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Management Will Host Investor Conference Call at 11:00 AM ET Today
LIVINGSTON, N.J.--(Business Wire)--
Columbia Laboratories, Inc. (Nasdaq: CBRX) today reported financial results for
the three- and nine-month periods ended September 30, 2009.
Highlights for the quarter and subsequent events included:
* Total progesterone sales increased 11% and domestic sales of CRINONE® 8%
(progesterone gel) also rose 11% versus the immediately preceding quarter.
* Net revenues were $7.9 million as compared to $11.1 million for the third
quarter of 2008. The 2008 period included a one-time recognition of $2.9 million
of previously deferred revenues relating to the termination of the STRIANT®
(testosterone buccal system) license for Europe due to the bankruptcy of the
Company`s licensee; without those revenues, net revenues for the 2009 third
quarter decreased 4% from 2008 levels.
* PREGNANT Study enrollment continues to rise with six sites added in the third
quarter and an additional 11 sites thus far in the fourth quarter, bringing the
total number of sites to 51. The Company confirmed its plan to file with the FDA
for PROCHIEVE® 8% (progesterone gel) in the short cervix population near
year-end 2010, assuming positive data.
* Four presentations of new data supporting the use of CRINONE® 8% over other
progesterone formulations were given at the annual meeting of the American
Society of Reproductive Medicine, heightening the peer-to-peer dialogue among
the Company`s infertility targets. Of particular note was the Brigham and
Women`s Hospital presentation of the results of the largest prospective,
randomized clinical study demonstrating that CRINONE is equally effective and
significantly better tolerated than intramuscular injections of progesterone for
luteal phase support in In Vitro Fertilization and Embryo Transfer cycles.
* On October 28, 2009, Columbia strengthened its balance sheet with $10.7
million dollars in net proceeds raised through the sale of common stock and
warrants. These funds will enable the Company to complete the PREGNANT Study and
to develop next-generation progesterone products, both critical to delivering
long-term returns.
"CRINONE 8% revenues and prescriptions have grown quarter over quarter in 2009
despite the economic downturn and its lingering impact on decisions to proceed
with infertility treatments. We remain focused on growing this business by
emphasizing that CRINONE is clinically proven to be as effective as other
progesterones and widely preferred by patients for its once-daily convenience
and needle-free application," stated Robert S. Mills, Columbia`s president and
chief executive officer.
"Enrollment in the PREGNANT Study increased in the third quarter of 2009 with
the addition of six new clinical sites. We maintain our conviction that if study
outcomes are positive, we will file with the FDA for PROCHIEVE 8% in the short
cervix population near the end of 2010 and, assuming approval, pave the way for
significant long-term growth," Mills concluded.
Third Quarter Financial Results
Net revenues for the third quarter of 2009 were $7.9 million, compared to $11.1
million for the third quarter of 2008. The 2008 third quarter included $2.9
million in previously deferred revenues.
Total net revenues from Progesterone Products decreased 2% to $6.3 million in
the third quarter of 2009 as compared to $6.5 million in the third quarter of
2008. This reflects lower domestic sales of CRINONE® 8% and PROCHIEVE®,
partially offset by higher sales of CRINONE in foreign markets. Comparing the
three months ended September 30, 2009 with the same period in 2008:
* CRINONE net revenues from non-U.S. sales were 70% higher. The increase was
largely a result of a 7% increase in unit volumes in 2009 coupled with a $0.6
million decrease in the third quarter of 2008 foreign CRINONE revenues for
estimated sales price adjustments.
* Net revenues from domestic CRINONE sales decreased 17%, with unit volume
accounting for about 15% of the decrease. Total prescriptions for CRINONE for
the three months ended September 30, 2009 were 6% higher than for the same
period in 2008. This increase in prescriptions was achieved despite a major
economic downturn impacting patients` decisions to postpone or forego elective
infertility procedures that are not reimbursed in many major markets, including
states such as California.
* Net revenues for PROCHIEVE, which the Company is no longer promoting for
infertility, were $0.4 million lower than for the same period in 2008.
Net revenues from the Company`s Other Products were $1.6 million in the third
quarter of 2009. This compares to $4.7 million in the third quarter of 2008,
during which the Company recognized $2.9 million in previously deferred revenue
as a result of the termination of the STRIANT® license for Europe. Net revenues
for Replens® increased by $0.3 million while net revenues for RepHresh® and
STRIANT declined by $0.3 million and $0.2 million, respectively.
Gross profit was $5.3 million in the third quarter of 2009 compared to $8.3
million in the third quarter of 2008, primarily due to the acceleration of the
previously deferred revenue as a result of the termination of the STRIANT
license for Europe in 2008. Without the acceleration of the previously deferred
revenue, gross profit would have remained essentially the same.
Total operating expenses were $8.8 million in the third quarter of 2009 compared
to $8.3 million in the prior year period. The increase breaks down as follows:
* Selling and distribution expenses were $3.1 million in the third quarter of
2009, an 11% decrease from $3.5 million in 2008, reflecting primarily lower
marketing costs.
* General and administrative costs were $2.1 million in the third quarters of
both 2009 and 2008.
* Research and development costs increased to $2.3 million in the third quarter
of 2009 from $1.5 million in 2008, reflecting higher clinical trial expenses for
the PREGNANT Study due to increased patient enrollment levels.
* The Company amortized $1.3 million of the acquisition cost for the U.S.
license rights to CRINONE 8% in the third quarters of both 2009 and 2008.
Other income and expense for the third quarter of 2009 aggregated to a net
expense of $2.4 million versus a net expense of $2.0 million in the third
quarter of 2008.
As a result, the Company reported a net loss of $5.9 million, or $0.11 per basic
and diluted share, for the third quarter of 2009 as compared to a net loss of
$2.1 million, or $0.04 per basic and diluted share, for the third quarter of
2008.
Cash and Equivalents
As of September 30, 2009, Columbia had cash and cash equivalents of $7.3
million. This compares to cash and cash equivalents of $9.2 million at June 30,
2009 and $12.5 million at December 31, 2008. On October 28, 2009, the Company
raised $10.7 million in net proceeds from the sale of 10,900,000 shares of
common stock and warrants to purchase 5,450,000 shares of common stock in a
registered direct offering. With an exercise price of $1.52, the warrants have
the potential to generate an additional $8.3 million. Furthermore, this
transaction will enable the Company to complete the ongoing PREGNANT Study and
to develop its next-generation progesterone products whether or not it proceeds
with a partnership.
Quarterly Conference Call
As previously announced, Columbia Laboratories will discuss financial results of
the third quarter ended September 30, 2009, on a conference call as follows:
Date: Thursday, November 5, 2009
Time: 11:00 AM ET
Dial-in numbers: 888-515-0224 (U.S. & Canada) or 201-526-1837
Live webcast: www.cbrxir.com, under "Events"
The teleconference replay will be available two hours after completion through
Thursday, November 12, 2009, at 888-632-8973 (U.S. & Canada) or 201-499-0429.
The replay passcode is 41415078. 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`s U.S. sales organization markets CRINONE 8% (progesterone gel) in the
United States for progesterone supplementation as part of an Assisted
Reproductive Technology treatment for infertile women with progesterone
deficiency and 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 is conducting, in collaboration with the NIH, the PREGNANT
(PROCHIEVE Extending GestatioN A New Therapy) Study, a randomized, double blind,
placebo controlled 450-patient Phase III clinical trial evaluating the ability
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 the study is a
reduction in the incidence of preterm birth at less than or equal to 32 weeks
gestation vs. placebo.
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" 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 November 5, 2009, the date on
which they were 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) and STRIANT (testosterone buccal system) in the U.S.; the
successful marketing of CRINONE 8% by Merck Serono; the timely and successful
development of PROCHIEVE 8% to reduce the risk of preterm birth in women with a
short cervix in mid-pregnancy; the timely and successful completion of 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 the short cervix indication for PROCHIEVE 8% by the U.S. Food and
Drug Administration and international regulatory agencies; whether we elect to
exercise our right to extend the balance due on the PharmaBio royalty agreement
to 2011; our ability to obtain financing in order to fund our operations and
repay our debt as it comes due; the impact of competitive products and pricing;
the strength of the U.S. 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 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.
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Nine Months Ended Three Months Ended
September 30, September 30,
2009 2008 2009 2008
NET REVENUES $ 23,647,848 $ 29,177,914 $ 7,902,957 $ 11,117,358
COST OF REVENUES 6,680,929 8,769,496 2,561,560 2,859,590
Gross profit 16,966,919 20,408,418 5,341,397 8,257,768
OPERATING EXPENSES:
Selling and distribution 8,999,177 9,809,695 3,096,810 3,494,083
General and administrative 7,708,514 6,628,649 2,147,515 2,079,201
Research and development 6,206,028 5,051,949 2,258,656 1,510,186
Amortization of licensing right 3,783,546 3,783,546 1,261,182 1,261,182
Total operating expenses 26,697,265 25,273,839 8,764,163 8,344,652
Loss from operations (9,730,346 ) (4,865,421 ) (3,422,766 ) (86,884 )
OTHER INCOME (EXPENSES):
Interest income 33,801 249,496 5,057 58,836
Interest expense (6,275,439 ) (5,871,513 ) (2,070,104 ) (1,998,832 )
Other, net (438,576 ) (82,915 ) (365,449 ) 6,792
Total other expenses (6,680,214 ) (5,704,932 ) (2,430,496 ) (1,933,204 )
Loss before taxes (16,410,560 ) (10,570,353 ) (5,853,262 ) (2,020,088 )
State income taxes (16,930 ) (54,750 ) - (30,048 )
NET LOSS $ (16,427,490 ) $ (10,625,103 ) $ (5,853,262 ) $ (2,050,136 )
NET LOSS PER COMMON SHARE:
Basic and diluted $ (0.30 ) $ (0.20 ) $ (0.11 ) $ (0.04 )
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING:
Basic and diluted 54,397,545 52,073,900 54,455,731 52,613,653
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30 December 31
2009 2008
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents of which $4,228,668 and $ 7,331,577 $ 12,497,382
$12,099,318 is interest bearing
Accounts receivable, net of allowances for 3,228,851 3,562,277
doubtful accounts of $100,000 and $100,000
Inventories 2,312,211 2,377,139
Prepaid expenses and other current assets 386,475 1,102,525
Total current assets 13,259,114 19,539,323
Property and equipment, net 744,667 821,857
Intangible assets - net 20,031,514 23,815,060
Other assets 1,853,631 1,446,249
TOTAL ASSETS $ 35,888,926 $ 45,622,489
LIABILITIES AND SHAREHOLDERS' DEFICIT
Current Liabilities:
Current portion of financing agreements $ 134,526 $ 168,034
Accounts payable 2,482,689 2,085,463
Accrued expenses 4,855,400 4,980,643
Total current liabilities 7,472,615 7,234,140
Notes payable 32,207,556 30,074,966
Deferred revenue 267,298 305,433
Long-term portion of financing agreements 14,679,091 13,126,210
TOTAL LIABILITIES 54,626,560 50,740,749
COMMITMENTS AND CONTINGENCIES
Contingently Redeemable Series C Preferred Stock,
600 and 775 shares issued and outstanding in 2009 and 2008, respectively 600,000 775,000
(liquidation preference of $600,000 and $775,000)
SHAREHOLDERS' DEFICIT:
Preferred stock, $.01 par value; 1,000,000 shares authorized
Series B Convertible Preferred Stock, 130 shares issued and outstanding 1 1
(liquidation preference of $13,000)
Series E Convertible Preferred Stock, 59,000 shares issued and 590 590
outstanding (liquidation preference of $5,900,000)
Common Stock $.01 par value; 100,000,000 shares
authorized; 54,849,986 and 54,007,579 shares issued in 2009 and 2008, 548,499 540,076
respectively
Capital in excess of par value 231,726,951 228,686,942
Less cost of 131,935 and 63,644 treasury shares (280,813 ) (189,229 )
Accumulated deficit (251,537,195 ) (235,109,705 )
Accumulated other comprehensive income 204,333 178,065
Shareholders' deficit (19,337,634 ) (5,893,260 )
TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIT $ 35,888,926 $ 45,622,489
Columbia Laboratories, Inc.
Lawrence A. Gyenes, 973-486-8860
Senior Vice President, Chief Financial Officer & Treasurer
or
Rx Communications Group, LLC
Melody A. Carey, 917-322-2571
Co-President
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