Columbia Laboratories Reports First 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-month period ended March 31, 2008. Highlights for, and subsequent to, the quarter include: * Net revenues of $9.1 million, a 36% increase from $6.7 million in the first quarter of 2007; * Completed enrollment 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). ); * Presented data demonstrating 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) reduced the rate of cervical shortening in women at risk for preterm preterm /pre·term/ (-term´) before completion of the full term; said of pregnancy or of an infant. pre·term adj. birth at the Society for Maternal-Fetal Medicine's 2008 Annual Meeting; * Initiated the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study of PROCHIEVE 8% to reduce the risk of preterm 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; and, * Filed patent applications in the U.S. and around the world for use of progesterone to prevent or treat preterm birth in women with a short cervix. "I am very pleased with our financial performance for the period," stated Robert S. Mills, Columbia's president and chief executive officer. "First quarter 2008 financial results reflect another strong quarter, our fifth consecutive quarter of revenue growth, and the highest-ever quarterly sales figure for the Company. "We also advanced our R&D programs for vaginal lidocaine and the PREGNANT Study. In the latter study, nine of 19 participating study sites have Institutional Review Board (IRB IRB See: Industrial Revenue Bond ) approvals and patient screening is underway at most of those sites. We maintain our previously stated timeline for this study and expect to report results in the first half of 2009. Our patent applications, if allowed, would strengthen our intellectual property position, providing patent protection until the year 2028 for PROCHIEVE 8% in women with a short cervix at mid-pregnancy." First Quarter Financial Results Net revenues for the first quarter of 2008 were $9.1 million, compared to $6.7 million for the first quarter of 2007, an increase of 36%. Net revenues from progesterone products increased 25% in the first quarter of 2008. Revenues were $5.9 million in the first quarter compared with $4.7 million in the first quarter of 2007. The increase primarily reflects increases in PROCHIEVE 8% and international CRINONE([R]) 8% sales. Net revenues from "other products" were $3.1 million in the first quarter of 2008 as compared with $2.0 million in the first quarter of 2007. This 50% increase reflects higher sales of Replens([R]), RepHresh([R]) and 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). Gross profit grew 32% from $4.6 million to $6.1 million. 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. decreased from 69% to 67% reflecting the impact from the increased sales in "other products" and international CRINONE([R]) 8% which have a lower gross profit margin than CRINONE 8% in the U.S. 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 $8.5 million in the first quarter of 2008, a 32% increase compared to $6.5 million in the prior year period. * Selling and distribution expenses were $3.3 million in the first quarter of 2008, a 72% increase from $1.9 million in the first quarter of 2007, primarily reflecting costs associated with the expansion of the sales force from 23 to 35 persons in the second half of 2007, market research to aid the Company in marketing CRINONE 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 7% to $2.1 million in the first quarter of 2008 from $2.0 million a year ago. * Research and development costs increased 37% to $1.8 million in the first quarter of 2008 from $1.4 million in the first 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 increase was offset by costs of 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 trial of PROCHIEVE([R]) 8% to prevent recurrent preterm birth, which was completed in early 2007. * In the first quarter of 2008 and 2007, the Company amortized $1.3 and $1.2 million, respectively, of the acquisition cost for the U.S. license rights to CRINONE 8% acquired from Merck Serono In September 2006, Merck KGaA announced its intent to purchase the majority of Serono shares from Ernesto Bertarelli and the Bertarelli family. The Merck-Serono merger was announced on September 21, 2006. Merck KGaA and Serono operated as distinct entities until at least January 2007. in December 2006. * Other income and expense for the first quarter of 2008 was a net expense of $1.9 million versus $1.7 million (restated) in the first quarter of 2007. As a result, the Company reported a net loss of $4.2 million, or $0.08 per basic and diluted share, for the first quarter of 2008 as compared to a net loss of $3.5 million (restated), or $0.07 per basic and diluted share (restated), for the first quarter of 2007. As of March 31, 2008, Columbia had cash and cash equivalents of $13.1 million. This compares to cash and cash equivalents of $17.2 million at December 31, 2007, and reflects the February 29, 2008 final payment of $3.6 million to PharmaBio Development, Inc. under a 2002 financing agreement. Quarterly Conference Call As previously announced, Columbia Laboratories will hold a conference call to discuss financial results of the first quarter ended March 31, 2008, as follows: [TABLE OMITTED] The teleconference replay will be available two hours after completion through Thursday, May 15, 2008 at (888) 203-1112 (U.S. only) or (719) 457-0820. The replay passcode is 7317428. 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 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 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 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. Replens([R]) and RepHresh([R]) are registered trademarks of Lil' Drug Store Products, Inc. [TABLE OMITTED] [TABLE OMITTED] |
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