EX-99.1 CHARTER 2 exhibit99-1.htm EXHIBIT 99.1 8.07.08 PRESS RELEASE exhibit99-1.htm
 
 

 
 

 
 

 
 
 
 
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 EXHIBIT 99.1


NEWS

COLUMBIA LABORATORIES REPORTS
SECOND QUARTER 2008 FINANCIAL RESULTS


Management will host Conference Call at 11:00 AM ET Today
 
LIVINGSTON, NJ - August 7, 2008-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 to prevent and treat dysmenorrhea
    (a condition typified by painful menstruation); 

    ● 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 birth in women with a short cervix at mid-pregnancy; 
 
    ●Increased visibility for CRINONE 8% (progesterone gel) via interviews of Dr. David Keefe, 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 radios 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.

"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 8% in both the U.S. and foreign markets and PROCHIEVE 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 orders.
 
 
 

Columbia Laboratories Reports Second Quarter 2008 Financial Results                                                                                                                                                        Page 2 of  5
August 7 , 2008


 
 
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 increased from 62% to 68% reflecting a shift in product sales mix from RepHresh toward CRINONE® 8%, a higher-margin product.
 
Total operating expenses 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® 8% in the U.S., and sponsorships of medical conventions.
 
§ General and administrative costs 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:
 
 Date:  Thursday, August 7, 2008
 Time:  11:00 AM ET
 Dial-in numbers:  877-397-0272 (U.S. & Canada) or 719-325-4936
 Live webcast:  www.cbrxir.com, under "Events"
 
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® 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.
 
 

 
Columbia Laboratories Reports Second Quarter 2008 Financial Results                                                                                                                                                        Page 3 of  5
August 7 , 2008


 
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.
RepHresh® is a registered trademarks of Lil’ Drug Store Products, Inc.

Contact:
James A. Meer, Senior Vice President, CFO & Treasurer
Columbia Laboratories, Inc.
(973) 486-8860

Melody A. Carey, Co-President
Rx Communications Group, LLC
(917) 322-2571

Financial Tables Follow
 

 
 

 

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

 
     
Six Months Ended
   
Three Months Ended
 
     
June 30,
   
June 30,
 
           
Restated
         
Restated
 
     
2008
   
2007
   
2008
   
2007
 
                           
NET REVENUES
    $ 18,332,549     $ 13,971,634     $ 9,263,821     $ 7,287,014  
                                   
COST OF REVENUES
      5,909,906       4,875,476       2,949,809       2,803,289  
Gross profit
      12,422,643       9,096,158       6,314,012       4,483,725  
                                   
OPERATING EXPENSES:
                                 
Selling and distribution
      6,587,605       4,061,132       3,328,039       2,163,850  
General and administrative
    4,549,448       3,899,773       2,429,537       1,915,248  
Research and development
    3,541,763       2,359,600       1,695,156       1,008,699  
Amortization of licensing right
    2,522,364       2,483,404       1,261,182       1,261,183  
      Total operating expenses
 
    17,201,180       12,803,909       8,713,914       6,348,980  
                                   
       Loss from operations
 
    (4,778,537 )     (3,707,751 )     (2,399,902 )     (1,865,255 )
OTHER INCOME (EXPENSE):
                                 
Interest income
      190,660       505,589       54,339       242,033  
Interest expense
      (3,872,681 )     (3,904,416 )     (1,953,595 )     (1,969,862 )
Other, net
      (114,409 )     (18,773 )     (27,013 )     3,709  
        (3,796,430 )     (3,417,600 )     (1,926,269 )     (1,724,120 )
                                   
Net loss
    $ (8,574,967 )   $ (7,125,351 )   $ (4,326,171 )   $ (3,589,375 )
                                   
NET LOSS PER COMMON SHARE:
                               
Basic and diluted
    $ (0.17 )   $ (0.14 )   $ (0.08 )   $ (0.07 )
                                   
WEIGHTED AVERAGE NUMBER OF
                               
COMMON SHARES OUTSTANDING:
                               
 Basic and diluted
      52,083,106       50,713,299       52,127,332       51,342,528  
                                   

 
 

 


COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
 
 CONDENSED CONSOLIDATED BALANCE SHEETS
 

   
June 30,
   
December 31,
 
   
2008
   
2007
 
   
(Unaudited)
       
ASSETS:
           
 Cash and cash equivalents
  $ 10,570,820     $ 17,221,811  
  Accounts receivable, net
    4,292,466       3,810,993  
   Inventories
    3,722,981       3,047,129  
Prepaid expenses and other current assets
    681,894       1,287,300  
 Total current assets
    19,268,161       25,367,233  
                 
Property and equipment, net
    688,020       651,967  
  Intangible assets, net
    26,337,424       28,859,788  
  Other assets
    1,590,501       1,710,289  
TOTAL ASSETS
  $ 47,884,106     $ 56,589,277  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
Current portion of financing agreements
  $ 165,888     $ 3,786,538  
Accounts payable
    3,236,060       2,215,942  
  Accrued expenses
    4,616,761       4,903,881  
 Total current liabilities
    8,018,709       10,906,361  
  Notes payable
    28,764,380       27,536,178  
  Deferred revenue
    3,222,015       3,580,880  
Long-term portion of financing agreements
    12,254,619       11,425,601  
TOTAL LIABILITIES
    52,259,723       53,449,020  
                 
Contingently redeemable Series C Convertible Preferred
               
Stock, 1,125 shares issued and outstanding in 2008 and 2007
    1,125,000       1,125,000  
                 
Stockholders' (deficit) equity
               
  Preferred Stock, $0.01 par value; 1,000,000 shares authorized
               
    Series B Convertible Preferred Stock, 130 shares issued
               
      and outstanding in 2008 and 2007
    1       1  
    Series E Convertible Preferred Stock, 59,000 shares and 63,547
               
     shares issued and outstanding in 2008 and 2007
    590       635  
  Common Stock, $0.01 par value; 100,000,000
               
    authorized; 52,378,676 and 51,730,151 shares issued
               
    and 52,319,032 and 51,712,151 outstanding
               
    in 2008 and 2007 respectively
    523,787       517,302  
Capital in excess of par value
    223,537,759       222,376,941  
Less cost of 59,644 and 18,000 treasury shares in 2008 and 2007
    (172,189 )     (54,030 )
  Accumulated deficit
    (229,608,163 )     (221,033,196 )
Accumulated other comprehensive income
    217,598       207,604  
TOTAL STOCKHOLDERS' (DEFICIT) EQUITY
    (5,500,617 )     2,015,257  
TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT)
               
EQUITY
  $ 47,884,106     $ 56,589,277  
                 
                 
See notes to condensed consolidated financial statements