quarter, bringing to 33 the total number of study sites. Administrative delays in bringing new centers online and the reluctance of some eligible patients to enroll in a placebo-controlled study have led to a slower than anticipated growth in recruitment. Although enrollment is now not expected to be completed until late 2005, Columbia remains confident that, with a positive outcome, the Company can still file with 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 mid-2006. Columbia's other near term R&D program involves 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 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. . An abstract highlighting positive outcomes of an early lidocaine vaginal gel study was published in the April 2005 supplement to Obstetrics obstetrics (ŏbstĕ`trĭks), branch of medicine concerned with the treatment of women during pregnancy, labor, childbirth (see birth), and the time after childbirth. & Gynecology gynecology (gīn'əkŏl`əjē), branch of medicine specializing in the disorders of the female reproductive system. Modern gynecology deals with menstrual disorders, menopause, infectious disease and maldevelopment of the . The Company also completed a dosing study for lidocaine vaginal gel during the second quarter and analysis of the results is underway. The results will determine the appropriate dose for the Phase II study now scheduled to start in the second half of 2005. Also, during the quarter data from a pilot study investigating the effects of hormone hormone, secretory substance carried from one gland or organ of the body via the bloodstream to more or less specific tissues, where it exerts some influence upon the metabolism of the target tissue. supplementation, including Prochieve(R) 8%, following clomiphene citrate clomiphene citrate (klō´m n brand names: Clomid, Serophene, Milphene; drug class: therapy were published in Current Medical Research and Opinion. The study suggests that administering a sequential estrogen and 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. supplementation regimen regimen /reg·i·men/ (rej´i-men) a strictly regulated scheme of diet, exercise, or other activity designed to achieve certain ends. reg·i·men n. 1. , including Prochieve(R) 8%, with clomiphene citrate may increase the rate of pregnancy, as compared to clomiphene citrate therapy alone, but, because this was a pilot study, the difference did not reach statistical significance. Financial Overview Net revenues for the second quarter of 2005 were $6.3 million up from $4.7 million in the second quarter of 2004. Net revenues from promoted products were $1.7 million in the second quarter of 2005 as compared with $1.1 million in the second quarter of 2004, primarily as a result of increased sales of the Prochieve line of products to trade customers to meet prescription demand. Net revenues from partnered products were $4.6 million in the second quarter of 2005 as compared with $3.6 million in the second quarter of 2004, primarily as a result of an increase in the sale of RepHresh(R) and Crinone(R) to our marketing partners. Net revenues increased from $4.3 million in the first quarter of 2005, to $6.3 million in the second quarter of 2005. Net revenues in the second quarter of 2005 reflect a provision for product returns amounting to $1.6 million. During the quarter the Company re-evaluated its estimate for product returns to take into consideration additional factors related to inventory and return practices of its primary trade customers. 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 65% in the second quarter of 2005, versus 61% in the second quarter of 2004. The higher percentage resulted from an increase in overall production and a change in product mix in the second quarter of 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. in the first quarter of 2005 was 58%. Selling and distribution expenses were $2.1 million in the second quarter of 2005, a 57% decrease from $4.9 million in the second 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 second quarter of 2004 to approximately 28 persons in the second quarter of 2005. General and administration costs decreased 9% to $1.7 million in the second quarter of 2005 from $1.9 million a year ago. The reduction in expenses was primarily the result of a decrease in insurance premiums. Research and development costs were $1.2 million in the second quarter of 2005, a 13% decrease from $1.4 million in second quarter of 2004. The reduction reflects a decrease in costs associated with obtaining regulatory approvals for Striant in Europe and costs associated with completing Striant 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 follow-up studies partially offset by increasing costs related to the ongoing Phase III trial for Prochieve(R) 8% in preventing preterm delivery in pregnant women who are at high risk. As a result, for the second quarter of 2005 the Company reported a net loss of $1.6 million, or $0.04 per basic and diluted share, as compared to a net loss of $6.6 million, or $0.16 per basic and diluted share, in the second quarter of 2004. During the second quarter of 2005, the Company raised $6.9 million in gross proceeds through the sale of Series E Convertible Preferred Stock in a private placement to institutional investors. As of June 30, 2005, Columbia had cash and cash equivalents of $9.0 million. The Company believes that it has sufficient cash to meet its operating plan for 2005. Outlook The second quarter net loss from operations of $1.0 million and the first six months net loss from operations of $4.5 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. Second quarter net revenues of $6.3 million and the first six months net revenues of $10.6 million are also in line with the Company's previously projected revenue range of $22 million to $28 million for fiscal year 2005. Quarterly Conference Call As previously announced, Columbia Laboratories will hold a conference call on August 2, 2005 at 11:00 AM ET to review financial results of the second quarter ended June 30, 2005.
Access information
Date: August 2, 2005
Time: 11:00 AM ET
U.S./Canada dial-in number: (800) 299-0433
International dial-in number: (617) 801-9712
Access code: 20683035
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 August 9, 2005 at 11:59 PM ET at (888) 286-8010 (U.S.) and (617) 801-6888 (International). The replay password is 56268229. The webcast will be archived for on-demand listening for one year on Columbia Laboratories website, www.columbialabs.com. About Prochieve(R) 8% (progesterone 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 33 study sites nationwide. 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 directly at (973) 994-3999. 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 pelvic /pel·vic/ (pel´vik) pertaining to the pelvis. pel·vic adj. Of, relating to, or near the pelvis. 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)
Six Months Ended Three Months Ended
June 30, June 30,
2005 2004 2005 2004
---- ---- ---- ----
NET REVENUES $ 10,614,422 $ 9,203,637 $ 6,333,845 $ 4,663,958
COST OF REVENUES 4,062,440 3,502,871 2,245,435 1,817,675
------------ ------------- ----------- -----------
Gross profit 6,551,982 5,700,766 4,088,410 2,846,283
------------ ------------- ----------- -----------
OPERATING
EXPENSES:
Selling and
distribution 5,000,396 9,748,148 2,101,793 4,875,242
General and
administrative 3,522,722 3,782,737 1,696,964 1,854,991
Research and
development 2,540,822 3,056,663 1,248,597 1,439,952
------------ ------------- ----------- -----------
Total operating
expenses 11,063,940 16,587,548 5,047,354 8,170,185
------------ ------------- ----------- -----------
Loss from
operations (4,511,958) (10,886,782) (958,944) (5,323,902)
------------ ------------- ----------- -----------
OTHER INCOME
(EXPENSE):
Interest income 86,399 118,976 40,561 59,007
Interest expense (1,365,966) (1,435,536) (625,353) (751.355)
Loss on sale of
intangible
assets - (577,917) - (577,917)
Other, net (13,218) (76,850) (46,300) (9,113)
------------ ------------- ----------- -----------
(1,292,785) (1,971,327) (631,092) (1,279,378)
------------ ------------- ----------- -----------
Net loss ($5,804,743) ($12,858,109)$(1,590,036) $(6,603,280)
============ ============= =========== ===========
NET LOSS PER
COMMON SHARE:
(Basic and
diluted) $ (0.14) $ (0.32) $ (0.04) $ (0.16)
============ ============= =========== ===========
WEIGHTED AVERAGE
NUMBER OF
COMMON SHARES
OUTSHANDING:
(Basic and
diluted) 41,751,934 40,207,797 41,751,934 40,675,011
============ ============= =========== ===========
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, December 31,
2005 2004
------------- -------------
(Unaudited)
ASSETS
Current assets-
Cash and cash equivalents $ 8,966,533 $ 19,781,591
Accounts receivable, net 4,675,858 4,260,379
Inventories 2,594,732 2,742,544
Prepaid expenses and other current
assets 444,915 1,155,673
Total current assets 16,682,038 27,940,187
------------ ------------
Property and equipment, net 1,119,094 1,207,041
Other assets 120,321 121,140
------------ ------------
TOTAL ASSETS $ 17,921,453 $ 29,268,368
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIENCY)
Current liabilities-
Note payable - short-term $ --- $ 10,000,000
Current portion of financing
agreements 1,105,049 2,753,486
Accounts payable 1,471,609 2,772,107
Accrued sales returns and other
accrued expenses 2,975,817 3,111,198
------------ ------------
Total current liabilities 5,552,475 18,636,791
Deferred revenue 4,350,873 4,239,060
Long-term portion of financing
agreements 19,588,719 18,923,440
------------ ------------
TOTAL LIABILITIES 29,492,067 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 175,410,133 168,587,536
Accumulated deficit (185,582,581) (181,777,838)
Accumulated other comprehensive income 183,592 241,827
-------------- -------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (11,570,614) (12,530,923)
-------------- -------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 17,921,453 $ 29,268,368
============== =============
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