Columbia labs (AMEX:COB)
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Columbia Laboratories Reports 2003 Third Quarter Financial Results
Company Provides Earnings Outlook for 2003 and 2004
LIVINGSTON, N.J., Nov. 12 /PRNewswire-FirstCall/ -- Columbia Laboratories, Inc.
today announced financial results for the third quarter and nine months ended
September 30, 2003. For the third quarter of 2003, the Company reported a loss
of $4,254,547, or $0.11 per share, on sales of $8,763,957, as compared to a net
loss of $1,879,189, or $0.05 per share, on sales of $4,040,534 in the third
quarter of 2002.
Third quarter 2003 sales reflect a 117% increase over third quarter 2002, as a
result of the introduction of Striant(TM) (testosterone buccal system) and
increased sales of products to marketing partners. They also reflect a 78%
increase in sales over second quarter 2003, as a result of the introduction of
Striant(TM) and increased sales of Prochieve(R) 8% (progesterone gel). Selling
and distribution expenses for the third quarter increased by 439% over third
quarter 2002 as a direct result of the costs of marketing, including those
associated with the Striant(TM) launch, and the costs of establishing and
significantly expanding a dedicated sales force to promote the Company's five
brands.
For the nine-month period ended September 30, 2003, the net loss was $13,325,225
or $0.37 per share on sales of $17,289,303, as compared to a net loss of
$10,115,630 or $0.30 per share on sales of $7,072,494 in the nine months ended
September 30, 2002. 2003 nine-month sales represent a 144% increase over the
same period in 2002.
As previously announced, during third quarter 2003, the Company raised $26
million through a private placement with a group of institutional investors and
ended the quarter with $34.9 million in cash.
"We are encouraged by the improvement made in our overall sales picture over the
past nine months, as well as the FDA approval and US distribution of
Striant(TM)," commented Fred Wilkinson, president, chief executive officer and
chairman. "We've proven that we can develop a commercially viable product, move
it through the regulatory process in a timely manner, and launch it into the
marketplace. We have also made significant strides in progressing our R & D
programs, highlighted by the initiation of a phase III study with Prochieve(R)
8% in reducing the risk of premature delivery. If this treatment proves to be
effective, it could help significantly to solve a major public health concern."
Outlook:
Columbia provides earnings estimates for the fourth quarter 2003 of a loss of
between $0.14 and $0.17 per share based on revised sales estimates of between
$5.0 and $7.1 million. For the year 2003, the Company estimates a loss of
between $0.50 and $0.54 per share. The lower sales estimates for fourth quarter
result from slower than anticipated uptake of Striant(TM), significantly lower
purchases of products by strategic partners, and continued delays in the trade
distribution of the Company's OTC product line.
For the year 2004, the Company now estimates sales of $45 to 65 million, which
is based in part upon very early prescription data for Striant(TM). As a result
of these revised sales estimates, the Company estimates earnings for 2004 of
between a loss of $0.15 per share and a profit of $0.09 per share for the year.
"Our new estimates reflect a slower than anticipated adoption cycle for our
products, as we are selling new brands as well as unique and novel delivery
systems," stated Wilkinson. "We now recognize that response to our promotional
efforts will take time. Additional areas for improvement as it relates to our
selling effort by our recently expanded sales force have been identified and we
are working closely with Innovex to put in place some aggressive productivity
enhancements. Based on our recent experience in the field and from continued
market research, we remain confident in both the value of our product line to
patients who can benefit from these therapies, as well as in opportunities for
increasing revenue from their use."
PROTERM Study:
In a separate press release, Columbia is announcing the initiation of the
PROTERM (PROgesterone Gel for Reducing PreTERM Labor and Delivery) Study, a
major phase III clinical trial designed to examine the safety and efficacy of
Prochieve(R) 8% in preventing preterm delivery in pregnant women at high risk.
The Company previously announced the successful completion of the formulation
optimization phase for the development of desmopressin in a buccal system.
"We are very pleased with the continuing progress from our focused research and
development programs as they will serve as the foundation for our next stage of
growth," stated Wilkinson. "The Company has met the milestones of initiating
the PROTERM Study, as well as our goals for the desmopressin buccal formulation.
Aggressive implementation of the PROTERM Study and out- licensing of
desmopressin are top priorities for our team."
About Columbia Laboratories
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company
dedicated to research and development of women's health care and endocrinology
products, including those intended to treat infertility, dysmenorrhea,
endometriosis and hormonal deficiencies. Columbia has introduced Striant(TM)
(testosterone buccal system) for treatment of hypogonadism in men. Columbia's
products primarily utilize the Company's patented Bioadhesive Delivery System
(BDS) technology. For more information, please visit
http://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 the company and its management team. Such statements include
estimates for the fourth quarter 2003, estimates for 2004, estimates based on
prescription trends for Striant(TM) early in the product launch, implementation
of the PROTERM Study, and out-licensing the desmopressin buccal system.
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 successful marketing of existing products, including Striant(TM)
(testosterone buccal system), Prochieve(R) 8% (progesterone gel), Prochieve(R)
4% (progesterone gel), RepHresh(R) Vaginal Gel, and Advantage-S(R) Contraceptive
Gel; timely and successful development of new products; timely and successful
completion of clinical studies; success in obtaining acceptance and approval of
new products by the FDA and international regulatory agencies; and competitive
economic and regulatory factors in the pharmaceutical and health care 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, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Nine Months Ended Three Months Ended
September 30, September 30,
2003 2002 2003 2002
NET SALES $17,289,303 $7,072,494 $8,763,957 $4,040,534
COST OF SALES 6,838,074 3,769,402 3,023,359 1,916,372
Gross profit 10,451,229 3,303,092 5,740,598 2,124,162
OPERATING EXPENSES:
Selling and
distribution 16,012,352 2,221,096 7,470,881 1,384,804
General and
administrative 4,471,313 3,507,664 1,491,025 1,232,148
Research and
development 2,198,883 3,457,346 608,885 1,139,717
Litigation settlement
expense -- 3,960,000 -- --
Product recall costs -- (449,489) -- --
Total operating
expenses 22,682,548 12,696,617 9,570,791 3,756,669
Loss from
operations (12,231,319) (9,393,525) (3,830,193) (1,632,507)
OTHER INCOME
(EXPENSE):
Interest income 65,836 33,814 54,388 12,125
Interest expense (1,242,750) (643,445) (517,535) (237,447)
Other, net 83,008 (112,474) 38,793 (21,360)
(1,093,906) (722,105) (424,354) (246,682)
Net loss $(13,325,225) $(10,115,630) $(4,254,547) $(1,879,189)
NET LOSS PER COMMON
SHARE - BASIC AND DILUTED $(0.37) $(0.30) $(0.11) $(0.05)
WEIGHTED AVERAGE
NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC AND DILUTED 36,689,369 34,034,284 38,795,145 35,087,980
Sept. 30, 2003 Dec. 31, 2002
(unaudited)
Balance Sheet Data:
Cash and cash
equivalents $34,877,241 $5,018,365
Working capital 35,096,029 4,717,320
Total assets 50,210,755 12,766,307
Convertible
subordinated note
payable 10,000,000 10,000,000
Stockholders' equity
(deficiency) 13,671,486 (8,394,943)
DATASOURCE: Columbia Laboratories, Inc.
CONTACT: James Apostolakis, Vice Chairman, +1-212-588-1900, or David
Weinberg, Chief Financial Officer, +1-973-994-3999, both of Columbia
Laboratories, Inc.; or Investors, Ritu Baral of The Trout Group,
+1-212-477-9007, ext., 25, for Columbia Laboratories, Inc.
Web site: http://www.columbialabs.com/