-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DhWh9ekyF9nd/Tjsc4G/MdHQkndjOV6hr4txb4QI0oHg8US6iRSlyeZTpTBdrz8l FZ8PAg5vGCHoeKTwpUgQ1A== 0000821995-10-000079.txt : 20101104 0000821995-10-000079.hdr.sgml : 20101104 20101104101710 ACCESSION NUMBER: 0000821995-10-000079 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101104 DATE AS OF CHANGE: 20101104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COLUMBIA LABORATORIES INC CENTRAL INDEX KEY: 0000821995 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592758596 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-10352 FILM NUMBER: 101163548 BUSINESS ADDRESS: STREET 1: 354 EISENHOWER PARKWAY CITY: LIVINGSTON STATE: NJ ZIP: 07039 BUSINESS PHONE: 9739943999 MAIL ADDRESS: STREET 1: 354 EISENHOWER PARKWAY CITY: LIVINGSTON STATE: NJ ZIP: 07039 8-K 1 form8k.htm form8k.htm


UNITED STATES
 
SECURITIES AND EXCHANGE COMMISSION
 
WASHINGTON, D.C.  20549
 

 

 

 
FORM 8-K
 

 

 

 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of report (Date of earliest event reported) November 4, 2010
 

 
                                            COLUMBIA LABORATORIES, INC.                                               &# 160;                                     
 
(Exact name of registrant as specified in its charter)
 
Commission File No.  1-10352
 
Delaware
 
59-2758596
(State of Incorporation)
 
(I.R.S. Employer
Identification No.)
     
354 Eisenhower Parkway
Livingston, New Jersey
 
 
07039
(Address of principal
executive offices)
 
Zip Code
     
Registrant’s telephone number, including area code:  (973) 994-3999
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
 

 


 
Item 2.02
Results of Operations and Financial Condition
 
On November 4, 2010, Columbia Laboratories, Inc. (the “Company”), issued a press release entitled, “Columbia Laboratories Reports Third Quarter 2010 Financial Results” (the “Press Release”). A copy of the Press Release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
 
The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in this Current Report shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended.
 

Item 9.01                      Financial Statements and Exhibits
 
 (d)
Exhibits. 
 
 
99.1*
Press Release dated November 4, 2010, entitled “Columbia Laboratories Reports Third Quarter 2010 Financial Results.”
 
*  The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in this Current Report shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended.
 

 
 

 

 
SIGNATURE
 

 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date:  November 4, 2010
 

 
COLUMBIA LABORATORIES, INC.
 
By: /S/ Lawrence A. Gyenes
Lawrence A. Gyenes
Senior Vice President, Chief Financial Officer
& Treasurer

 
 

 

Exhibit Index
 
Exhibit No.
Description
99.1*
Press Release dated November 4, 2010, entitled “Columbia Laboratories Reports Third Quarter 2010 Financial Results.”
*  The information contained in this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 18. Furthermore, the information contained in this Current Report shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended.

 
 

 

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 letterhead  
COLUMBIA LABORATORIES REPORTS
THIRD QUARTER 2010 FINANCIAL RESULTS

Management will host Conference Call at 11:00 AM ET Today
LIVINGSTON, NJ — November 4, 2010 — Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced financial results for the three- and nine-month periods ended September 30, 2010.  Third quarter results are not typical of past or future quarters due to the accounting for the sale of the Company’s progesterone related assets to Watson Pharmaceuticals, the concurrent elimination of all Company debt effective July 2, 2010, and certain one-time expenses.  Key financial results for the quarter and subsequent events include:
 
  • Total net revenues increased 79% to $14.2 million in the third quarter of 2010 compared to $7.9 million in the third quarter of 2009, driven primarily by $8.5 million in revenue related to the gain on the sale of the progesterone assets to Watson.  A total of $34 million in deferred gains are being amortized at the rate of $8.5 million over four quarters, representing the estimated remaining development period for the potential preterm birth indication.
  • Total net product revenues were $5.1 million in the third quarter of 2010 compared with $7.8 million in the third quarter of 2009, primarily as a result of the transfer, on July 2, 2010, of the CRINONE®/PROCHIEVE® (progesterone gel)  assets, including responsibility for future product sales in the U.S., to Watson.
  • In late October, the last infant was born from the PREGNANT Study of PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy.  The Company expects to report study results in December 2010.
  • Cash and cash equivalents stood at $22.4 million as of September 30, 2010. This compares to cash and cash equivalents of $14.8 million at December 31, 2009.
 
“Closing the Watson Transactions in early July greatly improved Columbia's future profit outlook,” said Frank C. Condella, Jr., Columbia’s president and chief executive officer.  “With the transfer of the progesterone assets to Watson completed and their larger sales force now trained, we look forward to CRINONE’s continued growth in the infertility market as we prepare for the opportunity that hopefully awaits us in preterm birth.
 
“Our focus now is the completion of the PREGNANT Study.  We eagerly anticipate reporting top-line results of this pivotal Phase III clinical trial next month.  Strong positive data could trigger a $6 or $8 million milestone payment from Watson and pave the way for us to file an NDA in the first half of 2011,” concluded Condella.
 
Third Quarter Financial Results
Total net revenues were $14.2 million in the third quarter of 2010 compared to $7.9 million in the third quarter of 2009. The significant increase in net revenues was driven primarily by $8.5 million in revenue related to the gain on the sale of the progesterone assets to Watson.
 
Net product revenues were $5.1 million in the third quarter of 2010 compared with $7.8 million in the third quarter of 2009, primarily as a result of the transfer on July 2, 2010, of the CRINONE/PROCHIEVE assets, including responsibility for future product sales in the U.S., to Watson. Other factors affecting net product revenues were an 8% decrease in net revenues from Merck Serono for international sales of CRINONE 8% due to seasonal ordering patterns, partially offset by higher sales of Replens® and RepHresh® OTC products to Lil’ Drug Store Products, Inc. (“Lil' Drug Store”) and product sold to Watson under the new supply agreement.  Royalties on sales by Watson were approximately $0.5 million.
 
Gross profit margin increased from 68% in the third quarter of 2009 to 79% in the third quarter of 2010, reflecting the deferred gain on the sale of the progesterone assets to Watson.  Excluding the deferred gain recognition, the gross profit margin for the third quarter would have been 48%, reflecting primarily the lower-margin OTC product sales to Lil' Drug Store as well as product sales to Watson.
 
  • Total operating expenses were $10.3 million in the third quarter of 2010, an 18% increase compared to $8.8 million in the prior year period due to an unusual number of one-time expenses.
  • Selling and distribution expenses increased to $3.9 million in the third quarter of 2010 compared to $3.1 million in the third quarter of 2009, primarily due to a reserve of $2.2 million for the back royalties which may be owed to Bio-Mimetics, Inc. if the ongoing dispute is not resolved in Columbia’s favor.  The remaining expense is primarily related to severance, accelerated vesting of stock options, contract wind-down costs as a result of the sale to Watson and a modest spend in support of STRIANT® (testosterone buccal system) offset, in part, by reduced sales and marketing costs following Watson’s assumption of those responsibilities in July 2010.
  • General and administrative costs increased to $4.3 million in the third quarter of 2010 compared to $2.1 million in the same period a year ago, due to $1.7 million in Watson transaction-related costs and the cost associated with accelerated vesting of stock options.
  • Research and development costs decreased to $2.0 million in the third quarter of 2010 compared to $2.3 million in the third quarter of 2009, driven by lower costs of the PREGNANT Study, which is expected to be completed in the fourth quarter of 2010.
  • Last year, the Company amortized $1.3 million of the acquisition cost for the U.S. license rights to CRINONE, which it acquired from Merck Serono in December 2006. The asset was sold to Watson on July 2, 2010.
Other income and expense for the third quarter of 2010 was a net expense of $0.6 million versus a net expense of $2.4 million in the third quarter of 2009, reflecting primarily the elimination of $2.3 million in interest expense upon retirement of the Company’s debt on July 2, 2010. The third quarter of 2010 other income and expense reflects the non-cash loss on the extinguishment of the Company’s debt, partially offset by the reversal of the fair value of the embedded derivative as of the previous quarter end.
 
As a result, the Company reported net income of $0.3 million for the third quarter of 2010 as compared to a net loss of $5.9 million for the third quarter of 2009.
 

 
 
 

 
 
As of September 30, 2010, Columbia had cash and cash equivalents of $22.4 million. This compares to cash and cash equivalents of $14.8 million at December 31, 2009. The increase in cash primarily reflects the $62.0 million in proceeds from the Watson Transactions, partially offset by $42.2 million of cash used to retire the Company’s debt, $3.0 million used to repurchase 3.3 million shares of the Company’s common stock, transaction costs of $4.2 million, severance of $1.0 million, cash interest expense of $2.4 million, and net cash used in operating activities during this period of $1.6 million.
 
Financial Outlook
The closing of the Watson Transactions significantly strengthened the Company’s balance sheet.  The Company expects the cash balance at December 31, 2010, will be in excess of $20.0 million.  Under the agreement with Watson, the Company is committed to spend up to $7.0 million (beginning January 1, 2010) to complete the PREGNANT Study and file the NDA; through September 30, 2010, approximately $4.4 million had been spent.  Regardless of the study outcome, the Company expects to be at least cash flow neutral in 2011. With a successful PREGNANT Study, however, the Company expects to move to sustained profitability and to begin to realize the benefits of tax-sheltered income through its significant net operating loss carryforwards.
 
Quarterly Conference Call
As previously announced, Columbia will hold a conference call to discuss financial results for the third quarter of 2010 on November 4, 2010.  Investors and other interested parties may access the conference call as follows:

    Date:
Thursday, November 4, 2010
    Time:
11:00am ET
    Dial-in numbers:
(877) 303-9483 (U.S. & Canada) or (760) 666-3584
    Live webcast:
www.columbialabs.com, under the "Events" tab
 
 
The teleconference replay will be available two hours after completion through Thursday, November 11, 2010, at (800) 642-1687 (U.S. & Canada) or (706) 645-9291. The conference ID for the replay is 16372909. The archived webcast will be available for one year on the Company’s investor website, www.columbialabs.com, under "Events."
 
About Columbia Laboratories
Columbia Laboratories, Inc. is focused on developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company's strategy is to fund new development projects through proof of concept, then partner for later-stage clinical development and commercialization. CRINONE® 8% (progesterone gel) is marketed by Watson Pharmaceuticals in the United States and by Merck Serono in foreign countries.

Columbia is conducting a randomized, double-blind, placebo controlled Phase III clinical program, called the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study, to evaluate the safety and efficacy of PROCHIEVE® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo. The Company expects to report top line study results in December 2010.

Columbia's press releases and other company information are available online at columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to 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 l imited to, the following: the successful marketing of CRINONE®/PROCHIEVE® by Watson Pharmaceuticals, Inc., in the United States; the successful marketing of CRINONE by Merck Serono outside the United States; the timely and successful completion of the ongoing Phase III 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; successful development of a next-generation vaginal progesterone product; success in obtaining acceptance and approval of new products and new indications for current products by the United States Food and Drug Administration and international regulatory agencies; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies, particularly the euro; 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 SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.

STRIANT® is a registered trademark of Columbia Laboratories, Inc.
 
CRINONE® and PROCHIEVE® are registered trademarks of Watson Pharmaceuticals, Inc.
 
RepHresh® and Replens® are registered trademarks of Lil’ Drug Store Products, Inc.
 
Contact
Lawrence A. Gyenes
Seth Lewis
Senior Vice President, Chief Financial Officer & Treasurer
Vice President
Columbia Laboratories, Inc.
The Trout Group LLC
(973) 486-8860
(646) 378-2952
 
 

 
Financial Tables Follow
 






 
 

 

COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
             
   
Nine Months Ended
September 30,
   
Three Months Ended
September 30,
 
   
2010
   
2009
   
2010
   
2009
 
REVENUES
                       
Net product revenues
  $ 21,702,045     $ 23,318,938     $ 5,117,378     $ 7,807,945  
Royalties
    544,349       256,683       540,380       75,713  
Other revenues
    8,537,003       72,227       8,503,655       19,299  
Total net revenues
    30,783,397       23,647,848       14,161,413       7,902,957  
COST OF PRODUCT REVENUES
    6,232,062       6,680,929       2,969,827       2,561,560  
Gross profit
    24,551,335       16,966,919       11,191,586       5,341,397  
OPERATING EXPENSES:
                               
Selling and distribution
    9,882,039       8,999,177       3,925,408       3,096,810  
General and administrative
    12,451,067       7,708,514       4,339,349       2,147,515  
Research and development
    6,609,318       6,206,028       2,034,183       2,258,656  
Amortization of licensing right
    2,522,364       3,783,546       -       1,261,182  
Total operating expenses
    31,464,788       26,697,265       10,298,940       8,764,163  
(Loss) income from operations
    (6,913,453 )     (9,730,346 )     892,646       (3,422,766 )
OTHER INCOME (EXPENSE):
                               
Interest income
    24,625       33,801       22,416       5,057  
Interest expense
    (4,832,641 )     (6,488,859 )     (12,549 )     (2,283,524 )
Change in fair value of derivative
    -       -       4,829,036       -  
Loss on debt extinguishment
    (5,156,775 )     -       (5,156,775 )     -  
Change in fair value of redeemable warrants
    (133,128 )     -       (133,128 )     -  
Other, net
    (201,684 )     (225,156 )     (184,024 )     (152,029 )
Total other expenses
    (10,299,603 )     (6,680,214 )     (635,024 )     (2,430,496 )
(Loss) income before taxes
    (17,213,056 )     (16,410,560 )     257,622       (5,853,262 )
State income taxes
    (2,200 )     (16,930 )     -       -  
NET (LOSS) INCOME
  $ (17,215,256 )   $ (16,427,490 )   $ 257,622     $ (5,853,262 )
                                 
NET (LOSS) INCOME PER COMMON SHARE:
                               
Basic & diluted
  $ (0.24 )   $ (0.30 )   $ 0.00     $ (0.11 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
                               
Basic & diluted
    70,987,668       54,397,545       82,010,063       54,455,731  


 
 

 

 COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
   
September 30,
   
December 31,
 
   
2010
   
2009
 
   
(Unaudited)
       
ASSETS
           
Current Assets:
           
Cash and cash equivalents of which $8,240,760 in 2010 and
$12,225,732 in 2009 is interest bearing
  $ 22,434,558     $ 14,757,615  
Accounts receivable, net of allowances for doubtful accounts
of $100,000 in 2010 and 2009, respectively
    2,447,988       4,262,851  
Inventories
    2,766,766       2,532,722  
Prepaid expenses and other current assets
    218,169       1,097,525  
Total current assets
    27,867,481       22,650,713  
Property and equipment, net
    564,925       691,479  
Intangible assets, net
    -       18,770,332  
Other assets
    483,883       1,644,695  
TOTAL ASSETS
  $ 28,916,289     $ 43,757,219  
                 
LIABILITIES AND SHAREHOLDERS' DEFICIT
               
Current Liabilities:
               
Current portion of financing agreements
  $ -     $ 144,897  
Accounts payable
    1,944,315       3,662,091  
Accrued expenses
    6,963,451       4,588,088  
Redeemable warrants
    5,643,021       -  
Total current liabilities
    14,550,787       8,395,076  
Notes payable
    -       32,965,863  
Long-term portion of financing agreements
    -       15,234,406  
Deferred revenue
    25,835,106       328,367  
TOTAL LIABILITIES
    40,385,893       56,923,712  
                 
COMMITMENTS AND CONTINGENCIES
               
Contingently Redeemable Series C Preferred Stock,
 600 shares issued and outstanding in 2010 and 2009, respectively   (liquidation preference of $600,000)
    600,000       600,000  
                 
SHAREHOLDERS' DEFICIT:
               
Preferred stock, $.01 par value;1,000,000 shares authorized
               
Series B Convertible Preferred Stock, 130 shares issued and
outstanding (liquidation preference of $13,000)
    1       1  
Series E Convertible Preferred Stock, 59,000 shares issued and
outstanding (liquidation preference of $5,900,000)
    590       590  
Common Stock $.01 par value; 100,000,000 shares
authorized; 84,434,611 and 65,761,986 shares issued in 2010 and 2009, respectively
    844,345       657,619  
Capital in excess of par value
    264,496,821       242,637,646  
Less cost of 3,521,499 and 131,935 treasury shares in
2010 and 2009, respectively
    (3,403,090 )     (280,813 )
Accumulated deficit
    (274,194,519 )     (256,979,263 )
Accumulated other comprehensive income
    186,248       197,727  
Shareholders' deficit
    (12,069,604 )     (13,766,493 )
TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIT
  $ 28,916,289     $ 43,757,219  

 
 

 

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