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COLUMBIA LABORATORIES REPORTS FIRST QUARTER 2008 FINANCIAL RESULTS

Management will host Conference Call at 11:00 AM ET Today

LIVINGSTON, NJ— May 8, 2008—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 to prevent and treat dysmenorrhea (a condition typified by painful menstruation);
  • Presented data demonstrating PROCHIEVE® 8% (progesterone gel) reduced the rate of cervical shortening in women at risk for preterm 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 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) 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® 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®, RepHresh® and STRIANT® (testosterone buccal system).

Gross profit grew 32% from $4.6 million to $6.1 million. Gross profit margin decreased from 69% to 67% reflecting the impact from the increased sales in “other products” and international CRINONE® 8% which have a lower gross profit margin than CRINONE 8% in the U.S.

Total operating expenses 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 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 trial of PROCHIEVE® 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 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:

Date: May 08, 2008
Time: 11:00 AM ET
Dial in Numbers (877) 440-5785 (U.S. & Canada) or (719) 325-4902
Live Webcast www.cbrxir.com, under “Events”

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® 8% (progesterone gel) and PROCHIEVE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company’s partners market CRINONE® 8%, STRIANT®, and three other products to additional U.S. and foreign markets. The Company’s research and development programs include 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 at mid-pregnancy and a vaginal lidocaine product to prevent and treat dysmenorrhea. For more information, please visit www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act 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® 8% (progesterone gel), PROCHIEVE® 8% (progesterone gel), and STRIANT® (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® 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® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA 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®, CRINONE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc. Replens® and RepHresh® are registered trademarks of Lil’ Drug Store Products, Inc.

Company Contact: 

Investor and Media Contact: 
James A. Meer Melody A. Carey,
Senior Vice President, CFO & Treasurer Co-President, Rx Communications, LLC
(973) 486-8860 (917) 322-2571

 

Financial Tables Follow

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES

 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

 

 

Three Months Ended

March 31,

 

 

  2008

 

2007(Restated)

 

 

 

 

 

NET REVENUES

9,068,728

 

$

6,684,620

COST OF REVENUES

 

2,960,097

 

 

2,072,187

Gross Profit

 

6,108,631

 

 

4,612,433

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

Selling and distribution

 

3,259,566

 

 

1,897.282

General and administrative

 

2.119,911

 

 

1,984,525

Research and development

 

1,846,607

 

 

1,350,901

Amortization of license right

 

1,261,182

 

 

1,222,221

Total operating expenses

 

8,487,266

 

 

6,454,929

Loss from operations

 

(2,378,635)

 

 

(1,842,496)

 

 

 

 

 

 

OTHER INCOME (EXPENSE):

 

 

 

 

 

Interest income

 

136,321

 

 

263,556

Interest expense

 

(1,919,086)

 

 

(1,934,554)

Other, net

 

 (87,395)

 

 

(22,482)

Total other (expense)

 

(1,870,160)

 

 

(1,693,480)

 Net loss

 $

(4,248,795)

 

 $

(3,535,976)

 

 

 

 

 

 

 NET LOSS PER COMMON SHARE:

 $

(0.08)

 

 $

(0.07)

(Basic and diluted)

 

 

 

 

 

 WEIGHTED-AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

 

51,964,036

 

 

50,081,448

 (Basic and diluted)

 

 

 

 

 

 

 

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES

 CONDENSED CONSOLIDATED BALANCE SHEETS

  

 

 

 

 March 31, 2008

 

 

December 31, 2007

 

 

 (unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets-

 

 

 

 

 

Cash and cash equivalents

$

13,132,875

 

17,221,811

Accounts receivable, net

 

2,600,884

 

 

3,810,993

Inventories

 

3,371,034

 

 

3,047,129

Prepaid expenses and other current assets

 

1,053,579

 

 

1,287,300

Total Current Assts

 

20,158,372

 

 

25,367,233

Property and equipment, net

 

716,143

 

 

651,967

Intangible assets, net

 

27,598,606

 

 

28,859,788

Other assets

 

1,651,165

 

 

1,710,289

TOTAL ASSETS

50,124,286

 

56,589,277

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities-

 

 

 

 

 

Current portion of financing agreements

164,630

 

3,786,538

Accounts payable

 

2,520,370

 

 

2,215,942

Accrued expenses

 

4,888,681

 

 

4,903,881

Total current liabilities

 

7,573,681

 

 

10,906,361

Notes payable – long term note

 

28,140,314

 

 

27,536,178

Deferred revenue

 

3,401,440

 

 

3,580,880

Long-term portion of financing agreements

 

11,834,099