Columbia Laboratories Reports Second Quarter 2008 Financial Results.Management will host Conference Call at 11:00 AM ET Today LIVINGSTON, N.J. -- Columbia Laboratories, Inc. (Nasdaq: CBRX) today reported financial results for the three- and six-month periods ended June 30, 2008. Highlights for, and subsequent to, the quarter include: * Net revenues for the second quarter of 2008 were $9.3 million, a 27% increase from $7.3 million in the second quarter of 2007; * Net revenues for the first half of 2008 were $18.3 million, a 31% increase from $14 million in the first half of 2007; * Completed patient treatment and follow up in the Phase II clinical study of vaginal 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 to prevent and treat 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. (a condition typified by painful menstruation menstruation, periodic flow of blood and cells from the lining of the uterus in humans and most other primates, occurring about every 28 days in women. Menstruation commences at puberty (usually between age 10 and 17). ); * Study centers are screening and enrolling patients in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study of PROCHIEVE 8% to reduce the risk of preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. birth in women with a short cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. at mid-pregnancy; * Increased visibility for CRINONE[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) via interviews of Dr. David Keefe David Edward Keefe (born June 23, 1957 in Dagenham) is an English former professional footballer. David Keefe, a winger, began his football career as an apprentice with Southend United, making his league debut prior to turning professional in July 1975. , professor at the University of South Florida • • [ , on the Conceive On-air Network and Dr. George Creasy, Columbia's vice president of clinical research, on CBS (Cell Broadcast Service) See cell broadcast. radio's Health & Well Being Report. "The second quarter 2008 was another strong quarter for Columbia," stated Robert S. Mills, Columbia's president and chief executive officer. "It was our sixth consecutive quarter of increased revenues, and we posted the Company's highest-ever quarterly sales figures sales figures npl → cifras fpl de ventas . "Our R&D programs for vaginal lidocaine and the PREGNANT Study remain on schedule. We look forward to reporting Phase II lidocaine study results near the end of August and expect to report results of the PREGNANT Study late in the first half of 2009. Both of these programs address very large markets and, if successful, offer significant potential upside for the Company and our investors." Second Quarter Financial Results Net revenues for the second quarter of 2008 were $9.3 million, compared to $7.3 million for the second quarter of 2007, an increase of 27%. Net revenues from progesterone products increased 59% to $6.8 million in the second quarter of 2008 compared with $4.3 million in the second quarter of 2007. The increase reflects increased sales of CRINONE([R]) 8% in both the U.S. and foreign markets and PROCHIEVE([R]) 4%. Net revenues from our other products were $2.5 million in the second quarter of 2008 as compared with $3.0 million in the second quarter of 2007, due to the timing of RepHresh([R]) orders. Gross profit grew 40% from $4.5 million in the second quarter of 2007 to $6.3 million in the second quarter of 2008. 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 62% to 68% reflecting a shift in product sales mix sales mix See product mix. from RepHresh toward CRINONE([R]) 8%, a higher-margin product. Total 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. were $8.7 million in the second quarter of 2008 compared to $6.3 million in the prior year period. * Selling and distribution expenses were $3.3 million in the second quarter of 2008, an increase from $2.2 million in the second quarter of 2007, primarily reflecting costs in 2008 associated with the expansion of the sales force in the second half of 2007 from 20 to 32 persons, market research to aid the Company in marketing CRINONE([R]) 8% in the U.S., and sponsorships of medical conventions. * 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. increased to $2.4 million in the second quarter of 2008 from $1.9 million a year ago. The increase was primarily related to increased professional fees and compensation expense. * Research and development costs increased to $1.7 million in the second quarter of 2008 from $1.0 million in the second quarter of 2007. The increase was primarily related to costs of the PREGNANT Study and the continued development of lidocaine for women with dysmenorrhea. * The Company amortized $1.3 million of the acquisition cost for the U.S. license rights to CRINONE 8% in the second quarter of both 2008 and 2007. * Other income and expense for the second quarter of 2008 aggregated to a net expense of $1.9 million versus $1.7 million in the second quarter of 2007. As a result, the Company reported a net loss of $4.3 million, or $0.08 per basic and diluted share, for the second quarter of 2008 as compared to a restated net loss of $3.6 million, or $0.07 per basic and diluted share, for the second quarter of 2007. As of June 30, 2008, Columbia had cash and cash equivalents of $10.6 million. This compares to cash and cash equivalents of $13.1 million at March 31, 2008. During the quarter, working capital increased by $1.9 million. Quarterly Conference Call As previously announced, Columbia Laboratories will hold a conference call to discuss financial results of the second quarter ended June 30, 2008, as follows: [TABLE OMITTED] The teleconference replay will be available two hours after completion through Thursday, August 14, 2008 at (888) 203-1112 (U.S. & Canada) or (719) 457-0820. The replay passcode is 9575641. The archived webcast will be available for one year on the Company's investor website, www.cbrxir.com, under "Events." About Columbia Laboratories Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women's healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE([R]) 8% (progesterone gel) and PROCHIEVE([R]) 8% (progesterone gel) in the United States 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. The Company also markets STRIANT([R]) (testosterone 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. The Company's partners market CRINONE([R]) 8%, STRIANT([R]), and three other products to additional U.S. and foreign markets. The Company's research and development programs include the PREGNANT (PROCHIEVE([R]) Extending GestatioN A New Therapy) Study of PROCHIEVE([R]) 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy and a vaginal lidocaine product to prevent and treat dysmenorrhea. 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: This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will," "plan," "expect," "estimate," "should," and similar expressions. Such forward-looking statements involve certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE[R] 8% (progesterone gel), PROCHIEVE[R] 8% (progesterone gel), and STRIANT[R] (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE[R] 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the clinical studies of our vaginal lidocaine product candidate and the ongoing Phase III PREGNANT (PROCHIEVE[R] Extending GestatioN A New Therapy) Study of PROCHIEVE[R] 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current 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; the impact of competitive products and pricing; 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 undertakes no obligation to publicly update any forward-looking statements. PROCHIEVE([R]), CRINONE([R]) and STRIANT([R]) are registered trademarks of Columbia Laboratories, Inc. RepHresh([R]) is a registered trademarks of Lil' Drug Store Products, Inc. Financial Tables Follow [TABLE OMITTED] [TABLE OMITTED] |
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