EX-99.1 2 v05254_ex99-1.htm
  Exhibit 99.1  
   
NEWS   
     
Contact:       David Weinberg 
  Chief Financial Officer 
  (973) 994-3999 x7933 
     
  Amy Raskopf 
  Manager, Investor Relations 
  (973) 994-3999 x7925 
       

354 Eisenhower Parkway
Plaza I, Second Floor
Livingston, NJ 07039

TEL: (973) 994-3999
FAX: (973) 994-3001

     

Columbia Laboratories Reports Second Quarter 2004 Financial Results

LIVINGSTON, NJ - August 4, 2004 - Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced financial results for the second quarter and six months ended June 30, 2004. Highlights of the quarter included:

  • Restructured sales force began direct promotion of full product portfolio

  • Striant™ SR (testosterone buccal system) launched in the U.K. by ArdanaBioscience

  • Advanced global commercialization strategy by filing for MutualRecognition Procedure in European Union countries for Striant SR

  • Completed sale of OTC portfolio and related supply and professionalpromotion agreements, valued at $11 million through 2009

  • Positive data from two clinical studies comparing Striant ® (testosteronebuccal system) to other testosterone replacement therapies published inpeer-reviewed journals

  • Advanced enrollment in PROTERM™ study of Prochieve ® 8%(progesterone gel) in preventing preterm delivery

  • Reduced operating expenses from first quarter 2004 levels

Fred Wilkinson, Chairman, President and Chief Executive Officer of Columbia Laboratories, stated, “In the second quarter of 2004, Columbia Laboratories was unequivocally focused on advancing our core prescription business in women’s healthcare and endocrine-related disorders. We took decisive steps to advance our strategic initiatives within a tight operating structure. This included training, deploying and supporting our newly restructured sales force; completing the sale of our portfolio of over-the-counter women’s healthcare products; aggressively advancing partnering discussions for our non-core desmopressin buccal candidate; and, building enrollment in the PROTERM™ study, which is evaluating Prochieve® 8% in a potential new indication, the prevention of preterm birth.”

     

 

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Columbia Laboratories Reports Second Quarter 2004 Financial Results
August 4, 2004

“While we began to make inroads into the testosterone replacement market, Striant’s growth was slower than anticipated. We are encouraged by the positive reception to Striant’s proven efficacy and favorable side effect profile, and the recent broadening of the prescribing physician base beyond the higher-prescribing early adopters. We maintain our conviction that Striant offers significant benefits over other testosterone replacement therapies and should gain traction in the market over the coming months as these physicians and their patients increase their familiarity and comfort with Striant.”

“To support our sales objectives, we recently implemented complementary programs, including a toll-free Striant patient support hotline that connects new Striant patients with healthcare professionals at Columbia Laboratories. We initiated locally-oriented speaker programs where local physicians communicate their positive experiences and comfort with Striant directly to other area physicians, and we maintained our voucher program for Striant with key physicians as well.” Wilkinson concluded, “We continue to evaluate new options to maximize the commercial potential of our products, and will persist in judiciously allocating our resources where we believe they will most effectively build shareholder value and contribute to the Company’s future growth”

Financial Overview

For the second quarter of 2004, the Company reported a loss of $6,603,280, or $0.16 per basic and diluted share, on sales of $4,663,958, as compared to a loss of $4,366,608, or $0.12 per basic and diluted share, on sales of $4,919,800 in the second quarter of 2003. This includes a one time charge of $577,917, or $0.01 per share, for the sale of Columbia’s OTC products; without this charge, the net loss per share would have been $0.15 for the second quarter of 2004, an improvement of $0.01 per share from the net loss of $0.16 per share in the first quarter of 2004.

Net sales for the second quarter of 2004 decreased 5.2% over second quarter of 2003 to $4.7 million, primarily due to reduced sales to wholesalers and chain drugstores in the current year period for the Company’s women’s healthcare products, offset by modest reorders from some customers for Striant during the quarter. Net sales increased $124,279, or 3%, from the first quarter of 2004.

Gross profit as a percentage of net sales increased to 61% in the second quarter of 2004 versus 57% in 2003. This reflects the addition of Striant, which was introduced in the third quarter of 2003 and which has higher margins than the Company’s women’s healthcare products, to the product sales mix. The gross profit margin in the first quarter of 2004 was 63%.

“Through our diligent management of resources, we reduced operating expenses by $247,178, or 3%, from first quarter levels,” noted David Weinberg, Chief Financial Officer of Columbia Laboratories. “We achieved this by reducing general and administrative costs by $72,755 and research and development costs by $176,759 from first quarter levels, while maintaining our level of spending on selling and distribution. We will continue to focus on conserving capital while simultaneously advancing our strategic initiatives to drive future growth.”

Selling and distribution expenses were $4.9 million in the second quarter, a 6.5% increase over the second quarter of 2003, reflecting increased sales force costs for promotion of the Company’s products in the U.S. and including the growth of the sales force from approximately 50 persons in the second quarter of 2003 to approximately 80 persons in the second quarter of 2004. Increased sales force costs were partially offset by decreased product marketing expenses, which were higher in the 2003 quarter due to preparation of materials to support the launch of Prochieve 4% and Striant.

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Columbia Laboratories Reports Second Quarter 2004 Financial Results
August 4, 2004

General and administration costs increased 19.5% from second quarter 2003 levels to $1.9 million due to increases in insurance premiums, non-legal professional fees and salary expense including the hiring of additional administrative personnel subsequent to the second quarter of 2003.

Research and development costs were $1.4 million, a 118.5% increase over second quarter 2003, predominantly reflecting costs related to the ongoing PROTERM™ (PROgesterone Gel for Reducing PreTERM Labor and Delivery) study. This Phase III, randomized, double-blind, placebo-controlled, multicenter study is evaluating the efficacy, safety and tolerability of Prochieve 8% in preventing preterm birth in pregnant women who have either a history of a spontaneous preterm delivery, or have a cervical length of 2.5 cm or less. Patient enrollment in this study is ongoing at twelve centers in the U.S., and five additional centers are expected to begin enrolling patients in the third quarter of 2004. To date the enrollment rate has been on par with rates seen in other national trials in this patient population, including the Maternal Fetal Medicine Network trial. The Company continues to expect completion of this study in the initial 12–18 month time frame. Positive results from the PROTERM study would support a potential label extension for Prochieve 8%, positioning Columbia to address this sizeable market in which there is significant unmet clinical need. The March of Dimes estimates that one in ten singleton babies born in the U.S. are born prematurely. Women interested in participating in the PROTERM study should visit www.centerwatch.com/proterm for additional information.

For the six-month period ended June 30, 2004, the net loss was $12,858,109 or $0.32 per share on sales of $9,203,637 as compared to a net loss of $9,070,678 or $0.26 per share on sales of $8,525,346 in the six months ended June 30, 2003. Without the one time charge of $577,917, or $0.01 per share, from the sale of Columbia’s OTC products, the net loss per share would have been $0.31 for the six months ended June 30, 2004.

Columbia had cash and cash equivalents of $29.8 million at June 30, 2004, which includes $6.4 million from the sale of Common Stock to SJ Strategic Investments LLC.

Quarterly Conference Call

As previously announced, Columbia Laboratories will hold a conference call on August 4, 2004 at 8:30 AM EDT to review financial results of the second quarter and six months ended June 30, 2004.

Access information   
Date:           Wednesday August 4, 2004 
Time:           8:30 AM EDT 
U.S./Canada dial-in number:              877-407-8031 
International dial-in number:           201-689-8031 
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 11, 2004 at 11:59 PM ET at 877-660-6853 (U.S.) and 201-612-7415 (International). The conference account number is 1628, and the ID number is 111036.

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Columbia Laboratories Reports Second Quarter 2004 Financial Results
August 4, 2004

The webcast will be available for on-demand listening for one year on Columbia Laboratories Web site, www.columbialabs.com.

About Columbia Laboratories

Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women’s health care and endocrinology products, including those intended to treat infertility, dysmenorrhea, endometriosis and hormonal deficiencies. Columbia markets Striant® (testosterone buccal system) for treatment of hypogonadism in men, Prochieve® 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency, and Prochieve® 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company has developed a buccal delivery system for peptides. Columbia’s products primarily utilize the Company’s Bioadhesive Delivery System (BDS) technology. For more information, please visit www.columbialabs.com.

This press release contains statements that constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements include statements regarding the intent, belief or current expectations of Columbia 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. Such risks and uncertainties include, among other things, the success of the restructured sales force, success in obtaining approval of Striant™ SR in European countries through the Mutual Recognition Procedure, the successful marketing of Striant®, Prochieve® 8% and Prochieve® 4% in the US; successful marketing of Striant™ SR by Ardana Bioscience, Ltd. in the U.K.; successful marketing of Columbia’s former portfolio of OTC products by Lil’ Drug Store Products, Inc; the impact of competitive products and pricing; the timely and successful development of products; timely and successful completion of clinical studies; successful enrollment of subjects in, and the outcome of, the PROTERM™ study; success in obtaining acceptance and approval of new products by the FDA and international regulatory agencies; successful partnering of the desmopressin buccal candidate; and 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.

Striant® and Prochieve® are registered trademarks and PROTERM™ is a trademark of Columbia Laboratories, Inc.

(Tables follow)

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Columbia Laboratories Reports Second Quarter 2004 Financial Results August 4, 2004

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

  June 30,
2004
  December 31,
2003
 
 

 
ASSETS  (unaudited)      
           Current assets-         
                     Cash and cash equivalents  $  29,755,399        $  30,965,517  
                     Accounts receivable, net    3,482,651     4,780,921  
                     Inventories    3,574,149     2,469,224  
                     Prepaid expenses and other current assets    808,790     2,240,920  
 

 
                               Total current assets    37,620,989     40,456,582  
           Property and equipment, net    941,037     961,995  
           Intangible assets, net        920,418  
           Other assets    160,914     140,654  
 

 
                             TOTAL ASSETS  $  38,722,940   $  42,479,649  
 

 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)         
           Current liabilities-         
                     Note payable  $  10,000,000   $   
                     Current portion of financing agreements    3,003,454     1,228,865  
                     Accounts payable    2,481,161     2,806,236  
                     Accrued expenses    1,114,658     2,731,692  
 

 
                               Total current liabilities    16,599,273     6,766,793  
           Note payable—long-term        10,000,000  
           Deferred revenue    4,528,846     3,879,618  
           Long-term portion of financing agreements    17,829,857     15,746,695  
 

 
                                 TOTAL LIABILITIES    38,957,976     36,393,106  
 

 
 
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 2004 and 2003    1     1  
                     Series C Convertible Preferred Stock, 3,250 shares issued and    32      
                             outstanding in 2004 and 2003        32  
           Common stock, $0.01 par value; 100,000,000 authorized         
                     41,751,934 and 39,679,381 shares issued and outstanding in         
                     2004 and 2003, respectively    417,519     396,794  
           Capital in excess of par value    168,679,158     162,146,561  
           Accumulated deficit    (169,506,323 )    (156,648,214 ) 
           Accumulated other comprehensive income    174,577     191,369  
 

 
                       TOTAL STOCKHOLDERS’ EQUITY (DEFICIENCY)    (235,036 )    6,086,543  
 

 
                       TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY         
                             (DEFICIENCY)  $  38,722,940   $  42,479,649  
 

 

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Columbia Laboratories Reports Second Quarter 2004 Financial Results
August 4, 2004

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)

  Six months ended   Three months ended  
  June 30,    June 30,  
 
 
 
  2004   2003   2004   2003  
 
 
 
 
 
NET SALES  $ 9,203,637        $ 8,525,346        $ 4,663,958        $ 4,919,800  
COST OF GOODS SOLD  3,502,871   3,814,715   1,817,675   2,137,367  
 
 
 
 
 
     Gross profit (loss)  5,700,766   4,710,631   2,846,283   2,782,433  
 
OPERATING EXPENSES:         
     Selling and distribution  9,748,148   8,541,471   4,875,242   4,578,865  
     General and administrative  3,782,737   2,980,288   1,854,991   1,552,472  
     Research and development  3,056,663   1,589,998   1,439,952   658,887  
 
 
 
 
 
Total operating expenses  16,587,548   13,111,757   8,170,185   6,790,224  
 
 
 
 
 
 
           Loss From Operations  (10,866,782 )  (8,401,126 )  (5,323,902 )  (4,007,791 ) 
 
 
 
 
 
OTHER INCOME (EXPENSE):         
     Interest income  118,976   11,448   59,007   2,459  
     Interest expense  (1,435,536 )  (725,215 )  (751,355 )  (355,532 ) 
     Loss on sale of intangible assets  (577,917 )    (577,917 )   
     Other, net  (76,850 )  44,215   (9,113 )  (5,744 ) 
 
 
 
 
 
  (1,971,327 )  (669,552 )  (1,279,378 )  (358,817 ) 
 
 
 
 
 
 
           Net loss  $ (12,858,109 )  $ (9,070,678 )  $ (6,603,280 )  $ (4,366,608 ) 
 
 
 
 
 
 
NET LOSS PER COMMON SHARE:         
     (Basic and diluted)  $ (0.32 )  $ (0.26 )  $ (0.16 )  $ (0.12 ) 
 
 
 
 
 
 
WEIGHTED AVERAGE NUMBER OF                 
COMMON SHARES OUTSHANDING:         
     (Basic and diluted)  40,207,797   35,619,030   40,675,011   35,782,522  
 
 
 
 
 

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